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Introduction. About a quarter of the world's population suffers from helminthic invasion. Praziquantel is a drug for the treatment of helminthiasis caused by cestodes and trematodes. The development of generic drugs for the fight against helminthiasis in Russia seems to be relevant.The aim of the study was to compare the pharmacokinetics profiles of generic Praziquantel and Biltricid® (reference drug), to assess their safety during their bioequivalence study.Materials and methods. An open, randomized, crossover, four-period, replicative design study was conducted on 32 male healthy volunteers.Results. Similar pharmacokinetic profiles of praziquantel were found when volunteers took Praziquantel and Biltricid®. According to the analysis of variance, the main factors that make a significant contribution to the observed variability of the data were interindividual differences in volunteers and the sequence of taking drugs. 90% CI of the ratios of AUC0-t, AUC0-∞, and Cmax of the tested drug to the reference one were in the range of 80-125%. Praziquantel preparations have been found to have a satisfactory safety profile.

The aim of this study is to develop a universal, rapid and affordable method for the identification of dydrogesterone, troxerutin, and ademetionine in drugs by multisensor digital colorimetry using a unique two-dimensional code. The developed approach can be applied to rapid detection of counterfeit drugs at the preliminary stage of the analysis (before using more expensive specialized equipment). Materials and methods. To implement the proposed approach, the substances of dydrogesterone (“Abbott Biologicals B.V.”, Netherlands), troxerutin (JSC “Interfarma”, Prague, Czech Republic) and ademetionine (LLC “Farmamed”, Moscow, Russia) , troxerutin capsules 300 mg (LLC “Pranafarm”, Samara, Russia), lyophilisate for an intravenous solution and the intramuscular administration “Heptral” ® (ademetionine) 400 mg (“Abbott Laboratories”, GMBH, Germany), tablets “Duphaston” ® (dydrogesterone) 10 mg (“Abbott Healthcare Products B.V.”, Netherlands), were used. A multisensor colorimetry method has been implemented using the following set of 8 sensors (C 1 -C 8 ): an intact solution – a 96% (v/v) aqueous ethanol solution – C 1 ; 1 mM alcoholic solution of anthraquinone green (CAS#4403-90-1) – C 2 ; a 0.2% aqueous solution of 3-methylbenzothiazolinone hydrazone (CAS#1128-67-2) – C 3 ; a 0.2% methyl orange aqueous solution (CAS#547-58-0) – C 4 ; a 1 mM alcoholic solution of sulforhodamine B (CAS#3520-42-1) – C 5 ; a 1 mM alcoholic solution of 1-hydroxypyrene (CAS#5315-79-7) – C 6 ; 1 mM alcoholic solution of allura red AC (CAS#25956-17-6) – C 7 ; a 1 mM aqueous solution of iron (III) chloride – C 8 . Transparent flat-bottomed polypropylene plates with 96 cells, with a cell volume of 350 µl (Thermo Fischer Scientific, USA, cat. No. 430341) were used as a base for the chip. For obtaining raster images, an Epson Perfection 1670 office flatbed scanner (CCD-matrix) with a removable cover was used. The obtained digital images of the cells were processed using the ImageJ software (Wayne Rasband, National Institutes of Health, USA; http://imagej.nih.gov/ij) with a 24-bit RGB color model (8 bits per channel). Results. The adequacy of the developed approach was confirmed by the analysis of the above-listed drugs. It has been shown that the results obtained have no statistically significant differences from the values determined by the spectrophotometric method. Conclusion. The possibility of using multisensor digital colorimetry for pharmaceutical analysis has been shown. The developed methods for the identification of the active substances can serve as a good supplement to the more expensive traditional methods.

Significant progress has been made in the development of genetic technologies in recent decades. Currently, high-performance sequencing and, most importantly, genome editing technologies are widely used and available for laboratories in Russia. Existing technologies are not without drawbacks that significantly hinder further development, in addition, all the necessary reagents and materials, as well as equipment, are produced exclusively abroad. The review highlights the international experience of using genome editing technologies for the treatment and prevention of genetic diseases, vector-borne and viral infections, it offers recommendations for the development of this area in the Russian Federation. Attention is drawn to the legal and ethical regulation, mainly at the level of basic principles. The conclusion is formulated on the need for accelerated adaptation of basic ethical and legal principles for genome editing activities in scientific biomedical activities.

