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

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.