Colloquy-4m

Muniyal ayurveda

– quality control – dna based molecule particles and scar marker

Safety

Efficacy

#biological biochemical

Safety

1. Evidence of safety of Ayurvedic formulation

-2.5 million patient treated

Lack of the safety data

2. Method of the preparation

Marana and sodhana preparation methods .

Intentionally contamination

Deliberately adulteration

2008 destructive temperature and the dissociation property to plasma.. analogue should br matched to thr analogur ….. several reasons.

Lak of the quality control is the still the major issue

Toxiity testing is started to adobt in the Ayurvedi

2010 – toxicity testing made the compulsory

Guidelines is given-

Schedule 1 is there for the study if the

Others

UsFDA

CSMUK

Noael- without any adverse effect

Tdl

Moa

Safety study of the ayurvedic

Rstionle for the toxicolofy testing syurbedic products

1. Acute oral toxicity – single dose

2, subacute- 28 days

3. Chronic toxicity

Subchronic -3month

Ayurveda medicine maynot be relevant to the acute major is chronic study cumulative toxicity

Irritational study

Allergic sensitization

Reproductive study- segmental and generation

Carcinogens

Mutagenesity

Biocompatibility

Ecotoxicology- n peproperfor the dumping mehanism

Supplementary toxicity

Idea about them

ChAllenges

– form is different then the pharmacodynamics my be different

– …bauer and tittel 1990 aueb

Drug interaction

Geographical variation (fugh berman 2000)

Current scenario

– ayush gcp guidelines modified from the modern medicines

Insol n tablet

423,407, 408 (subchronic) , 452 (chronic)

Apple folders

Clinical trail protocol

https://grants.nih.gov/policy/clinical-trials/protocol-template.htm

integrated addendum to iCH Good clinical practice

………………………………………………………………………………….

IDE Clinical Trial Protocol Template NIH-FDA Phase 2 and 3 IND

NIH-FDA Clinical Trial Protocol Template – v1.0 7 Apr 2017

Protocol_Template_NIH

 

PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING GROSS BEHAVIORAL STUDY

SIGNS & SYMPTOMS
General impression
Increased motor activity
Convulsion: Tonic
Clonic
Straubs  reaction
Muscle spasm
Catatonia
Opisthotonus
Hyperaesthesia
Decreased motor activity
Muscle relaxation
Anaesthesia
Arching and rolling
Lacrimation
Diarrhoea
Writhing
Salivation Viscid
Watery
Respiration Stimulation
Depression
Failure
Skin colour Blanching
Cyanosis
Vasodilatation
Grip strength
Visual placing response
Tail pinch response
Auditory response
mucus membrane
Piloerection

 

Time after drug administration Exitus  

CNS Depression

 

 

ANS

 

CNS Stimulation

Analgesia Others

Learning about the synergism/ Potentialiation , and antagonistic in comparission to the additional

(Evans, 55)

Content discussed:

  • modernized should  achieve three types of efficiency (high efficiency, quick efficiency, and long-lasting efficiency) and three areas of “small” advantages (small dosage, low toxicity, and fewer adverse reactions). 

Drug delivery system vs synergism, synergism = potentiation, synergism vs polyvalent action. 

 

  • Synergism is an effect larger than additive, whereas antagonism is smaller than additive.
  •  combinations of these rather than with
    isolated compounds. TCM, in particular, uses complicated recipes
    and it has sometimes been thought that the inclusion of some herbs
    was unnecessary, but the rationale for such combinations is gaining
    increasing acceptance. A TCM herbal treatment for eczema was the
    subject of a clinical trial of 37 young patients (M. P. Sheehan and J. D.
    Atherton, Br. J. Dermatol., 1992, 126: 179–184), and investigations
    were carried out to identify the ‘active constituent(s)’ of the mixture.
    However, a programme of pharmacological tests failed to find a
    single active herb or compound: it was the herbal mixture that was so
    effective (J. D. Phillipson, reported in European Phytotelegram,
    1994, 6: 33–40)
  • To do so requires the extract to be fractionated, tested, recombined and retested
    in various permutations to see how each is interacting with the others.To do so
    requires the extract to be fractionated, tested, recombined and retested
    in various permutations to see how each is interacting with the others.
  • issue: polyvalent action
  • no real evidence as to which compounds are interacting.
  • In some cases, the active ingredients
    may not even be fully known, and if synergy is involved, then
    bioassay-led fractionation (the usual method for identifying actives)
    would not even be possible (see P. Houghton, Phytother. Res., 2000,
    14(6): 419–423). The identities of the main actives of many important
    herbs are still under discussion, and it would be unwise to
    exclude, by overpurification, any constituents that might contribute
    to efficacy
  • Enhancement or reduction of absorption or bioavailability : Ayurvedic formulae often have herbs such as liquorice
    or pepper included specifically to reduce or increase bioavailability
    of other ingredients, and this can be considered a form of synergy.
  • Multiple pharmacologocal effects demonstrated in single plant (E. 59)- Anupana concept.
  • New technology for looking of looking synergy and other interactions:

