益气通脉胶囊质量标准的研究

Quality standard for Yiqi Tongmai Capsules

目的建立益气通脉胶囊(川芎、赤芍、三七等)的质量标准。方法显微鉴别三七、川芎,TLC法定性鉴别川芎、赤芍、三七、西洋参,HPLC法测定三七皂苷R_1、人参皂苷Rg_1、人参皂苷Re、人参皂苷Rb_1的含有量。结果三七、川芎显微特征稳定;TLC斑点清晰,阴性无干扰;4种成分在各自范围内线性关系良好(r≥0.998 0),平均加样回收率93.63%～105.46%,RSD 1.6%～2.0%。结论该方法重复性好,专属性强,可用于益气通脉胶囊的质量控制。

AIM To establish the quality standard for Yiqi Tongmai Capsules ( Chuanxiong Rhizoma, Paeoniae Radix Rubra, Notoginseng Radix et Rhizoma, etc.). METHODS Microscopic identification was performed on Notoginseng Radix et Rhizoma and Chuanxiong Rhizoma. TLC was adopted in the qualitative identification of Chuanxiong Rhizoma, Paeoniae Radix Rubra, Notoginseng Radix et Rhizoma and Panacis quinquefolii Radix. HPLC was used for the content determination of notoginsenoside R1, ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1. RESULTS Notoginseng Radix et Rhizoma and Chuanxiong Rhizoma demonstrated stable microscopic characteristics. The TLC spots were clear without negative inference. Four constituents showed good linear relationships within their own ranges (r≥0.998 0), whose average recoveries were 93.63%-105.46% with the RSDs of 1.6%-2.0%. CONCLUSION This reproducible and specific method can be used for the quality control of Yiqi Tongmai Capsules.