An effective, affordable, and rapid method for the analysis of drugs based on chloramphenicol is developed using multisensory digital colorimetry. The use of a two-dimensional code for the identification and quantification of chloramphenicol with the minimum level of informational noise is proposed. The principal component analysis is used to increase the reliability of the results of the determination of the medicinal substance. The adequacy of the developed approach is confirmed by the analysis of chloramphenicol preparations in the form of two dosage forms: tablets and eye drops. The accuracy of the results is confirmed by the standard addition method. The results prove that the preparations do not have statistically significant differences from the values declared by the manufacturer.

Methods for determining the genotoxic impurity N-nitrosodimethylamine (NDMA) in valsartan drug substance by gas chromatography (GC) with mass-spectrometric detection in SIM and MRM modes using direct introduction and vapor-phase analysis are compared. The obtained LOQ and DL differed insignificantly. The test results led to the conclusion that use of a method corresponding to the capabilities and equipment of the laboratory was advisable.

A method for multiplex digital colorimetric qualitative analysis of nonsteroidal anti-inflammatory drugs (meloxicam, acetylsalicylic acid and its metabolites, paracetamol), β-adrenoblockers (carvedilol), secretolytics (bromhexine), fluoroquinolones (ofloxacin), metabolic stimulants (meldonium dihydrate), etc., was developed. The molecular chip operating efficiency was confirmed by verifying the authenticity of >40 medicinal substances. The proposed universal approach was new in principle and could be used for pharmaceutical quality control.

The use of nanostructured components in drug manufacturing and, more specifically, targeted drug delivery has recently become a major trend in the pharmaceutical industry. Nanodrugs encompass a wide range of pharmaceutical agents containing dendrimers, nanocrystals, micelles, liposomes, and polymer nanoparticles. Liposomes are the most well-studied nanoparticles and effective drug carriers. However, the more complex their structure is, the more process controls are needed and the more quality attributes have to be monitored, including the chemical properties of the liposomal fraction such as the shape, size and charge of the nanoparticle, conjugation efficacy, and distribution of the active ingredient. We believe that quality control of key liposome characteristics should rely on dynamic and laser light scattering coupled with electrophoresis, differential scanning calorimetry, cryo-electron microscopy, nuclear magnetic resonance, laser diffraction analysis, and gel filtration chromatography.

New approach to spectrophotometric and colorimetric determination of meloxicam, lornoxicam, tenoxicam in drugs using 7-chloro-4-nitrobenz-2-oxa-1,3-diazole (NBD chloride) is developed. The techniques are based on alkaline hydrolyses of oxicams with NBD chloride and the subsequent spectrophotometric and colorimetric determination of the colored products of reaction. The linearity range of calibration dependence is 1-10 mg/ml for lornoxicam and tenoxicam, 0.5-5 mg/ml for meloxicam. The advantages of developed methods are rapidity and cost-efficiency. This approach can be used for screening control of drug quality.

The design and operations principles of a prototype of optical device based on an office flatbed photo scanner with a slide adapter are described in the paper. The developed device is intended for the analysis of liquid-phase samples by colorimetry, photometry, fluorimetry and nephelometry. Teflon cassettes designed for fixing cuvettes on glass plate of the scanner. Teflon wedge-shaped inserts for cuvettes have been developed to optimize the conditions of colorimetric analysis. These inserts allow varying the thickness of the absorbing layer of solutions. Multilayer absorption filters with a variable bandwidth are proposed for light monochromatization. Filters are obtained by the method of inkjet printing on polymer films. A violet laser pointer is used as a light source for fluorimetric and nephelometric analysis. The principal possibility of measuring the absorption and fluorescence spectra using photo scanner is shown. The analytical capabilities of the developed prototype of an optical molecular analyzer are demonstrated when determining riboflavin in an injection solution, acetylsalicylic acid and magnesium hydroxide in Cardiomagnyl® drug.

Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. The average time from the moment of initial approval of a drug in the aforementioned countries and jurisdictions to the moment of registration in Russia is 4 years and 8 months, with a median value of 2.5 years. It has been shown that half of this term is spent on the performance of the procedures of the expertise of the drug registration dossier in the Russian Federation. Conclusion: To attain the goal of adequate supplies to the population of the Russian Federation of the most up-to-date, high quality, safe, and efficacious medications, apart from the support of national originators of innovative drugs, we are required to upgrade the existing system of original drug registration. Improvement should be primary focused on the drugs already approved by the leading national regulatory authorities in order to ensure innovative medicine access for Russian patients.

