Chervonskaia G P, Kravchenko A T, Runova V F, Bedniagin V M, Grinberg K N
Zh Mikrobiol Epidemiol Immunobiol. 1988 Dec(12):85-90.
The cytotoxic action (CTA) of chemical substances contained as admixtures in medical immunobiological preparations on human diploid cells has been studied. Such chemical substances as rivanol and merthiolate in admissible concentrations show the highest degree of CTA. The results obtained in this investigation indicate that different concentrations of chemical substances may produce equal CTA; thus, thiolate in toxic in a dose of 0.8 microgram/ml; the same CTA is produced by aluminium sulfate in a concentration of 500 micrograms/ml. Small doses of chemical substances, producing no explicit manifestations of the cytotoxic effect, may have latent CTA determined by additional methods of investigation. CTA may be manifested as lethal, sublethal and latent cell lesions. In working out regulations on the test for CTA it is expedient to indicate admissible residual amounts of chemical substances contained in finished medical immunobiological preparations, considering that these amounts must be incapable of producing CTA in cell cultures. The conclusion has been made on the expediency of denoting small amounts of chemical substances capable of producing latent CTA as tentatively tolerable doses.
对医学免疫生物制品中作为添加剂所含化学物质对人二倍体细胞的细胞毒性作用（CTA）进行了研究。诸如利凡诺和硫柳汞等处于允许浓度的化学物质显示出最高程度的CTA。本研究获得的结果表明，不同浓度的化学物质可能产生相同的CTA；因此，硫柳汞在剂量为0.8微克/毫升时具有毒性；硫酸铝在浓度为500微克/毫升时产生相同的CTA。小剂量的化学物质，未产生细胞毒性作用的明显表现，可能具有通过额外研究方法确定的潜在CTA。CTA可表现为致死性、亚致死性和潜在性细胞损伤。在制定CTA检测规定时，考虑到成品医学免疫生物制品中所含化学物质的允许残留量必须不能在细胞培养物中产生CTA，指明这些残留量是适宜的。已得出结论，将能够产生潜在CTA的少量化学物质指定为暂定耐受剂量是适宜的。
