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Requirements for standard viral vaccine samples for veterinary medicine 兽医用标准病毒疫苗样品的要求
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-10
I. Matveeva, T. A. Skotnikova, L. A. Neminushchaia, N. K. Eremets, V. I. Eremets, E. Markova, P. Krasochko
One of the branches of domestic biotechnology is the production of immunobiological drugs, including vaccines for medical and veterinary purposes. Despite the general decline observed in the global economy in recent years, the pharmaceutical market is developing. In 2020, the biological drug market could exceed $250 billion. In the Russian Federation and the countries of the Eurasian Economic Union, serious actions are being taken to harmonize national regulatory requirements with international rules and foreign control systems in the field of the production of immunobiological drugs and quality control. It should be noted the price availability of domestic vaccines, their high adaptation to the Russian epizootic situation, since they were created on the basis of strains characteristic of the territory of the country and the Eurasian continent. For the prevention of diseases such as foot-and-mouth disease, anthrax, trichophytia, microsporia, brucellosis, domestic vaccines are used in Russia. The main component of the strategy for the production of veterinary vaccines to increase competition of products is ensuring their quality. Products of Russian companies that do not have the practice of applying international standards cannot be competitive. This leads to the loss of the domestic market. Currently, regulatory documents of the Russian Federation and the Eurasian Economic Union have established uniform requirements for the organization of the production and quality control of medicines for medical and veterinary use. Within the framework of these documents, areas related to the development and certification of standard samples of various levels are actively developing, the purpose of which is to quantify the specific activity of drugs and the metrological characteristics of the methods used to evaluate quality, stability indicators, as well as control of auxiliary substances. The use of auxiliary substances and pharmaceutical substances is regulated by regulatory documentation: GF, FFS, FS, FSP or industry standards. This is necessary, since heterogeneity of drug quality parameters is possible due to various factors, including uncontrolled and uncontrolled.
国内生物技术的一个分支是生产免疫生物药物,包括用于医疗和兽医目的的疫苗。尽管近年来全球经济普遍下滑,但制药市场仍在发展。2020年,生物药物市场可能超过2500亿美元。在俄罗斯联邦和欧亚经济联盟国家,正在采取认真行动,使免疫生物药物生产和质量控制领域的国家监管要求与国际规则和外国管制制度相协调。应该指出的是,国产疫苗的价格低廉,对俄罗斯流行病的高度适应,因为它们是根据该国领土和欧亚大陆特有的毒株生产的。为了预防口蹄疫、炭疽、毛藻病、微孢子虫、布鲁氏菌病等疾病,俄罗斯使用国产疫苗。提高产品竞争力的兽医疫苗生产战略的主要组成部分是确保其质量。没有采用国际标准的做法的俄罗斯公司的产品不可能具有竞争力。这导致了国内市场的损失。目前,俄罗斯联邦和欧亚经济联盟的管理文件对医疗和兽医用药品的生产和质量控制的组织制定了统一的要求。在这些文件的框架内,与各级标准样品的开发和认证有关的领域正在积极发展,其目的是量化药物的比活性和用于评估质量、稳定性指标以及辅助物质控制的方法的计量特征。辅助物质和药物的使用受监管文件的监管:GF、FFS、FS、FSP或行业标准。这是必要的,因为药物质量参数的异质性可能是由于各种因素造成的,包括不受控制和不受控制。
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引用次数: 0
Efficiency of fluorescein-conjugated anti-rabies and anti-chlamydia antibodies freeze-dried 冻干荧光素偶联抗狂犬病和抗衣原体抗体的效力
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-5
V. Klyukina, L. S. Lyulkova, O. V. Anisina, K. A. Glinsky, V. Lobanova, M. S. Svyatenko
