Concentration Of Active Substance Research Articles

Analysis of the Impact of Black Tea Waste on The Fertility Quality of Rainbow Chili Plants (Capsicum annum L.)

Black tea is a drink commonly consumed in Indonesia, so it is not uncommon for dregs to be found to be wasteful. Waste is a serious problem that, if not handled properly, will have specific environmental impacts. Many people use tea waste as fertilizer without knowing the danger it causes to plants without further processing. This research aimed to analyze the effects of black tea waste on the fertility quality of rainbow chili plants (Capsicum annum L.). The type of research is qualitative research. The method used in this research is qualitative observation to observe the maximum height, the time to reach the maximum height, the entire leaf width, the time when the first flower appears, the time when the first fruit appears when the first fruit matures, the length of the first fruit, and the middle circumference of the first fruit of the rainbow chili plants (Capsicum annum L.) which were planted in potting soil given black tea waste with different ratio. From all the parameters observed, it was found that the best quality of rainbow chili plants (Capsicum annum L.) was in potting soil with a definite ratio of not too much but also not too little. From this fact, black tea waste can fertilize plants, but with a specific maximum level limit. Excessive amounts of tea waste can trigger alkalinity in the soil, which reduces plant fertility, and the presence of active substances such as polyphenols in it can kill decomposing bacteria, which causes new problems for the soil. Further research is still needed, especially in overcoming alkalinity and the content of active substances that can kill decomposing bacteria in the soil in black tea waste before it can be made into a commercial product like planting medium.

Development and validation of an analytical method for acetamiprid determination in plant protection products using HPLC-DAD

AbstractPlant protection products (PPP), crucial for agricultural production, are experiencing increased global demand, particularly with the growing need for food production. To meet this demand, robust analytical methods are essential for confirming the presence and determining active substance concentrations in PPP. This study introduces an analytical method utilizing high-performance liquid chromatography with a diode array detector (HPLC-DAD) for determination of acetamiprid in water-soluble powder formulations. The method, validated according to SANCO/3030/99 rev.5, demonstrated exhibited adequate accuracy and precision, with repeatability expressed as the ratio of the standard deviation (% RSD) to the relative standard deviation (% RSDr) being lower than 1. Recoveries for the active substance at concentrations above 10% ranged from 97% to 103%. The developed method is also characterized by suitable linearity, confirmed by a correlation coefficient >0.99. Specific chromatographic profiles were generated, and acetamiprid content in 180 formulations was analyzed, including reference products. The developed method aligns with “green chemistry” principles, minimizing solvent use and emphasizing energy efficiency. Overall, it offers a comprehensive approach for qualitative and quantitative analysis, ensuring the reliability of PPP quality control.

Epigallocatechin-3-gallate protects sepsis‐induced myocardial dysfunction by inhibiting the nuclear factor-κB signaling pathway

Sepsis-induced myocardial dysfunction (SIMD) has become one of the most lethal complications of sepsis, while the treatment was limited by a shortage of pertinent drugs. Epigallocatechin-3-gallate (EGCG) is the highest content of active substances in green tea, and its application in cardiovascular diseases has broad prospects. This study was conducted to test the hypothesis that EGCG was able to inhibit lipopolysaccharide (LPS) induced myocardial dysfunction and investigate the underlying molecular mechanisms. The cardiac systolic function was assessed by echocardiography. The cardiomyocyte apoptosis was determined by TUNEL staining. The expression of inflammatory factors and apoptosis-related protein, cardiac markers were examined by Western Blot and qRT-PCR. EGCG effectively improve LPS-induced cardiac function damage, enhance left ventricular systolic function, and restore myocardial cell vitality. It can effectively inhibit the upregulation of TLR4 expression induced by LPS and inhibit IκB α/NF- κB/p65 signaling pathway, thereby inhibiting cardiomyocyte apoptosis and improving myocarditis. In conclusion, EGCG protects against SIMD through anti-inflammatory and anti-apoptosis effects; it was mediated by the inhibition of the TLR4/NF-κB signal pathway. Our results demonstrated that EGCG might be a possible medicine for SIMD prevention and treatment.

