Kravchenko A T, Dzagurov S G, Chervonskaia G P
Zh Mikrobiol Epidemiol Immunobiol. 1983 Mar(3):87-92.
The methods of the quality control of medical biological preparations, including tests on animals, do not ensure the complete absence of toxicity in a final product. The use of the method of "subcultures with the introduced preparation" makes it possible to determine the toxicity of both specific and nonspecific components of vaccines and sera from the number of dead and damaged cells. The toxic action of preparations kills and damages the cells at the site of injection, thus inducing the formation of autoantigens whose effect on the body cannot be predicted. Thus thimerosal, commonly used as preservative, has been found not only to render its primary toxic effect, but also capable of changing the properties of cells. This fact suggests that the use of thimerosal for the preservation of medical biological preparations, especially those intended for children, is inadmissible.
医学生物制品的质量控制方法,包括动物试验,并不能确保最终产品完全没有毒性。使用“引入制剂的传代培养”方法可以根据死亡和受损细胞的数量来确定疫苗和血清中特定和非特定成分的毒性。制剂的毒性作用会杀死和损伤注射部位的细胞,从而诱导自身抗原的形成,而其对身体的影响无法预测。因此,常用作防腐剂的硫柳汞不仅会产生其主要毒性作用,还能够改变细胞的特性。这一事实表明,将硫柳汞用于医学生物制品的保存,尤其是用于儿童的制品,是不可接受的。