孙昱,萧惠来.添加兴奋剂相关化学成分的中西药复方制剂说明书分析[J].药物评价研究,2019,42(7):1264-1270
添加兴奋剂相关化学成分的中西药复方制剂说明书分析
Labeling analysis on combination drug of traditional Chinese medicine and pharmaceutical chemicals with stimulant related chemical constituents
投稿时间:2019-03-13  
DOI:10.7501/j.issn.1674-6376.2019.07.002
中文关键词:  中西药复方制剂;兴奋剂;含量范围;质量标准;药品说明书
英文关键词:combination drug of traditional Chinese medicine and pharmaceutical chemicals;stimulant;content range;specification;labeling
基金项目:
作者单位E-mail
孙昱 国家药品监督管理局 药品审评中心, 北京 100022  
萧惠来 国家药品监督管理局 药品审评中心, 北京 100022 penglai8051@aliyun.com 
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中文摘要:
      为了解兴奋剂相关中西药复方制剂的含量控制现状,对添加兴奋剂相关化学成分的中西药复方制剂质量标准及说明书进行了分析。介绍了已被直接添加到中西药复方制剂的7种兴奋剂相关化学成分,梳理了269个有效批准文号,共涉及47个品种。得到的主要结论为添加兴奋剂相关化学成分的中西药复方制剂,其药品规格或说明书中未能完全体现所含化学药的含量,存在一定的安全隐患,特别在联合用药时,可能增加不良反应风险,同时可能导致运动员误服兴奋剂。建议对中西药复方制剂中的化学药成分及毒性成分进行控制,制定含量范围,为进一步完善质量标准和说明书提供参考,并充分引起医药行业对兴奋剂相关问题的重视。
英文摘要:
      In order to understand the content control status of combination drug of traditional Chinese medicine and pharmaceutical chemicals with stimulant related chemical constituents, the specifications and labeling of combination drug of traditional Chinese medicine and pharmaceutical chemicals with stimulant related chemical constituents were analyzed in this paper. The research includes the introduction of seven stimulus-related chemical constituents that have been directly added to the combination drug of traditional Chinese medicine and pharmaceutical chemicals, and the sorting out of 269 valid drug approval numbers, involving a total of 47 varieties. The main conclusion is that the combination drug of traditional Chinese medicine and pharmaceutical chemicals fails to fully reflect the content of the pharmaceutical chemicals contained in its drug specifications or labeling, and there are certain safety risks, especially in the combination of drugs, which may raise the risk of adverse reactions, and may lead to athletes taking stimulant by mistake. It is suggested to control the chemical and toxic constituents in the combination drug of traditional Chinese medicine and pharmaceutical chemicals, and establish the content range, so as to provide reference for further improving the specifications and labeling. Therefore, the pharmaceutical industry should pay more attention to the issues related to stimulant.
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