The Central Scientific-Research Laboratory
12 Kulikivska str., Kharkiv, 61002, Ukraine
Phone/fax: +380577062312
е-mail: cndl@nuph.edu.ua
Head of the laboratory:
Dmytro V. Lytkin
Phone: +380502876971
е-mail: d.v.lytkin@gmail.com
The Central Scientific-Research Laboratory (CSRL) was founded on November 1, 1989 and since this time it has been a scientific, methodical and experimental center of the NuPH for research work on the development and pharmacological study of new drugs.
From 1989 until 2012, Professor Iakovlieva Larisa Vasil’evna, Doctor of Pharmaceutical Sciences, the Honoured Worker of Science and Technology of Ukraine, was the unchangeable head of the CSRL.
Professor Iakovlieva Larisa Vasil’evna – the head of the department of pharmacoeconomics, the Honoured Worker of Science and Technology of Ukraine, the member of the NuPH Scientific Council and two Specialized Scientific Councils as well as the State Commission on Scientific Problems Formulation in the field of Pharmacy, curator of the section “Pharmacology” of the Commission on Scientific Problems Formulation of NuPH, the member of the editorial board of the journals “Vìsnik farmacìï” and “Upravlìnnâ, ekonomìka ta zabezpečennâ âkostì v farmacìï” (NuPH), “Pharmaceutical review”(Ternopil), “Clinical pharmacology and pharmacoeconomics” (Moscow), vice editor of the journal “Klìnìčna farmacìâ”, the member of the Central Formulary Committee of Ukraine, the member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the head of the Ukrainian branch of the interregional public organization “Society of Pharmacoeconomics and Outcomes Research.”
During the entire period of holding a position of the Head of the laboratory Larisa Vasil’evna ensured its development and promoted the implementation of GLP principles into its work. During the work at the Central Scientific-Research Laboratory, L.V. Iakovlieva contributed to the development of NuPH scientific directions and initiated new modern directions of research: search and development of new anti-inflammatory, anti-ulcer, heroprotective, anabolic, adaptogenic, venoprotective, wound healing agents. In these fields, the laboratory takes leading positions in Ukraine and the post-Soviet countries.
From 2013 until 2015, Professor Shtrygol’ Sergej Yurjevich, Doctor of Medicine, headed the CSRL.
Professor Shtrygol’ Sergej Yurjevich, Doctor of Medicine, the head of the department of pharmacology of NuPH, Honourable Professor of NuPH. He is the author of more than 840 scientific, educational and methodical works, among them there are 3 monographs, 78 patents and author’s invention certificates, more than 490 articles (25 articles are indexed in Scopus database), more than 12 textbooks and tutorials, 25 official newsletters of Ukrmedpatentinform, 4 methodical recommendations approved by regulatory organs. Professor S.Yu. Shtrygol’ is the member of the NuPH Scientific Council and the Specialized Scientific Council Д 64.605.03, as well as the Council for the Approbation of Results of Dissertation Research (14.03.05 – pharmacology, pharmaceutical and medical sciences), expert of the committee of the professional examination of the Center of Testing under the Ministry of Healthcare of Ukraine. He is the member of the Board of the All-Ukrainian public organization “Association of pharmacologists of Ukraine,” which is the part of the International Union of Basic and Clinical Pharmacology (IUPHAR), the Head of the regional (Kharkiv, Sumy, Chernihiv) section of the “Association of pharmacologists of Ukraine,” the member of the editorial council of the Ukrainian Pharmaceutical Encyclopaedia, editorial board of the journals “Ukraïns’kij bìofarmacevtičnij žurnal” and “Vìsnik farmacìï”, editorial council of the journal “Pharmaceutical review”, awarded by the Honorary Certificate of the Ministry of Healthcare of Ukraine.
Under his leadership, the laboratory introduced a number of new scientific directions, namely, in the fields of neuropharmacological research, pharmacology of water and salt metabolism, deepened the possibilities of experimental verification of organoprotective agents, expanded cooperation with Ukrainian pharmaceutical establishments and companies.
From 2015 until 2018, senior researcher Koshova Olena Yuriivna, PhD in Pharmaceutical Sciences the CSRL.
