通脉软胶囊质量标准研究

Study on the quality standard for Tongmai softgel capsules

目的建立通脉软胶囊的质量标准。方法采用TLC法对处方中人参、冰片进行了定性鉴别;采用HPLC法对方中的人参皂苷Rg1、Re、Rb1进行了含量测定。结果本品定性鉴别薄层色谱特征明显,专属性强;平均回收率:人参皂苷Rg1为98.40%,RSD=1.88%;Re为98.21%,RSD=1.94%;Rb1为98.48%,RSD=1.42%。结论薄层色谱鉴别和含量测定方法准确可行、重复性好、方法简便,可作为通脉软胶囊的质量控制方法。

Objective To establish the quality standard for Tongmai softgel capsules. Methods Panax ginseng and bomeol were identified with TLC ; and Ginsenoside Rg1, Re, Rb1 in the capsules were assayed by HPLC. Results The TLC characteristic for identification by TLC was distinct and highly specific. The average recovery rate： Ginsenoside Rg1 ： 98.40%, RSD = 1.88% ; Re： 98.21%, RSD = 1.94% ; Rb1 ： 98.48%, RSD = 1.42%. Conclusion The identification and quantification methods were accurate, reliable, and repeatable, which might be used in the quality control of Tongmai softgel capsules.