世界中医药

作者	单位
靳玉瑶1，2，李安平1，2	1 山西中医药大学研究生院，晋中,030019； 2 山西振东制药股份有限公司，长治，047100

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中文摘要:

目的：通过欧盟药品注册法规及标准的研究，建立复方中成药欧盟简化注册评价指标体系及模糊综合评价模型，以期为复方中成药欧盟简化注册品种选择提供参考。方法：运用Delphi专家咨询法构建复方中成药欧盟简化注册评价指标体系，运用模糊综合评价法构建了模糊综合评价模型。结果：得到2个一级指标、3个二级指标、18个三级指标以及各指标权重，构建了模糊综合评价模型。对A企业113个复方中成药品种评价后，有61个品种不适宜进行欧盟简化注册。结论：运用模糊综合评价法构建的评价指标体系及综合评价模型，能够有效的运用于对注册品种的评价，对复方中成药欧盟简化注册具有参考意义。

English Summary:

Based on the study of EU drug registration regulations and standards,to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine and the fuzzy comprehensive evaluation model,aiming to provide references for the variety choice of the EU simplified registration of compound Chinese patent medicine.Methods:Delphi expert consultation method was applied to establish the evaluation index system of the EU simplified registration of compound Chinese patent medicine,and the fuzzy comprehensive evaluation method was used to establish the fuzzy comprehensive evaluation model.Results:A total of 2 first grade indexes,3 second grade indexes,18 third grade indexes and their weights were obtained.After evaluating 113 varieties of the compound Chinese patent medicine in enterprise A,61 varieties are not suitable for the EU simplified registration.Conclusion:The evaluation index system and the fuzzy comprehensive evaluation model established by the fuzzy comprehensive evaluation method can be effectively used in the evaluation of registered varieties,and have reference significance in the EU simplified registration of compound Chinese patent medicine.

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