昆明医科大学学报2024，Vol.45Issue(6)：69-74,6.DOI:10.12259/j.issn.2095-610X.S20240609
阿司匹林肠溶片的制备及体内外评价
Preparation and in Vitro-in Vivo Evaluation of Aspirin Enteric-coated Tablets
摘要
Abstract
Objective To prepare aspirin enteric-coated tablets and investigate its in vitro-in vivo release characteristics.Methods The powder was directly pressed into tablets,and a coating solution with a solid content of 20%was prepared with the aqueous dispersion of enteric-coated material L30D-55,talcum powder and triethyl citrate(1∶1∶0.1)for enteric coating,and the weight gain ranged from 15%to 20%,so that 0.1 g aspirin enteric-coated tablets were prepared,that is,the self-made preparation(T).Taking 0.1 g(Bayaspirin®)enteric-coated tablets(R)as reference preparation,the in vitro release and in vivo postprandial pharmacokinetics of the two preparations were investigated.Results The f2 factor of the in vitro release curves of T and R was greater than 50;Cmax,AUC0-t and AUC0-∞ of acetylsalicylic acid all meet the corresponding RSABE or ABE bioequivalence evaluation criteria.Conclusion There is a good consistency between the in vitro release of T and R and the postprandial pharmacokinetics in vivo.关键词
阿司匹林肠溶片/体内外评价/生物等效性/高变异药物Key words
Aspirin enteric-coated tablets/Evaluation in vitro-in vivo/Bioequiavailability/Highly variable drug分类
医药卫生引用本文复制引用
段丽萍,陈晓雪,杨志,吴银双,刘峻宇,金笛..阿司匹林肠溶片的制备及体内外评价[J].昆明医科大学学报,2024,45(6):69-74,6.基金项目
云南省创新引导与科技型企业培育计划基金资助项目(202004AR040019) （202004AR040019）
