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目的建立中药制剂中非法添加化学药品的检测方法。方法采用制备薄层色谱将掺有非法添加化学药品的中药制剂进行分离、浓缩后,测定其红外光谱图,将可疑成分的红外光谱图与其在薄层色谱上对应对照品的红外光谱图进行比较,根据它们的峰位置、峰形状和相对峰强度来判定中药制剂中是否非法添加了化学药品。结果用该方法对3种镇静安神类和1种止喘类中药制剂进行检测,我们检测出解郁安神颗粒中有非法添加的地西泮,丹莲安神胶囊中有非法添加的氯硝西泮,消喘灵中有非法添加的醋酸泼尼松和地西泮。结论将制备薄层色谱与红外光谱法结合起来,可快速准确地判定中药制剂中是否含有非法添加的化学药品,为中药制剂中非法掺入化学药品的检测提供了一种新的方法和手段。
Objective To establish a test method for illegally adding chemicals to traditional Chinese medicine preparations. Methods The traditional Chinese medicine preparations with illegally added chemicals were separated and concentrated by preparative thin-layer chromatography. The infrared spectra were determined. The infrared spectra of the suspicious components were compared with the infrared spectra of the corresponding reference substance on thin-layer chromatography , According to their peak position, peak shape and the relative peak intensity to determine whether the Chinese medicine preparations illegally added chemicals. Results With this method, three kinds of sedative and sedative classes and one type of traditional Chinese medicine for antitussive were tested. We detected that diazepam was illegally added to Jieyu Anshen granule, while Danlipushen Capsule had illegally added clonazepam There is an illegal addition of prednisone and diazepam in Chrysanthemum. Conclusion The combination of thin-layer chromatography and infrared spectroscopy can quickly and accurately determine whether the traditional Chinese medicine preparations contain illegally added chemicals, thus providing a new method and method for the testing of illegally incorporated chemicals in traditional Chinese medicine preparations.