New Species of Herbal Medicines in the Russian Pharmacopoeia: Nomenclature and Quality Requirements (Review)

INTRODUCTION. The expansion the nomenclature of herbal drugs and the development of standards for its quality allows us to provide the Russian pharmaceutical industry with new sources of biologically active substances for the creation of effective herbal drug preparations based on them with a favorable safety profile. 

AIM. Assessment of changes in the nomenclature and requirements for the quality of herbal drugs in the State Pharmacopoeia of the Russian Federation (Ph. Rus.).

DISCUSSION. Herbal drugs are widely represented in foreign and in our pharmacopoeias. The number of monographs for new species of herbal drugs, as well as updated monographs previously included in the State Pharmacopoeia is growing. If the Ph. USSR X includes 45 monographs for herbal drugs, XI edition – 83 monographs, whereas the Ph. Rus. XV already has 118 monographs. Starting with the Ph. Rus. 13th edition, 106 monographs have been updated and 12 monographs have been included for new species of herbal drugs. It is required a comprehensive analysis of herbal drugs, starting with an assessment of the source of raw materials and ending with proof of the therapeutic efficacy of herbal drug preparations based on it, to include a new quality standard in the Ph. Rus. The requirements for the quality of herbal drugs have undergone changes: in qualitative and in quantitative determination, analysis of substances with therapeutic activity is more and more often used; qualitative reactions have been mainly replaced by chromatographic methods of analysis using standard samples of active substances or markers (active or analytical). For some species of herbal drugs impurities are identified (including unacceptable ones). Requirements with limits tests for the content of toxic substances (heavy metals and arsenic, radionuclides, residual pesticides) have been introduced.

CONCLUSIONS. The inclusion of new species of herbal drugs in Ph. Rus. is accompanied by a significant change in quality requirements and their updating for species of herbal drugs previously included in the pharmacopoeia. Quality control of herbal drugs using new indicators will ensure the authenticity of herbal drugs and increase the safety of their use, which in turn will expand the range of effective and safe herbal drug preparations.

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