CN1141982C

CN1141982C - Anticoagulant hemodialysis liquid

Info

Publication number: CN1141982C
Application number: CNB021146713A
Authority: CN
Inventors: 桂保松; 高卫华; 姚纲练; 桂琳
Original assignee: 桂保松
Priority date: 2002-07-11
Filing date: 2002-07-11
Publication date: 2004-03-17
Anticipated expiration: 2022-07-11
Also published as: CN1418707A

Abstract

The present invention relates to an anticoagulant hemodialysis liquid which has the advantages of obvious anticoagulant effects, good biocompatibility, simple, convenient and safe use, no metabolic alkalosis and no hypernatremia. The present invention comprises 100 to 400 g/L of sodium chloride, less than 6 g/L of magnesium chloride, less than 18 g/L of potassium chloride, 20 to 100 g/L of sodium citrate, 2 to 15 g/L of citric acid and less than 60 g/L of dextrose. A manufacturing method of the present invention comprises the following operating steps: (1) a clean plastic drum is flushed by reverse osmosis water, is disinfected by ethanol, and is flushed by water for injection to be reserved; (2) the powder of the sodium citrate, the magnesium chloride and the potassium chloride, and citric acid are weighed according to the content of each component and the gnotobiotic operating rule, the weighed dextrose is added after the powder of the sodium citrate, the magnesium chloride and the potassium chloride, and the citric acid are fully dissolved by adding right amount of water for injection to be dissolved and filtered, and the total amount of the water for injection is added to be uniformly stirred; (3) finally, the solution is contained in the disinfected plastic drum.

Description

A kind of anticoagulant hemodialysis liquid

One, technical field:

The present invention relates to a kind of blood dialysis solution that is used for blood purification treatment, especially relate to a kind of anticoagulant hemodialysis liquid

Two, background technology:

In recent decades, many acute renal failures and chronic renal failure patients's life has not only been saved in the development of blood purification technology, has also brought Gospel for all kinds of poisoning patients and many critical patients.The biggest problem in the high-risk bleeding patient blood purification treatment is to keep the anticoagulant problem of extracorporeal circulation at present, particularly be associated with the hemodialysis patient of bleeding tendency, it is hemorrhage that existing anticoagulant method all can add the heavy patient, brings very big difficulty for the enforcement of blood purification technology.Comprehensive research both at home and abroad, the high-risk bleeding patient for the dialysis indication is arranged does not also have a kind of ideal anticoagulant method at present, that can consider to use has or not the heparin blood dialysis, but the nursery work load is too big, and the dialyser blood coagulation easily takes place, and the curative effect that causes dialysing is undesirable.Recent study shows, citrate partially anti-freezing function method has shown a lot of superioritys in hemodialysis, can obviously reduce hemorrhage incidence rate, and the advantage that has the raising urea nitrogen clearance and prolong the blood filter useful life, but this anticoagulant method complex operation, and can cause metabolic alkalosis and hypernatremia, be difficult to apply.

Three, summary of the invention:

The present invention provides a kind of anticoagulant hemodialysis liquid in order to solve the weak point in the above-mentioned background technology, and it has tangible anticoagulant effect, no metabolic alkalosis and hypernatremia, safety easy to use.

For achieving the above object, the technical solution used in the present invention is:

A kind of anticoagulant hemodialysis liquid, its special character are to comprise following each component: sodium chloride 100～215b, magnesium chloride 4.5～6b, potassium chloride 9～18b, sodium citrate 78～100b, citric acid 9～15b, glucose 35～60b, wherein b is g/L.

A kind of manufacture method of anticoagulant hemodialysis liquid, its special character are to comprise following operating procedure: (1) is washed the Plastic Drum of cleaning with reverse osmosis water, and uses ethanol disinfection, and the flushing of reuse water for injection is standby; (2) according to each components contents and limit bacterium operation rules, take by weighing sodium chloride 100～215b, magnesium chloride 4.5～6b, potassium chloride 9～18b, sodium citrate 78～100b, citric acid 9～15b, wherein b is g/L, after adding an amount of water for injection and dissolving fully, add the glucose 35～60b that weighs up, wherein b is g/L, dissolution filter, add to the full amount of water for injection again, stir evenly; (3) be contained at last in the Plastic Drum that disinfects.

The present invention against existing technologies, its advantage is:

The present invention adopts sodium citrate can be made into anticoagulant hemodialysis liquid as base and anticoagulant, physicochemical property is stable, the citrate blood dialysis solution has tangible partially anti-freezing function effect, can keep the blood purification cardiopulmonary bypass time, and its anticoagulant effect obviously is better than not having the heparin hemodialysis; Use the present invention not have metabolic alkalosis and hypernatremia, more traditional local sodium citrate anticoagulant handy and safe also can improve the clearance rate of dialyser by reducing the activation of blood coagulation system.

Four, the specific embodiment:

The present invention includes following each component: sodium chloride, magnesium chloride, potassium chloride, sodium citrate, citric acid, glucose.Each constituent content scope is: sodium chloride 100～215g/L, magnesium chloride 4.5～6g/L, potassium chloride 9～18g/L, sodium citrate 78～100g/L, citric acid 9～15g/L, glucose 35～60g/L, manufacture method of the present invention comprises following operating procedure: (1) is washed the Plastic Drum of cleaning with reverse osmosis water, and use ethanol disinfection, the flushing of reuse water for injection is standby; (2) according to each components contents and limit bacterium operation rules, take by weighing sodium citrate, sodium chloride, magnesium chloride, potassium chloride powder and citric acid, after adding an amount of water for injection and dissolving fully, add the glucose dissolving that weighs up, after the filtration, add to the full amount of water for injection again, stir evenly; (3) transfer pH value with acetic acid, make that the pH value of dialysis solution is between 7.2～7.4 after 34 times of the dilutions, become to be contained in the Plastic Drum that disinfects at last.

