Cocktail" test systems are used for phenotyping the metabolic activity of human cytochrome P450 isoenzymes. The vast majority of "cocktails" for phenotyping include caffeine, based on data on the metabolism of which the activity of the CYP1A2 isoenzyme is determined. The use of pellets as a dosage form consisting of many particles for "cocktail" test systems makes it easy to change the composition and dosage of the test system depending on the needs of CYP research, and also provides easier acceptance of the test system by the patient in geriatric studies. Aim. Development of pellets containing caffeine for a "cocktail" test system using the methodology of a complete factor experiment. Materials and methods. Pellets containing caffeine (Shandong Xinhua Pharmaceutical Co., Ltd., China) were manufactured by extrusion-spheronization in the ESI 25 apparatus (Tofflon, China). The obtained pellets were subjected to technological tests in accordance with the GF of the Russian Federation XV. The quality of the pellets obtained and their dissolution profile were evaluated. Results and discussion. With the help of a complete factorial experiment, the optimal composition of pellets was selected, the optimal amount of granulating liquid was selected, and the parameters of the extrusion-spheronization process were worked out. Conclusion. As a result of the conducted research, the composition and technology of production of caffeine pellets for the cocktail test system were developed using a complete factorial experiment. A technological scheme for the production of pellets has been developed. Optimal conditions for humidification of the pellet mass were selected for the extrusion-spheronization technology.

Introduction. Medicinal plants are currently of increased interest. However, the deterioration of the environmental situation significantly complicates the conduct of resource research. At the same time, some types of medicinal plant raw materials can be natural concentrators of elements, which makes it possible to use herb as natural sources of essential minerals. One of these types of raw materials is herbs of red clover and medium clover. Objective: Study of the elemental composition of meadow clover and medium clover herbs collected in two districts of the Moscow region. Material and methods. Trace elements were determined using an inductively coupled plasma atomic emission spectrometer (ICP-AES) Avio 200 by Perkin Elmer, normalized heavy metals using an atomic absorption spectrometer with electrothermal atomization (ETAAS). Results. 10 trace elements were determined in the studied samples: of these, the content of Al, B, Ba, Fe, Mn, Sr, Zn is on average at the level of 10-3 %, Ca, Mg, K, P, S at the level of 0.2-1.0 %. The content of Ag, Be, Bi, Co, Cr, Cu, Li, Mo, Ni, Sb, Sn, Ti, V, Zr was at the detection limit and didn’t exceed 10-4 %, Cd, Pb, As, Hg were not detected in the analyzed samples. Conclusion. It was found that the analyzed samples have a similar elemental composition. Taldomsky and Losino-Petrovsky districts of the Moscow region can be considered as potential places for collecting raw materials. However, the studied herb cannot be considered as a potential source of trace elements.

Moldavian Dragonhead (Dracocephalum moldavica L.) is an annual herb. In FGBNU VILAR a new variety of Moldavian Dragonhead «Nezhnost» has been developed. From the herb of the Moldavian Dragonhead, a technology has been developed for obtaining a dry purified extract, which has received the code name «Rozmatin». By NMR (1H and 13C) and HPLC-DAD-MS using standard samples and literature data, the qualitative and quantitative composition of the dry extract "Rozmatin" from the herb of the Dracocephalum moldavica was established. Rosmarinic, caffeic and ferulic acids, rosmarinic acid 3-O-glucoside, luteolin-7-O-β-D-glucuronide, acacetin-7-O-β-D-glucopyranoside (tilianin), apigenin-7-O-β-D-glucoside (Cosmosiin), apigenin-7-O-β-D-glucuronide, chrysoeryol-7-O-β-D-glucuronide, apigenin-7-O-β-D-(6ʺ-O-malonyl) glucoside, acacetin-7-O-β-D-glucuronide, acacetin-7-O-β-D-(6ʺ-malonyl) glucoside, schizotenuin F were identified. It was found that the content of rosmarinic acid in "Rosmatin" is 56.6%, the amount of flavonoids - about 27%. The study of anti-inflammatory and gastroprotective activity of "Rozmatin" in doses of 10 mg/kg, 100 mg/kg was carried out. A dose-dependent anti-inflammatory effect with suppression of the development of the exudative phase of inflammation, as well as a dose-dependent gastroprotective effect of "Rozmatin"", significantly exceeding the similar effect of the referent drug omeprazole, was revealed. Earlier it was found that "Rozmatin" has a tonic effect on the cardiovascular and nervous systems.

