盐酸罗沙替丁醋酸酯脉冲控释微丸体外释放度考察  

Study on the release rate of roxatidine acetate hydrochloriae pulsatile controlled-release pellets in vitro

作　　者：廖鹏[1] 陈燕忠[1] 吕竹芬[1] 蔡霞[1] 

机构地区：[1]广东药学院,广东省药物新剂型重点实验室,广东广州510006

出　　处：《中国医院药学杂志》2010年第21期1819-1823,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:研究盐酸罗沙替丁醋酸酯脉冲控释微丸的体外释放度。方法:考察不同溶出方法、释放递质、转速对控释微丸体外释药的影响,并阐述了控释微丸的释药机制及释药特点。结果:释放递质的pH对微丸释药的影响最明显。前2h递质为0.1mol.L-1的盐酸溶液,2h后调节pH6.8,采用转篮法,转速100r.min-1,恒温(37±0.5)℃,微丸释药良好。结论:该法可作为盐酸罗沙替丁醋酸酯脉冲控释微丸12h体外释放度的研究方法,时滞之后,微丸零级释药明显,具备优良控释制剂的特征。OBJECTIVE To study the release rate in vitro of roxatidine acetate hydrochloride pulstile controlled-release pel- lets （RPCP）. METHODS The effects of different dissolution methods, dissolution medium and stirring rate were investigated. The releasing mechanism and characteristics were explained, too. RESULIS The release behavior of RPCP was influenced most greatly by the pH value of dissolution medium. The release behavior of pellets were good in 0. 1 mol. L-1 HC1 solution at the first 2 h and in phosphate buffer solution （pH 6. 8） after 2h with the stirring rate of 100 r.min-1 by basket stirring method at （37±0.5）℃. CONCLUSION This method can be used to study the release rate in vitro of 12 h RPCP. The description of dissolution profiles suggested the zero equation became the most appropriate model to describe the release kinetics of RPCP and have excellent charceteristies of controlled-release formulation.

关 键 词：盐酸罗沙替丁醋酸酯 脉冲控释微丸 体外释放 

分 类 号：R917[医药卫生—药物分析学]