2015年版《中国药典》(一部)中含毒性饮片成方制剂的归纳与分析

Classification and Analysis of Set Prescription Preparations Containing Toxic Decoction Pieces in 2015 Edition of Chinese Pharmacopoeia(PartⅠ)

目的:为加强含毒性饮片成方制剂(简称"含毒中成药")的临床安全用药与监管提供参考。方法:整理2015年版《中国药典》(一部)中收载的含毒中成药,进行归纳分析并提出提高其临床安全用药水平的建议。结果与结论:2015年版《中国药典》(一部)共收载含毒中成药474种,占成方制剂的31.75%。含毒性饮片的口服制剂、外用制剂、肌内注射品种分别为435(其中12个为既可口服又可外用的品种)、38、1个,分别占含毒中成药的91.77%、8.02%、0.21%。含有1、2、3味及3味以上毒性饮片的成方制剂分别有318、93、32、31个,分别占含毒中成药的67.09%、19.62%、6.75%、6.54%。目前,有关含毒中成药的基础研究比较薄弱,说明书信息并不完善,缺乏临床用药指导依据,建议加强含毒中成药的基础研究,开展特殊人群用药研究,提高临床合理使用中成药水平,加强上市后安全性再评价,以保障含毒中成药的临床用药安全。

OBJECTIVE：To provide reference for strengthening safe use and supervision of set prescription preparations containing toxic decoction pieces [called＂Chinese patent medicine（CPM） containing toxicity＂for short] in clinic. METHODS：The CPM containing toxicity in 2015 edition of Chinese Pharmacopoeia（part Ⅰ）were summarized and analyzed to put forward the suggestion on improving safe use of them in clinic. RESULTS CONCLUSIONS：A total of 474 CPM containing toxicity are included in 2015 edition of Chinese Pharmacopoeia（part Ⅰ）,accounting for 31.75% of set prescription preparations. There are435 oral preparations（12 preparations both for oral and external use）,38 preparations for external use,one intramuscular injection,accounting for 91.77%,8.02%,0.21% of CPM containing toxicity,respectively. There are 318,93,32,31 set prescription preparations containing 1,2,3 or more ingredients toxic decoction pieces,accounting for 67.09%,19.62%,6.75%,6.54%,respectively. At present,basic research on CPM containing toxicity is weak;the information of the instructions is not perfect;guidance for clinical drug use is absent. It is suggested to strengthen basic research on CPM containing toxicity,develop drug use study among special population,improve rational use of Chinese patent medicine and strengthen post-marketing safety reevaluation so as to guarantee the safety of CPM containing toxicity use in clinic.