Safety assessment of biological raw materials in the system of medicines quality assurance

2020 ◽  
pp. 63-72
Author(s):  
Yu. Olefir ◽  
E. Sakanyan ◽  
I. Osipova ◽  
V. Dobrynin ◽  
M. Smirnova ◽  
...  

The entry of a wide range of biotechnological products into the pharmaceutical market calls for rein-forcement of the quality, efficacy and safety standards at the state level. The following general monographs have been elaborated for the first time to be included into the State Pharmacopoeia of the Russian Federation, XIV edition: "Viral safety" and "Reduction of the risk of transmitting animal spongiform encephalopathy via medicinal products". These general monographs were elaborated taking into account the requirements of foreign pharmacopoeias and the WHO recommendations. The present paper summarises the key aspects of the monographs.

Author(s):  
Irina L. Drozdova ◽  
Yanina S. Trembalya ◽  
Daria D. Bogoslovskikh ◽  
Kulpan K. Orynbasarova ◽  
Murat A. Omiraliev

The genus Alfalfa of the legume family (Fabaceae) includes about 60 species of herbaceous plants. One of the most widespread representatives in Russia and Kazakhstan is Medicago lupulina L. In the scientific medicine of Russia and Kazakhstan Medicago lupulina L. is currently not used. There is no approved pharmacopoeial article for this plant. However, this species has long been used in traditional medicine for a variety of diseases. For introduction into scientific medicine, it is necessary to develop authenticity indicators and conduct a study of morphological and anatomical signs of the structure of Medicago lupulina L. flowers. Objective: to conduct a macro-and microscopic study of the structure of the alfalfa hop flowers; to identify and characterize the signs that are of differential importance in the diagnosis of raw materials. Materials and methods. The study of morphological and anatomical features of Medicago lupulina L. was carried out in accordance with the articles of the State Pharmacopoeia of the Russian Federation of the XIV edition and the State Pharmacopoeia of the Republic of Kazakhstan. Freshly harvested, dried and fixed raw materials were used for the study. Results. For the first time, macro- and microdiagnostic signs of flowers of Medicago lupulina L. were described. Conclusion. For the first time macroscopic and microscopic features of flowers of Medicago lupulina L. were identified and described, which can be used to determine the authenticity of raw materials, as well as to develop the sections «External signs» and «Microscopic signs» of modern regulatory documentation.


2020 ◽  
Vol 1 (10(79)) ◽  
pp. 12-18
Author(s):  
G. Bubyreva

The existing legislation determines the education as "an integral and focused process of teaching and upbringing, which represents a socially important value and shall be implemented so as to meet the interests of the individual, the family, the society and the state". However, even in this part, the meaning of the notion ‘socially significant benefit is not specified and allows for a wide range of interpretation [2]. Yet the more inconcrete is the answer to the question – "who and how should determine the interests of the individual, the family and even the state?" The national doctrine of education in the Russian Federation, which determined the goals of teaching and upbringing, the ways to attain them by means of the state policy regulating the field of education, the target achievements of the development of the educational system for the period up to 2025, approved by the Decree of the Government of the Russian Federation of October 4, 2000 #751, was abrogated by the Decree of the Government of the Russian Federation of March 29, 2014 #245 [7]. The new doctrine has not been developed so far. The RAE Academician A.B. Khutorsky believes that the absence of the national doctrine of education presents a threat to national security and a violation of the right of citizens to quality education. Accordingly, the teacher has to solve the problem of achieving the harmony of interests of the individual, the family, the society and the government on their own, which, however, judging by the officially published results, is the task that exceeds the abilities of the participants of the educational process.  The particular concern about the results of the patriotic upbringing served as a basis for the legislative initiative of the RF President V. V. Putin, who introduced the project of an amendment to the Law of RF "About Education of the Russian Federation" to the State Duma in 2020, regarding the quality of patriotic upbringing [3]. Patriotism, considered by the President of RF V. V. Putin as the only possible idea to unite the nation is "THE FEELING OF LOVE OF THE MOTHERLAND" and the readiness for every sacrifice and heroic deed for the sake of the interests of your Motherland. However, the practicing educators experience shortfalls in efficient methodologies of patriotic upbringing, which should let them bring up citizens, loving their Motherland more than themselves. The article is dedicated to solution to this problem based on the Value-sense paradigm of upbringing educational dynasty of the Kurbatovs [15].


