伸筋通络胶囊质量标准制定

Establishment of Quality Standard of ShenJin TongLuo Capsules

目的建立伸筋通络胶囊的质量控制标准。方法采用薄层色谱法对制剂中丹参和醋香附进行鉴别;采用高效液相色谱法测定制剂中丹酚酸B含量。结果薄层色谱斑点清晰,专属性强,分离度好。高效液相色谱法测定结果,丹酚酸B在0.08576~0.8576μg与峰面积呈良好线性关系(r=0.9994),平均加样回收率99.02%,RSD 0.3%(n=6)。结论方法操作简单、准确,专属性和重现性良好,可有效控制伸筋通络胶囊的质量。

OBJECTIVE To establish the quality standard of Shenjintongluo capsules.METHODS Salviae Miltiorrhizae Radix et Rhizoma,and Cyperi Rhizoma were identified by TLC.The content of salvianolic acid B was determined by RP-HPLC.RESULTS The spots in the TLC were fairly clear,and no interference was shown in the blank samples.Salvianolic acid B showed a good linear relationship with the peak area within a range of 0.08576-0.8576μg(r=0.9994).The average rate of recovery was 99.02%(RSD 0.3%,n=6).CONCLUSION The method is simple and accurate,with good specificity and reproducibility,which could be used for quality control of Shenjintongluo capsules.