Introduction. The study of rheological properties (dynamic and plastic viscosity, yield strength, the degree and presence of a thixotropic effect, the nature of the type of flow) are important for the development of soft dosage forms. These properties affect the stability of the dosage form during storage, its technological and consumer characteristics .Aim. Study of the main rheological parameters of the developed gels and creams on various carrier bases.Materials and methods. Meloxicam as active ingredient and excipients: sodium alginate, twin-80, propylene glycol, cremophor, glycerin, essential oils of lemon and orange, carbopol 980, polyethylene glycol-400 (PEG-400), viburnum bark, chamomile flowers, chlorhexidine bigluconate 20 %, menthol, sorbitol, corn oil, distilled monoglycerides (MHD), cetyl alcohol, coconut oil, salicylic acid, emulsion wax, preparation OS-20, triethanolamine (TEA), and euxil PE 9010 were used for the preparation of ex[eroimental samples. Three laboratory samples of soft formulations with the mass of 100 g each were prepared. The rheological properties of the samples were tested 24 hours after their preparation using Anton Paar DV-2P viscometer (Anton Paar GmbH, Austria), spindle L4. The structural and mechanical properties of the samples were tested using a device designed at the St. Petersburg State Chemical and Pharmaceutical University under thesupervision of Professor, Doctor of Pharmaceutical Sciences V. A. Vainshtein.Results and discussion. The greatest mechanical stability was observed for the sample No. 1 (gel based on alginate) and sample No. 3 (cream). The ascending and descending hysteresis loop curves indicates that the test samples have thixotropic properties. Samples No. 1 and 2 have upward and downward flow curves superimposed on each other.This phenomenon is typical for all gels and is their feature. The relaxation of the structure of an elastic-plastic material after the deformation caused by the introduction of a tester stock occurs according to the logarithmic law. At rest, when the tester stockis not introduced into the material, the structure of tested samples is intact and samples has a maximum density (static viscosity). The introduction of the tester stock into the sample results in plastic deformation and forced flow. The tension at the moment of tester stock introduction reflects the yield strength.Further, with the immersed tester devoce, a thixotropic recovery of the destroyed structural bonds occurs. Such a pattern in the dynamics of structure resistance is observed for structured (non-Newtonian) liquids.Conclusion. The rheological properties of three experimental soft formulations made on different carrier bases were investigated. The importance of rheological studies in the drug development of high e quality soft formulations was shown.

РезюмеВведение. В условиях пандемии использование биологически активных компонентов шлемника байкальского (Scutellaria baicalensis Georgi) приобретает особое значение. Ценность растения становится причиной чрезмерной эксплуатации подземных органов шлемника, что приводит к сокращению ареала распространения популяции и ненадлежащих условий сбора и заготовки. Для предотвращения угрозы исчезновения вида перспективной технологией становится культивирование клеток растения в условиях in vitro. Благодаря этому появляются перспективы исследования физиологии и биохимии растительных клеток, направленной регуляции синтеза ценных вторичных метаболитов и создания лекарственных средств без вмешательства в естественную среду обитания. Современные технологии открывают возможности автоматизации культивирования клеток с целью сведения к минимуму вмешательства человека на протекание процесса. Тем не менее, культивирование растительных клеток -вероятностный процесс, зависящий от ряда факторов. Использование инструментов риск-менеджмента позволит снизить число нежелательных последствий, приводящих к опасным и критическим состояниям клеточных культур. Цель. Анализ рисков, возникающих при культивировании in vitro шлемника байкальского (Scutellaria baicalensis Georgi). Материалы и методы. Объект исследования -суспензионные культуры Scutellaria baicalensis, полученные из рыхлых каллусов растения. Выращивание суспензий клеток шлемника проводили в плоскодонных конических колбах объемом 250 мл в условиях постоянного перемешивания на шейкере (скорость вращения 100 об/мин). Цикл субкультивирования составляет 21 сутки. Для микроскопии клеточной биомассы использовали прижизненный краситель 0,1 % нейтральный красный (НК) и 0,025 % раствор Эванса голубого (ЭГ). Оценку рисков процесса проводили с помощью диаграммы причинно-следственных связей (диаграммы Исикавы). Результаты и обсуждение. Установлено, что для клеток в суспензионных культурах шлемника характерна вытянутая овальная форма. Первичные суспензии характеризовались наличием клеток преимущественно паренхимного типа (70 ± 2,0 %). Для первичных суспензий характерна крупная агрегированность. Диаметр агрегатов достигал порядка 8-15 мм. Отмечена зависимость ростовых свойств суспензии шлемника байкальского от плотности инокулята. При уменьшении количества пересаживаемой биомассы клетки проявляли склонность к деструкции. Полученные результаты обозначили необходимость анализа рисков лабораторной технологии суспензионного культивирования шлемника байкальского. Выделено пять наиболее значимых факторов при культивировании растительных клеток: качество каллуса, качество приготовленной жидкой питательной среды, исправность и пригодность оборудования, действия оператора и пригодность технологии получения клеточных культур и отбора проб для анализа показателей жизнеспособности биомассы. Заключение. Предложен алгоритм анализа защищенности суспензионной культуры шлемника байкальского. На основании оценки рисков можно сделать вывод о вероятности нежелательных последствий и их влиянии на процесс. Инструментар...