This article presents the results of a study of the effectiveness of anti-rabies and anti-chlamydia antibodies conjugated with fluorescein, freeze-dried. Immunobiological products lyophilization is one of the most reliable ways to preserve their physicochemical and biological properties, since this is a soft drying method, in which the dried product is frozen, then it is placed in a vacuum chamber, where the solvent is sublimated. Lyophilization allows you to get drugs without losing their shape, structural integrity and more importantly, without losing their biological activity. The study aimed to standardize methods for the purification of FITC conjugates, as well as reagents used in the production and drying of FITC conjugates. We used conjugates of anti-rabies and anti-chlamydia antibodies labeled with fluoresceinisothiocyanate (FITZ) obtained by hyperimmunization of sheep and rams using an immunostimulant. We tested the ability of various concentrations of dextran T-70 to retain the specific activity of fluorescent conjugates of anti-rabies and anti-chlamydia antibodies when added dextran T-70 to them before the lyophilization. To determine the optimal amount of T-70 dextran filler, prepared 1%, 2%, 3%, 4%, and 5% solutions in 10mm phosphate-salt solution. We found that the effectiveness of dextran T-70 as a filler substance in the lyophilization of FITC conjugates depends on its concentration. The optimal stabilizing vehicle for lyophilization of both fluorescent conjugates is 2-3% concentration of dextran T-70 in 10 mM phosphate-buffered saline. Analysis of the results of the quality of FITZ-conjugates allows us to conclude about the high quality of biological products prepared during freeze-drying of the material in the developed temperature regime using dextran T-70 as a filler substance. As a result of the studies, the technology for the preparation of lyophilized FITC conjugates of anti-rabies and anti-chlamydia antibodies for diagnostic test systems was optimized. The specific activity and stability of the physicochemical characteristics of the preparations after lyophilization and during subsequent storage for two years were observed.
本文介绍了冻干荧光素偶联的抗狂犬病和抗衣原体抗体的有效性研究结果。免疫生物产品冷冻干燥是保存其理化和生物特性的最可靠方法之一,因为这是一种软干燥方法,将干燥的产品冷冻,然后将其放入真空室中,使溶剂升华。冷冻可以让你在不失去形状、结构完整性的情况下获得药物,更重要的是,在不失去生物活性的情况下。该研究旨在标准化FITC缀合物的纯化方法,以及用于生产和干燥FITC缀合物的试剂。我们使用了用荧光素硫氰酸盐(FITZ)标记的抗狂犬病和抗衣原体抗体的缀合物,该抗体是通过使用免疫刺激剂对绵羊和公羊进行超免疫获得的。我们测试了不同浓度的右旋糖酐T-70在冷冻干燥前添加右旋糖聚糖T-70时保留抗狂犬病和抗衣原体抗体的荧光缀合物的特异性活性的能力。为了确定T-70葡聚糖填充剂的最佳用量,在10mm磷酸盐溶液中制备1%、2%、3%、4%和5%的溶液。我们发现右旋糖酐T-70作为填充物在FITC缀合物冷冻干燥中的有效性取决于其浓度。用于冷冻干燥两种荧光缀合物的最佳稳定载体是在10mM磷酸盐缓冲盐水中2-3%浓度的右旋糖酐T-70。对FITZ缀合物的质量结果的分析使我们能够得出结论,在使用右旋糖酐T-70作为填充物质的开发温度条件下,在材料的冷冻干燥过程中制备的生物产品具有高质量。作为研究的结果,优化了用于诊断测试系统的抗狂犬病和抗衣原体抗体的冻干FITC缀合物的制备技术。观察了冻干后和随后储存两年期间制剂的物理化学特性的比活性和稳定性。
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引用次数: 0
Scientific basis for the development and production of biologics in VNITIBP VNITIBP生物制剂开发和生产的科学依据
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-1
A. Zaberezhny
The main activities of FGBNU VNITIBP are the development and improvement of industrial production technologies for effective means of prevention and treatment of animal diseases, the creation of test systems for rapid indication and identification of biological agents for the prevention and treatment of animal diseases, including birds. The Institute is responsible for scientific and technological progress in the field of biotechnological production. The article analyzes the achievements of the Institute over 50 years and outlines a program for further research.
