DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY OF CAPSULES CONTAINING VITIS VINIFERA L. LEAF RED EXTRACT DRY

DOI: https://doi.org/10.29296/25877313-2020-08-03
Issue: 
8
Year: 
2020

T.V. Kachalina Ph.D. (Pharm.), Leading Research Scientist, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) E-mail: kachalina_tat@bk.ru N.A. Malysheva Senior Research Scientist, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) O.A. Semkina Ph.D. (Pharm.), Senior Research Scientist, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) E-mail: semkinaolga@gmail.com M.A. Djavakhyan Dr.Sc. (Pharm.), Chief Research Scientist, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow)

Relevance. Development of dosage forms for the treatment of chronic venous insufficiency is an actual task of pharmaceutical technology due to the high prevalence of this disease. The extract has antioxidant, capillary-strengthening, anti-sclerotic, cardiovascular and anti-inflammatory effects. The aim of the study was to develop the composition and technology of hard gelatin capsules containing Vitis vinifera L. red leaves dry extract to ex-pand the range of domestic drugs with a venotonic effect. Objects of research: Vitis vinifera L. red leaves dry extract. Excipients: corn starch CleanSet 03703 (Cargill, the Netherlands), dextran Emdex (Dex-trates-JRS Pharma), lactose 80M (Lactochem Crystals, the Netherlands), microcrystalline cellulose MCC-101 (JRS Pharma, Germany), calcium stearate (Himmed, Russia), Aerosil A380 (GOST 14922-77). Results. The composition and production technology of capsules containing Vitis vinifera L. red leaves dry extract are substantiated. The quality indica-tors of Vitis vinifera L. red leaves dry extract in dosage form — capsules — were determined: appearance, uniformity of capsule mass, disintegration of capsules, authenticity, quantitative content of the sum of phenolic compounds in terms of rutin. All quality indicators comply with the requirements of the draft regulatory documentation “Vitis vinifera L. red leaves dry extract, 180 mg capsule”. Conclusion. Based on the results obtained, the composition of the capsules was developed: Vitis vinifera L. red leaves dry extract, corn starch, aero-sil, calcium stearate. The developed composition made it possible to obtain a mass for encapsulation by simply mixing the ingredients, followed by filling hard gelatin capsules. Capsules with Vitis vinifera L. red leaves dry extract expand the range of medicines for the prevention and treatment of chronic venous insufficiency.

Keywords: 
production technology
technological
capsules
dry extract
grape culture
chronic venous insufficiency

References: 
  1. Dzhavahjan M.A. Sovremennoe sostojanie i perspektivy sozdanija lekarstvennyh preparatov dlja profilaktiki i lechenija hronicheskoj venoznoj nedostatochnosti. Voprosy obespechenija kachestva lekarstvennyh sredstv. 2016; 2:4-13.
  2. Ferubko E.V., Leskova T.E., Kolhir V.K., Dul V.N., Sidelnikov N.I. Issledovanie farmakologicheskoj aktivnosti vinograda list'ev krasnyh jekstrakta suhogo (Vitis vinifera L.). Razrabotka i registracija lekarstvennyh sredstv. 2017; 3:156-159.
  3. Patent na izobretenie RUS 2568908 22.08.14. Sposob poluchenija sredstva, obladajushhego antioksidantnoj aktivnost'ju. V.N. Dul, T.D. Dargaeva, A.A. Kir'janov, O.L. Sajbel', T.A. Sokolskaya, E.V. Ferubko, N.L. Shilina, A.I. Gromakova.
  4. Krepkova L.V., Bortnikova V.V, Kuzina O.S., Borovkova M.V., Dzhavahjan M.A. Doklinicheskoe izuchenie bezopasnosti kapsul, sozdannyh na osnove vinograda list'ev krasnyh jekstrakta suhogo. Voprosy biologicheskoj, medicinskoj i farmacevticheskoj himii. 2018; 11:45-50.
  5. Leskova T.E., Ferubko E.V., Kolhir V.K., Sokolskaya T.A. Izuchenie nekotoryh specificheskih farmakologicheskih svojstv jekstrakta vinograda krasnyh list'ev. Sbornik materialov kongressa. Tezisy dokladov. ZAO RIC «Chelovek i lekarstvo». 2013. S. 373-374.
  6. Dul V.N., Dargaeva T.D., Sajbel' O.L. Razrabotka metodik kontrolja kachestva suhogo jekstrakta krasnyh list'ev vinograda kul'turnogo. Molodye uchenye i farmacija XXI veka. 2014. S. 72-72.
  7. Bagirova V.L., Demina N.B., Devjatkina I.A., Tencova A.I., Denisov A.A. Sovremennye aspekty ispol'zovanija vspomogatel'nyh veshhestv v tehnologii lekarstvennyh preparatov. Farmateka. 1998; 6:34-36.
  8. Gosudarstvennaja farmakopeja Rossijskoj Federacii. Izd. XIV (tt. 1-3). Minzdrav RF; URL: http://www.femb.ru/feml.
  9. Sagaradze V.A., Dzhavahjan M.A., Fedjaeva E.Ju. Razrabotka i validacija metodiki kolichestvennogo opredelenija summy flavonoidov v kapsulah, soderzhashhih suhoj jekstrakt krasnyh list'ev vinograda kul'turnogo. Voprosy obespechenija kachestva lekarstvennyh sredstv. 2017; 3(17):40–44.