Introduction. The review is dedicated to the scientific analysis of the composition, properties and features of the biological effects on the man's organism of the Lycium Fruit as a prospective plant raw material for the production of innovative drugs. Text. The most important aspects related to plant raw materials of various types of Lycium are considered, such as, the worldwide prevalence of plants and the unification of raw materials numerous synonymous names, the generalization of pharmacopoeia data, the qualitative and quantitative composition of Lycium components, their structural features, biological effects on vital body systems. The review also presents the problem of the absence of general pharmacopoeia monographs on Lycium raw materials in Russia, despite the cultivation of Lyceum ruthenicum M. plants in Russia. This fact opens up significant opportunities to develop the Russian regulatory document for Lycium , as a promising pharmaceutical raw material. Conclusion. The obtained results demonstrate the potential of introducing into pharmacy a new type of pharmaceutical raw material and a new finished products based on them, as well as predicting the biological activity of the substances of Lycium fruit and mechanisms of alkaloids, flavonoids, polysaccharides and Lycium carotenoids action.

Abstract. The possibility of using arabinogalactan in the preparation of oral tablets based on the natural bioflavonoid dihydroquercetin has been shown. The composition and technology of tablets using the wet granulation method has been developed. The quantitative content of dihydroquercetin in tablets was determined by HPLC. Aim. Development the composition and technology of dihydroquercetin tablets for oral administration using arabinogalactan.

Abstract. Dihydroquercetin (DHQ) is a bioflavonoid from the flavonol group with a wide spectrum of pharmacological activity. Antioxidant, strengthens the walls of blood vessels. Medicinal product based on dihydroquercetin for topical use. Aim. Development of a dosage form of dihydroquercetin in the form of a gel for topical use and evaluation of its physicochemical properties, general toxic effects and safety. Materials and methods. The gel was obtained on an EKROS PE-8100 laboratory overhead stirrer (EKROS, Russia). The substance of dihydroquercetin of the LLC "Chemistry of Woods" company was used. Dimethyl sulfoxide, glycerin, and polyethylene glycol 400 were used as solvents for the active substance. Gelling agents were used, such as: hydroxyethyl cellulose, carbomer brand Carbopol Ultrez 10, poloxamer 407, polymer compositions of the French company Seppic Sepineo p600 and Sepineo Derm. Benzyl alcohol and sodium benzoate are used as antimicrobial preservatives. Trilon B was used as a stabilizer. Purified water served as a dispersion medium. Aggregate stability of the gels was evaluated according to GOST 29188.3-91 COSMETIC PRODUCTS [1]. Colloidal stability - on the centrifuge of the laboratory brand PE-6906. Thermal stability was determined by thermostating the gel samples in an electric dry-air thermostat of the TS-1/20 SPU brand. Dynamic viscosity was determined on a Brookfield DV3T rotational viscometer [2]. The release of DHQ from the model gel compositions was determined by L. The content of DHQ in the dialysate was determined by HPLC (n=5) [3]. Results and discussion. The solubility of the substance of dihydroquercetin was determined for the implementation of the technological process for the manufacture of a gel based on it with increased bioavailability. Chromatography conditions were selected for the determination of dihydroquercetin in the gel by HPLC-UV. The safety and absence of a local irritant effect were established with the use of 2% dihydroquercetin gel. Conclusion. As a result of the research, the composition and technology of a 2% dihydroquercetin gel for topical use have been developed. A technological scheme for obtaining the gel has been developed. The results of the toxicity study of 2% dihydroquercetin gel showed that the gel is non-toxic and safe drug.

