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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 study the prescription of buckwheat dispersible tablets and to determine the pretreatment technology of dispersible tablets with epicatechin as index. Methods: The optimal prescription was screened by the pre-test and the orthogonal test. The epicatechin was taken as the index. According to the orthogonal test design method, the effects of ethanol concentration, solid-liquid ratio and extraction time on alcohol extraction were investigated. Application of high performance liquid chromatography analysis of extraction results. Results: The disintegration time of buckwheat dispersible tablets is less than 3min, and can be uniformly dispersed, and in line with the “People’s Republic of China Pharmacopoeia” (2010 edition) standards. The optimum conditions of ethanol extraction were ethanol concentration 60%, solid-liquid ratio 1: 15 and extraction time 1 h. The content of epicatechin per tablet was 151.35 g, equivalent to 0.154 g of extract powder. Conclusion: The prescription of buckwheat dispersible tablets is simple and feasible. The optimized alcohol extraction is reasonable and reliable without the interference of auxiliary materials. It is suitable for the sample preparation under the content determination of dispersible tablets.