进口中成药说明书现状调研与修订完善建议  

Status and Improving Suggestions of the Leaflets of Imported Chinese Patent Drugs

作　　者：张晓朦[1] 周月[1] 张冰[1] 曹丽丽 王海南[3] 张体灯[3] 刘春[3] Zhang Xiaomeng Zhou Yue Zhang Bing Cao Lili Wang Hainan Zhang Tideng Liu Chun(Department of Clinical Chinese Pharmacy, Beijing University of Chinese Medicine, Beijing 100029, Cina China Center for Food and Drug International Exchange Department of Durg and Cosmetics Registration, China Food and Drug Administration)

机构地区：[1]北京中医药大学,北京100029 [2]中国食品药品国际交流中心 [3]国家食品药品监督管理总局药品化妆品注册管理司

出　　处：《药物流行病学杂志》2017年第8期565-567,582,共4页Chinese Journal of Pharmacoepidemiology

基　　金：国家食品药品监督管理总局中国食品药品国际交流中心研究课题项目;北京中医药大学教育科学研究重点课题(编号:XJY15002)

摘　　要：目的:调研进口中成药说明书现状,提出其修订完善思考与建议。方法:以国家食品药品监督管理总局官网公布的40个进口中成药品种为研究对象,采用对比法与统计学方法,分别对比其原产地与境内产品性质、说明书差异,境内说明书与我国现行说明书管理的差异。结果:共收集进口中成药说明书64份,其中原产地24份,境内40份。在产品性质方面,3个品种在原产地为保健品,其他均作药物用。对比24组原产地与境内说明书,功能主治、用法用量、禁忌以及注意事项等方面表述存在差异。境内说明书的警示语、不良反应、禁忌、注意事项等安全性信息存在缺失或描述不当的问题。结论:进口中成药说明书需要加强修订和完善,以保障临床合理用药。Objective： To investigate the status of the leaflets of imported Chinese patent drugs,and put forward suggestions to improve them. Methods： The origin and domestic leaflets of 40 imported Chinese patent drugs were collected,which were listed on the official website of China Food and Drug Administration. By using the comparison and bibliometric methods,the differences of drug property and leaflet describing between origin and domestic,and that between domestic leaflets and relevant regulations,were explored. Results： 64 leaflets of imported Chinese patent drugs were collected,including 24 origin ones and 40 domestic ones. In the terms of drug property,3 of 40 imported Chinese patent drugs were products for health care in the origin,while others were for treatment. Comparing the origin and domestic leaflets,the statements in the items of indication,dosage,contraindication and precaution were presented inconsistencies. And the analysis of 40 domestic leaflets demonstrated that the descriptions of warning,adverse drug reaction,contraindication and precaution were missing or inappropriate. Conclusion： The leaflets of imported Chinese patent drugs needed to be revised and improved,which could ensure rational drug use.

关 键 词：进口中成药 药品说明书 完善 合理用药 

分 类 号：R951[医药卫生—药学]