For the introduction to the State Pharmacopoeia of Ukraine of the monograph «Equisetum stem»

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For the introduction to the State Pharmacopoeia of Ukraine of the monograph «Equisetum stem»

Kotov A.G., Vovk O.G., Kotova E.E., Tykhonenko T.M.

Ukrainian scientific pharmacopoeial center for quality of medicines

Equisetum arvense L. has been found to be synantropophytic specie with holarctic type of area. It was widely used in officinal medicine. Herbal drug E. arvense was described in the monographs of the European Pharmacopoeia, Pharmacopoeia of Hungary, DAB, SP XI. This article presented the results of studies, based on which this type of herbal drug introduced to the State Pharmacopoeia of Ukraine. Study of quality indices of stems of this herbal drug in accordance with SP XI and EP showed that a set of quality indecies (TLC determination in raw herbal material of other Equisetum species and hybrids, quantification of flavonoids) and their requirements (foreign matter, ash insoluble in hydrochloric acid, total ash) have been found to be wider in EP. Therefore, at the development SPU monograph «Equisetum stem», requirements of EP monograph “Equisetum stem” were taken as a basis. As samples for this study, samples of E. arvense of 2007-2008, provided by domestic producers, have been used. Based on studies of samples of herbal drug E. arvense, the monograph «Equisetum stem» has been introduced into the SPU; the requirements of this monograph corresponded to the requirements of the relevant EP monograph. In the monograph «Equisetum stem», for the characteristic «Loss on drying» the national part has been devepoled, the limit for this test has been proposed in accordance with the value given in SP XI; this aproach corresponded to the concept of development of monographs on herbal drugs and on the quality of herbal material, available in the pharmaceutical market of Ukraine.
Study of the essential oil of Inula helenium L. herb of Ukrainian flora

Yerenko O.K., Mazulin O.V., Burak V.P., Mazulin G.V.

The State Medical University of Zaporozhye

The physical and chemical properties and composition of essential oil of Inula helenium L. herb to expand the resource base for drugs with expectorant and anti-inflammatory effects have been studied. The herb of Inula helenium L., which was harvested in 2010-2011 from different regions of Ukraine during flowering, has been examined. A content of essential oil has been estimated by the Clevenger apparatus. An identification and quantification of components was performed by gas chromatography-mass spectrometry. In I. helenium herb, harvested during flowering, a significant content of essential oil (up to ((2.50 ± 0.03) %) has been estimated. High rates of acid, ether and ether number after acetylation in essential oil of I. helenium indicated the presence in it of free and bounded alcohols and acids, esters. In the essential oil of I. helenium have been identified up to 50 components, of which 37 have been identified the first time. Main compounds of the essential oil of I. helenium herb were: alantolactone ((34.28±3.12) %), thymol ((11.03±1.02) %), carvacrol ((7.25±0.72) %), eugenol ((6.57±0.55) %), isoalantolactone ((4.87±0.52) %), -eudesmol ((2.00±0.22) %), cis-p-menth-2-en-1-ol ((1.64±0.14) %), pentacosane ((1.63±0.15) %), squalene ((1.26±0.11) %). The total content of compounds with antimicrobial effect (thymol and carvacrol) in the essential oil has been about up to 18.28 %. The total content of biological effective sesquiterpene lactones, which showed anti-inflammatory effects, in essential oil has been up to 41.49 %. The herb of I. helenium was a valuable raw herbal drug for the manufacturing of antimicrobial and antiinflammatory drugs.

Study of volatile compounds of Malva sylvestris L.

Terninko I.I., Onishchenko U.E.

