330份中成药说明书和标签的规范性问题辨析

Analyzing on rule problems about 330 portions of traditional Chinese medicine preparations drug instructions and labels

目的辨析中成药说明书、标签标识存在的问题,为生产企业规范药品说明书、标签提供参考。方法对收集到的中成药说明书、标签,根据国家药监局相应规范检查分析。结果部分中成药说明书、标签的个别项目不规范。结论少许中成药说明书、标签所标注的内容待规范。

Objective To identify the problelns existing in drug instructions and labels of traditional Chinese medicine preparations,and provide references for relating manufacturers. Methods The collected 330 drug instructions and labels of traditional Chinese medicine preparations with the redes provided by SFDA were compared and analyzed. Results 18.8% of the samples cannot meet the rule of SFDA. Conclusion Only few drug instructions and labels of traditional Chinese medieine preparations can meet the rule of SFDA which implies that authorities should emphasize the rule more and strengthen the supervision over drug manufacturers.