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A kind of preparation method of high-quality dalteparin sodium

The technology of high-quality dalteparin sodium and heparin sodium is applied in the preparation of medicinal chemicals and the field of high-quality dalteparin sodium, which can solve the problems of inability to realize industrialized production, complicated operation steps, long purification cycle, etc., and achieves low cost, The effect of improving heparin yield and simple method

Active Publication Date: 2016-01-06
CHANGZHOU QIANHONG BIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the product quality of dartparin sodium obtained by ion exchange chromatography and molecular exclusion method is high, the operation steps are cumbersome, the purification cycle is long, and the cost is high. It is only suitable for the purification of a small amount of dartparin sodium and cannot be industrialized.

Method used

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  • A kind of preparation method of high-quality dalteparin sodium

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Effect test

Embodiment 1

[0034] A preparation method of high-quality dalteparin sodium: ①Add 30kg of high-quality heparin sodium to the reaction tank, then add 100L of water for injection to make it completely dissolved, adjust the pH to 6.0 with 1mol / L acetic acid, and control the temperature at 70 ℃, add 150 g of sodium nitrite, stir and react at room temperature for 5 hours to obtain a heparin degradation solution. ② Add an appropriate amount of sodium hydroxide solution to the heparin degradation solution to adjust the pH of the system to 8 to terminate the degradation reaction, and then add 300 g of sodium borohydride for reduction for 2 hours. After the reaction is completed, adjust the pH of the system to 7.0 with an appropriate amount of sodium hydroxide solution, and discharge. That is, the reducing solution is obtained. 3. Add 0.5 times the volume of alcohol to the reducing solution in step 2. according to the ratio of weight (kg) of the reducing solution: volume of alcohol (L)=1:0.5, stir a...

Embodiment 2

[0036]A preparation method of high-quality dalteparin sodium: 1. Add 30 kg of heparin sodium high-quality goods accurately weighed into a reaction tank, then add 100 L of water for injection, and stir at room temperature until it is completely dissolved to obtain a solution; use 1 mol / L of acetic acid to adjust the pH to 3.5, the temperature was controlled at 70° C., 170 g of sodium nitrite was added, and the mixture was stirred and reacted at room temperature for 4.5 hours to obtain a heparin degradation solution. ② Add an appropriate amount of potassium hydroxide solution to the above-mentioned heparin degradation solution to adjust the pH of the system to 8.5 to terminate the degradation reaction, then add 320 g of sodium borohydride for reduction for 2 hours, and after the reaction is completed, adjust the pH of the system to 6.2 with an appropriate amount of potassium hydroxide solution to obtain reducing solution. 3. Add 0.5 times the volume of alcohol to the reducing so...

Embodiment 3

[0038] A preparation method of high-quality dalteparin sodium: 1. Add 30 kg of heparin sodium high-quality goods accurately weighed into a reaction tank, then add 100 L of water for injection, and stir at room temperature until it is completely dissolved to obtain a solution; use 1 mol / L of acetic acid to adjust the pH to 2.5, the temperature was controlled at 70° C., 200 g of sodium nitrite was added, and the mixture was stirred and reacted at room temperature for 4.5 hours to obtain a heparin degradation solution. ②Add an appropriate amount of sodium hydroxide solution to the above-mentioned heparin degradation solution to adjust the pH of the system to 9.5 to terminate the degradation reaction, then add 400 g of sodium borohydride for reduction for 2 hours, and after the reaction is completed, adjust the pH of the system to 6.8 with an appropriate amount of sodium hydroxide solution to obtain reducing solution. ③Add 18L of alcohol to the reducing solution in step ② accordin...

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Abstract

The invention relates to a method for preparing high-quality dalteparin sodium. The method comprises the steps: (1) degrading: dissolving heparin sodium, adjusting the pH value, adding sodium nitrite, and stirring; (2) carrying out reduction: adding a hydroxide solution until a degrading reaction is terminated, then, adding sodium borohydride to reduce, and adjusting the pH value; (3) carrying out alcohol precipitation: carrying out first-time alcohol precipitation and second-time alcohol precipitation sequentially with alcohol, so as to obtain a dissolved solution subjected to twice alcohol precipitation; (4) carrying out ultrafiltration: carrying out ultrafiltration on the dissolved solution subjected to twice alcohol precipitation with an ultrafiltration membrane with the molecular weight cutoff of 10,000, and stopping ultrafiltration when the solution is concentrated to 45% the original volume; (5) disinfecting; (6) freeze-drying. According to dalteparin sodium prepared by the method disclosed by the invention, the quality is obviously higher than that in the EP (European Pharmacopeia) standard of the current version, the heparin yield is obviously increased, and the method is simple and feasible; in addition, the method is short in production time, mild in conditions and low in cost, is applicable to industrial production and has important application prospects.

Description

technical field [0001] The invention relates to the preparation of a medicinal chemical in the field of medicine and chemistry, in particular to a preparation method of high-quality fine dalteparin sodium. Background technique [0002] Dartparin sodium is a low-molecular-weight heparin sodium salt. Dartparin sodium is a low-molecular-weight heparin, which is suitable for the prevention of coagulation and deep vein thrombosis in hemodialysis; unstable coronary artery disease; prevention of surgery-related thrombosis form. Approved by the FDA in 1996 for the prevention of deep vein thrombosis in patients undergoing hip replacement or abdominal surgery. It is also used simultaneously with aspirin to prevent the onset of ischemic cardiac complications and non-Q wave myocardial infarction in patients with unstable angina. Data from clinical studies show that there is no overall difference in the efficacy and safety of dartparin between elderly patients and young patients. [0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 周翔金晶叶鸿萍
Owner CHANGZHOU QIANHONG BIOPHARMA
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