CAJ | 학술논문

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。
목적：연구중서약복방제제존재적풍험병위구건풍험관리체계제출상응건의。방법：통계중국약전2010년판일부중적중서약복방제제，검색화사열상관문헌、법율법규、약품표준、표첨화설명서，분석존재적문제，탐토가능조성차류제제풍험적원인。결과：중서약복방제제존재조방결핍족구적과학의거，산품연발과정중안전성평개불족，산품추엄과도선전，설명서중불량반응신식불완선，사용과정중존재초제량복용등문제，기잠재풍험교대。결론：풍험관리대우중서약복방제제적용약안전십분중요，요종감독관리화전업기술량방면착수구건병완선기풍험관리체계。
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 deifciency of CWMCP mainly included: preparation lack of sufifcient scientiifc 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.