Introduction: It is important to standardize a tincture prepared from the herb and root of Paeonia anomala L, which is widely used as a sedative in traditional medicine, based on the results of the studies its chemical composition, biological and pharmacological activities. Moreover, there is a need to carry out a quantitative stability testing in order to establish the ability to maintain quality under certain storage condition, shelf-life and to develop suitable packaging information. Materials and methods: Standardization parameters of prepared Paeonia anomala tincture have been evaluated according to WHO guidelines for the determination of crude drug material, plant preparations and finished products technical parameters, along with the Mongolian National Pharmacopoeian (MNP) and Russian XIV Pharmacopoeian methods for tincture. The color of a tincture, dry residue, special density, alcohol content, and microbiological content were determined according to the methods described in MNP. A qualitative analysis of biological active constituents has been evaluated by thin-layer chromatography, the total phenolic compounds were determined by the reaction with Folin Chicalteu reagent and total monoterpene glycosides by the reaction with hydroxylamine in alkaline solution and ferric (III) chloride following spectrophotometric examination, respectively.
The stability testing study was performed according to the “General requirements for the stability testing study of drug-active compounds” MNS-6439-2014 using the real-time methods for the standardization parameters of the tincture. Conclusions The standardized parameters of tincture prepared from the herb and root of Paeonia anomala L. were approved by the National Reference Laboratory for Food Safety analysis. Consequently, the Mongolian pharmacopoeian article on Paeonia anomala tincture was officially permitted under the number ҮФӨ-0327-2017.
The stability study of tincture was carried out according to the MNS-6439-2014 by real-time tests for 24 months which provided that the changes in tincture quality were within the permitted limits. Consequently, it can conclude that the storage condition and shelf-time of Paeonia anomala tincture are 2 years under not above 25°С.