Разработка и регистрация лекарственных средств (Dec 2023)

Development of Technology of Phytosubstantiation of <i>Silybum marianum</i> L. Fruits as a Component of Complex Therapy of Liver Diseases

  • B. A. Peres,
  • A. P. Procyuk,
  • A. B. Zelencova,
  • I. E. Kauhova,
  • M. V. Aroyan,
  • E. K. Novikova

DOI
https://doi.org/10.33380/2305-2066-2023-12-4-1582
Journal volume & issue
Vol. 12, no. 4
pp. 101 – 110

Abstract

Read online

Introduction. Currently, the problem of liver diseases is widespread among the population, especially non-alcoholic fatty liver disease, as well as medicinal liver lesions. In this regard, there is a need to find new solutions in the development of hepatotropic therapy drugs. In clinical practice, several hepatoprotective agents are often used simultaneously in the form of separate drugs or combinations. The combined use of substances in one finished dosage form (FDF) can provide both an enhancement of a particular pharmacological effect and an expansion of the spectrum of hepatotropic action. Components of plant origin are often introduced into the composition of combined hepatoprotectors. Silybum marianum L. fruits contain at least 2.4 % of the amount of flavolignans in terms of silybin, which causes the hepatoprotective effect of medicines based on them and explains the prospects of using this vegetable raw material in the treatment of liver diseases.Aim. Development of technology for obtaining a dry extract of Silybum marianum L. fruit, enriched with silybin.Materials and methods. The objects of the study were Silybum marianum (L.) Gaertn. fruits from producer 2, harvested in June 2022. The quality indicators of the finished product, a dry extract of Silybum marianum (L.) fruit, were determined by the methods described in the SP XIV ed. Statistical processing of the research results was carried out in accordance with SP XIV ed., Volume I, p. 289, GM.1.1.0013.15 "Statistical processing of the results of a chemical experiment".Results and discussion. The optimal method of extraction of medicinal plant raw materials is proposed, which allows to obtain the highest yield of biologically active substances. A method of purification of ethanol-water extraction after extraction is proposed. The technology of dry extract of Silybum marianum (L.) fruit has been developed. Standardization of the obtained dry extract was carried out.Conclusion. In the course of the study, the technology of dry extract of Silybum marianum (L.) fruit was developed. The quality indicators of phytosubstantiation, dry extract of Silybum marianum (L.) fruits enriched with silybin were determined.

Keywords