多索茶碱冻干粉针的制备及质量控制  

Preparation and Quality Evaluation of Doxofylline for Injection

作　　者：杨成雄[1] 张勇慧[2] 

机构地区：[1]荆楚理工学院药学院,湖北荆门448000 [2]华中科技大学同济药学院,湖北武汉430030

出　　处：《荆门职业技术学院学报》2008年第6期49-51,55,共4页Journal of Jingmen Technical College

摘　　要：目的:制备多索茶碱冻干粉针并对其进行质量检查。方法:制备工艺采用脱炭、过滤、细菌内毒素检查和冷冻干燥,并对其有关物质和含量等项目进行了检测。结果:最佳处方为每100支用多索茶碱10.5 g,甘露醇30.0 g;本品在5%葡萄糖注射液和0.9%NaC l注射液中室温放置4 h稳定性良好;有关物质及多索茶碱含量符合规定。结论:本研究表明多索茶碱冻干粉针的制备工艺稳定,质量可控。Objective：To prepare and evaluatethe Doxofylline for injection. Methods： The formulation was optimized with an orthogonal design. The main adjuvant of Doxofylline for Injection is Manitol. We evaluated the Doxofylline for Injection in identification and relative material and contents. Results：The formulation was boxofylline10.5 g, manico130.0 g in100 rami ;The stability and quality of the Doxofylline for Injection in 5% glucose injection and 0.9% NaCl injection had not been changed after 4 under room temperature. Conclusion： The research on the Doxofylline for Injection indicated it＇s artwork and quality were good.

关 键 词：多索茶碱冻干粉针 制备工艺 质量评价 

分 类 号：R927.2[医药卫生—药学]