Determination of Anthracene Derivatives in the Antihaemorrhoidal Medicinal Herb Mixture Proctophytol® Using the European Pharmacopoeia Method

Abstract

Specialists in pharmacognosy are facing an important task of improving quality control methods for combination herbal medicinal products in order to enable reliable assessment of the content of active substances that are responsible for the drug’s pharmacological effect.The aim of the study was to investigate the possibility of using the European Pharmacopoeia method to determine the total content of anthracene derivatives in the antihaemorrhoidal medicinal herb mixture Proctophytol® and to propose limit values for the total content of anthracene derivatives.Materials and methods: individual mixture components containing anthracene derivatives, such as senna leaves and frangula bark, as well as model mixtures containing these individual components in a 1:1 ratio, and a model mixture imitating Proctophytol® were used in the study. The determination of the anthracene derivatives content was carried out using spectrophotometry.Results: it was demonstrated that the European Pharmacopoeia method could be used to assess the quality of Proctophytol® in terms of anthracene derivatives total content. The spectrophotometric method described in the European Pharmacopoeia has advantages over the methods described in manufacturer specifications for Russian products, because it allows for thorough extraction of the active substances and is standardized for anthracene derivatives.Conclusions: the European Pharmacopoeia method was adjusted to determine anthracene derivatives in the medicinal herb mixture Proctophytol®. It was proposed to use 70% ethanol instead of 70% methanol as extraction solvent. The authors identified optimum sample weights and test solution dilutions, and calculated and verified the limit for anthracene derivatives content—“Not less than 1.9%”. The adjusted method can be recommended for inclusion in the monographs of the State Pharmacopoeia of the Russian Federation for medicinal herb mixtures similar to Proctophytol®.