FGBNU VNITIBP的主要活动是开发和改进用于有效预防和治疗动物疾病的工业生产技术,创建用于预防和治疗动物疾病(包括鸟类)的生物制剂的快速指示和鉴定的测试系统。该所负责生物技术生产领域的科技进步工作。文章分析了该研究所50多年来取得的成就,并提出了进一步研究的计划。
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引用次数: 0
The efficiency of using protein hydro-lyzate to stimulate the reproductive function of minks and improve the commercial properties of animal skins 水解蛋白水解物刺激水貂生殖功能和提高兽皮商业性能的效果
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-2
A. I. Albulov, M. Frolova, A. V. Grin, A. Eliseev, A. Abramov
From the point of view of solving the problem of feed supply in fur farming, the use of biologically active additives that normalize the protein balance is of great interest. The hydrolyzate obtained by the technology developed by us from the waste of fur farming is a highly digestible protein, is characterized by a high content of amine nitrogen, and contains all non-replaceable amino acids. The introduction of hydrolyzate from sable muscle tissue into the main diet of minks allowed to reduce by 1.3 times the number of missing female minks, to increase the yield of mink puppies per main female, increase the viability of the offspring. The efficiency of feeding the protein hydrolyzate in the diet of caged minks was assessed by the commercial properties of the skins. The most important indicators are the thickness of the skin and the ratio of its layers, on which the duration of processing of raw materials during production operations and indicators of the physical and mechanical properties of the skins depend. Analysis of the obtained measurements made it possible to conclude that feeding with protein hydrolyzate led to an increase in the thickness of the skin of various topographic areas of mink skins. The maximum value of the epidermis thickness was observed on the rump part, the minimum - on the spinal region, while the maximum number of guard hairs was noted on the spinal part, the minimum - on the lateral part of the mink skins. Thus, the results obtained indicate the effectiveness of using a protein hydrolyzate to stimulate the reproductive function of minks and improve the commercial properties of animal skins.
从解决毛皮养殖中饲料供应问题的角度来看,使用生物活性添加剂来规范蛋白质平衡是非常有意义的。通过我们开发的技术从毛皮养殖的废物中获得的水解产物是一种高度可消化的蛋白质,其特征是胺态氮含量高,并且含有所有不可替代的氨基酸。将貂皮肌肉组织的水解产物引入水貂的主要饮食中,可以将失踪雌性水貂的数量减少1.3倍,从而提高每只主要雌性水貂幼犬的产量,提高后代的生存能力。通过水貂皮的商业特性来评估在笼中水貂日粮中喂养蛋白质水解产物的效率。最重要的指标是表皮的厚度及其层的比例,生产操作过程中原材料加工的持续时间以及表皮的物理和机械性能指标都取决于此。对所获得的测量结果的分析可以得出结论,用蛋白质水解液喂养导致水貂皮不同地形区域的皮肤厚度增加。在貂皮的尾部观察到表皮厚度的最大值,在脊椎区域观察到最小值,而在脊椎部分观察到保护毛的最大数量,在外侧部分观察到最小数量。因此,所获得的结果表明,使用蛋白质水解物来刺激水貂的生殖功能和改善动物皮肤的商业特性是有效的。
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引用次数: 0
Selection the optimal dose of application associated vaccine against rota-, coronavirus infection and colibacillosis in calves 小牛轮状病毒感染、冠状病毒感染和大肠杆菌病联合疫苗应用的最佳剂量选择
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-17
Y. P. Yaromchyk, P. Krasochko, P. Krasochko, V. M. Eremets, T. A. Skotnikova
The main rules for choosing the means of specific prophylactic against colibacillosis (escherichiosis) in cattle is the need to match the antigenic spectrum of the vaccine strains with epizootic strains isolated by diagnostic veteri-nary institutions from pathological material taken from dead calves. Only in this case one should expect high results of the preventive efficacy of the applied vac-cines. The design of vaccines based on pathogenicity factors of bacterias is the most promising direction in the development of new bioproducts of specific pre-vention of infectious diseases of farm animals. Researchs in the areas to choice the optimal doses and ratios of monocompo-nents, determining the optimal immunizing dose, and choosing a adjuvant is an im-portant part of research work on the creation of vaccines. We completed work to establish the optimal dose when using the associated vaccine against rota-, coronavirus infection and colibacillosis of cattle by vaccinat-ing cows in different doses of the test vaccine. Subsequently, serological studies of the blood of animals were carried out, according to the results of which the indica-tors of the best immune response were determined by comparing the established levels of biosynthesis of specific antibodies from animals of the experimental and control groups. A number of indicators of possible reactogenicity of the tested vac-cine were also studied. When conducting studies of blood serum of cows, the indi-rect hemagglutination reaction and agglutination reaction were performed. Serolog-ical blood tests carried out were accompanied by the necessary controls to ensure the reliability of the results. According to the results of studies of blood serum of cows in the experimental groups, immunization of cows with an associated vaccine against rota-, coronavirus infection and colibacillosis of cattle in different volumes led to a significant level of antiviral and antibacterial antibodies. The optimum dose for virus antigens with infectious titres from 7,0 lg and 5,5-TCI50/sm3 for vaccinated cows forms 1,5 sm3 for each viral monocomponents. The optimum dose for each vaccine strains E.coli F4, F5, Аtt25, F41 and 987P forms from 1,5-2,5 milliard bacterial cells for each bacterial monocomponents.
