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目的:通过药品说明书现状的调查分析,希望厂方能重视药品说明书并规范说明。方法:随机抽取150种中成药药品说明书,进行15项分析。结果:只有不到10％的药品说明书符合国家药品监督管理局发布的《药品包装、标签和说明书管理规定》(暂行)的格式及内容。结论:中成药说明书亟待规范。
Objective: Through the investigation and analysis of the status of the drug instruction manual, it is hoped that the factory can attach importance to the drug instruction manual and standardize the description. Methods: 150 kinds of proprietary Chinese medicines were randomly selected and 15 analyses were performed. Results: Only less than 10% of the drug labeling complied with the format and content of the Provisions for the Administration of Pharmaceutical Packaging, Labeling, and Specification (Provisional) issued by the State Drug Administration. Conclusion: The Chinese patent medicine specification needs to be regulated.