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Consummate skills on drug standardization

INTRODUCTION

 The ayurvedic practice of drug formulation and drug
adminstration are based on clearly defined and formally
standardised principle and practices.

 At the same time they allow subjective modification and
adptation to a great extent .

 This give rise to development of different regional
traditions. Each traditions has its own unique standards.

STANDARDIZATION:

 The word verbally means degree of excellence.

 The word standardization implies the application of suitable

methods and process by which optimum conditions are

ensured for obtaining predictable results and

products, which confirm certain sets of standard in

quality, purity, safety and shelf life etc.

NEED FOR STANDARDIZATION
 To safe guard and strengthen the interest of the

manufacturers of ethical Ayurvedic products, the

physicians and the consumers with quantitatively best

Ayurvedic medicines.

 Now a days people are not ready to believe the older truth
as it is, but they will accept the same older truth in the
focus of new scientific cameras analytical approach.

TRADITIONAL METHODS OF
STANDARDIZATION:
They are largely organoleptic . The quality parameter are
measured by the 5 sensory organs.
 For ingredients
The aroma of chandan.
The color of rakta chandana.

 For processes
For avaleha processing – tantumat
For kalaka of tailas for external use – khara paka

For kalaka of taila for nasya – mridu paka
For kalaka of taila for internal use – chikkana paka
Limit of boiling for tailas – frothing
Limit of boiling for ghriths – subsiding off
frothing.
For products
Smell and colour of tailas
Taste of kashayas
Rekhapurnathhwam for bhasmas.

MODERN METHODS OF STANDRADIZATION

 Standardization of crude drugs is needed for achieving
genuine raw drugs, which affects the safety and purity and
quality of the medicine. So to ensure the therapeutic
excellence of Ayurvedic medicines, this must be the first
step of standardization.

 It also include the shelf life, packaging and transport of raw
drugs.

STANDARDIZATION OF CRUDE DRUGS
 Identification - Macroscopic and microscopic
identification, fingerprint, chemical markers study by
chromatography, spectrophotometer and x ray deflection.

 Collection - Places, season and mode of collection

 Drying - It includes two main principles temperature
control, regulation of airflow

 Storage and preservation - There are important for
maintaining the degree of quality of drugs.

STANDARDIZATION IN
PHARMACEUTICALPROCESSES
 Regarding apparatus
 Regarding fuel
 Regarding duration

 Regarding procedure.

PARAMETERS FOR STANDERED FINISHED
PRODUCTS
Raw Material is to be standardized in QC laboratory
Storage of the raw material under suitable conditions.

Analysis of the Raw material at the time of Use.

Manufacturing Process (The process also to be standardized)

Standardization of the finished product in QC laboratory.

 OFFICIAL STANDARDS FOR FINISHED
PRODUCTS

 Physio chemical parameters for
dasamoolarishtam.
 Total solids 25.0-30.0%
 Specific gravity 1.10-1.15
 Reducing sugars 19.0-25.0%
 Non reducing sugars NMT 1%
 PH 3.50-6.00%
 Alcohol content 3.00-7.50%

HURDELS IN THE PATH OF STANDARDIZATION

 These standards are definitely a step forward from the

traditional procedures. But they cannot be perceived as

final, because there is definate scope for improvement.

SOLUTIONS FOR STANDARDIZATION

 There should be a uniform standard cultivation method for

each and every drug to avoid variation in quality and

chemical contaminations

 For standardization one has to conduct study to understand

what chemical changes are happening after each process.

Which can standardize one uniform level or range.

DISCUSSION

 It is better that one should establish the effect of medicine

with clinical trials, not with chemical composition.

 Standardization is a need of this era but it should not be in

such way, which is ultimately going to be harmful to

ayurvedic physicians only.

 The whole exercises of standardization are not for
understanding of ayurvedic principles but for logical
conviction of the whole world. As the people believes in
facts with figures.

 Mother’s love to her child can’t be measures with help of
kilograms, quintals etc. but it is present like wise ayurveda
is also a science which cant be proved with help of modern
methodology.

CONCLUSION

Above suggested standardization procedures are time

consuming but it is:
 Easy to follow
 Accurate
 Long lasting and rewarding.
 Causes minimal deviation from quality

 Applicable to all herbal formulations

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Consummate skills on drug standardization

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Consummate skills on drug standardization