Open Access Open Access  Restricted Access Access granted  Restricted Access Subscription or Fee Access

Vol 70, No 8 (2021)

Articles

The problem of a unified approach to certifying standard samples for drug quality control

Zhigalina A.A., Strelova O.Y., Kotova N.I., Malakhova A.Y., Tsekhanskaya E.A.

Abstract

Due to the Russian pharmaceutical industry's great demand for standard samples (SSs), the authors have carried out a content analysis of the legislative and regulatory framework that defines the terminology for SSs and their requirements. They present the general classification of SSs, have identified and discussed the topical problems of the adequacy of translating the foreign normative documents in terms of terminology and establishing the quality indices for SSs depending on how they are used. An analysis of regulatory documents has revealed critical differences in the requirements for estimation of SS quality indicators (identity, purity, and assay). However, General Pharmacopoeia Article 1.1.0007.18 «Standard Samples» in the 14th edition of the Russian Federation's State Pharmacopoeia differentiates the requirements for SSs according to their intended use: Pharmacopoeia SS (PSS) for identity, PSS for testing for purity and impurities, and PSS for assay. The GOST lacks this difference and all the requirements are the same for a universal SS. It is shown that it is necessary to certify SS in such a way that if necessary, the latter can be used as a universal one and meet the requirements for estimating the corresponding individual indicator.
Farmaciya (Pharmacy). 2021;70(8):5-11
pages 5-11 views

Development of a bioanalytical procedure for determination of a new antioxidant by a voltammetric method

Shinko T.G., Terentyeva S.V., Ivanovskaya E.A., Prosenko O.I.

Abstract

Introduction. The new promising sulfur-containing phenolic antioxidant dodecyl (3,5-dimethyl-4-hydroxybenzyl) sulfide has been developed at the Department of Chemistry, Novosibirsk State Pedagogical University. The antioxidant activity of this compound has been shown in studies using various models. It has also been found to be able to have hepatoprotective and anti-inflammatory activities, hemorheological, antiaggregatory, antiplatelet, and pronounced protective effects in cerebral ischemia. Objective: to develop a bioanalytical procedure for estimating the content of dodecyl (3,5-dimethyl-4-hydroxybenzyl) sulfide in biological material for further pharmacokinetic studies Material and methods. Differential pulse voltammetry was chosen to develop this procedure. The determination was carried out on a working mercury-film (amalgam) electrode using a silver chloride electrode as a reference electrode. The background electrolyte was a mixture of 95% ethanol and 2M sodium hydroxide solution (4:6). Results. The electrochemical behavior of dodecyl (3,5-dimethyl-4-hydroxybenzyl) sulfide was investigated and conditions for its rat serum quantification were selected. The developed procedure was validated. This procedure could establish the pharmacokinetic parameters of dodecyl (3,5-dimethyl-4-hydroxybenzyl) sulfide in the rats after its single intragastric administration at a dose of 500 mg/ kg. Conclusion. The developed procedure for the voltammetric determination of rat serum dodecyl (3,5-dimethyl-4-hydroxybenzyl) sulfide can be used to identify its pharmacokinetic parameters during preclinical studies.
Farmaciya (Pharmacy). 2021;70(8):12-18
pages 12-18 views

The content of macronutrients in the raw material of medicinal plants cultivated in the North-West of the Russian Federation

Klemper A.V., Gravel I.V., Generalova Y.E., Luzhanin V.G.

