UDC 615.322:615.451.16:582.688.3

Kotova E.E., Kolychev I.O., Shishko Т.V., Kotov A.G., Koshovyi O.M.

State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines», Kharkiv

The National University of Pharmacy

Questions the introduction into the SPU of the national monograph «Bilberry shoots»

In medicine and pharmacy widely used fruits and shoots of bilberry usual. Decoction of the fruit is used as an astringent in colitis, diarrhea and entorokolitis. Shoots of bilberry used in diseases of the gastrointestinal tract and diabetes. Pharmacological action shoots of bilberry normal structure caused by a variety of biologically active substances. Pharmacological action shoots blueberry caused by a variety of biologically active substances: tannins (epicatechin, halokatehin, epihalokatehin); flavonoids (kaempferol, rutin, astrahalin, quercetin, hyperoside, izokvertsytryn, avikulyaryn); anthocyanins (cyanidin, delfinidyn, petunidyn); phenolcarbonic acids and their derivatives (chlorogenic, caffeic, quinic acid); hydroquinone and arbutin.

In Ukraine registered 4 drugs based on blueberry shoots used in diabetes type II. They domestic production, which creates prerequisites for the development of monographs for medicinal plants.

The expediency of standardizing bilberry raw material. A comparative analysis of the indicators of quality of medicinal plants bilberry (Vaccinium myrtillus L.) described in the monograph of the German Pharmaceutical Codex (DAC) and temporary pharmacopoeia article (TPA) 42-1609-86.

Six samples investigated bilberry shoots to meet their quality requirements of DAC and TPA. A method for the quantitative determination of biologically active substances bilberry shoots, which is taken as a basis for a unified methodology for SPU «Determination of tannins in herbal drugs». Based on these studies developed a draft national monograph SPU «Blueberry shoots».

Keywords: bilberry shoots, standardization, monograph, identification, quantification, the State Pharmacopoeia of Ukraine.

 

UDC 543.06:664-035.67

Leontiev D.D., Kotov A.G., Leontiev D.A.

State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines», Kharkiv

Development of identification methods of food colorants Е104, Е110, Е129, Е133, Е171 in capsule shells

The practicality of the optimization of methods’ development aimed at simultaneous identification of maximal outfit of food colorants included as a compound of a particular medical agent is shown. Auxiliary substances which are used during the production of a shell of a medical agent, exert versatile interfering influence on the determination of food colorants. UV-spectrums of colorants can be totally different for various chosen conditions for analysis. This does not afford to develop the single method for simultaneous identification of all food colorants and the universal one for all medical agents. With the purpose of saving instrument time, chemical agents and the analyst’s time, it is effective to develop such methods, which allow to identify as much colorants as possible during one analysis. As an object of the research gelatin capsules «soceco » size 0 yellow/brown opaque were chosen. For laboratories analyzing medical agents, the most available and effective for simultaneous identification of colorants, are the HPLC, TLC и UV-visible spectroscopy methods, for that reason the analysis method development was conducted for these methods. In consideration of multi-agent composition of capsule cap body, for the chosen object of the analysis the identification can be done exceptionally using several methods ⎯ with various sample preparation and final analytic operation. Identification methods of the following colorants were developed by us: Quinoline yellow (Е104), Sunset yellow FCF (Е110), Allura Red AC (Е129), Brilliant Blue (Е133) and titanium dioxide (Е171) in firm capsule caps «soceco» size 0 yellow/brown opaque. The methods are based on the combination of using color test and absorption spectrophotometry in UV-perceptible area for capsule bodies, color test and highly-effective liquid chromatography for capsule caps. The introduced methods afford to remove the interfering influence of the sample matrix and optimized for maximal ease of determination of the particular outfit of colorants in particular caps.

Keywords: food colorants, identification, capsule shells, optimization of method development.

 

UDC 615.322:615.072:615.244

Litvinenko V.I., Popova T.P., Popova N.V., Georgievskiy V.P.

State Enterprise «State Scientific Center for Drugs and Medical Products», Kharkiv

National University of Pharmacy, Kharkiv, Ukraine

On the izosalipurposide-standards in the control of raw materials and phytopreparations from Helichrysum arenarium

The identity and quality of immortelle’s inflorescence and drugs in Ukraine and other countries determined by flavonoids. It was found that for this purpose izosalipurposide, quercetin and rutin are used. In our country, the technology of preparation and methods of analysis of herbal materials and drugs of immortelle with the help of specific chalcone — izosalipurposide were developed.

Izosalipurposide standard is a crystalline powder of yellow color without a specific smell. The powder is well soluble in alcohol, slightly soluble in acetone, bad soluble in water.

Identification of chalcone in a series of samples was adjusted by chromatographic analysis and a number of physicochemical methods.

The comparative analysis of the requirements of a different Pharmacopoeias indicates that for the analysis of immortelle’s (Helichrysum arenarium) flowers should be used izosalipurposide- standard or izohelichrisine (or 6-O-β-D-glucopyranoside 2,4,6,4’-tetrahydroxychalkon) which may contain impurity helichrisine.

