RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BENGALURU.
SYNOPSIS BY
DR. RASHMIKALA H.B.
FOR THE DEGREE OF AYURVEDA VACHASPATI
M.D. (AYURVEDA) IN RASASHASTRA
TITLE OF THE TOPIC
PHARMACEUTICO-ANALYTICAL & EXPERIMENTAL EVALUATION OF ANTI-HYPERLIPIDEMIC ACTIVITY OF TAMRA BHASMA PREPARED BY
HANDIKA METHOD
NAME OF THE INSTITUTE
GOVERNMENT AYURVEDIC MEDICAL COLLEGE,
DHANWANTARI ROAD,
BENGALURU-560009
KARNATAKA
From,
DR. RASHMIKALA H.B.
I year M.D. (Ayu) Scholar,
Department of Post Graduate Studies in Rasashastra,
Government Ayurvedic Medical College,
Bengaluru.
To,
THE REGISTRAR
Rajiv Gandhi University of Health Sciences,
Bengaluru, Karnataka.
Through,
The Principal and HOD of Post Graduate Studies in Rasashastra.
Government Ayurvedic Medical College,
Bengaluru.
Respected Sir,
Sub- Submission of completed Proforma for Registration of subject for dissertation.
I request you to kindly register the below mentioned synopsis against my name for the submission for dissertation to the Rajiv Gandhi University of Health Sciences, Bengaluru for partial fulfilment of M.D (Ayu) Rasashastra.
TITLE OF DISSERTATION
PHARMACEUTICO-ANALYTICAL & EXPERIMENTAL EVALUATION OF ANTI-HYPERLIPIDEMIC ACTIVITY OF TAMRA BHASMA PREPARED BY HANDIKA METHOD
Here with, I am enclosing completed proforma for registration of the subject for dissertation.
Thanking you,
Place- Bengaluru Your’s sincerely,
Date-
(Dr. Rashmikala H.B.)
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BENGALURU, KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. Name of the Candidate and ResidentialAddress / DR. RASHMIKALA H. B.
I year M.D.(Ayu) Scholar,
Dept. Of PG Studies in Rasashastra,
Government Ayurvedic Medical College,
Bengaluru-560009
------
DR. RASHMIKALA H. B.
D/O Basappa D.K.
Hosur Village and Post,
Yasalur Hobli, Sakaleshpur Taluk,
Hassan district, Karnataka-573137
2. Name of the Institution / Government Ayurvedic Medical College,
Dhanwantari Road,
Bengaluru-560009
3. Course of Study and Subject / M.D.(Ayurveda)
RASASHASTRA
4. Date of Admission to the Course / 17-11-2012
5. Title of the Topic / PHARMACEUTICO-ANALYTICAL & EXPERIMENTAL EVALUATION OF
ANTI-HYPERLIPIDEMIC ACTIVITY OF TAMRA BHASMA PREPARED BY
HANDIKA METHOD .
6. BRIEF RESUME OF THE WORK
6.1) NEED FOR THE STUDY
Treatment through metallo-mineral preparations is appraised to be ‘Daivi chikitsa’ and Rasaushadhis are rightly said so because of the unique qualities they possess like quicker recovery from disease, effectiveness even in smaller dosage, long shelf life etc. Rasashastra, the branch of Ayurvedic pharmaceutics emphasizes not just on preparation of cogent medicines but also on its therapeutic usage.
Tamra, being one among metals has wider therapeutic utility with elixir like qualities when prepared rightly. But the toxic nature of Tamra is seen in it’s impure state and is emphasized by the ashta mahadoshas as bhrama, murcha, vidaha, swedana, kledana, vanti, aruchi and chittasantapa1. Therefore, Shodhana, Marana and Amrutikarana are assigned to make it safe & suitable for internal use.
I and enhancing the nectar like properties of Bhasma3 explained in this procedure.
The pharmacodynamics of such superior quality of Tamra bhasma includes madhura, kashaya, tikta and amla rasas, katu vipaka with laghu guna1b.Properties like pitta-kaphahara, lekhana1b, stoulyahara2a makes it clinically efficient in cases like Kushta, Pandu, Krimi, Shopha, Kasa, Shwasa, Kshaya, Amlapitta etc1c. Modern research works too have analysed the role of copper in lipid metabolism. It is also known that the deficiency of copper raises blood cholesterol4. With Hyperlipidemia being a burning problem and also a symptom in many disorders, research works are needed to be carried out to benefit the society.
