复方归芍妇康胶囊的制备与质量控制

Preparation and Quality Control of Compound Guishao Fukang Capsules

目的:制备复方归芍妇康胶囊,建立其质量控制方法。方法:采用薄层色谱法对当归和益母草进行定性鉴别,采用HPLC对复方归芍妇康胶囊中的芍药苷进行含量测定。结果:芍药苷在0.303～1.515μg与峰面积呈良好的线性关系(r=0.9998);平均回收率为99.66%,RSD=0.27%(n=6)。结论:该制剂制备工艺稳定,含量测定方法准确可靠,重现性好,可用于复方归芍妇康胶囊的质量控制。

Objective ：To prepare compound Guishao Fukang Capsules and establish its quality control method. Methods ： TLC was used to identify Angelica sinensis and Herba leonuri, HPLC was used to determine the content of paeoniflorin in compound Guishao Fukang Capsules. Results：The linear ranges of paeoniflorin was 0. 303 - 1. 515μg （ r = 0. 999 8 ）, the average recovery was 99.66 %, RSD was 0. 27 % （ n = 6）. Conclusion： The preparation was stability, the content determination method was accurate reliable and reproducible and can be used in the quality control of compound Guishao Fukang Capsules.