Zingiber officinale




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Influence of hydroalcoholic extract of zingiber officinale(Rosc) on anti-diabetic effect of pioglitazone and anti-hypertensive effect of amlodipine.

M. Pharmacy Dissertation Protocol Submitted to

Rajiv Gandhi University of Health Sciences, Karnataka

Bangalore – 560 041.
By

Mr.PRAKASH.L B.Pharm

Under the Guidance of



Prof. KALYANI DIVAKAR, M.Pharm. (PhD)

H.O.D OF PHARMACOLOGY





P.G. Department of Pharmacology,

Acharya & B.M.Reddy College of Pharmacy,

Soldevanahalli, Chikkabanavara (Post)

Hesaraghatta Main Road, Bangalore – 560090.
2007-08

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION




1

Name of the candidate and address



Mr. PRAKASH.L

S/O Sri Lingappa.R

#301,Rudreshwara Nilaya,

Nagavarapalya,

C.V.Raman Nagar Post,

Bangalore-560093.




2

Name of the institution

Acharya & B.M. Reddy College Of Pharmacy.

Soldevanahalli, Hesaraghatta Road, Chikkabanavara (Post),

Bangalore -560090.

Phone No: 080-65650815



3

Course of study and subject

M. PHARMA.

PHARMACOLOGY.


4

Date of admission

June - 2007.




5

Title of the topic

Influence of hydroalcoholic extract of zingiber officinale (Rosc) on anti-diabetic effect of pioglitazone and anti-hypertensive effect of amlodipine.






6.

Brief resume of intended work


6.1 Need of the work
6.2 Review of Literature
6.3 Objectives of the study

Enclosure I


Enclosure II
Enclosure III


7.

Materials & Methods


7.1 Source of data
7.2 Methods of collection of data ( Including sampling ,procedure if any)
7.3 Does the study require investigation on animals?

If yes give details


7.4 Has ethical clearance been obtained from your institution in case of 7.3

Enclosure IV


Enclosure V

Enclosure VI


Yes (Copy Enclosed)




8.

List of references


Enclosure VII





9.

Signature of the candidate








10.

Remarks of the guide







11.

Name & Designation of


11.1 Guide

11.2 Signature of Guide


11.5 Head of the Department

11.6 Signature of HOD




Prof. Kalyani Divakar M.Pharm. (Ph.D)

H.O.D, Department of Pharmacology,

Acharya & B.M.Reddy College of Pharmacy,

Soldevanahalli, Chikkabanavara (Post)

Hesaraghatta Main Road , Bangalore – 560 090

Prof. Kalyani Divakar M.Pharm. (Ph.D)

H.O.D, Department of Pharmacology,

Acharya & B.M.Reddy College of Pharmacy,

Soldevanahalli, Chikkabanavara (Post)

Hesaraghatta Main Road , Bangalore– 560 090




12.

Remarks of the Principal

12.1 Signature



PRINCIPAL

Dr. DIVAKAR GOLI M.Pharma, Ph.D

Acharya & B. M. Reddy College of pharmacy,

Soldevanahalli, Hesaraghatta main road,

Chikkabanavara (post),

Bangalore-560090.



Enclosure - I
6. BRIEF RESUME OF INTENDED WORK
6.1 NEED OF THE WORK:-

Diabetes mellitus is a metabolic disorder characterized by

hyperglycemia, hyperlipemia, negative nitrogen balance and sometimes ketonemia,

one of the common metabolic disorders and 1.3% of the population suffers from this disease throughout the world.1


Pioglitazone belongs to novel class of oral anti-diabetic drugs they are selective agonists for the nuclear peroxisome proliferators- activated receptor which enhances the transcription of several insulin responsible genes. Pioglitazone lowers serum triglyceride levels and raises HDL levels without much change in LDL levels.2
Hypertension is a clinical condition of persistant raised arterial pressure, primarily due to increased resistance in the systemic circulation.3
Amlodipine is the first line of anti-hypertensive drug, pharmacologically it is most distinct dihydropyridine (DHP) derivative and act by blocking Ca2+ channel.2
Drugs are used to prevent, diagonise, to treat, or to cure many diseases disorders. However, they must be used safely with precaution to ensure that they are safe and effective. Many drugs owes to interacts with the body in different ways, like with our daily diet or lifestyle, which has great significant impact on a drug's ability to show its effects which may be enhanced or decreased.
An extensive literature survey from all scientific sources revealed that zingiber officinale(Rosc) has anti-diabetic and anti-hypertensive activity. But the influence of the crude drug with diabetic and hypertensive patients who are under treatment is not clear. Hence the present study is planned to find out the influence of hydroalcoholic extract of zingiber officinale(Rosc) with various doses on the anti-diabetic effect of pioglitazone and anti-hypertensive effect of amlodipine.


