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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 Through the standard test and exploratory study of 34 batches of samples of the eyesight supernatant, the quality and standard status of the species were analyzed and evaluated. Method standard test based on “Chinese Pharmacopoeia” 2010 edition of a method. Exploratory research using microscopic identification method to check the prescription powder raw materials; GC method for the overall control of the quality of volatile components in the eyesight supernatant; HPLC determination of the prescription ingredients of ripe rhubarb and licorice; HPLC-DAD gradient At the same time, the active constituents of Fructus Gardeniae, Radix Paeoniae Rubra, Fructus Aurantii, Citrus epidermis, Radix Scutellariae and other five medicinal herbs were assayed by the method of detoxification. Results according to the current test standard test, 33 batches of samples meet the requirements, the passing rate of 97.1%. Conclusion This experiment increased the standard of specificity, controllability and safety, to provide further reference for further revision of drug standards and control of drug quality.