In this paper we proposed the method of X-ray fluorescence (XRF) determination of some essential trace elements in medicinal herbs and vitamin-mineral complexes at the level of 100-101 mg/ml. To increase sensitivity and selectivity of the determination we simple and effective approach based on the extraction of metal ions from aqueous solutions with chemically modified polyurethane foam sorbents followed by direct XRF analysis. The conditions of sorption preconcentration of Co(II), Ni(II) and Zn(II) ions with modified sorbents were optimized. The proposed approach is used for the determination of trace elements in several kinds of medicinal herbs (coltsfoot leaves, nettle leaves and yarrow herb) and vitamin-mineral complexes («Alfavit», «Vitrum» and «Multi-tabs»).

The original approach was developed and used for screening analysis of more than 40 pharmaceuticals (nonsteroidal analgesics and anti-inflammatory drugs, β-adrenoblockers, secretolytics, fluoroquinolones, metabolic stimulants and others) by digital colorimetry with the use of office flatbed scanner. The proposed technique is based on the simultaneous several colorimetric reactions with different molecular sensors placed in a 96-well plate, and its subsequent optical scanning. Computer processing of the bitmap image and multisensory signal discretization allows to obtain a unique barcode suitable for identification and determination of active substances in drugs. This approach can be used for testing the quality of pharmaceuticals.

The simple and available technique of colorimetry and indirect X-ray fluorescence determination of tetracycline hydrochloride (in the form of colored complex with iron(III) ions) and cyanocobalamine (in the form of the colored thiocyanate complex with cobalt(II) ions) is offered. The analytes were separated from the accompanying components by sorption to polyurethane foam based on ethers. The conditions of sorption separation and measurement of analytical signal of these substances are optimized. The obtained results of tetracycline drugs and injection solution B12 vitamin are in satisfactory agreement with data declared by the manufacturer.

Introduction Tissue engineering has become a new promising strategy for repairing damaged organs of the urinary system, including the bladder. The basic idea of tissue engineering is to integrate cellular technology and advanced bio-compatible materials to replace or repair tissues and organs. Aim of the study is the objective reflection of the current trends and advances in tissue engineering of the bladder using acellular matrix through a systematic search of preclinical and clinical studies of interest. Materials and methods Relevant studies, including those on methods of tissue engineering of urinary bladder, was retrieved from multiple databases, including Scopus, Web of Science, PubMed, Embase. The reference lists of the retrieved review articles were analyzed for the presence of the missing relevant publications. In addition, a manual search for registered clinical trials was conducted in clinicaltrials.gov. Results and discussion Following the above search strategy, a total of 77 eligible studies were selected for further analysis. Studies differed in the types of animal models, supporting structures, cells and growth factors. Among those, studies using cell-free matrix were selected for a more detailed analysis. Conclusion Partial restoration of urothelium layer was observed in most studies where acellular grafts were used for cystoplasty, but no the growth of the muscle layer was observed. This is the main reason why cellular structures are more commonly used in clinical practice.

Stem and progenitor cells being introduced into the body have the ability to stimulate regeneration of tissues and organs by differentiating into specialized cells. Stem cell therapy is used in urology to treat various disorders, including erectile dysfunction, urinary incontinence, Peyronies disease, and male infertility. This review presents the results of international preclinical and clinical research on stem cell based medications for treating the above diseases. The most promising appears to be the use of adipose tissue-derived mesenchymal stem cells.

In the paper, results of a substantial study of nano- and microparticles of atmospheric suspensions contained in snow in winter 2011-2012 in Blagoveshchensk have been presented. Distribution of airborne particles of different origin in 25 areas of sampling differing in anthropogenic loadings has been determined. Large and average-sized traffic centers supply in the atmosphere microparticles of rubber, asphalt and various metals and their oxides (Fe, Ni, Co, Cu, Fe, Bi, W). Railway junctions are a source of microparticles of Fe and soot which get to the atmosphere because of friction of metal surfaces and diesel locomotive engines operation. Parks and suburban districts are a source of micro- and macroparticles of natural minerals and rocks and of vegetable detritus. It has been shown that composition of atmospheric suspensions of Blagoveshchensk completely corresponded to ecogeographi-cal prerequisites - the bank of two large rivers, small impact of enterprises and motor transport, a large railway junction.

