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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 carry out standard test and exploratory research on 119 batches of samples of Gengnian An, and make an overall analysis and evaluation of the quality and standard status of the breed. Methods: The standard test based on the 2005 edition of Chinese Pharmacopoeia supplement, including TLC identification and determination of HPLC content. Exploratory research using microscopic identification method to check the prescription of raw powder medicine; Identification of Polygonum multiflorum thin-layer chromatography identification and further study; established under the same chromatographic conditions for the determination of the more ingredients in the safety of 6 (2,3 , 5,4’-tetrahydroxystilbene-2-O-β-D-glucoside, verbascoside, curculigoside, paeonol, harpagoside, and schisandrin) have been identified. Results: According to the current quality standard test, the pass rate of 100%; according to exploratory research test to improve the controllability of the method. Conclusion: Exploratory research has increased the specificity, controllability and safety of standards, providing reference for further revision of drug standards and control of drug quality.