正交设计试验多目标同步优化氨利口腔膜剂处方  

Multi-objective Simultaneous Optimization of Amlexanox and Lidocaine Hydrochloride Oral Membrane Formula by Orthogonal Design

作　　者：李雪梅[1,2] 赵倩[2] 陆媛媛[2] 符旭东[1] 

机构地区：[1]广州军区武汉总医院药剂科,武汉430070 [2]湖北中医药大学药学院

出　　处：《中国药师》2014年第3期400-403,共4页China Pharmacist

基　　金：武汉市科技攻关计划(编号:201161038346)

摘　　要：目的:对氨利口腔膜剂进行处方优化。方法:以聚乙烯醇(PVA17-88)、羧甲基纤维素纳(CMC-Na)、甘油为成膜材料,以膜的柔软性、成膜性、光滑性、均匀性、溶出度作为考察指标,采用正交设计优化处方。结果:最佳成膜材料处方为PVA17-88 3.0 g,CMC-Na 2.0 g,甘油2.5 ml。按照最优处方制备的膜剂符合《中国药典》的有关规定,膜剂体外释药曲线符合Higuchi方程。结论:该膜剂处方和制备工艺可行。Objective： To optimize the formula of amlexanox and lidocaine hydrochloride oral membrane. Methods ： The oral mem- brane was prepared using polyvinyl alcohol （PVA17-88） , sodium carboxymethyl cellulose （CMC-Na） and glycerol as the film materi- als. The orthogonal design method was used to optimize the formula with the softness, film forming ability, smoothness, uniformity and release rate as the indices. Results： The best formula was 3.0 g PVAIT-88, 2.0 g CMC-Na and 2.5ml glycerol. The quality of the oral membrane was accorded with the regulation described in Chinese pharmacopoeia, and in vitro release behavior was fitted Higuchi model equation. Conclusion： The formula and the preparation method are both feasible.

关 键 词：氨来呫诺 盐酸利多卡因 聚乙烯醇17-88 羧甲基纤维素钠 

分 类 号：R944.9[医药卫生—药剂学]