盐酸莫西沙星片处方筛选及制备工艺的优化  

Optimization of moxifloxacin hydrochloride tablets by formulation screening and preparation process

作　　者：李禄辉 刘伟芬 宗兰兰[2] 郭猛 

机构地区：[1]河南应用技术职业学院制药工程学院,开封475004 [2]河南大学纳米杂化材料应用技术国家地方联合工程研究中心,开封475004

出　　处：《国际药学研究杂志》2017年第9期894-900,共7页Journal of International Pharmaceutical Research

基　　金：河南省重点科技攻关项目(172102310361)

摘　　要：目的筛选盐酸莫西沙星片剂的处方并优化其制备工艺。方法以休止角、振实密度、硬度、脆碎度、崩解时限、片重差异、溶出度等为指标,对处方各组分的用量、黏合剂溶剂、黏合剂用量、制粒筛网目数、颗粒干燥工艺等进行考察,以确定最优处方和工艺。结果当黏合剂溶剂为水,黏合剂用量为6 ml,过筛目数为26目,50°C干燥1 h时,能制备出各项检测指标都符合《中国药典》2015年版四部片剂要求的盐酸莫西沙星片,且其溶出曲线与市售制剂一致性良好。结论采用本文研究的处方和工艺制得的盐酸莫西沙星片剂质量符合标准要求,可用于盐酸莫西沙星片的仿制。Objective To screen prescriptions for moxifloxacin hydrochloride tablets and optimize its preparation technology.Methods Taking the angle of repose,tap density,hardness,friability,disintegration time,tablet weight difference,and dissolution rate as indexes,the amount of each component,binder solvent,amount of binder,size of the mesh for granulation and particle drying process were investigated.The optimal formulation and process were determined based on the above results.Results With water as the binder solvent,binder volume of 6 ml,screen mesh number of 26 mesh,and finally drying 1 h at 50℃,the indicators of the tablet prepared met the quality requirements of tablet in the second part of the Pharmacopoeia of People′s Republic of China the 2015 version.And the dissolution profile was in good agreement with the commercially available preparation.Conclusion The quality of moxifloxacin hydrochloride tablets prepared by the optimal formulation and process in this study is in accordance with the standard.The prescription and process can be used for the preparation of generic drugs of moxifloxacin hydrochloride tablets.

关 键 词：盐酸莫西沙星 片剂 湿法制粒 处方筛选 工艺优化 一致性 

分 类 号：R943[医药卫生—药剂学]