选择牛大肠杆菌病(escherichiosis)特异性预防手段的主要规则是,需要将疫苗株的抗原谱与兽医诊断机构从死小牛的病理材料中分离出的流行株相匹配。只有在这种情况下,人们才应该期待应用真空吸尘器的预防效果的高结果。基于细菌致病因子的疫苗设计是开发针对农场动物传染病的特异性预防新生物产品的最有希望的方向。选择单成分的最佳剂量和比例、确定最佳免疫剂量和选择佐剂等领域的研究是疫苗研制工作的重要组成部分。我们通过给奶牛接种不同剂量的试验疫苗,完成了在使用牛轮状病毒、冠状病毒感染和大肠杆菌病相关疫苗时确定最佳剂量的工作。随后,对动物血液进行了血清学研究,根据研究结果,通过比较实验组和对照组动物特异性抗体的生物合成水平,确定了最佳免疫反应的指标。还研究了测试的vaccine可能的反应原性的一些指标。在对奶牛血清进行研究时,进行了直接血凝反应和凝集反应。在进行血清学血液测试的同时,还进行了必要的控制,以确保结果的可靠性。根据对实验组奶牛血清的研究结果,用不同体积的牛轮状病毒、冠状病毒感染和大肠杆菌病相关疫苗免疫奶牛,可产生显著水平的抗病毒和抗菌抗体。接种疫苗的奶牛感染滴度为7,0lg和5,5-TCI50/sm3的病毒抗原的最佳剂量为每种病毒单组分形成1,5sm3。每种疫苗菌株大肠杆菌F4、F5、Аtt25、F41和987P的最佳剂量由每种细菌单组分的1.5至2.5毫克细菌细胞形成。
{"title":"Selection the optimal dose of application associated vaccine against rota-, coronavirus infection and colibacillosis in calves","authors":"Y. P. Yaromchyk, P. Krasochko, P. Krasochko, V. M. Eremets, T. A. Skotnikova","doi":"10.30917/ATT-VK-1814-9588-2021-1-17","DOIUrl":"https://doi.org/10.30917/ATT-VK-1814-9588-2021-1-17","url":null,"abstract":"The main rules for choosing the means of specific prophylactic against colibacillosis (escherichiosis) in cattle is the need to match the antigenic spectrum of the vaccine strains with epizootic strains isolated by diagnostic veteri-nary institutions from pathological material taken from dead calves. Only in this case one should expect high results of the preventive efficacy of the applied vac-cines. The design of vaccines based on pathogenicity factors of bacterias is the most promising direction in the development of new bioproducts of specific pre-vention of infectious diseases of farm animals. Researchs in the areas to choice the optimal doses and ratios of monocompo-nents, determining the optimal immunizing dose, and choosing a adjuvant is an im-portant part of research work on the creation of vaccines. We completed work to establish the optimal dose when using the associated vaccine against rota-, coronavirus infection and colibacillosis of cattle by vaccinat-ing cows in different doses of the test vaccine. Subsequently, serological studies of the blood of animals were carried out, according to the results of which the indica-tors of the best immune response were determined by comparing the established levels of biosynthesis of specific antibodies from animals of the experimental and control groups. A number of indicators of possible reactogenicity of the tested vac-cine were also studied. When conducting studies of blood serum of cows, the indi-rect hemagglutination reaction and agglutination reaction were performed. Serolog-ical blood tests carried out were accompanied by the necessary controls to ensure the reliability of the results. According to the results of studies of blood serum of cows in the experimental groups, immunization of cows with an associated vaccine against rota-, coronavirus infection and colibacillosis of cattle in different volumes led to a significant level of antiviral and antibacterial antibodies. The optimum dose for virus antigens with infectious titres from 7,0 lg and 5,5-TCI50/sm3 for vaccinated cows forms 1,5 sm3 for each viral monocomponents. The optimum dose for each vaccine strains E.coli F4, F5, Аtt25, F41 and 987P forms from 1,5-2,5 milliard bacterial cells for each bacterial monocomponents.","PeriodicalId":8625,"journal":{"name":"Athletic Therapy Today","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42333640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and manufacture of erythrocyte pullorosis diagnosticum for the diagnosis of avian pullorosis typhoid 鸡白脱伤寒红细胞诊断液的研制
