色素在药品中使用的监管及检测方法

Supervision and Detection Methods of Colorants in Drugs

色素广泛使用于药品行业,最常用的色素分类及编号系统为《染料索引》。我国明确禁止中药染色,但尚无相关法规规定色素作为辅料在药品中的使用,而美国、欧盟、日本均有相关规定限制色素的使用。我国色素相关的药品标准主要为中药中非法染色的检测方法,文献报道的多色素检测方法主要针对食品和中药材中的检测,以及胶囊壳等特殊基质或铝色淀等特殊色素的检测。

Colorants are widely used in the pharmaceutical industry,and the most commonly colorant classification and numbering system is the"Color Index".The dyeing of traditional Chinese medicine is explicitly prohibited in China,but there are no relevant laws and regulations on the use of colorants as excipients in drugs,while the US,the EU,and Japan all have relevant regulations to restrict the use of colorants.The colorant-related drug standards in China are mainly the detection methods of illegal dyeing in traditional Chinese medicine,and the multi-colorant detection methods reported in the literature are mainly the detection of food and traditional Chinese medicine,as well as the detection of a special matrix such as capsule shell or special colorants such as aluminum lakes.