更年安片质量分析

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.

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