完善已上市中药说明书安全信息项内容的探讨  

Discussion on improving the safety information items of the instructions of listed traditional Chinese medicine

作　　者：苏雯 西村一郎 林生文 李林 曾庆钱 SU Wen;NISHIMURA Ichiro;LIN Shengwen;LI Lin;ZENG Qingqian(Guangzhou Huangpu District New Drug Application Service Center,Guangzhou 510663,China;Guangdong Institute of Traditional Chinese Medicine,Guangzhou 510630,China;World Federation of Chinese Medicine Societies Real-World Research Professional Committee,Beijing 100028,China)

机构地区：[1]广州市黄埔区新药申报服务中心,广东广州510663 [2]广东省中药研究所,广东广州510630 [3]世界中医药学会联合会真实世界研究专业委员会,北京100028

出　　处：《广东药科大学学报》2023年第4期93-100,共8页Journal of Guangdong Pharmaceutical University

摘　　要：目的基于《中药注册管理专门规定》第七十五条的最新法规要求,以点带面摸清把握中药生产企业已上市中药说明书安全信息项[禁忌]、[不良反应]、[注意事项]内容缺欠或不足之现实,探讨填缺补足其内容的措施。方法以广州市生物医药产业聚集区428个中药批准文号及12家持有人中药企业为对象,对其已上市中药说明书安全信息项内容进行了调查和分析。结果与结论当前中药说明书安全信息[禁忌]、[不良反应]、[注意事项]内容为“尚不明确”的数量甚大、情况普遍,其中[禁忌]项占比84.11%,[不良反应]项占比89.48%,[注意事项]项占比22.66%;提出了完善已上市中药说明书安全信息项内容的理念、路径与步骤,方略、手段与措施。Objective To find out the reality that the safety information items[contraindications],[adverse reactions]and[precautions]of listed traditional Chinese medicine(TCM)instructions of Chinese medicine production enterprises are lacking or insufficient,and explore the measures to make up their contents,based on the latest regulatory requirements of Article 75 of the Special Provisions on the Administration of Traditional Chinese Medicine Registration.Method Based on 12 TCM manufacturers and 428 listed Chinese medicine varieties in the biomedical industry cluster area of Guangzhou,the safety information items of listed TCM instructions were investigated and analyzed.Results and Conclusion At present,the contents of safety information[contraindications],[adverse reactions]and[precautions]in the instructions of TCM are"unclear"in a large number of them,in which[contraindications]account for 84.11%,[adverse reactions]account for 89.48%and[precautions]account for 22.66%.The strategies,means and measures to improve the content of the safety information items in the instructions of listed Chinese medicines were discussed and suggested.

关 键 词：中药注册专门规定 中药说明书 安全信息 三项完善 

分 类 号：R288[医药卫生—中药学]