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-11
R. Melnik, N. S. Klyushentseva, N. Melnik
The article is devoted to the problems of diagnostics of poultry typhoid fever and the development of a technology for the manufacture of diagnosticum against this disease. A method of making erythrocyte diagnosticum for the diagnosis of poultry typhoid fever is shown, including obtaining the bacterial mass of Salmonella pullorum-gallinarum, isolating the antigenic fraction from it by treating the bacterial mass with a surfactant with the addition of soda or alkali in distilled water at 93-96 °C, followed by sensitization of formalinized erythrocytes, their purification and obtaining the target product in the form of 10% suspension, characterized in that 1-1.5% aqueous solution of Desmol is used as a surfactant to isolate the antigenic fraction, taken in a final weight concentration of 0, 1-0.3%, and the sensitization of formalinized erythrocytes is carried out in the presence of the sodium salt of chitosan succinate taken in a final weight concentration of 0.5-1.5%. In the industrial production of the diagnosticum at the initial stage, the bacterial suspension was necessarily mixed and the optical concentration was measured photometrically. The concentration of the surfactant solution was adjusted to 25 ml of microbial cells in 1 ml. At the second stage, antigen-sensitin was obtained and stored at 4 ° C. Sheep erythrocytes were used for sensitization. At the third stage, 20% formalized ram erythrocytes were obtained. Formalized erythrocytes were washed five times until the supernatant was completely cleared and sensitized. At the fourth stage, 300-500 ml was added to 1 liter of erythrocyte suspension for sensitization. sensitin and kept in a water bath at a temperature of 600С. At the fifth stage, the sensitized erythrocytes were washed to remove residual sensitin not associated with erythrocytes. Obtaining highly effective erythrocyte diagnostics for the diagnosis of avian pullorosis typhoid is an urgent problem. We have produced, improved and optimized the technology of industrial production of erythrocyte pullor antigen from the Salmonella pullorum-gallinarum strain for the diagnosis of avian pullorosis-typhus. We have theoretically substantiated and tested in production conditions a new method of resuspension, extraction, clarification of the bacterial mass. Used surfactants (surfactants) to obtain sensitin.
本文论述了禽伤寒的诊断问题及研制禽伤寒诊断剂的技术。本文介绍了一种用于家禽伤寒诊断的红细胞诊断液的制备方法,包括获取鸡白痢沙门氏菌菌团,在蒸馏水中加入苏打或碱的表面活性剂,在93-96℃条件下对菌团进行处理,分离其抗原部分,然后将形成化红细胞致敏,纯化,以10%悬浮液的形式获得目标产物。其特点是用1-1.5%的Desmol水溶液作为表面活性剂,分离最终质量浓度为0.1% -0.3%的抗原部分,并在最终质量浓度为0.5-1.5%的琥珀酸壳聚糖钠盐存在下进行形成化红细胞的致敏。在诊断菌的工业生产初期,必须对菌悬液进行混合,并用光度法测定其光学浓度。将表面活性剂溶液的浓度调整为1 ml微生物细胞25 ml。第二阶段,获得抗原-致敏素,保存在4℃。在第三阶段,获得20%的正规化公羊红细胞。形成的红细胞洗涤5次,直到上清完全清除并致敏。第四阶段,在1升红细胞悬液中加入300-500 ml致敏。敏敏素并保存在温度为600С的水浴中。在第五阶段,将致敏的红细胞清洗以去除与红细胞无关的残留致敏素。获得高效的红细胞诊断方法对禽白痢伤寒的诊断是一个迫切需要解决的问题。对鸡白痢-斑疹伤寒诊断用鸡白痢-鸡白痢沙门氏菌红细胞白痢抗原的工业化生产工艺进行了改进和优化。我们从理论上证实了一种新的重悬、提取、澄清菌团的方法,并在生产条件下进行了试验。用表面活性剂(表面活性剂)获得致敏素。
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引用次数: 0
Selection of adjuvants in the design of an inactivated vaccine against respiratory infections of cattle 牛呼吸道感染灭活疫苗设计中佐剂的选择
