健肝灵胶囊质量标准研究

Study on Quality Standard for Jianganling Capsules

目的建立健肝灵胶囊的质量标准。方法采用TLC法鉴别五味子、灵芝、丹参。HPLC法测定五味子甲素、五味子乙素的含量,选择C18柱,乙腈-水-醋酸（80∶19∶1）为流动相,流速：1.0mL.min-1,检测波长：249nm。结果TLC色谱中可明显鉴别五味子、灵芝、丹参,五味子甲素线性范围0.095-0.76μg,r=0.9998,平均回收率为99.6%,RSD=0.8%;五味子乙素线性范围0.1084-0.8672μg,r=0.9998,平均回收率为100.4%,RSD=0.9%。结论定性、定量方法简便、可靠、准确、专属性强,可用于该药品的质量控制。

Objective To establish the method for quality control of Jianganling Capsules. Methods Fructus schisandrae chinensis, Ganoderma, Radix et Rhizoma Salviae miltiorrhizae in this medicine were identified by TLC. The deoxyschizandrin and γ-schisandrin were determined by HPLC. The acetonitrilewater-acetic acid （80 ： 19 ： 1） solution was used as the mobile phase, the column was C18, the flow rate was 1.0mL· min^-1. The detection wavelength was at 249nm. Results These herbs could be identified by TLC. For the deoxyschizandrin, the linear range was 0. 095-0.76μg, r=0. 9998 and the average recovery was 99.6% with RSD of 0.8%. For the γ-schisandrin, the linear range was 0. 1084-0. 8672pig, r= 0. 9998 and the average recovery was 100.4% with RSD of 0. 9%. Conclusions The method is simple, reliable, and accurate. It can be applied to the quality control of the drug.