Vol 69, No 3 (2020)

To ensure the quality of a pharmaceutical substance and ready-made drugs during development and optimization processes and a process change, it is necessary to carefully control one of its most important indices - impurities. Mercury is a heavy metal that can enter the body with seafood and hydrobionts, so the substances derived from marine biocenosis products may contain mercury as an impurity. It is important not only to carry out a qualitative analysis, but also to find an effective quantitative analysis of mercury-containing drugs at all stages of a production process. The aim of this investigation was to review the literature on methods for determining mercury in biological objects. The paper presents data on existing up-to-date methods to determine mercury, as one of the toxic elements that can accumulate and is contained in organic substances, as well as in pharmaceutical production sources, including those based on protamine. The review of the literature has shown that pharmacopoeial (dithizone extraction/photocolorimetry), spectrophotometric (including flameless or cold vapor atomic absorption spectrometry), chromatographic (mainly high performance liquid chromatography) and electrochemical (including voltammetric analysis) techniques are used to measure mercury as an impurity in the sources of pharmaceutical production.

Introduction. The number of patients who need nootropic drugs is constantly growing both in Russia and around the world. In this connection, it is relevant to design effective and safe medicines for the treatment and prevention of these diseases. Chemical screening of a nootropic herbal tea and its individual components has shown that they contain nitrogenous compounds, including amino acids. Taking into account the important role of amino acids in the functioning of the nervous system, a more detailed study of this group of biologically active compounds is of scientific and practical interest. Objective: to investigate the qualitative and quantitative composition of free and bound amino acids in the nootropic herbal tea. Material and methods. The investigation object was an air-dry ground nootropic herbal tea. A detailed qualitative and quantitative analysis was carried out by TLC and HPLC with pre-column derivatization of samples and separation of amino acids by reversed-phase chromatography on a fluorometric detector, by applying the Waters AccQ Tag method. Results. The amino acid composition of a nootropic herbal tea was represented by 16 amino acids in free and bound forms, 7 of which were essential. The total content of free and bound amino acids was 1.165 and 3.216%, respectively. Conclusion. The investigation of biologically active substances in the nootropic herbal tea provided data on the composition and quantitative content of amino acids.

Introduction. The need to use standardized procedures for determining the specific safety of human immunoglobulin infusion formulations is due to the variability of critical parameters related to the use of biological reagents. Therefore, the problems with the development and certifying tests of standard samples are of particular relevance. Objective: to analyze methodological approaches to developing and certifying a standard sample to determine the anticomplementary activity of human immunoglobulin preparations. Material and methods. Standard samples of human immunoglobulin (foreign [Biological Reference Preparation (BRP) approved by the European Directorate for the Quality of Medicines and Healthcare (France)] and Russian batches) were used. Methods for systematic analysis and document examination were applied. Anticomplementary activity was determined by a method based on the ability of human immunoglobulins to bind complement, by preventing the lysis of sensitized sheep red blood cells in the complement binding reaction. Results. Comparative analysis and generalization of the experience in developing and certifying Russian and foreign standard human immunoglobulin samples for determining anticomplementary activity revealed the distinctive features of the Russian standard one. They lie in the two-component pattern and the presence of certified anticomplementary activity values for positive and negative controls, expressed as (Xmean±2Sx) with a 0.95 confidence interval, which makes it possible to use of this standard sample for confirming the stability of an analytical procedure and to evaluate possible trends to change the testing process. The advantage of the foreign standard sample of human immunoglobulin (BRP) is that several laboratories can be attracted to participate in certifying tests. Conclusion. Two approaches were identified in the methodology for the development and certifying tests of a standard human immunoglobulin sample to determine anticomplementary activity, and can also be used by the manufacturers of human immunoglobulin infusion formulations to develop and certify standard samples of their enterprise.

Introduction. Providing the population with effective, safe, and high-quality medicines is the main task of a pharmacy facility, the performance of which is determined by both the functioning of the facility as a whole and the direct activity of specialists in the workplaces. The quality control of medicines, one of the important elements of the quality system (QS) consists of a sequence of actions that are known and fully understood by an analytical pharmacist, but its qualitative conduct is ensured by a massive amount of information and the exact observance of all the details of the analysis, so it is important to regulate the order for conducting key working procedures, which will ensure control over many local parameters that in their combination have a rather large impact on the quality of work and the correctness of yielded results. The analytical pharmacist's work requires a systematic increase in the level of professional knowledge, the use of the current advances in drug quality control, the introduction of advanced experience, and the scientific organization of labor. Objective: to analyze the activities of pharmacy specialists who perform functions of controlling the quality of medicines and developing methodological approaches to standardizing the activities of an analytical pharmacist. Materials and methods. The personnel arrangements of 60 pharmacies that are part of the network of AO «Petersburg Drugstores», which produce drugs on prescription and by the requirements of healthcare facilities, job descriptions of an analytical pharmacist. An individual working time photography method was used. Results. The investigation revealed the characteristics of the age structure and service length in the vast majority of analytical pharmacists and identified the need to develop special approaches to labor adaptation and organization from the point of view of methodological support to these workers. The investigators defined the pattern of an analytical pharmacist's working day and identified working processes that took the most execution time: quality control of an extemporal formulation, intrapharmacy procurement, and pharmaceutical substances. The above types of work account for 84.8% of the total working time. Five standard operating procedures (SOPs) were developed to be used in the working place of an analytical pharmacist. A total of 27 algorithms for analyzing various drugs, such as the internal normative documents of the QS, which contain a sequential order of actions in all types of intrapharmacy quality control for a specific prescription, were developed and introduced in the pharmacy facilities. Conclusion. An analysis of the expenditure of an analytical pharmacist's working time allowed the authors to propose approaches to standardizing significant working processes as QS documents, such as SOPs, analysis algorithms that describe the optimal sequence of the specialists' actions to achieve the required quality of the process, its effectiveness and efficiency.