From,

DR.NILESH N GAWASI MD(Ayu) SCHOLAR

Department of Post Graduate Studies in Rasashastra

TaranathGovernmentAyurvedicMedicalCollege.

Bellary- 583101.

To,

THE REGISTRAR,

RajivGandhiUniversity of Health Sciences, Bangalore,

Karnataka.

Through,

The Principal and Head of the Department of Rasashastra

TaranathGovernmentAyurvedicMedicalCollege,

Bellary- 583101.

Respected Sir,

Sub: Submission of Completed Proforma for Registration of Subject of Dissertation.

I request you to kindly register the below mentioned subject against my name for the submission of dissertation to the RajivGandhiUniversity of health sciences Bangalore for the partial fulfillment of M.D (Ayu)

Title of the Dissertation:

“PHARMACEUTICO-ANALYTICAL AND TOXICOLOGICAL STUDY OF SWARNAMAKSHIKA BHASMA ON WISTAR ALBINO RATS - AN EXPERIMENTAL STUDY”

Here with I am enclosing submitting synopsis for your kind consideration

Thanking You Sir,

Yours faithfully,

Place:Bellary: DR.NILESH N GAWAS

Date:

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES, KARNATAKA,

BANGALORE

ANNEXURE-І І

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

  1. Name of the candidate and address: Dr.NILESH N GAWASI M.D (Ayu) Department of post Graduate

studies in Rasa shastra

Taranath Govt Ayurvedic

MedicalCollege

BELLARY-5831

DR.NILESH N GAWAS S/O NAGESH G

H.N0:429, RUMEVADI CROSS

KHANAPUR-591302

DIST: BELGAUM, KARNATAKA.

  1. Name of the Institution : TARANATH GOVERNMENT

AYURVEDICMEDICALCOLLEGE,

BELLARY-583101

  1. Course of Study and Subject : 1st Year M.D(Ayu)Rasashastra
  1. Date of admission to course : 06 FEBRUVARY 2012
  1. Title of the Topic : “PHARMACEUTICO-ANALYTICAL AND TOXICOLOGICAL STUDY OF SWARNAMAKSHIKA BHASMA ON - ANEXPERIMENTAL STUDY”.

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 Need for the study:

Rasashastra dealing with Pharmacology holds a valid response of Drug designing and Analyzing with a vision to produce safe drug. Newer medicines have to be invented, evolved.Probably the result was evolution of Mineralo-metallic medicines after years of hard work,observations,experiments and research.The situation has taken such a turn now that along with efficacy,safety has become a major concern for Ayurvedic drugs.

Swarnamakshika is one among the MAHARASAS, which has given very much importance in both Dathuvada and Dehavada. It is compound of copper, iron,and sulphur along with other trace elements. Swranamakshika bhasma1 as a wide range of therapetical uses and it is also mentioned as a ingredient in many formulations. Swaranamakshika in its bhasma form offers an improved state of Tamra bhasma pre treated by Gandhaka and Louha in its original form.as it contains copper and iron as a main elements both this are well known for there toxic effects. Hence a positive hypothesis is made that with Classical therapeutic dosage the safety of Swarnamakshika bhasma is to be known,so a proper evaluation of these drugs would serve as an important tool for better understanding of them so as to provide scientific data and statistical validation for safety and efficacy, the present study is entiteld as “PHARMACEUTICO-ANALYTICAL AND TOXICOLOGICAL STUDY OF SWARNAMAKSHIKA BHASMA ON WISTAR ALBINO RATS - AN EXPERIMENTAL STUDY”.Is undertaken.

6.2 Review of Literature:

  • Review of SHODHANAof SWARNAMAKSHIKA2.
  • Review ofMARANA of SWARNAMAKSHIKA3.
  • Review ofAMRITIKARNAOF SWARNAMAKSHIKA BHASMA4.
  • Concept of toxicology will be reviewed5.

