更年安片质量分析  

Quaily analysis of Gengnianan tablets

作　　者：施法[1] 侯峰[1] 郭汉文[1] 田金苗[1] 张满来[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《药物分析杂志》2012年第3期533-536,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:通过对更年安片119批次样品进行标准检验及探索性研究,对该品种的质量及标准状况作出总体分析及评价。方法:标准检验依据中国药典2005年版增补本,包括TLC鉴别及HPLC含量测定。探索性研究采用显微鉴别法以检查处方中原粉投料药材;对何首乌及五味子的薄层色谱鉴别进行再研究;建立了在同一色谱条件下测定更年安片中6个化学成分(2,3,5,4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、毛蕊花糖苷、仙茅苷、丹皮酚、哈巴俄苷、五味子醇甲)已明确)的HPLC方法。结果:按现行质量标准检验,合格率100%;按探索性研究检验,提高了方法的可控性。结论:探索性研究增加了标准的专属性、可控性及安全性,为进一步修订药品标准、控制药品质量提供参考。Objective：To analyze 119 Gengnian an tablets according to the quality standard,and research on the sample,and analyze and evaluate the global quality control and standard condition of this variety.Methods：The quality standards were Chinese Pharmacopoeia（2005）enlarged edition including the TLC method and the HPLC method.The exploratory research inspection was to develop microscopic identification with raw powder;restudying the TLC identifications with Polygoni Multiflori Radix and Schisandrae Chinensis Fructus;and establishing a method for simultaneous determination of six active components（2,3,5,4′-tetrahydroxystilbene-2-O-β-D-glucoside,acteoside,curculigoside,paeonol,harpagoside,schisandrin）in the same condition Results：Qualified sample rate was 100% according to the current standard of quality inspecting,and the controllability of the method was improved.Conclusion：The results of test indicate that exploratory research increases specificity,controllability and safety of the standard.It will provide the reference for further revising drug standard,monitoring drug quality.

关 键 词：更年安片 何首乌 五味子 2 3 5 4'-四羟基二苯乙烯-2-O-β-D-葡萄糖苷 毛蕊花糖苷 仙茅苷 丹皮酚 哈巴俄苷 五味子醇甲 质量分析 高效液相色谱法 薄层色谱法 

分 类 号：R917[医药卫生—药物分析学]