耳用地塞米松热敏性凝胶的制备及性能的检测  

Preparation of Dexamethasone Thermosensitive Otic Gel and Test for Its Characteristics

作　　者：王勤[1] 程雪峰[1] 李聪[1] 顾健[1] 敖华飞[1] 

机构地区：[1]上海交通大学医学院附属第三人民医院耳鼻咽喉-头颈外科,上海201900

出　　处：《医学综述》2014年第19期3593-3595,共3页Medical Recapitulate

摘　　要：目的 制备耳用地塞米松热敏性凝胶,并对其体外释放性能进行检测.方法 制备以泊洛沙姆407为载药基质的地塞米松热敏性凝胶,根据适用于接近中耳温度的34℃作为筛选标准,选择最佳处方浓度的泊洛沙姆407,并对体外释放性能进行研究.结果 地塞米松检测浓度的线性范围为4.0- 24.0 mg/L,在该范围内吸光度（A）和浓度（C）呈良好的线性关系,即C（mg/L）=44.241A-1.860（r =0.998,n=6）;其平均回收率为100.43％,RSD =0.848％（n =6）;泊洛沙姆407最佳处方浓度为17％;药物释放具有一定的缓释性,释放过程符合零级动力学方程.结论 该耳用地塞米松热敏性凝胶具有缓释性能,整个制备过程简便,极具开发前景.Objective To prepare the dexamethasone thermosensitive gel for otitis drug delivery,and detect its capability of drug release in vitro.Methods Poloxamer 407 was used as the loading matrix for the dexamethasone ear drop,the best prescription concentration of poloxamer was selected under the temperature of 34 ℃ which was close to the temperature of the middle ear,the Franz vertical diffusion cell method was used to study the capability of drug release.Results The detected concentration of dexamethasone was in the linear range of 4.0-24.0 mg/L,and in this range the concentration（C） had a well linear relationship with absorbance（A）：C（mg/L）=44.241A-1.8604（r=0.998,n =6）.The average rate of recovery was 100.43 ％ and RSD =0.848％ （n =6）.The best concentration of poloxamer in prescription was 17％,the drug release was slow which followed zero-order kinetics.Conclusion Dexamethasone thermosensitive otic gel has the characteristics of slow release,and the preparation is simple in method and easy to control in dosage,therefore,it shows a promising future in development.

关 键 词：地塞米松 泊洛沙姆407 热敏型耳用凝胶 体外释放 

分 类 号：R764.33[医药卫生—耳鼻咽喉科]