国产格列苯脲片溶出度比较研究

Comparative Study on Dissolution of China Produced Glibenclamide Tablets

目的:分别考察来自3个不同厂家共9个批号的格列苯脲片的体外溶出情况,从而比较药品质量的内在差异,评价本品现有溶出度测定法的质量可控性。方法:分别参照《中国药典》2010年版、《日本橙皮书》2010年版及《英国药典》2009年版方法测定格列苯脲片体外溶出度,绘制溶出曲线。结果:按各国药典标准,A、C两厂药物溶出速度不均匀,批间差异较大。B厂药物溶出曲线相似度较高。结论:《中国药典》2010年版所收载单点法存在缺陷,不能全面评价药品内在质量,亦不能反映批间差异,相关质量标准有待提高。溶出试验在口服固体制剂内在品质评价中的重要性应引起药品生产企业足够的重视,口服固体制剂生产工艺水平仍需进一步提高。

Objective： To investigate the in vitro dissolution of 9 batches of glibenclamide tablets ＇from 3 manufacturers, and to compare the differences in their intrinsic quality and analyze the quality controllability of current dissolution method. Methods： In vitro dissolution of glibenclamide tablets was determined according to the methods described in Chinese Pharmacopoeia 2010 edition, Japa- nese Orange Book 2010 edition and British Pharmacopoeia 2009 edition, and the dissolution curves were drawn. Results： According to the pharmacopoeia drug standards of various countries, in vitro drug dissolution of A and C plants was uneven with poor uniform and large difference among various batches. The similarity of dissolution behavior of B pharmaceutical factory was the best. Conclusion： The single-point method in Chinese Pharmacopoeia 2010 edition can not fully assess the intrinsic quality of drugs and exhibit the differ- ences among batches. So the current method and related standards need to be improved. The importance of dissolution test in evalua- ting intrinsic quality of oral administration solid preparations shell be paid enough attention. The production process of solid prepara- tions still needs to be further improved as well.