妇科炎宁片的质量标准研究

Study on the Quality Standard of Fukeyanning Tablet

目的:建立妇科炎宁片的质量标准。方法:采用薄层色谱法对妇科炎宁片中人参、黄柏、当归进行定性鉴别;黄柏中盐酸小檗碱的含量通过高效液相进行测定,并据此制定合理的含量限度。结果:薄层色谱中各样品特征斑点显色清晰,阴性样品无干扰;高效液相色谱法测出盐酸小檗碱在0.0279～0.168μg/mL范围内与峰面积线性关系良好,r=0.9993,平均回收率为96.02%,RSD为1.47%。结论:该方法简便可行、准确、专属性强,可有效控制妇科炎宁片的质量。

Objective： To establish the quality control standard of Fukeyanning tablet. Methods： The method of TLC was used to i- dentify Panax ginseng, Cortex Phellodendri and angelica root. The content of Berberine Hydroehloride was determined by HPLC. Results：The spots in the TLC were clear and distinguished well,and the negative sample didn＇t interfere the identification of TLC. Berberine Hydrochloride showed a good linear relationship with its peak area in the range of 0. 0279-0. 168μg （r=0. 9993）respec- tively. The average recovery rate was 96.02%and RSD was 1.47%. Conclusion： The method is feasible, accurate and specific, so it could effectively control the quality of Fukeyanning tablets.