vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2025-15-6-692-700vedomostiregmed-823Research ArticleЛЕКАРСТВЕННЫЕ СРЕДСТВА РАСТИТЕЛЬНОГО ПРОИСХОЖДЕНИЯHERBAL MEDICINAL PRODUCTSАлкалоиды термопсиса: обзор методов количественного определенияQuantitation Methods of Thermopsis Alkaloids: A Reviewhttps://orcid.org/0000-0002-7818-5303АнтоноваН. П.AntonovaN. P.

Антонова Наталия Петровна, канд. биол. наук 

Петровский б-р, д. 8, стр. 2, Москва

Natalia P. Antonova, Cand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051

nantonova@expmed.ruhttps://orcid.org/0000-0002-8160-7829КахрамановаС. Д.KakhramanovaS. D.

Кахраманова Сабина Джейхуновна, канд. фарм. наук 

Петровский б-р, д. 8, стр. 2, Москва

Sabina D. Kakhramanova, Cand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051

ksd113@yandex.ruhttps://orcid.org/0009-0004-9988-8931АлиджановаС. Д.AlidzhanovaS. D.

Алиджанова Султана Джумалиевна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Sultana D. Alidzhanova

8/2 Petrovsky Blvd, Moscow 127051

alidjanovasd@expmed.ruhttps://orcid.org/0000-0002-3278-1994ПрохватиловаС. С.ProkhvatilovaS. S.

Прохватилова Светлана Степановна, канд. фарм. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Svetlana S. Prokhvatilova, Cand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051

prokhvatilova@expmed.ruhttps://orcid.org/0000-0001-8389-4799ШеферЕ. П.SheferE. P.

Шефер Елена Павловна, канд. фарм. наук 

Петровский б-р, д. 8, стр. 2, Москва, 127051

Elena P. Shefer, Cand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051

shefer@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202519122025156692700Copyright © Антонова Н.П., Кахраманова С.Д., Алиджанова С.Д., Прохватилова С.С., Шефер Е.П., 20252025Антонова Н.П., Кахраманова С.Д., Алиджанова С.Д., Прохватилова С.С., Шефер Е.П.Antonova N.P., Kakhramanova S.D., Alidzhanova S.D., Prokhvatilova S.S., Shefer E.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/823ВВЕДЕНИЕ

ВВЕДЕНИЕ. Основными алкалоидами травы термопсиса ланцетного являются термопсин (N-метилцитизин), пахикарпин и анагирин; в семенах преобладает цитизин, применяемый для лечения табачной зависимости. Различия в токсичности и фармакологической активности индивидуальных алкалоидов требуют не только контроля их общей суммы, но и мониторинга содержания каждого из них.

ЦЕЛЬ

ЦЕЛЬ. Оценка перспективности применения отдельных аналитических методов для количественного определения алкалоидов термопсиса.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Фармакопейный титриметрический метод является трудоемким, длительным, недостаточно точным, поскольку определение конечной точки титрования сопряжено с существенной погрешностью; требует использования токсичных растворителей и может быть использован только для определения суммы алкалоидов без их дифференциации. Спектрофотометрические методы не позволяют надежно определять индивидуальные алкалоиды из-за недостаточной селективности (наложение спектров отдельных алкалоидов), результаты чувствительны к условиям пробоподготовки. Наиболее надежными инструментальными методами для качественного и количественного анализа травы термопсиса являются тонкослойная хроматография и высокоэффективная жидкостная хроматография.

ВЫВОДЫ

ВЫВОДЫ. В фармакопейном анализе для разделения и количественного определения индивидуальных алкалоидов (идентификации цитизина и термопсина), а также для идентификации примесей семян термопсиса в лекарственных препаратах, не предназначенных для лечения табачной зависимости, могут быть использованы методы тонкослойной и высокоэффективной жидкостной хроматографии.

 

 

INTRODUCTION

INTRODUCTION. The major alkaloids of Thermopsis lanceolata R. Br. herb are thermopsine (N-methylcytisine), pachycarpine, and anagyrine, while the seeds predominantly contain cytisine used to treat tobacco addiction. Differing toxicity and pharmacological activity of separate alkaloids requires both control of their total content and monitoring of each individual alkaloid.

AIM

AIM. This study aimed to prospectively assess the use of certain analytical methods for quantitation of Thermopsis alkaloids.

DISCUSSION

DISCUSSION. Pharmacopoeial titrimetric method is labour-intensive, time-consuming, has low detection accuracy of the test solution at the titration endpoint, uses toxic solvents, and, most importantly, only determines the sum of alkaloids without differentiating them. Spectrophotometric methods as well do not allow for the reliable determination of individual alkaloids due to the lack of selectivity (spectral overlap for certain alkaloids), and the determination depends heavily on the sampling conditions. So far, the most reliable instrumental methods for Thermopsis herb assay are thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC).

CONCLUSIONS

CONCLUSIONS. TLC and HPLC methods can be used in pharmacopoeial analysis to isolate and quantify individual alkaloids (identify cytisine and thermopsine), as well as to identify the impurities from Thermopsis seeds in medicinal products not intended for the treatment of tobacco addiction.

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The authors declare that there are no conflicts of interest present.