不同厂家生产的盐酸曲马多缓释片整片与半片的三维释放特性考察

目的:对不同厂家(A、B、C)的盐酸曲马多缓释片的整片与半片进行pH-时间-释放度考察,探讨整片与半片体外释放机制的差异.方法:转篮法,用紫外分光光度法检测,描绘其三维释放图像,将释放数据用相似因子法、Peppas方程进行分析.结果:在同一pH条件下,A、C的整片与半片释放曲线不相似,释放机制也不相同;B的整片与半片释放曲线相似,释放机制相同.结论:不同厂家盐酸曲马多缓释片整片与半片的体外释放不尽相同.

Study on the 3-D release characteristics of tramadol hydrochloride sustained-release tablets from different factories(one and 1/2 tablet)

OBJECTIVE To study the three-dimension (pH-time-release) release characteristics of tramadol hydrochloride sustained-release tablets (one tablet and 1/2 tablet) from different factories(A,B,C) and explore the release mechanism. METHODS According to ChP (2000) dissolution method I, using different pH buffer as dissolution medium, the content of tramadol hydrochloride was determined by ultraviolet spectrophotometry at 270 nm. The experiment data were analyzed by similarity factor method and Regter Peppas model. RESULTS The release curves and the release mechanism of one tablet and 1/2 tablet of A,C under different pH were not similar. However, the release curves and the release mechanism of one tablet and 1/2 tablet of B were similar. CONCLUSION The 3-D release characteristics of one tablet and 1/2 tablet of the sustained release tablets from three factories are aeve not different.