The State Institution «State Medical University of Lugansk»

Volatile compounds could be represented by different classes of organic compounds, such as hydrocarbons, terpenoids, steroids, fatty acids, etc. These substances were widely distributed in the plant kingdom and exhibited a wide range of pharmacological effects. They were part of the vitamins involved in the metabolism, lowered cholesterol levels in the blood and were intermediates in the synthesis of other biologically important compounds. Therefore, the study of the complex volatile compounds with a view to their future use was promising phytochemical study. Malva sylvestris L. was a plant of Malvaceae family; it had significant experience in the application in traditional medicine. However, the lack of a comprehensive pharmacognostic study and fragmented literature data about the chemical composition caused limited application of mallow in the officinal medicine. A sum of lipophilic substances has been obtained by exhaustive extraction with chloroform of the leaves and roots of M. sylvestris in a Soxhlet apparatus. By gas chromatography-mass spectrometry, the qualitative and quantitative composition of the volatile compounds in the obtained extracts and fruit of M. sylvestris has been studied. .In fruits have been found 43 substances, 38 of which were identified; in the lipophilic extract of the leaves of M. sylvestris have been identified 37 substances, in the lipophilic extract of the roots have been found 38 substances, 25 components of these extracts have been identified.

Rubus candicans Weihe as a source of flavonoids

Kovalev S.V.

National University of Pharmacy

Genus Rubus L. included over 200 species, of which 19 species have been distributed in Ukraine. Since ancient times infusions and decoctions of dried fruits of blackberry have been used as a diaphoretic drugs. The infusion of the leaves was used as an expectorant for the treatment of diseases of the upper respiratory tract. Blackberry leaves were also used for heavy bleeding and anemia. Prolonged intake of tea from blackberry leaves improved metabolism in diabetes. Drugs from the leaves and young shoots were used as anti-inflammatory agent in gingivitis, stomatitis and sore throat. They were also recommended as a disinfectant and anti-inflammatory agent for the treatment of urinary tract infections. A decoction of the leaves and fruits of blackberry lowered a blood pressure. Blackberry leaves contained about (9.3-24.3) per cent of extractives (including sugars, organic acids, cellulose, tannins, pectins). As biologically active substances blackberry fruit and leaves were marked micro and macro elements and vitamins A, C, B1, B2 and C. Phytochemical study of shoots of Rubus candicans Weihe, occurring in Ukraine, for the detection and isolation of phenolic compounds has been conducted. Using known methods of chemical reactions and chromatographic analysis flavonoids have been identified in a hydroalcoholic extract, ethyl acetate and butanol fractions in alcohol. The structure of the selected phenolic compounds was established by physicochemical methods (UV-, IR-, NMR-spectroscopy), chemical and biochemical methods of analysis. For the first time from shoots Rubus candicans Weihe have been isolated 8 phenolic compounds (astragalin, izokvertsetrin, hyperoside, kaempferol- 3-O-arabinoside, kaempferol, quercetin, rutin) and their structure have been determined.
Rosmarinic acid in pharmacopoeial herbal drugs

Popova N.V.

National University of Pharmacy

Rosmarinic acid has been found to be an ester of caffeic acid and 3-(3,4-dihydroxyphenyl) lactic acid. It was contained in herbal drugs of Boraginaceae, Lamiaceae families, etc. Rosmarinic acid has beenfound to be a biologically active substanceshowing an antiviral, antibacterial, antiinflammatory, antioxidant effects. It was studied the content of rosmarinic acid in the known types of pharmacopoeial herbal drugs for the further development of antiviral, antibacterial and anti-inflammatory drugs. An identification of rosmarinic acid was carried out by paper chromatography and thin layer chromatography. To determine the content of rosmarinic acid in the test species HPLC was used. The content rosemary acid in studied samples has been found to be: in Melissa officinalis L. herb - about 2.5 per cent, in M. officinalis flowers – about 3.3 per cent, in M. officinalis leaves – about 2.8 per cent; in Rosmarinus officinalis L. leaves – about 3.1 per cent, in Thymus vulgaris L. herb – about 2.1 per cent; in T. serpyllum L. grass - about 2.25 per cent, in Mentha piperita L. herb - about 0.38 per cent, in M. piperita leaves - about 0.50 per cent, in Salvia officinalis L. leaves - about 1.45 per cent, in Lavandula angustifolia Mill. flowers - about 0.09 per cent, in Plantago major L. leaves - about 0.35 per cent, P. lanceolata L. leaves - about 0.40 per cent.

