Low-molecular-weight heparin calcium injection

A low-molecular-weight heparin calcium and injection technology, which is applied in the fields of high-quality low-molecular-weight heparin calcium injection, water injection, powder injection and infusion, can solve the problems of cumbersomeness, long production cycle, and unsuitable for industrial production.

Active Publication Date: 2013-09-25
江苏大同盟制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these preparation methods are too cumbersome and have a long production cycle, so they are not suitable for industrial production.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1, raw material preparation process

[0030] 1. Acidification: Take 30.0kg of water for injection and add it to a 50L sterilized clean stainless steel bucket, then weigh 5.0kg of heparin sodium that has passed the inspection, and add it into the stainless steel bucket under stirring to dissolve it. After all the solution is dissolved, add the treated acidic resin (add the acidic resin to adjust the pH of the solution to 2.5~2.7), and continue to stir for 0.5 hours after the pH is qualified. The resin was removed by filtration. 2. Cracking: under stirring, weigh 50g of sodium nitrite and add it to the resin-removing solution in portions (about 0.5 hours to add), continue to stir and react for 2 hours after adding, then stop stirring, put it in the refrigerator at low temperature and continue cracking for 48 Hour. 3. Neutralization: Take out the lysate from the refrigerator, slowly add calcium oxide, adjust the pH value of the solution to 6.0-6.5, and then fi...

Embodiment 2

[0031] Embodiment 2, raw material preparation process

[0032] With the method of Example 1, step (2) after cracking for 48 hours, further includes, adding acidic resin at low temperature to adjust the pH value to 2.5 ~ 2.7 again and adding 5 grams of cysteine, stirring for 30 minutes; then proceed to step (4 ) of alcohol precipitation. Finally, 3050 grams of low-molecular-weight heparin calcium were obtained.

Embodiment 3

[0033] Embodiment 3, raw material preparation process

[0034] 1. Acidification: Take 30.0kg of water for injection and add it to a 50L sterilized clean stainless steel bucket, then weigh 5.0kg of heparin sodium that has passed the inspection, and add it into the stainless steel bucket under stirring to dissolve it. After all dissolved, add glacial acetic acid to adjust the pH value to 3.0, and continue to stir for 0.5 hours after the pH is qualified. 2. Cracking: under stirring, weigh 50g of sodium nitrite and add it to the resin-removing solution in portions (about 0.5 hours to add), after adding, continue to stir and react for 2 hours, then stop stirring, put it in the refrigerator at low temperature and continue cracking for 48 Hour. 3. Neutralization: Take out the lysate from the refrigerator, slowly add calcium oxide, adjust the pH value of the solution to 6.0-6.5, and then filter. 4. Alcohol precipitation: add 10% anhydrous calcium chloride ethanol solution in a magne...

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PUM

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Abstract

The invention belongs to the technical field of medicinal preparation dosage forms and specifically relates to a low-molecular-weight heparin calcium injection, including hydro-acupuncture, powder injection and transfusion. The invention aims to provide low-molecular-weight heparin calcium and a low-molecular-weight heparin calcium product so as to overcome defects in the prior art. The invention provides the low-molecular-weight heparin calcium and the low-molecular-weight heparin calcium product which have advantages of high activity, low sodium and nitrate and simple technology. The low-molecular-weight heparin calcium injection provided by the invention is prepared by the following process: acidic resin acidification, sodium nitrite cracking, calcium oxide neutralization, alcohol precipitation of an anhydrous calcium chloride ethanol solution, filtration and drying. The invention provides the low-molecular-weight heparin calcium injection which is safe, effective, stable and quality-controllable.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparation dosage forms, and in particular relates to a high-quality low-molecular-weight heparin calcium injection, including water injection, powder injection and infusion. Background technique [0002] Bioactive heparin has been in clinical use for nearly a hundred years since it was discovered. It is the drug of choice for preventing postoperative thrombosis and treating acute venous thrombosis. In addition, heparin and its derivatives are also widely used for regulating blood lipids, anti-inflammatory, anti- It is still one of the most important biochemical drugs for allergies and immune regulation, and it is also one of the main foreign exchange-earning drugs exported in my country. [0003] Heparin is a kind of mucopolysaccharide, which widely exists in animal organs and tissues such as intestinal mucosa and lung, and becomes medicinal heparin sodium after fat removal and protein re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/14A61K31/727C08B37/10A61P7/02
Inventor 王美心刘本朝陈创华
Owner 江苏大同盟制药有限公司
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