光纤传感过程分析比较不同厂家缬沙坦胶囊的溶出度

Dissolution process analysis and comparison of valsartan capsules from different producers by fiber-chemical sensor

目的:考察不同厂家缬沙坦胶囊体外溶出度曲线,比较不同厂家药品的内在质量,为药品质量控制和临床用药提供参考。方法:用光纤传感过程分析技术监测4个厂家缬沙坦胶囊在pH 6.8,pH 4.5,pH 1.2及水4种溶出介质的溶出过程。采用f2因子法对溶出曲线的相似性进行评价。结果:4个厂家缬沙坦胶囊在pH 6.8磷酸盐缓冲液中30 min时溶出度均大于80%符合药典规定,但溶出曲线差异很大;在其他3种介质中的溶出度偏低且存在较大差异;比较结果说明不同药厂缬沙坦胶囊的质量存在显著性差异。结论:采用FODT法过程分析检测固体制剂的溶出曲线比单点溶出度测定更能直观反映不同厂家制剂工艺、均匀度和药品质量的差异。对不同来源的相同制剂考察不同溶出介质的溶出曲线是非常有必要的。

Objective：To investigate the dissolution curves and compare internal quality of Valsartan capsules from different manufacturers so as to make a reference for drug quality control and clinical medication.Method：The dissolution process of Valsartan capsules was monitored in the following 4 mediums：pH 6.8,pH 4.5,pH 1.2 and water by fiber-optic dissolution test system.The dissolution curve was evaluated by f2 similar factor.Results：The dissolution rate of Valsartan capsules from 4 manufacturers exceeded 80% in 30 min and accorded with the Chinese Pharmacopoeia（ChP） in pH 6.8 buffer solution,but dissolution curve was respective various in each medium.The result indicated that it was significant difference among the quality of Valsartan capsules.Conclusion：The dissolution curve using fiber-optic dissolution tester process analysis to monitor the dissolution of solid preparation that is straighter to reflect preparation technology,uniformity and drug quality than one-point dissolution.It is necessary to inspect the dissolution of oral solid preparation from different manufacturers in the different mediums.