Inclusive Scenario of Natural Products Obtained From Agar Plant (Aquilaria SP.) In Bangladesh- A Review

Agarwood is the resinous heartwood obtained from the injured parts of trees under Thymelaeaceae family particularly from Aquilaria species. Agarwood is considered as the most prized non-timber forest product (NTFP) used in attars as well as medicines. Quality of agarwood is the determiner for defining its commercial value. Different countries use different grading system to explain the quality of agarwood. In Bangladesh, more than 45 compounds have been identified so far, mostly sesquiterpenoids, alkanes, fatty acid and other volatile aromatic compounds that are responsible for its fragrance and high prices. Ether extract, total phenolic contents, flavonoid, antioxidant and microbiological tests have shown tremendous positive results. Chemical profiling of agar products is the best identified using GC-MS technique by the various authors. Present review discusses the full scenario of Aquilaria production, inoculation, extraction methods, determination of agarwood quality and chemical constituents of agar oils and possibilities and barriers of this industry in Bangladesh. J. Bio-Sci. 29(2): 151-173, 2021 (December)

FUNCTIONAL MAPPING OF THE MEDICINES’ QUALITY CONTROL SYSTEM PROCESSES IN THE SVERDLOVSK REGION

The article describes the results of subject-object and risk-based mapping of the medicines’ quality control system. Identification and procedural structuring of key processes of drug quality control systems in Russia was carried out. The matrix of key procedures was formed in coordinates of agency, target, time, and level characteristics for qualitative mapping of the processes and procedures. To quantify the control measures modality in the coordinates "product-context", the structural coefficient of distribution of procedures was calculated for each section of the commodity distribution network: the product emphasis in the production/ manufacturing segment and the environmental emphasis in the system of market distribution of medicines. Based on the results of risk-based mapping, it was determined that the segments of wholesale and retail pharmaceutical activities are characterized by a shift in control measures to the segment of external reactive procedures, which seems to be a negative trend. It is shown that the production of medicines is the leading segment in the implementation of risk-based quality control procedures for medicines, while in the wholesale and retail trade segment this indicator is 95% lower. The key target for optimization measures is the regional wholesale and retail segment of the pharmaceutical market due to the risk-based selective approach to checking compliance with licensing requirements and a large number of control objects.

MODERN APPROACHES TO THE FORMATION OF PROFESSIONAL COMPETENCIES OF PHARMACISTS ON ISSUES OF MEDICINES QUALITY ASSURANCE

The aim: To analyze, summarize and substantiate modern approaches to the formation of the professional competencies of pharmacists on issues of medicine quality assurance in Ukraine. Materials and methods: In this study, we performed systematic review, systematic and comparative analysis, content analysis, generalization, document analysis, logical and graphical modeling to address those issues. Conclusions: We showed that the curriculum and program of the «Basic foundations of the functioning of quality systems in pharmacy institutions» thematic improvement cycle for pharmacists have been substantiated and developed. The content of the program provides an opportunity to prepare pharmacists for independent work in the field of implementation and support of effective quality systems in pharmacy institutions and hospital pharmacy services. In the context of substantiation of modern approaches to the preparation of pharmacists in the field of medicines quality assurance, the experience and advantages of such modern forms of training of pharmacists as the use of training bases and blended learning have been studied. The modern approaches to the formation of the professional competencies of pharmacists on issues of medicine quality assurance in Ukraine have been analyzed, summarize and substantiated.

Safety assessment of biological raw materials in the system of medicines quality assurance

The entry of a wide range of biotechnological products into the pharmaceutical market calls for rein-forcement of the quality, efficacy and safety standards at the state level. The following general monographs have been elaborated for the first time to be included into the State Pharmacopoeia of the Russian Federation, XIV edition: "Viral safety" and "Reduction of the risk of transmitting animal spongiform encephalopathy via medicinal products". These general monographs were elaborated taking into account the requirements of foreign pharmacopoeias and the WHO recommendations. The present paper summarises the key aspects of the monographs.

Development of methods and the study of microbiological purity of the gel of a complex dense extract of hypericum herbs and calendula flowers

In pharmaceutical industry antimicrobial preservatives that restrict multiplication of microorganisms and decrease bioburden are usually added in composition of hydrophilic medicines that include components of natural origin to prevent possible risks of functional changes in drugs characteristics caused by microbial contamination. Therefore, microbiological purity (MBP) is a crucial criteria for medicines quality. The purpose of the work was to develop the MBP testing methodology for complex gel containing dense extract of hypericum herbs and calendula flowers using structural-mechanical and technological studies. Methodology for MBP testing of proposed gel was developed and justified considering criteria given in State Pharmacopoeia of Ukraine 2.0. Originality of MPT methodology consists in the gel’s antimicrobial action neutralization to decrease possible risks of false results occurrence (including microorganisms inhibited by antimicrobial action of the gel). The applicability of the methodology was determined comparing the number of test cultures CFUs in presence of gel under specified condition with number of CFUs in positive control. The methodology is suitable for microbiological purity testing of the sample, as well as for the Preservatives Efficacy Testing (PET). When applying the developed methodology, the antimicrobial action of the sample is completely eliminated. While developing the MPT methodology compliance with following acceptance criteria was confirmed for tested sample: Absence of Staphylococcus aureus (in 1 g); Absence of Pseudomonas aeruginosa (in 1 g); Total aerobic microbial count (TAMC) – 10² CFU per 1 g; Total combined yeasts and molds count (TYMC) – 10¹ CFU per 1 g. All the tested samples met the requirements of the 2.0. version of State Pharmacopoeia of Ukraine for non-sterile dosage forms for oromucosal and dermal use.

Analytical Chemistry of the 21st Century: New Face of the Science

The paper constitutes a review of the analytical chemistry general state, changes in its development trends, as well as substantial rise of both its tasks volume and complexity and its potential. The place that the analytical chemistry takes among other sciences is briefly considered, and its instrumentation improvement is noted. Author focuses on the russian scientists’ advances in this sphere, particularly those whose investigation were supported by the Russian Foundation for Basic Research. Examples of the new analytical methods creation, the original analytical approaches development and the important applied tasks solution in spheres of medicine, environmental protection and the food and medicines quality and safety control are given. Author attempts to forecast the analytical chemistry development prospects for the next 10–15 years.