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Chonsurid for venous injection administration and its preparing method

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

Active Publication Date: 2008-12-31
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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  • Chonsurid for venous injection administration and its preparing method
  • Chonsurid for venous injection administration and its preparing method
  • Chonsurid for venous injection administration and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The chondroitin sulfate crude product of biological extraction is 60.0g, add 3.0L of caustic alkali aqueous solution of 12% (mass ratio), dissolve, heat 1.5h treatment, temperature is controlled at 30 ℃, then the obtained liquid is subjected to solid-liquid separation, and the obtained solid Partially dissolved in citric acid aqueous solution, 50 ml of ethanol and 8.5 ml of caustic soda were added thereto until the pH was above 10, resulting in 43.2 g of precipitate, which was washed and dried to obtain 40.6 g of precipitate of chondroitin sulfate.

[0048] Add 2 L of water to the obtained precipitate, stir to dissolve, and carry out ultrafiltration purification. In the ultrafiltration purification process, the cut-off molecular weight is 30,000-50,000 to obtain the refined chondroitin sulfate solution, and the content of the refined chondroitin sulfate is more than 98.9% (measured by CPC method). The content of other impurities such as protein is less than 2%.

[0049...

Embodiment 2

[0051] The chondroitin sulfate crude product of biological extraction is 60.0g, add 12% (mass ratio) caustic alkali aqueous solution 3.5L, dissolve, heat 1.0h treatment, temperature is controlled at 35 ℃, then the obtained liquid is subjected to solid-liquid separation, and the obtained solid Partially dissolved in aqueous lactic acid solution, 60 ml of ethanol and 9.5 ml of caustic soda were added thereto until the pH was above 10, resulting in 41.2 g of precipitate, which was washed and dried to obtain 40.8 g of precipitate of chondroitin sulfate.

[0052] The precipitate was added with 3 L of water, stirred and dissolved, and purified by ultrafiltration. In the ultrafiltration purification process, the cut-off molecular weight is 35,000-45,000 to obtain the refined chondroitin sulfate solution, and the content of the refined chondroitin sulfate is more than 99.1% (CPC method). The content of other impurities such as protein is less than 1.5%.

[0053] The refined chondroit...

Embodiment 3

[0055] The chondroitin sulfate crude product of biological extraction is 60.0g, add 3.0L of caustic alkali aqueous solution of 20% (mass ratio), dissolve, heat 1.0h treatment, temperature is controlled at 25 ℃, then the obtained liquid is subjected to solid-liquid separation, and the obtained The solid part was dissolved in malic acid aqueous solution, 50ml of ethanol and 8.5ml of caustic were added thereto until the pH was above 10, resulting in 43.7g of precipitate, which was washed and dried to obtain 41.2g of precipitate of chondroitin sulfate.

[0056] Add 2 L of water to the precipitate, stir to dissolve, and carry out ultrafiltration purification. In the ultrafiltration purification process, the cut-off molecular weight is 40,000-50,000 to obtain the refined chondroitin sulfate solution, and the content of the refined chondroitin sulfate is more than 99.1% (measured by CPC method). The content of other impurities such as protein is less than 2%.

[0057] The refined ch...

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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 invention relates to a preparation method of high-purity chondroitin sulfate substantially free of impurities, and a preparation containing the chondroitin sulfate as an active ingredient for intravenous administration. Background technique [0002] Chondroitin Sulfate (Chondroitin Sulfate, CS) is one of the main components of mammalian connective tissue. It is mainly distributed in cartilage, bone, tendon, ligament, sarcolemma and blood vessel wall. The cartilage tissue of animals such as pigs, cattle, and sheep and the cartilage of aquatic products such as sharks are used as raw materials, and are produced by biochemical extraction technology. [0003] So far, there are many patents and literature reports about chondroitin sulfate, but there are few reports about the further purification of the crude product of chondroitin sulfate to extremely high purity. Since chondroitin sulfate is extracted from biological tissues, the animal fat, protein, p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/737A61K9/08A61K9/14A61K9/10
Inventor 李战
Owner NANJING GRITPHARMA CO LTD
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