菖远胶囊的质量标准研究

目的研究菖远胶囊的质量控制方法。方法采用TLC法鉴别制剂中远志、川芎、丹参、人参药材;采用HPLC法测定制剂中的α-细辛醚的含量。结果检出远志、川芎、丹参、人参药材的特征斑点;α-细辛醚的回归方程：Y=11 291 939X-6 181 679,r=0.999 8,线性范围为0.12～1.20 mg/mL;平均回收率为99.69%,RSD值为1.33%;三批含量测定结果分别是0.036%（批号：20110605）、0.035%（批号：20110610）、0.034%（批号：20110615）。结论所建立的标准可用于该制剂的质量控制。

Study on quality standard for Changyuan Capsule

Objective To establish the quality standard for Changyuan Capsule.Methods Polygala,Szechwan lovage rhizome,Danshen roo,Ginseng were identified by TLC,and the content of α-asaricin was determined by HPLC in the preparation.Results Polygala,Szechwan lovage rhizome,Salvia miltiorrhiza,Ginseng,Radix TLC had good specificity.The αasaricin regression equation was Y=11 291 939X-6 181 679,r=0.999 8,the concentration range was 0.12-1.20 mg/mL. And the average recovery was 99.69%,and the RSD value was 1.33%.The content of α-asaricin were 0.036%(batch number:20110605),0.035%(batch number:20110610),0.034%(batch number:20110615),respectively,in three batchs of preparations.Conclusion The standard motheds can use to control the preparation of quality control.