Improved low-molecular weight heparin calcium raw material medicine and preparation thereof

A low-molecular-weight heparin and calcium raw material technology, which is applied in the field of improvement of known marketed pharmaceutical raw materials, can solve problems such as unfavorable drug quality

Active Publication Date: 2017-05-31
HAINAN UNIPUL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this is also in line with the current national standards, it is obviously very detrimental to the improvement of drug quality

Method used

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  • Improved low-molecular weight heparin calcium raw material medicine and preparation thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0040] Example 1: (1) Acidification: Take 24.0kg of water for injection and add it to a 50L sterilized clean stainless steel bucket, then weigh 5.0kg of heparin sodium, add it into the stainless steel bucket under stirring to dissolve it; add strong acid Cationic resin (pre-treated with 6N hydrochloric acid) to adjust the pH of the solution to 2.0~2.4, and continue to stir for 0.5 hours after the pH is qualified; filter to remove the resin (wash the resin with an appropriate amount of water). (2) Cleavage: Under stirring, weigh 100g of sodium nitrite and dissolve it in 6Kg of 50% ethanol (v / v) solution, add it to the solution of resin removal, stir and react for 2 hours after adding, then stop stirring, put Put it in the refrigerator and continue cracking for 48 hours at low temperature; (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, add sodium borohydride solution to neutralize unreacted ...

Embodiment 2

[0041] Example 2: (1) Acidification: Take 20.0kg of water for injection and add it to a 50L sterilized clean stainless steel bucket, then weigh 5.0kg of heparin sodium, add it into the stainless steel bucket under stirring to dissolve it; add strong acid Cationic resin (pre-treated with 6N hydrochloric acid) to adjust the pH of the solution to 2.0~2.4, and continue to stir for 0.5 hours after the pH is qualified; filter to remove the resin (wash the resin with an appropriate amount of water). (2) Cracking: Under stirring, weigh 100g of sodium nitrite and dissolve it in 10Kg of 50% ethanol (v / v) solution, add it to the solution of resin removal, stir and react for 2 hours after adding, then stop stirring, put Put it in the refrigerator and continue cracking for 48 hours at low temperature; (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, add sodium borohydride solution to neutralize unreacted...

Embodiment 3

[0042]Example 3: (1) Acidification: Take 19.0kg of water for injection and add it to a 50L sterilized clean stainless steel bucket, then weigh 5.0kg of heparin sodium, add it into the stainless steel bucket under stirring to dissolve it; add strong acid Cationic resin (pre-treated with 6N hydrochloric acid) adjusts the pH of the solution to 2.0~2.4, and continues to stir for 0.5 hours after the pH is qualified; filter to remove the resin (wash the resin with an appropriate amount of water), and slowly add 1L of ethanol. (2) Cracking: Under stirring, weigh 100g of sodium nitrite and dissolve it in 10Kg of 50% ethanol (v / v) solution, add it to the solution of resin removal, stir and react for 2 hours after adding, then stop stirring, put Put it in the refrigerator for 48 hours at low temperature; (3) Neutralization: Take out the lysate from the refrigerator; slowly add calcium oxide to adjust the pH value of the solution to 6.0-6.5, add sodium borohydride solution to neutralize t...

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, particularly relates to a low-molecular weight heparin calcium raw material medicine and a preparation thereof, and aims at providing low-molecular weight heparin calcium and a low-molecular weight heparin calcium product to overcome the defects of the prior art. The raw material medicine is prepared by the processes of acid resin acidification, sodium nitrite pyrolysis, calcium oxide neutralization, anhydrous calcium chloride ethanol solution alcohol precipitation, and filtering and drying. Particularly, nitrous acid pyrolysis with relatively low pH area and relatively high dose is achieved in the presence of ethanol with a certain concentration range, the low-molecular weight heparin calcium preparation up to the standard is prepared, and a safe, effective, safe and quality-controlled low-molecular weight heparin calcium preparation is finally provided.

Description

technical field [0001] The present invention belongs to the technical field of improvement of known marketed drug raw materials, and specifically relates to a high-quality raw material of low-molecular-weight heparin calcium (also called "natroparin calcium" raw material), which can be used to prepare the existing low-molecular-weight heparin calcium raw material. Preparations such as needles and powder injections. Background technique [0002] Low molecular weight heparin (also known as low molecular weight heparin, LMWH) is a kind of oligosaccharide mixture with lower molecular weight obtained by fractionating or degrading unfractionated heparin as the starting material. It has anti-Xa activity and can inhibit the formation of thrombus and arteriovenous thrombosis in vivo and in vitro, but it does not affect platelet aggregation and the combination of fibrinogen and platelets. It is an anticoagulant drug developed in the 1980s, which is obtained by splitting unfractionate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10A61K31/727A61P7/02
CPCA61K31/727C08B37/0075
Inventor 夏文晖殷三福
Owner HAINAN UNIPUL PHARMA
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