Current Requirements for the Degree of Fineness of Herbal Substances and Herbal Medicinal Products

Abstract

The introduction of monographs on new types of herbal substances, which were not included in the previous editions of the State Pharmacopoeia of the Russian Federation (Ph. Rus.), and the introduction of the new powder dosage form of herbal medicinal products require alignment of requirements for the degree of fineness of medicinal products. The aim of the study was to compare Russian and foreign pharmacopoeial requirements for the degree of fineness of herbal substances and herbal medicinal products. The analysis demonstrated that in the case of cut herbal substances and powder, the Ph. Rus., XIV edition, establishes limits for the percent of particles that pass through and particles that are retained by a sieve with a specified pore diameter. In the case of whole herbal substances, the Ph. Rus. establishes limits for the percent of particles that pass through a sieve with a specified pore diameter. The monographs of the world leading pharmacopoeias include general requirements for the size of particles in all powders produced from chemically synthesized substances, as well as from naturally occurring and mineral substances, while individual monographs have no requirements for the degree of fineness of herbal substances. The national pharmacopoeias of the Eurasian Economic Union member states also include requirements for the degree of fineness of herbal substances, but they are not sufficient. The results of the analysis of the established limits demonstrate the need to change the controlled size of small and large particles for some types of herbal substances.