IMPROVEMENT OF METHODS FOR STANDARDIZATION OF STYPHNOLOBIUM JAPONICUM FRUITS

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 metabol-ic 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 indi-cators, 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 (morpholog-ical and anatomical and diagnostic features) and quality indicators (nomenclature of numerical indicators) of this type of raw material have been clari-fied. To confirm the authenticity of the raw materials, a thin-layer chromatography (TLC) technique has been developed. A technique for quantitative de-termination of the content of active substances has been developed. The proposed quality criteria are included in the new edition of the pharmacopoe-ial monograph. Conclusions. As a result of the conducted studies, the diagnostic features of the raw materials were identified and supplemented, a method for con-firming 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 in-cluded in the State Pharmacopoeia of the Russian Federation, XV edition.