摘要
目的:为保证聚丙烯输液瓶密度测量结果的准确性,对关键操作步骤开展影响因素研究,确定其影响显著性,以指导试验操作。方法:采用定制试验设计筛查试验,研究聚丙烯输液瓶密度测定过程中取样量、浸渍深度、加热回流、取样部位和牌号等因素对测量结果的影响。结果:加热回流对测量结果有显著影响,经加热回流后的聚丙烯输液瓶密度显著增大。同时瓶底密度稍大于瓶口。其他因素影响不显著。结论:定制试验设计可经济、高效筛查出聚丙烯输液瓶密度测量影响因素,可作为测量方法影响因素研究的有力工具。
Objective:To ensure the accuracy of density measurement of polypropylene infusion bottle,the influence factors of the key operation steps were studied to determine the significance of the impact,so as to guide the experimental operation.Methods:The custom test design was applied to design the experiment to study the influence of sampling amount,immersion depth,heating reflux,sampling position and brand on the density measurement results of polypropylene infusion bottle.Results:The procedure of performing a heating reflux had a significant effect on the measurement results,and the density of polypropylene infusion bottle increased significantly after the procedure.At the same time,the bottom density of the bottle was slightly higher than that of the bottleneck.The effect of other factors was not significant.Conclusion:The customized test screen out the significant influence factors of the density measurement for the polypropylene infusion bottle economically and effectively,which offers a powerful tool to investigate the influence factors of measuring method.
作者
谢兰桂
赵霞
孙会敏
XIE Lan-gui;ZHAO Xia;SUN Hui-min(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2019年第7期1310-1314,共5页
Chinese Journal of Pharmaceutical Analysis
基金
中国食品药品检定研究院学科带头人培养基金项目(2017X2)
关键词
聚丙烯输液瓶
药包材
密度
浸渍法
定制试验设计
polypropylene infusion bottle
pharmaceutical packaging material
density
immersion method
customized design