Development of a method of quantitative determination of the impurity 4-amino-4H-1,2,4-triazole in the active pharmaceutical ingredient of 1-(-phenylethyl)-4-amino-1,2,4-triazolium bromide

Georgievsky G.V., Zinchenko A.A., Kucherenko L.I., Shapovalova L.I.

Ukrainian Scientific Pharmacopoeial Center for Quality of medicines

NPO «Pharmatron», Zaporozhye

Studies on the use of HPLC for the quantification of the critical quality index (presence of impurities) of the new original active pharmaceutical ingredient (API) 1-(-phenylethyl)- 4-amino-1,2,4-triazolium bromide, which exceeded by the strength and speed of antihypertensive effect of the reference drug (carvedilol) and structural analogue (kardiotril), have been conducted. It was shown that the total chromatographic separation of API with its basic synthesis products (4-amino-4H- 1,2,4-triazole and 1--bromoethylbenzene) could be achieved with the use of 250 mm х 4.6 mm steel column(Spherisorb ODS 2), size particles of 5 μm, phosphate buffer pH 2.5 (containing lithium dihydrogen phosphate), gradient elution with acetonitrile (0 per cent to 100 per cent), rate of the mobile phase - 0.8 mL/ min, column temperature about 30 °C; wavelength – 210 nm. Obtained data allowed to develop a method of quantitative determination of the impurity 4-amino-4H-1,2,4-triazole and to regulate the content of the impurity in the API at the level ≤0.5 per cent. The developed method has been studied in accordance with validation characteristics: specificity, limit of detection, linearity, precision. The total uncertainty of the results of all method was 3.48 per cent, which did not exceed the limit of 5.12 per cent.

Development and validation of the method of identification of isoflavonoids and triterpenoid saponins in the tincture «Аterofit-norma» by TLC

Khokhlova E.A., Vishnevska L.I., Garna S.V., Kotov A.G.

National University of Pharmacy

Ukrainian scientific pharmacopoeial center for quality of medicines

In the quality control of herbal drugs for the identification TLC was traditionally used. The aim of this work was the development and validation of methods of identification of the main classes of biologically active substances of the complex tincture «Aterofit-norma» by TLC. The tincture contained composition of the following herbal drugs: Crataegi fructus, Crataegi folium cum flore, Trifolii pratense inflorescence, Gnaphalii uliginosi herba; it has been obtained by maceration, as the extractant ethanol 50 per cent has been used. The main objective was to develop specific methodologies for determining all the components in this drug. To identify the tincture the following groups of substances have been selected: flavonoids (specific for all components of the tincture), isoflavonoids (specific to Trifolium pratense L.), triterpenoid saponins (specific for Crataegus sp., Gnaphalium uliginosum L.). The method of identification of triterpene saponins and isoflavones in tincture «Aterofitnorma » by TLC has been designed and validated . Validation characteristics of this method (specificity, precision, intermediate precision and robustness) have been investigated.

Matter of the update of SPU tables of higher single and daily doses of extemporaneous drugs

Zdoryk O.A., Georgiyants V.A., Gryzodub A.I., Tovmasyan E.K.

National University of Pharmacy

Ukrainian scientific pharmacopoeial center for quality of medicines

One of the ways to strengthen the quality control of drugs, manufactured in pharmacies, has been found to be an introduction of new and updating existing articles for extemporaneous drugs in SPU. It was demonstrated an actuality in supplementing and updating of the tables for the higher single and daily doses, which were given in the SPU, and in introduction of clarification for the rules of dose calculation. This paper provided a comparative description of monographs of the Pharmacopoeias of USSR, Austria, the Czech Republic, Argentina, Belarus, Slovakia, the United States on the calculation of daily doses of active pharmaceutical ingredients in drugs and spreadsheet analysis of the maximum recommended therapeutic dose. The basic dosing regimens of active pharmaceutical ingredients in the extemporaneous drugs in accordance with the age, weight and body surface area have been determined. The purpose of the monograph, name and format of the table have been defined; it has been discussed the basic terms, concepts, approaches to the calculation doses, which is scheduled to be introduced to SPU. A systematic discussion of the concept of updates and additions to the table of higher single and daily doses of toxic and potent drugs for adults, given in SPU, have been conducted.

