CN108653302A - B solid pharmaceutical preparations and its preparation method and application are tieed up greatly in a kind of celebrating for treating stomach trouble - Google Patents
B solid pharmaceutical preparations and its preparation method and application are tieed up greatly in a kind of celebrating for treating stomach trouble Download PDFInfo
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- CN108653302A CN108653302A CN201810684572.4A CN201810684572A CN108653302A CN 108653302 A CN108653302 A CN 108653302A CN 201810684572 A CN201810684572 A CN 201810684572A CN 108653302 A CN108653302 A CN 108653302A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
- A61K31/51—Thiamines, e.g. vitamin B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7135—Compounds containing heavy metals
- A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/12—Magnesium silicate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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Abstract
B solid pharmaceutical preparations and its preparation method and application are tieed up greatly in the celebrating that the invention discloses a kind of for treating stomach trouble, and it includes component which, which ties up greatly B solid pharmaceutical preparations,:3800 4200g of gentamicin sulphate (in terms of gentamicin), vitamin B128 12g, vitamin B1900 1200g, vitamin B2350 500g, vitamin B6300 450g, 1800 2100g of talcum powder, 49000 51000g of starch, gelatin hollow capsule make 200000 altogether.The present invention is by optimizing each component compatibility and preparation process, the big dimension B solid pharmaceutical preparations of celebrating obtained can provide steady, lasting effective blood drug concentration with sustained release, avoid or reduce peak valley phenomenon, be conducive to improve the safety that drug uses, reduce the adverse reaction of drug.
Description
Technical field
The invention belongs to pharmaceutical technology field more particularly to a kind of celebrating for treating stomach trouble tie up greatly B solid pharmaceutical preparations and its
Preparation method and application.
Background technology
For a long time, stomach trouble is a kind of multiple common disease, frequently-occurring disease, with the continuous increase of live and work pressure,
The dyspeptic ratio of people is in rising trend, and the pathogenetic fundamental cause of stomach is cold, wet, gas, blood and bacterium infection, pylorus spiral
Bacillus infection;Helicobacter pylori has substantial connection with active chronic gastritis, with the chronic stomach of peptic ulcer merger activity
Inflammation also has relationship.The characteristics of its stomach trouble is recurrent exerbation, is not recovered for a long time, and different degrees of pain and worry is brought to patient, very
To being lifelong worry.No matter illness is light, again, the health of all different degrees of influence patient, or even develops into gastric cancer, can not
It reverses, threatens to the mankind.But the drug effect of these drugs for being used to treat stomach trouble is very limited at present, not only side effect it is big,
It is expensive, and treatment time is longer, and it is easy recurrence.
At home, recall rate of the helicobacter pylori in chronic superficial gastritis and atrophic gastritis is respectively
79.61%, 76.09%, the recall rate in duodenal ulcer and gastric ulcer is respectively 84.62%, 77.78%.Sulfuric acid is celebrated
Big mycin, up to 86.8%, has good therapeutic effect to the clearance rate of helicobacter pylori to chronic gastritis and peptic ulcer.
Gentamicin sulphate oral absorption is seldom, is conducive to inhibit helicobacter pylori;Compound vitamins can improve patient's appetite, promote
Into digesting and assimilating.Our hospital's clinic often in 100ml compound vitamins solution be added 240000IU gentamicine sulphate injections and
0.5mg vitamin Bs12Injection mixes the diseases such as loss of appetite, indigestion, enteritis caused by orally taken for curing gastritis and gastritis, takes
Obtain curative effect well.However found in practical clinical, it is existing to be added in 100ml compound vitamins solution
240000IU gentamicine sulphate injections and 0.5mg vitamin Bs12The method of injection still remains following defect:Quality is not
Stablize, the shelf-life is short, and vitamin B12 equistability is poor, and needs matching while using, and production capacity is limited;Therefore, it is lacked for above-mentioned
It falls into, it is necessary to which innovation is advanced optimized to existing compound preparation.
Invention content
The present invention is to solve a kind of celebrating for treating stomach trouble that the above problem in the prior art proposes to tie up B solid systems greatly
Agent and its preparation method and application.
