CN112179728A - Raw materials of quality control material of thrombelastogram instrument and manufacturing process thereof - Google Patents
Raw materials of quality control material of thrombelastogram instrument and manufacturing process thereof Download PDFInfo
- Publication number
- CN112179728A CN112179728A CN201910599132.3A CN201910599132A CN112179728A CN 112179728 A CN112179728 A CN 112179728A CN 201910599132 A CN201910599132 A CN 201910599132A CN 112179728 A CN112179728 A CN 112179728A
- Authority
- CN
- China
- Prior art keywords
- quality control
- parts
- weight
- sheep
- fibrinogen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000003908 quality control method Methods 0.000 title claims abstract description 122
- 239000000463 material Substances 0.000 title claims abstract description 88
- 239000002994 raw material Substances 0.000 title claims abstract description 57
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 13
- 241001494479 Pecora Species 0.000 claims abstract description 112
- 108010049003 Fibrinogen Proteins 0.000 claims abstract description 75
- 102000008946 Fibrinogen Human genes 0.000 claims abstract description 75
- 229940012952 fibrinogen Drugs 0.000 claims abstract description 75
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims abstract description 72
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 claims abstract description 72
- 239000012452 mother liquor Substances 0.000 claims abstract description 52
- 210000002966 serum Anatomy 0.000 claims abstract description 52
- GHXZTYHSJHQHIJ-UHFFFAOYSA-N Chlorhexidine Chemical compound C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 GHXZTYHSJHQHIJ-UHFFFAOYSA-N 0.000 claims abstract description 49
- 229960003260 chlorhexidine Drugs 0.000 claims abstract description 49
- 239000011787 zinc oxide Substances 0.000 claims abstract description 36
- HHLFWLYXYJOTON-UHFFFAOYSA-N glyoxylic acid Chemical compound OC(=O)C=O HHLFWLYXYJOTON-UHFFFAOYSA-N 0.000 claims abstract description 28
- 229940088594 vitamin Drugs 0.000 claims abstract description 12
- 239000011782 vitamin Substances 0.000 claims abstract description 12
- 229930003231 vitamin Natural products 0.000 claims abstract description 12
- 235000013343 vitamin Nutrition 0.000 claims abstract description 12
- 150000003722 vitamin derivatives Chemical class 0.000 claims abstract description 12
- YNUVAJRGRQBLLB-UHFFFAOYSA-N (5-methyl-2-propan-2-ylcyclohexyl) 2-oxoacetate Chemical compound CC(C)C1CCC(C)CC1OC(=O)C=O YNUVAJRGRQBLLB-UHFFFAOYSA-N 0.000 claims abstract description 8
- 230000002950 deficient Effects 0.000 claims abstract description 7
- 238000007710 freezing Methods 0.000 claims description 35
- 230000008014 freezing Effects 0.000 claims description 35
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 claims description 28
- 238000002156 mixing Methods 0.000 claims description 19
- 210000004369 blood Anatomy 0.000 claims description 18
- 239000008280 blood Substances 0.000 claims description 18
- 239000003146 anticoagulant agent Substances 0.000 claims description 16
- 229940127219 anticoagulant drug Drugs 0.000 claims description 16
- 239000000126 substance Substances 0.000 claims description 7
- 108010073385 Fibrin Proteins 0.000 claims description 6
- 102000009123 Fibrin Human genes 0.000 claims description 6
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 claims description 6
- 229950003499 fibrin Drugs 0.000 claims description 6
- 238000004108 freeze drying Methods 0.000 claims description 6
- 230000001105 regulatory effect Effects 0.000 claims description 6
- 238000010257 thawing Methods 0.000 claims description 6
- 238000004806 packaging method and process Methods 0.000 claims description 5
- 239000011550 stock solution Substances 0.000 claims description 4
- 230000000844 anti-bacterial effect Effects 0.000 abstract description 29
- 230000003385 bacteriostatic effect Effects 0.000 abstract description 7
- 230000007547 defect Effects 0.000 abstract description 3
- 210000002381 plasma Anatomy 0.000 description 70
- 238000001816 cooling Methods 0.000 description 31
- 239000004033 plastic Substances 0.000 description 30
- 238000004891 communication Methods 0.000 description 19
- 238000007789 sealing Methods 0.000 description 15
- 239000000523 sample Substances 0.000 description 14
- 238000000034 method Methods 0.000 description 11
- 230000004888 barrier function Effects 0.000 description 9
- 230000003750 conditioning effect Effects 0.000 description 9
- 239000012535 impurity Substances 0.000 description 9
- 230000001580 bacterial effect Effects 0.000 description 8
- 230000023555 blood coagulation Effects 0.000 description 8
- 230000015271 coagulation Effects 0.000 description 8
- 238000005345 coagulation Methods 0.000 description 8
- 239000000645 desinfectant Substances 0.000 description 8
- 230000008569 process Effects 0.000 description 8
- 238000001556 precipitation Methods 0.000 description 6
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 5
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 5
- 239000003114 blood coagulation factor Substances 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
- 241000192125 Firmicutes Species 0.000 description 4
- 241000233866 Fungi Species 0.000 description 4
- 241000700605 Viruses Species 0.000 description 4
- 229960002233 benzalkonium bromide Drugs 0.000 description 4
- KHSLHYAUZSPBIU-UHFFFAOYSA-M benzododecinium bromide Chemical compound [Br-].CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 KHSLHYAUZSPBIU-UHFFFAOYSA-M 0.000 description 4
- 239000003093 cationic surfactant Substances 0.000 description 4
- 238000001514 detection method Methods 0.000 description 4
- 230000002401 inhibitory effect Effects 0.000 description 4
- 239000001509 sodium citrate Substances 0.000 description 4
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 4
- 238000003860 storage Methods 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 3
- 239000012190 activator Substances 0.000 description 3
- 230000000903 blocking effect Effects 0.000 description 3
- 229940019700 blood coagulation factors Drugs 0.000 description 3
- 238000006073 displacement reaction Methods 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000020764 fibrinolysis Effects 0.000 description 3
- 230000003993 interaction Effects 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- 239000002985 plastic film Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 2
- 108010094028 Prothrombin Proteins 0.000 description 2
- 102100027378 Prothrombin Human genes 0.000 description 2
- 108010000499 Thromboplastin Proteins 0.000 description 2
- 102000002262 Thromboplastin Human genes 0.000 description 2
- 238000010523 cascade reaction Methods 0.000 description 2
- 238000005119 centrifugation Methods 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229960002897 heparin Drugs 0.000 description 2
- 229920000669 heparin Polymers 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 229940039716 prothrombin Drugs 0.000 description 2
- 239000005995 Aluminium silicate Substances 0.000 description 1
- 241000283707 Capra Species 0.000 description 1
- 239000003154 D dimer Substances 0.000 description 1
- AFSDNFLWKVMVRB-UHFFFAOYSA-N Ellagic acid Chemical compound OC1=C(O)C(OC2=O)=C3C4=C2C=C(O)C(O)=C4OC(=O)C3=C1 AFSDNFLWKVMVRB-UHFFFAOYSA-N 0.000 description 1
- ATJXMQHAMYVHRX-CPCISQLKSA-N Ellagic acid Natural products OC1=C(O)[C@H]2OC(=O)c3cc(O)c(O)c4OC(=O)C(=C1)[C@H]2c34 ATJXMQHAMYVHRX-CPCISQLKSA-N 0.000 description 1
- 229920002079 Ellagic acid Polymers 0.000 description 1
- -1 Kaolinitum Chemical compound 0.000 description 1
- 239000005909 Kieselgur Substances 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 206010051077 Post procedural haemorrhage Diseases 0.000 description 1
- 206010050902 Postoperative thrombosis Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 230000004520 agglutination Effects 0.000 description 1
- 235000012211 aluminium silicate Nutrition 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 238000007675 cardiac surgery Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 229960002852 ellagic acid Drugs 0.000 description 1
- 235000004132 ellagic acid Nutrition 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 108010052295 fibrin fragment D Proteins 0.000 description 1
- 239000003527 fibrinolytic agent Substances 0.000 description 1
- 230000003480 fibrinolytic effect Effects 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
- FAARLWTXUUQFSN-UHFFFAOYSA-N methylellagic acid Natural products O1C(=O)C2=CC(O)=C(O)C3=C2C2=C1C(OC)=C(O)C=C2C(=O)O3 FAARLWTXUUQFSN-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 150000003904 phospholipids Chemical class 0.000 description 1
- 238000001959 radiotherapy Methods 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
Images
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/42—Low-temperature sample treatment, e.g. cryofixation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Pathology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- General Physics & Mathematics (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The raw materials of a quality control material of a thromboelastogram instrument and a manufacturing process thereof comprise a raw material of a quality control material 1 and a raw material of a quality control material 2, wherein the raw material of the quality control material 1 comprises: factor-rich sheep plasma, sheep serum, a vitamin stock mother liquor, chlorohexidine, isopropanol, nano zinc oxide and glyoxylic acid menthyl ester in parts by weight; the quality control product 2 comprises the following raw materials: factor-deficient sheep plasma, sheep serum, fibrinogen mother liquor, chlorohexidine, isopropanol, nano zinc oxide and menthyl glyoxylate. The manufacturing process is combined, so that the defects that the quality control product 1 and the quality control product 2 prepared in the prior art are insufficient in antibacterial and bacteriostatic properties and the stability of the quality control product 1 and the quality control product 2 is insufficient are effectively overcome.