The article presents quantitative determination content for the residual organic solvents in a combined herbal medicine based on motherwort herb (Herba Leonuri), hawthorn fruits (Crataegus spp.) and jacob’s ladder herb (Polemonium caeruleum L.), by the use of Gas Chromatography (GC) accompanied by Flame Ionization Detector (FID). In accordance to the requirements of Russia State pharmacopoeia 14th edition, General Pharmacopoeia Monograph 1.1.0008.15 "Residual organic solvents" and 1.2.1.2.0004.15 "Gas chromatography", the measurement of residual solvents is mandatory. You can now take advantage of GC equipment with faster temperature changes combined with shorter GC capillary columns to achieve significant efficiency gains and faster analysis times. In the present study, using a flame ionization detector, a gas chromatographic method for determining the residual levels of ethanol in a combined herbal medicine based on motherwort herb, hawthorn fruit and jacob’s ladder herb was tested, and the separation was performed on a column ZB-624 (G43 6% cyanopropylphenyl 94% dimethylpolysiloxane) using Agilent 7890А, with installation for Head Space analysis Agilent 7694Е, USA, Agilent. The retention time of standard ethanol was 7.09 minutes. It resulted that the linearity for ethanol is between 10-150% of the rated content. The method was approved in accordance with Russia State pharmacopoeia 14th edition, General Pharmacopoeia Monograph 1.1.0012.15 "Validation of analytical methods". The described method is simple, sensitive, durable, reliable and reproducible for determining the quantitative content for the residual organic solvents in a combined herbal medicine based on motherwort herb, hawthorn fruits and jacob’s ladder herb.

Cocktail test systems are being used for determination of individual activity of cytochrome P450 isoenzymes in a patient. The usage of test systems allows taking into account the phenotypic features of drug metabolism to prescribe the most effective drug therapy. Aim. Development of a test system in the form of a solid gelatin capsule containing microtablets of caffeine, efavirenz, flurbiprofen, metoprolol tartrate and evaluation of their technological properties. Development of a method for the determination of marker components of a "cocktail" formulation using the Proton NMR spectroscopy method. Materials and methods. Microtabletes containing caffeine, efavirenz, flurbiprofen (Molekula Limited, UK) and metoprolol tartrate (KONO Chem Co., LTD, China) were manufactured on a tablet press of the XSpress type (BOSCH, Germany), in one of the sockets of which a 12-punch press tool with a diameter of 2 mm matrix holes was inserted. The resulting microtablets passed pharmaceutical and technological tests for dosage forms in accordance with the Pharmacopoeia of the Russian Federation XIV edition. Finnipipette F1 mechanical pipettes were used to sample the solvent and analytic solution, and a Vortex 2 shaker, an ultrasonic water bath, a Minispin Plus centrifuge, benzoic acid, and DMSO-d6 were used for sample preparation. Results and discussion. A common solvent has been selected for all active substances of the test system. Conditions for the introduction of probe preparations into the filler substance of the sorbent have been selected. Tableting parameters have been worked out. Conclusion. As a result of the conducted research, the composition and production technology of a cocktail test system for rational pharmacotherapy have been developed. A technological scheme for obtaining microtablets of probe preparations has been developed. For a mixture of active substances, the conditions for quantitative analysis were selected using the Proton NMR spectroscopy method.

