Smielova N. Development of methods for inulin quality control in the plant origin substances and the medicinal raw material Inula helenium L.

Українська версія

Thesis for the degree of Candidate of Sciences (CSc)

State registration number

0419U004897

Applicant for

Specialization

  • 15.00.02 - Фармацевтична хімія та фармакогнозія

11-11-2019

Specialized Academic Board

Д 64.605.01

National University of Pharmacy

Essay

he thesis is devoted to a comprehensive study of plant origin inulin substances and the analysis of the national medicinal raw materials (MRM) Inula helenium L. An analytical review of the modern medical product and dietary supplement of plant origin consisting of inulin substances and rhizomes and roots of Elecampane has been carried out. A multi-method research of active pharmaceutical ingredient of inulin quality assessment in accordance with the physico-chemical characteristics has been performed, fructan structural components have been educed by chemical reactions of identification, substance purity according to the leading pharmacopoeias requirements has been studied, modern criteria for their standardization in the development of national regulatory documentation have been suggested. New techniques of inulin identification in the substances and MRM of Elecampane have been developed for the first time by a TLC method, HPTLC and the technique of its quantification by a HPLC method with evaporative light scattering detector, validation characteristics have been studied. The current technique of inulin quantification by absorption spectrophotometry (ultraviolet and visible) method for a routine analysis has been optimized, revalidation of the technique has been performed. The conditions for inulin extraction from MRM of Elecampane in gravimetric determination, using pre-ultrasonic treatment, have been identified for the first time. Manuscript projects for “InulinN”, “Inulin for the dietary supplements productionN”, “Rhizomes and roots of ElecampaneN”, have been newly developed and suggested for SPhU introduction.

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