de Rizzo E, Pereira C A, Fang F L, Takata C S, Tenório E C, Pral M M, Mendes I F, Gallina N M
Seção de Cultura de Tecidos e Controle, Virologia do Instituto Butantan, São Paulo, Brasil.
Rev Saude Publica. 1990 Feb;24(1):51-9. doi: 10.1590/s0034-89101990000100009.
Three different lots of measles vaccines produced with the Biken CAM-70 virus strain were requested from the central cold store of the Public Health Department of the State of S. Paulo, Brazil, and assays on photosensitivity at 2-8 degrees C, and on stability at 28, 36.5 and 45 degrees C were carried out to find out for how long these vaccines would maintain their minimum potency, established as being 3.70 log10 or 5000 TCID50 (50% tissue culture infective dose) per human dose. The analysis of the adjusted straight regression lines indicated that, with the passage of time, the potency of lyophilized or reconstituted vaccines, as well as of vaccines exposed to or protected from light decreased. Light-exposed vaccines, however, became less potent than vaccines protected from the light. None of the vaccine lots studied, reconstituted and stored at 2-8 degrees C, exhibited homogeneity as to sensitivity to light. When freeze-dried vaccines had their photosensitivity studied at 2-8 degrees C, lots 1 and 2 presented greater thermal degradation when exposed to light than when protected from it. However, in both instances, it was found that potency fell below that taken as minimum for the Biken CAM-70 virus strain. At all other temperatures considered, even when protected from light, lots 1 and 2 did not retain the minimum potency. Lot 3 kept the expected stability for 60 days at 2-8 degrees C when protected from light and for 40 days when unprotected, but its thermal degradation at other temperatures was more intense (28 degrees C: 5 days; 36.5 degrees C: 2 days; 45 degrees C: 0.5 day).(ABSTRACT TRUNCATED AT 250 WORDS)
从巴西圣保罗州公共卫生部的中央冷藏库中获取了三批不同的、由比肯CAM - 70病毒株生产的麻疹疫苗,并分别在2 - 8℃下进行了光敏感性检测,以及在28℃、36.5℃和45℃下进行了稳定性检测,以确定这些疫苗能在多长时间内保持其最低效力,该最低效力设定为人用剂量每剂3.70 log10或5000 TCID50(50%组织培养感染剂量)。对调整后的直线回归线分析表明,随着时间推移,冻干或复溶后的疫苗效力,以及暴露于光照或避光保存的疫苗效力均会下降。然而,暴露于光照下的疫苗比避光保存的疫苗效力下降得更快。所研究的疫苗批次,在2 - 8℃复溶并储存后,对光的敏感性并不一致。当在2 - 8℃研究冻干疫苗的光敏感性时,第1批和第2批在光照下比避光时热降解更严重。但在这两种情况下,均发现效力低于比肯CAM - 70病毒株的最低效力标准。在所有其他考虑的温度下,即使避光保存,第1批和第2批也无法保持最低效力。第3批在避光条件下于2 - 8℃可保持预期稳定性60天,未避光时为40天,但在其他温度下其热降解更剧烈(28℃:5天;36.5℃:2天;45℃:0.5天)。(摘要截断于250字)