Peculiarities of tropane alkaloids determination in Datura Stramonium L. leaves
DOI:
https://doi.org/10.15587/2313-8416.2015.56940Keywords:
standardization, monograph, natural extracts, Datura stramonium, tropane group of alkaloidsAbstract
The questions of the search, pharmacological activity and standardization of natural extracts are appropriate and important for national pharmaceutical science and practice. Since 2000, one of the key points of the Action Plan to ensure the integration of Ukraine into the European Union is development of the State Pharmacopoeia of Ukraine harmonized with the European Pharmacopoeia (PhEur).
Aim: A comparative analysis of herbal material according to the methods for tropane group alkaloids determination, as described in the PhEur and in the 11th Edition of USSR Pharmacopoeia Monographs «Stramonium leaf».
Methods: Datura leaves samples have been harvested during 2010-2012 in different regions of Ukraine for experimental research. Identification of tropane group alkaloids was carried out by the method of thin-layer chromatography (TLC) and by Vitali-Morin colour reaction. According to the PhEur method, firstly Dragendorff reagent and then Sodium nitrite solutions were used for the TLC plates spraying. Alkaloids assay was carried out by alkalimetry method with indicator determination of equivalence point.
Results: Datura leaves qualitative features, defined by PhEur and the 11th Edition of USSR Pharmacopoeia Monographs «Stramonium leaf», as well as their rationing have been analyzed. Certain differences concerning regulated quality parameters of herbal material have been determined. A comparative analysis of the natural extracts by described in the given normative documents methods for determination of tropane group alkaloids content has been done. After spraying the TLC plates with Sodium nitrite solution, red-brown zones corresponding Hyoscyamine were determined. Hyoscine zones were characterized by less intense color. As a result of quantitative determination it was determined that the alkaloids content in analyzed Datura leaves samples was within the limits regulated by the PhEur and the 11th Edition of USSR Pharmacopoeia – more than 0,25% calculated as atropine.
Conclusion: Having analyzed the assay methods, described in the PhEur and the 11th Edition of USSR Pharmacopoeia Monographs «Stramonium leaf», applied for the determination of tropane group alkaloids in Datura leaves, certain differences in tests preparation were determined. Nevertheless, both of the methods allow determination of tropane group alkaloids content in Datura leaves samples. The obtained experimental data are relevant and were considered when developing the State Pharmacopoeia of Ukraine Monograph «Stramonium leaf»
References
Kotov, A. G. (2012). Rules of presentation and procedure of development of monographs for herbal drugs. Management, Economics and Quality Assurance in Pharmacy, 1, 4–10.
Kotov, A. G. (2009). Study of development and introduction of monographs on herbal drugs into the State Pharmacopoeia of Ukraine. Pharmacom, 1, 5–19.
Siderits, R. (2004). Complete Herbal. London: The English Physitian, 255.
The State Pharmacopoeia of Ukraine. Ukrainian scientific Pharmacopoeial center for quality of medicines. 1st Ed. (2001). Kharkiv: RIREG, 556.
European Pharmacopoeia 7th ed. (2009). Strasbourg: European Department for the Quality of Medicines, 5092.
Schollkraut, G. (1992). Deutsches Arzneibuch. Stuttgart: Govi–Verlag GmbH, 286.
The State Pharmacopoeia of USSR. Issue 2. General methods of analysis. Herbal products. USSR Ministry of Health. 11th Ed. completed (1989). Moscow: Medicine, 400.
Kotova, E. E., Kotov, A. G., Tikhonenko, N. I. (2008). Matters of introduction into SPU of the monograph «Belladonna leaf». Pharmacom, 1, 8–15.
Guide for the elaboration of monographs on herbal drugs and herbal drag preparations (2007). European Directorate for the Quality of Medicines, Strasbourg Cedex, France, 22.
Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin (2006). European Medicines Agency, Evaluation of Medicines for Human Use. London: EMEA, 11.
Grisodub, A. I., Georgiyevsky, G. V., Tikhonenko, T. M., Georgiyevsky, V. P. (2004). Matters of introduction of monographs on herbal drags in the State Pharmacopoeia of Ukraine. Pharmacom, 4, 3–17.
Downloads
Published
Issue
Section
License
Copyright (c) 2015 Володимир Анатолійович Міщенко, Юлія Сергіївна Прокопенко
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.
Authors, who are published in this journal, agree to the following conditions:
1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons CC BY, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.
2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.