Abstract

Introduction. Macronutrients play an important role in the activity of herbal medicines. Since the daily dose of medicinal raw plant materials that contain no poisonous or potent biologically active substances is quite high (up to 10-20 g), these can be considered as a source of essential macronutrients, calcium, potassium, sodium, and magnesium in particular. Objective: to investigate whether the raw materials of medicinal plants cultivated in the North-West of the Russian Federation can be used as a source of vital macronutrients. Material and methods. The investigation objects were raw materials of 19 species of medicinal plants from the collection garden of the Saint Petersburg State Chemicopharmaceutical University, which contain various groups of biologically active substances (essential oils, flavonoids, polysaccharides, coumarins, carotenoids, and anthracene derivatives). The content of calcium, potassium, sodium, and magnesium in the plant raw materials was estimated by atomic emission spectrometry. Results. Comparison of the findings with the adequate level of consumption of macronutrients has shown that garden sage (Salvia officinalis) leaves can be considered as a source of calcium; marshmallow (Althaea officinalis) herb can be a source of potassium; and milky iris (Iris lactea) herb is a source of magnesium for humans. Conclusion. The sufficiently high concentrations of calcium, potassium, sodium, and magnesium in the investigated types of raw materials allow them to be considered as a potential source for the correction of macronutrient deficiency.
Farmaciya (Pharmacy). 2021;70(8):19-25
pages 19-25 views

Investigation of morphological, anatomical, and diagnostic characteristics of Volga setwell (Valeriana wolgensis Kazak) raw material by luminescence microscopy

Kolosova O.A., Trineeva O.V., Sorokina A.A., Gudkova A.A.

Abstract

Introduction. As of now, Pharmacopeia Article (PA) 2.5.0009.15 «Setwell (Valeriana officinalis) rhizomes and roots» in the 14th Edition of the Russian Federation's Pharmacopeia does not specify the list of closely related species that can be harvested and used, as is laid down for other types of plant materials (for example, PA.2.5.0106.18 «Brier (Rosa) hips»). The morphological convergence of related species and simultaneously the description of the multitude of different intraspecific forms complicate the differentiation of the species of the Officinales series; therefore, microscopic analysis is used to determine their identity. The literature lacks information on the use of the luminescence analysis described in the Pharmacopoeia to assess the identity of the rhizomes and roots of various setwell species, which determines the relevance of such investigations. Objective: to investigate the morphological, anatomical and diagnostic features of Volga setwell (Valeriana wolgensis Kazak) raw material by luminescence microscopy. Material and methods. The investigation object was the dried aboveground and underground parts of Volga serwell growing in the Voronezh Region. The morphological, anatomical, and diagnostic signs of the raw materials were macroscopically and microscopically examined by luminescence microscopy using a Micromed-3 Lum luminescent microscope. Results. Luminescence microscopy was used to determine and visualize the morphological signs of the aboveground parts of Volga setwell and the anatomical markers of its underground parts. The investigators established the nature of the structure and luminescence of trichomes, conductive elements, and parenchyma of the Volga setwell leaf blade. They revealed the feature of the luminescence of the hypodermis and ground parenchyma of the setwell root, which makes it possible to use this feature as an identification sign when establishing the identity of this raw material. Conclusion. The findings can be used to compile «keys» for the identification of closely related plant species by anatomical features. Investigations will contribute to the further comprehensive study of setwell species belonging to the Officinales Grub., which account for 8 to 11 species according to different data.
Farmaciya (Pharmacy). 2021;70(8):26-30
pages 26-30 views

The morphological and anatomical structure of Asian mint (Mentha asiatica Boriss) growing in Tajikistan

Sakhratov V.A., Evdokimova G.N., Malkova T.L.

Abstract

Introduction. Asian mint (Mentha asiatica Boriss.) is widespread in Tajikistan and is used in folk medicine as an antispasmodic and anti-inflammatory agent. Investigations on the introduction of this plant species into medical practice in Tajikistan is relevant and require a comprehensive study of the plant. Objective: to investigate the morphological and anatomical features of Asian mint herb to establish its diagnostic signs. Material and methods. The investigation object was the Asian mint herb harvested in the Republic of Tajikistan. The Asian mint herb was macroscopically and microscopically examined according to the procedures described in the 14th Edition of the Russian Federation's State Pharmacopoeia. The anatomical structure of the leaves and stems of the plant was examined using BIOLAM R-14 and Motic microscopes; photos were taken employing the Motic Educator software. Results. The appearance of Asian mint that shows abundant pubescence with bluish-green hairs over the entire plant surface and with a rounded and tetrahedral stem was examined. The anatomical and diagnostic signs required to characterize the identity of Asian mint raw material were established; these were numerous simple hairs on both sides of the leaf; essential oil glandules and large stomata on the lower side of the leaf; the signs were characterized quantitatively and recorded on micrographs. Conclusion. The findings make it possible to significantly analyze the identity of Asian mint herb and can be used in the development of regulatory documents for the introduction of this type of plant raw material into the medical and pharmaceutical practice of the Republic of Tajikistan as an independent drug.
Farmaciya (Pharmacy). 2021;70(8):31-35
pages 31-35 views

