温脾汤颗粒剂质量标准研究

Quality standard research of Wenpi Decoction granule

目的：建立温脾汤颗粒剂的质量标准。方法采用薄层色谱法对制剂中大黄,人参,当归进行鉴别,采用高效液相色谱法测定处方大黄中的大黄素与大黄酚,并进行方法学考察。结果采用薄层色谱法均能检出大黄,人参,当归的特征斑点,分离度好；高效液相色谱法测出在大黄素0.0105-0.1048μg,r=1.0000,大黄酚0.0201-0.2013μg,r=1.0000范围内呈良好的线性关系,大黄素与大黄酚的平均回收率分别为99.09%,98.81%；RSD分别为1.29%,0.25%。结论建立的质量标准方法简便、重现性好,可用于温脾汤颗粒剂的质量控制。

Objective To estabLish a quality standard for Wenpi Decoction granule. Methods TLC was used to identify Rhu-bard,Ginseng and Angelica. The content of Emodin,Chrysophanol was measured by HPLC,and methodology was studied. Results The developed TLC spot had quite clear features and good separation. The linear ranges of Emodin, Chrysophanol were within 0. 010 5 -0. 104 8 μg,0. 020 1 -0. 201 3 μg,and the average recoveries were 99. 09%（RSD of 1. 29%）,98. 81%（RSD of 0. 25%） . Conclusions The method is simple and reproducible,and can be used for the quality control of Wenpi Decoction granule.