Elemental impurities in Ayurvedic formulation: Guidelines & management
1Nidhi Bais and Ravikant Gupta
1Faculty of Pharmacy, Oriental University, Indore - 453555 India baisnidhi21@gmail.com, ravikant491990@gmail.com 9179440930
ABSTRACT
Traditional medicinal herbs, herbs supplement and other medicines are used by the majority of people in the world. Toxicity associated with the use of Ayurvedic product due to their iron content is a public health concern. Some of these preparations are considered to be harmful to health due to the presence of toxic substances, hence it is very important to value the possible risks associated to their consumption. Metal in formulation act bytheir intrinsic activity, catalytic activity, preservative and nanocarriers. Ayurvedic products due to specific processing like shodhan, maran, satvapatan, do not have metal in toxic form. A significant usage hazard of complementary medicines is the presence of heavy metalloids such as arsenic As, cadmium Cd, lead Pb, and mercuryHg. Heavy metal in ayurvedic formulation above prescribed limit may be fatal. The permissible limit set by FAO – WHO herbal medicine are 10µg per g for mercury, 0.3µg per g for cadmium and 50µg per g for zinc. The permissible limit for iron, copper,magnesium and chromium has not established. Plant and animal product may have heavy metal due to high accumulation by their defense mechanism, physiology of environmental variations. Improper manufacturing processes might lead to higher levels of heavy metals remaining in the final product which may be dangerous. They may also be present as impurity rather than being added willfully. Heavy metals possess tendency to accumulate in vital organs and hence, pose a particular health risk. The presence of impurities in drug samples, whether herbal or pharmaceutical, is of great concern, not only because some contaminants are essentially toxic, but also they might have a detrimental effect. The stability of the drug and the lifespan, or they can cause undesirable effects. The quality assurance of herbal formulations is the main concern of current phytomedical era due to the increase in toxicity reports. As a consequence, both organic and inorganic elemental impurities must be monitored and controlled in final dosage form starting from the raw materials itself. This article deals with the various aspects of heavy metals in Ayurvedic medicines such as their sources, methods used for their determination, their therapeutic significance, their toxic effects and also summarizes various guidelines and limits for their regulation.11,30,41