Received: 30.01.2023 / Accepted: 19.06.2023 / Published online: 30.06.2023
UDC 615.451.13:633.88
DOI 10.53511/PHARMKAZ.2023.73.24.037
A.M. Dzhumabaeva, Z.B. Sakipova, L.N. Ibragimova, A.T. Kabdenova, D.B. Duisenbekova, M.B. Ibraeva,
B.O. Minbaev, A.E. Bolatbekova
Asfendiyarov Kazakh National Medical University Almaty, Republic of Kazakhstan
OBTAINING EXTRACTS FROM THE ROOTS OF FERULA PENNINERVOUS
(FERULA PENNINERVIS REGEL & SCHMALH.) OR KELLER’S FERULA
(FERULA KELLERI KOSO-POL)
Resume: At the pharmaceutical company Fitoleum LLP (Esik, Kazakhstan) a technology for obtaining thick
and dry extracts of ferula penninervis or Keller’s ferula was developed, and the technological process of the
pilot series was transferred and validated. As a result of the research, the regulating normative documentation
for the proper production process under the established conditions was developed. Comparable data were
obtained on the studied technological parameters of three successively produced batches of each product,
and the validity of the considered technological processes for the production of extracts was confirmed.
Introduction. The ferula plant (lat. Ferula) belongs to the umbrella family (Apiaceae). In folk medicine, it is
widely used to treat dermatological, neuropsychiatric, ophthalmic and infectious diseases. Ferula penninervis
(Ferula penninervis Regel & Schmalh.) and Keller’s ferula (Ferula Kelleri Koso-Pol) are of scientific and
practical importance, having a wide distribution area in the southern region of the Republic of Kazakhstan,
in areas with high solar insolation.
Full-scale studies of representatives of the genus Ferula — ferula penninervis and Keller’s ferula, and the
development of herbal pharmaceutical substances from their roots were carried out at S.D. Asfendiyarov
Kazakh National Medical University.
The aim of the study is to develop an optimal technology for obtaining an extract from the roots of the
ferula penninervis (Ferula penninervis Regel & Schmalh.) or Keller’s ferula (Ferula Kelleri Koso-Pol) and its
validation at the Fitoleum LLP enterprise in accordance with national requirements [1].
Materials and methods. Description of the production process. In the production of extracts, the following
ingredients are used: dried roots of ferula penninervis or Keller’s ferula, collected in late autumn 2017 in
the Kordai Pass, in accordance with the requirements of the relevant standard of cultivation and collection
practice (GACP) [2]; purified water and ethanol 96% of pharmacopoeial quality .
The technological process consists of the following classical operations: preparation of medicinal plant
materials (MPM), preparation of the extractant, obtaining an extract from the MPM, purification of the extract,
removal of the extractant, packaging and labeling (Figure 1).
Keywords: roots, ferula penninervis (Ferula penninervis Regel & Schmalh.), Keller’s ferula (Ferula Kelleri
Koso-Pol), extract, critical parameters, process validation, control charts.
REFERENCES
1 Republic of Kazakhstan. Rule of Ministry of Health of the Republic of Kazakhstan dated February 4, 2021 GR DSM-15 «On Approval of Good Pharmaceutical
Practices» [Registered with the Ministry of Justice of the Republic of Kazakhstan on February 17, 2022 No. 26831]. – Astana, 2022. Legal system adilet.zan.kz
2 Patent No. 7447 Republic of Kazakhstan, «Method of obtaining an extract from ferula roots». 2022/0289.2 appl. 05.04.2022, pub. 12.08.2022 / Dzhumabayeva
A.M.; patent holder Asfendiyarov Kazakh national medical University. — p. 2
3 Patent No. 7353 Republic of Kazakhstan, «Method of obtaining an extract from ferula roots with antitumor activity in vitro.» 2022/0298.2 appl. 05.02.2022,
pub. 10.05.2022 / Dzhumabayeva A.M.; patent holder Asfendiyarov Kazakh national medical University. – p. 2.
4 WHO Guidelines for Good Cultivation and Collection Practices (GACP) of Medicinal Plants // World Health Organization. — Geneva: – pp. 55-59.
5 Pharmacopoeia of the Republic of Kazakhstan. V.1,2,3 — Almaty: Zhibek Moly Publishing House, 2008. — pp. 570-578.
6 ICH Q8 «Pharmaceutical development»// URL: https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline ; ICH Q10
«Pharmaceutical Quality System»// URL: https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system-scientific-guideline ; the concept of the PAT//
URL: https://www.ema.europa.eu/en/documents/presentation/presentation-process-analytical-technologies-view-point-regulators-jean-louis-robert_en.pdf and
the draft FDA Guidelines for Process Validation // URL: https://www.fda.gov/files/drugs/published/Process-Validation—General-Principles-and-Practices.pdf .
7 Alexandrov A.A. Monitoring of processes and quality of drugs in accordance with GMP Industrial Review // GMP Rules of the EAEU from 03.11.2016, No.
6 (17) — 2009. — pp. 86-89.
8 GOST R 50779.42-99. Statistical methods Shewhart control charts. Date of introduction 2000-01-01. – Мoscow: pub. house of standards, 2000.- pp.12-14.
9 Statistical Distribution Models for Some Nonparametric Goodness-of-Fit Tests in Testing Composite Hypotheses // Communications in Statistics — Theory
and Methods, 2010. Vol. 39.-No. 3. — pp. 460-471.
10 Minitab Inc., 2007 — p.152 – ISBN: N/AB, version 19.
