摘要
目的为妊娠期中成药暴露人群的风险评估及用药指导提供参考。方法以药品说明书及2015年版《中国药典(一部)》为基础,查阅古今典籍及生殖毒性、胚胎毒性相关文献,形成基于暴露人群的中成药妊娠期安全性信息数据库,分析暴露中成药的品种特点及安全性证据。结果该调查共涉及1105个中成药,被《中国药典(一部)》收录且标注为妊娠禁忌的有73个,其中妊娠禁忌信息与药品说明书标注相符的有48个(65.75%);含2015年版《中国药典(一部)》分类为"禁用""忌用""慎用"药材的中成药分别为46,1,207个,药品说明书标注所含药材禁忌信息的有68个;含西药成分的中成药有27个,常用成分包括对乙酰氨基酚、马来酸氯苯那敏、咖啡因等。结论妊娠期中成药的安全性证据不足,且一致性较差,部分中成药药品说明书存在妊娠期安全性信息缺失、描述不规范,提供信息不可靠等问题。该调查可为中成药妊娠期安全性研究提供参考。
Objective To provide a basis for risk assessment and medication consultation for population exposed to Chinese patent medicine during pregnancy.Methods Based on the drug package insert and the Chinese Pharmacopoeia(2015 Edition,Volume Ⅰ),a database of Chinese patent medicines for the safety of exposed population during pregnancy was formed by consulting ancient and modern books and modern studies on reproductive toxicity and embryotoxicity.Besides,the Chinese patent medicines were investigated and analyzed in terms of the property of variety and safety evidence for exposure during pregnancy.Results A total of 1105 varieties of Chinese patent medicines were involved in this investigation,and there were 73 varieties listed in the Chinese Pharmacopoeia(2015 Edition,VolumeⅠ)and marked as pregnancy contraindications,of which 48 varieties(65.75%)were consistent with the labels in the drug package insert.There were respectively 46 varieties,1 variety and 207 varieties of Chinese patent medicines containing medicinal materials categorized as″forbidden″″contraindicated″and″used with caution″for pregnancy in the Chinese Pharmacopoeia(2015 Edition,VolumeⅠ),and the drug package insert of 68 varieties in total were consistent with the contradictions of their contained drugs.A total of 27 varieties contained Western medicine ingredients,among which acetaminophen,chlorpheniramine maleate and caffeine were commonly used.Conclusion The safety evidence of Chinese patent medicines during pregnancy is insufficient and inconsistent,and there are some problems in the drug package insert of Chinese patent medicines,such as lack of safety information for pregnancy,non-standard description and unreliable information.This investigation can provide a reference for the safety study of Chinese patent medicines during pregnancy.
作者
王柯静
吕宗杰
张小娟
陈小红
陈琳
WANG Kejing;LYU Zongjin;ZHANG Xiaojuan;CHEN Xiaohong;CHEN Lin(Depanmen of Pharmacy,Chongqing Health Center for Women and Children,Chonngqing,Chian 401147)
出处
《中国药业》
CAS
2021年第20期8-13,共6页
China Pharmaceuticals
基金
重庆市科学技术委员会技术创新与应用示范项目[cstc2018jscx-msybX0101]。
关键词
妊娠期
中成药
药师门诊
安全性
药品说明书
pregnancy
Chinese patent medicines
pharmacist consultation clinic
security
drug package insert