Description
Technical Field
The invention relates to the technical field of elastogram instrument quality control materials, in particular to a raw material of a quality control material of a thromboelastogram instrument and a manufacturing process thereof.
Background
The thromboelastogram apparatus reproduces the coagulation process in the human body to the maximum extent through a methodology principle of simulating the environment in the human body in vitro, and evaluates the interaction result of all coagulation factors in blood in the coagulation process, so that the coagulation holomorphy under the combined action of the coagulation factors, fibrinogen, platelets and a fibrinolytic system is qualitatively and semi-quantitatively analyzed. By measuring various parameters in the blood coagulation process, the blood coagulation process of the patient is more comprehensively shown.
In the blood coagulation detection method, as long as the blood coagulation factor cascade reaction is involved in the detection principle, the corresponding detection reagent mainly contains a specific activator and exogenous phospholipid serving as a platelet factor III substitute. The activator comprises Kaolin, Kaolinitum, diatomaceous earth, ellagic acid, silica, tissue factor, etc. When the activator comes into contact with blood or plasma, it activates the corresponding intrinsic or extrinsic coagulation pathway.
The upper computer system comprises a first single chip microcomputer module, a nixie tube display module, an alarm module, a wireless communication module, a storage module and a key module, and is used for checking indexes such as Prothrombin Time (PT), partial prothrombin time (PTT) or D-Dimer and the like in a conventional laboratory, only checking one part of in-vitro plasma and coagulation cascade reaction, namely the condition of an internal or exogenous coagulation bypass or a fibrinolysis part, tracing the whole coagulation process in a fragment and part way, and the result is often influenced by heparin substances. The Thromboelastography (TEG) can completely monitor the whole process from blood coagulation to blood clot formation and fibrinolysis of a blood sample, and realizes the detection and evaluation of blood coagulation factors, fibrinogen, platelet aggregation function, fibrinolysis and other aspects of blood coagulation overall appearance. Because the monitoring time is short, the result can be realized within 15-20 minutes, and the result is not influenced by heparin substances, the method is widely applied to the condition monitoring of postoperative bleeding and/or thrombosis in the middle or later period of cardiac surgery, organ transplantation, tumor and radiotherapy.
The thromboelastogram sample is a whole blood sample of a patient, and the instrument adopts a coagulation method, namely a physiological blood coagulation condition is simulated, a certain reagent is added, blood agglutination reaction is started, fibrinogen in the sample is converted into cross-linked fibrin, and the sample is coagulated. The motor inside the instrument drives the sample cup carrying the blood sample to rotate at a certain angle (4 degrees and 45 minutes) and period (such as 10 seconds), once the sample is solidified, the metal probe arranged in the sample cup receives the shearing stress of the sample, and then the sample rotates left and right. The rotation of the metal probe is sensed by the non-contact angular rotation sensor, and the dynamic change of the measured sample can be automatically recorded by the software of the instrument, so that a recording map is generated.
The important parameters involved in the blood coagulation curves are the R-value, K-value, Angle-value, MA-value, which represent the following meanings:
the R value is a blood coagulation stage, and the time required for the curve amplitude to rise to 2mm is detected, and corresponds to the process that fibrin begins to form caused by the gradual activation of various blood coagulation factors;
the K value is the time required for the amplitude of the curve to rise from 2mm to 20mm, corresponding to the fibrin cross-linking and its interaction with platelets, and therefore K is used to assess the speed or kinetic characteristics of the clot strength reaching a certain level;
the Angle value is an included Angle between the maximum curve radian tangent and the level, reflects the interaction between fibrin and platelets together with the K value, and becomes an important substitute index when the K value of severe hypoprofusion of a patient cannot be measured;
the MA value is the maximum amplitude, corresponding to the maximum intensity of the clot, and the influencing factors are fibrinogen and platelets, wherein the effect of platelets is greater than the effect of fibrinogen.
The existing effective preparation method of the quality control material of the thromboelastogram instrument, namely the following manufacturing method of the quality control material 1 and the quality control material 2, comprises the following steps:
collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain plasma; collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain serum; dividing the plasma obtained in S1 into 3 portions, part 1, part 2 and part 3 respectively; centrifuging the part 1 to obtain lower plasma which is factor-rich sheep plasma, and adjusting R, K, Angle and MA values; adding barium sulfate into the part 2, mixing, centrifuging to obtain upper plasma which is factor-poor sheep plasma, and regulating R, K, Angle and MA values; freezing the part 3 at low temperature, and thawing until the whole part is thawed to obtain fibrinogen; adding the prepared fibrinogen into the goat serum prepared by S2 to obtain fibrinogen mother liquor, wherein the fibrinogen accounts for 5-20% by mass; uniformly mixing 2-6 parts by weight of the prepared factor-rich sheep plasma, 2-5 parts by weight of the prepared sheep serum and 1-4 parts by weight of the fibrinogen mother liquor prepared by S7, and adjusting the R value to 0-4min, the K value to 0-2min, the Angle value to 75-87deg and the MA value to 42-63mm to obtain a quality control product 1; uniformly mixing 1-4 parts by weight of the prepared factor-deficient sheep plasma, 5-10 parts by weight of sheep serum prepared by S2 and 0.3-2 parts by weight of fibrinogen mother liquor prepared by S7, and adjusting the R value to 1-5min, the K value to 0-6min, the Angle value to 60-80deg and the MA value to 25-41mm to obtain a quality control product 2; and subpackaging the obtained quality control product 1 and the obtained quality control product 2, and freeze-drying to obtain the quality control product. The anticoagulant is 3.8 wt% sodium citrate solution. The centrifugal rotating speeds are all 3000rpm/min, and the centrifugal time is all 10 minutes; the centrifugation speed is 3000rpm/min, and the centrifugation time is 30 minutes. The addition ratio of the plasma to the barium sulfate is as follows: 0.4 to 0.6 parts by weight of barium sulfate is added to 1 volume part of blood plasma. The freezing temperature is-60-80 ℃, the freezing time is 4-10h, and the unfreezing temperature is 2-8 ℃.
The quality control product 1 and the quality control product 2 prepared in the way have insufficient antibacterial and bacteriostatic properties in the specific use process, so that the stability of the quality control product 1 and the quality control product 2 is insufficient.
Disclosure of Invention
In order to solve the problems, the invention provides the raw materials of the quality control material of the thromboelastogram instrument and the manufacturing process thereof, and effectively overcomes the defects that the quality control material 1 and the quality control material 2 prepared in the prior art are insufficient in antibacterial and bacteriostatic properties and the stability of the quality control material 1 and the quality control material 2 is insufficient.