There are studies carried out on Tamra Bhasma, but till today no study has been carried out to evaluate the significance and importance of method of preparation of Tamra Bhasma by following Handika method.
Hence, in the present study it is planned to prepare Tamra bhasma by Handika1a method, analyse and evaluate experimentally its anti-hyperlipidemic activity in Albino rats.
6.2) REVIEW OF LITERATURE
A) Drug Review
1. Characteristic features of Tamra, Gandhaka, Hingula and other associated drugs will be reviewed and collected from different Rasa and modern texts.
2. Different procedures of Tamra bhasma preparation with method and media will be reviewed & collected from different Rasa texts.
3. Pharmacodynamics, uses and yogas of Tamra Bhasma will be reveiwed from different Ayurveda and Rasa texts.
B) Process Review
· Samanya shodhana of Gandhaka3a.
· Extraction of Parada from shodhita Hingula1d.
· Samanya1e and Vishesha1f Shodhana of Tamra.
· Tamra Marana by using Handika as told in Ayurveda Prakasha1a.
C) Disease Review
Relevant information regarding Hyperlipidemia will be documented to understand its patho-physiology.
D) Experimental Review
All relevant information regarding the method of experimental evaluation of Anti-hyperlipidemic activity will be reviewed and compiled from standard pharmacology texts.
PREVIOUS WORKS DONE
1. Physico-chemical Analysis and Toxicity study of Tamra bhasma prepared with various methods by Dr. Sudeendra V Honawad from RGUHS-2003.
2. Pharmaceutical and analytical study of Tamra parpati by Dr. Gazala Husain from RGUHS-2003.
3. Study of various Tamra Bhasmas- Dr. Rai R K, IMS, BHU, Varanasi-2003.
4. Pharmaco-analytical and chronic toxicity study of Tamra Bhasma by Dr. Morbale Ayurveda Mahavidyalaya, Mangal S from KLES’s BMKAMC , RGUHS-2004.
5. Physico chemical analysis of samanya and vishesha shodhita tamra bhasma and toxicological study of tamra bhasma by Dr. Shambuling V. Teggi from RGUHS-2004.
6. Preparation of Somanathi tamra bhasma and its clinical study in parinama shula by Dr. Gopikrishna M. from SDM college of Ayurveda, Udupi, RGUHS-2004.
7. Preparation and physico-chemical analysis of Bhunaga Satwa Bhasma and its comparative toxicity study with Tamra Bhasma(Market sample) by Dr.Manojkumar Patil from Shri B M Kankanwadi Ayurveda Mahavidyalaya, Belgaum.RGUHS-2005.
8. Preparation and analysis of Tamra Bhasma in various procedures as per Rasa Tarangini by Dr. Anupama G Bijjal from Shri D G Melmalagi Ayurvedic Medical College and Hospital, Gadag.RGUHS-2006.
9. Pharmaceutico-analytical and anti bacterial activity of Tamra Bhasma and Somanathi Tamra Bhasma- A Comparative Study by Dr. Shwetha Singh by JSS Ayurvedic Medical College, Mysore. RGUHS- 2008.
10. Pharmaceutico-analytical Study of Amritikarana w.s.r to Tamra Bhasma- Dr.Archana Kamath from SDM College of Ayurveda, Kuthpady. RGUHS-2008
11. Role of shodhana in the preparation of Tamra bhasma w s r to its Anti- hyperlipidemic activity by Dr. Chandrashekar Jagtap, GAU, Jamnagar-2008.
12. Pharmaceutico –analytical study of Tamra sindoora and its anticonvulsant activity on albino rats an experimental study by Dr.Swaroopa P. From Pandit Taranath Government college Bellary from RGUHS-2009.
6.3) OBJECTIVES OF THE STUDY
To carry out ……
· Shodhana of Gandhaka3a .
· Extraction of Parada from shodhita Hingula1d.
· Samanya1e and Vishesha Shodhana1f of Tamra along with physico-chemical study.
· Bhasmeekarana of Tamra using Handika method1a followed by physico-chemical
analytical study.
· Experimental evaluation of Anti-hyperlipidemic activity of Tamra bhasma in Wistar Albino rats.
