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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 process of ammonia to xanokou buccal tablets and to establish the quality standard of ammonia to xanokou buccal tablets. Methods: The ratio of the total amount of carbomer and hydroxypropyl methylcellulose in the prescription (factor A) and the weight ratio of carbomer and hydroxypropyl methylcellulose (factor B) The fluidity and dissolubility of granules were taken as the index of study. The orthogonal test design was adopted to optimize the prescription and the content of amiloxanil was determined by HPLC. RESULTS: The optimal formulation consisted of 60% of the total amount of carbomers and hydroxypropylmethylcellulose in the formulation and a weight ratio of carbomer to hydroxypropylmethylcellulose of 1: 3. Ammonia Xuannuo tablet obtained good taste, smooth and beautiful surface, uniform color, moderate hardness, easy to take, reliable quality. Conclusion: The prescription of amloxanide buccal tablets preparation is simple and reasonable with quality controllable.