In order to overcome the defects in the prior art, the invention provides a solution for the raw materials of a quality control material of a thromboelastogram instrument and a manufacturing process thereof, which comprises the following specific steps:
the raw materials of a quality control material of a thromboelastogram instrument comprise a raw material of a quality control material 1 and a raw material of a quality control material 2, wherein the raw material of the quality control material 1 comprises:
factor-rich sheep plasma, sheep serum, a vitamin stock mother liquor, chlorohexidine, isopropanol, nano zinc oxide and glyoxylic acid menthyl ester in parts by weight;
the quality control product 2 comprises the following raw materials:
factor-deficient sheep plasma, sheep serum, fibrinogen mother liquor, chlorohexidine, isopropanol, nano zinc oxide and menthyl glyoxylate.
The fibrinogen mother liquor is prepared by dissolving fibrinogen in sheep serum, wherein the mass percentage of the fibrinogen in the fibrinogen mother liquor is 7% -15%.
The quality control product 1 comprises the following raw materials in parts by weight:
3 to 5 parts of factor-rich sheep plasma, 1 to 3 parts of sheep serum, 2 to 6 parts of vitamin stock solution, 0.2 to 0.4 part of chlorohexidine, 0.1 to 0.5 part of isopropanol, 0.2 to 0.4 part of nano zinc oxide and 0.2 to 0.4 part of menthyl glyoxylate.
The quality control product 2 comprises the following raw materials in parts by weight:
2 to 6 parts of factor-poor sheep plasma, 6 to 8 parts of sheep serum, 0.6 to 1.8 parts of fibrin stock solution, 0.3 to 0.5 part of chlorohexidine, 0.2 to 0.6 part of isopropanol, 0.1 to 0.7 part of nano zinc oxide and 0.3 to 0.5 part of menthyl glyoxylate.
The manufacturing process of the quality control material of the thrombelastogram instrument comprises the following specific steps:
step 1: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain plasma;
step 2: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain sheep serum;
and step 3: dividing the plasma obtained in step 1 into 3 parts, namely part 1, part 2 and part 3;
and 4, step 4: centrifuging the part 1 to obtain lower plasma which is factor-rich sheep plasma, and adjusting R, K, Angle and MA values;
and 5: adding barium sulfate into the part 2, mixing, centrifuging to obtain upper plasma which is factor-poor sheep plasma, and regulating R, K, Angle and MA values;
step 6: freezing the part 3 at low temperature, and thawing until the whole part is thawed to obtain fibrinogen;
and 7: adding sheep serum into fibrinogen to obtain a fibrinogen mother liquor, wherein the fibrinogen accounts for 7-15% of the fibrinogen mother liquor by mass;
and 8: uniformly mixing 3-5 parts by weight of factor-rich sheep plasma, 1-3 parts by weight of sheep serum, 2-6 parts by weight of a vitamin stock mother liquor, 0.2-0.4 part by weight of chlorhexidine, 0.1-0.5 part by weight of isopropanol, 0.2-0.4 part by weight of nano zinc oxide and 0.2-0.4 part by weight of menthyl glyoxylate, and adjusting the R value to 0-4min, the K value to 0-2min, the Angle value to 75-87deg and the MA value to 42-63mm to obtain a quality control product 1;
and step 9: uniformly mixing 2-6 parts by weight of factor-poor sheep plasma, 6-8 parts by weight of sheep serum, 0.6-1.8 parts by weight of fibrinogen mother liquor, 0.3-0.5 parts by weight of chlorhexidine, 0.2-0.6 parts by weight of isopropanol, 0.1-0.7 parts by weight of nano zinc oxide and 0.3-0.5 parts by weight of glyoxylate, and adjusting the R value to 1-5min, the K value to 0-6min, the Angle value to 60-80deg and the MA value to 25-41mm to obtain a quality control product 2;
step 10: and (3) packaging the quality control product 1 and the quality control product 2, and freeze-drying to obtain the quality control material of the thromboelastogram instrument.
Thus, the invention has the advantages that:
the chlorhexidine in the raw materials of the invention is named chlorhexidine, the chemical name is chlorhexidine, the chlorhexidine is a cationic surfactant, the chlorhexidine is quite strong in broad-spectrum bacteriostasis and sterilization, is a better bactericidal disinfectant, and particularly has stronger antibacterial action on gram positive bacteria and gram negative bacteria than benzalkonium bromide; the isopropanol has strong bactericidal capacity, belongs to a middle-effect disinfectant and can kill bacterial propagules, viruses and fungi; the nano zinc oxide is also a raw material with good bactericidal performance; menthyl glyoxylate is also effective in inhibiting bacterial growth. The antibacterial and bacteriostatic properties of the quality control product 1 and the quality control product 2 are improved, and the stability of the quality control product 1 and the quality control product 2 is improved.
Drawings
FIG. 1 is a schematic diagram of the raw materials of the quality control material of the thromboelastogram apparatus of the present invention.
Fig. 2 is a structural diagram of a server chassis of the present invention.
Fig. 3 is a structural view of the cooling fin of the present invention.
Fig. 4 is a structural view of the connection of a first lead screw and a second lead screw of the present invention.
Detailed Description
The invention will be further explained with reference to the drawings.
Example 1
As shown in fig. 1-4, the raw materials of the quality control material of the thromboelastogram apparatus include a raw material of a quality control material 1 and a raw material of a quality control material 2, wherein the raw materials of the quality control material 1 include:
factor-rich sheep plasma, sheep serum, a vitamin stock mother liquor, chlorohexidine, isopropanol, nano zinc oxide and glyoxylic acid menthyl ester in parts by weight;
the quality control product 2 comprises the following raw materials:
factor-deficient sheep plasma, sheep serum, fibrinogen mother liquor, chlorohexidine, isopropanol, nano zinc oxide and menthyl glyoxylate.
The fibrinogen mother liquor is prepared by dissolving fibrinogen in sheep serum, wherein the mass percentage of the fibrinogen in the fibrinogen mother liquor is 7%.
The quality control product 1 comprises the following raw materials in parts by weight:
the factor-rich sheep plasma preparation comprises, by weight, 3 parts of factor-rich sheep plasma, 1 part of sheep serum, 2 parts of a fibrinogen mother liquor, 0.2 part of chlorohexidine, 0.1 part of isopropanol, 0.2 part of nano zinc oxide and 0.2 part of menthyl glyoxylate.
The quality control product 2 comprises the following raw materials in parts by weight:
2 parts of factor-poor sheep plasma, 6 parts of sheep serum, 0.6 part of fibrinogen mother liquor, 0.3 part of chlorohexidine, 0.2 part of isopropanol, 0.1 part of nano zinc oxide and 0.3 part of menthyl glyoxylate. The chlorhexidine is named chlorhexidine, has a chemical name of chlorhexidine, is a chlorohexidine chloride, is a cationic surfactant, has quite strong broad-spectrum antibacterial and bactericidal effects, is a better bactericidal and disinfectant medicine, and particularly has stronger antibacterial effects on gram-positive bacteria and gram-negative bacteria than benzalkonium bromide; the isopropanol has strong bactericidal capacity, belongs to a middle-effect disinfectant and can kill bacterial propagules, viruses and fungi; the nano zinc oxide is also a raw material with good bactericidal performance; menthyl glyoxylate is also effective in inhibiting bacterial growth.
