Standardization of Ayurvedic Dosage Forms

Ayurved Standards
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1. Taxonomical Estimation

 Authentication of drug material

Taxonomic authentication is the method of perfectly recognizing (identifying) the species, for instance, morphological characters, microscopy, physiological and biochemical examinations, verifying (authenticating), and removing (eliminating) adulteration from herbal, organic or Ayurvedic medicines to make sure their safety, therapeutic potency, and efficacy. 

2. Organoleptic /Sensory

the organoleptic and sensory methods is a scientifically evaluation of the sensory attributes of any herbal material e.g.; taste, sight, touch, odour & hearing. It helps to improve and maintain the quality of formulations.

3. Foreign Matter

It is defined as anything which is not the original drug like if we are using root material of any herb but sample containing same plant’s stems along with root drug sample it would be considered as foreign matter or contaminating drug sample. e.g.  Ashwgandha’s plant roots are useful part for medicinal purpose. If sample containing leaves, stems, flower and fruit of same plant along with roots than it would be considered as foreign material for Ashwgandha root’s sample. Root means only root sample not other things of the same plant. Some-time raw drug contain the inorganic material with plant sample like sand, stone and some time it contain substitute of the plant like gujnja plant bark use as a substitute of yathimadhu. some time sample contain adulteration with other same resembled sample. like black pepper adulterated with papaya dried seed. Same in case of mineral and animal origin raw material.  

4. Microscopic Evaluation

Microscopic examining is the method involving thin sections of the raw drug under the microscope which help to identify the histological aspects. It can be used to examine the purity of powdered drug, adulteration, substituents and other species in crude drugs.

5. Physicochemical Parameters

Physicochemical parameters are the useful standardization methods to evaluate the purity of the raw material like ash value indicate the idea about the sample inorganic composition like earthy material sand metals etc. extractive value water soluble and acid insoluble shows the low or high rate of the contamination of the raw sample. Also, these values give the idea after result our sample’s composition is water soluble more or alcohol soluble more which gives the idea to formulation type and root of administration for further. pH of the raw material indicates its acidic and base nature.

6. Pharmacognostical Parameters

Pharmacognostical parameters revealed about the both macroscopy and microscopy. It is also screening the presence of various type of phytochemical groups like glycosides, steroids, alkaloids and phenolic compound. Which is very important to standardize the raw material as well as final formulation.

7. Pharmacological Parameters

Pharmacological parameters are important to examine the effects of drug in system. and likewise system reaction towards the drug. By these parameters we can estimate the potency of the drug. It is help to improve the new drug discovery in the field of ayurveda.

8. Toxicological parameters

This study is helpful and important to determine the safe starting dose for clinical trials and parameters used to vigilance the side effects of the drug. This study possesses the potential risks of drug candidate such as adverse effects, dose response relationships and safe dosage ranges. It is also helpful to promote the new drug discovery and pharmacovigilance.

        

No.

 Parameters for Evaluation

1

Taxonomical Estimation

Authentication of drug material

2

Organoleptic /Sensory

Colour

Odour

Appearance

Powder particle size distribution

Powder Flow

Clarity

 

 

3

Foreign Matter

Of Foreign Plant

Of own plant

Of other plant

Mineral

4

Microscopic Evaluation

Qualitative:

Palisade ratio

Vein islet

Vein termination

Stomatal index

Stomatal number

5

Physicochemical Parameters

Qualitative:

pH

Disintegration time

Friability

Hardness

Sedimentation rate

Solubility

Viscosity

Ash Values

*Total Ash

*Acid insoluble Ash

* Aater soluble

*Sulphated Ash

 

 

 

Extractive value

*Water soluble

*Ethanol soluble

*Ether soluble

 

 

 


 

 


Oil related values

* Saponification value

* Acid value

*Ester value

 

 

 

 

 

6

Pharmacognostical Paramete 

 

Swelling Index

Foaming Index

Melting range

Optical rotation

Moisture content

*Loss on drying

*Aziotropic mixture method

* Karl fischer method

*Spectroscopic method

*Electrometric method

 

 

 

7

Pharmacological Parameters

(bio assay of estimate potency)

Bitterness

Astringent activity

Antimicrobial Activity

Hemolytic activity

Antioxidant Activity

Nitric oxide Scavenging Activity

 

8

Toxicological parameters

(Establishment of Safety)

Limit test

Pesticide content

Heavy metal content

Aflatoxin

Radioactive contaminant

Bioburden

Fungal

*Bacterial

*Pathogenic

*Non-pathogenic


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