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-12
A. Prytychenko, P. Krasochko, N. K. Eremets, O. V. Provotorova
Infectious diseases of young farm animals are a serious problem for the livestock industry. Modern industrial technology of keeping animals, contributing to the emergence of viral diseases, often leads to a decrease in the immunological reactivity of their body, due to the underdevelopment of the immune system of young animals (primary immunodeficiency), food toxicosis, insufficient and unbalanced in various components feeding, as well as the impact of stress factors inherent in industrial technology – rearing animals, transportation, microclimate changing, forming large groups of animals, small feeding area, intensive exploitation. These factors negatively affect the immune system and metabolic processes, which leads to a significant decrease in their resistance to infectious diseases. In turn, the causative agents of viral respiratory diseases inhibit the cellular and humoral components of the immune system. Epizootological monitoring shows that viruses of infectious rhinotracheitis, viral diarrhea, parainfluenza-3 and respiratory syncytial infection in cattle are the main cause of pathological processes in respiratory diseases of young animals. Animal specific prophylactic methods are effective in preventing infectious diseases. Immunization of a pregnant herd promotes the birth of young animals with a full-fledged immune system. In mixed infections, it is difficult to determine the leading role of a particular infectious agent, therefore the most effective method for preventing such diseases is associated vaccines. In the process of designing a vaccine, the selection of antigens and an adjuvant is of great importance, contributing to the formation of a specific and long-term immunity. We studied the comparative efficacy of adjuvants and the antigenic activity of the selected viral strains of infectious rhinotracheitis, viral diarrhea, parainfluenza-3 and respiratory syncytial infection of cattle. The dynamics of biosynthesis of antiviral antibodies after immunization in cows were determined.
幼畜的传染病是畜牧业面临的一个严重问题。饲养动物的现代工业技术导致了病毒性疾病的出现,由于幼兽免疫系统发育不足(原发性免疫缺陷)、食物中毒、各种成分喂养不足和不平衡,以及工业技术中固有的压力因素的影响——饲养动物、运输、小气候变化、形成大群动物、饲养面积小、集约开发。这些因素对免疫系统和代谢过程产生负面影响,导致他们对传染病的抵抗力显著下降。反过来,病毒性呼吸道疾病的病原体会抑制免疫系统的细胞和体液成分。动物流行病学监测表明,牛传染性鼻气管炎、病毒性腹泻、副流感病毒-3和呼吸道合胞体感染是幼兽呼吸道疾病病理过程的主要原因。针对动物的预防方法在预防传染病方面是有效的。对怀孕的牛群进行免疫接种可以促进具有成熟免疫系统的幼兽的出生。在混合感染中,很难确定特定传染源的主导作用,因此预防此类疾病的最有效方法是相关疫苗。在设计疫苗的过程中,抗原和佐剂的选择至关重要,有助于形成特异性和长期免疫力。我们研究了佐剂的比较效力和选定的感染性鼻气管炎、病毒性腹泻、副流感病毒-3和牛呼吸道合胞体感染病毒株的抗原活性。测定了奶牛免疫后抗病毒抗体生物合成的动力学。
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引用次数: 0
Lyophilization biologicals products. Equipment. Technology. Validation. 冻干生物制品。设备技术验证。
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-14
E. S. Serbis, Matveeva I.N., V. I. Eremets
Тhe aseptic process of industrial production of sterile lyophilized biological products is completed by one of the critical stages of the technological process, the freeze-drying. GOST R ISO 13408-3-2011 defines the term lyophilization as a synonym for the sublimation. Sublimation - the physical process on which the freeze-drying method is based. This paper discusses the issues of freeze drying that engineers and biologists, production technologist, designers of dry preparations, and quality specialists face