Protective effect of Aegopodium podagraria L. and trifolin in hepatic ischemia-reperfusion at rats

Koyro O.O., Shtrygol S.Yu.

National University of Pharmacy

An efficacy of drugs at the base of Aegopodium podagraria L. leaves, in particular, of an extract (200 mg/kg and 1 g/ kg). a tinkture (1 ml/kg and 5 ml/kg), a protein-polysaccharide complex (200 mg/kg) and a flavonoid trifolin (kaempferol 3-Ogalactoside, 50 mg/kg) in hepatic ischemia-reperfusion at rats has been studied. It has been found that drugs at the base of Aegopodium podagraria and trifolin not only increased a survival of animals, but also inhibited cytolysis, promoted normalization of protein concentration and plasma glucose, reduced regulation of lipid peroxidation, reduced the severity of complications from kidney. The tincture (5 ml/kg), the extract (1 g/kg), the protein-polysaccharide complex (200 mg/kg) and trifolin (50 mg/kg) have been not less effective then silibore (200 mg/kg). The beneficial effects of the extract (1 g/kg) and trifolina on the antioxidant defense system has been expressed in maintaining of the normal levels of ceruloplasmin in plasma, whereas the protein-polysaccharide complex promoted an activation of catalase and superoxide dismutase of the liver. Trifolin and protein-polysaccharide complex, as the tincture (1 ml/kg), increased the content of thiol compounds in the liver. Prognostically favorable sign of the pathological process was the increase of the capacity of the liver to glycogen accumulation at the treatment with the extract (1 g/kg) and trifolin.These data substantiated the feasibility of further studies of drugs and biologically active substances of Aegopodium podagraria as hepatoprotective drugs and required indepth study of the mechanisms of their action.

Efficacy of Prostatilen, solution for injection, on the model of prostatic hyperplasia and its acute toxicity

Maslova N.F., Litvinova E.V., Kalnitskaya A.A., Klyzhko D.Yu.

State Enterprise «State Scientific Center of Drugs and Medical Products», Kharkov

National University of Pharmacy, Kharkiv

One of approaches at the treatment of patients with chronic prostatitis and benign prostatic hyperplasia was found the use of drugs at the base of a complex of peptides, which have been isolated from the prostate gland of cattle (Prostatilen, Vitaprost, Raveron), and which have been manufactured in the form of lyophilized powder for injection. The purpose of this study was to investigate the pharmacological activity and acute toxicity Prostatilen, domestic preparation, solution for injection (JSC «Lekhim-Kharkiv). Experimental prostatic hyperplasia has been caused by subcutaneous administration of testosterone to rats for 21 days. In the study of a specific pharmacological effect on the model of prostatic hyperplasia at rats it has been found that Prostatilen, solution for injection (JSC «Lekhim- Kharkov»), restored diuresis (against water load) to the level of intact animals, reduced the mass and volume of an enlarged prostate gland at the pathology, reduced high activity of alkaline phosphatase in the blood compared to the control of pathology. On the studied pharmacological effects it has been found no different from Prostatilen - Biopharma, powder for injection (JSC «Biopharma»). Study of acute toxicity, which has been conducted on two species of animals (mice, rats), with two routes of administration (intraperitoneal, intramuscular), showed that these drugs had low toxicity and were equally well tolerated and did not cause the death of animals. The above leads to the conclusion that Prostatilen, solution for injection, could be recommended for the treatment of chronic prostatitis and benign prostatic hyperplasia as an effective and safe remedy.

Study of chondroprotective and anti-inflammatory effects of recombinant antagonist of interleukin-1 receptor

Shchokina K.G.

