酶解纤维蛋白基培养基制备霍乱化学疫苗组分可行性的实验证实

Q3 Medicine
V. R. Vol’nikov, O. S. Durakova, R. R. Salikhov, Yu. I. Samokhvalova, N. G. Avdeeva, O. D. Klokova, M. N. Kireev, O. A. Volokh
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引用次数: 0

摘要

本研究的目的是通过实验证实使用基于酶促纤维蛋白水解物的营养培养基来获得化学霍乱疫苗的特定成分的可能性:霍乱毒素和O-抗原。材料和方法。我们使用了霍乱弧菌569B和霍乱弧菌M-41的生产菌株。在实验室发酵罐中进行8小时的浸没式低容量培养,自动维持培养参数,并在基于酶促纤维蛋白水解液的营养培养基上加入葡萄糖,该营养培养基含有(1.0±0.1)g/l的胺氮,pH值为(8.0±0.1)。从福尔马林处理的培养液离心液中获得霍乱毒素和O-抗原。应用免疫化学方法测定霍乱弧菌抗原在培养和分离阶段的特异性活性。霍乱疫苗的最终剂型的制备和肠溶包衣片剂的包衣是根据监管文件进行的。结果和讨论。已经表明,在基于酶促纤维蛋白水解物的培养基上培养提供了具有高水平抗原特异活性的霍乱弧菌生产菌株的生物量的稳定生长。实验室批次的成品剂型与商业批次的化学霍乱疫苗的主要特性的比较分析表明,符合监管文件的要求。研究结果表明,利用以酶促纤维蛋白水解物为基础的营养培养基培养生产菌株和获得霍乱疫苗的特定成分是可行的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Experimental Substantiation of Feasibility of Using Enzymatic Fibrin Hydrolyzate-Based Medium to Obtain Components of Chemical Cholera Vaccine
The aim of the study was to experimentally substantiate the possibility of using a nutrient medium based on enzymatic fibrin hydrolyzate in order to obtain specific components of chemical cholera vaccine: cholerogen-anatoxin and O-antigen. Materials and methods. We used production strains of Vibrio cholerae 569B and V. cholerae M-41. Submerged low-volume cultivation was carried out in a laboratory fermenter for 8 hours, with automatic maintenance of cultivation parameters and feeding with glucose on the nutrient medium based on enzymatic fibrin hydrolyzate, containing (1.0±0.1) g/l of amine nitrogen, pH being (8.0±0.1). Cholerogen-anatoxin and O-antigens were obtained from detoxified formalin-treated centrifugates of culture liquids. The specific activity of V. cholerae antigens at the stages of cultivation and isolation was determined applying immunochemical methods. The preparation of the finished dosage form of the cholera vaccine and the coating of the tablets with an enteric coating was carried out in accordance with the regulatory documentation. Results and discussion. It has been shown that cultivation on the medium based on enzymatic fibrin hydrolyzate provides a stable growth of the biomass of V. cholerae production strains with a high level of specific activity of antigens. Comparative analysis of the main properties of the finished dosage form of laboratory batches with a commercial batch of chemical cholera vaccine has demonstrated compliance with the requirements of regulatory documentation. The results obtained has led us to conclusion that it is feasible to use the nutrient medium based on enzymatic fibrin hydrolyzate for cultivating production strains and obtaining specific components of the cholera vaccine.
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来源期刊
Problemy Osobo Opasnykh Infektsii
Problemy Osobo Opasnykh Infektsii Medicine-Infectious Diseases
CiteScore
1.90
自引率
0.00%
发文量
79
审稿时长
12 weeks
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