Analysis of some trends of the pharmaceutical market of rodenticides in Ukraine and the peculiarities of their use for deratization

Analysis of some trends of the pharmaceutical market of rodenticides in Ukraine and the peculiarities of their use for deratization

Effect of integrated use of Zircon and Siliplant on productivity of <i>Echinacea purpurea</i> roots in Western Caucasus

Echinacea purpurea L. – is a perennial medicinal plant, from the herb of which dozens of preparations have been created that are used to strengthen the immune system, in the treatment of inflammatory diseases. At present, oxyconic acids and alkamides have been found in the plant’s root system, and the preparations «Anginol» and «Prostanov» have been created on their basis. The production and creation of new medicinal products from the roots and rhizomes of the Echinacea purpurea depends on a stable raw material base, which can be ensured by obtaining maximum yields of roots. As a result of studies to determine the timing of harvesting, methods to increase the yield of the underground mass in the conditions of the Krasnodar Territory, it was revealed that the high yield of roots and rhizomes of Echinacea purpurea was determined on plantations III-IV years of growing, which averaged 10 c/ha, they had an oxyconic acid content of 3,9%. In the future, there is a decrease in yield to 8 c/ha, and active substances to 2.1%. Dual treatments treatments Zircon (0.04 l/ha) and Siliplant (0.5 l/ha) both separately and in the mixture gave the opportunity to increase the yield for III and IV years to 28–30% and improve the quality of raw materials, the content of active substances increased by 5–7%. The complex use of these drugs in the V year of vegetation allows to increase the yield of roots to 10.3 c/ha with a high content of oxidic acids – 2.55%. It was revealed that foliar fertilization of vegetative plants with two-component system Siliplant + Zircon promotes the adaptation of Echinacea purpurea to dry weather conditions and makes it possible to obtain stable yields of medicinal raw materials with high quality regardless of weather conditions.

The Effect of Drought on the Content of Active Substances of Flax Fibers

ABSTRACT The aim of the research was to identify differences in the content of phenolic acids in flax fibers and antioxidant activity of the fibers depending on the soil moisture level during plant growth and flax variety. The experiment involved cultivating flax under controlled conditions with constant levels of irrigation: 25%, 35%, and 45% of field water capacity (FWC). The experiment conducted in the vegetative hall of the Institute of Natural Fibers and Medicinal Plants, National Research Institute in Poland was repeated three times: in 2019, 2020, and 2021. The fibers were extracted from the straw with use of dew retting method. Flax fibers exhibit biological activity. In current study, the impact of drought during flax growth on the antioxidant activity of fibers was determined, as bioactive fibers of linen clothing touching the skin can contribute to neutralizing free radicals formed next to human body. The antioxidant activity of tested fibers was examined using DPPH and FRAP methods. The quantity of phenolic acids may affect the antioxidant capacity of the fibers. The research results showed that the cultivation of flax plants at a soil moisture level of 45% FWC favors the development of antioxidant activity in the fibers.

ОПРЕДЕЛЕНИЕ ЧЕТВЕРТИЧНЫХ АММОНИЙНЫХ СОЕДИНЕНИЙ В ДЕЗИНФЕКТАНТАХ МЕТОДОМ ТИТРОВАНИЯ

The aim of this work is to consider the titrimetric method for determining quaternary ammonium compounds (QAC), as well as to determine the content of substances of this group in various disinfectants. The choice of the method depends on the specific characteristics of the QAC, the purpose of the analysis, and the availability of equipment. Chemical methods such as titration are preferred for QAC analysis because they are generally more reliable and less susceptible to interference. The content of active substances in six studied samples of disinfectants corresponds to the manufacturer's specified or slightly exceeds the specified norm.

