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Quality control method of macaque stone bovinebezoar powder

A quality control method and technology of Niuhuang powder, applied in the field of quality control of Houzao Niuhuang powder, can solve the problems of few identification items, lack of content measurement items, unable to reflect content and other problems, achieve strong specificity, ensure drug safety and Effectiveness

Active Publication Date: 2008-04-30
GUANGZHOU BAIYUNSHAN QIXING PHARMA
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Problems solved by technology

The product standard is recorded in the tenth volume of the Ministry of Health's drug standard for traditional Chinese medicine preparations, the standard number is WS3-B-2050-95. In the original standard, only Chuanbei, amber, pearl, cinnabar, and whole The microscopic identification of scorpions and the TLC identification of bezoar have few identification items and lack of content determination items, which cannot reflect whether the product contains monkey jujube, whether it is fed with in vitro cultured bezoar instead of artificial bezoar, and the content of cinnabar in the product. Failure to fully control drug quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0022] Example: Take Houzao Niuhuang Powder with batch number 5003-3 produced by the applicant.

[0023] 1. Identify the in vitro cultured bezoar (bilirubin) contained in Houzao Niuhuang Powder:

[0024] Take 0.16g of Houzao Niuhuang Powder, add 5ml of a mixed solution of chloroform-glacial acetic acid (4:1), ultrasonicate for 5 minutes, filter, and the filtrate is used as the test solution. Take another bilirubin reference substance, add chloroform-glacial acetic acid (4:1) mixed solution to make a solution containing 0.5mg per 1ml, as the reference substance solution. Test according to thin-layer chromatography (Appendix VIB, Chinese Pharmacopoeia 2005 Edition), draw 5 μl of each of the above two solutions, spot them on the same silica gel G thin-layer plate, and mix with cyclohexane-ethyl acetate-methanol-glacial acetic acid ( 10:3:0.1:0.1) as developer, develop, take out, and dry. In the chromatogram of the test product, spots of the same color appear on the correspondin...

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Abstract

The invention discloses a quality control method of monkey bezoar and cow-bezoar powder. The quality control standards of the former monkey bezoar and cow-bezoar powder is revised, lamella distinguish method of bilirubin, monkey bezoar, grassleaf sweelflag rhizome, alpinia zerumbet and licorice is added, lamella check method of hyodesoxycholic acid is also added, and further assay method of cinnabar and cholic acid is added. The quality control method of the monkey bezoar and cow-bezoar powder of the invention has a strong specificity, and the quality of the product is more effectively controlled, further the safety and the efficiency of medicines taking by human bodies are guaranteed.

Description

technical field [0001] The invention relates to a quality control method of compound preparation traditional Chinese medicine, in particular to a quality control method of Houzao Niuhuang Powder. Background technique [0002] Houzao Niuhuang Powder is a drug with positive clinical efficacy in treating convulsions in children. It has been on the market for many years. , Shichangpu, cinnabar, cardamom, artificial musk, saltpeter, borneol, alum (calcined), licorice, and scorpion (made) are prepared according to the conventional process of traditional Chinese medicine powder. The product standard is recorded in the tenth volume of the Ministry of Health's drug standards for traditional Chinese medicine preparations, and the standard number is WS. 3 -B-2050-95, in the original standard, there were only microscopic identification of Chuanbei, amber, pearl, cinnabar, and scorpion, and thin-layer identification of bezoar. There were few identification items and lack of content dete...

Claims

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Application Information

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IPC IPC(8): A61K36/9064A61P29/00A61P25/00G01N30/90G01N31/16G01N15/02A61K31/045A61K31/122A61K33/00A61K33/06A61K35/10A61K35/413A61K35/58A61K35/64A61K35/32A61K35/618A61K35/646
Inventor 黄夏敏刘声波颜美婷顾利红林彤伍建芬
Owner GUANGZHOU BAIYUNSHAN QIXING PHARMA
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