Total bile acid extract of bear bile powder and preparation method and application of injection thereof

Abstract

The invention relates to a total bile acid extract of bear bile powder and a preparation method and application of injection thereof. The total bile acid extract of the bear bile powder is prepared by the following steps of: performing reflux extraction on the bear bile powder by using ethanol; recovering the ethanol from extracting solution, and concentrating the extracting solution; and performing alkaline hydrolysis, neutralization, acidification, ethyl acetate extraction, ethyl acetate crystallization and ethanol crystallization. The invention also provides a method for preparing the injection from the total bile acid extract of the bear bile powder. The prepared total bile acid extract of the bear bile powder and the injection thereof can be used for preparing medicaments for resisting bacteria and viruses, relieving cough and reducing sputum and protecting liver and gallbladder. The invention can improve the extraction yield and purity of ursodesoxycholic acid in the total bile acid extract of the bear bile powder and reduce the chenodeoxycholic acid content simultaneously, so the ursodesoxycholic acid content in the total bile acid extract of the bear bile powder is no less than 70 percent and the chenodeoxycholic acid content is no more than 20 percent. The ursodesoxycholic acid content in the total bile acid extract of the bear bile powder is higher, and the ursodesoxycholic acid yield is high and is over 18 percent generally.

Description

technical field [0001] The invention relates to a preparation method of a traditional Chinese medicine preparation, in particular to a preparation method and application of a bear bile powder total bile acid extract and an injection thereof. Background technique [0002] At present, traditional Chinese medicine injections are receiving more and more attention, but due to complex ingredients, backward technology, lack of quality standards, and many adverse reactions in clinical use, they have been recognized as high-risk products. The reason is mainly that the extraction purity of the active ingredients is not high, and the ineffective ingredients and unknown ingredients are not clear. [0003] Bear bile powder is the dried bile of black bear or brown bear, which is made from natural bear bile or artificially drained bear bile. Bear bile powder has the effects of clearing heat, calming convulsions, improving eyesight and killing insects. Contains bile acids, bile pigments, ...

AI Technical Summary

Problems solved by technology

[0004] The use of bear bile powder in the preparation of injections has been reported and the product has been put on the market, but the target of its extraction is generally the total bound bile acid mainly tauroursodeoxycholic acid and taurourchenodeoxycholic acid. Although the process is simple, But it is not easy to purify, especially the ratio of the two main combined bile acids cannot be controlled, and the side effects are relatively large

[0005] At present, the method for extracting ursodeoxycholic acid from bear bile powder is mainly completed by steps such as alkali hydrolysis saponification, neutralization acidification, ethyl acetate extraction, ethyl acetate crystallization and recrystallization, and the yield is about 10%. The content of ursodeoxycholic acid in the product is relatively low, generally about 60%, and the content of chenodeoxycholic acid is relatively high, generally above 25%, and the color of the crystal is darker, generally yellow or light yellow, indicating that impurities The content is relatively large, so it is not suitable for some special dosage forms of drugs, such as injections, etc.

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