中国药业2025，Vol.34Issue(15)：40-45,6.DOI:10.3969/j.issn.1006-4931.2025.15.007
苯磺贝他斯汀片制备工艺与处方优化
Optimization of Preparation Process and Prescription for Bepotastine Besilate Tablets
摘要
Abstract
Objective To optimize the prescription and preparation process of Bepotastine Besilate Tablets.Methods Wet granulation and direct powder compression were performed on bepotastine besilate and excipients,respectively.The content uniformity,isomeric impurities and dissolution profile were taken as evaluation indicators to screen the optimal process.The similarity factor(f2)of the dissolution curve in water was taken as the evaluation index to optimize the dosage of hydroxypropyl methylcellulose(HPMC)and magnesium stearate in the prescription.Results The dissolution profiles of Bepotastine Besilate Tablets prepared by two different preparation processes were fitted with the reference formulation,with f2>50.However,the stability of samples prepared by direct powder compression was better.The optimal prescription for one Bepotastine Besilate Tablet was 3 mg of HPMC and 1 mg of magnesium stearate.Conclusion The optimal prescription and preparation processes are convenient,economical,with a short production cycle and stable product quality.关键词
苯磺贝他斯汀/粉末直接压片/湿法制粒/处方优化/制备工艺优化Key words
bepotastine besilate/direct powder compression/optimization wet granulation formula/prescription optimization/preparation process optimization分类
医药卫生引用本文复制引用
廖志雄,周亮..苯磺贝他斯汀片制备工艺与处方优化[J].中国药业,2025,34(15):40-45,6.基金项目
浙江省科技计划项目[2023C03105]. （）