Elaboration of approaches to standardizing love-in-a-mist (Nigella sativa) herb

Mubinov A.R., Kurkin V.A., Avdeeva E.V.

Abstract

Introduction. Love-in-a-mist (Nigellasativa L.) is a representative of the ranunculaceous family (Ranunculaceae). Nigellasativa L. is insufficiently studied as compared with other Nigella L. species, including wild fennel (Nigella damascena); however, it is a promising type of medicinal plant material, for which hepatoprotective, hypoglycemic, antioxidant, antibacterial, anthelmintic, and general healthimproving actions have been described. In addition to the use of the main raw material, such as the seeds of Nigella sativa L., of interest are its aboveground parts (herb) that have still been little studied and have not had a wide application in scientific medicine. Therefore, there is a need for pharmacognostic studies, followed by the development of regulatory documents confirming the identity and quality of this medicinal plant for promising raw materials. Objective: to develop a procedure for quantification determination of the amount of flavonoids in the Nigella sativa L. herb. Material and methods. The investigation object was the Nigella sativa L. herb harvested in July 2021 in the Ulyanovsk Region and in the Botanical Garden of the Samara Medical University. Direct and differential spectrophotometries were used to develop the procedure. Results. The optimal conditions were determined for quantification of the amount of flavonoids in the Nigella sativa L. herb; these were an extractant of 70% ethanol; a raw material-extractant ratio of 1:30; an extraction time of 45 min, and a raw material grinding size of 2 mm. Validation studies showed the validity of the developed procedure. Conclusion. The procedure was developed for quantification of the amount of flavonoids in the Nigella sativa L. herb, by using differential spectrophotometry at an analytical wavelength of 412 nm, calculated with reference to the standard sample (SS) - rutin. The content of the amount of flavonoids in the herb of the Nigella sativa L. cultivated in the Ulyanovsk and Samara Regions ranges 1.17 to 1.71%. The error of single determination at 95% confidence probability is ±4.17%.
Farmaciya (Pharmacy). 2021;70(8):36-41
pages 36-41 views

Pharmacoepidemiological analysis of the consumption of antibacterial drugs in the Russian Federation in the period 2008-2020

Ivanova D.D., Temirbulatov I.I., Sychev I.N., Lazareva N.B.

Abstract

Introduction. Effective and safe pharmacotherapy for infectious diseases is extremely difficult due to the growing resistance of pathogens to available drugs. Due to different resistance mechanisms, the pathogens of the ESKAPE group are a group of dangerous causative agents of nosocomial infectious diseases. Every year, hospitals purchase a large quantity of antibacterial drugs (ABDs), but not all of them are effective against resistant pathogens. The study of the characteristics of the consumption of ABDs in the hospital sector contributes to the rational use of drugs by hospitals. Objective. To study the dynamics, pattern, and regularities of use of J01 subgroup ABDs by hospitals in the Russian Federation in the period 2008-2020. Material and methods. A retrospective pharmacoepidemiological analysis was made for the J01 subgroup ABDs purchased by Russian hospitals in 2008-2020. The analysis was carried out using the data published in the Unified Information System in the field of procurement and in the database of IQVIA Holdings Inc. A separate analysis was done for ABDs that are active against the ESKAPE pathogens. Results. There was an increase in the volume of consumption of J01 subgroup drugs and ABDs that are active against the ESKAPE group. In 2020, the maximum consumption of J01 ABDs was recorded, which is due to the greatest COVID-19 spread. Among the federal districts, the Central Federal District makes the most ABD purchases. Among the analyzed ABDs, the largest quantities of tigecycline, piperacillin + [tazobactam], cefotaxime + [sulbactam] and cefepime + [sulbactam] were purchased for the needs of hospitals in all federal districts of Russia. Conclusion. There was a substantial increase in the consumption of ABDs in both quantitative and value terms. In value terms, there was a fairly large increase in the use of ABDs that are active against the ESKAPE group pathogens.
Farmaciya (Pharmacy). 2021;70(8):42-48
pages 42-48 views

