牛黄解毒片中一测多评技术的应用探讨

Application of Quantitative Analysis of Multi-components by Single-marker in Niuhuang Jiedu Tablets Shijiazhuang Ping'an Huisheng PharmaceuticalScience and Technology Limited Company

目的:探讨一测多评技术在中成药牛黄解毒片成品质量控制中的应用。方法:采用一测多评技术,参考2010年版药典中黄连药材的质控模式,对牛黄解毒片中芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚的含测结果进行比较,并进行了方法可行性探讨。结果:三个厂家的牛黄解毒片含量可以用一测多评法进行测定,其计算值与实测值间无差异,药典简易多评技术计算含量略有差异。结论:在对照品稀缺的前提下,采用一测多评技术同步测定中成药中多成分的含量,并以此控制成品质量均一性,准确可行。

Objective:to explore the application of quantitative analysis of multi-components by single-marker(QAMS) in the quality control of Niuhuang Jiedu Tablets.Methods: With QAMS,referring to the quality control mode on Chinese goldthread rhizome drugs in Pharmacopoeias(2010 edition),compare the following ingredients contents in Niuhuang Jiedu Tablets:aloe-emodin,rhein,emodin,chrysophanol and emodin monomethyl ether,and explore the feasibility of all approaches.Results: Niuhuang Jiedu Tablets of three manufacturers could be determined by QAMS,and there was no difference between the computed value and the determined value,but slight difference existed with simple multi-components evaluation technique in Pharmacopoeias.Conclusion: With rare reference substance,QAMS for detecting multi-components contents in Chinese patent medicine so as to control the product homogeneity is acurate and feasible.