OTC中药说明书范本中的一些问题及建议

Model Package Inserts of OTC Traditional Chinese Medicines:Problems and Suggestions

目的:促进非处方药(OTC)中药说明书范本的规范化。方法:对国家食品药品监督管理局网站中的4341份OTC中药说明书范本进行整理、归纳并分析。结果:经不完全统计,OTC中药说明书范本中存在相同通用名称的品种其功能主治等不同等七大类问题。结论:OTC中药说明书范本中问题不少,有关部门应加以重视,对其进一步规范。

OBJECTIVE： To standardize model package inserts of OTC traditional Chinese medicines （TCM） . METH- ODS： 4 341 model package inserts of OTC TCM retrieved from the website of State Food and Drug Administration （SFDA） were given a meta- analysis. RESULTS： Through an incomplete statistical analysis, 7 major problems were found in the model package inserts, for example, the kinds of TCM that were of the same generic name were different in functions and indications. CONCLUSIONS： There are many problems in the model package inserts of OTC TCM, which call for the efforts of the concerned department to facilitate the standardization of the model package inserts of OTC TCM.