Quality Analysis of Snake Bile and Its Preparations
CHEN Xiao-yong1,2, ZHANG Jie3, FAN Ye-qin3, CHEN Jia-chun3, WEI Feng4, MA Shuang-cheng4, NIE Jing1,2*
1. Hubei Institute for Drug Control, Wuhan 430075, China; 2. Hubei Engineering Research Center for Drug Quality Control, Wuhan 430075, China; 3. Tongji School of Pharmacy, Huazhong University of Science and Technology, Wuhan 430030, China; 4. National Institutes for Food and Drug Control, Beijing 100050, China
Abstract：OBJECTIVE To study the bile acid components in snake bile and other animal bile, and establish the quality control method of the snake bile and its preparations. METHODS Acetonitrile-methanol and 10 mmol·L-1 ammonium acetate was used as mobile phase system and 18 alkyl silane bonded silica gel was used as filling agent. Liquid chromatography-mass spectrometry was used to qualitatively identify and quantitatively analyze the bile acid components in snake bile and other animal bile, and the adulteration control and content determination method of bile acid in snake bile and its preparations were optimized to establish a suitable quality control method of snake bile and its preparations. RESULTS The examination method was highly specialized and suitable for the quality control of snake bile and its preparations.The linear relationship of sodium taurocholate between 0.302-9.053 μg is good, r=0.999 3, the repeatability test and accuracy test results are good, and the RSD is smaller than 3.0%. CONCLUSION The established quality control method can guarantee the quality and safety of snake bile and its preparations.
陈晓颙, 张洁, 范叶琴, 陈家春, 魏锋, 马双成, 聂晶. 蛇胆药材及其成方制剂质量控制方法研究[J]. 中国药学杂志, 2019, 54(17): 1380-1386.
CHEN Xiao-yong, ZHANG Jie, FAN Ye-qin, CHEN Jia-chun, WEI Feng, MA Shuang-cheng, NIE Jing. Quality Analysis of Snake Bile and Its Preparations. Chinese Pharmaceutical Journal, 2019, 54(17): 1380-1386.
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