The manufacturing process of the quality control material of the thrombelastogram instrument comprises the following specific steps:
step 1: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain plasma;
step 2: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain sheep serum;
and step 3: dividing the plasma obtained in step 1 into 3 parts, namely part 1, part 2 and part 3;
and 4, step 4: centrifuging the part 1 to obtain lower plasma which is factor-rich sheep plasma, and adjusting R, K, Angle and MA values;
and 5: adding barium sulfate into the part 2, mixing, centrifuging to obtain upper plasma which is factor-poor sheep plasma, and regulating R, K, Angle and MA values;
step 6: freezing the part 3 at low temperature, and thawing until the whole part is thawed to obtain fibrinogen;
and 7: adding sheep serum into fibrinogen to obtain a fibrinogen mother liquor, wherein the mass percent of the fibrinogen in the fibrinogen mother liquor is 7%;
and 8: uniformly mixing 3 parts by weight of factor-rich sheep plasma, 1 part by weight of sheep serum, 2 parts by weight of a vitamin raw mother liquor, 0.2 part by weight of chlorhexidine, 0.1 part by weight of isopropanol, 0.2 part by weight of nano zinc oxide and 0.2 part by weight of menthyl glyoxylate, and adjusting the R value to 0min, the K value to 0min, the Angle value to 75deg and the MA value to 42mm to obtain a quality control product 1;
and step 9: uniformly mixing 2 parts by weight of factor-poor sheep plasma, 6 parts by weight of sheep serum, 0.6 part by weight of fibrinogen mother liquor, 0.3 part by weight of chlorhexidine, 0.2 part by weight of isopropanol, 0.1 part by weight of nano zinc oxide and 0.3 part by weight of glyoxylate, and adjusting the R value to 1min, the K value to 0min, the Angle value to 60deg and the MA value to 25mm to obtain a quality control product 2;
step 10: and (3) packaging the quality control product 1 and the quality control product 2, and freeze-drying to obtain the quality control material of the thromboelastogram instrument.
The anticoagulant in the step 1 and the step 2 is 3.8 wt% of sodium citrate solution.
In the step 1 and the step 4, the centrifugal rotating speed of the step 5 is 3000rpm/min, and the centrifugal time is 10 minutes; the centrifugal speed of the step 2 is 3000rpm/min, and the centrifugal time is 30 minutes.
The adding proportion of the plasma and the barium sulfate in the step 5 is as follows: 0.4 parts by weight of barium sulfate was added per 1 part by volume of plasma.
In the step 6, the freezing temperature is-60 ℃, the freezing time is 4 hours, and the unfreezing temperature is 2 ℃.
Through tests, the R, K value, the Angle value and the MA value of the quality control material of the thromboelastogram instrument are similar to the performance of the quality control material of the existing thromboelastogram instrument in the market, and can be completely replaced mutually, and in addition, new raw materials are added, so that the antibacterial and bacteriostatic performances of the quality control product 1 and the quality control product 2 are improved, and the stability of the quality control product 1 and the quality control product 2 is improved.
During the low-temperature freezing in step 6, because there is a temperature requirement for the low-temperature freezing, it is necessary to record the temperature data during the low-temperature freezing, and then by installing a temperature sensor in the low-temperature freezing place, the temperature sensor is connected with a controller, the controller can be a PLC, a single chip microcomputer, an ARM processor or an FPGA processor, the controller is connected with a wireless communication module, the wireless communication module is connected with a server in a wireless network, the wireless communication module can be a 3G module or a 4G module, the wireless network can be a 3G network or a 4G network, so that the temperature data in the low-temperature freezing place can be collected by the temperature sensor and then sent to the controller, and then the temperature data is sent to the server by the controller for storage, and the server is often installed in a server case, and a through exhaust port is opened on the server case for exhaust cooling, if the server case is arranged outdoors, the servers in the server case can be damaged under the condition of airflow or precipitation with particulate impurities, and the conventional server case has no protection device at the position of the exhaust port, so that the server case with the exhaust port protection device is introduced.
The temperature sensor is arranged in a low-temperature freezing place and connected with a controller, the controller can be a PLC, a single chip microcomputer, an ARM processor or an FPGA processor, the controller is connected with a wireless communication module, the wireless communication module is connected with a server in a wireless network, the wireless communication module can be A3G module or a 4G module, the wireless network can be A3G network or a 4G network, so that temperature data in the low-temperature freezing place can be acquired through the temperature sensor and then sent to the controller, the temperature data are transmitted to the server by the controller to be stored, the server is arranged in a server case with an air outlet protection device, the server case with the air outlet protection device comprises a hollow cuboid box body A1, and a cooling piece A2 is fixedly arranged at the lower end of the upper wall plate of the hollow cuboid box body A1, the cooling plate A2 is a cuboid structure with a cavity inside, the wall surface of the cooling plate A2 is provided with a conditioning port A3, the top and the bottom of the conditioning port A3 are both provided with a barrier plate A5, a barrier plate A5 is fixedly arranged between the inner surfaces of the cooling plate A2, in addition, a knob A4 is arranged in the opening A3, a knob A4 is arranged by penetrating through the outer surface of the barrier piece A5, one end of the knob A4 is provided with a first screw groove A6, the first screw groove A6 is in threaded connection with a first lead screw A7, the other end of the knob A4 is provided with a second screw groove A8, the second screw groove A8 is in threaded connection with a second lead screw A9, a clamping opening T0 is arranged in the first lead screw A7, the second lead screw A9 is clamped in the clamping opening T0, in addition, the first screw a7 is fixedly provided with a moving plate T1 at the head of the second screw a9, the moving plate T1 is of a cuboid structure, the wall surface of the moving plate T1 is fixedly provided with a sealing head T2 made of a plastic material, the sealing head T2 made of the plastic material is combined with an air outlet T3, and the air outlet T3 is arranged on the wall surface of the cooling plate a 2.
The knob A4 is a ring-shaped framework, two ends of the knob A4 are both provided with limit blocks, the limit blocks are ring-shaped frameworks, and the limit blocks limit the knob A4 at one time.
The diameter of the first wire groove A6 is larger than that of the second wire groove A8, and a plastic sheet with corrugated bulges on the wall surface is sleeved on the outer side wall of the knob A4.
The plastic material seal heads T2 are of an arch-shaped structure, the wall surface of the plastic material seal head T2 is fixedly connected with the wall surface of the movable sheet T1, in addition, a plurality of plastic material seal heads T2 are arranged, and the plurality of plastic material seal heads T2 are uniformly distributed on the wall surface of the movable sheet T1.
The exhaust port T3 is a columnar framework, the number of the exhaust ports T3 is a plurality, a plurality of exhaust ports T3 penetrate through the outer surface of the cooling plate A2, and a plurality of exhaust ports T3 are uniformly distributed on the wall surface of the cooling plate A2.
When the air conditioner is in use, the rotating handle A4 is rotated, because the rotating handle A4 is constrained between the pair of blocking pieces A5 by the limiting blocks, the rotating handle A4 cannot move vertically during rotation, and the screw groove A6 and the screw groove A8 at the two ends of the rotating handle A4 are respectively combined with the screw rod A7 and the screw rod A9 to draw the pair of moving pieces T1 to move, at this time, the screw rod A7 moves downwards, the screw rod A9 is clamped in the clamping port T0 in the screw rod A7, the moving routes of the screw rod A7 and the screw rod A9 are separated, the concurrent movement of the pair of moving pieces T1 is achieved, during the movement of the moving piece T1, the sealing head T2 of the plastic material on the wall surface of the plastic material is clamped by the inner surface of the cooling piece A2, the sealing head T2 of the plastic material is pressed to the position of the exhaust port T2, and the exhaust port T2 is sealed, so that the air conditioner controls the number of the exhaust port T2 through rotation or rotates to seal all the air flow through the rotating handle A2, the damage of the server structure caused by the air flow and the rainwater with the particulate impurities reaching the inner side of the hollow cuboid box A1 from the air outlet T3 to the inner side of the hollow cuboid box A1 is avoided.
A knob is arranged in the conditioning opening, the knob concurrently controls a pair of moving pieces to move, so that the sealing heads made of plastic materials on the moving pieces block the exhaust openings, a certain amount of exhaust openings can be opened to perform cooling by virtue of the condition in the hollow cuboid box body, and the exhaust openings are closed to perform protection on the servers in the server case with the exhaust opening protection device in airflow or precipitation weather with particulate impurities; a clamping interface is arranged in the first screw rod, and the second screw rod is clamped in the clamping interface to increase the movement displacement of the pair of movable pieces, so that the exhaust port can be adjusted conveniently.