Introduction. Dihydroquercetin is a flavonoid from the group of flavanonols with a wide spectrum of pharmacological activity. Its positive therapeutic profile was established for chronic venous insufficiency, chronic obstructive pulmonary disease and bronchial asthma, for the prevention of stroke. Its use leads to an improvement in the course of atherosclerosis and Alzheimer's disease. In addition, it is characterized by radio-protective, antidote, anti-inflammatory, anti-allergic, reparative, hepatoprotective effects. Currently, there are no drugs containing dihydroquercetin on the domestic pharmaceutical market. However, the pronounced therapeutic potential of dihydroquercetin, the economic and technological availability of its substance indicate the relevance of the development of dosage forms based on this molecule.Aim. Development of the optimal composition and technology of tablets based on dihydroquercetin and assessment of their physico-chemical properties, general toxic effect and safety.Materials and methods. The tablets were obtained by direct compression on a laboratory rotary XS press (Robert Bosch GmbH, Germany). The flowability and bulk density of the powders were checked by tester ERWEKA GT (ERWEKA GmbH, Germany). Tablets hardness and geometric dimensions were checked by tester SOTAX HT1 (SOTAX AG, Switzerland), the friability of the tablets was checked by tester SOTAX F2 (SOTAX AG, Switzerland), disintegration time was checked by tester DISI-A touch (CHARLES ISCHI AG, Switzerland). Pharmaceutical substance dihydroquercetin of the company "Khimiya Drevesiny" was used as an active pharmaceutical substance. Silicated cellulose for direct compression, aerosil 200, sodium starch glycolate and magnesium stearate were used as a excipients. The qualitative and quantitative content of dihydroquercetin in tablets was determined using HPLC-UV (Agilent 1260 Infinity II). The tablets were dissolved in a certain volume of the mobile phase, and then the solution was filtered (0.22 microns PTFE syringe filters, VWR, USA). The following reagents were used: acetonitrile for chromatography and concentrated phosphoric acid, "BDA", Russian Pharmacopoeia XIV, OFS.1.3.0001.15 "Reagents. Indicators". Determination of acute, subacute toxicity and local irritant effect was carried out according to the generally accepted method according to Russian Pharmacopoeia XIV on mature male and female white mice and rats in the laboratory of Pathomorphology and Drug toxicology of the Central Research Laboratory (REC) of the RUDN. The study was performed on 36 healthy sexually mature outbred mice with a body weight of 18–20 g and on 30 healthy sexually mature outbred rats with a body weight of 180–200 g. The drug is administered to animals once intragastrically with the help of an atraumatic probe in the form of a suspension prepared from crushed DQV tablets on 1 % starch gel. The comparison preparation was 1 % starch gel. The duration of observation of laboratory animals is 14 days for the study of acute toxicity and 30 days for the assessment of subacute. Daily clinical examination of the animals was performed, physiological parameters were evaluated, and the condition was recorded. The choice of doses was carried out according to the already available data on toxicity requirements described in the OESD regulatory documentation No. 425. A detailed clinical examination of the animal is carried out in the holding cage, in the hands and in the open area. Note the manifestation and expression, where acceptable, of signs of intoxication. The frequency of the examination depends on the severity of the intoxication pattern, but not less often than on the 2nd, 7th and 14th day of the experiment. Body weight is recorded immediately, on the 2nd, 7th day, and immediately before euthanasia. Deviations in the consumption of feed and water by the animals in the group planting cages are recorded visually on a daily basis. Food deprivation is performed the night before euthanasia. Animals are deprived of food, but not water. The animals are subjected to euthanasia by being placed in an ether-containing desiccation chamber 14 days after the administration of the study drug and the reference drug.Results and discussion. The technological characteristics of the substance of dihydroquercetin for the implementation of the technological process of making tablets based on it have been determined. It has been found that the substance dihydroquercetin has very poor flowability. Four types of excipients were used to improve the technological properties of the active substance. In the course of tabletting, the pressing modes were selected. The optimal pressing force was 5 kN. The depth of filling was – 7 kN. The optimal distance between of the punches was 2.5 mm. The rotor speed was constant at 15 rpm. The speed of the feeder is 25 rpm. Chromatography conditions were selected for the determination of dihydroquercetin in tablets by HPLC-UV method. The lethal dose for a single administration was determined, and the toxic effects of repeated repeated administration of the drug dihydroquercentin in the dosage form of an oral tablet were evaluated. The local irritant effect of the drug during oral administration was evaluated in laboratory animals. In the course of the conducted experiments, the absence of a local irritant effect was established when using tablets based on dihydroquercetin, when determining the toxicity class, the drug is assigned to the III class of "Moderately toxic" substances.Conclusion. The formulation and technology of tablets based on dihydroquercetin have been developed. It was found that the optimal composition for the manufacture of tablets with dihydroquercetin by direct compression should contain a filler silicated cellulose, sodium starch glycolate, aerosilglidant and a sliding agent – magnesium stearate. The HPLC-UV technique for identification and determination of the quantitative content of dihydroquercetin in tablets has been developed and validated. It is shown that in addition to the main peak, the peaks of bioflavones of eriodictyol and quercetin are determined on the chromatogram of tablets. This may contribute to the expansion of the spectrum of pharmacological activity of the tablets obtained. On the basis of the developed composition and production technology of tablets based on dihydroquercetin, an assessment of the general toxic effect and safety of the preparation based on bioflavonoids of the Daurian leaflet was carried out. The average lethal dose of the drug (LD50) was established, which, when administered orally to mice, corresponded to 159 mg/kg. During the study, the clinical picture of intoxication was evaluated. With intragastric administration of the drug, at a dose of 159 mg/kg, the death of 50 % of the animals in the experimental group was observed.