The National Pharmaceutical University

An osteoarthritis was found to be one of the most common diseases, a medical and socio-economic problem and took one of the first places among the causes of long-term disability of population in the World. Therefore, the search for new chondroprotectors was an urgent task of pharmacology and medicine. More and more attention was devoted to the cytokine mechanisms of the development of osteoarthritis. It was known that proinflammatory interleukin-1 (IL-1) in cells of the bone and cartilage stimulated production of proteases by chondrocytes , increased production of prostaglandin E2, enhanced the proliferation of synovial fibroblasts and chondrocytes. It was possible therefore that antagonist of IL-1 receptors should show chondroprotective effects. Data of the study of chondroprotective effects of the original recombinant antagonist of IL-1 (ARIL-1) receptor on the model of systemic steroid osteoarthritis (STS) at rats have been presented. It was determined that in the STS under the influence of the drug has decreased the content of all markers of metabolism of connective tissue in blood serum of animals, especially chondroitinsulfate and sialic acids. At effect on the level of the major metabolites of connective tissue, ARIL-1 prevailed glucosamine hydrochloride. Also ARIL-1 significantly reduced the total amount of glycosaminoglycans by reducing the fraction of chondroitin-6-sulfate, content of which reached the level of intact animals. ARIL-1 positively influenced on the sum and fractions of glycosaminoglycans in serum, slowed down the development of inflammatory and destructive processes in cartilage tissue at the level of the reference chondroprotector glucosamine hydrochloride. Analysis of biochemical data against experimental osteoarthritis showed high chondroprotective and anti-inflammatory potential of ARIL-1.

Judicial pharmacy: global trends of scales of drug crimes and addictions according to data of compilation of facts of withdrawal from illegal trafficking of illicit psychoactive substances

Shapovalov V.V., Shapovalova V.A., Musoev S.M.

General Directorate of Health of the Kharkiv Regional State Administration

Medical Academy of Postgraduate Education, Kharkiv

Tajik National University

At review of the scientific literature on the judicial pharmacy, pharmaceutical and medical law, criminal law, criminal, neurological, psychiatric, addictologial and medico-legal, it have been demonstrated that the illegal trafficking of substances and drug-related crimes remained relevant problem in the World. In the process of compilation of data of judicial pharmacy, the extent of organized transnational and cross-border drug trafficking have been studied. According to the data of judicial pharmaceutical monitoring of the extent of drug-related crime, drug addiction and trafficking of illicit drugs in Ukraine, Afghanistan, Israel, Mexico, Pakistan, Tajikistan, Kazakhstan, USA, Russia and EU countries, global trends of distribution of opium derivatives, amphetamine, cannabis, cocaine and other psychoactive substances have been examined. An abuse of substances has been divided into: 1) regular abuse from 3 to 10 times a day, 2) frequent abuse of up to 3 times a day, 3) rare abuse of up to 1 time a day, or up to 1 time in a few days or a week. Users of illegal substance have been found to be drug addicts and were registered in the substitution therapy programs. A problem of HIV/AIDS, premature deaths, crimes, suicides, hepatitis and tuberculosis among drug addicts remained very relevant. The results of the judicial-pharmaceutical study of drug addiction situation in the world could be a starting point for the development of State programs against international drug trafficking, drug abuse and related socially dangerous diseases among different population groups.

Comparative structural statistical analysis of morbidity with temporal disability of the staff of Pharmaceutical Company «Darnitsa» (1996-2000 and 2006-2010). Social strategy and tactics

Zagorii G.V.

The National Medical Academy of Postgraduate Education of Shupyk P.L.

