FIELD: medicine.
SUBSTANCE: group of inventions relates to methods for assessing the quality of a batch of a composition based on medicinal herbs. A method for assessing the quality and potential in vivo activity of a test batch of a composition based on medicinal herbs includes analysis of a test batch of a composition based on medicinal herbs by one or several biological analysis methods selected from: (a) analysis of a response associated with signal transduction activity, which includes measurement of a response associated with signal transduction activity against one or more signaling pathways selected from a group consisting of TNFa-NFkB, TLR2-NFkB, TLR4-NFkB, IL6-stat3, IFNg-stat1/1, IFNa-stat1/2, DEX-GR, COX-2, iNOS, NRF2, TGFb-Smad2/3, TPA-AP1, CREB, wnt3a-Lef/b-cat, VD3-VDR, ER-alpha, ER-beta, DHT-AR and aldosterone-MR; and (b) gene expression analysis, where gene expression analysis includes quantification of one or several protein coding genes selected from a group consisting of ICAM, IRF5, AKR1C1, HO1, GCLC, GCLM, Axin2, GDF15, IGFBP3, OKL38, PIM1, SERTAD, SOS1, BHMT2, CPT1A, SLC7A11, CD24, EMP2 and KRT23; and then a comparison of the results of the biological analysis of the test batch with the results obtained for a known batch of a composition based on medicinal herbs, which has a known level of in vivo activity; where, if the results obtained for the test batch have a correlation coefficient from 0.95 to 1.0 with the results obtained for a known batch, the test batch is determined as having quality sufficiently corresponding to the quality of the known batch, and potential in vivo activity (options).
EFFECT: above-described methods, including biological analyses, such as analysis of the response associated with the signal transduction activity, or gene expression analysis, effectively predict the potential in vivo activity of the tested batch of a composition based on medicinal herbs better than LC-MS chemical analysis.
8 cl, 3 dwg, 2 tbl, 3 ex
