The given paper presents the results of long-term monitoring of the hydrological regime of spring flood, soil, vegetation and productivity of estuaries of the high Sakmar-Tanalyk plain in the steppe zone of the Trans-Urals of the Republic of Bashkortostan. It is found that large water storage reservoirs built in 1986-2012 on the Tanalyk River and its feeders have reduced the amount, frequency and duration of flooding due to high flow and rainfall. It showed lower productivity of natural hayfields from 2.87 to 1.96 t/h as well as the reduction of valuable moisture-loving grasses (wheat grass, slough grass) in the botanical composition of grass from 61 to 32%. It is revealed that the decisive role in replenishing soil moisture reserves of floodplain estuaries takes place during flooding by flood waters. A single spring flooding is found to provide one cut of natural grasses. Long-term flood irrigation (about 30 years) led to 15 cm silt deposit, enriched the upper layers of meadow-Chernozem saline soils (Luvic chernozems sodic) with organic matter and nutrients, and improved the structural and aggregate composition. The salinity quality changed from chloride-sulfate to sulfate-sodic. The salinity level altered from medium to weak.

In this study, we aimed to calculate dependencies for assessing the value of weight loss during lyophilization of diagnostic preparations depending on the drying temperature and time. A model solution for lyophilization was Hottinger broth with gelatin (1.5%) and peptone (10%) used as stabilizers. To achieve the aim, a full factorial experiment 23 was planned and implemented, the investigated factors in which were the temperature and time of final drying, as well as the amount of substance in the primary packaging. Using ampoules as containers for primary packaging, a regression equation was obtained. The conducted statistical processing of the obtained equation showed the feasibility of the developed mathematical model. According to the model, an increase in the drying temperature and time leads to a decrease in the amount of weight loss; however, weight loss increases under an increase in the amount of substance in the secondary packaging. As a result of the experiments, a correspondence between the experimental and calculated values of weight loss during drying was revealed. The effect of the height of the material under drying on the weight loss was studied when drying an equivalent amount of substance in vials. The developed mathematical model for drying in ampoules was modified to describe the process of lyophilization in vials. The experimental results confirmed the possibility of calculating weight loss during drying using the proposed model. The developed dependencies can be used for estimating the value of weight loss during lyophilization of various substances, which is of particular importance in terms of reducing costs when establishing the temperature and time parameters of drying new biological products and modifying production regimes when changing the amount of product, type of primary packaging or desorption conditions.

A review of national and foreign scientific and patent literature, as well as the regulatory documents on the lyophilisation of inactivated vaccines, is presented. According to the State Register of Medicinal Products, all inactivated vaccines produced in dried form in the Russian Federation are obtained by freeze-drying. The excipients (drying media) used in the freeze-drying of vaccines are evaluated in terms of their qualitative and quantitative composition. A review of the features of the main stages of freeze-drying processes, e.g. freezing, sublimation (primary drying) and desorption (secondary drying) is given alongside an analysis of their distinctive features. The information on inactivated vaccines in the lyophilisate form registered in the Russian Federation is systematised. Available information on inactivated vaccines produced in the United States in the form of a lyophilisate is also presented. An analysis of the literature data reveals a significant variety of excipients used in lyophilisation. The influence of the sealing method of consumer packaging on the quality of preparations is considered, i.e. either in the oxygen or inert gas media or under vacuum. It is noted that the entire range of vaccines produced and registered in Russia is sealed under vacuum or in inert gas (i.e. in the absence of oxygen). A number of examples are cited to demonstrate the effect of technological freeze -drying process parameters on the quality of the preparations. It is shown that the preservation of a vaccine's properties during freeze-drying is influenced by a number of parameters, including the freezing rate and the temperature-time parameters of the primary drying and desorption processes. It is est ablished that the correct selection of the qualitative and quantitative characteristics of the drying medium contributes to the preservation of the target properties of lyophilised preparations. The analysis of literature data allows the influence of the parameters described in the review to be considered when developing the technology for the production of immunobiological preparations for the prevention and treatment of infectious diseases.* Российский научно-исследовательский противочумный институт «Микроб», г. Саратов, Российская Федерация ** Саратовский государственный аграрный университет им. Н.И. Вавилова, г. Саратов, Российская Федерация Komissarov A.V., Bibikov D.N., Volokh O.A., et al. Lyophilisation of inactivated… Комиссаров А.В., Бибиков Д.Н., Волох О.А. и др. Лиофилизация вакцин, не содержащих… 404 ФИЗИКО-ХИМИЧЕСКАЯ БИОЛОГИЯ / PHYSICOCHEMICAL BIOLOGY Резюме: Представлен обзор отечественной и зарубежной научной и патентной литературы, а также нормативных документов, посвященных вопросам лиофилизации вакцин, не содержащих живых микроорганизмов. По данным Государственного реестра лекарственных средств выявлено, что все вакцины, не содержащие живых микроорганизмов и выпускаемые в сухой фо рме в Российской Федерации, получены путем сублимационного высушивания. Дано представление о качественном и количестве...

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