Enclosure – II

6.2 REVIEW OF LITERATURE:-



Zingiber officinale-Rosc. (Ginger)

It consists of fresh rhizomes of zingiber officinale(Rosc) belonging to the family zingiberaceae.4



SYNONYMS:-5

HINDI - ADRAK

KANNADA - SHUNTI

BENGALI - ADA

TAMIL - INJI

TELUGU - SONTI
DESCRIPTION OF THE PLANT:-6

A perennial herb with a subterranean, digitutely branched rhizome producing stems up to 1.5 cm in height with linear lanceolate sheathing leaves (5-30 cm long and 8-20 mm wide) that are alternate, smooth and pale green. Flower stems shorter than leaf stems and bearing a few flowers each surrounded by a thin bract and situated in axils of large, greenish yellow obtuse bracts, which are closely arranged at end of flower stem forming collectively an ovate oblong spike.


DESCRIPTION OF PLANT MATERIAL OF INTREST:-6

Ginger occurs in horizontal, laterally, irregularly, branching piece 3-16 cm long, 3-4 cm wide, up to 2 cm thick, somewhat fibrous branches known as “fingers” Arise obliquely from the rhizome, are flattish, obovate, short, about 1-3 cm long fracture short and starchy with projecting fibers.


GEOGRAPHICAL DISTRIBUTION:-6

The plant is probably native to south East Asia and is cultivated in the tropical regions in both the eastern and western hemispheres. It is commercially grown in Africa, China, India and Japan. India is the world’s largest producer.




CHEMICAL CONSTITUENTS:-6

Rhizome contains 1-4% essential oil and oleoresin, sesqiterpenes hydrocarbons (responsible for aroma). These compounds includes (-)-Zingiberene,

(+)-arcurcume, (-) β- sesquiphellandrene and β- bisaboline , monoterpene aldehyde and alcohols.
Traditional Therapeutic Uses:-

Uses described in folk medicine:- Used in the treatment of cataracts, insomnia, baldness, Antibacterial, Dyspepsia, flatulence, colic, vomiting, diarrhoea, narcotic antagonist, migraine, rheumatic disorders.
Therapuetic uses with scientific support:-


  1. Gingerol inhibits metastasis of MDA-MB-231 human breast cancer cells.7



  2. Zingiber officinale Roscoe prevents acetaminophen-induced acute hepatotoxicity by enhancing hepatic antioxidant status.8




  1. Zingiber officinale Roscoe alone and in combination with α-tocopherol protect the kidney against cisplatin-induced acute renal failure.9




  1. Anti-allergic activity of some selected plants in the Zingiberaceae family.10




  1. Antioxidant activity of a ginger extract (Zingiber officinale).11



  2. In vivo anthelmintic activity of ginger against gastrointestinal nematodes of sheep.12



  3. The modulatory effects of the volatile oil of ginger on the cellular immune response in vitro and in vivo in mice.13



  4. Beneficial effects of Zingiber officinale on goldthioglucose induced obesity.14



  5. The efficacy of ginger for the prevention of postoperative nausea and vomiting: A meta-analysis.15




  1. Effect of ethanolic extract of Zingiber officinale on dyslipidaemia in diabetic rats.16



  2. Comparative evaluation of hypoglycemic activity of some Indian medicinal plants in alloxan diabetic rats.17



  3. Antiemetic efficacy of ginger (Zingiber officinale) against cisplatin-induced emesis in dogs.18



  4. Effect of ginger (Zingiber officinale Rosc.) and fenugreek (Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients with coronary artery disease.19




  1. Ginger treatment of hyperemesis gravidarum.20



  2. Ginger (zingiber officinale) in migraine headache.21

16. Ginger Lowers Blood Pressure Through Blockade of Voltage-Dependent



Calcium Channels.22
17. Analgesic, antiinflammatory and hypoglycaemic effects of ethanol extract of

Zingiber officinale (roscoe) rhizomes (zingiberaceae) in mice and rats.23

Enclosure – III
6.3 OBJECTIVES OF THE STUDY:-

  • Extraction with hydroalcohol.

  • Preliminary Phytochemical analysis.

  • To study the Influence of hydroalcoholic extract of zingiber officinale(Rosc) on anti- diabetic effect of pioglitazone and anti-hypertensive effect of amlodipine.


Enclosure – IV
7. Materials and Methods:-
7.1 SOURCE OF DATA:-

        The source of data will be obtained from experiments which involves:-

  1. Laboratory based studies

  2. Literature survey, CD ROM, Chemical abstracts

  3. National & International Journal

  4. Text books.

  5. Internet.

  6. Journal of ethno pharmacology.

  7. Indian journal of pharmacology.

  8. Phytomedicine.


Enclosure – V

7.2 METHOD OF COLLECTION OF DATA

(including sampling procedure if any):-
Field and laboratory studies:-

Field work:-

The fresh rhizome of Zingiber officinal(Rosc) will be collected, and it will be authenticated.


Laboratory work:-

Animals

Male Wistar albino Rats (150-250 gm) will be selected for Anti-diabetic and Anti-hypertensive activity. They will be housed in cages on a 12-h light:12-h dark cycle and will be allowed free access to laboratory diet.

