RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

COMPLETED PROFORMA FOR REGISISTRATION OF

SUBJECT FOR DISSERTATION

TITLE: A COMPARATIVE PHARMACEUTICO-ANALYTICAL STUDY OF ABHRAKA BHASMA SAMPLES PREPARED WITH AND WITHOUT AMRITIKARANA

BY

DR.ARYA.S.VARMA

MD (AYU) SCHOLAR,

RASASHASTRA DEPARTMENT

MUNIYAL INSTITUTE OF AYURVEDA

MANIPAL

GUIDE

DR. DINESH NAYAK, M.D. (AYU)

PROFESSOR,

DEPT. OF RASASHASTRA AND BHAISHAJYA KALPANA,

MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES,

MANIPAL

GO-GUIDE

DR. SATHYANARAYANA B, M.D (AYU)

PRINCIPAL AND H O D,

DEPT. OF RASASHASTRA AND BHAISHAJYA KALPANA,

MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES,

MANIPAL

2008-2009

Muniyal Institute Of Ayurveda Medical Sciences,

Manipal

1) Name of the Candidate :DR.ARYA.S.VARMA

Permanent Address :ANANTHASREE,

ARYANCODE,

OTTASEKHARAMANGALAM.P.O

NEYYATTINKARA

THIRUVANANTHAPURAM DIST

KERALA STATE

2) Name of the institution :MUNIYAL INSTITUTE OF

AYURVEDA MEDICAL SCIENCES,

MANIPAL.

3) Course of study & Subject : MD(AYU) RASASHASTRA

4) Date of admission of course : 25TH JULY 2008

5) Title of the topic : A COMPARATIVE

PHARMACEUTICO-ANALYTICAL

STUDY OF ABHRAKA BHASMA

SAMPLES PREPARED WITH

AND WITHOUT AMRITIKARANA.

6) Brief Resume of Intended Work:

6.1) Need for the study: Abhraka Bhasma is a very popularly used preparation in Ayurveda either as a single drug or in several formulations.Processes of Abhraka are referred as Pancha Samskara, Mārana and Amritikarana being important among them in relation to the therapeutic application. Amritikarana is a special process mentioned to eliminate residual toxicity of Abhraka Bhasma. Even after subjecting Dhānyabhraka to the specified number of Putas and the appearance of all Bhasma lakshanas , Amritikarana is advised. Lohitikarana is a process mentioned to regain the original colour of Abhraka Bhasma that may be lost after Amritikarana. Eventhough there are several studies on Abhraka Bhasma, importance of Amritikarana and Lohitikarana are yet to be scientifically evaluated. Hence ,it was decided to take up to work to evaluate the samples of plain Abhraka Bhasma, Abhraka Bhasma with Amritikarana alone and Amritikarana and Lohitikarana both. Scientific evaluation of the samples prepared as per the Standard Operative Procedure by considering suitable physico-chemical parameters is expected to add considerable inputs to the existing knowledge.

6.2) Review of Literature:

-Various textual references of Shodhana1 and Mārana as mentioned in the classics will be discussed. Krishna Vajrabhraka sample that has been selected is qualitatively certified as per the classical and modern analytical parameters.

-The description of Dhānyabhraka Nirmana2 is an intermediary process and its reference is being quoted in classics.

-Different methods of Mārana3of Abhraka are being told in the classics and an authentic reference as per AFI is selected for the present study

-Various drugs viz Māraka gana’s 4 are been also mentioned in Rasa Tarangini.

-Lohitikarana5 is an essential stage before carrying out Amritikarana , as per the reference in Rasa Tarangini.

-Various references of Amritikarana6 of Abhraka are told and reference of Āyurveda Prakāsa is being selected.