Senior researcher Koshova Olena Yuriivna, PhD in Pharmaceutical Sciences, Senior Researcher of the Central Laboratory of NUPh. She is the author of more than 300 scientific papers (patents, newsletters, articles, reviewed in the Scopus and WebOfScience databases). Under the leadership of Elena Yurievna, modern American, European and international methods of preclinical study of drugs were implemented in the laboratory. The intralaboratory protocols of pharmacological and toxicological studies were modernized according to the requirements of GLP – due to it, over time, CSRL of NUPh achieved the international level. The laboratory capabilities in the field of basic and practical immunological research have been significantly improved. New mechanisms of endocrine aging in biological objects were experimentally identified and studied, potential aspects of the toxicity of unexplored xenobiotics were investigated. Thanks to the leadership of Elena Yurievna, the laboratory has become a regular participant in prestigious annual and targeted programs of interlaboratory measurement in the field of biomedicine.
Scientific directions and types of scientific researches of the Central Scientific Research Laboratory:
- Determination of the pharmacological properties of the substances of synthetic and natural (including herbal) origin, generic drugs and known drugs, which undergo pre-clinical studies for new indications;
- New drugs discovery and development;
- Pre-clinical studies of the specific pharmacological action of the drugs belonging to the following clinical and pharmacological groups:
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- Determination of general toxicity parameters:
- acute toxicity;
- toxicity in repeated administrations (subacute, subchronic, chronic);
- cumulative effect.
- Specific toxicological studies:
- reproductive toxicity, teratogenic action, embryotoxic and gonadotoxic action;
- immunogenicity;
- sensitizing effect;
- mutagenicity;
- local irritative action;
- ulcerogenicity;
- pyrogenic action.
- Histological, histochemical and histomorphometric studies;
- Training of scientific staff of the highest qualification: candidates and doctors of sciences by speciality «Pharmacology»
The Central Scientific Research Laboratory of the NuPH is the base for the research work scientists of the medical and biological departments, which have the possibility have an access to:
- laboratory facilities;
- laboratory instruments and equipment;
- possibility to work with the laboratory animals.
The laboratory is located in a two-storey building with an area of more than 800 m2. It has specialized departments of pharmacological, biochemical and toxicological research, operational facilities and vivarium. CSRL is equipped with the modern instruments and devices, which guarantee obtaining reliable data in experiments with animals and biological material. Thus, preclinical studies are conducted in accordance with the requirements of the State Expert Center of the Ministry of Healthcare of Ukraine.
The vivarium is equipped with a system of cages for keeping animals with individual ventilation in each cage which is ISO 5 cleanroom. Such a system forms a barrier at the level of each cage and provides protection of animals from microorganisms, as well as a permanent microclimate in a cage. Standardization of animal housing (stability of the temperature and humidity, absence of drafts) contributes to an improvement in the quality of research conducted and allows obtaining statistically significant results on a smaller number of animals. In addition, it significantly reduces the spread of allergens of animal origin in the air and provides safe working conditions.
CSRL is equipped with the following instruments and devices:
- StatFax4700 Microstrip Reader with thermoshaker (AWARENESS Technology Inc, USA);
- Biochemical semi automated analyzer MapLab Plus (BSI, Italy);
- Artificial ventilation apparatus for small animals (the People’s Republic of China);
- Spectrophotometer SF 46;
- Electrophotocolorimeter KFK-3;
- Electrocardiograph AeKIT-03M2;
- AXIS AD300 laboratory balances (Poland);
- рН meter;
- Blood coagulometer RT-2204C (Mindray, the People’s Republic of China);
- Blood Pressure Monitor LE-5001 (Italy);
- Hematocrit Centrifuge SM-70 (Latvia);
- Apparatus «UZM-1» (for tissue freezing);
- Trinocular microscope MC 400 (Мicros, Austria);
- Microscope Granum (Ukraine);
- Camera KKhN-2.94 with a monoblock МВ 109 S;
- Reverse osmosis system PVRO-95;
- Digital thermometer with 12 sensors;
- High Temperature Sterilizer HP-40 (Ukraine);
- Portable surgical luminaire L734-II 4 with a reflector (Biomed, Ukraine);
- Digital plethysmometer for the evaluation of the inflammatory response in the limbs of the small laboratory animals;
- Device for the measurement of the static load on the limbs of the small laboratory animals (indicating pain threshold);
- Apparatus “Hot plate/cold plate” (measuring pain threshold);
- Apparatus for the combined open field test for rodents;
- The elevated plus maze apparatus for rodents.
The apparatus for the Morris water maze test is being developed.
The quality and high methodological level of scientific research carried out in the CSRL of NuPH corresponds to the requirements of the State Expert Center of the Ministry of Healthcare of Ukraine, which is confirmed by the certificates of this regulator since 1996. The certificate No. 21 dated April 30, 2009, confirms the permission to carry out preclinical research of drugs in the CSRL of NuPH.
The certificate of attestation of the measuring laboratory № 058/15 dated 12.08.2015 of the Ministry of Health of Ukraine certifies that the CSRL of NuPH meets the necessary requirements and is certified for carrying out measurements in the field of healthcare.
