Extraction technology of crude heparin sodium

An extraction process, the technology of heparin sodium, which is applied in the field of drug extraction, can solve the problems of low purity, temperature, unreasonable solution concentration control, and many impurities in crude heparin sodium, and achieve the effect of clear steps and easy division of labor and cooperation

Inactive Publication Date: 2015-11-18
JIANGSU LIANZHONG CASING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present crude product heparin sodium is mainly prepared by physical and chemical methods to precipitate heparin sodium, but in the process of extraction, the temperature and solution concentration in many processes are unreasonably controlled, resulting in more impurities in crude product heparin sodium. very low purity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] The invention discloses a crude heparin sodium extraction process, the main steps are as follows:

[0019] 1) Hydrolysis: Put the crushed raw materials into the reactor, and add a hydrolyzate 6 to 8 times the volume of the raw materials into the reactor. The components of the hydrolyzate are water, protease and salt, and the content of protease is 1 / 2 of the weight of water. 0.1~0.2%, the content of salt is 2~4% of water weight. Add NaOH to adjust the pH of the solution to 8~9; heat the solution to 40~50°C and keep it warm for 2.5~3h; heat the temperature to 90~100°C and add HCl to adjust the pH of the solution to 6~7 and keep it warm for 30min ; Filter with nylon mesh cloth, filter the residue according to the above steps for secondary filtration, and combine the filtrate twice;

[0020] 2) Adsorption: Add Rohm and Haas AMBERLITE FPA98CL resin to the filtrate, assuming that the filtrate just submerges the resin, adjust the temperature to 65~70°C, stir and adsorb for 7...

Embodiment 2

[0025] On the basis of Example 1, the content of each component of the hydrolyzate in step (1) is changed, the content of protease is 0.2-0.3% of the water weight, and the content of table salt is 4-6% of the water weight.

Embodiment 3

[0027] On the basis of Example 1, the content of each component of the hydrolyzate in step (1) is changed, the content of protease is 0.3-0.4% of the water weight, and the content of table salt is 6-8% of the water weight.

[0028] The results of Example 1, Example 2 and Example 3 show that the crude product heparin sodium prepared in Example 2 has less impurities and high precision, and its effect is the best.

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PUM

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Abstract

The invention relates to an extraction technology of crude heparin sodium. The extraction technology comprises the following steps: hydrolysis: putting broken raw materials into a reaction kettle, adding a hydrolysis liquid into the reaction kettle, adding resin into filtrate, stirring, siphoning the supernatant liquid, collecting the resin, washing the resin in clean water till the resin is neutral, and draining; desorption: soaking the resin with dilute saline water, discarding the soaking solution, adding concentrated saline water into the resin twice, stirring, washing, filtering, and keeping the washing liquid; alcohol precipitation: adding ethyl alcohol into the washing liquid, stirring, carrying out standing, discarding the supernatant liquid, keeping the bottom sediment, draining the sediment, adding ethyl alcohol, washing, unwatering, and collecting dehydrated heparin sodium sediment; drying: drying the heparin sodium sediment in vacuum. The extraction technology of crude heparin sodium provided by the invention has the following advantages: all the steps are clear, so that labor division and cooperation are facilitated; the contents of various important additives have quantitative marks and are authenticated through tests, and the sequence among the additives is clear.

Description

technical field [0001] The invention relates to the field of medicine extraction, in particular to a crude heparin sodium extraction process. Background technique [0002] As an anticoagulant, heparin was officially used in clinical treatment in 1935 and has a history of more than 70 years. So far, it is still the most effective and clinically used anticoagulant drug in the world, and it has been included in the Pharmacopoeia of major countries in the world. [0003] The present crude product heparin sodium is mainly prepared by physical and chemical methods to precipitate heparin sodium, but in the process of extraction, the temperature and solution concentration in many processes are unreasonably controlled, resulting in more impurities in crude product heparin sodium. The purity is very low. Contents of the invention [0004] The technical problem to be solved by the present invention is to provide a crude heparin sodium extraction process with high purity and reasona...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 顾永军
Owner JIANGSU LIANZHONG CASING
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