脑泰乐片质量控制标准研究

Quality control standard of Naotaile tablets

目的:建立脑泰乐片的质量控制标准。方法:采用薄层色谱法对处方中所含丹参和天麻进行定性鉴别;采用高效液相色谱法对制剂中淫羊藿苷进行含量测定。结果:薄层定性鉴别的斑点清晰,分离效果良好,阴性对照无干扰。淫羊藿苷含量在3～60μg/ml范围内线性关系良好(r=0.9999)。平均加样回收率为99.24%,相对标准差(RSD)为1.72%(n=6)。结论:本法操作简便,结果准确,重复性好,可作为该制剂的质量控制标准。

Objective：To establish the quality control standard of Naotaile tablets.Methods：The Radix Salviae Miltiorrhizae and Rhizoma Gastrodiae in the prescription were qualitatively identified by the thin layer chromatography（TLC）,and the concentration of Icariin was detected by the high performance liquid chromatography（HPLC）.Results：The TLC spots were clear and well isolated without interference from negative control.The calibration curves for Icariin were linear in the range of 3-60 μg/ml（r=0.9999）.The average recovery（n=6）was 99.24% and relative standard deviation（RSD）was 1.72%.Conclusion：This method is a feasible and reproducible procedure for quality control of Naotaile tablets,with accurate detection results.