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Process for preparing high purity sodium heparin by purification of crude sodium heparin

A technology for separating and purifying crude heparin, applied in the field of high-purity low-molecular-weight heparin sodium, can solve the problems of unstable quality, long production cycle, low product yield, etc., and achieve reasonable molecular weight distribution, low production cost and high yield. Effect

Inactive Publication Date: 2006-10-11
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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Problems solved by technology

This traditional process has long production cycle, low product yield and unstable quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 1. The anticoagulant potency is 11 billion crude heparin sodium dissolved in 1500 liters of 1% NaCl solution;

[0021] 2. The solution is separated by a high-speed centrifuge to remove insoluble matter, and NaCl is added to the obtained clear solution until the NaCl concentration reaches 0.5M;

[0022] 3. The solution was placed in 1200 liters of Amberlite 958 resin and mixed evenly to make heparin sodium be absorbed.

[0023] 4. When the USP u<50iu / ml of the liquid phase is detected, it means that the heparin sodium has been completely absorbed by the resin, and the waste liquid is discarded.

[0024] 5. Prepare 600L of 1.0M NaCl solution, wash the resin until the anticoagulant titer in the washing liquid reaches 50-400u / ml, then discard the washing liquid (or collect the raw material for preparing heparinoid sodium).

[0025] 6. The above-mentioned resin was eluted with 800 L of 2.2M NaCl solution for 4 hours, and the eluate was collected; continued to be eluted agai...

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PUM

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Abstract

This invention is purification method of raw heparin sodium. The product high-quality heparin sodium could be used for injection. The procedure is as followings: we use raw heparin sodium as material and purify to get high-quality heparin sodium with ion-exchange chromatography, kalium hypermanganicum oxidization, ultrafiltration and organic solvent fractional precipitation in the order we describe here. The ion-exchange chromatography helps remove most of foreign substance and ultrafiltration remove manganese ions, heavy metal ions and pigments. We choose NaCl solution as washing liquid to make sure the separation of heparin sodium and other foreign substances. This invention is advantageous in low cost, stable quality, high yieldness, and the apposite molecular and weight range. It's also approximate for alarge scale production.

Description

technical field [0001] The invention relates to a method for separating and purifying crude heparin sodium into high-purity low-molecular-weight heparin sodium for injection. Background technique [0002] Heparin sodium has been used clinically as an anticoagulant drug for 60 years. In the early years, heparin sodium was isolated from dog liver, hence the name "heparin". Later, it was found that the content of heparin in bovine lung was higher. After World War II, heparin was extracted from intestinal mucosa. Since the 1980s, low-molecular-weight heparin for the treatment and prevention of thrombosis has been developed by chemically modifying heparin sodium molecules. At present, the top four pharmaceutical companies in the world have low molecular weight heparin products. In 2005, the global sales of heparin products exceeded 4 billion US dollars. [0003] At present, tens of thousands of people across the country are engaged in the production of crude products of small...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 唐明龙
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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