摘要
目的本研究以Eudragit RS30D和Eudragit RL30D的混合物为包衣材料,制备日服2次的酒石酸美托洛尔包衣缓释微丸,并将星点设计-效应面法应用于处方筛选过程中。方法以微丸在1,4,8h的释放度作为考察指标,将Eudragit RS30D与Eudragit RL30D的比例和包衣增重为自变量,采用星点设计-效应面优化法,对缓释包衣处方进行优化。结果经F2(相似因子)检验,3批自制样品的释药曲线与理论释药曲线基本一致。结论星点设计-效应面优化法可用于酒石酸美托洛尔微丸缓释包衣处方的优化,所建模型具有较好的预测能力和实用性。
OBJECTIVE To prepare a twice daily sustained release pellets of Metoprolol Tartrate with blends of Eudragit RS 30D and Eudragit RL 30D as sustained coating material and optimize the coating formulation with central composite design-response surface methodology. METHODS Drug release from the coated pellets after 1,4 and 8 h were used as responses and central composite design-response surface methodology was applied to optimize sustained coating formulation, namely Eudragit RS 30D/ Eudragit RL 30D ratio in sustained coating material and polymer load （weight gain）, which were based on single factor tests. RESULTS Using similarity factor （ F2 ）, the dissolution profiles of three batches were found to be similar with the expected target profile. CONCLUSION Central composite design-response surface methodology can be applied to optimize the coating formulation for Metoprolol Tartrate sustained release pellets and the models developed in this study are proved to be predictable and feasible.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第7期512-515,共4页
Chinese Pharmaceutical Journal
