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.
出处
《中国药师》
CAS
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)
关键词
氨来咕诺
含片
制备
正交设计
Amlexanox
Buccal tablets
Preparation
Orthogonal design