Posaconazole Loading and Release Behavior in Surface-Modified Mesoporous Silica Nanoparticular System

In conventional drug treatments, high toxic effects, low solubility, and low bioavailability of the active substance cause insufficient drug release in the target tissue and undesirable side effects in healthy tissue. Various drug delivery systems are utilized to eliminate these undesirable effects. Mesoporous silica nanoparticles (MSN) are biocompatible biomaterials that have a large surface area, high pore volume, and enhanced adsorption capacity. With MSN-mediated controlled drug release, the active substance concentration in the blood is kept within the desired therapeutic range. Posaconazole (PCZ) is an antifungal agent. Absorption of PCZ is difficult due to its low solubility in aqueous and acidic environments, low therapeutic effect and low bioavailability. The use of controlled drug release systems avoids these problems and facilitates the absorption and release of PCZ. In this study, it is aimed to enhance the PCZ adsorption and release by using a drug delivery system. MSNs were synthesized by sol-gel method, and surface modification of nanoparticles was achieved using (3-Aminopropyl) triethoxysilane (APTES). PCZ was loaded on APTES-modified MSN successfully. MSN, APTES-modified MSN and PCZ loaded APTES-modified MSN were characterized. Diffusion controlled release of PCZ was observed in drug release studies.

Design and validation of analytical methods for quantitative determination of active ingredients in extemporal combined medicine in spray form

The aim of the work was the development and study of the validation characteristics of the method of quantitative determination of phenylephrine hydrochloride, nitrofural and diphenhydramine hydrochloride when they are simultaneously present in an extemporaneous combined medicinal product in the form of a spray using liquid chromatography method.
 Materials and methods. Agilent 1260 liquid chromatographs, equipped with a diode-matrix and UV detector from the company "Agilent technologies", USA. Chromatographic columns 250×4.6 mm filled with octadecylsilyl silica gel for chromatography (Zorbax StableBond SB-Aq, Agilent company), mobile phase - 0.1 % aqueous solution of trifluoroacetic acid R - methanol R, elution mode - gradient; mobile phase speed – 1.2 ml/min; the detection wavelength is 220 nm.
 Results. The determined chromatographic conditions ensure proper separation of the peaks of the substances to be determined: phenylephrine hydrochloride, nitrofural and diphenhydramine hydrochloride in their joint presence, and do not have a negative effect on the quantitative assessment of their content. Validation tests were conducted to confirm the suitability of the analytical method for the performance of the task - control of the quantitative content of active substances in the combined medicinal product in the form of a spray. The determined validation characteristics indicate that the method is characterized by appropriate specificity, linearity, correctness and convergence in the range of application for phenylephrine hydrochloride (range 0.499-0.749 mg/ml, ΔZ=0.44 ≤ max ΔZ=3.20, d=0.22 ≤ max d=1.02, a=0.01 max a=5.1, r = 0.9997 min r= 0.9924), nitrofural (range 0.154-0.231 mg/ml, ΔZ=0.44 ≤ max ΔZ=3.20, d=0.62 ≤ max d=1.02, a=0.0006 max a=5.1, r = 0.9996 min r= 0.9924) and diphenhydramine hydrochloride (range 0.499-0.749 mg/ml, ΔZ=0.50 ≤ max ΔZ=3.20, d=0.05 ≤ max d=1.02, a=0.076 max a=5.1, r = 0.9999 min r= 0.9924).
 Conclusions. An analytical technique for the quantitative determination of phenylephrine hydrochloride, nitrofural and diphenhydramine hydrochloride when simultaneously present in an extemporaneous combined medicinal product in the form of a spray by the method of high-performance liquid chromatography was developed. The determined validation parameters confirm the correctness of the methodology. The proposed HPLC technique was used to study the chemical stability of the spray for the treatment of allergic rhinitis

Обоснование рецептурных компонентов и определение параметров распылительной сушки при получении кормового витамина A/D<sub>3</sub>

The work describes the development of formulations and optimization of spray drying technology for the production of protected feed vitamin A/D3 for cattle. The emulsion optimal flow rate to the nozzle for analysed samples № 1, № 4, № 5, and № 6 was 15, 10, 5, and 30 mL/min, respectively. Samples № 2 and № 3 did not match with the requirements because of large size and they were not studied. Particles with sizes ranging from 200 to 700 μm were obtained. It was found that the optimal temperature of incoming air for samples № 1, № 4, № 5, and № 6 ranges from 70 °C to 80 °C. At the same time, the moisture content of the resulting granules did not exceed 8%. The optimal pressure of the pneumatic sprayer during the production of samples № 1, № 4, and № 6 was 0.08 MPa, for sample № 5 the optimal pressure was 0.05 MPa. The concentration of active substances (vitamins A and D3) of samples № 1, № 4, and № 5 based on gelatin, apple pectin and agar-agar corresponded to the declared ones (A/D3 1000/200 thousand IU/g, no less). The granules were insoluble in hot water and were recommended for the feed rations development.