Author(s):  
O. K. Halchynska ◽  
◽  
Ya. V. Yarmolenko ◽  

The main condition for ensuring the economic efficiency of agricultural livestock rearing is the maintenance of wellbeing of farm animals, which is characterized by high productive qualities and the necessary reproductive capacity. At the same time, outbreaks of diseases of various etiologies, including parasitic, are often the cause of reduced productivity of animals. Pest insects control is important in the conditions of intensive animal husbandry, when at big farms and complexes animals are concentrated in large numbers. This increases the risk of reproduction and rapid spread of many insects that parasitize farm animals and are carriers of infectious and invasive diseases and cause economic damage due to reduced animal productivity and quality of raw materials. Protection of animals from ecto- and endoparasites requires the development and creation of highly effective antiparasitic drugs, because providing the necessary range of means to combat diseases of animals, inexpensive in price, in user-friendly forms is a way to further development of animal husbandry. Recent years mark a development of the domestic market of medicines for veterinary use, an increase in the number of registered drugs, the development of enterprises producing medicines, an increase in the number of companies engaged in pharmaceutical activities in both wholesale and retail. All this speaks of the prospects of the market of medicines for veterinary use. Specialists working in the field of production and sale of medicines need immediate, objective and reliable information on the state of the pharmaceutical market. This information has a significant volume and dynamism. Identifying the peculiarities of the formation of the market of veterinary goods at the state level should contribute to the improvement of management methods in this sphere, and the development of veterinary entrepreneurship. Therefore, the reorientation of domestic pharmaceutical companies to the principles of marketing will ensure the search, development and production of effective and competitive drugs, which will meet the pressing needs of customers. The aim of the work was to study the structure of the domestic pharmaceutical market, namely veterinary insectoacaricides. Our research focused on such tasks as studying the nomenclature of veterinary insectoacaricides of foreign and domestic manufacturers by the following indicators: manufacturers, species, forms of release and means of administration. The study of imported products also focused on the country of manufacture according to the State Register of Medicines. The study uses the methods of survey, analysis, comparison, generalization to get the required information. Statistical method was used to process the obtained data. Insectoacaricides are a significant share of the domestic pharmaceutical market. The study group is represented by 186 drugs of domestic and foreign manufacture, which is about 3% of the total number of all registered drugs. Of the 186 registered drugs, 35.5% (66) are imported and 64.5% (120) are domestic. Among insectoacaricides of foreign manufacture, the largest market share is occupied by Merial and KRKA, d.d., Novo mesto – 10.6% each (7 drugs each), KVP Pharma and Veterinar-Product GmbH – 9.1% (6 drugs), and among domestic companies the products of TOV “UKRBIONIT”; VK “KRUG”; TOV “NOVA PLUS” comprises 14.2% (17 drugs), TOV “Vetsintez” and TOV “NOVA PLUS” - 10.8% (13 drugs each), TOV “MEDIPROMTEK”, TOV company “Product”, TOV “NVP “SUZIRIA” – 8.3% (10 drugs each). The implementation of marketing activities which includes the research of the pharmaceutical market, allows companies to better adapt to market economy conditions, determine tactics of competitive behavior, adapt to change, improve strategy, change the production process according to consumer requirements and needs.


2019 ◽  
Vol 19 (1-2) ◽  
pp. 13-18
Author(s):  
D. A Zhdanov ◽  
V. B Braslavsky

The article is devoted to the development of new and perspective for the State Pharmacopoeia of the Russian Federation (SP RF) techniques for determining of the moisture (loss on drying) of medicinal plant raw materials of the morphological group “Fruit” and medicinal plant preparations by the use of infrared thermogravimetric (IRTGM) method. The techniques for determination of moisture (loss on drying) IRTGM-method as exemplified by the fruit of the following medicinal plants: Silybum marianum (L.) Gaertn., Rosa cinnamomea L. and Anethum graveolens L. were developed. The comparable results for determining of the moisture (loss on drying) of the medicinal plant raw materials of investigated plants were obtained by means of two methods: IRTGM and pharmacopoeial method, which allow us to recommend the developed techniques for inclusion into the relevant monographs of the State Pharmacopoeia of the Russian Federation.