7.0 MATERIALS AND METHODS
7.1 SOURCE OF DATA:
a) Source of drug:
Genuine Hingula, Gandhaka and Tamra will be procured from authentic sources and data pertaining to these will be recorded.
b) Preparation of formulation:
Necessary processing of raw materials and preparation will be carried out in
pharmacy section of Post-graduate department of Rasashastra at Government Ayurvedic
Medical College, Bengaluru.
c) Source of animals:
Healthy Wistar Albino rats will be procured from registered animal house.
d) Place of work:
1) Preparation of Tamra bhasma will be carried out in the Department of Rasashastra, Government Ayurvedic Medical College Bengaluru.
2) Basic Analytical Study will be carried out at Accredited Laboratory.
3) Animal study will be carried out at S.D.M Centre for Research in Ayurveda and Allied Sciences, Kuthpady, Udupi-574118.
7.2) METHODS OF COLLECTION OF DATA
a. Literary Data
1) The relevant classical and up to date literature of Tamra bhasma will be collected from Rasa and Ayurveda texts.
2) All relevant and up to date literature and research on Copper including it’s toxicity will be reviewed.
b. Pharmaceutical Data
1) Genuine Gandhaka, Hingula and Tamra will be procured from authentic sources.
2) Shodhana of Gandhaka will be done by Bhudhara yantra method3a.
3) Shodhana of Hingula will be done by giving bhavana with Nimbu swarasa for 1 yama in khalwa yantra followed by extraction of Parada from Hingula will be done by urdwa pathana method1d.
4) Samanya Shodhana of Tamra will be done by heating and dipping in Takra, Kanjika, Gomutra, Tila taila, Kulatta kwatha, successively, 7 times in each media1e.
5) Vishesha Shodhana of Tamra will be done by boiling in Gomutra containing Amla
Kshara dravya for 1 prahara1f.
6) Preparation of Tamra bhasma through Handika Method1a .
Method of Preparation of Tamra bhasma –
Ingredients : Shuddha Tamra -1part
Hingulottha Parada-1/4part
Shuddha Gandhaka-1part
Kanya rasa - Q. S.
Panchamrita - Q. S.
Surana kanda - Q. S.
Procedure : Parada and Gandhaka are triturated for 2 yama till it becomes kajjali. Then mardana with kanyarasa and pisti will be prepared and it is to be applied over Tamra patras and dried.Then the remaining kajjali is to be filled inside the handika & Tamra patra will be kept inside kajjali & closed with sharava ,sandhibandana will be done with ash and jala. The remaining portion of handika will be filled with Common salt /ash till its neck and it will be covered with a lid, sealed, dried and heated in a dridhagni for 4 prahara.
After swanga sheetha, it will be triturated with panchamritha and kept inside surana kanda, covered with kapad mitti and 3 Gaja putas will be given .
c. Analytical Study:
As per the parameters mentioned in assessment criteria, analytical study will be conducted on prepared Tamra bhasma in authorized laboratory.
Assessment Criteria
Prepared drug will be subjected to following tests.
- All Bhasma Parikshas, (Rekhapurnata, Varitara, Apunarbhava, etc.) mentioned in Rasa texts.
1) Organoleptic tests
· Colour
· Taste
· Smell
· Consistency
2) Physico-chemical Analysis
· Loss on drying at 1100C
· Total Ash value
· Acid insoluble Ash value
· Water soluble Ash value
· Determination of pH
3) Chemical Tests
Qualitative and Quantitative estimation of elements present.
4) Special Instrumental Methods
XRD
SEM-EDAX
d) Experimental Study
Methodology for animal studies:
Animals required : Wistar albino rats
Animal storage condition :The animals will be housed in a well ventilated room, under standard husbandry conditions, fed with standard rodent pellet diet and tap water ad libitum.
Inclusive criteria : Normal adult wistar albino rats of either sex weighing between 150-200 gm
Exclusive criteria: 1. Rats with detectable deformities
2. Underweight/obese rats
3. Pregnant rats
Dose - The human dose of test drug will be converted into animal dose by using standard
dose converting formula 6 :
Rat Dose = Human dose x Surface area factor 0.018 x 5 (gives per kg body weight dose).
Mode of administration – Orally.
Grouping : 5 Groups are selected with 6 animals in each group.
