CN1141982C - Anticoagulant hemodialysis liquid - Google Patents
Anticoagulant hemodialysis liquid Download PDFInfo
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- CN1141982C CN1141982C CNB021146713A CN02114671A CN1141982C CN 1141982 C CN1141982 C CN 1141982C CN B021146713 A CNB021146713 A CN B021146713A CN 02114671 A CN02114671 A CN 02114671A CN 1141982 C CN1141982 C CN 1141982C
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- Prior art keywords
- water
- chloride
- injection
- sodium citrate
- citric acid
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- 238000001631 haemodialysis Methods 0.000 title claims abstract description 23
- 230000000322 hemodialysis Effects 0.000 title claims abstract description 22
- 239000003146 anticoagulant agent Substances 0.000 title claims abstract description 19
- 229940127219 anticoagulant drug Drugs 0.000 title claims abstract description 19
- 239000007788 liquid Substances 0.000 title claims abstract description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 33
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims abstract description 22
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 20
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 18
- 239000001509 sodium citrate Substances 0.000 claims abstract description 18
- 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 claims abstract description 18
- 239000008215 water for injection Substances 0.000 claims abstract description 14
- 229910001629 magnesium chloride Inorganic materials 0.000 claims abstract description 11
- 239000001103 potassium chloride Substances 0.000 claims abstract description 11
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 10
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 10
- 239000011780 sodium chloride Substances 0.000 claims abstract description 9
- 238000001223 reverse osmosis Methods 0.000 claims abstract description 5
- 238000004519 manufacturing process Methods 0.000 claims abstract description 4
- 238000000034 method Methods 0.000 claims description 10
- 239000008103 glucose Substances 0.000 claims description 8
- 238000004140 cleaning Methods 0.000 claims description 4
- 238000011010 flushing procedure Methods 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 4
- 238000003756 stirring Methods 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- 241000894006 Bacteria Species 0.000 claims description 3
- 238000011017 operating method Methods 0.000 claims description 3
- 238000004090 dissolution Methods 0.000 claims description 2
- 208000029422 Hypernatremia Diseases 0.000 abstract description 4
- 206010027423 Metabolic alkalosis Diseases 0.000 abstract description 4
- 230000002429 anti-coagulating effect Effects 0.000 abstract description 3
- 239000000843 powder Substances 0.000 abstract description 3
- 239000000243 solution Substances 0.000 abstract description 2
- 239000008121 dextrose Substances 0.000 abstract 2
- 210000004369 blood Anatomy 0.000 description 19
- 239000008280 blood Substances 0.000 description 19
- 238000000502 dialysis Methods 0.000 description 9
- 239000000385 dialysis solution Substances 0.000 description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 7
- 230000004087 circulation Effects 0.000 description 6
- 208000032843 Hemorrhage Diseases 0.000 description 5
- 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 5
- 238000005516 engineering process Methods 0.000 description 5
- 229960002897 heparin Drugs 0.000 description 5
- 229920000669 heparin Polymers 0.000 description 5
- 238000000746 purification Methods 0.000 description 5
- 239000011575 calcium Substances 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 description 3
- 102000009123 Fibrin Human genes 0.000 description 3
- 108010073385 Fibrin Proteins 0.000 description 3
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 3
- 208000034158 bleeding Diseases 0.000 description 3
- 230000000740 bleeding effect Effects 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 239000012141 concentrate Substances 0.000 description 3
- 230000008021 deposition Effects 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 238000010790 dilution Methods 0.000 description 3
- 239000012895 dilution Substances 0.000 description 3
- 229950003499 fibrin Drugs 0.000 description 3
- 210000003677 hemocyte Anatomy 0.000 description 3
- 229940000351 hemocyte Drugs 0.000 description 3
- 239000011734 sodium Substances 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 230000023555 blood coagulation Effects 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000007710 freezing Methods 0.000 description 2
- 229940019334 heparin group antithrombotic drug Drugs 0.000 description 2
- 230000003204 osmotic effect Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 208000009304 Acute Kidney Injury Diseases 0.000 description 1
- 241000282472 Canis lupus familiaris Species 0.000 description 1
- 206010053567 Coagulopathies Diseases 0.000 description 1
- 206010062713 Haemorrhagic diathesis Diseases 0.000 description 1
- 208000005374 Poisoning Diseases 0.000 description 1
- 208000001647 Renal Insufficiency Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- PNNCWTXUWKENPE-UHFFFAOYSA-N [N].NC(N)=O Chemical compound [N].NC(N)=O PNNCWTXUWKENPE-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 230000002612 cardiopulmonary effect Effects 0.000 description 1
- 208000020832 chronic kidney disease Diseases 0.000 description 1
- 208000022831 chronic renal failure syndrome Diseases 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 238000004737 colorimetric analysis Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 235000012489 doughnuts Nutrition 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 208000031169 hemorrhagic disease Diseases 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 230000020971 positive regulation of blood coagulation Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000004445 quantitative analysis Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000009738 saturating Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
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- External Artificial Organs (AREA)
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
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 (2)
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021146713A CN1141982C (en) | 2002-07-11 | 2002-07-11 | Anticoagulant hemodialysis liquid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021146713A CN1141982C (en) | 2002-07-11 | 2002-07-11 | Anticoagulant hemodialysis liquid |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1418707A CN1418707A (en) | 2003-05-21 |
| CN1141982C true CN1141982C (en) | 2004-03-17 |
Family
ID=4743232
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB021146713A Expired - Fee Related CN1141982C (en) | 2002-07-11 | 2002-07-11 | Anticoagulant hemodialysis liquid |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1141982C (en) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102006039675B4 (en) * | 2006-08-24 | 2015-10-22 | Fresenius Medical Care Deutschland Gmbh | Method and device for filling an adding device of a therapy device |
| CN101254316B (en) * | 2007-12-04 | 2010-06-23 | 中国人民解放军第二军医大学 | Blood filtering replacement liquid prescription special for anti congealing |
| CN102973943A (en) * | 2012-12-17 | 2013-03-20 | 李大鹏 | Novel blood storage anticoagulant and preparation method thereof |
| CN107854481A (en) * | 2017-10-27 | 2018-03-30 | 宋宏婷 | A kind of collocation method of blood dialysis solution |
| CN107684558A (en) * | 2017-10-27 | 2018-02-13 | 宋宏婷 | A kind of blood dialysis solution |
| CN107890471A (en) * | 2017-10-27 | 2018-04-10 | 宋宏婷 | A kind of anticoagulant hemodialysis liquid |
| CN108685942A (en) * | 2018-04-23 | 2018-10-23 | 杨荣利 | It is a kind of for citrate anti-freezing without calcium displacement liquid/dialyzate |
| CN113826611A (en) * | 2021-08-11 | 2021-12-24 | 北京尚修堂医药科技有限公司 | A kind of sodium citrate solution and preparation technology |
| CN119454938B (en) * | 2024-11-15 | 2025-07-25 | 广州骐骥生物科技有限公司 | Citric acid dialysis concentrated solution and preparation method thereof |
-
2002
- 2002-07-11 CN CNB021146713A patent/CN1141982C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1418707A (en) | 2003-05-21 |
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