微生物法测定威替米星原料药和注射液的效价  

Determining activity of vertilimicin in drug substance and injections by microbi ological method

作　　者：舒薇[1,2] 刘振[1] 段更利[1] 王文风[1] 

机构地区：[1]复旦大学药学院药物分析教研室 [2]上海市闸北区中心医院药剂科,上海200070

出　　处：《中国新药与临床杂志》2005年第6期471-473,共3页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:建立测定威替米星效价的方法并用于其原料药及注射液的质量控制。方法:以短小芽孢杆菌作为试验菌种,采用二剂量法测定威替米星的效价,并对其原料药及2种规格的注射液各3批样品进行了测定。结果:按生物检定统计法进行可靠性测验,结果显示效价测定结果可信限率均小于5%。结论:本法可以用于威替米星原料药及注射液的效价测定。AIM: To establish a microbiological method for determining the activity of ve rtilmicin in drug substance and injections. METHODS: Bacillus pumilus was used for testing the activity of vertilmicin through two-dosage method. RESULTS:Reliability test was performed according to the biological statistics a nd the confidence limit rates of the outcoming activities were all less than 5 % . CONCLUSION:Microbiological method can be used for determination of vertilmicin i n drug substance and injections.

关 键 词：微生物学技术 威替米星 氨基糖苷 类 效价 

分 类 号：R927.2[医药卫生—药学] R978.12