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Differences in the standardization of medicinal products based on extracts of chondroitin sulfate

https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.083

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Abstract

Objective: a comparative analysis of 6 different chondroprotectors for injection, containing chondroitin sulfate (CS) based on natural extracts.

Material and methods. Five samples were studied for each CS extract. The preparations were compared on the basis of profiles of trace element composition, sulfur content, chromatographic analysis and test for total protein. In each sample, the concentration of 72 elements was determined, then averaging was performed and the variances of the content of each element were calculated. To assess the content of the protein fraction, a modified Lowry method with bicincholic acid was used. Chromatographic profiles of the studied CS extracts were measured to estimate the molecular weight distribution.

Results. The studied samples differ significantly from each other in the total and individual content of sulfur, toxic and conditionally toxic microelements. According to the analysis of sulfur and trace elements, a cluster of more standardized CS extracts was identified. It was shown that the assessments of the pharmaceutical quality of the studied extracts made by the elemental profile, correspond to the assessments of the quality by the degree of proteins elimination and by the molecular weight characteristics of CS extracts. In particular, the highest total content of toxic elements was found for CS-6 (14.87±1.81 μg/l) and CS-2 (9.20±1.12 μg/l), and the lowest – for CS-4 (1.46±0.23 μg/l), CS-3 (1.92±0.33 μg/l) and CS-1 (2.98±0.25 μg/l). The highest content of protein impurities was also found in CS-6 (9.62 mg/ml) and CS-2 (6.64 mg/ml), and the lowest – in CS-1 (2.87 mg/ml). At the same time, the highest amount of sulfur was found CS-1 (6400 mg/kg) and much less – for CS-2 (370 mg/kg) and CS-6 (100 mg/kg). Significant amounts of the high-molecular fraction of CS (1–40 kDa) were found only in CS-1, and only trace amounts of high-molecular CS forms were present in CS-2 and CS-6.

Conclusion. The highest content of cholesterol and sulfur and, at the same time, the lowest content of toxic microelements and proteins were distinguished by the extract obtained from the trachea of a bovine.

About the Authors

O. A. Gromova
Institute of Pharmacoinformatics, Federal Research Center “Informatics and Management”, Russian Academy of Sciences; Big Data Storage and Analysis Center, Lomonosov Moscow State University
Russian Federation

Olga A. Gromova – Dr. Med. Sc., Professor, Research Supervisor, Institute of Pharmacoinformatics, Federal Research Center “Informatics and Management”, Russian Academy of Sciences; Leading Researcher, Big Data Storage and Analysis Center, Lomonosov Moscow State University. Scopus Author ID: 7003589812; ResearcherID: J-4946-2017; RSCI SPIN-code: 6317-9833

4 Vavilov Str., Moscow 2119333
1 Leninskie Gory, Moscow 119991



I. Yu. Torshin
Institute of Pharmacoinformatics, Federal Research Center “Informatics and Management”, Russian Academy of Sciences; Big Data Storage and Analysis Center, Lomonosov Moscow State University
Russian Federation

Ivan Yu. Torshin – PhD (Phys. Math.), PhD (Chem.), Senior Researcher, Institute of Pharmacoinformatics, Federal Research Center “Informatics and Management”, Russian Academy of Sciences; Big Data Storage and Analysis Center, Lomonosov Moscow State University. Scopus Author ID: 7003300274; ResearcherID: C-7683-2018; RSCI SPIN-code: 1375-1114

4 Vavilov Str., Moscow 2119333
1 Leninskie Gory, Moscow 119991



B. Ts. Zaychik
Bakh Institute of Biochemistry, Federal Research Center for Biotechnology, Russian Academy of Sciences
Russian Federation

Boris Ts. Zaychik – PhD (Tech.), Senior Researcher. ResearcherID: J-4946-2017; RSCI SPIN-code: 3757-3395

33 Leninskiy Prospekt, Moscow 119071



E. V. Shikh
Sechenov University
Russian Federation

Evgeniya V. Shikh – Dr. Med. Sc., Professor, Chief of Chair of Clinical Pharmacology and Propaedeutics of Internal Diseases. Scopus Author ID: 6506179061; ResearcherID: B-7786-2018; RSCI SPIN-code: 2397-8414

8/2 Trubetskaya Str., Moscow 119991



A. O. Ruzhitskiy
Bakh Institute of Biochemistry, Federal Research Center for Biotechnology, Russian Academy of Sciences
Russian Federation

Aleksandr O. Ruzhitskiy – Researcher. Scopus Author ID: 7003589812; ResearcherID: J-4946-2017; RSCI SPIN-code: 3757-3395

33 Leninskiy Prospekt, Moscow 119071



A. N. Galustyan
Saint Petersburg State Pediatric Medical University
Russian Federation

Anna N. Galustyan – MD, PhD, Chief of Chair of Pharmacology with a Course in Clinical Pharmacology and Pharmacoeconomics. RSCI SPIN-code: 3303-7650

2 Litovskaya Str., Saint Petersburg 194100



I. S. Sardaryan
Saint Petersburg State Pediatric Medical University
Russian Federation

Ivan S. Sardaryan – MD, PhD, Associate Professor, Chair of Pharmacology with a Course in Clinical Pharmacology and Pharmacoeconomics. Scopus Author ID: 572006721; RSCI SPIN-code: 9522-9761

2 Litovskaya Str., Saint Petersburg 194100



I. V. Sarvilina
Medical Center "Novomeditsina"
Russian Federation

Irina V. Sarvilina –Dr. Med. Sc., Professor, Chief Physician. RSCI SPIN-code: 7308-6756

74 Sotsialisticheskaya Str., Rostov-on-Don 344002



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For citation:


Gromova O.A., Torshin I.Yu., Zaychik B.T., Shikh E.V., Ruzhitskiy A.O., Galustyan A.N., Sardaryan I.S., Sarvilina I.V. Differences in the standardization of medicinal products based on extracts of chondroitin sulfate. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2021;14(1):50-62. (In Russ.) https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.083

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