One-Step Preparation of Fiber-Based Chlorzoxazone Solid Dispersion by Centrifugal Spinning.

An amorphous fiber-based solid dispersion of chlorzoxazone was prepared for the first time by employing centrifugal spinning, using polyvinylpyrrolidone as the fiber-forming polymer. After optimization of the spinning parameters, the obtained fibers were characterized using a set of analytical techniques, both in a solid- and solution-state. Morphological characterization revealed a slightly aligned, defect-free fibrous structure with an average fiber diameter of d = 3.07 ± 1.32 μm. The differential scanning calorimetric results indicated a crystalline-to-amorphous transition of the active substance during the centrifugal spinning process, while gas chromatographic determinations revealed a residual ethanol content of 0.42 ± 0.04%. UV spectroscopy indicated the incorporation of chlorzoxazone in the fibrous structures, with an average active substance content of 15.91 ± 0.36 w/w%. During small-volume dissolution studies, the prepared fiber mats presented immediate disintegration upon contact with the dissolution media, followed by rapid dissolution of the active substance, with 84.8% dissolved at 1 min and 93.7% at 3 min, outperforming the micronized, pure chlorzoxazone. The obtained results indicate that centrifugal spinning is a low-cost, high-yield, viable alternative to the currently used methods to prepare fiber-based amorphous solid dispersions of poorly soluble drugs. The prepared chlorzoxazone-loaded microfibers could be used as a buccal dosage form for the systematic delivery of chlorzoxazone and could potentially lead to a rapid onset of action and longer efficacy of the muscle relaxant drug.

Transcriptomic and Metabolomic Profiling Reveals the Variations in Carbohydrate Metabolism between Two Blueberry Cultivars.

Blueberry is a high-quality fruit tree with significant nutritional and economic value, but the intricate mechanism of sugar accumulation in its fruit remains unclear. In this study, the ripe fruits of blueberry cultivars 'Anna' and 'Misty' were utilized as experimental materials, and physiological and multi-omics methodologies were applied to analyze the regulatory mechanisms of the difference in sugar content between them. The results demonstrated that the 'Anna' fruit was smaller and had less hardness than the 'Misty' fruit, as well as higher sugar content, antioxidant capability, and lower active substance content. A total of 7067 differentially expressed genes (DEGs) (3674 up-regulated and 3393 down-regulated) and 140 differentially abundant metabolites (DAMs) (82 up-regulated and 58 down-regulated) were identified between the fruits of the two cultivars. According to KEGG analysis, DEGs were primarily abundant in phenylpropanoid synthesis and hormone signal transduction pathways, whereas DAMs were primarily enriched in ascorbate and aldarate metabolism, phenylpropanoid biosynthesis, and the pentose phosphate pathway. A combined multi-omics study showed that 116 DEGs and 3 DAMs in starch and sucrose metabolism (48 DEGs and 1 DAM), glycolysis and gluconeogenesis (54 DEGs and 1 DAM), and the pentose phosphate pathway (14 DEGs and 1 DAM) were significantly enriched. These findings suggest that blueberries predominantly increase sugar accumulation by activating carbon metabolism network pathways. Moreover, we identified critical transcription factors linked to the sugar response. This study presents new understandings regarding the molecular mechanisms underlying blueberry sugar accumulation and will be helpful in improving blueberry fruit quality through breeding.

