Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents)

Abstract

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs. Correspondence

Antimicrobial activity of crude extracts and fractions of Vernonia polyanthes Less (assa-peixe) flowers

“…Studies have shown that there are several types of flavonoids that present biological activity, which produce significant anti-inflammatory (Calixto, 2000) and antimicrobial action (Schlemper et al, 1998;Sartori et al, 2003). Antimicrobial activity of the flavonoids is probably related to its capacity in complexing extracellular and soluble proteins such as structures from bacterial cell walls.…”

Recent developments in qualitative and quantitative analysis of phytochemical constituents and their metabolites using liquid chromatography–mass spectrometry

“…In 2008 Zhou et al analyzed caged xanthones possessing a unique 4-oxa-tricyclo[4.3.1.0 3,7 ]dec-2-one scaffold in the resin of Garcinia hanburyi (gamboges) (Fig. 1) [89].…”

“…As most productive sources, medicinal plants provide a large number of molecules that could be screened to find potential lead compounds for drug discovery [1,2]. Nowadays, the main concerns for the phytotherapeutics are the efficacy, safety and quality of phytomedicines [3,4]. Usually, a herb contains hundreds of chemical constituents but only a few components are bioactive [5].…”

Study of the Anti-Inflammatory Activity of Flavonic Extract of Globularia alypum L.

“…Thus, the medicinal plants' usage has gradually abandoned the empirical method and become based on explicatory facts [1]. According to data from the World Health Organization (WHO), more than 80% of the population of developing countries still relies on medicine originating from natural plants as their main source of healthcare [2]. Globularia alypum L. is an aromatic and medicinal plant belonging to the Globulariaceae family, found throughout the Mediterranean area and largely used and considered for its therapeutic virtues [3].…”