摘要
目的:考察不同残氧量对注射用头孢西丁钠稳定性的影响.方法:在环境相对湿度低于 35%条件下,称取头孢西丁钠按照1.0 g的规格进行分装,将分装后的药品放入真空干燥箱中并连接氮气瓶,直接充入氮气(残氧量分别控制在≤2%、(2%,3%]、(3%,4%]和(4%,8%]),用胶塞扣住并轧盖,将药品分别放置在高温(40℃±2℃)、高湿(相对湿度92.5%±5%)和光照(4 500 lux±500 lux)条件下,于第 0 天、第 10 天、第 15 天和第 30 天取样检测,分别考察性状、酸度、溶液颜色、有关物质的变化.结果:残氧量对样品的性状、酸度、溶液颜色和有关物质的影响无显著差异.结论:在 3 种放置条件下,不同残氧量水平对注射用头孢西丁钠稳定性无显著影响.
Abstract
Objective:To investigate the effect of different residual oxygen on the stability of cefoxitin sodium for injection.Methods:Under the condition that the relative humidity of the environment is lower than 35%,cefoxitin sodium is weighed and packaged according to the specification of 1.0 g,and the packaged drug is put into a vacuum drying oven and connected to a nitrogen cylinder,directly filled with nitrogen(the residual oxygen amount is controlled at≤2%,(2%,3%],(3%,4%]and(4%,8%]respectively),buckled and capped with a rubber stopper,and the drug is placed at high temperature(40℃±2℃),high humidity(relative humidity 92.5%±5%)and light(4 500 lux±500 lux)conditions,samples are taken on the 0th,10th,15th and 30th days to investigate the changes of properties,acidity,solution color and related substances,respectively.Results:There is no significant difference in the effect of residual oxygen on the properties,acidity,solution color and related substances of the samples.Conclusion:There is no significant difference between different residual oxygen on the stability of cefoxitin sodium for injection under the three placement conditions.
维普
万方数据