Investigation into the degradation of air and runoff pollutants using nano g-C3N4 photocatalytic road surfaces

Exhaust emissions and road runoff pollution pose significant environmental challenges, leading to severe air pollution and irreversible soil damage, respectively. The adoption of self-cleaning road surfaces with photocatalytic properties has emerged as an effective approach to combat both types of pollution. Currently, nano titanium dioxide (TiO2) stands as the most widely used semiconductor for photocatalytic pavements. However, its limited light/radiation utilization remains a concern. To address this, the present study focuses on the use of the green nanomaterial graphene-like phase carbon nitride (g-C3N4), which has a smaller band gap to improve its light utilization. Comprehensive characterizations were performed to elucidate its physical/chemical properties. Subsequently, photocatalytic road coatings with various active substance contents were prepared by incorporating g-C3N4 into epoxy resin, and the functional pavement's performances were evaluated. A laboratory assessing method for the degradation of runoff pollution and NO contaminant was devised, enabling the evaluation of the redox capacity of semiconductive photocatalysts. Experimental results demonstrate that the nano g-C3N4 photocatalytic coating exhibits significant enhancement in degradation efficiency for a typical water pollutant, methylene blue (MB), being 2.76 times that of the nano TiO2 photocatalytic coating. Additionally, its ability to degrade NO gaseous contaminant under visible-light irradiation is 7 times more than the control sample of TiO2 coating. Moreover, the photocatalytic coating has good anti-slip property and long-term performance. Thus, nano g-C3N4 proves to be a more suitable semiconductor material for self-cleaning road surfaces, holding tremendous potential to mitigate diverse pollution arising from transportation under natural light conditions.

Excessive Dilution of Oral Antibiotic Suspensions and Oversized Bottles: An Exploratory Survey Based on Pediatrician’s Experiences in Kabul

Medication errors in the reconstitution of oral suspensions, which include excessive dilution, may affect the treatment outcome despite the correct diagnosis and selection of appropriate treatment. Objective: To document the practice of parents/caregivers adding more than double the recommended volume of water to oversized bottles of oral Azithromycin or Cefixime suspensions. Method: An exploratory survey was conducted using self-administered anonymous questionnaires. It involved the participation of 32 pediatricians from different pediatrics departments at Maiwand Teaching Hospital, an inner-city hospital in Kabul. The survey aimed to gather pediatricians' experiences with parents/caregivers adding excessive water to Azithromycin or Cefixime oral suspensions to approximately twice the recommended concentration Results: Twenty-five participating pediatricians (78.1%) reported encountering at least one instance where more than double the recommended amount of water was added to Azithromycin or Cefixime suspensions. The majority of these cases (84%) were observed in the outpatient department. Eighteen participants (72%) thought the issue was rare or infrequent, while seven (28%) thought it was frequent. Conclusion: Bottles of oversized oral antibiotic suspensions had been filled up with water to nearly their full volumes, which reduced the concentration of active substances to half or less, and may threaten the treatment outcome. This problem is not confined to any particular country but can arise in any situation where non-healthcare professionals reconstitute pediatric oral suspensions using oversized bottles. Improved reconstitution education, separate diluent bottles for oral suspension, and the establishment of standards and ceilings relative to total dose volume for oral suspension bottles are recommended.

DyCeModel: a tool for 1D simulation for distribution of plant hormones controlling tissue patterning

DyCeModel: a tool for 1D simulation for distribution of plant hormones controlling tissue patterning

РАЗРАБОТКА СОСТАВА И ОПРЕДЕЛЕНИЕ ПОКАЗАТЕЛЕЙ КАЧЕСТВА СИРОПОВ С ИЗВЛЕЧЕНИЯМИ ИЗ СЫРЬЯ ФАРМАКОПЕЙНЫХ РАСТЕНИЙ СЕМЕЙСТВА ROSACEAE