with. Freeze-drying consists of three stages: freezing, freeze-drying and drying. Each stage has its own critical points, input and output parameters. The task of the developer of freeze-drying technology is to determine the need for each parameter and the sufficiency of their quantity. Equipment, technology and regulatory documents are considered as interdependent elements that make up freeze drying as a system. An integrated approach to the freeze-drying process includes the development of modes, equipment control, and internal documentation. The key parameters of the process are the qualitative and quantitative characteristics (reference values, measurement procedures, acceptable range of values) of the semi-finished liquid product and the finished freeze-dried product. Characteristics of the semi-finished liquid product are the temperature of complete crystallization; upper and lower eutectic temperatures; maximum permissible heating temperature (thermo-lability); density; specific (biological) activity. Freeze-drying process characteristics are: at the freezing stage - reaching the temperature of complete crystallization in the entire volume of the material received for drying; at the sublimation stage - maintaining the temperature in the dried material in the range between the lower and upper eutectic temperatures (without going beyond the upper); at the drying stage - reaching the maximum temperature in the material. The duration of each stage depends on the vial in which the dried material is packed, the volume of packaging, and the features of heat, mass, and energy exchange in the sublimation plant. Standard operating procedures (SOPs) should be designed with these features in mind. For example, for different packages (2ml or 10ml) in vials of the same volume, or for the same packaging in vials of different volumes, for example, 2ml in vial of 10-ml or 20-ml, separate SOPs are required in each case. In the current practice of industrial production, the quality of the lyophilized product is evaluated by humidity (GOST 24061-2012). In our work, to assess the quality of the process, we measured the decrease in the mass of liquid material during drying. We recommend measure both indicators, since they complement each other.
无菌冻干生物制品工业生产的无菌过程是由工艺过程的关键阶段之一——冷冻干燥完成的。GOST R ISO 13408-3-2011将术语冷冻干燥定义为升华的同义词。升华-冷冻干燥方法所基于的物理过程。本文讨论了工程师和生物学家、生产技术专家、干燥制剂设计师和质量专家面临的冷冻干燥问题。冷冻干燥包括三个阶段:冷冻、冷冻干燥和干燥。每个阶段都有自己的临界点、输入和输出参数。冷冻干燥技术开发人员的任务是确定每个参数的需求及其数量的充足性。设备、技术和监管文件被视为构成冷冻干燥系统的相互依存的要素。冷冻干燥过程的综合方法包括开发模式、设备控制和内部文件。该过程的关键参数是液体半成品和冻干成品的定性和定量特征(参考值、测量程序、可接受的值范围)。液体半成品的特征是完全结晶的温度;上下共晶温度;最大允许加热温度(热不稳定性);密集特异性(生物)活性。冷冻干燥工艺的特点是:在冷冻阶段-达到完全结晶的温度,在整个体积的材料中接受干燥;在升华阶段-将干燥材料的温度保持在低共晶温度和高共晶温度之间的范围内(不超过上限);在干燥阶段-达到材料的最高温度。每个阶段的持续时间取决于干燥材料包装的小瓶、包装的体积以及升华装置中的热量、质量和能量交换的特征。标准操作程序(SOP)的设计应考虑到这些特点。例如,对于相同体积小瓶中的不同包装(2ml或10ml),或者对于不同体积小瓶中相同包装,例如,10ml或20ml小瓶中的2ml,在每种情况下都需要单独的SOP。在目前的工业生产实践中,冻干产品的质量通过湿度进行评估(GOST 24061-2012)。在我们的工作中,为了评估过程的质量,我们测量了干燥过程中液体材料质量的下降。我们建议衡量这两个指标,因为它们相辅相成。
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引用次数: 0
Experience of using stimulating feeding for honey bees "BiHit" in the Moscow region and the Republic of Crimea 在莫斯科地区和克里米亚共和国使用刺激喂养蜜蜂“BiHit”的经验
Pub Date : 2021-02-01 DOI: 10.30917/ATT-VK-1814-9588-2021-1-16
M. Frolova, A. I. Albulov, E. Kovaleva, A. Eliseev, A. V. Grin
