20150708 ECA新闻：修订后HMPC草药问答 - 药群论坛

EMA's HMPC (Committee on Herbal Medicinal Products) has revised the questions & answers document on (traditional) herbal medicines.

EMA的HMPC（草药产品委员会）刚修订了（传统）草药的问答文件。

With revision 5 the following question was added to the Q&A document as compared to the previous version number 4 from August 2014.

与2104年8月的第4版相比，在第5版中，增加了以下问答。

Is testing of benzene (class 1 solvent) for herbal preparations necessary?

Some solvents used for extraction, purification or during manufacture of a herbal preparation may contain benzene as an impurity. As a consequence, there might be benzene residues in herbal preparations.

有些用于草药萃取、精制或生产中的溶剂可能含有苯杂质，因此，草药制品中可能会有苯残留。

The most commonly used solvents for the manufacture of herbal preparations are ethanol and water or combinations thereof. Ethanol of chemical origin may contain benzene as an impurity whereas ethanol obtained from fermentation does not normally contain any benzene. Therefore the production process of ethanol used in herbal preparations should be taken into account.

草药制品生产中最常用的溶剂的是乙醇和水或其混合物。化学来源的乙醇可能含有苯成为杂质，而发酵来源的乙醇则通常不含苯。因此，需要考虑用于草药制品生产中的乙醇的生产工艺。

Ethanol, methanol and acetone complying with their European Pharmacopoeia monographs should not exceed 2 ppm of benzene, which is the ICH limit. Therefore, the content of benzene in other solvents should not exceed the ICH limit of 2 ppm either. Where solvents exceeding the ICH limit are used, potential benzene residues should be identified and quantified.

根据欧洲药典各论，乙醇、甲醇和丙酮中含苯不应超过2ppm，这个限度是ICH的限度。因此，苯在其它溶剂中的含量不应超过ICH限度即2ppm.如果所用溶剂超过了ICH限度，则应对可能的苯残留进行识别和确认。