川参胶囊质量标准研究

Study on the quality standard of Chuanshen Capsules

目的：建立川参胶囊的质量标准。方法采用TLC法分别对胶囊中的牡丹皮、丹参和赤芍进行定性鉴别；采用 HPLC法对制何首乌中二苯乙烯苷进行了含量测定。结果牡丹皮、丹参和赤芍薄层鉴别具有较好的专属性，阴性对照无干扰；有效成分二苯乙烯苷在0．6260～3．7540μg（r＝0．9999）范围内呈良好的线性关系，平均回收率为99．4％，RSD为1．1％（n＝6）。结论所建立的标准简便易行、专属性强，可用于该制剂的质量控制。

Objective To set up the quality standard for Chuanshen Capsules .Methods TLC was adopted for carring out research for Cortex Moutan ,Radix Salviae Miltiorrhizae and Paeoniae Radix Rubra in the capsules .HPLC was adopted for quantative analysis of stilbene glycoside .Results The TLC of Cortex Moutan ,Radix Salviae Miltiorrhizae and Paeoniae Radix Rubra showed good specificity ,and no interference was observed .The calibration curve of stilbene glycoside was in good linearity over the range of 0 .626 0‐3 .754 0 μg （r=0 .999 9） and the average recovery was 99 .4% ,RSD=1 .1% （n=6） .Conclusion The method was simple ,sensitive and accurate ,and can be used for the quality control of Chuanshen Capsules .