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文章摘要
chen chengggui.Uncertainty Analysis of Content in Magnesium Valproate Sustained Release Tablets by Volumetric[J].中国药物评价,2019,36(3):169-174
容量法测定丙戊酸镁缓释片含量的不确定度分析
Uncertainty Analysis of Content in Magnesium Valproate Sustained Release Tablets by Volumetric
投稿时间:2019-05-02  修订日期:2019-05-17
DOI:
中文关键词: 容量法  丙戊酸镁缓释片  不确定度
英文关键词: Volumetric method  Magnesium valproate sustained release tablets  Uncertainty
基金项目:
作者单位E-mail
陈承贵 深圳市药品检验研究院 370843986@qq.com 
庞发根 深圳市药品检验研究院  
庞赛 深圳市药品检验研究院  
梁爱仙 深圳市药品检验研究院  
刘敏 深圳市药品检验研究院  
李玉兰 深圳市药品检验研究院 liyulan@szdic.org.cn 
王铁杰 深圳市药品检验研究院  
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中文摘要:
      目的:容量法测定丙戊酸镁缓释片含量,并对其进行不确定度评定。方法:用EDTA滴定液络合供试品溶液中的镁离子,通过金属指示剂的变色原理确定滴定终点,获得消耗ETDA滴定液的体积(滴定时颜色从紫色变为蓝色,即为滴定终点),以滴定度求算丙戊酸镁含量;再建立计算含量的数学模型,找出影响不确定度的因素,并对各个分量进行评估。结果:丙戊酸镁缓释片标示百分含量为99.1%,扩展不确定度为1.0%(k=2)。结论:EDTA容量法测定丙戊酸镁缓释片含量的绝对误差小于0.5%,相对误差保持在0.5%以下,该不确定度评定结果准确、可靠,为该类药品检验提供技术指导;通过分析影响不确定度的因素,找出影响检测结果的主要原因,提高检测结果的可信度。
英文摘要:
      Objective: To establish an volumetric method for the content determination of magnesium valproate sustained release tablets and evaluate the uncertainty in the measurement. Methods:With EDTA complexometric titration fluid of magnesium ions of test sample solution, titration end point, determined by metal indicator discoloration principle for consumption EDTA titration volume of fluid (colour from purple to blue when titration, namely for the titration end point), to calculate titration degree valproic acid magnesium content. To build mathematical model to calculate the content, and find out the influence factors of uncertainty, and to evaluate each component. Results:The marked content for magnesium valproate sustained release tablets was 99.1%, the expanded uncertainty was 1.0% (k=2). Conclusion: EDTA volumetric method was developed for the determination of magnesium valproate sustained release tablets content of absolute error less than 0.5%, the relative error remain below 0.5%, the uncertainty of evaluation results are accurate and reliable, to provide technical guidance for the drug inspection. By analyzing the influence of uncertainty factors, affecting the main reason for the test results, improve the reliability of test results.
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