Example 2
As shown in fig. 1-4, the raw materials of the quality control material of the thromboelastogram apparatus include a raw material of a quality control material 1 and a raw material of a quality control material 2, wherein the raw materials of the quality control material 1 include:
factor-rich sheep plasma, sheep serum, a vitamin stock mother liquor, chlorohexidine, isopropanol, nano zinc oxide and glyoxylic acid menthyl ester in parts by weight;
the quality control product 2 comprises the following raw materials:
factor-deficient sheep plasma, sheep serum, fibrinogen mother liquor, chlorohexidine, isopropanol, nano zinc oxide and menthyl glyoxylate.
The fibrinogen mother liquor is prepared by dissolving fibrinogen in sheep serum, wherein the mass percentage of the fibrinogen in the fibrinogen mother liquor is 7% -15%.
The quality control product 1 comprises the following raw materials in parts by weight:
the sheep blood plasma factor-rich sheep blood plasma composition comprises, by weight, 4 parts of sheep blood serum, 4 parts of a fibrinogen mother liquor, 0.3 part of chlorhexidine, 0.3 part of isopropanol, 0.3 part of nano zinc oxide and 0.3 part of menthyl glyoxylate, wherein the factor-rich sheep blood plasma is prepared by mixing the sheep blood serum and the fibrinogen mother liquor in a certain proportion.
The quality control product 2 comprises the following raw materials in parts by weight:
the sheep blood plasma with the weight parts of 4 parts of factors lacking, sheep blood serum with the weight parts of 7 parts, fibrinogen mother liquor with the weight parts of 1.2 parts, chlorohexidine with the weight parts of 0.4 part, isopropanol with the weight parts of 0.4 part, nano zinc oxide with the weight parts of 0.4 part and menthyl glyoxylate with the weight parts of 0.4 part. The chlorhexidine is named chlorhexidine, has a chemical name of chlorhexidine, is a chlorohexidine chloride, is a cationic surfactant, has quite strong broad-spectrum antibacterial and bactericidal effects, is a better bactericidal and disinfectant medicine, and particularly has stronger antibacterial effects on gram-positive bacteria and gram-negative bacteria than benzalkonium bromide; the isopropanol has strong bactericidal capacity, belongs to a middle-effect disinfectant and can kill bacterial propagules, viruses and fungi; the nano zinc oxide is also a raw material with good bactericidal performance; menthyl glyoxylate is also effective in inhibiting bacterial growth.
The manufacturing process of the quality control material of the thrombelastogram instrument comprises the following specific steps:
step 1: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain plasma;
step 2: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain sheep serum;
and step 3: dividing the plasma obtained in step 1 into 3 parts, namely part 1, part 2 and part 3;
and 4, step 4: centrifuging the part 1 to obtain lower plasma which is factor-rich sheep plasma, and adjusting R, K, Angle and MA values;
and 5: adding barium sulfate into the part 2, mixing, centrifuging to obtain upper plasma which is factor-poor sheep plasma, and regulating R, K, Angle and MA values;
step 6: freezing the part 3 at low temperature, and thawing until the whole part is thawed to obtain fibrinogen;
and 7: adding sheep serum into fibrinogen to obtain a fibrinogen mother liquor, wherein the mass percent of the fibrinogen in the fibrinogen mother liquor is 11%;
and 8: uniformly mixing 4 parts by weight of factor-rich sheep plasma, 2 parts by weight of sheep serum, 4 parts by weight of fibrinogen mother liquor, 0.3 part by weight of chlorhexidine, 0.3 part by weight of isopropanol, 0.3 part by weight of nano zinc oxide and 0.3 part by weight of menthyl glyoxylate, and adjusting the R value to 2min, the K value to 1min, the Angle value to 81deg and the MA value to 52mm to obtain a quality control product 1;
and step 9: uniformly mixing 4 parts by weight of factor-poor sheep plasma, 7 parts by weight of sheep serum, 1.2 parts by weight of fibrinogen mother liquor, 0.4 part by weight of chlorhexidine, 0.4 part by weight of isopropanol, 0.4 part by weight of nano zinc oxide and 0.4 part by weight of glyoxylic acid menthyl ester, and adjusting the R value to 3min, the K value to 3min, the Angle value to 70deg and the MA value to 33mm to obtain a quality control product 2;
step 10: and (3) packaging the quality control product 1 and the quality control product 2, and freeze-drying to obtain the quality control material of the thromboelastogram instrument.
The anticoagulant in the step 1 and the step 2 is 3.8 wt% of sodium citrate solution.
In the step 1 and the step 4, the centrifugal rotating speed of the step 5 is 3000rpm/min, and the centrifugal time is 10 minutes; the centrifugal speed of the step 2 is 3000rpm/min, and the centrifugal time is 30 minutes.
The adding proportion of the plasma and the barium sulfate in the step 5 is as follows: 0.5 parts by weight of barium sulfate was added per 1 part by volume of plasma.
In the step 6, the freezing temperature is-70 ℃, the freezing time is 7 hours, and the unfreezing temperature is 5 ℃.
Through tests, the R, K value, the Angle value and the MA value of the quality control material of the thromboelastogram instrument are similar to the performance of the quality control material of the existing thromboelastogram instrument in the market, and can be completely replaced mutually, and in addition, new raw materials are added, so that the antibacterial and bacteriostatic performances of the quality control product 1 and the quality control product 2 are improved, and the stability of the quality control product 1 and the quality control product 2 is improved.
During the low-temperature freezing in step 6, because there is a temperature requirement for the low-temperature freezing, it is necessary to record the temperature data during the low-temperature freezing, and then by installing a temperature sensor in the low-temperature freezing place, the temperature sensor is connected with a controller, the controller can be a PLC, a single chip microcomputer, an ARM processor or an FPGA processor, the controller is connected with a wireless communication module, the wireless communication module is connected with a server in a wireless network, the wireless communication module can be a 3G module or a 4G module, the wireless network can be a 3G network or a 4G network, so that the temperature data in the low-temperature freezing place can be collected by the temperature sensor and then sent to the controller, and then the temperature data is sent to the server by the controller for storage, and the server is often installed in a server case, and a through exhaust port is opened on the server case for exhaust cooling, if the server case is arranged outdoors, the servers in the server case can be damaged under the condition of airflow or precipitation with particulate impurities, and the conventional server case has no protection device at the position of the exhaust port, so that the server case with the exhaust port protection device is introduced.
The temperature sensor is arranged in a low-temperature freezing place and connected with a controller, the controller can be a PLC, a single chip microcomputer, an ARM processor or an FPGA processor, the controller is connected with a wireless communication module, the wireless communication module is connected with a server in a wireless network, the wireless communication module can be A3G module or a 4G module, the wireless network can be A3G network or a 4G network, so that temperature data in the low-temperature freezing place can be acquired through the temperature sensor and then sent to the controller, the temperature data are transmitted to the server by the controller to be stored, the server is arranged in a server case with an air outlet protection device, the server case with the air outlet protection device comprises a hollow cuboid box body A1, and a cooling piece A2 is fixedly arranged at the lower end of the upper wall plate of the hollow cuboid box body A1, the cooling plate A2 is a cuboid structure with a cavity inside, the wall surface of the cooling plate A2 is provided with a conditioning port A3, the top and the bottom of the conditioning port A3 are both provided with a barrier plate A5, a barrier plate A5 is fixedly arranged between the inner surfaces of the cooling plate A2, in addition, a knob A4 is arranged in the opening A3, a knob A4 is arranged by penetrating through the outer surface of the barrier piece A5, one end of the knob A4 is provided with a first screw groove A6, the first screw groove A6 is in threaded connection with a first lead screw A7, the other end of the knob A4 is provided with a second screw groove A8, the second screw groove A8 is in threaded connection with a second lead screw A9, a clamping opening T0 is arranged in the first lead screw A7, the second lead screw A9 is clamped in the clamping opening T0, in addition, the first screw a7 is fixedly provided with a moving plate T1 at the head of the second screw a9, the moving plate T1 is of a cuboid structure, the wall surface of the moving plate T1 is fixedly provided with a sealing head T2 made of a plastic material, the sealing head T2 made of the plastic material is combined with an air outlet T3, and the air outlet T3 is arranged on the wall surface of the cooling plate a 2.