The results of the physico-chemical and chromatographic analysis of samples of izosalipurposide-standard show that they meet the requirements of Pharmacopoeial reference standard (PhRS).

HPLC analysis of the samples of izosalipurposide show that

the content of the basic substance is not less than 97 %, and impurity helichrisine was about (1.90-2.20) %.

Obtained from Ukrainian herbal materials immortelle’s inflorescences izosalipurposide sufficiently well characterized and allows objectively monitor the quality of herbal materials and drugs, therefore it is recommended for certification like PRS of the State Pharmacopoeia of Ukraine.

Keywords: izosalipurposide, Helichrysum arenarium, reference standard, herbal drug.

 

UDC 543.054:615.07:54-39

Blazheyevskiy M.Ye.

National University of Pharmacy, Kharkiv

Application derivatization by means of peroxy acid oxidation reactions in pharmaceutical analysis

This article describes derivatization chemistry used in conjugation with either spectrophotometry, fluorimetry or voltammetry methods to facilitate the determination of pharmaceuticals. Generally, derivatization is used in spectrophotometry, kinetic spectrophotometry, voltammetry and fluorimetry, principally to enhance detectability. The section considers derivatization of drugs such as phenothiazine derivatives, antibiotics and alkaloids. For spectrophotometry, fluorimetry and voltammetry sections, data are included giving the structures of the more important for derivatization agents, the analytes, and the corresponding reaction products. Derivatization for spectrophotometry, fluorimetry or voltammetric methods is often directed toward sulfides, tertiary aliphatic amines, amides that are difficult to detect at low levels by absorbance, luminescence, or electrochemical means. On the oxidation by means of peroxy acids or oxone of drugs was the primary focus in this article.

Keywords: derivatization, phenothiazine, antibiotics, alkaloids, spectrophotometry, fluorimetry, voltammetry, peroxy acid, oxone, oxidation.

 

UDC 547.917:547.724:547.48

Hudz N.I., Korytniuk R.S., Grygorieva O.V., Georgievsky G.V. Schubertova Z., Schimkova J.

Danylo Halytsky Lviv National Medical University, Ukraine

Shupyk National Medical Academy of postgraduate education, Kyiv, Ukraine

M.M. Gryshko National Botanical Garden of Ukraine of National Academy of Sciences, Kyiv, Ukraine

State Enterprise «Ukrainian Scientific Pharmacopeial Center of Quality of Medicines», Kharkiv, Ukraine

Institute of Biodiversity Conservation and Biosafety Faculty of Agrobiology and Food Resources Slovak University of Agriculture in Nitra

Approaches to determination 5-hydroxymethylfurfural in medicinal and food products

This article presents the analysis of published data on the methods of control quality and limits of 5-hydroxymethylfurfural (5-HMF) in the dextrose-containing medicinal products and food products containing sugars. 5-HMF is the product of dehydration of some carbohydrates. This compound is a marker for the quality and safety medicinal products and food products. Elevated concentrations of 5-HMF indicate overheating of products, their storage at elevated temperatures, long storage, as well as product falsification. In the pharmaceutical industry index «5-HMF and related compounds» is an indicator of the quality medicinal products for parenteral administration containing dextrose, solutions for peritoneal dialysis as well as certain excipients. There are three methods for the quantitative determination of 5-HMF in medicinal and food products: colorimetric method (Winkler method) at a wavelength of 550 nm, direct spectrophotometric method (White method) at a wavelength of 284 nm, as well as the method of HPLC with detection sample at a wavelength in the range 280–285 nm. The study indicates the establishment of 5-HMF limits in food products in many countries that is related to it's toxicological properties. In accordance with monograph of the European Pharmacopoeia for solutions for peritoneal dialysis, 5-HMF should not exceed 10 μg to 25 mg dextrose and 20 μg to dextrose 25 mg if these solutions contain bicarbonates. The content of 5-HMF in juices for children should not exceed 20 mg/kg, in rectified concentrated grape — less than 25 mg per kg of total sugars content. The content of 5-HMF in the honey must not exceed 40 mg/kg, for honey from countries with tropical climate — 80 mg/kg in accordance with the requirements of European Council Directive 2001/110/EC of 20.12.2001. In Turkey the content of 5-HMF in molasses on the base of grape juice must be not more than 25 ppm, other molasses — not more than 75 ppm. Limiting the concentration of 5-HMF in the regulations demonstrates the need for focusing on technological processes and the conditions of storage medicinal and food products containing sugars, especially the temperature factor in connection with toxical properties of 5-HMF.

Keywords: 5-hydroxymethylfurfural, dextrose, analysis techniques, Winkler method.

The publication was prepared with the active participation of researchers of international network AGROBIONET, as a part of international program «Agricultural biodiversity to improve nutrition, health and quality of life» (TRIVE ITMS26110230085) within the project AgroBioTech ITMS 26220220180. Co-author Nataliia Hudz (51600967) is grateful to the Agency Visegrad Fund for providing a scholarship for the research, during which the presented results and knowledge in this paper were received.

