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[预防性和治疗性制剂对细胞培养物毒性作用的评价。III. 通过L132连续细胞系中细胞损伤程度检测医学生物制剂的毒性特性]

[Evaluation of the toxic action of prophylactic and therapeutic preparations on cell cultures. III. The detection of toxic properties in medical biological preparations by the degree of cell damage in the L132 continuous cell line].

作者信息

Kravchenko A T, Dzagurov S G, Chervonskaia G P

出版信息

Zh Mikrobiol Epidemiol Immunobiol. 1983 Mar(3):87-92.

PMID:6845931
Abstract

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.

摘要

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。

相似文献

1
[Evaluation of the toxic action of prophylactic and therapeutic preparations on cell cultures. III. The detection of toxic properties in medical biological preparations by the degree of cell damage in the L132 continuous cell line].[预防性和治疗性制剂对细胞培养物毒性作用的评价。III. 通过L132连续细胞系中细胞损伤程度检测医学生物制剂的毒性特性]
Zh Mikrobiol Epidemiol Immunobiol. 1983 Mar(3):87-92.
2
[Evaluation of the toxic action of prophylactic and therapeutic preparations on cell cultures of different types and origin. II. The cytotoxic action of adsorbed DPT vaccine and its components on cells of the continuous L132 line].
Zh Mikrobiol Epidemiol Immunobiol. 1982 May(5):53-7.
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[Use of a diploid cell line for detecting the toxic components in medical immunobiological preparations].
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[Theoretical bases and experimental verifications in using cell cultures in developing new quality assessment and standardization criteria for medical immunobiological preparations].[在开发医学免疫生物学制剂新的质量评估和标准化标准中使用细胞培养的理论基础与实验验证]
Zh Mikrobiol Epidemiol Immunobiol. 1986 Jun(6):84-91.
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[Evaluation of the toxic effects of preventive and therapeutic preparations in transplantable cell cultures from different species and of different origins. I. Demonstration of the toxic properties of commercial batches of adsorbed DPT vaccine in cell cultures].
Zh Mikrobiol Epidemiol Immunobiol. 1981 Oct(10):84-7.
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Problems associated with the use of merthiolate as a preservative in anti-lymphocytic globulin.在抗淋巴细胞球蛋白中使用硫柳汞作为防腐剂相关的问题。
Toxicology. 1979 Mar-Apr;12(3):325-33. doi: 10.1016/0300-483x(79)90079-9.
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Dose-response study of thimerosal-induced murine systemic autoimmunity.硫柳汞诱导小鼠全身性自身免疫的剂量反应研究。
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Being on the track of thimerosal. Review.追踪硫柳汞。综述。
Acta Microbiol Immunol Hung. 2005;52(1):95-103. doi: 10.1556/AMicr.52.2005.1.5.
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[Cytogenetic control over the safety of merthiolate].
Zh Mikrobiol Epidemiol Immunobiol. 1989 Nov(11):46-52.

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