Introduction. Treatment and prevention of diseases of the oral mucosa is one of the priority tasks in dentistry. In practice, antibacterial agents are often used in the complex treatment of inflammatory and destructive processes. However, long-term, uncontrolled usage of such drugs leads to numerous complications: drug tolerance, weakening of the therapeutic effect, dysbiosis of the oral cavity and gastrointestinal tract, etc. Therefore, at present, the question of search for alternative to antibiotic therapy remains open. As an alternative, it is necessary considering the usage of effective and safe herbal medicines that are easy to digest, less toxic, practically do not cause side effects and allergic reactions, and have a light regulating and normalizing effect.Aim. The aim of the present study is to develop the composition and technology of effervescent granules for the preparation of a solution for rinsing the oral cavity based on phytosubstances.Materials and methods. Dry extracts were obtained from medicinal plant materials: medicinal sage leaves, medicinal calendula flowers, yarrow herb, medicinal rhizomes and roots and astragalus woolly herb. Sodium carbonate, citric acid, anhydrous, microcrystalline cellulose – 90 (EMCOCEL®90M), povidone (Plasdone™ K-29/32) and calcium stearate were used as auxiliary substances in the granule technology. In laboratory conditions, granules based on phytoextracts were obtained by pressing wet masses. Numerical indicators of medicinal plant raw materials, technological properties of dry extracts and granules, as well as indicators of the quality of granules were determined according to the methods described in the State Pharmacopoeia XIV.Results and discussion. The numerical indicators of medicinal plant raw materials (grinding of raw materials and the content of impurities, total ash in medicinal plant materials and ash insoluble in hydrochloric acid, humidity, content of extractives) were determined and the good quality of the raw materials used in the subsequent stages of drug development was confirmed. Dry extracts from each type of medicinal plant raw materials have been developed and the technological properties of dry extracts have been determined. The composition and technology of effervescent granules by pressing wet masses has been developed. To improve the flowability and reduce the hygroscopicity of the granulated material, microcrystalline cellulose – 90 (EMCOCEL®90M) was used as a filler. To create an effervescent dosage form, citric acid and sodium bicarbonate were added to the granules. The mass for granulation was moistened with a 10% alcohol-water solution of Plasdone™ K-29/32. A draft specification of quality indicators for effervescent granules based on phytoextracts is proposed.Conclusion. In the course of the research work, the numerical indicators of medicinal plant raw materials were determined and its quality was confirmed, which made it possible to use it for further production of dry extracts. The extraction conditions were selected for each type of raw material, dry extracts were developed, and quality indicators were determined in accordance with the requirements of the State Pharmacopoeia XIV. Excipients were selected taking into account the properties of dry extracts, the composition and technology of effervescent granules based on phytoextracts was developed, a draft specification for effervescent granules was proposed in accordance with the requirements of the State Pharmacopoeia XIV.

