CURRENT REQUIREMENTS FOR THE QUALITY OF HERBAL MEDICINAL PRODUCTS

Abstract

The article provides the results of a comparative analysis of requirements laid out in the State Pharmacopoeia of the USSR, XI ed. (SPh XI) and the State Pharmacopoeia of the Russian Federation, XIII ed. (SPh XIII) concerning quality evaluation and standardization of herbal substances, herbal medicines and other herbal products. The article discusses requirements for the criteria of herbal substances and herbal medicines quality control described in general chapters and monographs that were previously in force and that have recently been adopted. The article mentions new herbal substances that were included into the State Pharmacopoeia of the Russian Federation for the first time as well as herbal substances included into the State Pharmacopoeia of the USSR, X ed., not included into SPh XI, but included into SPh XIII. The article analyses the requirements described in the new general chapters that were recently included into SPh XIII: “Herbal substances. Herbal preparations”, “Determination of heavy metals and arsenic content in herbal substances and herbal medicinal products”, “Determination of water absorption factor for herbal substances”, “Buds”, “Cut-pressed granules”. The article suggests ways to improve methods of analysis of herbal substances and herbal medicinal products in view of recent advances in pharmacopoeial analysis and the increasing requirements for its quality.

Keywords

• state pharmacopoeia
• herbal substances
• herbal medicinal products
• quality parameters
• standardization
• methods of analysis
• biologically active substances
• monograph
• general chapter