В работе проводится качественное и количественное определение суммы органических кислот в водных извлечениях из травы Portulaca oleracea L. с использованием метода титрования и ТСХ; оценены основные метрологические характеристики. Предложены методики качественного и количественного определения суммы органических кислот в траве Portulaca oleracea L. Установлено содержание суммы органических кислот в исследуемом виде лекарственного растительного сырья. Относительная ошибка определения суммы органических кислот не превышает 5%. Содержание суммы органических кислот в траве Portulaca oleracea L. составляет не менее 2%. Подобраны условия и разработаны методики качественного (с помощью ТСХ) и количественного (методом титрометрии) определения суммы органических кислот в траве Portulaca oleracea L. Разработанные методики определения суммы органических кислот в траве Portulaca oleracea L. могут быть рекомендованы для включения в нормативную документацию на данный вид сырья. Статистические характеристики, полученные при определении повторяемости, соответствуют установленным критериям приемлемости аналитической методики определения суммы свободных органических кислот, что позволяет сделать вывод о ее валидности. Medicinal herbs are one of the most important treasures that are not fully exploited by human. They are available, cheap and rich in useful substances. Human has used it since ancient times for medication, food, insecticide, etc. One of these herbs is Portulaca oleracea L. it is a rich in useful substances, whether in terms of food or as medicine, and one of these substances are free organic acids which is known for its many benefits. The aim of this work is to study the content of free organic acids in the herb of Portulaca oleracea L. using a pharmacopoeial method for determining the amount of organic acids in rose hips. Qualitative confirmation of the content of free organic acids; selection of conditions and development of methods for determining the amount of free organic acids; validation assessment of the developed method in accordance with pharmacopoeial requirements. It determined the content of organic acids sum in aqueous extracts from medicinal plant raw materials (herb of Portulaca oleracea L.) in the work using the titration method and TLC. The main metrological characteristics are estimated. The relative error in determining the amount of organic acids in the herb Portulaca oleracea L. does not exceed 5%. The total organic acid content in the herb Portulaca oleracea L. is at least 2%. Repeatability is set for interval values and values within the interval: repeatability (100%). A method was developed for determining the total content of organic acids in the herb Portulaca oleracea L. by titrometry; the developed method for determining the amount of organic acids in the herb Portulaca oleracea L. can be recommended for inclusion in the regulatory documentation for this type of medicinal plant material. The statistical characteristics obtained in determining repeatability correspond to the established acceptance criteria for the analytical method for determining the amount of free organic acids, which allows us to conclude about its validity.