Embodiment 1:

(1) with the Plastic Drum of cleaning with reverse osmosis water flushing 3 times, and with 75% ethanol disinfection, reuse water for injection washes standby; (2) take by weighing sodium citrate 78g, sodium chloride 100g, magnesium chloride 4.5g, potassium chloride 9g and citric acid 9g, after being dissolved in an amount of water for injection and dissolving fully, add the glucose 35g dissolving that weighs up, after the filtration, add injection water to 1 again and rise concentrate dialysate, stir evenly; (3) be contained at last in the Plastic Drum that disinfects.

The present invention calculates principle according to dialysis solution basic demand and base, be made into 34 times of concentrate blood dialysis solution of citrate, by haemodialysis control unit dilution and detection, the dialysate samples after the timing acquiring dilution, detect its electrolyte, conductivity, pH value, observe its physicochemical property.And adopt open extracorporeal circulation method simulate blood dialysis, and gather dialysis fluid side and blood side sample, with colorimetry sodium citrate is carried out quantitative analysis by 6 kinds of dialyzers.10 dogs and the different period row of 30 routine high-risk bleeding renal failure patients there are not the hemodialysis of heparin bicarbonate, the hemodialysis of citrate hemodialysis liquid and the saturating hemodialysis of heparin bicarbonate blood, timing acquiring arterial end and vein end blood sample are measured activated clotting time (ACT), BUN and the Cr of arteriovenous end in the dialysis procedure and ALT, AST, TBIL, DBIL, the Ca before and after the dialysis ²⁺, Na ⁺, CI ^-, HCO ^3-, record changes of vital signs and dialysis procedure medium-sized vein are pressed and are changed, and utilize the fibrin layer deposition and the hemocyte of scanning electron microscopic observation filter doughnut inner membrance to assemble situation.

10 preparations of the present invention citrate concentrates the anticoagulant dialysis solution and all can detect by dialysis machine smoothly, enters the dialysis solution circulation, and its physicochemical property is stable: the pH value of circulation dialysis solution is stabilized between 7.2～7.4, and conductivity stablizes 14.0 ± 1, Na ⁺Concentration testing result scope is at 135～145mmoI/L, K ⁺The concentration detection range is at 3.5～4.0mmoI/L, CI ^-The concentration detection range is at 91～100mmol/L.(20 ℃-25 ℃) were placed 24,72 hours under the room temperature, pH value, conductivity and 1 all preceding no difference of science of statistics, microbial check conformance with standard.In-vitro simulated hemodialysis experiment shows that sodium citrate can enter the circulation of blood side by conventional filter, but different dialysers is to the percent of pass difference of sodium citrate, descending F60＞FB-130UGA＞GA-HP130＞FB-130AGA＞F6＞the WS-70 that is followed successively by of the sodium citrate concentration of blood circulation side, and significant difference is arranged, and F60 wherein and FB-130UGA can reach local concentration and surpass 6mmoI/L.In addition, sodium citrate is subjected to the influence of velocity of blood flow and osmotic pressure by the concentration of dialyzer, is not subjected to the acid-base value that blood circulation surveys and the influence of osmotic pressure.In the citrate hemodialysis liquid blood dialysis, the hemodialysis venous pressure did not raise in 4 hours, no extracorporeal circulation blood coagulation, the ACT of ACT behind the dialyser before than dialyser obviously prolongs (P＜0.01), the blood calcium of blood calcium behind the dialyser before than dialyser has the BUN behind remarkable decline (P＜0.01) dialyser, Cr has remarkable decline (P＜0.01) before than dialyser, compare with the bicarbonate hemodialysis of anticoagulant heparin, the whole blood clearance rate of its dialyser slightly improves, but no difference of science of statistics (P＞0.05), BUN after 4 hours dialyses, Cr, TBIL, DBIL obviously descends, and compares that there were significant differences (P＜0.01) before the dialysis.And ALT, AST, Ca ², K ⁺, Na ⁺, CI ^-, HCO ^3-All do not have and obviously change (P＞0.05).Scanning electron microscope shows: the fibrin deposition of citrate hemodialysis anticoagulant group is minimum, and hemocyte does not almost have gathering, and does not have heparin group and heparin group all has tangible fibrin deposition and hemocyte to assemble, even forms thrombosis.

Claims

1, a kind of anticoagulant hemodialysis liquid is characterized in that comprising following each component: sodium chloride 100～215b, magnesium chloride 4.5～6b, potassium chloride 9～18b, sodium citrate 78～100b, citric acid 9～15b, glucose 35～60b, wherein b is g/L.

2, a kind of manufacture method of anticoagulant hemodialysis liquid, it is characterized in that comprising following operating procedure: (1) is washed the Plastic Drum of cleaning with reverse osmosis water, and uses ethanol disinfection, and the flushing of reuse water for injection is standby; (2) according to each components contents and limit bacterium operation rules, take by weighing sodium chloride 100～215b, magnesium chloride 4.5～6b, potassium chloride 9～18b, sodium citrate 78～100b, citric acid 9～15b, wherein b is g/L, after adding an amount of water for injection and dissolving fully, add the glucose 35～60b that weighs up, wherein b is g/L, dissolution filter, add to the full amount of water for injection again, stir evenly; (3) be contained at last in the Plastic Drum that disinfects.