一清片多成分、多指标质量控制研究

Study on multiple constituents and index quality control of Yiqing tablets

[摘要] 目的：完善一清片的质量标准。方法：采用薄层色谱法对处方黄芩、大黄进行定性鉴别；采用高效液相色谱法测定黄芩苷、大黄素、大黄酚的含量；建立一清片中表小檗碱、黄连碱、巴马汀和小檗碱的一测多评方法；同时采用外标法测定上述4种生物碱的含量，比较计算值与实测值之间的差别。结果：薄层色谱中可检出黄芩、大黄，专属性强，阴性无干扰；本方法大黄素、大黄酚线性范围分别为5.21～156.24 ng、10.96～329 ng；平均回收率分别为94.49%、93.88%；RSD分别为1.18%、1.58%（n=6）；可用一测多评法测定一清片中4种原小檗碱型生物碱的含量，两种测定方法无显著差异。结论：本实验的方法可靠，结果准确，可运用于一清片的质量控制。

OBJECTIVE To improve quality standards of Yiqing tablets. METHODS METHODS Scutellaria Radix and Rhei Radix et Rhizoma in prescriptions were identified by TLC. Contents of Baicalin, emodin and chrysophanol were deter- mined by HPLC. Single marker （QAMS） method was established to quantify simultaneously the contents of epiberberine, cop- tisine, palmatine and berberine in Yiqing tablets. The contents of four protoberberine alkaloids detected by external standard method were compared with those by QAMS. RESULTS Results of TLC showed the same spots as those of Scutellaria Radix and Rhei Radix et Rhizome without negative interferences. A good linearity was shown for emodin and chrysophanol in the ranges of 5.21 - 156. 24 and 10. 956 - 328. 80 ng. Average recoveries were 94. 49% and 93.88%, respectively. RSDs were 1.2% and 1.6% （n = 6）, respectively. Contents of four main alkaloids in Yiqing tablets could be measured by QAMS, and there was no significant difference between external standard and QAMS. CONCLUSION The proposed method is reliable, ac- curate, and feasible for evaluation of quality of Yiqing tablets.