活性炭在注射剂生产中的潜在风险分析

Potential risk analysis of application of activated charcoal in injection manufacture

本文主要结合活性炭的质量标准与生产工艺,对比了国内外药典中活性炭标准要求,探讨了不同来源与制备工艺的活性炭对注射剂产品质量的影响,重点分析了活性炭在注射剂生产中去除热原的使用风险及其对注射剂元素杂质、不溶性微粒和主药含量的影响,对注射剂生产中使用活性炭的必要性与合理性进行了探讨。

In this article,the quality standards of activated charcoal in pharmacopoeia domestic and overseas were compared,and the effects of activated charcoal from different sources and by different preparation processes on the quality of injection were discussed. The risk of using activated charcoal to remove pyrogen in injection production was analyzed,and its effects on the elemental impurities,insoluble particles and drug content of injection,and the necessity and rationality of using activated charcoal in injection manufacture were discussed as well.