Systematization of experience in dealing with introduction the monographs on herbal drugs to State Pharmacopoeia of Ukraine 2.1-2.2
DOI:
https://doi.org/10.24959/uekj.18.16Keywords:
monographs, herbal drugs, development procedure, unified methods, national requirements, State Pharmacopoeia of UkraineAbstract
Data for monographs on herbal drugs introduced in the State Pharmacopoeia of Ukraine 2nd edition (SPhU 2.0), including in Appendixes 2.1-2.2, are summarized.
Aim. To systematize the experience of introduction the monographs on herbal drugs in SPhU 2.1-2.2 including the structure analysis of monographs, their content, the need to introduce national requirements and national quality control methods of herbal drugs.
Results. It is shown that during developing these monographs, the algorithm described in approved «Procedure for the development of monographs on the herbal drugs» was used, it is indicated the necessity to comply with the format of European Pharmacopoeia (Ph.Eur) in the structure of the document, it is necessary to use reliable and unified methods for quality control when developing methods, and also to use the experience of GF XI and the current state of herbal drugs production in Ukraine. All introduced monographs belong to 4 categories, namely: category 1 – a monograph on herbal drugs, which are described in both Ph.Eur. and in GF XI; category 2 is a monograph on herbal
drugs, which are described in GF XI and not described in Ph.Eur.; category 3 is a monograph on the herbal drugs, which are described in Ph.Eur. and not described in the GF XI and category 4 – revised monographs. The factors that determine the necessity of developing national monographs on herbal drugs are considered.
Conclusions. As a result of organized data on introduced monographs on herbal drugs to the SPhU 2.1-2.2, the tendency was demonstrated that monographs require the comparison of different approaches (Ph.Eur. and GF XI) are becoming less and monographs, which require revision of national regulations, are increasing. The use of unified quality control methods in the development of national monographs and the use of plant extracts as CRS SPhU for methods of identifying herbal drugs are argued.
References
Grizodub, A. I., Georgievskii, G. V., Tikhonenko, T. M., Georgievskii, V. P. (2004). Farmakom, 4, 3–17. 2. Tovmasian, E. K., Kotov, A. G., Grizodub, A. I., Georgievskii, V. P. (2004). Farmakom, 4, 17–23. 3. Derzhavna farmakopeia Ukrainy,1–e vyd. – Dopovnennia 2 (2008). Kharkiv: Naukovo-exspertnyi farmakopeinyi tsentr, 620. 4. Derzhavna farmakopeia Ukrainy, 2-e vyd. – Dopovnennia 1 (2016). Kharkiv: Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv, 359. 5. Derzhavna Farmakopeia Ukrainy, 2-e vyd. – Dopovnennia 2 (2018). Kharkiv: Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv, 335. 6. Kotov, А. G. (2009). Farmakom, 1, 5–19. 7. Kotov, A. G. (2011). Upravlìnnâ, ekonomìka ta zabezpečennâ yakostì v farmacìï, 6 (20), 6–22. 8. Kotov, А. G. (2012). Upravlìnnâ, ekonomìka ta zabezpečennâ yakostì v farmacìï, 1 (21), 4–10 9. Kotov, А. G., Garna, S. V., Kotova, Е. Е., Matvienko, Т. М., Prokopenkо, Iu. S., Vladimirovа, І. М. ...Glučhenko, А.V. (2016). Poryadok rozrobki ta vykladannya monografii na LRS dlya vvedennya do DFU. Kharkiv: NUPh, Institut pidvychennya kvalifikacii specialistiv farmacii, DP «Farmakopeinyi tsentr», 44. 10. Kotov, A. G., Kotova, E. E., Leontev, D. A., Grizodub, A. I. (2014). Farmakom, 3, 5–14. 