口服液体药用聚酯瓶易氧化物不确定度评定  

Uncertainty evaluation of the reducing substances in polyethylene terephthalate bottles for oral liquid preparation

作　　者：姚琳 张芳芳 YAO Lin;ZHANG Fangfang(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《上海医药》2022年第13期107-109,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立药用口服液体药用聚酯瓶的易氧化物测定不确定度评定方法。方法:依据标准YBB00102002-2015测定口服药用液体聚酯瓶的易氧化物并进行不确定评定。结果:药用聚酯瓶的易氧化物合成不确定度为0.03 mL,扩展不确定度为0.06 mL,结果表示为:(0.46±0.06)mL(k=2)。结论:口服液体药用聚酯瓶易氧化物测定不确定度主要来源于温度、取样面积、测量的重复性等的不确定度。Objective:To establish an uncertainty evaluation method for the determination of the reducing substances in the polyethylene terephthalate bottles for oral liquid preparation.Methods:The reducing substances in polyethylene terephthalate(PET)bottles for oral liquid preparation was determined and their uncertainty was evaluated based on YBB00102002-2015.Results:The combined uncertainty of reducing substances in the PET bottles was 0.03 mL and the expanded uncertainty was 0.06 mL.Uncertainty result was expressed as(0.46±0.06)mL(k=2).Conclusion:The uncertainty of reducing substances in PET bottles for oral liquid preparation is mainly derived from the uncertainty of temperature,sampling area and analysis repeatability.

关 键 词：聚酯瓶 易氧化物 不确定度 

分 类 号：R944.1[医药卫生—药剂学]