Background. Is to investigate clinical and pathogenetic features of bronchial asthma (BA) in residents of Siberia, Yakutia, and Russian Far East with mycotic sensitization. Materials and Methods. 45 BA patients in the age group of 24—58 year-olds have been checked. Among them 245 patients were residents of Amur region, 112 patients — residents of Novosibirsk region, and 86 — of the Republic of Yakutia (SAHA), the City of Mirniy. All the patients went through a complex clinical and allergological checkup. The results were processed with «STATISTICA 6» set of programs. Results of the research. Variation in mycotic sensitization in BA patients has proved to be region-bound. Conclusion. Mycotic sensitization in BA patients is marked by predominantly severe clinical course of bronchial asthma and high levels of IgE in the patients’ serum. In the Republic of Yakutia (SAHA) the number of such patients is higher than in Amur and Novosibirsk regions. In BA patients — residents of Amur and Novosibirsk regions — mycotic allergy is accompanied by the domestic one, while in Yakutia it is observed along with epidermal sensitization.

Regenerative medicine approaches, such as replacement of damaged tissue by ex vivo manufactured constructions or stimulation of endogenous reparative and regenerative processes to treat different diseases, are actively developing. One of the major tools for regenerative medicine are stem and progenitor cells, including multipotent mesenchymal stem/stromal cells (MSC). Because the paracrine action of bioactive factors secreted by MSC is considered as a main mechanism underlying MSC regenerative effects, application of MSC extracellular secreted products could be a promising approach to stimulate tissue regeneration; it also has some advantages compared to the injection of the cells themselves. However, because of the complexity of composition and multiplicity of mechanisms of action distinguished the medicinal products based on bioactive factors secreted by human MSC from the most of pharmaceuticals, it is important to develop the approaches to their standardization and quality control. In the current study, based on the literature data and guidelines as well as on our own experimental results, we provided rationalization for nomenclature and methods of quality control for the complex of extracellular products secreted by human adipose-derived MSC on key indicators, such as "Identification", "Specific activity" and "Biological safety". Developed approaches were tested on the samples of conditioned media contained products secreted by MSC isolated from subcutaneous adipose tissue of 30 donors. This strategy for the standardization of innovative medicinal products and biomaterials based on the bioactive extracellular factors secreted by human MSC could be applicable for a wide range of bioactive complex products, produced using the different types of stem and progenitor cells.V nastoiashchee vremia aktivno razrabatyvaiutsia podkhody regenerativnoĭ meditsiny, napravlennye kak na sozdanie zameshchaiushchikh povrezhdennye tkani konstruktsiĭ ex vivo, tak i na stimuliatsiiu éndogennykh protsessov reparatsii i regeneratsii pri razlichnykh zabolevaniiakh. Odnim iz osnovnykh instrumentov regenerativnoĭ meditsiny iavliaiutsia stvolovye i progenitornye kletki, k kotorym otnosiatsia mul'tipotentnye mezenkhimnye stvolovye/stromal'nye kletki (MSK). Poskol'ku osnovnym mekhanizmom regeneratornykh éffektov MSK schitaetsia parakrinnoe deĭstvie biologicheski aktivnykh faktorov, sekretiruemykh étimi kletkami, primenenie ékstratselliuliarnykh produktov sekretsii MSK dlia stimuliatsii regeneratsii tkaneĭ iavliaetsia perspektivnym podkhodom i obladaet riadom preimushchestv po sravneniiu s vvedeniem samikh kletok. Odnako, uchityvaia slozhnost' kak sostava, tak i mekhanizma deĭstviia preparatov na osnove produktov sekretsii MSK, otlichaiushchie ikh ot bol'shinstva farmatsevticheskikh sredstv, aktual'noĭ problemoĭ iavliaetsia razrabotka podkhodov k ikh standartizatsii i kontroliu kachestva. V dannoĭ rabote na osnovanii analiza literatury, normativnoĭ dokumentatsii i sobstvennykh éksperimental'nykh dannykh byli obosnovany nomenklatura i metodiki kontrolia kachestva ékstratselliuliarnogo kompleksa produktov sekretsii MSK zhirovoĭ tkani cheloveka po kliuchevym pokazateliam “Podlinnost'”, “Spetsificheskaia aktivnost'” i “Biologicheskaia bezopasnost'”. Aprobatsiia razrabotannykh podkhodov byla provedena na obraztsakh konditsionirovannoĭ sredy, soderzhashcheĭ produkty sekretsii MSK, vydelennykh iz podkozhnoĭ zhirovoĭ tkani 30 donorov. Razrabotannaia i aprobirovannaia nami strategiia standartizatsii dlia innovatsionnykh lekarstvennykh sredstv i biomaterialov na osnove biologicheski aktivnogo kompleksa produktov sekretsii MSK cheloveka mozhet byt' primenena k shirokomu krugu bioaktivnykh produktov slozhnogo sostava, poluchennykh s ispol'zovaniem razlichnykh tipov stvolovykh i progenitornykh kletok.