复方石乌止血散质量标准研究

Study on the quality standard of Fufang-Shiwu-Zhixue powder

目的 建立复方石乌止血散的质量标准.方法 采用显微鉴别法对蒲黄炭和海螵蛸进行鉴别;采用薄层色谱法对大黄、三七进行定性鉴别;采用反相高效液相色谱法测定制剂中三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1含量.结果 显微鉴别蒲黄炭和海螵蛸特征明显;薄层鉴别大黄及三七斑点清晰,阴性无干扰;三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1分别在0.16～1.58μg（r=0.9998）、0.58～5.81μg（r=0.9999）、0.33～3.29μg（r=1.0000）范围内线性关系良好,平均加样回收率为98.51%、97.80%、98.22%,RSD值分别为1.81%、2.04%、1.45%.结论 该法准确、简单、重复性好,适用于复方石乌止血散的质量控制.

Objective To establish the quality standard of Fufang-Shiwu-Zhixue powder. Methods The microscopical identification was adopted to analyze charred typha pollen and cuttlebone. TLC was used to identity rhubarb and radix notoginseng. UV-HPLC was used to determine the contents of notoginsenosides R1, ginsenosides Rg 1, ginsenosides Rb1. Results Microscopic identifications shower the characteristics of harred typha pollen and cuttlebone. The identified characteristics of rhubarb and radix notoginseng by TLC were distinct and the spots were clear. Notoginsenosides R1, ginsenosides Rg 1, ginsenosides Rb1 showed good linearity in the range of 0.16-1.58 μg （r=0.9998）, 0.58-5.81 μg （r=0.9999）, 0.33-3.29 μg （r=1.0000）, respervtively.The average recoveries were 98.51% （RSD=1.81%）, 97.80% （RSD=2.04%）, 98.22%（RSD=1.45%）. Conclusions The method is accurate, simple and repeatable, which could be used for the quality control of Fufang-Shiwu-Zhixue powder.