苄星青霉素及其注射用无菌粉末的可见异物检查  

Visible foreign materials inspection of benzathine benzylpenicillin and its Sterile powder for injection

作　　者：陈汝红 

机构地区：[1]河北省食品药品检验院,河北石家庄050011

出　　处：《中国医药科学》2012年第23期103-103,129,共2页China Medicine And Pharmacy

基　　金：河北省科研支撑计划(06276425)

摘　　要：目的建立苄星青霉素及其注射用无菌粉末的可见异物检查法。方法对可见异物检查用溶剂的种类和溶剂量进行了考察,针对不同工艺的样品,确定二甲基甲酰胺、二甲基亚砜、混合溶剂可供选用。结果样品在所选适量溶剂中全部溶解,明显可见异物和微细可见异物可被检出。结论本法简便、快速,适用于苄星青霉素及其注射用无菌粉末的可见异物检查。Objective To establish the methods for the inspection of visible foreign materials in benzathine benzylpenicillin and its sterile powder for injection.Methods The types and volume of solvents for inspecting visible foreign materials were investigated.Dimethylformamide,dimethylsulfoxide and mixed solvent were available for the samples of different processes.Results The samples dissolved completely in appropriate solvents and obviously visible foreign materials and faintly visible foreign materials were detected.Conclusion This method is simple and fast,suitable for the inspection of visible foreign materials in benzathine benzylpenicillin and its sterile powder for injection.

关 键 词：苄星青霉素 注射用无菌粉末 可见异物 检查 

分 类 号：R927.1[医药卫生—药学]