To achieve the above object, the present invention uses following technical scheme:
The first aspect of the invention is to provide a kind of celebrating for treating stomach trouble and ties up B solid pharmaceutical preparations greatly, specifically include with
Lower component:
Further, B solid pharmaceutical preparations, including following components are tieed up greatly in the celebrating for treating stomach trouble:
It is further preferred that B solid pharmaceutical preparations, including following components are tieed up greatly in the celebrating for treating stomach trouble:
Further, B solid pharmaceutical preparations are tieed up greatly in the celebrating for treating stomach trouble, and the gentamicin sulphate is anti-for Foochow
Sheng Su Group Co., Ltd produces, specification 636U/mg.
Further, the solid pharmaceutical preparation is oral preparation, and the oral preparation is tablet, capsule or granule.
The second aspect of the invention is to provide a kind of preparation of the big dimension B solid pharmaceutical preparations of the celebrating as described for treating stomach trouble
Method includes the following steps:
(1) by whole gentamicin sulphates, vitamin B12, vitamin B1, vitamin B2, vitamin B6, talcum powder, with
And the starch with talcum powder equivalent, it is placed in V-Mixer, stirs evenly;
(2) remaining starch is placed in another V-Mixer, and mixture made from above-mentioned steps (1) is poured into, stirred
Uniformly;
(3) solid pharmaceutical preparation is made in the medicinal powder that step (2) is uniformly mixed, is packed, inspection.
Further, the V-Mixer blender rotating speed employed in the step (1) and (2) is 15 revs/min, the time
60 minutes.
Further, the step (3) carries out medicinal powder filling, the automatic capsule filler using automatic capsule filler
Rotating speed is 32 revs/min.
Further, the film laminator is using Autoblisterpackagingmachine, process conditions:32 beats/min;Upper heating temperature:
116 ± 5 DEG C, lower heating temperature:120 ± 5 DEG C, heat sealing temperature:160±5℃.
The third aspect of the invention, which is to provide a kind of celebrating as mentioned for treating stomach trouble, to be tieed up greatly B solid pharmaceutical preparations and is controlling
Treat the application in chronic gastropathy.
The present invention is had the following technical effect that compared with prior art using above-mentioned technical proposal:
B solid pharmaceutical preparations are tieed up greatly in celebrating provided by the present invention for treating stomach trouble, for the deficiency of existing compound preparation, are passed through
Optimize each component compatibility and preparation process, the celebrating obtained for treating stomach trouble is tieed up greatly B solid pharmaceutical preparations and can be provided with sustained release
Steadily, lasting effective blood drug concentration avoids or reduces peak valley phenomenon, is conducive to improve the safety that drug uses, reduces medicine
The adverse reaction of object;Its preparation method of the present invention is simple, and operating parameter is controllable, and production cost is low, is suitble to enterprise scale production.
Specific implementation mode
The present invention is described in more detail below by specific embodiment, for a better understanding of the present invention,
But following embodiments are not intended to limit the scope of the invention.
Embodiment 1
(1) B solid pharmaceutical preparations, including following components are tieed up greatly in the celebrating for being used to treat stomach trouble:
(2) according to above-mentioned formula, the preparation method of the big dimension B solid pharmaceutical preparations of celebrating for treating stomach trouble includes the following steps:
(1) gentamicin sulphate 3600g, vitamin B are weighed1211g, vitamin B11200g, vitamin B2450g, dimension life
Plain B6300g, talcum powder 1800g, starch 2000g set V-Mixer and stir evenly, and rotating speed is 15 revs/min, 60 minutes time;
(2) starch 49000g is weighed, is set in V-Mixer, mixture made from above-mentioned steps (1) is poured into, rotating speed is
It 15 revs/min, 60 minutes time, stirs evenly;
(3) medicinal powder for being mixed evenly step (2), which is granulated, is made granule, or flattens and tablet is made, or uses automatic glue
Capsule filler is packed into capsule, and automatic capsule filler rotating speed is 32 revs/min, polishes and capsule is made;
(4) by the capsule film laminator (Autoblisterpackagingmachine of step (3) fore shaft:32 beats/min;Upper heating temperature:120
DEG C, lower heating temperature:120 DEG C, heat sealing temperature:165 DEG C) it is molded, it is packed, inspection.