An in-depth comparative analysis of the structure and the level of morbidity with TD employees at Pharmaceutical company «Darnitsa» for the period between 1996-2010. An attention has been devoted to the fact that the level of morbidity with TD employees at Pharmaceutical Company «Darnitsa» in comparison with the main sectors of the economy, began to grow rapidly from 1993 and reached a peak in 1995 and 1997 (113.1 % and 104.4 %, respectively. Identifying in 1995-1997, factors of negative impact on the level of morbidity with TD employees leaded to the development and adoption of urgent measures to reduce disability. In 1999 compared with 1997, the level of morbidity with TD employees has been reduced to 42.82 % (59.7 % and 104.4 %, respectively), and compared with 1995 it has been reduced to 52.79 % (59.7 % and 113.1 %, respectively). The period from 2000 to 2006 was characterized by the fact that measures for improvement of the welfare of personnel protection have been put into the place. These measures helped to stabilize the low level of morbidity with TD staff and to maintain it in the past 10 years. Data showed a decrease in the level of morbidity with TD for three main nosological groups (6, 9, 10) (in cases per 100 employees) in the period 2006-2010 compared to the period 1196-2000 for almost a one third – for 29.13 % (62.5 cases per 100 persons and 48.4 cases per 100 persons, respectively); for the 10th nosological group the decrease was 31.91 % (43.4 cases and 32.9 cases, respectively), for the 6th nosological groups – 153.49 % (10.9 cases and 4.3 cases, respectively), for the 9th nosological groups – 164.52 % (8.2 cases and 3.1 cases, respectively). However, the indicator «all diseases together» (18 nosological groups) increased (in cases of morbidity with TD employees to 100 employees) to 7.9 % (82.3 cases for 1996-2000 and 88.8 cases per 2006 - 2010). In-depth analysis of the structure and the level of morbidity with TD employees at Pharmaceutical company «Darnitsa» at 2006-2010 allowed to confirm the accuracy of the selected strategy and tactics in solving social program reform and rapid development of the company as a key link in ensuring Ukraine's population with highly effective, high quality, safe and affordable drugs.

Buying habits of consumers in the market of ACE inhibitors

Piven O.P.

National University of Pharmacy

Studies of the Ukrainian and foreign markets of ACE inhibitors at the example of the leading countries in the field of pharmacy (USA, Germany, Switzerland, UK) have been conducted. It has been found that ACE inhibitors still remained the leader in terms of consumption of a group of antihypertensive agents, both worldwide and in Ukraine. Enalapril and Lisinopril steadfastly continued to hold first and second place of antihypertensives in terms of sales and number of drugs’ prescription. Ukrainian market of ACE inhibitor drugs was represented by 60 one-component drugs (share was about 55 %) based on 12 commercial substances and by 49 combined drugs(share was about 45 %) based on 8 substances. 19 domestic manufacturers produced drugs based on 3 substances. ACE inhibitors of the III-generation were produced by Ukrainian industry at the base of lisinopril; new substances were not used, though they have come out of patent protection. Based on survey, an analysis of awareness and consumers’ preferences of visitors of pharmacies regarding ACE inhibitors. Most commonly used by visitors drugs were based on captopril, enalapril and lisinopril, which (with the exception of captopril) reflected the preferences in consumption abroad. It was shown that the price was one of the major points (along with efficiency and safety) on the decision to purchase an ACE inhibitor. Factors of impact and importance of the information for purchasing an ACE inhibitor have been determined. The share of the cost for the drug in consumers’ total costs has been estimated.

Marketing analysis of the range of gastrointestinal drugs at the example of proton pump inhibitors

Kotvitskaya A.A., Khodakivska V.P.

National University of Pharmacy

The main component of the success of the pharmaceutical companies have been found to be different types of analysis, the content of which depended on their strategic objectives and specific tactical tasks. The initial element of the marketing management, focused on an optimal balance between the goals of the organization and the needs of the consumers, was a marketing analysis. It was used at different stages of marketing activities, beginning from the development of marketing plans, evaluation of they implementation and monitoring of processes, designed by the plan. The analysis of the dynamics of the incidence and prevalence of gastrointestinal diseases in the Ukraine has been conducted. The range of gastrointestinal drugs (proton pump inhibitors), which is represented in the domestic pharmaceutical market, has been analyzed. The results could be used in the practice in pharmacy and the pharmaceutical companies in order to generate the optimal range, justified compilation of order, monitoring of the sale of certain items and for the conducting of the targeted policies to promote gastrointestinal drugs, including proton pump inhibitors.

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