氨来呫诺口含片的处方优化和质量标准研究  

Optimization of Formulation and Quality Standards of Amlexanox Buccal Tablets

作　　者：符旭东[1] 刘祖雄[1] 李瑞花[2] 

机构地区：[1]广州军区武汉总医院药剂科,武汉430070 [2]咸宁学院药学院

出　　处：《中国药师》2011年第6期801-804,共4页China Pharmacist

基　　金：武汉市科技攻关计划(编号:201 161038346)

摘　　要：目的:优化氨来呫诺口含片的处方工艺,并建立氨来呫诺口含片的质量标准。方法:以卡波姆和羟丙甲基纤维素的总量在处方中所占的比例(因素A)和卡波姆与羟丙甲基纤维素的重量比(因素B)为考察因素,以颗粒的流动性和溶化性作为考察指标,采用正交试验设计法优化处方,采用高效液相色谱法测定氨来呫诺含量。结果:最佳处方为卡波姆和羟丙甲基纤维素的总量在处方中占60%,卡波姆与羟丙甲基纤维素的重量比为1:3。制得的氨来呫诺含片口感好、表面光滑美观、色泽均匀、硬度适中、服用方便,质量可靠。结论:氨来呫诺含片制剂处方工艺简单合理,质量可控。Objective： To optimize the formulation and establish quality standards of amlexanox buccal tablets. Method： The formula was optimized by orthogonal design using the weight percentage of Carbopol and HPMC （factor A） and the weight ratio of Carbopol and HPMC （ factor B） as the factors, and dissolubility and fluidity of the granules as the indices. The content of amlexanox was determined by HPLC. Result： The optimum formulation was as following：the weight percentage of Carbopol and HPMC was 60% , the weight ratio of Carbopol and HPMC was l ： 3. The amlexanox buccal tablets could be obtained with good taste, smooth-surface, uniform color ,and appropriate rigidity with convenient administration. Conclusion： The preparation technology is easy and reasonable, and the quality can be controlled.

关 键 词：氨来咕诺 含片 制备 正交设计 

分 类 号：R944.4[医药卫生—药剂学]