·  Previous Work Done:

i) Abhraka Mahanibandha - Mishra.A.D, Ipgt&Ra,Jamnagar

ii) Abhraka Vijnanam-Sharma H.C,Ipgt& Ra,Jamnagar(1961)

iii)Easier And Shorter Method Of Preparation Ofabhraka Bhasma - Namboothiri.M.N.S. ,IPGTRA,Jamnagar(1969)

iv) A Comparative Pharmaco-Chemical Study On Abhraka Bhasma & Abhra Garbhapottali -Pati.R.T, IPGTRA, Jamnagar(1996)

v)Comparative study on Abhraka Satvabhasma -Maheswar.T, Banaras Hindu

University(1997)

vi)Pharmaceutical&Pharmaco-therapeutic studies on Abhraka Bhasma with

special reference to Amlapitta -Joshi.D, Banaras Hindu University(1973)

vii)Study on Satvapatana with special reference to Abhraka & Makshika -

Jha.C.B, Banaras Hindu University(1992)

viii)Abhraka Par Gaveshanatmaka Adhyayan -Pandya.S.S.

M.M.M.Govt.Ayurveda college,Udaipur.(1976)

ix)Various methods of Abhraka Shodhana and its chemical analysis-

Joshi(Ms).S.V ,Tilak Ayurveda Mahavidyalaya,Pune

x)A study of effect of heat on Abhraka for confirmation of its varieties and to

study the significance of odour in Abhraka classification - Mane.R.G. ,Tilak

Ayurveda Mahavidyalaya Pune

xi)Study on Abhraka with special reference to Dhānyabhraka- Dr.V

Shreeshananda Sharma ,RGUHS,Karnataka

6.3) Objective of the study:

1)  To carry out the literary review of the concepts of Shodhana, Mārana, Lohitikarana and Amritikarana and a detailed review of these concepts with regard to Abhraka as per textual references.

2)  To prepare Abhraka Bhasma by giving importance to quantum of heat by standardizing weight and number of cow dung, measuring the heat with Pyrometer and IR remote thermometer.

3)  To find out any changes in the observational samples

4)  To conduct an analytical study of 3 samples of Abhraka Bhasma viz;

a) Sample availed immediately after Mārana

b) Sample availed after the process of Amritikarana

c) Sample availed after the process of Amritikarana and Lohitikarana

5)  To carry out Acute Toxicity Study of above samples in compliance with OECD Guidelines-423(Acute Oral Toxicity-Acute Toxic Class Method) and the Standard Operating Procedures of CEFT,SRU

7.0) Materials & Methods:

7.1) Source of the Data:

Collection of the raw drugs and preparation of the medicine samples,will be carried out in at Muniyal Ayurvedic Research Centre attached to the Muniyal Institute of Ayurveda Medical Sciences, Manipal.

7.2) Method of Data Collection:

-This is a pharmaceutico-analytical study in which the preparation of Abhraka Bhasma under various stages after it undergoes proper purification and gets subjected to an intermediatory process called Dhānyabhraka..

-Shodhana of Vajrabhraka is done by Nirvapana in Godugdha or Triphala Kwatha for 7 times.

-Dhanyabhraka nirmana:Shodhita abhraka is bundled in a woolen bag with 1/4 quantity of paddy which is kept immersed in kanjika for a day.This is rubbed and the sediment is collected.

-The Mārana will be carried out as per the AFI’ standards.

-Dhanyabhraka is given Bhavana in Ravimoola kwatha , Nyagrodha moola kwatha, Kadali rasa and seven ,three and seven Gaja Putas are given respectively.

-Amritikarana is done by heating Abhraka Bhasma along with Triphala Kwatha and Goghritha in an Iron pan till the moisture content is lost.

-Lohitikarana is carried out by bhavana in Rakta varga dravyas and two Gaja putas are given.

-The observations of the pharmaceutical study at various stages will be observed and documented.

-All the samples availed will be assessed by physical and chemical analytical parameters and comparative study will be done.

Assessment criteria:

1. Analytical study:

All the 3 samples will be subjected to the following analytical study:

a) Organoleptic characteristics like colour, taste, odour, touch etc

b) Bhasma Pareeksha mentioned in classics.

c) Physico-chemical analysis

i)Loss on drying

ii)Ash value(Total &Acid Insoluble)

iii)Solubility in Alcohol &Water

iv)Particle Size Consistency

v)Qualitative chemical tests for silicates,calcium,Magnesium,Aluminium and Iron.

vi)pH value d)Qualitative and quantitative analysis with relevant instrumental methods like,

