Introduction
Now-a-days there is a renewed interest in drugs of natural origin simply because they are considered as green medicine and green medicine is always supposed to be safe.
Another factor which emphasizes this attention is the incidences of harmful nature of synthetic drugs which are regarded as harmful to human beings and environment.
The advantage of natural drugs is their easy availability, economic and less or no side effects but the disadvantage is that they are the victims of adulteration. The more effective the natural drug, the more its demand and the chances of non-availability increases. To meet the growing demand, the natural drug is easily adulterated with low grade material and this brought about the need for standardization and evaluation of crude drugs.
What is Standardisation of Drugs
Standardization of drugs means confirmation of its identity and determination of its quality and purity. According to WHO, standardization and quality control of herbals is the process involved in the physicochemical evaluation of crude drug covering aspects, such as selection and handling of crude material, safety, efficacy and stability assessment of finished product, documentation of safety and risk based on experience, provision of product information to consumer and product promotion.
The problems associated with unregulated herbal products highlight the major public health issues that can arise when their herbal ingredients have not been authenticated correctly.
Standardization of herbal drugs is not an easy task as numerous factors influence the bioefficacy and reproducible therapeutic effect. In order to obtain quality oriented herbal products, care should be taken right from the proper identification of plants, season and area of collection and their extraction and purification process and rationalizing the combination in the case of polyherbal drugs.
Side effects of herbal products may consist of allergic reactions, interactions with conventional drugs or intrinsic toxicity. Other reasons are related to preparation and manufacturing of the herbs, such as misidentification of plants, lack of standardization, contamination, substitution and adulteration of plants, failure of good manufacturing practice, and incorrect preparations and/or dosages.
Herbal drugs or it’s standardize extracts or pure active compound needs Analytical techniques to confirm its identity, quality, purity, potency, safety and efficacy of the plant.
Standardization is a system that ensures a predefined amount of quantity, quality & therapeutic effect of ingredients in each dose. Herbal product cannot be considered scientifically valid if the drug tested has not been authenticated and characterized in order to ensure reproducibility in the manufacturing of the product.
More Readings
Importance of Standardisation of Herbal Drugs
Methods of Herbal Drugs Evaluation