Improvement of methods for standardization of styphnolobium japonicum fruits

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Introduction. The search for natural sources of active compounds and the development of effective and safe drugs for the prevention and treatment of various diseases is one of the priority areas for the development of the pharmaceutical industry.

A promising object of research is the Styphnolobium japonicum fruits. Currently, due to the receipt of new data on the chemical composition of this raw material, new opportunities are opening up in its use for obtaining various substances and their practical application, as a means of correcting metabolic disorders during menopause, as well as neuroprotective drugs. This circumstance requires a revision of the quality requirements for the fruits of Styphnolobium japonicum.

Objective of the work – Clarification of the description of raw materials, diagnostic elements of the anatomical structure, norms of numerical indicators, as well as the development of a method for quantitative determination of the content of active substances for the preparation of a new edition of the pharmacopoeial article.

Material and methods. The object of the study was dried Styphnolobium japonicum fruits, harvested in 2016-2021 in the Republic of Crimea. The following equipment was used in the work: biological microscope BIO 2 LED (Altami, Russia); spectrophotometer UV-1800 (Shimadzu, Japan); HPLC-UV Prominence-i LC-2030C 3D (Shimadzu, Japan); HPLC-UV-MS/MS LCMC-8040 (Shimadzu, Japan).

Results. The results of the study of medicinal plant materials – Styphnolobium japonicum fruits are presented. The criteria of authenticity (morphological and anatomical and diagnostic features) and quality indicators (nomenclature of numerical indicators) of this type of raw material have been clarified. To confirm the authenticity of the raw materials, a thin-layer chromatography (TLC) technique has been developed. A technique for quantitative determination of the content of active substances has been developed. The proposed quality criteria are included in the new edition of the pharmacopoeial monograph.

Conclusions. As a result of the conducted studies, the diagnostic features of the raw materials were identified and supplemented, a method for confirming authenticity by TLC with a standard sample of sophoricoside was developed, and a nomenclature of numerical indicators and their norms was determined. For the quantitative assessment of biologically active substances, a method for determining the amount of phenolic compounds in terms of genistein was developed and validated.

Based on the data obtained, a pharmacopoeial monograph «Styphnolobium japonicum fruits» FS.2.5.0130 was developed and approved, which is included in the State Pharmacopoeia of the Russian Federation, XV edition.

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作者简介

E. Konyaeva

All-Russian Research Institute of Medicinal and Aromatic Plants

编辑信件的主要联系方式.
Email: lencon64@mail.ru
ORCID iD: 0000-0002-2154-3755
SPIN 代码: 8803-2418

Senior Research Scientist, Department of Chemistry of Natural Compounds, Center for Chemistry and Pharmaceutical Technology

俄罗斯联邦, Green Street 7, Moscow, 117216

V. Dul

All-Russian Research Institute of Medicinal and Aromatic Plants

Email: dvnslava@yandex.ru
ORCID iD: 0000-0001-7824-4417
SPIN 代码: 8192-5803

Ph.D. (Pharm.), Leading Research Scientist, Test Center, Center for Chemistry and Pharmaceutical Technology

俄罗斯联邦, Green Street 7, Moscow, 117216

A. Radimich

All-Russian Research Institute of Medicinal and Aromatic Plants

Email: vilarnii.radimich@mail.ru
ORCID iD: 0000-0002-1139-8902
SPIN 代码: 5452-2675

Senior Research Scientist, Department of Chemistry of Natural Compounds, Center for Chemistry and Pharmaceutical Technology

俄罗斯联邦, Green Street 7, Moscow, 117216

O. Saybel

All-Russian Research Institute of Medicinal and Aromatic Plants

Email: saybel@vilarnii.ru
ORCID iD: 0000-0001-8059-5064
SPIN 代码: 2842-4587

Dr.Sc. (Pharm.), Head of Center of Chemistry and Pharmaceutical Technology

俄罗斯联邦, Green Street 7, Moscow, 117216

参考

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  3. Pharmacopeia of the people’s republic of China. 2005; I.
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  6. FS 42-452-72 «Plod sofory japonskoj».
  7. Kuznecova I.V., Uspenskaja Ju.B. Primenenie fitojestrogenov u zhenshhin v period menopauzal'nogo perehoda i postmenopauze. Jeffektivnaja farmakoterapija. Jendokrinologija. 2013; 6(55); 44–51.
  8. Ahn J.W., Kim H.S., Damodar K. et al. Styphnolobium japonicum Fruit and Germinated Soybean Embryo Complex Extract for Postmenopausal-Symptom Relief. Nutrients. 2024 Sep 28; 16(19): 3297. doi: 10.3390/nu16193297.
  9. Thabit S., Handoussa H., ElSayed N.S. et al. A fruit extract of Styphnolobium japonicum (L.) counteracts oxidative stress and mediates neuroprotection in Caenorhabditis elegans. BMC Complement Med Ther. 2023 Sep 19; 23(1): 330. doi: 10.1186/s12906-023-04149-8.
  10. Sajbel' O.L., Guljaev S.M., Radimich A.I. i dr. Opredelenie flavonoidnogo sostava jekstrakta iz plodov sofory japonskoj i ocenka ego cerebroprotektornoj aktivnosti. Himiko-farmacevticheskij zhurnal. 2024; 12(58): 29–34. doi: 10.30906/0023-1134-2024-58-12-29-347.
  11. Gosudarstvennaja farmakopeja Rossijskoj Federacii XV izdanija [Jelektronnyj resurs]. Ministerstvo zdravoohranenija Rossijskoj Federacii, 2023. Rezhim dostupa: Izdanija Gosudarstvennoj farmakopei Rossijskoj Federacii (regmed.ru).

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2. Fig. 1. Diagnostic features of the anatomical structure of Styphnolobium japonicum fruits: 1 – pericarp epidermis with stomata (400x); 2 – pericarp parenchyma (400x); 3 – pericarp parenchyma with druses (400x); 4 – vascular bundles, druses and crystals (200x); 5 – cross-section of seed coat (200x): a – outer sclerenchyma layer; b – palisade layer; c – collenchyma layer; 6 – parenchyma cells with mucus (400x)

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3. Fig. 2. HPLC chromatogram of the aqueous-alcoholic extract from the Styphnolobium japonicum fruits (260 nm)

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4. Fig. 3. TLC chromatogram of extracts from Styphnolobium japonicum fruits from different collection sites (1 – 2016, Crimea; 2 – 2017, Crimea; 3 – 2021, Crimea) and sophoricoside (4)

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5. Fig. 4. UV-spectra of the extract from the Styphnolobium japonicum fruits (1), sophoricoside (2), genistein (3)

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