【作者】 张奇洲； 陈坚； 孔彬； 李新霞；

【Author】 ZHANG Qi-zhou~(1,2) CHEN Jian~1 KONG Bin~2 LI Xin-xia~1 (1.College of Pharmacy,Xinjiang Medical University,Urumqi 830054; 2.Xinjiang FOCS Biological Technical Development Co.,Ltd.,Urumqi 830011)

【机构】 新疆医科大学药学院； 新疆富科思生物技术发展有限公司；

【摘要】 目的:过程分析考察不同厂家生产的盐酸吡格列酮片/胶囊在四种不同介质中的溶出度,体外评价不同厂家生产的盐酸吡格列酮片/胶囊的生物等效性。方法:以水和不同pH条件下的缓冲液为溶出介质,采用光纤药物溶出度实时测定仪对六个不同厂家生产的盐酸吡格列酮片/胶囊进行溶出度测定,对其溶出行为进行比较。采用相似因子法（f₂）体外评价各制剂与所选对照制剂的生物等效性。结果:六个不同厂家生产的盐酸吡格列酮片/胶囊仅在pH1.2的溶媒中有较好的溶出,而在其余三种溶媒中均未达到溶出限度;在pH1.2的溶媒中,经相似因子法比较,仅有一种药品与所选对照制剂的溶出行为相似。结论:通过药品在四种溶媒中的溶出度试验,可全面评价药品内在质量。采用光纤药物溶出度实时测定仪采集数据,结合相似因子法可进行固体药物的体外生物等效性评价。更多还原

【Abstract】 Objective:To process analysis the drug dissolution of pioglitazone hydrochloride tablets/capsules from different manufactories in four mediums,evaluate the bioequivalence of pioglitazone hydrochloride tablets/capsules from different manufactories in vitro.Method:Monitoring the dissolution of pioglitazone hydrochloride tablets/cap-sules from six different manufactories by fiber-optic dissolution test system in water and different pH buffer and comparing their dissolution profiles.Evaluating the bioequivalence of reference product and test products by a simi-laxity factor（f₂）.Results:The dissolution of pioglitazone hydrochloride tablets/capsules from six different manu-facturers was corresponding a criterion in the medium of pH 1.2,but they have little dissolution in the other three mediums.The f₂ test was used to compare profiles from the different products in the medium of pH 1.2.It is the only one product that was similar to the reference product.Conclusion:Through dissolution test in four mediums, assessment of internal quality of medicine has been provided.The data of dissolution profile of solid medicine can be obtained by fiber-optic dissolution test system automatically.And a similarity factor（f₂）was used to assess the bioequivalence of medicine in vitro.更多还原