The knob A4 is a ring-shaped framework, two ends of the knob A4 are both provided with limit blocks, the limit blocks are ring-shaped frameworks, and the limit blocks limit the knob A4 at one time.
The diameter of the first wire groove A6 is larger than that of the second wire groove A8, and a plastic sheet with corrugated bulges on the wall surface is sleeved on the outer side wall of the knob A4.
The plastic material seal heads T2 are of an arch-shaped structure, the wall surface of the plastic material seal head T2 is fixedly connected with the wall surface of the movable sheet T1, in addition, a plurality of plastic material seal heads T2 are arranged, and the plurality of plastic material seal heads T2 are uniformly distributed on the wall surface of the movable sheet T1.
The exhaust port T3 is a columnar framework, the number of the exhaust ports T3 is a plurality, a plurality of exhaust ports T3 penetrate through the outer surface of the cooling plate A2, and a plurality of exhaust ports T3 are uniformly distributed on the wall surface of the cooling plate A2.
When the air conditioner is in use, the rotating handle A4 is rotated, because the rotating handle A4 is constrained between the pair of blocking pieces A5 by the limiting blocks, the rotating handle A4 cannot move vertically during rotation, and the screw groove A6 and the screw groove A8 at the two ends of the rotating handle A4 are respectively combined with the screw rod A7 and the screw rod A9 to draw the pair of moving pieces T1 to move, at this time, the screw rod A7 moves downwards, the screw rod A9 is clamped in the clamping port T0 in the screw rod A7, the moving routes of the screw rod A7 and the screw rod A9 are separated, the concurrent movement of the pair of moving pieces T1 is achieved, during the movement of the moving piece T1, the sealing head T2 of the plastic material on the wall surface of the plastic material is clamped by the inner surface of the cooling piece A2, the sealing head T2 of the plastic material is pressed to the position of the exhaust port T2, and the exhaust port T2 is sealed, so that the air conditioner controls the number of the exhaust port T2 through rotation or rotates to seal all the air flow through the rotating handle A2, the damage of the server structure caused by the air flow and the rainwater with the particulate impurities reaching the inner side of the hollow cuboid box A1 from the air outlet T3 to the inner side of the hollow cuboid box A1 is avoided.
A knob is arranged in the conditioning opening, the knob concurrently controls a pair of moving pieces to move, so that the sealing heads made of plastic materials on the moving pieces block the exhaust openings, a certain amount of exhaust openings can be opened to perform cooling by virtue of the condition in the hollow cuboid box body, and the exhaust openings are closed to perform protection on the servers in the server case with the exhaust opening protection device in airflow or precipitation weather with particulate impurities; a clamping interface is arranged in the first screw rod, and the second screw rod is clamped in the clamping interface to increase the movement displacement of the pair of movable pieces, so that the exhaust port can be adjusted conveniently.
Example 3
As shown in fig. 1-4, the raw materials of the quality control material of the thromboelastogram apparatus include a raw material of a quality control material 1 and a raw material of a quality control material 2, wherein the raw materials of the quality control material 1 include:
factor-rich sheep plasma, sheep serum, a vitamin stock mother liquor, chlorohexidine, isopropanol, nano zinc oxide and glyoxylic acid menthyl ester in parts by weight;
the quality control product 2 comprises the following raw materials:
factor-deficient sheep plasma, sheep serum, fibrinogen mother liquor, chlorohexidine, isopropanol, nano zinc oxide and menthyl glyoxylate.
The fibrinogen mother liquor is prepared by dissolving fibrinogen in sheep serum, wherein the mass percentage of the fibrinogen in the fibrinogen mother liquor is 15%.
The quality control product 1 comprises the following raw materials in parts by weight:
the factor-rich sheep plasma preparation comprises, by weight, 5 parts of factor-rich sheep plasma, 3 parts of sheep serum, 6 parts of a fibrinogen mother liquor, 0.4 part of chlorohexidine, 0.5 part of isopropanol, 0.4 part of nano zinc oxide and 0.4 part of menthyl glyoxylate.
The quality control product 2 comprises the following raw materials in parts by weight:
6 parts of factor-poor sheep plasma, 8 parts of sheep serum, 1.8 parts of fibrinogen mother liquor, 0.5 part of chlorohexidine, 0.6 part of isopropanol, 0.7 part of nano zinc oxide and 0.5 part of menthyl glyoxylate. The chlorhexidine is named chlorhexidine, has a chemical name of chlorhexidine, is a chlorohexidine chloride, is a cationic surfactant, has quite strong broad-spectrum antibacterial and bactericidal effects, is a better bactericidal and disinfectant medicine, and particularly has stronger antibacterial effects on gram-positive bacteria and gram-negative bacteria than benzalkonium bromide; the isopropanol has strong bactericidal capacity, belongs to a middle-effect disinfectant and can kill bacterial propagules, viruses and fungi; the nano zinc oxide is also a raw material with good bactericidal performance; menthyl glyoxylate is also effective in inhibiting bacterial growth.
The manufacturing process of the quality control material of the thrombelastogram instrument comprises the following specific steps:
step 1: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain plasma;
step 2: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain sheep serum;
and step 3: dividing the plasma obtained in step 1 into 3 parts, namely part 1, part 2 and part 3;
and 4, step 4: centrifuging the part 1 to obtain lower plasma which is factor-rich sheep plasma, and adjusting R, K, Angle and MA values;
and 5: adding barium sulfate into the part 2, mixing, centrifuging to obtain upper plasma which is factor-poor sheep plasma, and regulating R, K, Angle and MA values;
step 6: freezing the part 3 at low temperature, and thawing until the whole part is thawed to obtain fibrinogen;
and 7: adding sheep serum into fibrinogen to obtain fibrinogen mother liquor, wherein the mass percent of the fibrinogen accounting for the fibrinogen mother liquor is 15%;
and 8: uniformly mixing 5 parts by weight of factor-rich sheep plasma, 3 parts by weight of sheep serum, 6 parts by weight of a vitamin raw mother liquor, 0.4 part by weight of chlorhexidine, 0.5 part by weight of isopropanol, 0.4 part by weight of nano zinc oxide and 0.4 part by weight of menthyl glyoxylate, and adjusting the R value to 4min, the K value to 2min, the Angle value to 87deg and the MA value to 63mm to obtain a quality control product 1;
and step 9: uniformly mixing 6 parts by weight of factor-poor sheep plasma, 8 parts by weight of sheep serum, 1.8 parts by weight of fibrinogen mother liquor, 0.5 part by weight of chlorhexidine, 0.6 part by weight of isopropanol, 0.7 part by weight of nano zinc oxide and 0.5 part by weight of glyoxylic acid menthyl ester, and adjusting the R value to 5min, the K value to 6min, the Angle value to 80deg and the MA value to 41mm to obtain a quality control product 2;
step 10: and (3) packaging the quality control product 1 and the quality control product 2, and freeze-drying to obtain the quality control material of the thromboelastogram instrument.
The anticoagulant in the step 1 and the step 2 is 3.8 wt% of sodium citrate solution.
In the step 1 and the step 4, the centrifugal rotating speed of the step 5 is 3000rpm/min, and the centrifugal time is 10 minutes; the centrifugal speed of the step 2 is 3000rpm/min, and the centrifugal time is 30 minutes.
The adding proportion of the plasma and the barium sulfate in the step 5 is as follows: 0.6 parts by weight of barium sulfate was added per 1 part by volume of plasma.
In the step 6, the freezing temperature is 80 ℃, the freezing time is 10 hours, and the unfreezing temperature is 8 ℃.