Previous Works published in relation to the subject:

  1. Dr.Pillakadar “Study of effect of swarnamakshika bhasma with special reference to amalapita and pandu”-( Doctoral Desertation,Institute forpostgraduate teaching and research in ayurveda.Gujarat ayurveda university Jamnagar-1974)6 .
  2. Dr.Singh r p “Chemical,spectral and toxicological study ofswarnamakshika bhasma”–(Doctoral Desertation,Rishikul state ayurvedic college Kanpur university,Kanpur-1996)7 .
  3. Dr.Ajay kumar k a “Role of two different methods of shodhana in the preparation of swarnamakshika bhasma a pharmaceutico analytical study” from - (Doctoral Desertation, Govt. pandith taranath government ayurvedic medical college, bellary r.g.u.h.s bangalore-2008)8 .
  4. Dr.Sadguna d n “A comparative pharmaceutico-analytical study of swarna makshika bhasma prepared by kharpara pakva (open) and puta dagdha (close) method as described in rasratna samucchaya” - (Doctoral Desertation - Government ayurvedic medical college, bangalore r.g.u.h.s bangalore-2008 )9 .
  5. Dr.Arun prasad p v" Preparation and evaluation of swarna makshika bhasma with special reference to its anti-diabetic activity an experimental study” - (Doctoral Desertation - Ayurveda mahavidyalaya, hubli r.g.u.h.s bangalore - 2010 )10 .

6.3 Objectives of the study :

1. To do comprehensive literary review of SWARNAMAKSHIKA BHASMA.

2.Shodhana of SWARNAMAKSHIKA.

3.Maranaof SWARNAMAKSHIKA.

4.Amritikrana ofSWARNAMAKSHIKA BHASMA.

5. To carry out Physico-chemical analysis of SWARNAMAKSHIKA BHASMA.

6. Toassess the Toxicity of SWARNAMAKSHIKA BHASMA.

7. MATERIALS AND METHODS:

7.1 Sourceof Data:

  • Literary
  • Pharmaceutical
  • Analytical
  • Experimental
  1. Literary study:

Literary source will be collected from Ayurvedic classical textbooks, relevant modern text and published articles in reputed journals.

a)All the relevant classical and up to date literature ofSWARNAMAKSHIKABHASMA will be screened.

b) Experimental Toxicological study will be reviewed as per modern Pharmacology.

  1. Pharmaceutical study :

a)Genuine raw materials will be collected

b)Necessary processing of raw materials will be done in pharmacy section of P.G.Dept of Rasashastra in TaranathGovernmentAyurvedicMedicalCollege, Bellary.

  1. Analytical study :
  1. Basic Physico-chemical analysis will be done in laboratory, P.G.Dept of Rasashastra, TaranathGovernmentAyurvedicMedicalCollege, Bellary, Karnataka.
  2. Instrumental analysis of SWARNAMAKSHIKA BHASMAwill be carried out in established laboratories.

vi. Experimental study :

* The Toxicological studies will be conducted according to WHO protocols for screening for toxicology in the Pharmacology and Toxicology Lab attached to SDM Centre for Research in Ayurveda and Allied Sciences- Udupi. It is a DSIR recognized Scientific and Industrial Research Organization ( FNo-14/565/2011-TU-V).

Albino rats will be taken randomly from SDMC Animal house for the study and grouped into 4, each groupconsisting of 10 rats (5 male and 5 female)

Toxicological effect ofSWARNAMAKSHIKA BHASMA will be studied on Albino rats

* The rats will be maintained and fed with standard laboratory food and water.

7.2 Method of collection of data:

1.Litarary study

The relevant information from classical literature will be collected for the preparation of SWARNAMAKSHIKA BHASMA.

2.Pharmaceutical study:

a)The raw drug will be screened and data will be collected.

b)Shodhana of SWARNAMAKSHIKA-Swedanain kadalikanda swarasa by DOLAYANTRA method for 2 ghatikas.2

c) Marana of SWARNAMAKSHIKA - suddha swarnamakshika and 1/8part of shudda hingula are mixed together and ground well with nimbu swarasa and chakrikas are prepared and dried.These chakrikas are kept in sharava samputa and subjected to eight gajaputas,for each puta 1/8th quantity of hingula is added.3

d) Amritikarna of SWARNAMAKSHIKA - Swarnamakshika bhasma and ½ part of shuddha gandhaka are mixed together and grounded well with nimbu swarasa for three hours and bolus is prepared and dried well.this bolus is kept inside the surana kanda wrapped with mrit lepit vastra and dried well and subjected to gajaputa.4

3.Analytical study :

Physico-chemical analytical methods will be adopted as follows

Physical Tests –

  • Organoleptic – Varna, Sparsha, Gandha, Rasa.
  • pH Value
  • Ash Value
  • Water soluble ash
  • Acid insoluble ash
  • Loss on drying
  • Loss on ignition

Chemical Tests –

  • Qualitative tests-XRD,XRF,FTIR,NPST
  • Quantitative analysis by volumetric method
  1. Experimental study:

