Approach to the development of the monograph “Acorus calamus rhizome” for inclusion in the State Pharmacopoeia of Ukraine
DOI:
https://doi.org/10.24959/uekj.17.3Keywords:
Acorus calamus, rhizomes, standardization, identification, State Pharmacopoeia of UkraineAbstract
The rhizomes of Acorus calamus are widely used medicinal herbs (MH). The Article of The State Pharmacopoeia USSR XI edition of “Rhizomata Calami” is still working normative documents for this type of MH. This article regulates that the most methods control quality of raw materials are outdated and do not correspond to the modern requirements analysis MH. Given this, it is important to develop a national monograph based on world experience pharmacopoeial analysis of medicinal plants of this type raw material.
Aim. To compare the criteria of standardization calamus rhizomes in The State Pharmacopoeia of USSR (SPh) XI edition, The State Pharmacopoeia Republic of Belarus (GF RB), The German Pharmaceutical Code (Deutscher Arzneimittel Codex, DAS 2011), The Austrian Pharmacopoeia 2006 (Oesterreichisches Arzneibuch, OeAB) and Pharmacopoeia of the People’s Republic of China 2005 (CPh) and defining approaches to standardization raw materials in the design monograph “Acorus Calamus rhizomes” correspond to the modern requirements analysis MH.
Results. The analyzes of monographs of rhizomes calamus was conducted in next regulating documents (RD): SPh XI, SPh RB, DAS, OeAB, CPh. It was determined that the most of the presented RD include method of identification of raw materials by thin layer chromatography and determine the maximum permissible concentration of toxic substances – asarone.
Conclusions. The approaches to the development of the monograph “Acorus calamus rhizomes” for inclusion in the State Pharmacopoeia of Ukraine based on the analysis of monographs of calamus rhizomes in other RD
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