不同厂家生产的盐酸曲马多缓释片的三维释放特性考察  

Study on the 3-D release characteristics of tramadol hydrochlo ride sustained-release tablets from the different factories

作　　者：严伟[1] 王飞[1] 章明磊[2] 李晴宇[1] 孙国明[1] 李芸[1] 

机构地区：[1]杭州市第一人民医院药剂科,浙江杭州310006 [2]浙江医学高等专科学校01级

出　　处：《中国现代应用药学》2005年第2期142-145,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的　对不同厂家生产的盐酸曲马多缓释片进行pH 时间释放度考察,探讨其体外释放机制。方法　转篮法,用紫外分光光度法检测,描绘其三维释放图像,对释放数据分别用相似因子法分析,以零级,一级,Higuchi,Peppas方程进行拟合。结果　A、C片在不同pH条件下,均为非Fickian扩散,分别以Higuchi和一级方程为最佳拟合模型;B片为Fickian扩散,且释放行为受pH影响,以Higuchi(pH3. 0、pH7. 0)一级(pH1. 0、pH5. 5、pH6. 6、pH8. 0)方程为最佳拟合模型。结论　不同厂家的盐酸曲马多缓释片的体外释放行为受pH影响。OBJECTIVE To study the three-dimension (p H-time-release) release characteristics of tramadol hydrochloride sustained ta blets from the different factories (ABC).METHOD According to Chp (2000) dissolution method I.The accumul ation release percentage of tramadol hydrochloride sustained-release tablets un der the different pH conditions was determined by ultraviolet spectrophotometry at λ=270nm, then the release characteristics were explored by similarity factor method, Zero grade model, First grade model, Higuchi model and Regter - Peppas model.RESULTS The effect of pH (range from 1.0 to 8.0) on the dissolu tion of the A and C was little, the release mechanism of A and C belonged to unf ick diffusion. The curves of accumulative release were accorded with the Higuchi model (A) and First grade model(C), respectively. However, the release mechanis m of B was fick diffusion and the release behavior was affected by pH, the curve of accumulative release was accorded with Higuchi model (pH3.0,7.0) and First grade model (pH1.0,5.5,6.6,8.0).CONCLUSION The pH affect the release in vitro of the tramad ol hydrochloride sustained-release table of the three factories.

关 键 词：盐酸曲马多 缓释片 三维释放 相似因子法 Peppas方程 

分 类 号：R943.41[医药卫生—药剂学]