新通滞苏润江胶囊质量标准研究

Quality Standard of New Tongzhi Surunjiang Capsule

目的:建立新通滞苏润江胶囊的质量标准。方法:采用薄层色谱(TLC)法对方中番泻叶、西红花、秋水仙进行定性鉴别;采用高效液相色谱法测定该制剂中没食子酸含量。结果:TLC中斑点清晰、分离度好。没食子酸的进样量在0.1557～1.4013μg范围内与峰面积积分值呈良好线性关系(r=0.9998);平均回收率为101%,RSD=1.64%(n=9)。结论:所建标准可用于新通滞苏润江胶囊的质量控制。

OBJECTIVE： To establish the quality standard of New Tongzhi surunjiang capsule. METHODS： Qualitative identification of Folium Sennae, Crocus sativus and Colchicum auturnnale was conducted by TLC method. The content of gallic acid in the formulation was determined by HPLC. RESULTS： The TLC spots of Folium Sennae, Crocus sativus and Colchicurn auturnnale were clear and well -isolated. The linear range of gallic acid was 0.1557-1.4013μg（r=0.9998） with a mean recovery rate of 101% （RSD=1.64%, n = 9）.CONCLUSION ： The established standard is suitable for the quality control of New Tongzhi surunjiang capsule.