复方白葛胶囊的质量标准研究

Study on the Quality Standard of Fufang Baige Capsules

目的建立复方白葛胶囊的质量标准。方法采用薄层色谱法对处方中白芍、川芎、葛根3味中药进行定性鉴别,采用高效液相色谱法对制剂中的芍药苷进行定量测定。结果TLC法能定性检出白芍、川芎、葛根,斑点清晰,且阴性对照无干扰;HPLC法测定芍药苷在0.0617～0.9875μg范围内线性关系良好,平均加样回收率为98.80%,RSD=2.01%(n=9)。结论所建立的定性、定量检测方法操作简便、结果准确可靠、重现性好,能有效地控制复方白葛胶囊的质量。

Objective To establish a quality standard for Fufang Baige Capsules （FBC）. Methods The qualitative identification of Radix Paeoniae Alba, Rhizoma Chuanxiong and Radix Puerariae Lobatae in FBC was carried out by TLC, and the content of paeoniflorin was determined by HPLC. Results The relevant spots of Radix Paeoniae Alba, Rhizoma Chuanxiong and Radix Puerariae Lobatae on TLC plates were clear without the interference of the blank control. The content of paeoniflorin showed a good linearity in the range of 0. 06172 - 0. 9875μg . The average recovery was 98.80 % and RSD was 2.01%. Conclusion These qualitative and quantitative detection methods were simple, accurate, reliable and reproducible, and can be effectively used for the quality control of Fufang Baige Capsules.