Development of procedure for quantitative determination of triterpenoids and phytosterols in capsules with sabal palm fruit extract

封面

如何引用文章

全文:

开放存取 开放存取
受限制的访问 ##reader.subscriptionAccessGranted##
受限制的访问 订阅或者付费存取

详细

Introduction. Analysis of the pharmaceutical market shows that in the treatment of chronic prostatitis drugs containing Sabal palm fruit extract are used. During the research we developed a domestic analogue of the registered medicinal product containing this extract. In preparation of the regulatory documentation and registration dossier for the new drug, we carried out the research necessary for this purpose on the Sabal palm fruit, biologically active extract and soft gelatin capsules.

Objective of the study. Development and validation of the methodology for quantitative determination of triterpenoids and phytosterols in capsules containing Sabal palm fruit extract.

Material and methods. The objects of the study are pilot series of a medicinal product with the extract of palm Sabal fruit – soft gelatin capsules 160 mg/caps. and 320 mg/caps. The method underlying the determination of the sum of triterpenoids and phytosterols – differential spectrophotometry

Results and discussion. The pharmacological activity of Sabal palm fruit extract is associated with lipids, namely higher fatty acids, triterpenoids and phytosterols. The methodology of standardization of the new drug was developed taking into account their physico-chemical properties. The analysis provides alkaline hydrolysis, selective extraction of the unsaponifiable fraction, differential spectrophotometry after oxidation of sterols in the presence of sulfuric acid. The content of the analyzed substances in the drug: for dosage of 160 mg/caps. – not less than 5.5 mg/cup, for the dosage of 320 mg/cup. – not less than 11.0 mg/caps. in terms of β-amyrin.

Conclusion. The methods for quantitative determination of the sum of triterpenoids and phytosterols in a new drug preparation containing an extract of Sabal palm fruit have been developed, validated and tested. In the course of approbation of the method the norms of their quantitative content in the medicinal product were experimentally established. The method complies with all validation criteria, is characterized by ease of performance and can be used for standardization and quality control at all stages of industrial production of the medicinal product.

全文:

受限制的访问

作者简介

Svetlana Khodakova

ZAO "VIFITECH", GNTS PMB; Maykop State Technological University

Email: Svetlana.orlova.1986@bk.ru
ORCID iD: 0000-0002-0202-6699

senior engineer-chemist of the laboratory of OKK, fellow of the Department of Pharmacy

俄罗斯联邦, k. 84, Obolensk settlement, Moscow Region, 142279; 191, Pervomaiskaya str., Maykop, Republic of Adygea, 385000

Ifrat Zilfikarov

ZAO "VIFITECH", GNTS PMB; All-Russian Research Institute of Medicinal and Aromatic Plants; Maykop State Technological University

Email: dagfarm@mail.ru
ORCID iD: 0000-0002-8638-9963

professor of the Russian Academy of Sciences, Doctor of Pharmaceutical Sciences, head of the laboratory of OKK, chief researcher of the department of chemistry of natural compounds, leading researcher of the department of pharmacy

俄罗斯联邦, k. 84, Obolensk settlement, Moscow Region, 142279; 7, str. 1, Grina str., Moscow, 117216; 191, Pervomaiskaya str., Maykop, Republic of Adygea, 385000

Elena Babaeva

All-Russian Research Institute of Medicinal and Aromatic Plants

编辑信件的主要联系方式.
Email: babaevaelena@mail.ru
ORCID iD: 0000-0002-4992-6926

PhD in Biological Sciences, Leading Researcher of the Botanical Garden Laboratory

俄罗斯联邦, 7, str. 1, Grina str., Moscow, 117216

参考

  1. Sivkov A.V., Sinyuhin V.N. Permixon: place of drug in pathogenetic therapy of BPH. Experimental and clinical urology. 2017; 4: 50–62 (in Russian).
  2. Andreyeva D.M., LesiovskayaYe.Ye., Marchenko S.D., Savateyeva-Lyubimova T.N., Sivak K.V., Stosman K.I. Erectile Dysfunction: Advantages and Drawbacks of Plant-Derived Regulating Agents. Effective Pharmacotherapy. 2016; 2: 24–31 (in Russian).
  3. Kulchenko N.G., Yatsenko E.V. Phytotherapy for inflammatory diseases of the prostate. Research and Practical Medicine J. (Issled. prakt. med.). 2019; 6 (3): 87–97. doi: 10.17709/2409-2231-2019-6-3-8 (in Russian).
  4. Safonova E.O., Trofimov N.V. Analysis of the market of products based on plant-based raw materials used in urology. Remedium. 2020; 7–8: 34–41 (in Russian).
  5. European Pharmacopoeia 10.0. [Electronic edition]. Access mode: http://www.webofpharma.com/ (in Russian).
  6. Orlova S.E., Zilfikarov I.N. Standardization of Sabal palm fruit extract. Farmatsiya. 2012; 4: 16–7 (in Russian).
  7. Orlova S.E., Zilfikarov I.N. Technology and standardization of lipophilic extract from the fruits of Serenoa repens. 2 International. scientific-practical conference "Young Scientists in solving current problems of science": collection of works of young scientists. Part. 1. Vladikavkaz, 2011; 279–82 (in Russian).
  8. Orlova S.E., Zilfikirov I.N. Phytochemical analysis of fruits Serenoa repens. Traditional Medicine. 2011; 5: 257–8 (in Russian).
  9. State Pharmacopoeia of the Russian Federation: in 4 volumes. XIV ed. M., 2018. [Electronic resource]. Access mode: https://femb.ru/record/pharmacopea 14 (in Russian).

补充文件

附件文件
动作
1. JATS XML
2. UV absorption spectra of the products of the reaction with sulfuric acid of triterpenoids and phytosterols of palm fruit extract Sabal (1) and β-amyrine (2)

下载 (64KB)

版权所有 © Russkiy Vrach Publishing House, 2023