The development of the composition and technological process for capsules containing (Cichorium intybus L.) herb dried extract

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Introduction. Currently, the range of domestic medicines for the treatment of gastrointestinal, liver and kidney diseases is insufficient to meet the needs of the Russian population. Biologically active food supplements, which are widely used by Russians as a substitute for herbal medicines, do not address the issue of preventing and treating this group of conditions.

The aim of this study is to develop a composition and process for producing an oral dosage form – capsules containing a dry extract from the herb Cichorium intybus.

Material and method. The object of the research is the dry extract of chicory (Cichorium intybus L.), obtained from wild plant material. The excipients used in the formulation comply with relevant regulatory standards and are approved for use in medicinal preparations. This research was conducted using the methods outlined in the official standards of the 15th edition of the State Pharmacopoeia of the Russian Federation.

Results. Based on the study of the physical, chemical, and technological properties of the substance, various compositions of the extract with auxiliary substances were selected. The quality indicators of the extract and capsule mass were determined. Experimental samples were produced by sequentially mixing medicinal and auxiliary substances; pharmaceutical and technological tests were conducted. It was found that the optimal composition has microcrystalline cellulose, lactose monohydrate, and calcium stearate as auxiliary substances.

Conclusions. The composition and process for producing capsules containing a dry extract from the herb, chicory, have been developed. Stability of the capsules during storage over a period of two years and three months was investigated, and the shelf life was determined to be two years.

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作者简介

T. Kachalina

All-Russian Scientific Research Institute of Medicinal and Aromatic Plants

编辑信件的主要联系方式.
Email: kachalina_tat@bk.ru
ORCID iD: 0000-0002-3459-5335
SPIN 代码: 4334-9912

Ph.D. (Pharm.), Leading Research Scientist, Experimental and Technological Department 

俄罗斯联邦, 7 Green str., Moscow, 117216

N. Malysheva

All-Russian Scientific Research Institute of Medicinal and Aromatic Plants

Email: proeko@yandex.ru
ORCID iD: 0000-0003-3336-4428
SPIN 代码: 4278-5219

Senior Research Scientist, Experimental and Technological Department

俄罗斯联邦, 7 Green str., Moscow, 117216

О. Semkina

All-Russian Scientific Research Institute of Medicinal and Aromatic Plants

Email: semkina@vilarnii.ru
ORCID iD: 0000-0002-2611-4490
SPIN 代码: 1637-9398

Ph.D. (Pharm.), Leading Research Scientist, Experimental and Technological Department

俄罗斯联邦, 7 Green str., Moscow, 117216

О. Beloshapkina

All-Russian Scientific Research Institute of Medicinal and Aromatic Plants

Email: olga.beloshap@mail.ru
ORCID iD: 0000-0003-1743-1176
SPIN 代码: 6071-0474

Junior Research Scientist, Experimental and Technological Department 

俄罗斯联邦, 7 Green str., Moscow, 117216

参考

  1. Saybel O.L., Radimich A.I., Dargaeva T.D. et al. Phenolic Compounds and Hepatoprotective Activity of Chicory Herb Extract. Drug development & registration. 2021; 10(4): 36–45. (In Russ.). doi: 10.33380/2305-2066-2021-10-4-36-45.
  2. Saybel O.L., Rendyuk T.D., Dargaeva T.D. et al. Phenolic compounds and immunomodulating activity of chicory (Cichorium intybus L.) extract. Pharmacognosy Journal. 2020; 12(5): 1104–1107. doi: 10.5530/pj.2020.12.156.
  3. Kachalina T.V., Malysheva N.A., Semkina O.A. Technological approaches to the creation of solid dosage forms with substances of plant origin. Journal of Pharmaceuticals Quality Assurance Issues. 2022; 2(36): 18–27. (In Russ.). doi: 10.34907/JPQAI.2022.38.15.003.
  4. Kachalina T.V., Malysheva N.A. Razrabotka tverdoj lekarstvennoj formy jekstrakta travy cikorija obyknovennogo. Innоvatiоns in life sсienсes: sbornik materialov IV mezhdunarodnogo simpoziuma. 2022; 237–239. (In Russ.).
  5. Saybel O.L. Justification and choice of method herb cichory standardization (Cichorium intybus L.). 2021; 2(32): 4–11. (In Russ.). DOI: 10.34907/ jpqai.2021.52.51.002.
  6. Lupanova I.A., Ferubko E.V., Kurmanova E.N. et al. Experimental study of the anti-inflammatory activity of the herb dry extract Cichorium intybus L. in vivo. Sbornik materialov jubilejnoj mezhdunarodnoj nauchnoj konferencii «90 let – ot rastenija do lekarstvennogo preparata: dostizhenija i perspektivy». 2021: 563–567. (In Russ.). doi: 10.52101/9785870191003_2021_563.
  7. Saybel O.L., Radimich A.I., Dargaeva T.D. et al. Method for producing a medicinal product exhibiting hepatoprotective and antihepatotoxic actions. RU 2771028 C1. 25.04.2022. (In Russ.).

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2. Fig. 1. Micrographs of the chicory herb dry extract at magnifications of 450x and 920x

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3. Fig. 2. The curve of the integral volumetric particle size distribution of the chicory herb dry extract

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4. Fig. 3. Fractional composition of the chicory herb dry extract

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5. Fig. 4. The values of mass loss during the drying process for capsule samples of the studied materials

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6. Fig. 5. The visual representation of particle size values ranging from the smallest (D03) to the largest (D97) for the capsule masses samples containing dry extract of chicory herb; D03, D10, D50, D90 and D97 are particle sizes corresponding to volume fractions of 3%, 10%, 50%, 90% and 97% respectively

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7. Fig. 6. The appearance of capsules containing dry extract of chicory herb after 27 months of storage (sample No. 5)

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