盐酸环丙沙星片溶出度测定结果及不确定度分析  

Analysis of the Dissolution Rate and Its Uncertainty in Ciprofloxacin Hydrochloride Tablets Measurement

作　　者：李慧 刘琳 周雪艳 徐可 郝伟 LI Hui;LIU Lin;ZHOU Xue-yan;XU Ke;HAO Wei(Shijiazhuang Institute for Food and Drug Control,Hebei Shijiazhuang 050031,China)

机构地区：[1]石家庄市食品药品检验中心,河北石家庄050031

出　　处：《中国药物评价》2018年第5期333-335,共3页Chinese Journal of Drug Evaluation

摘　　要：目的:对盐酸环丙沙星片溶出度测定不确定度进行分析和评价。方法:按照《中华人民共和国药典》2015年版四部收载的方法测定盐酸环丙沙星片的溶出度分析影响不确定度的因素计算不确定度分量进而对不确定度测定结果进行风险分析。结果:本次试验溶出度测定结果平均值为86. 3%,其扩展不确定度为2. 3%(k=2),溶出度测定的合格率为100%,但接近限值的结果较多。结论:当实验结果处于限值或接近限值时对测定结果进行不确定度分析和评估,在一定程度上保证测定结果的可靠性,可为生产厂家提高药品质量提供参考。Objective： To evaluate dissolution rate and its uncertainty in ciprofloxacin hydrochloride tablets measurement. Methods： Risk analysis of the measurement uncertainty will be made on the bases of calculated uncertainty components according to the influential elements that have been analyzed by means of measurement ways of dissolution rate of ciprofloxacin hydrochloride tablets on the fourth part of China pharmacopoeia 2015. Results： The average result of dissolution rate is 86. 3% with the expanded uncertainty rate is 2. 3% （k =2） in the expedment. The qualified rate of the dissolution rate is i00 % , but there are more results approaching to the limit. Conclusion： Uncertainty analyses and evaluation will be made when experimental results are reaching to or nearly limits, this will be able to ensure the rationality scientificity of the measurement, which will contribute to the promotion and improvement of pharmaceutical produetion.

关 键 词：盐酸环丙沙星片 溶出度 不确定度 扩展不确定度 

分 类 号：R927.2[医药卫生—药学]