Through tests, the R, K value, the Angle value and the MA value of the quality control material of the thromboelastogram instrument are similar to the performance of the quality control material of the existing thromboelastogram instrument in the market, and can be completely replaced mutually, and in addition, new raw materials are added, so that the antibacterial and bacteriostatic performances of the quality control product 1 and the quality control product 2 are improved, and the stability of the quality control product 1 and the quality control product 2 is improved.
During the low-temperature freezing in step 6, because there is a temperature requirement for the low-temperature freezing, it is necessary to record the temperature data during the low-temperature freezing, and then by installing a temperature sensor in the low-temperature freezing place, the temperature sensor is connected with a controller, the controller can be a PLC, a single chip microcomputer, an ARM processor or an FPGA processor, the controller is connected with a wireless communication module, the wireless communication module is connected with a server in a wireless network, the wireless communication module can be a 3G module or a 4G module, the wireless network can be a 3G network or a 4G network, so that the temperature data in the low-temperature freezing place can be collected by the temperature sensor and then sent to the controller, and then the temperature data is sent to the server by the controller for storage, and the server is often installed in a server case, and a through exhaust port is opened on the server case for exhaust cooling, if the server case is arranged outdoors, the servers in the server case can be damaged under the condition of airflow or precipitation with particulate impurities, and the conventional server case has no protection device at the position of the exhaust port, so that the server case with the exhaust port protection device is introduced.
The temperature sensor is arranged in a low-temperature freezing place and connected with a controller, the controller can be a PLC, a single chip microcomputer, an ARM processor or an FPGA processor, the controller is connected with a wireless communication module, the wireless communication module is connected with a server in a wireless network, the wireless communication module can be A3G module or a 4G module, the wireless network can be A3G network or a 4G network, so that temperature data in the low-temperature freezing place can be acquired through the temperature sensor and then sent to the controller, the temperature data are transmitted to the server by the controller to be stored, the server is arranged in a server case with an air outlet protection device, the server case with the air outlet protection device comprises a hollow cuboid box body A1, and a cooling piece A2 is fixedly arranged at the lower end of the upper wall plate of the hollow cuboid box body A1, the cooling plate A2 is a cuboid structure with a cavity inside, the wall surface of the cooling plate A2 is provided with a conditioning port A3, the top and the bottom of the conditioning port A3 are both provided with a barrier plate A5, a barrier plate A5 is fixedly arranged between the inner surfaces of the cooling plate A2, in addition, a knob A4 is arranged in the opening A3, a knob A4 is arranged by penetrating through the outer surface of the barrier piece A5, one end of the knob A4 is provided with a first screw groove A6, the first screw groove A6 is in threaded connection with a first lead screw A7, the other end of the knob A4 is provided with a second screw groove A8, the second screw groove A8 is in threaded connection with a second lead screw A9, a clamping opening T0 is arranged in the first lead screw A7, the second lead screw A9 is clamped in the clamping opening T0, in addition, the first screw a7 is fixedly provided with a moving plate T1 at the head of the second screw a9, the moving plate T1 is of a cuboid structure, the wall surface of the moving plate T1 is fixedly provided with a sealing head T2 made of a plastic material, the sealing head T2 made of the plastic material is combined with an air outlet T3, and the air outlet T3 is arranged on the wall surface of the cooling plate a 2.
The knob A4 is a ring-shaped framework, two ends of the knob A4 are both provided with limit blocks, the limit blocks are ring-shaped frameworks, and the limit blocks limit the knob A4 at one time.
The diameter of the first wire groove A6 is larger than that of the second wire groove A8, and a plastic sheet with corrugated bulges on the wall surface is sleeved on the outer side wall of the knob A4.
The plastic material seal heads T2 are of an arch-shaped structure, the wall surface of the plastic material seal head T2 is fixedly connected with the wall surface of the movable sheet T1, in addition, a plurality of plastic material seal heads T2 are arranged, and the plurality of plastic material seal heads T2 are uniformly distributed on the wall surface of the movable sheet T1.
The exhaust port T3 is a columnar framework, the number of the exhaust ports T3 is a plurality, a plurality of exhaust ports T3 penetrate through the outer surface of the cooling plate A2, and a plurality of exhaust ports T3 are uniformly distributed on the wall surface of the cooling plate A2.
When the air conditioner is in use, the rotating handle A4 is rotated, because the rotating handle A4 is constrained between the pair of blocking pieces A5 by the limiting blocks, the rotating handle A4 cannot move vertically during rotation, and the screw groove A6 and the screw groove A8 at the two ends of the rotating handle A4 are respectively combined with the screw rod A7 and the screw rod A9 to draw the pair of moving pieces T1 to move, at this time, the screw rod A7 moves downwards, the screw rod A9 is clamped in the clamping port T0 in the screw rod A7, the moving routes of the screw rod A7 and the screw rod A9 are separated, the concurrent movement of the pair of moving pieces T1 is achieved, during the movement of the moving piece T1, the sealing head T2 of the plastic material on the wall surface of the plastic material is clamped by the inner surface of the cooling piece A2, the sealing head T2 of the plastic material is pressed to the position of the exhaust port T2, and the exhaust port T2 is sealed, so that the air conditioner controls the number of the exhaust port T2 through rotation or rotates to seal all the air flow through the rotating handle A2, the damage of the server structure caused by the air flow and the rainwater with the particulate impurities reaching the inner side of the hollow cuboid box A1 from the air outlet T3 to the inner side of the hollow cuboid box A1 is avoided.
A knob is arranged in the conditioning opening, the knob concurrently controls a pair of moving pieces to move, so that the sealing heads made of plastic materials on the moving pieces block the exhaust openings, a certain amount of exhaust openings can be opened to perform cooling by virtue of the condition in the hollow cuboid box body, and the exhaust openings are closed to perform protection on the servers in the server case with the exhaust opening protection device in airflow or precipitation weather with particulate impurities; a clamping interface is arranged in the first screw rod, and the second screw rod is clamped in the clamping interface to increase the movement displacement of the pair of movable pieces, so that the exhaust port can be adjusted conveniently.
The present invention has been described above by way of illustration in the drawings, and it will be understood by those skilled in the art that the present disclosure is not limited to the embodiments described above, and various changes, modifications and substitutions may be made without departing from the scope of the present invention.
Claims (5)
1. The raw materials of a quality control material of a thromboelastogram instrument are characterized by comprising a raw material of a quality control material 1 and a raw material of a quality control material 2, wherein the raw material of the quality control material 1 comprises:
factor-rich sheep plasma, sheep serum, a vitamin stock mother liquor, chlorohexidine, isopropanol, nano zinc oxide and glyoxylic acid menthyl ester in parts by weight;
the quality control product 2 comprises the following raw materials:
factor-deficient sheep plasma, sheep serum, fibrinogen mother liquor, chlorohexidine, isopropanol, nano zinc oxide and menthyl glyoxylate.
2. The raw material of the quality control substance of the thromboelastography instrument as the claim 1, wherein the fibrinogen mother liquor is prepared by dissolving fibrinogen in sheep serum, and the mass percentage of the fibrinogen in the fibrinogen mother liquor is 7-15%.
3. The raw materials of the quality control material of the thromboelastogram instrument according to claim 1, wherein the weight parts of the raw materials of the quality control material 1 are as follows:
3 to 5 parts of factor-rich sheep plasma, 1 to 3 parts of sheep serum, 2 to 6 parts of vitamin stock solution, 0.2 to 0.4 part of chlorohexidine, 0.1 to 0.5 part of isopropanol, 0.2 to 0.4 part of nano zinc oxide and 0.2 to 0.4 part of menthyl glyoxylate.
4. The raw materials of the quality control material of the thromboelastogram instrument according to claim 1, wherein the weight parts of the raw materials of the quality control material 2 are as follows:
2 to 6 parts of factor-poor sheep plasma, 6 to 8 parts of sheep serum, 0.6 to 1.8 parts of fibrin stock solution, 0.3 to 0.5 part of chlorohexidine, 0.2 to 0.6 part of isopropanol, 0.1 to 0.7 part of nano zinc oxide and 0.3 to 0.5 part of menthyl glyoxylate.
