Box-Behnken响应面设计法优化复方酮替阴道泡腾片处方  

Optimisation of the formula of ketoconazole and tinidazole effervescent tablets using Box-Behnken surface response design

作　　者：秦凌浩[1] 方耀高[2] 邹国省[2] 关浩彬[1] 李宝红[3] 周伟谦[2] 陈建嫄 

机构地区：[1]广东药学院,广东广州510006 [2]东莞市厚街医院,广东东莞523945 [3]广东医学院,广东湛江524023

出　　处：《中国医院药学杂志》2010年第17期1436-1439,共4页Chinese Journal of Hospital Pharmacy

基　　金：东莞市科技计划资助项目(编号:2007105150085)

摘　　要：目的:运用Box-Behnken响应面设计法优化阴道泡腾片的处方组成。方法:以泡腾体积和泡腾维持时间作为评价指标,采用Box-Behnken响应面设计法筛选处方组成,以Design-Expert软件进行数据拟合并与实际结果比较。结果:最佳处方为泡腾剂100mg(摩尔比碳酸氢钠∶柠檬酸=3∶1),F68 15mg,PEG6000 10mg,硬脂酸镁15mg,微晶纤维素60mg。泡腾体积和泡腾维持时间分别为9.2mL和11.2min。结论:经Box-Behnken响应面法优选的泡腾片处方组成,泡腾片理化性质稳定,各项指标与理论值均能较好地吻合,模型选用合理有效。OBJECTIVE To optimise the formula of ketoconazole and tinidazole effervescent tablets using Box-Behnken sur- face response design. METHODS The foam volume and the foam lasting time of the effervescent tablets were investigated as the indexes and optimized by Box-Behnken surface response design, which was carried out by the Design-Expert. ~TS Based on the experiment design, the optimal formula were： effervescent agent 100 mg （NaHCO3 ：Citric acid = 3：1 ）, F68 15 mg, PEG6000 10 trig,magnesium stearate 15 mg,MCC,2 60 mg. The foam volume and the foam lasting time of the effervescent tablets were 9. 2 mL and 11.2 min respeetively. CONCLUSION Each index of the optimized formula of effervescent t^blet was well fitted with the predicted value. The adopted model was reasonable and effective. In addition, the physieochemical properties of the optimised effervescent tablets by Box-Behnken were stable.

关 键 词：Box-Behnken响应面法 酮康唑 替硝唑 泡腾片 

分 类 号：R943[医药卫生—药剂学]