GROUP 1 / Normal Control rats receive distilled water (NC)GROUP 2 / Cholesterol control rats administered with hyperlipidemic diet (CC)
GROUP 3 / CC + Tamra bhasma 1 TED(5.625mg/kg body weight )
GROUP 4 / CC + Tamra bhasma ½ TED (2.8125mg/kg body weight)
GROUP 5 / CC + Tamra bhasma 2 TED(11.25mg/kg body weight)
· EVALUATION OF ANTI-HYPERLIPIDEMIC ACTIVITY5
Parameters to be evaluated -
1. Ponderal changes: - Body weight
- Weight of liver, heart and kidney
2. Biochemical parameters : - Lipid Profile
- Liver Function Tests
- Kidney Function Test
- Blood sugar
3. Histopathology study of liver, heart, kidney and aorta
Evaluation of the Drug Action -
· The selected rats of either sex will be assigned to 5 groups
· In group I, only water & normal diet will be administered without Hyperlipidemic diet.
· In group II, only Hyperlipidemic diet will be administered.
· For group III, IV, & V Hyperlipidemic diet & drug will be given for 25 days as mentioned in table. On 26th day, after overnight fasting the rats will be sacrificed, blood investigation will be done.
· The liver, kidney & heart will be excised out from sacrificed animal, weighed & transferred to fixing solution for histopathological examinations.
Clinical observation –
Rats of all the groups will be observed clinically for general physiological activities like-feed, water intake, general behaviour, alertness, bowel habits, and change in body weight.
· Statistical Analysis –
Analysis is done by one way ANOVA followed by Dennett’s multiple ‘t’ Test.
7.3 Does the study require any investigation or intervention conducted on patient or other humans or animals? If please describe.
Yes.
7.4 Has ethical clearance has been obtained from your institution in case 7.3?
Yes, applied for ethical clearance.
8. LIST OF REFERENCES
1) Sri Madhava, Ayurveda Prakasha, Arthavidyotini and Arthaprakasini Sanskrit and Hindi Commentaries by Vaidya Vachaspati Sri Gulrajsharma Mishra, 2nd edition Chaukhamba Bharati Academy,3rd chapter,verse-116, page no 368.
1a) ibid 3rd chapter, verses-129-133, page no 369-370.
1b) ibid 3rd chapter, verse-145, page no 373.
1c) ibid 3rd chapter, verse-146, page no 373.
1d) ibid 2nd chapter, verses 83-85, page no 277.
1e) ibid 3rd chapter, verse-48, page no 355.
1f) ibid 3rd chapter, verses-119-120, page no 368.
2) Vagbhatacharya. Rasa RatnaSamucchaya- edited by Dr.Kapidev Giri, translated by Dr.Indra Dev Tripathi with “Rasaprabha” Hindi commentary, edition: reprint 2009. Chaukamba Publications, 5th Chapter,Verse 13, page no 53.
2a)ibid,5th Chapter Verse-46, page no 57.
3) Sri Sadanand Sharma , Rasa Tarangini, edited by Pandit kashinath shastry , 2000 edition. Published by Motilal Banarasidas , Delhi. Taranga-2, verse-58.page no 24.
3a)ibid 8th Taranga, Verses 13-17,page no 177.
4) Klevay.met.al.2000.
5) Pharmaceutical standardization of Tamra Bhasma & to evaluate its Antihyperlipidemic and cardio protective activity in experimental models by Dr.Suhas V Nayak Dept. of RS & BK ,Inst for PG teaching and research in Ayurveda Gujarat Ayurveda university, Jamnagar.
Jan-2009.
6) Ghosh M.N, Fundamentals of experimental pharmacology, Chapter 30, 3rd edition, Kolkota, Hilton and Company, 2005, p-192.
9. SIGNATURE OF THECANDIDATE
10. REMARKS OF THE GUIDE
11. NAME AND DESIGNATION OF
THE GUIDE / DR. SRINIVAS. YADAV. K B.A.M.S, M.D(Ayu)
ASSISTANT PROFESOR,
Dept. of Rasashastra,
Government Ayurvedic Medical College,
Bengaluru.
11.1 SIGNATURE OF THE GUIDE
11.2 CO-GUIDE (IF ANY) / DR B. RAVISHANKAR Ph.d (pharmacology)
DIRECTOR,
S.D.M Centre For Research In Ayurveda
And Allied Sciences, Kuthpady
Udupi – 574118
11.3 SIGNATURE OF THE COGUIDE
11.4 NAME AND DESIGNATION OF
HOD / DR. SHOBHA.G.HIREMATH. M.D.(AYU), PhD(R.S) BHU
PROFESSOR & H.O.D,
Dept. of P.G Studies in Rasashastra,
Government Ayurvedic Medical College,
Bengaluru.
11.5 SIGNATURE OF HOD
12
12.1 REMARKS OF THE PRINCIPAL
12.2 SIGNATURE OF THE
PRINCIPAL
4