5. A manufacturing process of a quality control material of a thromboelastogram instrument is characterized by comprising the following steps:
step 1: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain plasma;
step 2: collecting fresh sheep whole blood, adding an anticoagulant, and centrifuging to obtain sheep serum;
and step 3: dividing the plasma obtained in step 1 into 3 parts, namely part 1, part 2 and part 3;
and 4, step 4: centrifuging the part 1 to obtain lower plasma which is factor-rich sheep plasma, and adjusting R, K, Angle and MA values;
and 5: adding barium sulfate into the part 2, mixing, centrifuging to obtain upper plasma which is factor-poor sheep plasma, and regulating R, K, Angle and MA values;
step 6: freezing the part 3 at low temperature, and thawing until the whole part is thawed to obtain fibrinogen;
and 7: adding sheep serum into fibrinogen to obtain a fibrinogen mother liquor, wherein the fibrinogen accounts for 7-15% of the fibrinogen mother liquor by mass;
and 8: uniformly mixing 3-5 parts by weight of factor-rich sheep plasma, 1-3 parts by weight of sheep serum, 2-6 parts by weight of a vitamin stock mother liquor, 0.2-0.4 part by weight of chlorhexidine, 0.1-0.5 part by weight of isopropanol, 0.2-0.4 part by weight of nano zinc oxide and 0.2-0.4 part by weight of menthyl glyoxylate, and adjusting the R value to 0-4min, the K value to 0-2min, the Angle value to 75-87deg and the MA value to 42-63mm to obtain a quality control product 1;
and step 9: uniformly mixing 2-6 parts by weight of factor-poor sheep plasma, 6-8 parts by weight of sheep serum, 0.6-1.8 parts by weight of fibrinogen mother liquor, 0.3-0.5 parts by weight of chlorhexidine, 0.2-0.6 parts by weight of isopropanol, 0.1-0.7 parts by weight of nano zinc oxide and 0.3-0.5 parts by weight of glyoxylate, and adjusting the R value to 1-5min, the K value to 0-6min, the Angle value to 60-80deg and the MA value to 25-41mm to obtain a quality control product 2;
step 10: and (3) packaging the quality control product 1 and the quality control product 2, and freeze-drying to obtain the quality control material of the thromboelastogram instrument.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910599132.3A CN112179728A (en) | 2019-07-04 | 2019-07-04 | Raw materials of quality control material of thrombelastogram instrument and manufacturing process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910599132.3A CN112179728A (en) | 2019-07-04 | 2019-07-04 | Raw materials of quality control material of thrombelastogram instrument and manufacturing process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112179728A true CN112179728A (en) | 2021-01-05 |
Family
ID=73915546
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910599132.3A Pending CN112179728A (en) | 2019-07-04 | 2019-07-04 | Raw materials of quality control material of thrombelastogram instrument and manufacturing process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN112179728A (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102128917A (en) * | 2010-12-07 | 2011-07-20 | 江西特康科技有限公司 | Clinical biochemical quality control products and preparation process thereof |
| US20150150863A1 (en) * | 2013-10-03 | 2015-06-04 | David Wise | Compositions and methods for treating pelvic pain and other conditions |
| CN106832439A (en) * | 2017-03-26 | 2017-06-13 | 广州市芯检康生物科技有限公司 | A kind of multi-functional instant composite of new aeroge for blood components protection and preparation method thereof |
| CN107588998A (en) * | 2017-01-12 | 2018-01-16 | 上海原科实业发展有限公司 | Thrombelastogram instrument quality-control product and preparation method thereof |
| CN108169467A (en) * | 2017-11-27 | 2018-06-15 | 中国科学院苏州生物医学工程技术研究所 | A kind of thrombelastogram instrument quality-control product and its preparation method and application |
| CN208780589U (en) * | 2018-06-29 | 2019-04-23 | 陕西聚点实业有限公司 | A kind of detecting head and detection instrument |
-
2019
- 2019-07-04 CN CN201910599132.3A patent/CN112179728A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102128917A (en) * | 2010-12-07 | 2011-07-20 | 江西特康科技有限公司 | Clinical biochemical quality control products and preparation process thereof |
| US20150150863A1 (en) * | 2013-10-03 | 2015-06-04 | David Wise | Compositions and methods for treating pelvic pain and other conditions |
| CN107588998A (en) * | 2017-01-12 | 2018-01-16 | 上海原科实业发展有限公司 | Thrombelastogram instrument quality-control product and preparation method thereof |
| CN106832439A (en) * | 2017-03-26 | 2017-06-13 | 广州市芯检康生物科技有限公司 | A kind of multi-functional instant composite of new aeroge for blood components protection and preparation method thereof |
| CN108169467A (en) * | 2017-11-27 | 2018-06-15 | 中国科学院苏州生物医学工程技术研究所 | A kind of thrombelastogram instrument quality-control product and its preparation method and application |
| CN208780589U (en) * | 2018-06-29 | 2019-04-23 | 陕西聚点实业有限公司 | A kind of detecting head and detection instrument |
Non-Patent Citations (1)
| Title |
|---|
| 国家执业药师资格考试研究组 编: "《中药学专业知识 （一）》", 科学技术文献出版社, pages: 177 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP1784639B1 (en) | Methods for preparing freeze-dried platelets, compositions comprising freeze-dried platelets, and methods of use | |
| Hartmann et al. | Diagnosis and treatment of trauma-induced coagulopathy by viscoelastography | |
| US20080145834A1 (en) | Freeze-dried platelets as a diagnostic agent | |
| CN105424945B (en) | A kind of coagulation activation detection reagent and preparation method thereof and purposes | |
| JP5074496B2 (en) | Standard / Reference / Control for Blood Coagulation Test | |
| AU742965B2 (en) | Coagulation controls for PT and APTT assays | |
| JP3330685B2 (en) | Liquid thromboplastin reagent | |
| CN105652022A (en) | Thromboelastography quality control material and preparation method thereof | |
| CN105092864A (en) | 3-level thrombelastogram quality control product and application thereof | |
| CN108169467B (en) | A kind of thrombelastogram instrument quality-control product and its preparation method and application | |
| US20110183311A1 (en) | Dry platelet preparations for use in diagnostics | |
| Sharpe et al. | Influence of treatment with ultralow-dose aspirin on platelet aggregation as measured by whole blood impedance aggregometry and platelet P-selectin expression in clinically normal dogs | |
| EP3937631A1 (en) | Canine blood platelet preparations | |
| Henson et al. | Disorders of hemostasis | |
| Halliez et al. | Detection of phosphatidyl serine on activated platelets' surface by flow cytometry in whole blood: a simpler test for the diagnosis of Scott syndrome. | |
| CN113325185A (en) | Multi-level quality control product, preparation method thereof and application thereof in thrombus elastogram detection | |
| Enk et al. | Correlation of plasma coagulation tests and fibrinogenClauss with rotational thromboelastometry parameters and prediction of bleeding in dogs | |
| CN107588998B (en) | Quality control product of thrombelastogram instrument and preparation method thereof | |
| KR20140051281A (en) | Coagulation controlling agents and devices comprising the same | |
| CN112179728A (en) | Raw materials of quality control material of thrombelastogram instrument and manufacturing process thereof | |
| Arbaeen et al. | Platelet concentrate functionality assessed by thromboelastography or rotational thromboelastometry | |
| Manzoni et al. | Viscoelastic coagulation testing in Neonatal Intensive Care Units: advantages and pitfalls in clinical practice | |
| Larsen et al. | Whole blood laboratory model of thrombocytopenia for use in evaluation of hemostatic interventions | |
| JP2015175850A (en) | Composition used as coagulation abnormality control plasma in in-vitro assay | |
| CN110470849A (en) | A kind of exceptional value quality-control product and preparation method thereof for hemostasis examination |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20210105 |
|
| RJ01 | Rejection of invention patent application after publication |