法莫替丁钙镁咀嚼片的制备及体内外评价  

The Preparation and in Vivo and in Vitro Characterization of Famotidine Calcium Magnesium Chewable Tablets

作　　者：史子豪 葛静 孙玉凡 王洪晶 秦杰子 施斌 贺敦伟 SHI Zihao;Ge jing;SUN Yufan;WANG Hongjing;QIN Jiezi;SHI Bin;HE Dunwei(School of Medicine and Pharmacy,Ocean University of China,Qingdao 266003,China;HQ Pharma(Shanghai)Co.,Ltd.,Shanghai 201807,China)

机构地区：[1]中国海洋大学医药学院,山东青岛266003 [2]上海则正医药科技股份有限公司,上海201807

出　　处：《生物化工》2025年第1期64-68,共5页Biological Chemical Engineering

摘　　要：目的:制备已拟定处方工艺的法莫替丁钙镁咀嚼片,对自研制剂制备方法的可行性进行体内外评价。方法:通过流化床制粒和湿法制粒工艺,制备法莫替丁钙镁咀嚼片,并通过溶出曲线、含量及生物等效性等方法进行相关体内外评价。结果:质量对比结果表明自研制剂的质量与参比制剂的质量一致,虽然自研制剂与参比制剂在各介质中的溶出曲线不完全相似,但自研制剂和参比制剂生物等效。结论:成功制备法莫替丁钙镁咀嚼片,制剂处方和工艺合理,稳定可行,降低了制剂成本,具有广阔的商业前景。Objective:To prepare famotidine calcium magnesium chewable tablets based on the proposed formulation composition and process,and to evaluate the feasibility of the self-developed preparation method through in vivo and in vitro characterization.Methods:Famotidine calcium magnesium chewable tablets are prepared using fluidized bed granulation and wet granulation techniques,followed by relevant in vivo and in vitro characterization by dissolution curve,content and bioequivalence.Results:Quality comparison shows that the self-developed formulation is consistent with the reference formulation in terms of quality.Although the dissolution profiles of the self-developed and reference formulations are not fully consistent across different media,the both formulations are bioequivalent.Conclusion:Famotidine calcium magnesium chewable tablets are successfully developed with an elegant and and feasible formulation composition and optimized process.The formulation is stable,cost-effective,and has significant commercial potential.

关 键 词：法莫替丁 咀嚼片 体外评价 体内评价 

分 类 号：R943[医药卫生—药剂学]