基于Minitab软件对2016-2020年某院制剂0.9%氯化钠注射液质量一致性分析

Quality Consistency of 0.9%Sodium Chloride Injection in a Hospital Based on Minitab Software during 2016-2020

目的分析2016-2020年某院制剂室配制的0.9%氯化钠注射液关键质量指标的变化趋势,评价产品质量的一致性。方法收集2016-2020年某院制剂室生产的534批0.9%氯化钠注射液的质量数据,其中氯化钠含量、溶液pH、渗透压摩尔浓度关键质量作为分析指标,应用Minitab软件建立Internet Monthly Report控制图,分析质量趋势并进行过程能力指数评定。结果2016-2020年该院配制的534批0.9%氯化钠注射液均符合国家法定标准,氯化钠含量波动范围呈逐年缩小趋势,溶液pH和渗透压的波动在正常范围。结论氯化钠注射液生产工艺稳定,产品质量一致性良好。

Objective To analyze the changes of key quality indexes of 0.9%sodium chloride injection prepared at our hospital,and to evaluate the consistency of product quality.Methods The data on the quality of 534 batches of 0.9%sodium chloride injection produced at our hospital between 2016 and 2020 were collected.The contents,pH and molarity of osmotic pressure were taken as indexes for analysis.Minitab software was used to establish a control chart of Internet monthly reports to analyze the trends of quality and evaluate the process capability indexes.Results The 534 batches of 0.9%sodium chloride injection prepared in our hospital all met the national standards,the range of fluctuation of contents decreased year by year,and the fluctuation of pH and osmotic pressure was within the normal range.Conclusion The production process of sodium chloride injection is stable and the product quality is consistent.