Pharmacopeial aspects of preparation of infusions and decoctions in pharmacies
An analytical review of pharmacopoeial aspects of preparation of infusions and decoctions in pharmacies is presented.
The aim of this work is to conduct a comparative analysis of pharmacopoeial requirements for the technology of infusions and decoctions in pharmacies.
Materials and methods of the research. Comparative analysis of pharmacopoeial requirements was performed using methods of systematic and structural-logical analysis.
Results and discussions. It was found that in many pharmacopoeias (European, British, Italian, French, Czech, Kazakh) there are no instructions on the pharmacy technology of these dosage forms. Only the pharmacopoeias of Japan, Austria, Belarus and Russia contain separate monographs on the extemporaneous preparation of infusions and decoctions.
After analyzing these monographs, it was found that the definition of infusions and decoctions as a dosage form differs. It was found that the Japanese Pharmacopoeia regulates the preliminary preparation of medicinal plant raw materials (soaking for 5 minutes in water), in other pharmacopoeias there is no such requirement. When conducting a comparative analysis of the technology of preparation of infusions and decoctions, we observe that the ratio of medicinal plant raw materials (MPRM) and extractant and extraction modes differ.
Conclusions. An analytical review of pharmacopoeial aspects of preparation of infusions and decoctions in pharmacies is presented.
A comparative analysis of the requirements for technology and quality control of infusions and decoctions in accordance with pharmacopoeial articles revealed both different and similar information. The results of the research showed that despite the differences in the structures of articles and names, as well as approaches to the definition of this dosage form, some requirements are similar (particle size of MPRM). The differences that were found include the ratio of MPRM and extractant, extraction modes.
Taking into account the data of the analysis and the existing national requirements, the authors proposed a draft general pharmacopoeial article “Infusions and decoctions made in pharmacies”.
Vymohy do vyhotovlennia nesterylnykh likarskykh zasobiv v umovakh aptek: nastanova ST-N MOZU 42-4.5:2015 (2015). Zatverdzheni Nakazom MOZ Ukrainy No. 398. 01.07.15. Kyiv, 109. Available at: https://tl.nuph.edu.ua/wp-content/uploads/2020/06/Вимоги-до-виготовлення-нестерильних-лікарських-засобів-умовах-аптек.pdf
Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: Derzh. p-vo «Ukr. nauk. farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
Derzhavna Farmakopeia Ukrainy. Vol. 2 (2014). Kharkiv: Derzh. p-vo «Ukr. nauk. farmakopeinyi tsentr yakosti likarskykh zasobiv», 724.
Derzhavna Farmakopeia Ukrainy. Vol. 3 (2014). Kharkiv: Derzh. p-vo «Ukr. nauk. farmakopeinyi tsentr yakosti likarskykh zasobiv», 732.
Gosudarstvennaya farmakopeya Rossiyskoy Federatsii XIII izd. Vol. 1–3 (2015). Moscow, 704.
Gosudarstvennaya farmakopeya SSSR: Vyp. 2. Obschie metody analiza. Lekarstvennoe rastitelnoe syre (1989). Moscow: Meditsina, 400.
Gosudarstvennaya farmanopeya SSSR. 10-ed. (1968). Moscow: Meditsina.
Gosudarstvennaya farmanopeya SSSR. 8-ed. (1952). Moscow: Medgiz.
Gosudarstvennaya farmanopeya SSSR. 9-ed. (1961). Moscow: Medgiz.
Gosudarstvennaya farmakopeya Respubliki Belarus (2007). Vol. 2. Minsk: Ministerstvo zdravookhraneniya Respubliki Belarus, 471.
Council of Europe. European Pharmacopoeia (2020). Strasbourg: Council of Europe. Available at: https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-10th-edition
British Pharmacopoeia 2020. London: The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
Pharmacopea ufficiale della Republica Italiano, XII ed. (2018). Roma, 1568.
Český lékopis 2017. Praga: Grada Publishing, spol. s. r. o., 2017, EDQM.
Gosudarstvennaya farmakopeya Respubliki Kazakhstan. Vol. I (2008). Almaty: Zhibek zholy.
Gosudarstvennaya farmakopeya Respubliki Kazakhstan. Vol. II (2008). Almaty: ZHibek zholy.
Gosudarstvennaya farmakopeya Respubliki Kazakhstan. Vol. III (2014). Almaty: ZHibek zholy.
The United States Pharmacopeia 42 – NationalFormulary 37 (2020). Washington: The United States Pharmacopeial Convention. Available at: https://www.worldcat.org/title/united-states-pharmacopoeia-the-national-formulary/oclc/1167504175&referer=brief_results
The Japanese Pharmacopeia, XVII ed. (2016). Available at: https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0019.html
Pharmacopee Française, XI ed. (2016). Paris. Available at: https://ansm.sante.fr/Mediatheque/Publications/Pharmacopee-francaise-Substances-d-origine-vegetale
Österreichisches arzneibuch. Wien 2006. (2006). Druck: Verlag Österreich GmbH. 560.
Yarnykh, T. G., Rukhmakova, O. A. (2015). Peculiarities of the Technology, Quality Control, and Pharmaceutical Development of Extemporaneous Preparations for Children. Pharmaceutical Chemistry Journal, 49 (2), 122–124. doi: http://doi.org/10.1007/s11094-015-1234-8
Jain, S. K. (2011). Stability protocols for different dosage forms. Magalayatan University.
Sarma, N., Giancaspro, G., Venema, J. (2016). Dietary supplements quality analysis tools from the United States Pharmacopeia. Drug Testing and Analysis, 8 (3-4), 418–423. doi: http://doi.org/10.1002/dta.1940
Tabajara de Oliveira Martins, D., Rodrigues, E., Casu, L., Benítez, G., Leonti, M. (2019). The historical development of pharmacopoeias and the inclusion of exotic herbal drugs with a focus on Europe and Brazil. Journal of Ethnopharmacology, 240, 111891. doi: http://doi.org/10.1016/j.jep.2019.111891
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