Author(s):  
Vladimir B. Bezgin

We examine the state of communes and farms, the attitude of the rural population to their organization and activities, as well as the state of collective farms on the eve and during the Tambov rebellion of 1920–1921. The relevance of the topic is determined by the need for a scien-tific understanding of the problem of insurrection in the Civil War and its manifestation in the form of a peasant rebellion led by A.S. Antonov. The purpose of the study is to establish the fate of collective farms during the armed protest of the Tambov peasants. The work was carried out on the basis of a wide range of archival sources, some of which are introduced into scientific circulation for the first time. The analysis of the problem is carried out taking into account the achievements of modern historiography of the issue and the use of scientific tools of advanced methodological approaches. We apply the entire arsenal of methods of historical research based on the principles of historicism, objectivity and consistency. It is established that the armed raids of rebel detachments on agricultural communes, Soviet farms were due to the need of the partisans for food, horses, forage, and the active participation of the local population in them stemmed from their view of the land and property of collective farms as rightfully belonging to them.


Author(s):  
Olga Lytvynenko ◽  
Diana Shelestiuk

The article deals with the problems of students’ healthcare of higher educational establishments. The Law of Ukraine «On Education», «The National Doctrine of the Development of Education in Ukraine», «The Concepts of Children and Youth Education in the National System of Education» emphasize the need to create organizational, psychological and pedagogical conditions for the personal and physical development and self-development of students, their self-realization in accordance with abilities, social and personal interests, preparation for independent life. The aim of the research is to find out the state of the students’ health culture formation and the ways to increase the level of health culture in the educational process of higher education. Pedagogical conditions for the health culture formation include the educational environment, that is the teacher of physical education, and the students’ involvement in sports and mass recreational work outside the classroom. It is necessary to offer students the opportunity to be engaged in motor activity at a time convenient for them, that is, to combine the directions of physical culture – physical education with mass sports, aimed at providing motor activity of students during their leisure time. The forms of conducting physical education classes (on a student’s choice) can be fitness classes, cheerleading, table tennis, badminton, power fitness, volleyball, football, aerobics, sports dances, etc. It is understandable that such forms of conducting classes require financial support to the higher educational establishments, which financially will not be able to provide themselves with such a wide range of health-motor programs. At the state level, this should be included into the legislative documents and be financially supported. An analysis of the questionnaire among students is given on the basis of which students choose modern, rather than classical, physical education, including strength fitness, dance fitness, cross-fitness, table tennis, badminton, football, volleyball, basketball; and a new form of conducting classes is a section work in stead of classical physical education classes.


Author(s):  
Bishimbayev V.K., ◽  
◽  
Issayeva A.U., ◽  
Nowak I., A. ◽  
Serzhanov G., ◽  
...  

Rational use of mineral resources is becoming an important task for the development and economic growth of Kazakhstan. The purpose of the research was to study the state of salt-containing raw materials to determine the prospects for rational use of mineral resources of the Dzhaksy-Klych Deposit, one of the salty halite lakes of the Aral region. Exploration studies have shown that the Deposit is layered, where the halite layer is underlain by a sulfate layer: astrakhanite, mirabilite, tenardite, located on a layer of silt, the bed of salt deposits is dark brown clays, less often - clay Sands. Mineralogically, the halite formation is represented by, %: halite – 90-96, epsomite -1,2-2,6, mirabilite -0,2-1,9, gypsum-0,2-1,4. The production of table salt results in waste containing 65.5% chlorides, 24.5% sulfates, 6.5% sodium carbonates, and 3.5% sodium silicates, which can be used for pharmaceutical and medical purposes. Bottom silty mud by its origin and chemical composition belongs to the mainland silt-sulfide type and can be used for Spa and balneological treatment. The reserves of sulphate salts in the field are significant, with the average thickness of the sulphate reservoir in the southern basin being 0.87 m, and in the Northern basin 0.91 m. Intergranular and surface brine containing sodium and magnesium chloride-sulfate salts is of particular interest. Analysis of the state of mineral resources of the Dzhaksy-Klych Deposit revealed prerequisites for expanding the range of opportunities for using salt-containing raw materials. A promising direction for the development of the mineral resource base is the production of soda based on sodium chloride, as well as the production of a commercial product based on sodium sulfate and magnesium chloride. Microbiological examination showed the presence of non-pathogenic forms of halophilic bacteria in the salt-containing raw materials, which indicates safety for use in pharmaceutical and medical practice. In the Aral sea region, there is every reason for the development of the cosmetology industry, where a wide range of cosmetology and pharmaceutical products can be produced based on a combination of salt-containing and local vegetable raw materials.


