摘要
目的:考察处方因素对体外释药行为的影响,筛选最佳片芯处方制备盐酸青藤碱膜控型肠溶控释片。方法:采用均匀设计优化片芯中乙基纤维素和微晶纤维素的用量,湿法制粒压片,滚转包衣锅法制备盐酸青藤碱膜控型肠溶控释片,进行体外释放度测定。结果:最佳片芯处方为:乙基纤维素52.1g,微晶纤维素39.5g。按处方制备3批样品,在pH6.8磷酸盐缓冲液中释放符合零级方程,零级释药相关系数(r=0.9975),10h内累积释药90%以上。结论:制备的盐酸青藤碱肠溶片基本符合设计要求。
OBJECTIVE To investigate the effect of formulation on release behavior, and select the optimized formulation to prepare Sinomenine Hydrochloride enteric controlled-release tablets. METHODS Uniform design was used to optimize the quantity of ethylcellulose and microcrystalline cellulose, Core tablets were prepared by wet granulation compression and subsequent spray coating with enteric semipermeable membrane, and their release characteristic was tested in vitro. RESULTS We prepared three batches of Sinomenine Hydrochloride enteric controlled-release tablets, The optimized amounts of ethylcellulose and microcrystalline cellulose were 52. 1 g and 39. 5 g, respectively. The drug release pattern was in accord with zero order kinetics（r= 0. 997 5） and more than 90% of Sinomenine Hydrochloride was released after 10h in pH 6. 8 PBS. CONCLUSION The prepared tablets were consistent with our design requirement.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2008年第24期2088-2091,共4页
Chinese Journal of Hospital Pharmacy
基金
湖南省博士后科研资助专项计划重点项目资助(编号:B070012)
关键词
盐酸青藤碱
肠溶控释片
均匀设计
sinomenine hydrochloride
enteric controlled-release tablets
uniform design
