生皮散质量标准研究

Study on Quality Standard of Sheng Pi Powder

目的:建立生皮散的质量控制方法及标准。方法:采用薄层色谱法对制剂中的药物进行鉴别;采用高效液相色谱法对制剂中三七的有效成分三七皂苷R_1、人参皂苷Rb_1和人参皂苷Rg_1进行含量测定。结果:薄层鉴别方法专属性强,重复性好,空白无干扰;三七皂苷R_1在0.216~1.512μg范围内线性关系良好;三七皂苷Rg_1在0.818~5.726μg范围内线性关系良好;三七皂苷Rb_1在0.816~5.712μg范围内线性关系良好。平均加样回收率为100.57%,RSD=1.32%。结论:建立的生皮散质量标准,其定性定量方法操作简便、专属性强、准确可靠,可以有效控制生皮散的质量。

Objective：To establish the quaLity control method and standard of sheng pi powder. Methods：TLC was used to identify the drug in the preparation, and Using high performance liquid chromatography （HPLC） method for preparation of the active components of notoginseng saponin R1 ,ginseng saponin Rb1 and Rg1 ginsenosides content determination. Results：TLC method for the identification of specific strong, good repeatability, blank without interference; Panax notoginseng saponins R1 inside the range of 0. 216-0. 216ptg good relationship; Panax notoginseng saponins Rg1 inside the range of 0. 818-0. 818 ug good relationship; Panax notoginseng saponins Rb1 inside the range of 0. 816-0. 816 μg is good. The average sample recovery rate was 100.57%, RSD = 1.32%. Conclusion：Establish the quality standards of sheng pi powder, and its qualitative quantitative method is simple, specific, accurate and reliable, and can effectively control the quality of the raw hides away.