中西药复方制剂的风险管理

目的:研究中西药复方制剂存在的风险并为构建风险管理体系提出相应建议。方法:统计中国药典2010年版一部中的中西药复方制剂,检索和查阅相关文献、法律法规、药品标准、标签和说明书,分析存在的问题,探讨可能造成此类制剂风险的原因。结果:中西药复方制剂存在组方缺乏足够的科学依据,产品研发过程中安全性评价不足,产品推广过度宣传,说明书中不良反应信息不完善,使用过程中存在超剂量服用等问题,其潜在风险较大。结论:风险管理对于中西药复方制剂的用药安全十分重要,要从监督管理和专业技术两方面着手构建并完善其风险管理体系。

Risk management of chinese-western medicine compound preparation

objective： To study potential risk of chinese-western medicine compound preparation（CWMCP） and offer suggestion about risk management system. Methods： Based on statistics of chinese-western medicine preparations containing toxic herbs in Chinese Pharmacopoeia （2010）, related literature, regulations, drug standard, the statements of drug labels and instructions were searched. The causes of insufficient were analyzed and the potential risk was investigated. Results： The deficiency of CWMCP mainly included： preparation lack of sufficient scientific evidence and safety evaluation, imperfect adverse reaction information, improper advertising, overdose, etc. Conclusion： It is very important to construct and perfect risk management system for CWMCP using management means and technical means.