THROUGH STANDARDIZATION OF THE SUBSTANCE FUCOIDAN AND ITS BASED PREPARATIONS

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DOI: https://doi.org/None
Issue: 
6
Year: 
2017

V.M. Kosman (1), PhD; E.D. Obluchinskaya (2), PhD; O.N. Pozharitskaya (1), PhD; M.N. Makarova (1), MD; A.N. Shikov (1), PhD 1-Saint Petersburg Institute of Pharmacy; 3, Zavodskaya St., Build. 245, Urban-Type Community, Vsevolozhsky District, Leningrad Region 188663, Russian Federation; 2-Murmansk Marine Biological Institute, Kola Research Centre, Russian Academy of Sciences; 17, Vladimirskaya St., Murmansk 183010, Russian Federation

Introduction. Fucoidans combine the properties of anticoagulants, thrombin inhibitors, and fibrinolytic drugs. They are promising for clinical use and are an alternative to heparin. When procedures are developed for quality control of herbal medicines, it is necessary to follow the principles of through standardization. Objective: to develop and validate standardization procedures for the pharmaceutical substance fucoidan and its based ready-made formulations (RMF) (ointments, tablets), by complying with the principles of through standardization. Material and methods. Fucoidan was isolated at the Murmansk Marine Biological Institute, Kola Research Center, Russian Academy of Sciences; experimental batches of fucoidan as ointments and tablets were designed and prepared at the Saint Petersburg Institute of Pharmacy. Results. The quantitative content of fucoidan forms the basis for the through standardization of its substance and RMFs. The content of fucoidan was determined by a spectrophotometric method based on the reaction of fucose with L-cysteine. The main difference between the analysis of a formulation and that of the relevant substance is to select an optimal procedure for sample preparation. The procedures were validated for the determination of the content of fucoidan in RMF and in the dissolution medium. The procedure is within the linear range of 0.0077–0.077 mg/ml of fucose; the systematic error is less than 0.5%; the intraday and interday precision is 1.3-1.5 and 1.5- 2.9%, respectively. Conclusion. The developed procedure is recommended for both the analysis of the substance and formulations, which will be able to ensure compliance with the principle of through standardization.
Keywords: 
fucoidan
bladder wrack
Fucus vesiculosus L.
through standardization
ointment
tablets
spectrophotometry
validation
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