清脂胶囊质量标准研究

Study on the quality standard of Qingzhi capsule

目的:建立清脂胶囊的质量控制方法。方法:对清脂胶囊中白术、白芍、柴胡进行薄层色谱鉴别;采用HPLC法对芍药苷进行含量测定。结果:薄层色谱斑点清晰,阴性对照无干扰;芍药苷进样量在0.104-1.040μg范围内线性关系良好(r=0.998 5),平均回收率为98.92%,RSD为0.61%(n=9)。结论:本研究建立的TLC和HPLC法专属性强、准确度高、重复性好,可用于清脂胶囊的质量控制。

Objective： To establish the method for quality control of Qingzhi capsule. Methods： Rhizoma Atratylodis Macrocephalae, Radix Pneoniae A lba and Radix Bupleuri in Qingzhi capsules were identified by TLC. The content of paeoniflorin in Qingzhi capsule was determined by HPLC. Results： The spots on the TLC plate were clear and the negative control sample didn＇t disturb. A good linearity was obtained for paeoniflorin in the range of 0.104-1.040 μg （r=0.998 5） with an average recovery of 98.92% and RSD of 0.61%（n=9）. Conclusion： The method is specific, accurate and reproducible, and can be used for quality control of Qingzhi capsule.