妇炎康片质量标准研究

Study on Quality Standard for Fuyankang Tablets

目的建立妇炎康片的质量标准。方法采用薄层色谱(TLC)对制剂中的赤芍、延胡索、黄柏、丹参、苦参、莪术进行鉴别,采用高效液相色谱(HPLC)法测定芍药苷的含量。结果TLC可鉴别出赤芍、延胡索、黄柏、丹参、苦参、莪术的特征斑点;芍药苷线性范围为0.1488～1.0416μg,平均回收率为100.28%(RSD=1.21%)。结论该测定方法简便可行、重复性好,可作为妇炎康片的质量监控。

Objective To establish a quality standard for Fuyankang tablets. Methods Radix Paeoniae Rubra, Rhizoma Curcumae, Radix et Rhizome Salviae Miltiorrhizae, Cortex Phellodendri Chinensis, Radix Sophorae Flavescentis, Rhizoma Corydalis were identified by TLC. The content of paeoniflorin was determined by HPLC. Results All components could be detected by TLC. The paeoniflorin had the linearity in range of 0. 148 8 - 1. 041 6 μg, the average recovery was 1.83%, and RSD was 1.21%. Conelusion The method is simple, feasible and reproducibile. It can be used as the quality control of Fuyankang Tablet.