过程分析考察不同厂家盐酸维拉帕米片的溶出度

Dissolution Comparison of Verapamil Hydrochloride Tablets from Different Manufacturers by Process Analysis

目的:利用光纤溶出度过程分析方法,监测盐酸维拉帕米片的溶出度,反映不同厂家及同一厂家不同批号盐酸维拉帕米片间的质量差异。方法:采用《中国药典》盐酸维拉帕米片溶出度检测方法中的条件,利用光纤传感溶出度实时过程分析方法考察4个不同厂家及同一厂家5个不同批号盐酸维拉帕米片的溶出度。结果:过程溶出曲线反映每一药片溶出过程全部信息。4个不同厂家盐酸维拉帕米片的溶出度均符合《中国药典》2010年版规定,但溶出速度和曲线存在差异。结论:光纤溶出度过程分析原位实时反映了药物体外溶出特性,并真实地反映了同一药物的药片存在明显的差异。对考察体内外相关性、评价药品品质和评价生物等效性提供了有效途径。

Objective：To compare the quality of verapamil hydrochloride tablets from different manufacturers and different batches from the same manufacturer by fiber-optic real time dissolution test system.Methods：The dissolution test was carried out according to the Chinese pharmacopoeia.The dissolution of verapamil hydrochloride tablets with five different batches from one factory and one batch from four different manufacturers were detected by fiber-optic real time dissolution test system.Results：The fiber-optic real time dissolution test could show the real dissolution performance of each tablet.The dissolutions of verapamil hydrochloride tablets produced by all the four manufactories met the standards of ChP2010,however,there were obvious differences in dissolution speed and curves.Conclusion：There are obvious differences among the tablets from different manufacturers,and the method provides an effective way to evaluate the drug quality and bioequivalence.