ELABORATION OF PHARMACOPOEIAL QUALITY STANDARDS FOR THE RAW MATERIAL AND HOMEOPATHIC MATRIX TINCTURE OF GALANTHUS

DOI: https://doi.org/10.29296/25419218-2018-04-10
Issue: 
4
Year: 
2018

D.O. Bokov(1, 2), I.A. Samylina(1) 1-I.M. Sechenov First Moscow State Medical University (Sechenov University); 2-4, Bolshaya Pirogovskaya St., Moscow 119991, Russian Federation; 2-Federal Research Center for Nutrition, Biotechnology, and Food Safety; 2/14, Ustyinsky Passage, Moscow 109240, Russian Federation

Introduction. Standardization of the homeopathic matrix tinctures (HMTs) and homeopathic medicinal plant raw material (HMPRM) of snowdrops (Galanthus L.), as well as pharmacopoeial articles prepared for inclusion in the State Pharmacopoeia of the Russian Federation, will guarantee the high quality of ready-made HMPRM, which is provided by an efficient system for monitoring the identity and good quality of pharmaceutical substances. Objective: to develop the identity and good quality indicators to be included in the draft normative documents on HMPRM and HMTs of Woronow’s snowdrop (Galanthus woronowii Losinsk.) and common snowdrop (Galanthus nivalis L.). Material and methods. The investigation objects were samples of HMPRM of Woronow’s and common snowdrops and their HMTs. The investigators used the following methods: pharmacopoeial pharmacognostic (macroscopic and microscopic analysis), spectral (atomic absorption spectroscopy, ultraviolet (UV) spectrophotometry), chromatographic (thin-layer chromatography, high performance liquid chromatography (HPLC), ultra-performance liquid chromatography, gas chromatography with different detection techniques, such as mass spectrometry, ultraviolet spectroscopy, refractometry), and biological studies. Results. The diagnostic significant signs of the homeopathic raw materials of Woronow’s snowdrop and common snowdrop were identified. The composition of biologically active compounds (amaryllis alkaloids, flavonoids, hydroxycinnamic acids, organic acids, amino acids, carbohydrates) was examined in both snowdrop species and their HMTs. A HPLC-UV method for the determination of alkaloids in the raw materials and HMTs was developed and validated. The normal numeric indicators (humidity, organic and mineral impurities, density, a dry residue, the amount of alkaloids) were established for snowdrop raw material snowdrops and HMTs. Conclusion. The authors have worked out and drawn up 4 draft pharmacopoeial articles on HMPRM and HMTs of two snowdrop species «Fresh Whole Woronow’s Snowdrop Plants», «Galanthus woronowii, Galanthus Homeopathic Matrix Tincture», «Fresh Whole Common Snowdrop Plants», «Galanthus nivalis, Galanthus Homeopathic Matrix Tincture».

Keywords: 
pharmaceutical substances
homeopathic medicinal plant raw material
Woronow’s snowdrop
Galanthus woronowii Losinsk.
and common snowdrop
Galanthus nivalis L.
homeopathic matrix tincture

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