中药材饮片及中成药中染色色素检测现状和通用检测方法的建立

Status of Testing Methods for Pigments in Chinese Material Medica,Decoction Pieces and Chinese Patent Medicine and Establishment of General Pigment Testing Methods

目的探索和建立中药材、饮片和中成药中染色色素的通用检验方法。方法通过对近年来已批准实施的中药材、饮片和中成药中染色色素补充检验方法及相关文献进行汇总归纳,结合实际经验和数据,按可能添加色素的色系进行分组,提出和建立以薄层色谱法( TLC)、高效液相色谱法( HPLC)和液质联用法( LC-MS)相结合的通用检验方法。结果采用所建立的方法对大批量代表性的样品进行了验证,923批样品中共检出15种染色色素。结论所建立的通用检验方法切实可行,为有关部门进行科学的监管以及相关标准方法的制定提供依据。

OBJECTIVE To explore and establish general testing methods for pigments in Chinese material medica, decoction pieces and Chinese patent medicine. METHODS The approved supplementary testing methods and relevant literatures for pigments in Chinese material medica, decoction pieces and Chinese patent medicine were reviewed and summarized. Based on the practical ex perience and data, the general test methods were proposed and established by TLC, HPLC and LC-MS. The pigments were grouped ac cording to color system. RESULTS A large number of representative samples were used for the method validation. Fifteen pigments were detected in 923 batches of samples. CONCLUSION The established general pigment test methods are feasible and could pro vide reference for the scientific supervision and the establishment of relevant standard method.