药品包装材料和容器炽灼残渣测量不确定度评定

Evaluation on measurement uncertainty of the testing result of residue of ignition in some drug packing materials and containers

炽灼残渣是衡量一些药品包装材料和容器品质的重要指标,同时测量不确定度是评价结果的重要手段,本文以口服固体药用高密度聚乙烯瓶、聚丙烯输液瓶、注射液用卤化丁基橡胶塞3种具代表性的产品为例,以建立炽灼残渣测量不确定度的评定方法。依据YBB00122002等标准的要求对各产品的炽灼残渣进行检测并按照JJF 1059的要求对其炽灼残渣测量结果不确定度进行分析评定。以口服固体药用高密度聚乙烯瓶为例,其炽灼残渣测量结果可以表示为U=(2.0±0.14)%,k=2,此测量不确定度评定方法具有实用价值。

Residue of ignition is an important index to evaluate the quality of drug packing materials and con- tainers, and the measurement uncertainty is an important means to evaluate results, here take the high density polyethylene bottle for oral solid medicine, polypropylene infusion bottle, halogenations butyl rubber for injection as examples to establish the evaluation method of measurement uncertainty.The residue of ignition results were tested in accordance with the standard YBB00122002,and so on. The uncertainty of the testing results were evalu- ated and described on JJF 1059.Take the solids medicinal high density of a polyethylene bottle for example, the testing result can be represented as U=（2.0±0.14）%, k=2. This evaluation method has a high practical value.