Авторы были добавлены в раздел «Вклад авторов». Вместо: Г. Бакореза, Р. А. Абрамович, Н. Н. Бойко, С. Лазар разработали схему выделения липофильных и гидрофильных компонентов семян N. sativa L. Д. И. Писарев, О. О. Новиков, А. В. Хромов и О. Г. Потанина провели аналитическое исследование выделенных фракций семян N. sativa L., обработку данных и интерпретацию результатов. Все авторы принимали участие в обсуждении результатов и написании текста статьи. Исправлено на: Г. Бакореза, Р. А. Абрамович, Н. Н. Бойко, С. Лазар разработали схему выделения липофильных и гидрофильных компонентов семян N. sativa L. С. В. Горяинов, В. А. Ивлев, С. Эспарса, Д. И. Писарев, О. О. Новиков, А. В. Хромов и О. Г. Потанина провели аналитическое исследование выделенных фракций семян N. sativa L., обработку данных и интерпретацию результатов. Все авторы принимали участие в обсуждении результатов и написании текста статьи.

В работе представлены результаты подбора экстрагента для получения густого экстракта из слоевищ лишайника рода Cladonia (ягеля). Показаны этапы разработки технологии получения спрея для полости рта и горла с антибактериальным действием на основе густого экстракта. Проведена стандартизация разработанного спрея по содержанию усниновой кислоты. Доклинические испытания подтвердили антибактериальную активность лекарственного средства на основе ягеля и его малотоксичность The results of choosing extractants for better usnic acid extraction from the lichen thallus of the genus Cladonia was presented in the article. It was shown the stages of the spray composition development with antibacterial effect obtained from thick yagel extract. The developed spray was standardized on the usnic acid content. Preclinical study have confirmed the antibacterial activity of medicinal products based on reindeer lichen and its low toxicity level.

Introduction. Seeds of Nigella sativa L. are widely known as a source of fatty oil with a very rare component-thymoquinone. The therapeutic potential of biologically active compounds of plant seeds covers a positive effect on the gastrointestinal tract, cardiovascular and immune systems. In addition, hypoglycemic, antioxidant, antitumor, oncoprotective, immunomodulating effects were found in thymoquinone. In addition to fatty oil and thymoquinone, a number of other significant compounds are present in the seeds, which also make up their own pharmacological asset. Aim. Study was to develop a processing flow chart and analyze the lipophilic and hydrophilic components of the seeds of N. sativa L.Materials and methods. The following methods were used as analytical methods: gas-liquid chromatography with a flame ionization detector - for the analysis of sterols and triterpenes; chromatography-mass spectrometry (gas-liquid chromatography with mass spectrometric detection) - for the study of essential oil; chromatography-mass spectrometry (high performance liquid chromatography with mass spectrometric detection) - to study flavonoids. To obtain individual fractions of biologically active compounds of seeds of N. sativa L., fractional extraction was used.Results and discussion. The principle of this approach in this case is to extract the entire lipid complex of seeds with n-hexane, followed by removal of the extractant. The thickened hexane extract is treated with ethyl alcohol, which extracts unsaponifiable compounds - terpenes, quinones, sterols and does not dissolve triacylglycerides. The seed meal remaining after hexane extraction is treated with ethyl alcohol 70 %, into which hydrophilic molecules, in particular flavonoids, pass.Conclusion. After transesterification, 5 compounds were identified in the lipophilic fraction of saponifiable lipids, the linoleic and oleic acids being dominant. A characteristic feature of this fraction is the presence of cis-11,14-eicosadiene acid, which can act as a marker element of the fatty oil of the seeds of N. sativa L. Sterols and triterpenes were found in the unsaponifiable fraction. The major component of this fraction is β-sitosterol. In addition to the indicated sterol, campesterol and stigmasteri are present. Triterpenes are represented by cycloartenol and its derivatives. Simple phenols, quinones and monoterpenes were found in the essential oil complex, p-cymol, thymoquinone and α-thuyen predominate. The hydrophilic fraction of the seeds of N. sativa L. includes flavonoids of the methoxylated series of flavones and kempferol glycosides.

