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Chonsurid for venous injection administration and its preparing method

A chondroitin sulfate and pathway technology, applied in the field of high-purity chondroitin sulfate and its preparation, can solve the problems of application limitation and low purity

Active Publication Date: 2006-08-23
NANJING GRITPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to its low purity, there are certain limitations in the route of administration, and its application in various types of neuropathic pain and diseases that require rapid or continuous treatment is greatly limited.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The crude product of biologically extracted chondroitin sulfate is 60.0g. Add 3.0L of 12% (mass ratio) caustic alkali aqueous solution, dissolve and heat for 1.5h, control the temperature at 30℃, and then separate the obtained liquid into solid-liquid. Partially dissolved in a citric acid aqueous solution, 50 ml of ethanol or 8.5 ml of caustic alkali was added to the pH to be above 10 to produce 43.2 g of precipitate, which was washed and dried to obtain 40.6 g of precipitate of chondroitin sulfate.

[0048] The obtained precipitate was added with 2L of water, stirred to dissolve, and purified by ultrafiltration. In the ultrafiltration purification process, the cutoff molecular weight is 30,000-50,000 to obtain the chondroitin sulfate refined product solution, and the content of the chondroitin sulfate refined product is determined to be more than 98.9% (determined by the CPC method). The content of other impurities such as protein is less than 2%.

[0049] Add the refined ...

Embodiment 2

[0051] The crude product of biologically extracted chondroitin sulfate is 60.0g, add 3.5L of 12% (mass ratio) caustic alkali aqueous solution, dissolve and heat for 1.0h, the temperature is controlled at 35℃, and then the obtained liquid is separated into solid and liquid, and the solid is obtained. Partially dissolved in lactic acid aqueous solution, 60 ml of ethanol and 9.5 ml of caustic alkali were added to the pH to be above 10 to produce 41.2 g of precipitate, which was washed and dried to obtain 40.8 g of precipitate of chondroitin sulfate.

[0052] Add 3L of water to the precipitate, stir to dissolve, and purify by ultrafiltration. In the ultrafiltration purification process, the cut-off molecular weight is 35,000-45,000 to obtain the chondroitin sulfate refined product solution, and the content of the chondroitin sulfate refined product is determined to be more than 99.4% (CPC method). The content of other impurities such as protein is less than 1.5%.

[0053] The refined ...

Embodiment 3

[0055] The crude product of biologically extracted chondroitin sulfate is 60.0g. After adding 20% ​​(mass ratio) of 3.0L caustic alkali aqueous solution, dissolving and heating for 1.0h, the temperature is controlled at 25℃, and then the obtained liquid is separated into solid and liquid. The solid part was dissolved in an aqueous solution of malic acid, 50 ml of ethanol or 8.5 ml of caustic alkali was added to the solution to a pH of 10 or higher to produce 43.7 g of precipitate, which was washed and dried to obtain 41.2 g of chondroitin sulfate precipitate.

[0056] The obtained precipitate was added with 2L of water, stirred to dissolve, and purified by ultrafiltration. In the ultrafiltration purification process, the cut-off molecular weight is 40,000-50,000 to obtain the chondroitin sulfate refined product solution, and the content of the chondroitin sulfate refined product is determined to be more than 99.1% (determined by the CPC method). The content of other impurities suc...

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Abstract

The present invention discloses chonsurid preparation capable of being used for venous injection and its preparation process. The purified chonsurid preparation may be used for intramuscular injection and intravenous injection after being added into glucose solution or physiological saline, and has convenient use. Owing to the raised purity of chonsurid, the chonsurid preparation may be injected directly into blood circulation system resulting in high blood medicine concentration, fast acting, high curative effect and less side effect.

Description

Technical field [0001] The present invention relates to a high-purity chondroitin sulfate substantially free of impurities and a preparation method thereof, and a preparation containing the chondroitin sulfate as an effective ingredient for intravenous administration. Background technique [0002] Chondroitin Sulfate (CS) is one of the main components of connective tissue in mammals. It is mainly distributed in cartilage, bone, tendon, ligament, muscle membrane and blood vessel wall. It belongs to the macromolecular acid mucopolysaccharide and is often used in industry. It is prepared by using the cartilage tissue of pigs, cattle, sheep and other animals and the cartilage of aquatic products such as sharks as raw materials, using biochemical extraction technology. [0003] So far, there are many patents and literature reports on chondroitin sulfate, but reports on the further purification of the crude chondroitin sulfate extraction to extremely high purity are rare. Since chondro...

Claims

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Application Information

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IPC IPC(8): A61K31/737A61K9/08A61K9/14A61K9/10
Inventor 李战
Owner NANJING GRITPHARMA CO LTD
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