不同类别化学药药品说明书贮藏温度标示的比较

Comparison of Storage Temperature Labeling between Different Classes of Chemistry Medicine Instructions

目的:比较不同类别的国产化学药说明书贮藏温度标示情况,为科学贮藏药品提供参考,为药品说明书修订提供依据。方法:收集某大药房正在销售的国产化学药药品说明书520份,分为内服处方药、内服非处方药、外用处方药和外用非处方药4类,对每一类药品说明书的"贮藏"项下温度标示情况进行统计、分析和比较。结果:(1)内服处方药、内服非处方药、外用处方药和外用非处方药说明书中"贮藏"项下温度标示符合药典术语的占比分别为90.46%、93.86%、87.50%和80.65%,外用非处方药显著低于内服非处方药;(2)内服处方药、内服非处方药、外用处方药和外用非处方药说明书中"贮藏"项下未标示贮藏温度的占比分别为63.49%、71.05%、35.00%和33.87%,内服药显著高于外用药;(3)少数药品说明书中"贮藏"项温度标示存在不当现象,如"30℃以下""25℃以下或不超过25℃""室温"或"室温(10℃~30℃)"和"15℃~30℃"等。结论:内服药未标示贮藏温度占比显著高于外用药,温度标示不当现象依然存在,未标示贮藏温度和贮藏温度标示不当的化学药说明书应尽快修订。

Objective:To provide referencefor scientifically stored drug and to provide the basis for revision of instructions of chemistry medicine,storage temperature labeling of domestic chemistry medicine instructionswere investigated,analyzed and compared.Methods:520 instructions of chemistry medicinewere gathered from some pharmacy in Nanchang.These medicines were divided into four classes:internal prescription medicine(IPM),internal nonprescription medicine(INM),external prescription medicine(EPM)and external nonprescription medicine(XNM).Statistics and analysis of storage temperature labeling in each class were conducted.Results:(1)The proportion of storage temperature labeling according with pharmacopoeia term in IPM,INM,EPM and XNM was 90.46%,93.86%,87.50%and 80.65%,respectively.The proportion of storage temperature labeling according with pharmacopoeia term in external nonprescription medicine was significantly lower than ones in internal nonprescription medicine.(2)The proportion of storage temperature not labeling in IPM,INM,EPM and XNM was 63.49%,71.05%,35.00%and 33.87%,respectively.The proportion of storage temperature not labeling in internal medicine were significantly higher than ones in external medicine.(3)The improper storage temperature labeling were also investigated,including"below 30℃","below or not more than 25℃","room temperature"or"room temperature(10℃-30℃)"and"15℃-30℃",and so on.Conclusion:The proportion of storage temperature not labeling in internal medicine were significantly higher than ones in external medicine.The improper storage temperature labeling in some instructions were also investigated.These instructions were revised as early as possible.