表儿茶素为指标的金荞麦分散片含量测定的研究

Study on Content Determination of Epicatechin in Jinqiaomai Dispersible Tablets

目的:研究金荞麦分散片的处方,并确定以表儿茶素为指标的分散片含量测定前处理工艺。方法:用预试验和正交试验筛选出优化处方;以表儿茶素为指标,依据正交试验设计法,重点考察乙醇浓度、料液比、提取时间3个因素对醇提效果的影响,应用高效液相色谱技术分析提取效果。结果:金荞麦分散片的崩解时间小于3min,且能均匀分散,并符合《中华人民共和国药典》(2010年版)的标准。醇提法最佳工艺是乙醇浓度60%、料液比1:15、提取时间1 h;以最终工艺测得每片表儿茶素的含量为151.35 g,相当于浸膏粉0.154 g。结论:金荞麦分散片的处方工艺简便可行;优化的醇提法不受辅料干扰,合理可靠,适用于分散片含量测定项下的样品前处理。

Objective：To prepare the Jinqiaomai Dispersible Tablets and establish the best preliminary technology for determination assay of Jinqiaomai Dispersible Tablets upon the target of epicatechin. Method ： We employed preliminary tests and orthogonal tests to gain the final preparation technology. Furthermore, based on the orthogonal tests, we investi- gated the influence of the concentration of ethanol, ratio of material to solvents and distilling time on extraction by apply- ing high performance liquid chromatography to determine content of epicatechin. Result ： Jinqiaomai Dispersible Tablets disintegrated in three minutes and uniformly dispersed, which were quietly up to the standard of Chinese Pharmacopeia of 2010 edition. The optimal pretreatment for content determination was established as follows： the concentration of ethanol 60% ,ratio of material to solvents 1 ： 15, distilling time 1 h. It conducted out that epicatechin in one tablet was 151.35 g, equal to 0. 154 g of Jinqiaomai extra powder. Conclusion： Not only the description of Jinqiaomai Dispersible Tablets was reasonable, but also the optimized extraction procedure of epicatechin was reliable for the content determination of Jinqiao- mai Dispersible Tablets out of the interference by adjuvants.