Embodiment 2
(1) B solid pharmaceutical preparations, including following components are tieed up greatly in the celebrating for being used to treat stomach trouble:
(2) according to above-mentioned formula, the preparation method of the big dimension B solid pharmaceutical preparations of celebrating for treating stomach trouble includes the following steps:
(1) gentamicin sulphate 4200g, vitamin B are weighed1212g, vitamin B1900g, vitamin B2500g, vitamin
B6450g, talcum powder 1800g, starch 3000g set V-Mixer and stir evenly, and rotating speed is 15 revs/min, 60 minutes time;
(2) starch 46000g is weighed, is set in V-Mixer, mixture made from above-mentioned steps (1) is poured into, rotating speed is
It 15 revs/min, 60 minutes time, stirs evenly;
(3) medicinal powder for being mixed evenly step (2), which is granulated, is made granule, or flattens and tablet is made, or uses automatic glue
Capsule filler is packed into capsule, and automatic capsule filler rotating speed is 32 revs/min, polishes and capsule is made;
(4) by the capsule film laminator (Autoblisterpackagingmachine of step (3) fore shaft:32 beats/min;Upper heating temperature:112
DEG C, lower heating temperature:125 DEG C, heat sealing temperature:160 DEG C) it is molded, it is packed, inspection.
Embodiment 3
(1) B solid pharmaceutical preparations, including following components are tieed up greatly in the celebrating for being used to treat stomach trouble:
(2) according to above-mentioned formula, the preparation method of the big dimension B solid pharmaceutical preparations of celebrating for treating stomach trouble includes the following steps:
(1) gentamicin sulphate 4000g, vitamin B are weighed1210g, vitamin B11000g, vitamin B2400g, dimension life
Plain B6400g, talcum powder 2000g, starch 2000g set V-Mixer and stir evenly, and rotating speed is 15 revs/min, 60 minutes time;
(2) starch 48000g is weighed, is set in V-Mixer, mixture made from above-mentioned steps (1) is poured into, rotating speed is
It 15 revs/min, 60 minutes time, stirs evenly;
(3) medicinal powder for being mixed evenly step (2), which is granulated, is made granule, or flattens and tablet is made, or uses automatic glue
Capsule filler is packed into capsule, and automatic capsule filler rotating speed is 32 revs/min, polishes and capsule is made;
(4) by the capsule film laminator (Autoblisterpackagingmachine of step (3) fore shaft:32 beats/min;Upper heating temperature:116
DEG C, lower heating temperature:120 DEG C, heat sealing temperature:160 DEG C) it is molded, it is packed, inspection.
Specific embodiments of the present invention are described in detail above, but it is intended only as example, the present invention is simultaneously unlimited
It is formed on particular embodiments described above.To those skilled in the art, it is any to the equivalent modifications that carry out of the present invention and
It substitutes also all among scope of the invention.Therefore, without departing from the spirit and scope of the invention made by impartial conversion and
Modification, all should be contained within the scope of the invention.
Claims (9)
1. B solid pharmaceutical preparations are tieed up greatly in a kind of celebrating for treating stomach trouble, which is characterized in that including following components:
2. B solid pharmaceutical preparations are tieed up greatly in the celebrating according to claim 1 for treating stomach trouble, which is characterized in that including with the following group
Point:
3. B solid pharmaceutical preparations are tieed up greatly in the celebrating according to claim 1 for treating stomach trouble, which is characterized in that the sulfuric acid celebrating
Big mycin produces for Foochow antibiotic Group Co., Ltd, specification 636U/mg.
4. B solid pharmaceutical preparations are tieed up greatly in the celebrating according to claim 1 for treating stomach trouble, which is characterized in that the solid system
Agent is oral preparation, and the oral preparation is tablet, capsule or granule.
5. a kind of preparation method of big dimension B solid pharmaceutical preparations of celebrating as described in claim any one of 1-4 for treating stomach trouble, special
Sign is, includes the following steps:
(1) by whole gentamicin sulphates, vitamin B12, vitamin B1, vitamin B2, vitamin B6, talcum powder, Yi Jiyu
The starch of talcum powder equivalent, is placed in V-Mixer, stirs evenly;
(2) remaining starch is placed in another V-Mixer, and mixture made from above-mentioned steps (1) is poured into, stirring is equal
It is even;
(3) solid pharmaceutical preparation is made in the medicinal powder that step (2) is uniformly mixed, is packed, inspection.
