药用辅料对药品安全性的影响  

The impact of pharmaceutical excipients on the drug safety

作　　者：杨锐[1] 孙会敏[1] 于丽娜[1] 袁松[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2012年第7期1309-1314,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：药用辅料和药物活性成分共同组成了我们日常使用的药品,药用辅料同药物活性成分一样全程参与了体内的吸收、分布、代谢、排泄过程,所以药用辅料的安全性直接影响到了药物制剂的安全性,本文从药用辅料本身的毒副作用、药用辅料同药物活性物质(API)的配伍禁忌、药用辅料有毒副作用的杂质以及其他引起的药品安全性问题的辅料因素等四个方面阐述了药用辅料同药品安全性的关系。Our daily used medicines were composed of pharmaceutical excipients and active pharmaceutical ingredi- ents （API）. The pharmaceutical excipients also involved in the whole process of absorption,distribution,metabolism and excretion in vivo as well as API. Therefore, the safety of pharmaceutical excipients was closely related to that of the pharmaceutical preparations. This review explained the relationship between the pharmaceutical excipients and medicines from the four aspects as below ：the toxicity and side effects of pharmaceutical excipients itself,incompati- bility of pharmaceutical excipients and API, the toxic impurity of pharmaceutical excipients and the other influencing factors of pharmaceutical excipients to the drug safety.

关 键 词：药用辅料 药品安全性 毒副作用 配伍禁忌 杂质 

分 类 号：R917[医药卫生—药物分析学]