明目上清片质量分析及探索性研究

Quality Analysis of Mingmu Shangqing Tablets

目的通过对明目上清片34批次样品进行标准检验及探索性研究,对该品种的质量及标准状况作出总体分析及评价。方法标准检验依据《中国药典》2010年版一部方法。探索性研究采用显微鉴别法以检查处方中原粉投料药材;GC法整体控制明目上清片中挥发性成分的质量;HPLC测定处方中熟大黄及甘草的特征性成分;HPLC-DAD梯度洗脱法同时分析测定栀子、赤芍、枳壳、陈皮、黄芩等5味药材的活性成分;NIR法分析明目上清片。结果按现行检验标准检验,33批样品符合规定,合格率97.1%。结论本实验增加了标准的专属性、可控性及安全性,为进一步修订药品标准、控制药品质量提供参考。

OBJECTIVE To investigate the status of the quality of Mingmu Shangqing tablets and to carry out exploratory re- search on its quality standard. METHODS Thirty-four batches of samples were tested according to the current quality standard in Pharmacopoeia of the People＇s Republic of China （2010） Volume I. The exploratory research including microscopic identification of the raw powders, analysis of the volatile constituents by GC, determination of the characteristic components of prepared Radix Et Rhi- zoma Rhei and Radix Glycytthiae by HPLC, and determination of the active components of Fructus Gardeniae, Radix Paeoniae Rubra, Fructus Aurantii, Pericarpium citri Reticulatae, and Radix Scutellariae by HPLC-DAD. RESULTS Thirty-three batches （97.1% ） met the current quality standard. CONCLUSION The exploratory research can increase the specificity, controllability and safety of the quality standard of Mingmu Shangqing tablets. It will provide reference for further revise of the drug standard and monitoring the drug quality.