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由于中药在生产和研发等诸多环节方面的特殊性,近年来有关中药不良事件的频发,导致人们对中药的安全性产生质疑,而加强中药上市后的风险评价至关重要。该文对中药上市后的风险因素进行了分析,包括药品质量风险、ADR不良反应风险以及不合理用药风险。根据风险因素分析可以构建中药上市后的风险评价指标体系,同时运用层次分析法和模糊评价相关理论,构建了中药上市后的层次模糊综合风险评价模型,可以对中药上市后的风险进行定量与定性分析,为中药上市后的风险管理提供了参考。
Due to the peculiarities of traditional Chinese medicine in many aspects such as production and R & D, the frequent occurrence of adverse events in Chinese medicine in recent years has caused people’s questions about the safety of Chinese medicines. Strengthening the risk assessment after the listing of Chinese medicines is of crucial importance. The paper analyzes the risk factors after the listing of Chinese medicine, including the quality of the drug, the risk of ADR adverse reactions and the risk of irrational drug use. According to the analysis of risk factors, we can construct the index system of risk evaluation after the listing of Chinese medicine. At the same time, we use the analytic hierarchy process and the related theories of fuzzy evaluation to construct a fuzzy comprehensive risk assessment model after the listing of Chinese medicine, which can quantify and characterize the risks after the listing of TCM Analysis, provide a reference for the risk management after the listing of Chinese medicine.