益胃颗粒的质量标准研究

摘要

目的:建立益胃颗粒的质量标准.方法:采用薄层色谱(TLC)法对制剂中黄连、延胡索、五味子进行定性鉴别;采用高效液相色谱法测定制剂中芍药苷的含量.色谱柱为XDB C18,流动相为甲醇-水(25:75,V/V),流速为1.0 ml/min,检测波长为230 nm,进样量为20μl.结果:TLC图斑点清晰,分离度好.芍药苷检查质量浓度线性范围为7.575~60.6 μg/ml(r=0.999 9);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率96.97%~102.51%,RSD为1.92%(n=9).结论:本方法操作简便,重复性好,可用于益胃颗粒的质量控制.%OBJECTIVE:To establish the quality standard for Yiwei granule. METHODS:TLC was conducted for the qualitative identification of Coptis chinensis,Corydalis yanhusuo and Schisandra chinensis;HPLC was conduced for the content determination of paeoniflorin. The column was XDB C18 with mobile phase of methanol-water(25:75,V/V)at flow rate of 1.0 ml/min,detection wave-length was 230 nm and injection volume was 20μl. RESULTS:The TLC showed clear spots and good separation. The linear range of paeoniflorin was 7.575-60.6 μg/ml(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 2.0%,recov-ery was 96.97%-102.51%(RSD=1.92%,n=9). CONCLUSIONS:The method is simple and reproducible,and can be used for the quality control of Yiwei granule.