微生物法考察威替米星注射液的生物学稳定性

Biological stability study of vertilmicin injection by microbiological method

目的:对威替米星注射液的生物学稳定性进行研究。方法:将威替米星注射液置于不同条件下考察其稳定性,采用微生物法和无菌检查法对放置样品的效价稳定性及是否长菌进行检测。结果:本品经高温试验(60.0±s2.0)℃10d,光照试验(4500lx)10d,加速试验[相对湿度(75±5)%,(40.0±2.0)℃]6mo,长期试验[相对湿度(60±5)%,(25.0±2.0)℃]12mo,其效价均未有明显变化,无菌检查亦符合规定。结论:本品在各放置条件下稳定性良好。

AIM: To perform biological stability study of vertilmicin injection. METHODS:Placing vertilmicin substances under different conditions for stabilit y s tudy and utilizing microbiological technique with aseptic method for testing the effective value and bacterial gro wth of the stabilized placement samples. RESULTS:No significant changes of effective value, with fulfillment of aseptic rule were found after high-temperature(60.0±s 2.0) °C 10 d, strong light (( 4 500 1x))10 d, acceleration(relative humidity ((70±5) %),(40.0±2.0) °C) 6 mo, and long term acceleration(relative humidity(60±5) %,(25.0±(2.0) °C)) (12 mo) te stings. CONCLUSION:Vertilmicin injection remains stable under different placeme nt conditions.