-X-Ray Diffraction

-SEM-EDAX

-ICP-MS

II. Toxicity Study

A comparative acute toxicity study of all the three samples will be done in compliance with OECD Guidelines-423(Acute Oral Toxicity-Acute Toxic Class Method)7,8,9,10,11,12,13,14,15,16,17,18 and the Standard Operating Procedures of CEFT, SRU

7.3) Does the study require any investigation or any intervention to be conducted on Patient or other humans or animals: YES

7.4) Has ethical clearance been obtained from your institution?: Animal study will be carried out at Centre for Toxicology and Developmental Research (CEFT),Sri Ramachandra University, Chennai

8) List of REFERENCES

1.  Acharya Sri Sadananda Sharma,Rasa Tarangini by Pandit Kashinath Shastry,11th edition,Motilal Banarasidas,New Delhi,2004,10th chapter,Shloka No. 20

2.  Acharya Sadananda Sharma ,Rasa Tarangini by Pandit Kashinath Shastry,11th edition,Motilal Banarasidas,New Delhi,2004,10th,chapter,Shloka No.26-28.

3.  Anonymous,AYURVEDIC FORMULARY OF INDIA,The controller of Publications,Civil Lines,New Delhi,Part 1,18/1,Shloka No.39-42

4.  Acharya Sri Sadananda Sharma, RasaTarangini by Kashinath Shastry,11th edition,Motilal Banarasidas,New Delhi,2004,10th chapter,Shloka No.56-64.

5.  Acharya Sri Sadananda Sharma, Rasatarangini by Pandit Kashinath Shastry,11th edition,Motilal Banarasidas,New Delhi,2004,10th chapter,shloka No.65-67

6.  Acharya Madhava, Ayurveda Prakasha by Sri Gulraj Sharma Pandit Shiv Sharma,4th edition 1994,Chaukhamba Bharati Acadamy Varanasi,2nd chapter,Shloka No.235

7.  Roll R., Höfer-Bosse Th. And Kayser D. (1986). New Perspectives in Acute Toxicity Testing of Chemicals, Toxicol. Lett., Suppl. 31, 86

8.  Roll R., Riebschläger M., Mischke U. and Kayser D. (1989). Neue Wege zur Bestimmung der akuten Toxizität von Chemikalien. Bundesgesundheitsblatt 32, 336-341.

9.  Diener W., Sichha L., Mischke U., Kayser D. and Schlede E. (1994). The Biometric Evaluation of the Acute-Toxic-Class Method (Oral). Arch. Toxicol. 68, 559-610

10.  Diener W., Mischke U., Kayser D. and Schlede E. (1995). The Biometric Evaluation of the OECD Modified Version of the Acute-Toxic-Class Method (Oral). Arch. Toxicol. 69, 729-734.

11.  Diener W., and Schlede E. (1999) Acute Toxicity Class Methods: Alterations to LD/LC50 Tests. ALTEX 16, 129-134

12.  Schlede E., Mischke U., Roll R. and Kayser D. (1992). A National Validation Study of the Acute-Toxic- Class Method – An Alternative to the LD50 Test. Arch. Toxicol. 66, 455-470.

13.  Schlede E., Mischke U., Diener W. and Kayser D. (1994). The International Validation Study of the Acute- Toxic-Class Method (Oral). Arch. Toxicol. 69, 659-670.

14.  OECD (2001) Guidance Document on Acute Oral Toxicity Testing. Environmental Health and Safety Monograph Series on Testing and Assessment N. 24. Paris.

15.  OECD (2000) Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Monograph Series on Testing and Assessment N 19.

16.  OECD (1998) Harmonized Integrated Hazard Classification System For Human Health And Environmental Effects Of Chemical Substances as endorsed by the 28th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals in November 1998, Part 2, p. 11

17.  Lipnick R L, Cotruvo, J A, Hill R N, Bruce R D, Stitzel K A, Walker A P, Chu I; Goddard M, Segal L, Springer J A and Myers R C (1995) Comparison of the Up-and Down, Conventional LD50, and Fixed Dose Acute Toxicity Procedures. Fd. Chem. Toxicol 33, 223-231.

18.  Chan P.K. and A.W. Hayes. (1994). Chap. 16. Acute Toxicity and Eye Irritancy. Principles and Methods of Toxicology. Third Edition. A.W. Hayes, Editor. Raven Press, Ltd., New York, USA.