11. Kotova, Е. Е., Коtоv, А. G. (2016). Farmakom, 2, 15–21. 12. Kotova, Е. Е., Коtоv, А. G. (2014). Farmakom, 4, 22–35. 13. Kuznietsova, V. Y., Kislichenko, V. S., Коtova, Е. Е., Коtov, А. G., Suschuk, N. А. (2016). Development of the method for qualitative analysis of shepherd’s purse herb to be included into the State Pharmacopoea of Ukraine draft national monograph. ScienceRise: Pharmaceutical Science, 4 (4), 24–29. https://doi.org/10.15587/2519-4852.2016.86172 14. Proskurova, Ya. О., Gubar, S. М., Gontova, Т. M., Yevsieieva, L. V., Kоtоvа, Е. Е., Коtоv, А. G. (2015). Upravlìnnâ, ekonomìka ta zabezpečennâ yakostì v farmacìï, 2 (40), 28–31. 15. Proskurova, Ya., Gubar, S., Kotova, E., Kotov, A., Datkhayev, U. (2017). Development of the method for centaury herb identification by thin layer chromatography for the State Pharmacopoeia of Ukraine monograph. The bulletin of the national academy of sciences of the Republic of Kazakhstan, 2, (366), 5 – 12. 16. Shishko, Т. V., Коtоvа, Е. Е., Vovk, О. G., Коtov, А. G. (2016). Farmakom, 1, 13–22. 17. Karpiuk, U., Kotova, E., Kotov, A., & Kyslychenko, V. (2017). Development of method for qualitative analysis of corn silk for implementation in the State Pharmacopoeia of Ukraine draft national monograph. ScienceRise: Pharmaceutical Science, 3 (7), 25–28. https://doi.org/10.15587/2519-4852.2017.103906 18. Karpiuk, U. V, Коtov, А. G., Коtova, Е. Е., Kislichenko, V. S. (2017). Farmakom, 1, 9–17. 19. Yaremenko, M. S., Gontova, T. M., Sira, L. M., Kotova, E. E., Kotov, A. G. (2017). Approach to the development of the monograph “Acorus calamus rhizome” for inclusion in the State Pharmacopoeia of Ukraine. Upravlìnnâ, ekonomìka ta zabezpečennâ yakostì v farmacìï, 1(49), 22–26. https://doi.org/10.24959/uekj.17.3 20. Galkin, А. Ya., Коtov, А. G. (2011). Ukrainskii medychnyi almanakh, 14, 1, 55–57 21. Iliina, Т. V., Kovalova, А. М., Коtov, А. G., Gamulya, О. V. (2013). Farmakom, 4, 16–22. 22. Коtova, Е. Е., Коtov, А. G. (2014). Farmakom, 1, 19–25. 23. Zolotaikinа, M. Iu., Gontova, Т. М., Gubar, S. М., Коtova, Е. Е., Коtov, А. G. (2015). Upravlìnnâ, ekonomìka ta zabezpečennâ yakostì v farmacìï, 6 (44), 9–12. 24. Zolotaikinа, M. IU., Gontova, Т. М., Коtova, Е. Е., Коtov, А. G., Gubar, S. М. (2016). ScientificJournal «ScienceRise: Pharmaceutical Science», 5 (22), 34–40. 25. Khokhlova, Е. А., Vishnevskaya, L. I., Kotov, A. G., Kichimasova, Ya. S. (2014). Farmakom, 2, 38–45. 26. Leont’ev, D. D., Mostryanska, N. М., Kotov, A. G., Kotova, E. E. (2013). Upravlìnnâ yakostì v farmacìï : materialy VII Naukovo-praktychnoi konferentsii, (Kharkiv, 17 travnia 2013 r.). (p. 95). Ministerstvo okhorony zdorovia Ukrainy. Kharkiv: NUPh. 27. Vovk, O. G., Kotov, А. G., Kotova, E. E. (2015). Farmakom, 2, 13–20. 28. Lenchyk, L. V., Kotov, A. G., Kotova, E. E., Kyslychenko, V. S. (2016). Development of method of qualitative analysis of bird cherry fruit for inclusion in the monograph of State Pharmacopoeia of Ukraine. Annals of Mechnikov Institute, 2,50–53. 29. Kolychev, І. О., Kotova, Е. Е., Shishko, T. V., Kotov, A. G., Koshovyi, О. М. (2016). Farmakom, 3, 9–14. 30. Kotov, A. G. (2017). Farmakom, 1, 17–22. 31. Kotova, E. E., Kotov, A. G., Kolychev, I. A., Kotov, S. A. (2017). Vestnik farmacìï, 3 (77), 62-67. Vitebsk.
Downloads
Published
Issue
Section
License
Copyright (c) 2018 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
