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机构地区:[1]首都医科大学附属北京天坛医院药剂科,北京100050
出 处:《药品评价》2014年第2期28-32,共5页Drug Evaluation
基 金:"北京基层医疗机构药物利用评价及用药合理性监测研究"。首都医学发展科研基金项目;编号:2009-3108
摘 要:目的:评价盐酸二甲双胍肠溶胶囊在不同pH条件下的溶出曲线。方法:参照2010版《中华人民共和国药典》附录XB、XD,采用桨法考察盐酸二甲双胍肠溶胶囊在pH分别为1.0、4.0、纯水条件下2h后调节为pH6.8磷酸缓冲液再溶出1h的溶出性能,HPLC法测定溶出液中二甲双胍浓度,DDSolver 1.0对溶出曲线进行分析。结果:盐酸二甲双胍肠溶胶囊在pH1.0、pH4.0及纯水2h内几乎不释放,而在pH6.8的磷酸盐缓冲液中45min内释放达90%以上。经软件DDSolver1.0分析3种pH条件下的溶出曲线是相似的。结论:该二甲双胍肠溶胶囊在不同pH条件下的溶出曲线是相似的,对于不同患者溶出性能一致,药品品质较佳。Objective: To re-evaluate the quality of a metformin hydrochloride enteric-coated capsule. Methods:The dissolution performance of metformin hydrochloride enteric-coated capsules by paddle method under different pH conditions such as 1.0, 4.0 and water was investigated according to the appendix XB and XD of China pharmacopoeia (2010 edition). Metformin concentration in dissolution liquid was determined by HPLC, and the dissolution curve was analyzed by DDSolver 1.0. Results:The enteric-coated capsule almost did not release metformin hydrochloride in pH 1.0, pH 4.0, and water, but released more than 90%metformin hydrochloride in pH6.8 phosphate buffer. The dissolution performances under different pH conditions were similar under analysis by DDSolver1.0. Conclusion:The dissolution curves of this metformin hydrochloride enteric-coated capsules under different pH conditions are similar, which ensured similar dissolution performance in most of the patients. This metformin hydrochloride enteric-coated capsule is a drug of quality.
关 键 词:盐酸二甲双胍肠溶胶囊 溶出曲线 高效液相色谱法
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