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
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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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