星点设计-效应面法优化氨来呫诺眼用温敏凝胶的处方  

Formulation optimization of Amlexanox Ophthalmic Thermosensitive Gels by central composite design-response surface methodology

作　　者：马莉[1] 罗梦颖 符旭东[2] 

机构地区：[1]广州军区广州总医院,广州510030 [2]广州军区武汉总医院药剂科,武汉430070

出　　处：《西北药学杂志》2017年第2期197-201,共5页Northwest Pharmaceutical Journal

摘　　要：目的研制氨来呫诺眼用温敏凝胶。方法采用冷法工艺制备氨来呫诺眼用温敏凝胶,以泊洛沙姆407和泊洛沙姆188为温敏凝胶材料,以二者用量为考察因素,以人工模拟泪液稀释前后的胶凝温度为考察指标,采用星点设计-效应面法进行处方优化并验证。结果氨来呫诺眼用温敏凝胶优化处方P407和P188的质量浓度配比为190∶40,胶凝温度为28.37℃,经模拟泪液稀释后胶凝温度为32.63℃。结论星点设计-效应面法优化处方的方法可行,建立的数学模型预测性好,该眼用温敏凝胶满足眼部用药的设计要求,可进一步研究开发。Objective To optimize the formulation of Amlexanox Ophthalmic Thermosensitive Gels.Methods Amlexanox Ophthalmic Thermosensitive Gels were prepared by cold dissolving method,in which poloxamer 407（P407）and poloxamer 188（P188）were used as carrier materials.Central composite design-response surface methodology was used to optimize the formulation with the amounts of P407 and P188as the influencing factors and the gelation temperature before and after the simulated tear fluid dilution as the indices.Results The optimized formulation was 190g·L^-1 P407 and 40g·L^-1 P188.Its gelation temperature was 28.37℃ and increased to 32.63 ℃ after the simulated tear fluid dilution.Conclusion Central composite design-response surface methodology was successfully used to optimize the formulation of Amlexanox Ophthalmic Thermosensitive Gels and the estimation of established model is suitable.The thermosensitive gel system satisfied the requirement of ophthalmic application.It is worth of further research.

关 键 词：氨来呫诺 泊洛沙姆 眼用温敏凝胶 

分 类 号：R94[医药卫生—药剂学]