冻干天花疫苗中残留水分对其在不同温度下稳定性的影响。
The effect of residual moisture in lyophilized smallpox vaccine on its stability at different temperatures.
作者信息
Sparkes J D, Fenje P
出版信息
Bull World Health Organ. 1972;46(6):729-34.
Abstract
In a study of the influence of residual moisture on the potency of freeze-dried smallpox vaccine, vaccine lots with moisture contents between 0.36% and 6.7% were used. These lots were stored at 4 degrees C, 24 degrees C, and 37 degrees C for up to 6 months, or were exposed to 100 degrees C for up to 3 hours, and were sampled at regular time intervals for assay. No loss in potency occurred at 4 degrees C where the moisture content was 4.8% or less. At 24 degrees C the critical moisture level was 2.5%, and at 37 degrees C it was 0.36%. At 100 degrees C the potency loss was more rapid and there were significant losses after 1 hour at a moisture level of 2.4% or more. A residual moisture content of less than 1% seems to be essential for satisfactory storage of freeze-dried smallpox vaccine.
摘要
在一项关于残留水分对冻干天花疫苗效力影响的研究中，使用了水分含量在0.36%至6.7%之间的疫苗批次。这些批次的疫苗分别在4℃、24℃和37℃下储存长达6个月，或在100℃下暴露长达3小时，并定期取样进行检测。在4℃且水分含量为4.8%或更低时，效力没有损失。在24℃时，临界水分水平为2.5%，在37℃时为0.36%。在100℃时，效力损失更快，在水分含量为2.4%或更高时，1小时后就会有显著损失。冻干天花疫苗要想储存良好，残留水分含量似乎必须低于1%。
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