盐酸曲马多缓释片的体外释放度研究  

Study on the External Release Characteristics of Tramadol Hydrochloride Sustained-Release Tablets

作　　者：王飞[1] 严伟[1] 俞建[1] 李芸[1] 

机构地区：[1]杭州市第一人民医院药剂科,杭州310006

出　　处：《海峡药学》2006年第2期55-57,共3页Strait Pharmaceutical Journal

摘　　要：目的 考察盐酸曲马多缓释片物体外释放度，探讨其体外释放机制。方法 参照《中华人民共和国药典》（2000版）二部附录释放度测定法持篮法，以0．1mol·L^-1。盐酸溶液为溶剂，转速为100r·min^-1，温度为（37±0．5）℃．采用紫外分光光度法测定，检测波长为270nm。并将释放数据分别用Peppas方程、Higuchi方程、一级方程、零级方程进行拟合。结果 线性范围为20～100μg·mL^-1。r=0．9998。1h累积释放25．42±0.81％，4h累积释放58．37±1．36％，10h累积释放92．67±1．08％。以Higuchi方程为最佳释药模型，并且释药机制为非Fickian扩散。结论 盐酸曲马多缓释片的体外释放符合缓释制剂要求。OBJECTIVE To study the extemal release characteristics of the tramadol hydrochloride sustained-releose tablets. METHODS According to CP （2000） relecse method,Hydrochloric acid（0. 1mol·L^-1）was used as the the solvent, the paddle rotated at 100r ·min^-1, the temperature was （37±0. 5）℃. The content of the tramadol hydrochloride was detenmined by ultraviolet spectrophotometry at λ = 270, then the release characteristics were explored by Regter-Peppas model. Higuchi model. First grade model. Zero grade model. RESULTS The range of lincarity was 20～100μg·mL^-1,r=0. 9998. The accumulatcd rclcasc in Hydrochloric acid solution were 25.42 ± 0.81N, at 1h, 58.37 ± 1.36% at 4h, 92.67 ± 1.08% at 10h. The curve of accumulative release was accorded with the Higuchi model, The release mechanism of the tramadol hydrochloride sustained-release tablets belonged to unfickian diffusion. CONCLUSION The release in vitro of the tramadol hydrochloride sustained-release tablets obey to sustained-release formula tule.

关 键 词：盐酸曲马多 缓释片 释放度 体外 

分 类 号：R944.4[医药卫生—药剂学]