Drugs standardization is very important for its effectiveness and is very particular for herbal medications.
Standardization is quiet necessary for herbal medications as they are mainly composed of several herb extracts along with other plant constituents. The purity is the concern which can be ensured by the standardization only. The potency of drug doesn't depend on its standardization, it only ensures that the formulation will be safe. Another point is, if you think that the herbal medications will show its action as fast as the general medicines it's a wrong concept. A general medicine consists of one or more pure extracted chemical compound(s), whereas, a herbal medicine remains with its classical raw form that's why you shouldn't expect a quicker relief, but it can ensure you lesser side effects rather than the modern medicines around the world.
Dear Sultan
You are taking standardization in different way. It just a short of quality control parameters. If the quality of your product is good and claimed for any activity, it always work. But for enhancing activity of any herbals by means of enrichment of extracts in particular environment is different from standardization and may be part of research.
Standardization is a process where reference parameters is already available or existing.
Standardisation is not important for effectiveness of herbal medicine. Instead it is required for its reach to the public...As standarisation involves the quality assessment of any medicine, herbal medicine lack it because of its multiconstituents. Detailed pharmacodynamic and pharmacokinetic profiles cannot be worked out and also chemical assays cant be done with respect to single constituent. Thus herbal medicine may be effective enough in chronic conditions but not acute one..Although they are effective ..they could not be standardised properly and thus remains very far from consumer reach.
My opinion here is - Its better to work on individual phytochemical (easily isolable or by semisynthesis) and they can be developed as leads in drug discovery instead of working on crude extracts...then the standardisation becomes easy in all aspects..
It is not success, but more importantly is safety and efficacy. Standardization is important for ensure the quality and safety of herbal product. As we want to build public’s trust (authorities and consumers), this process must be clearly described, especially the processing (harvesting, drying, storage and manufacturing), contents (phytochemicals), efficacy and reproducibility of herbal product.
My understanding of standardisation is that what is in one bottle should be exactly the same as what is in the next 10 bottles, even if the contents in the bottle are multiple constituents. With herbal medicines, standardisation is therefore not purification and isolation of individual components but rather ensuring that the extraction process of the crude product follows an established procedure each time and that the source of the plants used is also the same since extracts from plants grown in different environments will be expected to have slightly different composition.
It is also widely believed that crude herbal extracts work because of a poorly understood synergy of the multiple components. Purifying into single ingredients may often result in loss of potency or increase in toxicity due to the loss of intrinsic 'balancing' out of the mixed components.
Therefore, achieving standardisation of mixtures of thousands of components, obtained from many different sources is almost impossible and is therefore a major obstacle. What would probably work is establishing a parallel quality control system separate from conventional medicine that does not necessarily try to pinpoint all components but instead focuses on absence of toxins and also gathers data on patient safety and efficacy.
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