忆美尔颗粒剂的质量控制

The quality control for Yimeier granules

目的:为忆美尔颗粒剂提供质量控制的方法.方法:采用薄层层析(TLC)法对何首乌、远志、灵芝、枸杞分别进行了色谱鉴别.采用高效液相色谱(HPLC)法测定了颗粒剂中总异秦皮啶的含量.结果:TLC法专属性强,含量测定异秦皮啶在0.1～1 μg之间呈良好的线性关系,回收率为98.34%,RSD为1.50%.结论:本质量标准可有效地控制忆美尔颗粒剂的质量.

OBJECTIVE To study the identification and quantitative analysis of Yimeier granules.METHODS TLC was used for simultaneous identification of Radix Polygoni Multiflori,Radix Polygalaei Tenuifoliae, Canodermae Lucidi, Fructus Lycii Barbari. HPLC was used for the determination of isofraxidin.RESULTS The TLC identification was highly specific and the spots were clear.The linearity for isofraxidin was obtained over the range of 0.1～ 1 g.The average recovery of isofraxidin was 98.34% with RSD 1.50%.CONCLUSION This quality standard was capable of effectively controlling the quality of Yimeier granules.