期刊文献+

溶出度测定仪检定方法探讨及其测量不确定度评定

Discussion on the Calibration Method of Dissolution Tester and Its Measurement Uncertainty Evaluation
下载PDF
导出
摘要 溶出度测定仪是测量药物在固体制剂中释放速率和程度的仪器,广泛应用于药品检测,其校准结果的准确性直接影响药品质量。目前仅有JB/T 20076—2013《药物溶出试验仪》和《中华人民共和国药典》对溶出度测定仪的计量性能提出要求,但并没有相应的规程或规范对其溯源方法提出明确要求。本文研究了溶出度测定仪检定方法并对不确定度进行评定,该方法已被采纳为广东省地方检定规程。 Dissolution tester is an instrument to measure the rate and extent of drug release in solid preparations,which is widely used in drug testing,and the accuracy of its calibration results directly affects the reliability of drug quality.At present,only JB/T 20076—2013 Dissolution tester and Pharmacopoeia of the People's Republic of China put forward requirements on the metrological performance of the dissolution tester,and there is no corresponding protocol or specification for its traceability method to put forward clear requirements.In this paper,the dissolution tester calibration method is studied and the uncertainty is evaluated,and the method has been adopted as the local calibration procedure of Guangdong Province.
作者 温晓东 李艾橘 WEN Xiaodong;LI Aiju(Dongguan Institute of Guangdong Institute of Metrology,Dongguan 523343,China)
出处 《品牌与标准化》 2024年第3期242-244,共3页
关键词 溶出度 检定 不确定度 dissolution calibration uncertainty
  • 相关文献

参考文献1

二级参考文献27

  • 1Fotaki N,Vertzoni M.Biorelevant dissolution methods and their applications inin vitro-in vivo correlations for oral formulations. The Open Drug DeliveryJournal . 2010
  • 2GALIA E,NICOLAIDES E,REPPAS C, etal.New media discriminate dissolution properties of poorly soluble drugs. Pharmaceutical Research . 1996
  • 3Mudie Deanna M,Shi Yi,Ping Haili,Gao Ping,Amidon Gordon L,Amidon Gregory E.Mechanistic analysis of solute transport in an in vitro physiological two-phase dissolution apparatus. Biopharmaceutics & drug disposition . 2012
  • 4Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses(J)European Journal of Pharmaceutical Sciences . 2009 (2)
  • 5Anjanette P. Smith,Terry W. Moore,Benjamin J. Westenberger,William H. Doub.??In vitro dissolution of oral modified-release tablets and capsules in ethanolic media(J)International Journal of Pharmaceutics . 2010 (1)
  • 6Zi-qiang Li,Xin He,Xiumei Gao,Yan-yan Xu,Yue-fei Wang,Hui Gu,Rui-feng Ji,Shu-jun Sun.??Study on dissolution and absorption of four dosage forms of isosorbide mononitrate: Level A in vitro – in vivo correlation(J)European Journal of Pharmaceutics and Biopharmaceutics . 2011 (2)
  • 7Jipeng Hou,Xin He,Xuefang Xu,Xiaoyan Shi,Yanyan Xu,Changxiao Liu.??Application of an in vitro DDASS to evaluate oral absorption of two chemicals simultaneously: establishment of a level A in vitro – in vivo correlation(J)Drug Development and Industrial Pharmacy . 2012 (11)
  • 8Sandra Klein,Grzegorz Garbacz,Mitja Pi?lar,Igor Locatelli,Chong Liu,Werner Weitschies,Werner Siegmund,Ale? Mrhar,Marija Bogataj.??The role of individual gastric emptying of pellets in the prediction of diclofenac in vivo dissolution(J)Journal of Controlled Release . 2013 (3)
  • 9Marcel Arndt,Hitesh Chokshi,Kin Tang,Neil J. Parrott,Christos Reppas,Jennifer B. Dressman.??Dissolution media simulating the proximal canine gastrointestinal tract in the fasted state(J)European Journal of Pharmaceutics and Biopharmaceutics . 2013 (3)
  • 10Atsushi Kambayashi,Henning Blume,Jennifer B. Dressman.??Predicting the oral pharmacokinetic profiles of multiple-unit (pellet) dosage forms using a modeling and simulation approach coupled with biorelevant dissolution testing: Case example diclofenac sodium(J)European Journal of Pharmaceutics and Biopharmaceutics . 2014

共引文献15

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部