The preparation with better clinical efficacy are to be selected. After all the routine physical, chemical and pharmacological parameters are to be checked for all the batches to select the final finished product and to validate the whole manufacturing process.

The stability parameters for the herbal formulations which includes physical parameters, chemical parameters, and microbiological parameters.

Physical parameters include color, appearance, odor, clarity, viscosity, moisture content, pH, disintegration time, friability, hardness, flowability, flocculation, sedimentation, settling rate and ash values.

Chemical parameters includes limit tests, extractive values, chemical assays, etc.

Chromatographic analysis of herbals can be done using TLC, HPLC, HPTLC and GC, UV, Fluorimetry, GC-MS, etc.

Microbiological parameters include total viable content, total mold count, total enterobacterial and their count. Limiters can be utilized as a quantitative or semiquantitative tool to ascertain and control the amount of impurities like the reagents used during abstraction of various herbs, impurities coming directly from the manufacturing vessels, impurities from the solvents, etc.

Chemical decomposition of substances present in the formulation also produces several toxic or impure compounds during storage in undesirable conditions. Contaminants may come directly from the atmosphere also. This include mainly dust, sulfur dioxide, H2S, CO2, Arsenic, moisture, etc.


The guidelines set by WHO can be summarized as follows:

a.                   Reference to the identity of the drug. Botanical evaluation ? sensory characters, foreign organic matter, microscopical, histological, histochemical evaluation, quantitative measurements, etc.

b.      Reference to the physiochemical character of the drug. Chromatographic profiles, ash values, extractive values, refractive index, polarimetric readings, moisture content, volatile oil content, etc.

c.                   Reference to the pharmacological parameters. Biological activity profiles, bitterness values, haemolytic index, astringency, swelling factor, foaming index, etc.

d.              Toxicity details ? heavy metals like cadmium, lead, arsenic, mercury, etc. Pesticide residues.

 

e.         Microbial contamination ? Total viable aerobic count, pathogenic bacteria like enterobacteria, E. coli, salmonella, Pseudomonous aeruginosa, Staphylococcus aureus, etc. and presence of afflatoxins etc.

f.                     Radioactive contamination.

 

Modern herbal Ayurvedic monographs

In the modern herbal ayurvedic monographs the standardization parameters are discussed in a comprehensive way. According to the modern ayurvedic monograph the quality control protocols include the following:

Title, synonyms, publications related to that plant, constituents present, analytical methods.

Descriptive evaluation: Description of the drug, phytomorphological, microscopical, organoleptic evaluations, foreign matter, foreign minerals, etc.

 

Physicochemical parameters

Identity: Physical and chemical identity, chromatographic finger prints, ash values, extractive values, moisture content.

Strength: Ethanol and water extractive values, volatile oil and alkaloidal assays, quantitative estimation protocols, etc.

 

Biological Activity Evaluation

Bitterness values, astringency, swelling factor, form index, hemolytic index, etc.


Toxicological evaluation

Pesticide residues, heavy metals, microbial contamination like total viable aerobic count, pathogens like E. coli, Salmonella, P. aeruginosa, S. aureus, Enterobacteria, etc. 


Aflatoxins

The presence of aflatoxins can be determined by chromatographic methods using standard aflatoxins B1, B2, G1, G2 mixtures. Aflatoxin is a product of the microbial strain Aspergillus flavus.
 

Therapeutic Evaluation

Classical Evaluation as per Ayurvedic Literatures

Classical therapeutical attributes like Rasna, Guna, Virya, Vipaka and Karma classical formulations, doses, storage conditions.

The quality of the raw materials can be tested according to the following format:
Name of the drug (English, Regional names, Exact botanical nomenclature)
Part of the plant used
Area of collection
Distribution details
Season of Crop
Time and year of collection
Pesticide and insecticides
Condition of the drug (fresh or dry)
Form of the drug (powdered or intact or cuttings like etc.)


CONCLUSION

The subject of herbal drug standardization is massively wide and deep. There is so much to know and so much seemingly contradictory theories on the subject of herbal medicines and its relationship with human physiology and mental function.

For the purpose of research work on standardization of herbal formulations and neutraceuticals a profound knowledge of the important herbs found in India and widely used in Ayurvedic formulation is of utmost importance.

India can emerge as the major country and play the lead role in production of standardized, therapeutically effective Ayurvedic formulation. India needs to explore the medicinally important plants. This can be achieved only if the herbal products are evaluated and analyzed using sophisticated modern techniques of standardization such as UV-visible, TLC, HPLC, HPTLC, GC-MS, spectrofluorimetric and other methods.