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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
THANK U

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Consummate skills on drug standardization

  • 1.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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
  • 6. 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.
  • 7. 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.
  • 8. 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.
  • 9. STANDARDIZATION IN PHARMACEUTICALPROCESSES  Regarding apparatus  Regarding fuel  Regarding duration  Regarding procedure.
  • 10. 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.
  • 11.  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%
  • 12. 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.
  • 13. 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.
  • 14. 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.
  • 15. 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.
  • 16. 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