 

UDC 615.012.8:615.07

Ubohov S.H., Vetiutneva N.O., Fedorova L.O.

Shupyk National Medical Academy of Postgraduate Education, Kyiv

An integrative approach to building of model of quality assurance of medicinal products in the realization and medical use

One of the important areas of the pharmaceutical sector healthcare Ukraine is to create a quality assurance system of medicinal products, covering all stages of their life cycle. This system should be based on international standards and recommendations on the quality of pharmaceutical products. The aim is to study integrative approach to building of model of quality assurance of medicinal products on the stages of wholesale and retail sales and medical use. Materials research is the scientific works of domestic and foreign scientists; international, European and national regulatory documents; public data central and local executive authorities in the field of quality control of medicinal products, expert institutions, pharmaceutical companies and professional associations. Research methods are: logical, systematic and analytical, synthesis, structural and logical and graphic design. Scientifically substantiated of model of inter-sectoral integration of quality assurance system of medicinal products, structural and logical scheme integrative model of quality assurance of medicinal products at stages of realization and medical use. Grouped set of universal standards and industry guidelines, which are the methodological basis for an integrative model of quality assurance of medicinal products at the stage of wholesale and retail sales and medical use. Defined the scope of these regulations within this model.

Keywords: medicinal products, wholesale and retail sales, medical use, quality assurance, integrative model, standards ISO, good practices.

 

UDC 378.6:[615:005](477+73+4)(043.3)

Govorukha M.O.

Shupyk National Medical Academy of Postgraduate Education

Some questions of improvement of qualification on pharmaceutical management

Postgraduate training accumulates professional knowledge and skills that must be taught the specialist and which should be the model of the specialty «pharmacist». A system of continuing education should be as close as possible to the requirements of specialist practical pharmacy. Pharmaceutical business has a number of requirements to the managers they should be aware of all components of pharmaceutical management: administration, planning, organization, motivation of employees. The necessity of updating knowledge should be implemented during postgraduate training programmes which include the main activities of managers. For example, the program of art of managerial decision-making may include General management and characteristics of managers in the pharmacy; planning of pharmaceutical business strategy and goal setting; improving the model of organization and structure of the pharmaceutical business; labour resources: motivation, leadership, and professional burnout; the issues of communication and control. The proposed project of the program «personnel management », which can consist of the following content modules: functional responsibilities of managers in the pharmaceutical industry; issues of communication and control communication; problems and decision making; organization, planning and control activities; information management; psychology and motivation of the staff to the performance of duties; understanding leadership; work groups and teams; staff recruitment and selection process; management activities; andragogic approaches in training and personnel development; organizational culture; change management. Form of teaching can be both full-time and part-time using distance learning and Internet resources. A fixed allocation of hours to lectures, practical classes, seminars should be flexible depending on the knowledge of experts. It is anticipated that the proposed draft program of the thematic cycle of improvement of qualification of managers of the pharmaceutical industry will provide an opportunity to again practical skills in the application of modern instrumentation Manager in the management of its activities and human resources, will provide an opportunity to become a more effective Manager in pharmacy.

Keywords: pharmaceutical management, continuous professional education, training, project program, human resource management.

 

UDC 615.212:657.447]:616–006.6:[342.951:615]

Shapovalov V.V. (Jr.), Kulykova O.V., Shapovalov V.V., Shapovalova V.О.

Kharkiv Medical Academy of Postgraduate Education

Department of Healthcare of Kharkiv Regional State Administration

Studying availability of narcotic analgesic drugs for patients have found malignancies in Ukraine from position of forensic pharmacy

The article presents statistics on the prevalence of malignancies in the world and in Ukraine. Established that the number of cancer patients is growing. Determined that the topic issue is provision of patients have found malignancies with analgesic pharmacotherapy. Analyzed basic legislative and regulatory acts of Ukraine regulating the circulation of analgesic drugs and the availability of state funds for patients have found malignancies. Reviewed the size of spending from the state budget of Ukraine for the purchase of medicines for cancer in 2014. Noted that during the years 2012–2014 in the Kharkiv region was registered a decrease in the incidence of malignancies. By the examples of forensic and pharmaceutical practice considered the most widespread violations of patients have found malignancies rights concerning the availability of narcotic analgesic drugs. Analyzed the number of pharmacies in the Kharkiv region, which provide drugs and those which are licensed to narcotic drugs, psychotropic substances and precursors. The result found insufficient quantity of pharmacies have the right to release narcotic analgesic medicines to the population. Found that barriers in the pharmaceutical provision cancer may be the high cost of medication, the lack of pharmacies in remote areas of the region. Proposed editorial changes to the current legislation of Ukraine in order to improve accessibility to essential cancer drugs by enabling partial reimbursement of medicines by local budgets.

Keywords: forensic pharmacy, malignancies, availability, narcotic analgesic drugs, circulation, organization of pharmacy.