The largest number of plant species included in the State Pharmacopoeia of the Russian Federation belong to the Rosaceae family. However, the number of phytopreparations based on this plant raw material in the domestic pharmaceutical market is not so diverse. Taking into account the growing popularity of the medicinal form of syrups, the authors conducted a study aimed at developing the composition and technology for producing syrups with rhizomes and roots of Sanguisorba (Sanguisorbae officinalis rhizomata et radices), rhizomes of Potentilla (Potentillae erectae rhizomata), leaves of wild strawberries (Fragariae vescae folia), fruits of aronia (dry) (Aroniae melanocarpae sicco fructus), rowan fruits (Sorbi aucupariae fructus), rosehip fruits (Rosae fructus), cherry fruits (Padi avii fructus). Syrups were obtained using a technology using liquid extracts in the composition, which were obtained in accordance with the requirements of the OFS.1.4.1.0021.15 Extracts. For all the syrups obtained, quality indicators were determined: density, pH, refractive index, microbiological frequency. To determine the quantitative content of biologically active substances in the developed syrups, the authors used the principle of end-to-end standardization, involving the use of the same quality control methods used in the standardization of the initial medicinal plant raw materials. The total content of tannins was determined for syrups with rhizomes and roots of medicinal hemophlebus, rhizomes of lapchatka, cherry fruits, the total content of anthocyanins was determined for the syrup of aronia fruits, the total content of anthocyanins was determined for the syrups of rowan and rosehip fruits, the content of ascorbic acid was determined and for strawberry leaf syrup the total content of flavonoids in terms of rutin. According to the results of the conducted studies, the norms of the content of active substances in the studied forms were recommended.

DEVELOPMENT AND VALIDATION OF HPLC-METHOD FOR QUANTITATIVE DETERMINATION OF ETHYLBUTYLACETAMINOPROPIONATE IN SPRAYS

Ethylbutylacetaminopropionate is a selective activator of metabotropic ionic G-receptors of the nervous system of invertebrate animals, which leads to overexcitation of insects and their repelling from the source of this substance. Ethylbutylacetaminopropionate is used in insect acaricidal sprays as a repellent against mosquitoes, lice, fleas and ticks for pets.
 The aim of the work was to develop a method of identification and quantitative determination of ethylbutylacetaminopropionate in a spray for external use. The method was developed and validated by indicators of selectivity, linearity and suitability parameters of the chromatographic system. A spray repellent was used as a sample-object for the development of the technique. The standard sample and the test sample were dissolved in a mixture of acetonitrile and water in a volume ratio of 1:1, to a concentration of ethylbutylacetaminopropionate of 50 μg/ml. The samples were separated on a Dionex Ultimate 3000 chromatograph equipped with an Acclaim C18 chromatographic column 250×3.0, 3 μm. The mobile phase was a mixture of acetonitrile and water in a volume ratio of 60:40. Ethyl butylacetaminopropionate was detected at an absorption wavelength of 210 nm.
 Under the above conditions, it was possible to completely separate ethylbutylacetaminopropionate (retention time of the chromatographic peak – 4.9 min) and other components of the studied drug. At the same time, the suitability parameters of the chromatographic system did not exceed the limits specified in the recommendations of the USA Food and Drug Association. For ethylbutylacetaminopropionate, the efficiency of the chromatographic system was 15,100 theoretical plates The relative standard deviation (RSD) for the peak areas of the active substances was ± 0.31%, and the peak separation ratio (RS) of ethyl butylacetaminopropionate and other components of the drug was 25.0. The symmetry coefficient of the ethyl butylacetaminopropionate peak was 1.31. The calibration curve was linear in the recommended DFU 2.0 range (80–120% of the nominal concentration of active substance). The coefficient of linearity (R2) for ethyl butylacetaminopropionate was 0.9991.

Optimization of the pulsed vacuum drying process of green walnut husk through temperature adaptive regulation.