Hospital demand for biological agents for the treatment of patients with rheumatic diseases

Ugoltsova V.N., Shakirova D.K., Abdulganieva D.I., Safiullin R.S.

Abstract

Introduction. The socioeconomic burden of rheumatic diseases (RDs) is an important public health problem due to the annually growing epidemiological indicators and high patient disability rates. The use of expensive biological agents (BAs) in pharmacotherapy could achieve the major goal of treatment, such as remission and better quality of life in a number of cases. In the context of budget deficits, it is of great importance to determine the optimal hospital demand forecast for BAs, taking into account the influence of various factors on drug consumption, which will be able to increase the availability of targeted therapy for all patients in need. Objective: to determine the optimal hospital demand for BAs for the treatment of patients with RDs, by using the multifactorial mathematical modeling method. Material and methods. The materials were expert review questionnaires, 1181 case history sheets for patients diagnosed with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. Expert assessments, content analysis, correlation regression analysis, and multifactorial mathematical modeling were used. Results. Multifactorial mathematical models were developed and the 2020-2023 hospital demand forecast for BAs (rituximab, certolizumabapegol, golimumab, tocilizumab, and abatacept) was estimated. Conclusion. The short-term demand forecast calculated using multifactorial mathematical modeling was reliable and can be used when creating the optimal purchase order for BAs (rituximab, certolizumabapegol, golimumab, and tocilizumab).
Farmaciya (Pharmacy). 2021;70(8):49-53
pages 49-53 views

Selenium and selenium-containing drugs: importance for the body and prevention of various diseases

Dedov D.V.

Abstract

Introduction. Selenium is a trace element with pronounced catalytic properties. It is an important element for maintaining a healthy physiological state of the body. Selenium is involved in the regulation of immune system functions. Decreased selenium levels in patients with heart failure is associated with a deterioration of exercise tolerance, quality of life, and an unfavorable prognosis. Selenium deficiency causes irreversible damage in brain depletion. Selenium intake in physiological doses is crucial for human health and reproductive functions. Objective of the study. To study the literature data on Russian and foreign researches of significance of selenium and selenium-containing preparations for the organism and their role in prevention of various diseases. Material and methods. The review-analytical research of 6 Russian and 23 foreign articles was carried out. They were published in the period from 1994 till 2021. Results. It has been established that the biological activity of selenium is determined not only by the dose, but also by the chemical forms of the trace element. Its anticarcinogenic and cardioprotective effects essentially depend on them. It was found that Se exists in 2 forms: inorganic (selenite and selenite) and organic (selenomethionine and selenocysteine). The organic form of selenium, selenocysteine, is more bioavailable than other selenium derivatives. The above-ground part of the plant Astragalus woolly-flowered is a source of selenocysteine. It is used to manufacture SELENBIO for women vitamin-mineral complex. Important components of SELENBIO for women are also vitamins C, E and zinc. Conclusion. Components of SELENBIO for women are mutually complementary and reinforce each other's action. All together they provide a powerful total antioxidant effect, reliable protection of the female body from cardiovascular, hormonal, oncological diseases, pathology of the musculoskeletal system, while delaying the aging process, preserving the beauty and health of the skin, hair and nails.
Farmaciya (Pharmacy). 2021;70(8):54-56
pages 54-56 views

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies