不同厂家罗格列酮制剂在两种溶出介质中的溶出曲线比较研究

目的: 比较7个厂家罗格列酮制剂在两种溶出介质中的溶出曲线,为全面评价药品质量提供依据。 方法: 采用中国药典2005年版二部附录X C第二法的装置,分别测定了A、B、C、D、E、F、G 7个厂家罗格列酮制剂在0.1 mol·L^-1盐酸溶液和醋酸盐缓冲液(pH4.0)中的溶出曲线,并用f₂因子法进行了比较分析。 结果: 在0.1 mol·L^-1盐酸溶液中7个厂家罗格列酮制剂的溶出曲线基本一致,在醋酸盐缓冲液(pH4.0)中C、D、G 3家厂生产的制剂与A厂生产的原创药马来酸罗格列酮片溶出曲线基本一致,而B、E、F 3家厂生产的制剂与原创药溶出曲线有明显差异(f₂＜50)。 结论: 作为罗格列酮制剂的溶出介质,醋酸盐缓冲液(pH4.0)比0.1 mol·L^-1盐酸溶液对制剂质量具有更好的分辨能力。建议与原创药溶出曲线不一致的相关厂家改进制剂的处方工艺以提高药品质量。

Objective: To compare the dissolution profiles of rosiglitazone preparations from 7 pharmaceutical manufacturers in two dissolution mediums,and provide the basis for a comprehensive evaluation of the quality of rosiglitazone preparations. Methods: The dissolution profiles of rosiglitazone preparations from 7 pharmaceutical manufacturers(which were represented by A,B,C,D,E,F,G respectively) in 0.1 mol·L^-1 hydrochloric acid solution and acetate buffer(pH4.0) were determined by the method 2 in appendix X C of Chinese pharmacopoeia Vol Ⅱ(2005 edition),and comparatively analyzed by the f₂ factor method. Results: The dissolution profiles of rosiglitazone preparations from 7 pharmaceutical manufacturers in 0.1 mol·L^-1 hydrochloric acid solution were similar to each other.In acetate buffer(pH 4.0),the dissolution profiles of rosiglitazone preparations produced by manufacturer C,D,G were similar to that of the original drug(rosiglitazone maleate tablets) produced by manufacturer A,but the dissolution profiles of rosiglitazone preparations produced by manufacturer B,E,F were significant different from that of the original drug(f₂＜50). Conclusion: As the dissolution medium,acetate buffer(pH 4.0) is more suitable for rosiglitazone preparations as compared to 0.1 mol·L^-1 hydrochloric acid solution.It is advisable for the concerned manufacturers that the dissolution profiles of their preparations are different from that of the original drug to improve the product quality by changing the formulation and process.