This study aimed to optimize the temperature adaptive conditions of pulsed vacuum drying (PVD) for green walnut husk (GWH) to tackle the issues of severe environmental pollution and limited utilization of GWH. The results of the single-factor experiment revealed that the optimal drying temperature for PVD of GWH was 65°C, with a pulsed ratio of 9min: 3min. The drying time decreased from 10.87 to 6.32h with increasing drying temperature and from 8.83 to 6.23kW·h/kg with increasing pulsed ratio. Energy consumption also decreased with shorter drying time and shorter vacuum time. Under this optimal variable temperature drying condition, GWH exhibited the highest total active substance content, with respective values of 9.43mg/g for total triterpenes, 35.68mg/g for flavonoids, 9.51mg/g for polyphenols, and 9.55mg/g for quinones. The experimental drying data of GWH were best fitted by a logarithmic model, with R2 values ranging from 0.9927 to 0.9943. Furthermore, the observed microstructure of GWH corresponded to the variations in total active substance content. This study provided valuable theoretical guidance for addressing environmental pollution associated with GWH and facilitating the industrialization and refinement of GWH drying processes. PRACTICAL APPLICATION: There is a growing interest in harnessing the potential value of agricultural waste to transform low-cost raw materials into high-value products while mitigating environmental pollution. In this study, for the first time, the effects of variable temperature pulsed vacuum drying on the content of active substances, drying time, and energy consumption of green walnut husk (GWH) were investigated. The findings serve as a theoretical foundation for addressing environmental pollution issues associated with GWH and enabling the industrialization and precision drying of GWH.

Soft Gelatine Capsules- Critical Quality Attributes of Chosen Excipients and Capsules Parameters Following the Quality by Design Concept

Soft gel capsules are a common form of medicine and food supplements. Quality, productivity and manufacturing time is crucial for producers during their development and industrial operations. To ensure the best quality of the product, it is necessary to know all critical process steps and parameters. The use of QbD elements is to ensure the quality of the drug product throughout its "life cycle". Quality by design (QbD) and its elements are described by the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and in their guideline - chapter ICH Q8 (Pharmaceutical Development). One of the first steps in pharmaceutical product development is to prepare Quality Target Product Profile (QTPP) and analyse Critical Material Attributes (CMAs) and Critical Quality Attributes (CQAs) of excipients, active pharmaceutical ingredient (API) and final product. During this research, we investigated the CQAs of the excipients used in vitamin D3 soft gelatin capsules containing high doses of cholecalciferol, from 10 000 to 200 000 IU per capsule. We considered the viscosity of the gelatin mass, the effect of the addition of dye on the viscosity, and the impact of the colour of the gelatin mass on the active substance content in the final capsules. It was also investigated oily carriers (medium chain triglycerides and safflower oil) and antioxidants (alpha-tocopherol acetate vs butylhydroxytoluene), and their effect on API concentration in the capsule.

SULFONATE ADDITIVES TO LUBRICATING OILS

To expand the resource base and increase the efficiency of sulfonate additives, the possibility of obtaining them based on mixed raw materials - petroleum oil M-8 and alkylbenzene synthesized using propylene fraction C18-С30 oligomers was studied. It is shown that during sulfonation of mixed raw materials, the yield of sulfonic acids is 89-93%, the content of hard-to-recycle waste - acid tar is lower than during sulfonation of petroleum oil by 30-35%. The influence of the ratio of ingredients in the initial mixture on the indicators of neutral sulfonate was studied and the conditions for obtaining additives of the required quality were found. The properties of the developed additives in M-11 oil at a concentration of 5% were studied by standard methods. The composition and structure of sulfonates were studied by elemental analysis and IR spectroscopy. The resulting additives have a micellar structure. The results of laboratory tests have shown that neutral, medium - and highly alkaline semi-synthetic calcium sulfonates have high physico-chemical and functional properties. The neutral sulfonate is superior in yield, active substance content, and dispersing properties to NСК petroleum sulfonate and OLOA 246B additive. Medium- and high-alkaline additives in terms of physicochemical and detergent properties are at the level of commercial petroleum sulfonates C-150, C-300 and Hightech 6060M additives, and surpass them in dispersing, anti-corrosion properties and stability against oxidation. Alkaline semi-synthetic calcium sulfonates have a high stability of the colloidal dispersion to the action of water and have better performance compared to analogues. With an increase in the alkalinity of the obtained additives, the physicochemical properties improve, which is associated with the features of their colloidal structure. Using the developed neutral and high-alkaline additives as detergent-dispersant components, experimental motor oils М-10DM and М-10G2, were prepared, which meet the requirements in terms of quality. The high efficiency of semi-synthetic sulfonates allows them to be used in modern motor oils