泻肝安神胶囊质量标准研究

Study on quality standards for Xiegananshen Capsules

目的 :建立泻肝安神胶囊的质量标准。方法 :采用显微鉴别法对处方中茯苓进行鉴别 ;采用TLC法对处方中龙胆、栀子、当归、黄芩进行鉴别 ;用HPLC法测定龙胆苦苷的含量。结果 :在显微镜下检出茯苓 ;在TLC色谱中检出龙胆、栀子、当归、黄芩 ;龙胆苦苷在 2 .6～ 13μg范围内呈良好的线性关系 ,r =0 .9999,平均回收率 97.8%,RSD为 1.0 %。 结论 :所建立的方法简便可行 ,重现性好 ,为泻肝安神胶囊质量控制提供了方法。

Objective: To establish the quality standards for Xiegananshen Capsules. Methods: Poria in this prescription was identified by microscopic examination; Radix Gentianae, Fructus Gardeniae, Radix Angelicae Sinensis and Radix Scutellariae were identified by TLC. Gentiopicrin was determined by HPLC. Results: Poria could be detected by microscopic examination; Radix Gentianae, Fructus Gardeniae, Radix Angelicae Sinensis and Radix Scutellariae could be detected by TLC. Gentiopicrin showed a good linear relationship at a range of 2.6 ～13μg, r=0.9995. The average recovery was 97.8%, and RSD was 1.0%. Conclusion: The established methods are simple, feasible and reproducible. This study provided a method for the quality control of Xiegananshen Capsules.