6. the preparation method of the big dimension B solid pharmaceutical preparations of the celebrating according to claim 1 for treating stomach trouble, which is characterized in that
V-Mixer blender rotating speed employed in the step (1) and (2) is 15 revs/min, 60 minutes time.
7. the preparation method of the big dimension B solid pharmaceutical preparations of the celebrating according to claim 1 for treating stomach trouble, which is characterized in that
The step (3) carries out medicinal powder filling using automatic capsule filler, and the automatic capsule filler rotating speed is 32 revs/min.
8. the preparation method of the big dimension B solid pharmaceutical preparations of the celebrating according to claim 1 for treating stomach trouble, which is characterized in that
The film laminator uses Autoblisterpackagingmachine, and process conditions are:32 beats/min;Upper heating temperature:116 ± 5 DEG C, lower heating temperature
Degree:120 ± 5 DEG C, heat sealing temperature:160±5℃.
9. a kind of celebrating according to any one of claims 1-4 for treating stomach trouble ties up greatly B solid pharmaceutical preparations and is treating chronic stomach
Application in disease.
Priority Applications (1)
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CN201810684572.4A CN108653302A (en) | 2018-06-28 | 2018-06-28 | B solid pharmaceutical preparations and its preparation method and application are tieed up greatly in a kind of celebrating for treating stomach trouble |
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CN201810684572.4A CN108653302A (en) | 2018-06-28 | 2018-06-28 | B solid pharmaceutical preparations and its preparation method and application are tieed up greatly in a kind of celebrating for treating stomach trouble |
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CN108653302A true CN108653302A (en) | 2018-10-16 |
Family
ID=63773283
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CN201810684572.4A Pending CN108653302A (en) | 2018-06-28 | 2018-06-28 | B solid pharmaceutical preparations and its preparation method and application are tieed up greatly in a kind of celebrating for treating stomach trouble |
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Citations (6)
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---|---|---|---|---|
CN1546053A (en) * | 2003-12-05 | 2004-11-17 | 长春精优药业股份有限公司 | Vitamin B12 composition preparation and its application |
CN1712012A (en) * | 2004-06-23 | 2005-12-28 | 毛友昌 | Preparation containing compound gentamicin procaine |
EP1905436A4 (en) * | 2005-07-12 | 2008-09-24 | Fuchao Li | Synergistic time-delaying agent for local anestheic |
CN102048709A (en) * | 2010-12-17 | 2011-05-11 | 蚌埠丰原涂山制药有限公司 | Gentamycin sulfate capsule and preparation method thereof |
CN102226790A (en) * | 2011-03-31 | 2011-10-26 | 宁波双伟制药有限公司 | Method for determining procaine hydrochloride content in gentamycin procaine vitamin B12 particle by high performance liquid chromatography |
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2018
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CN1546053A (en) * | 2003-12-05 | 2004-11-17 | 长春精优药业股份有限公司 | Vitamin B12 composition preparation and its application |
CN1712012A (en) * | 2004-06-23 | 2005-12-28 | 毛友昌 | Preparation containing compound gentamicin procaine |
EP1905436A4 (en) * | 2005-07-12 | 2008-09-24 | Fuchao Li | Synergistic time-delaying agent for local anestheic |
CN102048709A (en) * | 2010-12-17 | 2011-05-11 | 蚌埠丰原涂山制药有限公司 | Gentamycin sulfate capsule and preparation method thereof |
CN102226790A (en) * | 2011-03-31 | 2011-10-26 | 宁波双伟制药有限公司 | Method for determining procaine hydrochloride content in gentamycin procaine vitamin B12 particle by high performance liquid chromatography |
CN102771670A (en) * | 2012-08-03 | 2012-11-14 | 中国农业科学院植物保护研究所 | Artificial diet for predative natural enemy insect-true bugs |
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Title |
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关志宇: "《药物制剂辅料与包装材料》", 31 January 2017, 中国医药科技出版社 * |
南京药学院药剂学教研组: "《药剂学 第2版》", 31 May 1985, 人民卫生出版社 * |
王淑花等: "庆大霉素+维生素B1+维生素B12联合针剂在手术切口中的应用", 《中国社区医师(医学专业)》 * |
陈志东等: "胃康胶囊的制备及质量标准的建立", 《中国药房》 * |
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