乳康胶囊质量标准研究

Quality Standard of Rukang Capsule

目的:建立乳康胶囊的质量控制方法。方法:对乳康胶囊中青皮、柴胡进行薄层色谱鉴别;采用HPLC对柴胡皂苷a、柴胡皂苷d进行总含量测定。结果:薄层色谱斑点清晰,阴性对照无干扰;柴胡皂苷a进样量在2.04～14.28μg(r=0.999 8)、柴胡皂苷d进样量在2.52-17.64μg(r=0.9995)线性关系良好。平均回收率为99.15%,RSD 0.54%(n=9)。结论:建立的TLC和HPLC专属性强、准确度高、重复性好,可用于乳康胶囊的质量控制。

Objective： To established the method for quality control of Rukang capsule. Method： Citri Reticulatae Pericarpium viride, Bupleuri Radix in Rukang capsule were identified by TLC. The content of saikosaponin a and Saikosaponin d in Rukang Capsule was determined by HPLC. Result： The spots on the TLC plate were clear and the negative control sample didnt disturb. A good linearity was obtained for saikosaponin a in the range of 2.04-14.28 μg （r=0.999 8） and saikosaponin d in the range of 2.52-17.64μg （r=0.9995）. The average recovery was 99.15% （RSD 0.54% , n =9）. Conclusion： The method are specific, accurate and reproducible, and can be used for quality control of Rukang capsule.