紫金化毒栓的质量标准研究

Study on quality standard for Zijin Huadu Suppository

目的：建立紫金化毒栓的质量标准。方法：采用薄层色谱法（TLC）对栓剂中金银花、连翘、关黄柏、五倍子进行定性鉴别[1];采用高效液相色谱法（HPLC）对制剂中绿原酸和连翘苷进行定量测定。结果：薄层鉴别专属性强、斑点清晰、分离度好;绿原酸和连翘苷进样量分别在0.07976~1.994μg（r=0.9998）、0.1202~3.005μg（r=0.9999）范围内线性关系良好,平均加样回收率（n=6）分别为98.11%、99.17%,RSD分别为0.92%、0.85%。结论：所建立的定性、定量分析方法简便快速、重复性好、准确度高,能够有效控制紫金化毒栓的质量。

Objective To establish the quality standard of the Zijin Huadu suppository. Methods Exert qualitative identification of Honeysuckle,Forsythia,Cortex Phellodendri,Galla chinensis by Thin Layer Chromatography（ TLC） and quantitative identification of chlorogenic acid and Phillyrin by High Performance Liquid Chromatography（ HPLC）. Results TLC identification shows great specificity,that spots are clear and resolution is good. When the injection volume of chlorogenic acid and forsythin are within the range respectively： 0. 07976- 1. 994 μg（ r = 0. 9998）,0. 1202- 3. 005 μg（ r = 0. 9999）,the linearity is favorable. The average recovery rate（ n = 6） of chlorogenic acid and forsythin are 98. 11% and 99. 17% while the RSD are 0. 92% and 0. 85%. Conclusion The qualitative and quantitative identification methods we established are simple and fast and have good repeatability and accuracy,by which we can effectively control the quality of Zijin Huadu Suppository.