2021 ◽  
Author(s):  
S.K. Mustafin ◽  
◽  
A.V. Rasskazov ◽  
◽  

The state and prospects of development of phosphorite ore resources as agrochemical raw materials of the Russian Federation are analyzed. The geological structure, composition of ores and the prospects for forecasting, assessing and integrated development of phosphorite deposits of the South Ural phosphorite basin are characterized.


2020 ◽  
Vol 10 (86) ◽  
Author(s):  
Lilia Gostishcheva ◽  

The article considers theoretical and practical aspects of management of foreign economic activity of chemical industry enterprises of Ukraine through the prism of crisis management. Attention is focused on the fact that at the moment chemical production in Ukraine is in the shadow of import substitution, and exports in general are losing production and economic potential, perseverance. The chemical industry is closely linked to the agro-industrial complex, and this issue is especially relevant in light of the possible food crisis, the arrival of which is predicted at the UN after the pandemic. That is why the answers at the state level should be found in the appropriate chronology, which will help to find a moment of distortion of the balance between justified imports and lost export potential. The aim of the anti-crisis strategy is to create a huge potential for environmentally friendly products through the introduction of appropriate innovations (based on domestic resources, such as bioethanol from biomass and stubble, biomethanol from solid waste, algae-based projects (from the Black and Azov Seas). The benefits of the strategy will be as follows: 1) dual benefits by reducing dependence on imports and increasing capacity for chemical production projects; 2) stimulating the overall growth of the chemical industry through public-private partnerships; 3) elimination of the current stagnant conditions of the industry caused by the consequences of the pandemic. Proposals to pursue a policy of reasonable protectionism in relation to import substitution for all participants in the domestic market are formulated. At the state level, in order to support the whole sector, it is advisable to adopt a model that emphasizes the use of appropriate fuels / raw materials based on domestic resources to reduce dependence on imports; replace mass imports with exclusive imports of only environmentally friendly and updated foreign innovative chemical technologies; attracting investment from TNC through appropriate government policies. The task of the Government in this situation is to carefully study the situation in each case and make a balanced decision.


2021 ◽  
Vol 108 ◽  
pp. 01003
Author(s):  
Evgeniy Vladimirovich Kirichek ◽  
Eduard Anatolievich Kononov ◽  
Golib Nurullo Kodirzoda

Today we are witnesses and participants in a historic event that is very important for Russia – preparation and adoption of amendments to the Constitution of the Russian Federation, reflecting both a legal identity and a vast long-term experience of the constitutional development of the Russian state with due consideration to the opinion of various strata of the population and extensive public discussion. Goal of the research is to show a special role of the Constitution of the Russian Federation from the position of its supremacy in combination with the doctrine of constitutional identity, which is essentially a trend of modern globalization processes, based on the analysis of doctrinal and practical issues, laws and regulations, decisions of the Constitutional Court of the Russian Federation, the European Court of Human Rights, and statistical data. The methodological basis of the research consists in the application of both general scientific and special methods developed in jurisprudence. During the research, the following methods of scientific knowledge played a special role: dialectical, historical, comparative law, statistical, logical, etc. A number of conclusions were drawn concerning, on the one hand, the development of a legal potential of the Constitution of the Russian Federation being a determining vector in preventing socio-political destabilization, and on the other hand, constitutional identity, in the broadest sense shown in the desire to know and formulate the own national, religious and other identities, to follow traditional family values, etc., and at the state level – prevention of violation of territorial integrity, state sovereignty, acknowledgement of constitutional and legal identity of the state.


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