Plants of Galanthus L. genus (snowdrops) used in Russian medicine for obtaining neurological and cardiovascular remedies, contain different types of carbohydrates (polysaccharides, monosaccharides) as additional biological active substances group. In present research the carbohydrate composition and content were investigated in the snowdrops herbal pharmaceutical substances (Galanthus woronowii Losinsk, Galanthus nivalis L.). Optimal conditions for TLC analysis, the extraction of crude herbal drugs, were determined; spectrophotometric procedures for quantifying the total carbohydrate content in terms of monosaccharides (fructose, glucose) were successfully developed. The results of the investigation can be used in quality control and standardization of crude herbal drugs containing carbohydrates, and for inclusion in pharmacopoeial monographs.

Background: Mucolytic and expectorant drugs are important elements in the pharmacotherapy of respiratory diseases. Phytopectol No 2 (Pectorales species No 2) is one of the herbal multi-component drugs (herbal teas). Pectorales species No 2 (PS No 2) is a mixture of three types of medicinal plants presented on the Russian pharmaceutical market. It consists of coltsfoot leaves (40%), plantain leaves (30%), and licorice roots (30%). The PS No 2 infusion is a dosage form prepared from crushed or powdered plant material. The PS No 2 infusion exhibits expectorant and anti-inflammatory activity; it is used in the treatment of respiratory diseases and to facilitate the release of sputum.\r\nPurpose: This review study aims to collect and analyze the literature data concerning the composition and content of polysaccharides, their monosaccharide composition in PS No 2 and its components. \r\nMethods: We used different scientific databases such as PubMed, Scopus, Web of Science, e-Library, Google Scholar for information search. \r\nResult: Nowadays, synthetic drugs, herbal remedies, and combined medicines with expectorant action are presented on the Russian and world markets. Herbal medicines can be classified into single drugs containing one plant/component, and medicines with two or more plants/components. Herbal medicines take leading places in the segment of the mucoactive drugs market along with synthetic ones in the Russian Federation. Most of the PS No 2 polysaccharides are arabinogalactans, rhamnogalacturonans, galacturonans, galactans. The arabinose (up to 15%), glucose (up to 26%), galactose (up to 23%), rhamnose (up to 40%), as well as galacturonic acid (up to 26%) are presented in monosaccharide composition of PS No 2 polysaccharide complex.\r\nConclusion: Polysaccharides of various types are the main group of biologically active compounds (BAC) in PS No 2. The monomer composition of the polysaccharides causing the pharmacological action of PS No 2 should be established to improve the standardization procedures of crude herbal drugs and to identify BAC. The ratio of these carbohydrates can serve as a marker parameter in the standardization of PS No 2.

Organicmoleculeshavebiologicalactivityforavarietyofstructuralfeatures,someactivitiesareassociatedwiththestructural basis of a known molecule, and others are associated with the type and orientation of additive modifications. However, acetylcholine (ACh) is the main neurotransmitter of the parasympathetic nervous system, the part of the autonomic nervous system that contracts smooth muscles, dilates blood vessels, increases body secretion, and slows the heartrate. Inthecentralnervoussystem,AChhasseveralrulesanditplaysanimportantroleinmemoryandlearning,aswellas,inthe abnormal deficiency of ACh in the brain in people with Alzheimer’s disease. In the past, it has been attempted to use ACh chlorideascholinergicstimulants,but,unfortunately,ithasbeenfoundthatitdoesnothavealastingeffectbecauseofitstoo short action duration due to its rapid hydrolysis by acetylcholinesterase (AChE) enzymes and the lack ofspecificity.

