[关键词]
[摘要]
摘 要:目的 在HPLC 法同时测定双青咽喉片中10 种成分(柠檬酸、没食子酸、新绿原酸、绿原酸、隐绿原酸、异绿原 酸B、异绿原酸A、异绿原酸C、甘草酸单铵及蒿酮)的基础上,建立一测多评法的方法学考察模式,验证此方法在双青咽 喉片中应用的可行性和技术适应性。方法 以双青咽喉片为研究对象,其所含的10 种成分为指标成分,采用3 种校正方法 分别建立各成分与没食子酸的相对校正因子(fk/s),计算各成分的量,实现一测多评;同时采用外标法和回归方程法测定该 10 种成分的量,并比较3 种fk/s 所得计算值与实测值的差异,以验证一测多评法的准确性和可行性。结果 3 批双青咽喉片 中10 种成分的计算值与实测值间无显著差异。结论 3 种校正方式的一测多评控制双青咽喉片的质量是可行的、准确的。
[Key word]
[Abstract]
Abstract: Objective To establish a new method of quantitative analysis on multi-components by single marker (QAMS) and validate its feasibility and technical adaptability in analysis on Shuangqing Yanhou Tablets for the simultaneous determination of 10 main constituents (citric acid, gallic acid, neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C, ammonium glycyrrhizinate, and artemisia ketone). Methods Using Shuangqing Yanhou Tablets as object, the above 10 constituents as indexes, three correction methods were used to establish the relative correction factor (fk/s) between each component and gallic acid, respectively then to calculate the amount of each component and finally to achieve QAMS. At the same time, the external reference method and regression equation method were used to determine the amounts of the above 10 constituents, to compare the difference between the calculated and real data of the three fk/s, and to validate the correctness and adaptability of QAMS. Results No significant difference was found in the quantitative results of 10 active constituents in three batches of Shuangqing Yanhou Tablets determined by the calculated and real data. Conclusion The QAMS by three correction methods is feasible and accurate to evaluate the contents of the 10 constituents in Shuangqing Yanhou Tablets.
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[基金项目]
基金项目:泸州市2010 年重点科技项目(泸市财企 [2010] 41 号);泸州医学院2010 年青年基金(泸医院 [2010] 108 号)