 

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Antidepressant property

Tail hanging methods of rat : 

WhatsApp Image 2018-07-12 at 11.38.54 AM

 

 

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SEDATIVE AND HYPNOTICS

SEDATIVE AND HYPNOTICS

Pentobarbitone sleeping time

Vomtrol, standard, test

 

Mice

Writhing time

Sleeping time

On 7th day_ 25 to 30mg per kg

After dose… latency to sleep…

10min… Duration of sleep- calculation of the sleep hours from start to wake up.

 

Drug- sedative in comparison should be increased

Control comparison

 

List of the sleeping hours

 

EXPERIMENTAL MODEL FOR ANTI_ PARKISONISM

Animal model we cannot get direction anto,, measure the symptoms >>> oxytrimor model is used to assess

Model test for muscle- muscle tone- rota rod

Riserpine induced catatonia model

 

Oxytoxin 80mg/kg

– salivation, lacrimation, tremor, ataxia moment, jerk moment of present

– Assessment – 10min, 20min, 60min,120min after giving th medicine

– 0- no, 1- mild, 2- moderate, 3- rigid

– Assessment for tremor, .. all of them

 

Reserpine induced catatonia

100mg/kg

Assessment

– Catatonia- iif placed one leg upside,,, muscle rigidiy occur and remiam for same position

– Ptosis

– Sedative

– Hypothermia

Grading- 1,2,3

0,1,2,3,4,5,6 hour assessment

 

Rota rod apparatus

For assessing muscle rogidity

 

Antipsychotic model

Instrument

– radial maize apparatus

– Tunnel apparatus

– Exploratory behavior whole body

– Cooks pool climbing apparatus

 

Assessment present of CAR- conditions awareness response

– bell or shock

– Response- climbing

 

Alarm.

No alarm

– two cases

Shock without alarm- jump (car)

Before alarm- cam present

And after- cam absent

If cam present – antipsychotic present

 

antiparkinoism

– grip stain meatsr

– Hold the mess

– Pull the tail

– Gnawing started

– Holding strength if the rat will be assessed

 

Exploitative behavior

 

Anticonvulsant

Anticonvulsion study

1. Chemical

2. Electrical

1. Chemical

Pentamethyltetrazole (PTZ)

It will be inducing convulsion- mice is preferred 80mg/kg intraperitonial

Assessement criteria

1. Onset of jerk moment

2. Number of myoclonic jerk

2. Straub tail

4. Clonic or tonic convulsion

5. Duration of death or recovery- This is the most important criteria for analysing the effect.

Duration/latency

1. Controlled- less

2. Test- more in intensity and number should be decreased

 

 

 

 

Electroconvulsion/ supramaximal electric shock convulsion technic

— shock instead of chemical via eye or ear

– 180mv in 0.2sec time to induce convulsion

Assessment will be done

**Stroma condition

Kindling model

– best on status epilepticus model

– daily inj ptz with 30mg/kg along with control group

– daily monitoring will be observed

– minimum day of 11

– all control group will go into death.

This model is done coninously for observation of long time period. The dose given 80mg/kg is reduced half to 40mg/kg and then observation is done. For observating at a time, the first rat is started at 0 sec, second rat at 3 sec and timely accordingly. The recording chart is made and collect the no of convulsion of the rat in which time interval. (SDM, 07/13 observation)

PHOTOS:

The criteria is fixed for the observation as 1,2,3,4,5.

 

 

Stretching inducing – strychnos nuxvomica

Kanic acid induced convulsion model

Ayurveda terminology

ayurveda dictionary

 

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Agada tantra terminology

 

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Normality curve distribution

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2548695/pdf/bmj00578-0032.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3915399/