CSRL of NuPH has implemented the Quality Management System, which includes a set of Standard Operating Procedures, a personnel training system, compliance and quality control measures, and aims at providing continuous standards throughout the entire study, from the development of the research protocol to the final report submission.
CSRL personnel:
- Doctors of Science – 1,
- Candidates of Science (PhD) – 3,
- Employees without scientific degree – 5;
- Senior Researchers – 4;
- Researchers – 2;
- Junior Researchers – 3.
- 1 dissertation for Candidate of Sciences degree is being carried out.
THE MAIN ACHIEVEMENTS of CSRL:
- The laboratory has developed methodological approaches to the study of mechanisms of aging and the determination of heroprotective properties of drugs that can prevent the development of
age-related pathology, slow down age-related changes in the body, lengthen the duration and improve the quality of life in the elderly. - The expediency of the natural antioxidant Elgacinum use as a a heroprotector for the prophylaxis of diseases associated with aging has been experimentally substantiated.
- Screening among [2,3-d]-pyrimidine-6-carbonic acid derivatives allowed identifying a leader, which anti-exudative and analgesic effect is not inferior to “Ortofen-ZT”, “Analgin-Darnitsa,” and “Ksefokam” tablets. This compound belongs to the class of the practically non-toxic substances, does not exert gastrotoxic and hepatotoxic action, substantiating the expediency of the development of the safe and effective inflammatory and analgesic drug.
- 8 monographs were published;
- 10 methodical recommendations for the pharmacological study of drugs have been developed;
- 125 patents were obtained.
The CSRL team participated in the development and preclinical studies of the following drugs:
Altanum (tablets) – the original herbal preparation for the treatment of gastrointestinal diseases, the manufacturer PJSC SIC “Borshchahivskiy CPP,” Kyiv;
Altanum ointment 2% (Unguentum altani 2%) – the novel combined drug possessing antimicrobial, anti-inflammatory and reparative action, the manufacturer PJSC SIC “Borshchahivskiy CPP,” Kyiv;
Piflamin (tablets) – the original herbal preparation with a hepatoprotective action, the manufacturer NuPH, “Vega” Ltd.;
Givitan (gel) – the drug in a medicinal form of gel for use in diseases of the musculoskeletal system and varicose veins, the manufacturer “Effect,” JSC;
Glucoribin (tablets) – the herbal preparation of anti-allergic action, the manufacturer of Pharmaceutical company “Health”, Kharkiv;
Elgacinum (tablets) – the original herbal cardioprotective drug, the manufacturer PJSC SIC “Borshchahivskiy CPP,” Kyiv;
Altabor (tablets) – the original herbal antiviral drug, the manufacturer PJSC SIC “Borshchahivskiy CPP,” Kyiv;
Ravisol (tincture) – the novel combined drug possessing hypolipidemic action, PJSC “Red Star,” Kharkiv.
CSRL closely cooperates with the domestic pharmaceutical companies, namely “Yuria Pharm,” PJSC “Red Star,” SPUC “Pharmaceutical Factory” Ltd., SIC Lugfarm Ltd., PJSC SIC “Borshchahivskiy CPP,”
In 2017/2018, the CSRL carried out 23 contract works and 9 research works (exploratory studies) without targeted funding.
Information on new drugs development:
- Tablets “Elgacinum” – an antioxidant with cardioprotective effect, produced by PJSC SIC “Borshchahivskiy CPP,” are in the 2nd phase of clinical trials;
- “Dolosan Forte,” tablets of analgesic action, produced by PJSC “Red Star,” are in the 1st phase of clinical trials.
Together with the scientists of PJSC “Red Star,” a composition “Glikopha” in the form of tablets has been developed, its specific pharmacological activity has been investigated, and the toxicological parameters of this composition are under study.
Exploratory studies that were conducted in CSRL during 2017/2018:
- The study of the pharmacological activity of Scutellaria baicalensis extracts;
- The determination of the acute toxicity of the substances encoded K-1 and K-2;
- The study of the pharmacological activity and toxicity of zeolite tablets and zeolite paste;
- The study of the pharmacological activity of Chamerion extract;
- The investigation of the mechanisms of hepatoprotective action of the novel herbal preparations;
- The study of the anti-inflammatory action of cream containing the extracts of verbena and sage;
- The study of the anti-inflammatory effect of gel and emulsion containing herbal extracts;
- The study of the analgesic activity of Sophora oil;
- The study of the pharmacological activity, acute and chronic toxicity of the Acorus calamus leaves tincture and rhizome tincture.
