What are Herbs?
Herbs are natural plants (Botanicals) which are used traditionally as food, flavorings and medicine for ages by human beings.
The science of herbals is as old as the human origin. The ancient herbal science was developed in India about 5000 years ago and is known as “AYURVEDA” the science of life.
Herbs are rich in secondary metabolites produced by plant for their own growth and development. These secondary metabolites are known as Phytochemicals (phytoconstituents.)
These phytochemicals show pharmacological action when consumed. Herbal based products are developed using these pharmacological properties.
HERBAL PRODUCTS DEVELOPED USING HERBS / BOTANICALS MAY BE RENAMED AS PHYTOPHARMACEUTICALS OR HERBACEUTICALS
Herbal medicines are being consumed by about 80% of the world population primarily in the developing countries for primary health care. There is an increased acceptance and usage of the herbals in western countries.
They have stood the test of time for their safety, efficacy, cultural acceptability and lesser side effects.
The basis of the herbal formulations / products development is to understand the property of an individual Herb with respect to;
1. Authentication / Identification of the herb
2. Selection of herb
3. Part of the herb to be used;
(Root, Rhizomes, Tuber, Stem, Bark, Leaf, Flower, Fruit, Seed, Galls or whole plant).
4. Extraction procedures to obtain desired Phytoconstituent(s);
a. Cold maceration – Soaking herb in water at room temperature for a specific period
b. Percolation – Soaking Herb in water/solvent for a specific period
c, Hot extraction – Extracting Herb in boiling water
d. Distillation - Volatile oils are removed from herbs by this process
e. Liquid CO2 extraction – Selective Extract obtained with very little damage to marker compounds.
f. Hydro-alcoholic extract – Combination of water and alcohol in a desired ratio used for extraction.
The extracts manufactured by the above methods may be evaluated for their respective phytoconstituents.
The following points may be considered while devising an herbal formulation.
A. Selection of the right herb
B. Daily dose of Herb as mentioned in the approved ayurvedic texts.
C. Extraction procedure adopted
D. Representation of the extract with reference to raw herb. (Herb to extract ratio)
E. Daily dose of the formulation (Product) e g. Once a day/ Twice a day/ Thrice a day
F. No two contradicting herbs to be incorporate in the formulation such as herb for relieving constipation
and drug for relief from loose motion and some of the herbals are not recommended in pregnancy and in lactating women.
G. Herbal drug design is an art that calls for very judicious combination of herbal raw powders or extracts, the formulation may include minerals in the form of Bhasma / calcined metals wherever necessary. The formulation must show very visible and marked effect during the clinical evaluation. - See more at: http://thscenter.com/blog/?p=5#sthash.VLlxwFeG.dpuf
H. Dosage forms;
e. Liquids / Syrup
5. Quantity of extract to be incorporated in the formula. Eg. Syrup for Cold & cough
Herbal product design is the process of developing, standardizing and validating an herbal product for the market
There are two very essential aspects while making a product;
A. Quality Assurance
B. Quality Control
A. Quality Assurance:-
To obtain wholesome and efficacious product, the inputs/ starting ingredients must be as per the established specifications as follows;
a. Authenticity of the herb by macroscopic and microscopic evaluation.
b. Proximal analysis such as
i. Foreign Matter
ii. Water extractive value
iii. Alcohol extractive value
iv. Ash value
v. Acid insoluble ash
vi. % (From Oil bearing materials)
vii. Pesticide residues
viii. Bacterial Contamination
c. Specific analysis for identification of marker compound(s) by
i. Extraction and by quantification by Gravimetric or Titrimetric methods
ii. High Pressure Liquid Chromatography (HPLC) and HPLC-MS
iii. Gas Chromatogaphy and GC-MS
v. Thin Layer chromatography
vi. High Pressure Thin Layer Chromatography
d. Herbal Extracts may be analyzed by any of the methods mentioned above.
Herbal product design includes the process of developing, standardizing, processing, and validating an herbal product for the market
B. Quality Control
It must be ensured that the product manufactured is as per the laid down specification before the products are put to use by the consumer. Confirmation to the specification may be done by various parameters. Setting of the Expiry date of the product is absolutely essential by carrying out the Stability study as per ICH guidelines in the final packing of the product. Herbal product would find its wider acceptance by the consumer only when the quality of the product is consistent with reference to all the parameters including microbial contamination, absence of heavy metals, and adequate level of marker phytoconstituent(s).
Standardization is a process that is used to ensure batch-to-batch consistency of the products. In some cases, standardization involves identifying specific chemicals (known as chemical markers) that can be used to a consistent product. If the chosen marker (s) is present at about the same amounts between batches of the same product, then it is likely that all of the ingredients in that product are present in equal proportions between these batches. This process provides a measure of quality control.
Standardization is achieved by choosing at least one chemical compound present in the herb or supplement and monitoring its concentration in each batch of product. Batches that do not meet the standard are to be modified accordingly. Standardization is not directly related to efficacy because it does not assess the total chemical composition of the product; rather, it only indicates consistency of contents and is not the measure of clinical efficacy. Depending upon the type of the dosage form of the product specifications parameters are taken into consideration for evaluation.
Please note as per WHO the microbial contamination level is higher than suggested here as we understand that it always better to have very low level of microbial load.
Herbal Product Design and Development