正交试验优选氢溴酸右美沙芬缓释片处方  

Optimization of the Formulation of Dextromethorphan Hydrobromide Sustained-release Tablets by Orthogonal Test

作　　者：胡连栋[1] 罗兆亮[1] 董珊红[1] 李莉[1] 

机构地区：[1]河北大学药学院,保定市071002

出　　处：《中国药房》2009年第34期2684-2686,共3页China Pharmacy

摘　　要：目的:优选氢溴酸右美沙芬缓释片处方。方法:以羟丙甲基纤维素(HPMC)为缓释材料,制备氢溴酸右美沙芬缓释片。采用正交试验,以体外累积释药率相关指标为评价指标,以处方中HPMC的用量、乳糖用量、乙基纤维素(EC)的浓度为因素进行处方的优化。对优化后处方所制制剂进行体外释药性验证试验及影响因素(高温、强光、高湿)考察。结果:最佳处方为HPMC30mg、乳糖50mg、EC浓度8%。制剂8h累积释药率达70%以上,影响因素试验中除高湿条件外制剂的稳定性均较好。结论:优化所得氢溴酸右美沙芬缓释片处方可行。OBJECTIVE： To optimize the formulation of dextromethorphan hydrobromide sustained release tablets. METHODS： The dextromethorphan hydrobromide sustained- release tablets were prepared with HPMC as sustained release matrix. Orthogonal test was performed to optimize the formulation with in vitro accumulative drug release rate as index and the amount of HPMC and lactose as well as ethylcellulose （EC） concentration as factors. Then verification test on the in vitro drug release characteristics of the optimized tablets were performed and the influencing factors （high temperature, high light, and high moisture） were investigated as well. RESULTS： The optimized formulation of dextromethorphan hydrobromide sus- tained- release tablets was as follows： 30 mg HPMC, 50 mg lactose, and 8% EC. The accumulative drug release rate at 8 h was above 70%. In the influencing factor test, the tablets were stable under all conditions except at high moisture condition. CONCLUSION ： The optimized formulation of dextromethorphan hydrobromide sustained - release tablets is feasible.

关 键 词：氢溴酸右关沙芬 缓释片 正交试验 累积释药率 

分 类 号：R943[医药卫生—药剂学] R974[医药卫生—药学]