Unfavorable environmental factors: pesticides, chemicals, poor nutrition of bee colonies lead to a decrease in the bee's immune defense. Currently, there is a continuous search for biologically active substances that stimulate the vital activity of bees and increase the egg-laying of queens. Analysis of scientific sources data has shown high efficiency for stimulating the viability and increasing the productivity of bees of such biologically active additives as chitosan and its derivatives, probiotic strains of bacteria Bacillus subtilis and Bacillus Lichineformis, as well as sources of vital amino acids. The experience accumulated to date in the use of chitosan and its derivatives in veterinary medicine makes it possible to classify chitosan as an effective adaptogen with multifunctional properties capable of providing the body's resistance to numerous adverse environmental factors and pathogens of various diseases. Due to the excess positive charge, chitosan acquires the properties of a highly active anionite. It binds and firmly holds ions of various heavy metals, radioactive isotopes, toxic elements with their subsequent removal from the body of animals, including bees. Chitosan and its derivatives have high antibacterial, sorption, fungicidal, antiviral activity, being a natural biocompatible product that is biodegradable to CO2 and H2O and does not pollute the environment. To stimulate the vital activity of bees and increase the egg-laying of queens, stimulating protein supplements are needed to cover the lack of vital amino acids, probiotic preparations that improve the microbiocenosis of the intestines of bees, sugar syrup. Earlier, at the preliminary stage of research, we developed a recipe for stimulating feeding for bees "BiChit", which includes low molecular weight chitosan, chitosan succinate, dry bacterial mass of Bacillus subtilis VKM B-2716D and Bacillus licheniformis VKM B-2717D, lactose-free edible glucose hydrolyzate, lactose-free whey. In this work, the influence of the multifunctional stimulating feeding "BiHit" on the economically useful traits of bee colonies based on private apiaries in the Moscow region and the Republic of Crimea has been studied. Studies have shown a positive effect of feeding on family strength, brood and honey production.
不利的环境因素:杀虫剂、化学品、蜂群营养不良会导致蜜蜂的免疫防御能力下降。目前,人们一直在寻找能刺激蜜蜂生命活动和增加蜂王产卵量的生物活性物质。对科学来源数据的分析表明,壳聚糖及其衍生物、枯草芽孢杆菌和地衣芽孢杆菌的益生菌菌株以及重要氨基酸来源等生物活性添加剂在刺激蜜蜂生存能力和提高蜜蜂生产力方面具有高效性。迄今为止,壳聚糖及其衍生物在兽医中的应用积累了经验,这使得将壳聚糖归类为一种具有多功能特性的有效适应原成为可能,它能够提供身体对多种不利环境因素和各种疾病病原体的抵抗力。由于过量的正电荷,壳聚糖获得了高活性阴离子的性质。它结合并牢固地固定各种重金属、放射性同位素和有毒元素的离子,随后将其从包括蜜蜂在内的动物体内清除。壳聚糖及其衍生物具有较高的抗菌、吸附、杀菌、抗病毒活性,是一种对CO2和H2O可生物降解且不污染环境的天然生物相容性产物。为了刺激蜜蜂的重要活动并增加蜂王的产卵量,需要刺激性蛋白质补充剂来弥补重要氨基酸、改善蜜蜂肠道微生物群落的益生菌制剂、糖浆的缺乏。早些时候,在研究的初步阶段,我们开发了一种刺激蜜蜂喂食的配方“BiChit”,其中包括低分子量壳聚糖、壳聚糖琥珀酸酯、枯草芽孢杆菌VKM B-2716D和地衣芽孢杆菌VKMB-2717D的干菌群、无乳糖可食用葡萄糖水解液、无乳糖乳清。在这项工作中,研究了多功能刺激喂养“BiHit”对莫斯科地区和克里米亚共和国私人养蜂场蜂群经济有用特性的影响。研究表明,喂养对家庭力量、繁殖和蜂蜜生产有积极影响。
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引用次数: 0
Chronic wasting disease (CWD) of cervids - a prion epizootic threatening the Northern territories of Russia 猪的慢性消耗性疾病(CWD)——一种威胁俄罗斯北部地区的朊病毒流行病
Pub Date : 2020-12-01 DOI: 10.30917/att-vk-1814-9588-2020-7-11
G. Nadtochey, S. Vangeli
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引用次数: 0
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Athletic Therapy Today
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