Introduction. Actual use of plant raw materials in the production of medicines is caused by a variety of bioactive substance complexes in their composition. These drugs have a wide range of therapeutic effects and in this regard, the properties and compositions of various plant materials are currently being actively studied. Aronia melanocarpa (chokeberry) has been the focus of scientific research for many years to identify various healing properties, and in 2015 its fresh and dried fruits are presented as a plant raw material in the State Pharmacopoeia of the Russian Federation, XIV edition. The variety of biologically active substance complexes of Aronia melanocarpa fruit allows its use in different fields (food and pharmaceutical industries). For this reason, the development of the composition and technology of effervescent tablets containing a complex of biologically active substances and possessing the following advantages: rapid release of active ingredients, high rate of BAS assimilation, usability and pleasant flavor are of interest.Aim. The aim of the present study is to develop the composition and technology of effervescent tablets with a biologically active complex from dried Аronia melanocarpa fruits.Materials and methods. Extracts enriched with anthocyanins were obtained from dried chokeberry fruits. As excipients in the technology of effervescent tablets, sodium carbonate, tartaric acid, lactose monohydrate, povidone (Plasdone™ K-29/32), polyethylene glycol 6000 and aspartame were used. Under laboratory conditions, granules (acidic and basic) were obtained by the method of punching wet masses, where extract (granulate 1) and ethyl alcohol 96 % (granulate 2) were used as a moisturizer. Numerical indicators of medicinal plant raw materials, technological properties of granulate and tableting mass, as well as quality indicators of effervescent tablets were determined according to the methods described in the State Pharmacopoeia of the Russian Federation, XIV edition.Results and discussion. Numerical indicators of dry fruits of Aronia melanocarpa (crushing of raw materials and the content of foreign impurities, total ash in plant raw materials and ash insoluble in hydrochloric acid, content of extractives) were determined, and the good quality of the raw materials used in the subsequent stages of drug development was confirmed. An extract enriched with anthocyanins has been developed. The composition and technology of effervescent tablets with separate granulation of acidic and basic components has been developed. Extract and ethyl alcohol 96 % were used as moisturizers, and aspartame was used to improve taste characteristics. A draft specification for the quality indicators of effervescent tablets based on enriched extraction has been proposed.Conclusion. In the course of the research work, the numerical indicators of medicinal plant raw materials were determined and its quality was confirmed, which enabled its use for further extraction. Extraction conditions were chosen, extracts were obtained. Excipients have been selected, the composition and technology of effervescent tablets based on the extracts of Aronia melanocarpa fruits have been developed, a draft specification for effervescent tablets has been proposed in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, XIV edition.

Introduction. Cultivation of biomass of plant cells as a method of obtaining raw materials has existed for quite a long time. Plant cells cultivated in vitro act as a source of valuable secondary metabolites such as phenols, alkaloids, phytosteroids, glycosides, etc. It is important to create conditions under which the accumulation of valuable biologically active substances will be observed in the strains. Cultivation involves the use of complex multicomponent nutrient media containing a certain set of macro-, microelements, vitamins, growth stimulants. Salvia officinalis has a wide spectrum of pharmacological action. Due to the limited growing area of medicinal sage, as well as the deterioration of the ecological situation in the growing regions, the use of a phytobiotechnological method for obtaining raw materials is relevant.Aim. The aim of the study is to obtain a viable callus culture of salvia officinalis (Salvia officinalis L.).Materials and methods. Leaves of an intact plant sage medicinal, of the Lamiaceae family (Salvia officinalis, Lamiaceae) were used as explants. The explants were pre-sterilized with 6 % sodium hypochlorite solution for 20 minutes and 70 % ethanol for 1 minute. It was cultivated on a nutrient medium according to the Murasig – Skoog recipe. Determination of cell viability using vital dyes was assessed using microscopy (digital microscope Bresser LCD 50x-2000x, Germany). High performance thin layer chromatography was performed using a HPTLC PRO SYSTEM (CAMAG AG, Switzerland).Results and discussion. After two weeks of cultivation, the formation of primary callus was observed on the surface of the explants. Visually, it was a thin layer of intensely dividing undifferentiated light yellow cells. During cultivation, the biomass of the resulting callus increased, it became looser and acquired a darker shade, and the nutrient medium also began to darken. The detected cells during microscopy can be divided into two types: the first type is cells of the meristematic type, the second type is cells of the parenchymal type. Microscopy showed that more than 95 % of all visualized cells are alive. In the following passages, no significant changes in the morphotype of the culture were noted. In the eleventh passage, a study of the growth activity of the strain was carried out. The maximum specific growth rate of 0.42 day-1 is observed on the 14–18th day of growth, while the biomass doubling time is the smallest and corresponds to the value of 1.66 days. During one cultivation cycle, the amount of biomass increases by 7.73 times. The results of a qualitative analysis by the method of high-performance thin-layer chromatography (HTPLC) show that the qualitative composition of the biomass of medicinal sage is generally close to that of intact plants.Conclusion. A viable stable strain of plant cells of salvia officinalis was obtained on a nutrient medium according to the Murasig – Skoog recipe with a half content of micro- and macrosols and phytohormones 2,4-D (6 mg/ml) and kinetin (1 mg/ml). For the following passages, it is recommended to use a nutrient medium according to the Murasig – Skoog recipe with a full content of micro and macrosols and phytohormones naphthylacetic acid (1 mg/ml) and kinetin (1 mg/ml). The bulk of the obtained heterogeneous callus is made up of cells of the meristematic and parenchymal type. The qualitative composition of BAS biomass of medicinal sage is generally close to that of intact plants.