Background. Anagrelide is used for the treatment of essential thrombocythemia. This drug selectively affects thrombocytes without inducing pronounced myelosuppression, which provides a satisfactory safety profile. Aim. To compare pharmacokinetics and to assess bioequivalence of two anagrelide drugs for oral administration in healthy volunteers. Materials & Methods. Open, randomized, two-period, twosequence, crossover study comparing pharmacokinetics and bioequivalence of anagrelide included 30 volunteers. The participants received a single dose of either test or reference drug, depending on the study period. Serial blood samples for pharmacokinetic analysis were collected within 12 hours after drug administration. Plasma anagrelide concentration was measured by high-performance liquid chromatography/mass spectrometry. Pharmacokinetic parameters were analyzed by non-compart-mental method. ANOVA analysis of variance was used for assessing the difference between the mean values of the AUC0-t, AUC0_ and Cmax pharmacokinetic parameters at 5 % significance level. Results. The mean values of maximum concentration (С ) after a single dose of anagrelide were 12.68 ± 2.99 ng/mL and 12.46 ± 3.15 ng/mL for test and reference drugs, respectively. Relative bioavailability was 1.16 ± 0.18. The AUC0-12 mean values calculated by anagrelide concentrations after a single dose of test and reference drugs were 30.38 ± 7.0 ng • h/mL and 28.78 ± 7.50 ng • h/mL, respectively, and the AUC0_ mean values were 31.13 ± 7.15 ng • h/mL and 29.55 ± 7.61 ng • h/mL, respectively. The assessment of main vital functions and laboratory parameters did not reveal any effect of the drugs on the health status of trial participants. Conclusion. Pharmacokinetic profile of the test drug (generic anagrelide) did not considerably differ from that of reference drug, which indicates in vivo bioequivalence of it. The assessment of drug safety yielded satisfactory tolerance; no serious adverse events have been reported.

This article presents results of the chemical composition study of the seeds oils lipid complex of Nigella Sativa L. grown under various geographic conditions. The task of the comprehensive study of the chemical composition of the plant and its individual parts remains relevant due to the wide spectrum of its pharmacological activity. The aim of this work is a comparative study of the fatty acid composition, a non-saponifiable fraction and the composition of essential oils of Nigella Sativa L. seeds grown in different regions of the world. Materials and methods. The combination of chromatography-mass spectrometry and 1H-NMR spectroscopy methods made it possible to study the qualitative and quantitative composition of Nigella Sativa L. lipid complex seeds. All the experiments were carried out in accordance with the requirements of the State Pharmacopoeia, 14th Ed, given in the corresponding general pharmacopeial monographs. Results. Profiles have been established and the content of fatty acids, sterines, triterpene alcohols, essential oils and thymoquinone found out in the lipid complex, has been estimated. The saponifiable portion of the complex is represented by triglycerides (81.7–95.3%), di(3.9–15.2%) and monoglycerides (0.7–4.1%). They mainly contain linoleic (55.8–60.6%), oleic (21.8–24.6%), palmitic (10.0–12.8%), stearic (2.4–3.2 %) and cis-11.14-eicosadiene (2.3–2.6%) acids. In the lipid complex, the contents of sterines and triterpene alcohols were 0.4–0.7%; up to 70% of the fraction was represented by β-sitosterol (22.5–29.2%), cycloartenol (20.1–36.6%) and 24 methylenecycloartanol (9.5–19.9%). In the trace amounts (up to 1.0%), cholesterol has been detected in all the samples. In the lipid complexes, the content of thymoquinone ranged from 0.7 to 2.6%. Conclusion. A comparative study of the seeds lipid complex of Nigella Sativa L. grown under various geographic conditions, has been carried out. The marker compounds as well as their content standards for determining the authenticity of raw materials (thymoquinone, para-cimen, cis-11.14-eicosadienic acid), have been identified.