感甦合剂的质量控制

Study on the quality control methods of Gansu mixture

目的:研究确定感甦合剂的质量控制方法。方法:采用薄层色谱(TLC)法对感甦合剂中竹叶柴胡、防风、黄芩进行定性鉴别;采用高效液相色谱(HPLC)法以乙腈-0.4%磷酸溶液(13∶87)、甲醇-水(25∶75)为流动相,在检测波长327,250 nm处分别测定绿原酸、葛根素含量。结果:TLC鉴别分离度好,专属性强。绿原酸在0.121 2～3.030 0μg、葛根素在0.088 96～2.224 0μg范围内分别具有良好的线性关系,相关系数r分别为1.0000、0.999 9,平均加样回收率分别为100.52%(RSD为1.20%)和100.62%(RSD为1.39%)。结论:该质量控制方法简便、准确、重复性好,可对感甦合剂质量进行有效控制。

OBJECTIVE To establish the quality control methods of Gansu mixture. METHODS TLC was used to identify Bupleurum Marginatum Wall. ex DC, Radix Saposhnikoviae and Radix Scutellariae in Gansu mixture. The chlorogenic acid and puerarin were determined by HPLC with a mobile phase of acetonitrile-0. 4%phosphoric acid （13：87） and methanol water （25： 75） respectively. The detection wavelengths were set at _327 nm and 250 nm. RESULTS The identification by TLC wasdistinct and highly specific. The linear ranges of ehlorogenie acid and puerarin were in the ranges of 0. 121 2 -3. 030 0μg（r= 1. 000 0） and 0. 088 96 - 2. 224 0 μg（r = 0. 999 9）, respectively. The sample recoveries were 100. 52% （RSD of 1.2（1%） and 101）. 62% （RSI） of 1.39%）, respectively. CONCLUSION The quality control methods are simple, accurate and reproducible, and can effectively control the quality of Gansu mixture.