Experimental Evaluation

1 / Sample / For Acute Toxicity- Approximately 12 albino rats.
For Repeated dose toxicity (Sub Acute Toxicity)- 40 albino rats
2 / Inclusive Criteria / (1) Healthy albino rats of either sex will be considered
(2) Weighing about 150-200g
3 / Exclusive Criteria / 1. Less than 150g-more than 200g.
2. Pregnant and diseased rats
3. Rats which are under trial of other experiments
4 / Grouping / Each group having 10 rats and will be kept in separate cages.
Group(1)-Control Group-10rats
Group(2)-Trial Group-10 rats(1st SampleSWARNAMAKSHIKA BHASMA)
Group(3)-Trial Group-10 rats(2nd SampleSWARNAMAKSHIKA BHASMA)
Group(4)-Trial Group-10 rats(3rd Sample SWARNAMAKSHIKA BHASMA)
5 / Intervention / Rat dose will be calculated on the basis of Human dose by using Standard Conversion Method.on the bases of body surface area ratio.
6 / Mode of Administration / Oral
7 / Duration / Two month
8 / Investigations / Histopathological study of Liver, Brain, Kidney,heart,uterus
Biochemical parameters- kidney and liver function test, serum sugar, serum total cholesterol and triglyceride.
Haemogram – 18 parameters pertaining to RBC, WBC and platelets.
9 / Comparison / The data from the test drug administered groups would be compared to control group.
10 / Assessment Criteria / Acute toxicity will be studied by following up & down or stair case method,( OECD guidelines 425) using AOT software and followed by sub acute toxicity study as per AYUSH Rule 170 guidelines..
11 / Statistical Analysis / The data generated would be presented as Mean ± SEM . The difference between the groups would be determined by employing one way ANOVA (Analysis of Variance) with Dunnet’s multiple ‘t’ test as post hoc test.

7.3) Does the study require any investigation or any intervention to be conducted

on Patient or other humans or animals:

Yes-Since this is an Experimental study on Albino rats of either sex that are maintained on Standard Laboratory, Foods and Water. The study is being conducted in a recognized, CP CSEA-registered centre.Under the expert guidence.

7.4) Has ethical clearance been obtained from your institution

Yes –concurrence has been obtained from the ethical committee of S.D.M.C.A Udupi, Certificate enclosed, Ethical clearance will be obtained during the next IAEC meeting, in Udupi.

8). Lists of References:

1.Acharya sri madhava Ayurveda prakasha edited by vaidya vachaspati shri gulrajsharma mishra,reprint 2007,varanasi,chaukhambha bharati academy publisher 1999,4th chapter,verses 9-10,410pp.

2.Shree Vagbhatacharya,Rasa Ratna Samuchchaya edited by Kaviraja Shree Ambikadatta Shastri, 8th edition,Varanasi,chaukhambha Amarabharati Publication,1998,2NDchapter verse 78,49pp.

3.Sri Sadananda Sharma , Rasa Tarangini edited by Pandith Kashinath Shastry, 11th edition,New Delhi, Motilal Banarasi Das Publication 1979 , 21st Taranga, verses 23-25,523pp.

4.Ibid.17th Taranga verses 40-42,418pp.

5.Paget GE and Barnes J.M Toxicity studies , In Evaluation of drug activities & Lawrence D.R and Bacharach A.l(Eds).Newyork, Academics press 1964,Vol 1, 135-165pp.

6.Dr.M.S.Baghel, Researches in Ayurveda, Second edn, Jamnagar,Mridu Ayurvedicpublication and sales,2005.30pp

7.Ibid,111pp

8.

9.Ibid.

10.Ibid.

9. SIGNATURE OF CANDIDATE:

10. REMARKS OF GUIDE :

11. NAME AND DESIGNATION ( IN BLOCK LETTERS )

11.1 GUIDE : Dr.M.S.DODDAMANI. M. D.(AYU)

PROFESSOR AND HEAD OF THE DEPARTMENT,

DEPARTMENT OF P.G.STUDIES IN RASASHASTRA,

TARANATHGOVTAYURVEDICMEDICALCOLLEGE

BELLARY-583101

11.2 SIGNATURE :

11.3 CO-GUIDE :

11.4 SIGNATURE :

11.5 HEAD OF THE DEPARTMENT

Dr.M.S.DODDAMANI. M. D.(AYU)

PROFESSOR AND HEAD OF THE DEPARTMENT,

DEPARTMENT OF P.G.STUDIES IN RASASHASTRA,

TARANATHGOVTAYURVEDICMEDICALCOLLEGE

BELLARY-583101

11.6 SIGNATURE

12.

12.1 REMARKS OF CHAIRMAN AND PRINCIPAL:

12.2

SIGNATURE