藏药如意珍宝丸的质量标准研究

Establishment of quality standard for Tibetan medicineRuyi-Zhenbao pill

目的：建立藏药如意珍宝丸的质量标准。方法采用薄层色谱法对诃子、降香、木香、沉香、荜茇、丁香、高良姜、红花、肉桂、决明子、乳香、人工牛黄12味中药进行鉴别，采用HPLC法测定没食子酸、去氢二异丁香酚、胡椒碱、桂皮醛含量。结果12味中药薄层色谱鉴别中斑点清晰，分离度好；测定没食子酸在0.106～0.901μg、去氢二异丁香酚在0.033～0.281μg、胡椒碱在0.007～0.060μg、桂皮醛在0.021～0.178μg范围内线性关系良好，平均回收率在98.47%～101.65%，RSD＜3.0%。结论所建立的鉴别和含量测定方法专属性强，准确性和重复性好，可用于如意珍宝丸的质量控制。

Objective To establish a quality standard for Tibetan medicineRuyi-Zhenbao pill. Methods Thin-layer chromatography （TLC） was applied to identify 12 Tibetan medicinal materials, and High performance liquid chromatography （HPLC） was employed to determine the contents of gallic acid, dehydrodiisoeugenol, piperine, and cinnamaldehyde.Results The identified characteristics of TLC were distinct and the spots were clear. Linearity of gallic acid, dehydrodiisoeugenol, piperine, and cinnamaldehyde were in the range of 0.106-0.901μg, 0.033-0.281μg, 0.007-0.060μg, and 0.021-0.178μg, respectively. Average recovery was in the range of 98.47%-101.65% （RSD〈3.0%）.Conclusions The method of identification and content determination was good in terms of specificity, accuracy and repeatability, and can be used for quality control ofRuyi-Zhenbaopill.