Pharmaceutical and technological evaluationof the substance and tablet mass of flacoside
- Authors: Gulenkov A.S.1, Malysheva N.A.1, Mizina P.G.1, Sheichenko O.P.1, Radimich A.I.1, Adamov G.V.1, Petrulenko K.E.2
-
Affiliations:
- All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
- Sechenov University
- Issue: Vol 28, No 2 (2025)
- Pages: 12-17
- Section: Pharmaceutical chemistry
- URL: https://journals.eco-vector.com/1560-9596/article/view/658424
- DOI: https://doi.org/10.29296/25877313-2025-02-02
- ID: 658424
Cite item
Open Access
Access granted
Abstract
Introduction. Flacoside substance with the active ingredient "fellamurin" is an individual natural flavonoid glycoside isolated from the leaves of Amur cork tree, possessing antiviral, hepatoprotective, antioxidant, immunostimulating activity, from which in the 1980s VILAR employees developed the composition and technology of tablets, launched industrial production, which made it possible to use them in the treatment of chronic liver and biliary tract diseases of various origins. However, in the 1990s, the production of the drug was suspended, but the COVID-19 pandemic contributed to the actualization of this development.
The aim of the work is to determine the pharmaceutical and technological parameters of the substance and tablet mass of flacoside, to establish their compliance with the requirements of the State Pharmacopoeia of Russia, XV edition, and to identify ways to improve the technology for obtaining tablets to resume production of the drug.
The technological parameters of the flacoside substance and the tablet mass obtained by wet granulation (in accordance with the previously developed Technological Regulations) were compared. The results of laser diffractometry, sieve analysis and optical microscopy showed that as a result of granulation, the particle size of the tablet mass increases significantly (from 0.02 mm to 1.3-1.5 mm).
The bulk density before and after compaction, as well as the angle of natural repose, corresponded to those obtained in the 1980s, which confirms the pharmaceutical and technological identity of the flacoside substance obtained in 2022.
A comprehensive pharmaceutical and technological assessment of powders based on 12 parameters, processed using the SeDeM expert system method, showed that the good compression index (GCI) of the flacoside substance, which is not suitable for direct pressing, increases by 1.30 (4.43 → 5.73) as a result of granulation, and the resulting tablet mass can be used for industrial pressing.
Full Text
About the authors
A. S. Gulenkov
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Author for correspondence.
Email: gulenkov@vilarnii.ru
ORCID iD: 0000-0002-1532-9330
SPIN-code: 9436-3210
Ph.D. (Pharm.), Leading Research Scientist, Department of Chemistry of Natural Compounds, Center for Chemistry and Pharmaceutical Technology
Russian Federation, 7-1 Grin str., Moscow, 117216N. A. Malysheva
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: gulenkov@vilarnii.ru
ORCID iD: 0000-0003-3336-4428
SPIN-code: 4278-5219
Senior Research Scientist, Experimental-technological Department, Center for Chemistry and Pharmaceutical Technology
Russian Federation, 7-1 Grin str., Moscow, 117216P. G. Mizina
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: pg-mizina@vilarnii.ru
ORCID iD: 0000-0001-6510-9603
SPIN-code: 7084-1962
Dr.Sc. (Pharm.), Professor, Advisor to the Director, Honored Scientist of the Russian Federation
Russian Federation, 7-1 Grin str., Moscow, 117216O. P. Sheichenko
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: gulenkov@vilarnii.ru
ORCID iD: 0000-0001-7099-4192
SPIN-code: 2527-6951
Ph.D. (Chem.), Senior Research Scientist, Department of Chemistry of Natural Compounds, Center for Chemistry and Pharmaceutical Technology
Russian Federation, 7-1 Grin str., Moscow, 117216A. I. Radimich
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: gulenkov@vilarnii.ru
ORCID iD: 0000-0002-1139-8902
SPIN-code: 5452-2675
Senior Research Scientist, Department of Chemistry of Natural Compounds, Center for Chemistry and Pharmaceutical Technology
Russian Federation, 7-1 Grin str., Moscow, 117216G. V. Adamov
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants
Email: gulenkov@vilarnii.ru
ORCID iD: 0000-0001-7347-175X
SPIN-code: 7394-5058
Ph.D. (Pharm.), Leading Research Scientist, Laboratory of Atomic-Molecular Bioregulation and Selection, Center for Plant Growing
Russian Federation, 7-1 Grin str., Moscow, 117216K. E. Petrulenko
Sechenov University
Email: gulenkov@vilarnii.ru
ORCID iD: 0009-0000-6828-4976
Post-graduate Student
Russian Federation, 8-2 Trubetskaya str., Moscow, 119991References
- Bortnikova V.V., Karabaeva V.V., Krepkova L.V. i dr. Flakozid-lekarstvennyj preparat iz list'ev barhata amurskogo, v terapii zabolevanij gepatobiliarnoj sistemy. Voprosy biologicheskoj, medicinskoj i farmacevticheskoj himii. 2020; 23(2): 18–23.
- Seregina P.A., Nesterova N.V., Ovsjannikov A.G., Harina A.S. Barhat amurskij: botaniko-geograficheskaja harakteristika, himicheskij sostav, opyt i perspektivy primenenija v medicine i farmacii. Tendencii razvitija nauki i obrazovanija. 2021; 71-1: 57–64.
- Patent RF na izobretenie RU 2787103 C1. Sposob poluchenija lekarstvennoj substancii iz list'ev barhata amurskogo. Shejchenko O.P., Radimich A.I., Ujutova E.V. i dr. Data podachi zajavki: 23.08.2022.
- Bortnikova V.V., Krepkova L.V. Jeksperimental'noe toksikologicheskoe izuchenie protivovirusnogo fitopreparata flakozid. Vestnik Rossijskogo universiteta druzhby narodov. Serija: Medicina. 2008; 7: 96–101.
- Karabaeva V.V., Krepkova L.V., Babaeva A.N. i dr. Retrospektivnyj analiz jeksperimental'nogo i klinicheskogo izuchenija flakozida pri virusnyh gepatitah. Razrabotka i registracija lekarstvennyh sredstv. 2021; 10(4): 169–176.
- Bortnikova V.V., Karabaeva V.V., Krepkova L.V. i dr. Retrospektivnyj analiz klinicheskogo izuchenija lekarstvennogo preparata «Flakozid» v terapii zabolevanij gepatobiliarnoj sistemy. Razrabotka i registracija lekarstvennyh sredstv. 2021; 10(3): 100–104.
- Budaev B.S., Kicul I.S., Banzarova L.P. i dr. Bolezni organov pishhevarenija: struktura i dinamika na regional'nom urovne. Problemy social'noj gigieny, zdravoohranenija i istorii mediciny. 2022; 30(2): 232–238.
- Dai S., Xu B., Shi G. et al. SeDeM expert system for directly compressed tablet formulation: A review and new perspectives. Powder Technology. 2019; 342: 517–527. doi: 10.1016/j.powtec.2018.10.027.
- Gulenkov A.S., Mizina P.G., Bahrushina E.O. i dr. Farmacevtiko-tehnologicheskoe issledovanie adsorbirovannogo zhidkogo rastitel'nogo jekstrakta antimikrobnogo dejstvija. Razrabotka i registracija lekarstvennyh sredstv. 2022; 11(2): 94–101; https://doi.org/10.33380/2305-2066-2022-11-2-94-101.
Supplementary files
