过程分析比较不同厂家盐酸吡格列酮片的溶出度

Dissolution comparison of pioglitazone hydrochloride tablets from different producers by process analysis

目的建立过程分析盐酸吡格列酮片溶出度的方法,比较同一厂家制剂溶出度的一致性及不同厂家盐酸吡格列酮片的溶出度。方法桨法,以(9→1000)盐酸溶液为溶出介质,转速75r.min-1,光纤药物溶出度实时测定仪检测3个厂家盐酸吡格列酮片的溶出度。结果A厂和C厂生产的盐酸吡格列酮片溶出度曲线一致性很好;B厂的溶出度曲线差异较大。结论利用光纤药物溶出仪实时、在线、过程监测的特点,计算机平台全面直观地反映各厂盐酸吡格列酮片的溶出度,为全面评价药物内在质量和生物等效性提供参考。

Objective To establish a method which can on-line monitor the dissolution of pioglitazone hydroehloride tablets,and to compare the drugs dissolution from different producers. Method The medium was hydrochloric acid solution （9→1000）. Paddle method was empolyed with the stirring rate of 75 r·min^-1. The dissolution of tablets was monitored by fiber-optic dissolution test system. Results The dissolution curves of the tablets from A and C manufacturers were concordant. But the dissolution curves of the tablets produced by manufacturer B were quite different. Conclusion An in-situ, process analysis of dissolution of pioglitazone hydrochloride tablets was established by fiber-optic dissolution test system automatically. An overall assessment of internal quality and bioequivalence of the medicine has been provided.