 

Solvents used:-

Ethanol, Distilled water.



Chemicals and reagents used:-

Alloxan monohydrate, Fructose, Pioglitazone, Amlodipine, Commercial assay kits.


Phytochemical analysis:-

Phytochemical constituents will be detected by phytochemical tests as per Kokate C.K.24


Pharmacological studies:-

Animal experimental models will be devised to assess the anti-diabetic

activity and anti-hypertensive activity.
Data analysis:-

Statistical analysis of the data will be evaluated by analysis of variance (ANOVA).



Methodology:-

  1. Extraction24

The fresh rhizomes of Zingiber officinale(Rosc) will be collected and crushed. It will be extracted with hydroalcoholic solvent in percolator to get sufficient crude extract. Extract is subjected to get concentrated product, then used to study the influence of Zingiber officinale(Rosc) on anti-diabetic effect of pioglitazone and anti-hypertensive effect of amlodipine.
(2) Pharmacological study design:-
I . Evaluation of Anti-diabetic activity on alloxan induced diabetic rats25

Rats of Wistar strain weighing 150–200 g are injected S.C with 100–175 mg/kg alloxan. Rats showing fasting blood glucose level above 150 mg/dL will be selected for the study.
Rats will be divided into seven groups each consisting of six animals.

Group 1: Normal control.

Group 2: Diabetic control.

Group 3: Pioglitazone 3 mg/kg.

Group 4: Hydroalcoholic extract of zingiber officinale (400 mg/Kg)23.

Group 5: Hydroalcoholic extract of zingiber officinale (800 mg/Kg)23.

Group 6: Hydroalcoholic extract 400 mg/Kg + pioglitazone (3 mg/Kg)27.

Group 7: Hydroalcoholic extract 800 mg/Kg + pioglitazone (3 mg/Kg)27.




ESTIMATION OF BIOCHEMICAL PARAMETERS:-

Following Bio-chemical parameters will be estimated using commercial

assay kit:-17


  • Blood glucose level.

  • Total cholesterol.

  • HDL.

  • LDL.

  • VLDL.

  • Triglycerides.

  • Serum albumin.

  • Total protein.


II . Evaluation of Anti-Hypertensive activity on Fructose induced hypertensive rats:-26

Male wistar weighing 210-250 g will be used and drinking fluid of animals consists of 10% fructose solution. Body weight, pulse rate and systolic blood pressure (SBP) will be measured every 3 days. once after induction of hypertension fructose will be not continued as drinking fluid.


Rats will be divided into seven groups consisting of six animals.

Group 1: Normal control.

Group 2: Hypertensive control.

Group 3: Amlodipine 1 mg/kg.

Group 4: Hydroalcoholic extract of zingiber officinale (3 mg/Kg).22

Group 5: Hydroalcoholic extract of zingiber officinale (6 mg/Kg).22

Group 6: Hydroalcoholic extract 3 mg/Kg + Amlodipine (1 mg/Kg).28

Group 7: Hydroalcoholic extract 6 mg/Kg + Amlodipine (1 mg/Kg).28


MEASUREMENT OF BLOOD PRESSURE:-26

Systolic blood pressure and heart rate body weight will be measured using standard method. The blood samples will be analyzed for total cholesterol (LDL,HDL,VLDL) serum urea, serum cholesterol and serum triglycerides level by using commercial assay kit.



Number of groups of animals required:-


Model

Name

Control

 

 



Negative Control 

Standard Drug

Hydroalcoholic Extract Of Ginger

Hydroalcoholic Extract + Drug

Total

No

Low

dose


High dose

Low

dose


High

dose


Alloxan induced diabetes

Group

I


Group

II


Group

III


Group

IV


Group

V


Group

VI


Group

VII





No. of

animals


6

 


6

6

6

6

6

6

42


Fructose induced hyper tension

Group

I


Group

II


Group

III


Group

IV


Group

V


Group

VI


Group

VII


 

 

 



No. of

animals


6

6

6

6

6

6

6

42
Total no of wistar albino rats = 84

ENCLOSURE – VI
7.3 Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please describe briefly.

Yes, The above study requires investigation on animals.


7.4 Has ethical clearance been obtained from your institution in case of 7.3?

The study is cleared from Ethical Committee of the institution. (Certificate enclosed).



ENCLOSURE – VII

8. REFERENCES: -

  1. Goodman and Gilman. The pharmacological Basic of Therapeutics. 10th ed. New York: GrawHill Medical Publishing Division; 2001:1639-1640.

  2. K.D.Tripathi. Essentials of medical pharmacology. 5th ed. New Delhi: Jaypee brothers medical publishers (p) Ltd:235-253.

  3. Salil K Bhattacharya, Parantapa Sen, Arunabha Ray. Pharmacology. 2nd ed:131.

  4. S.S Agarwal, B.Ptamrakar, M.Paridhavi. clinically useful herbal drugs. 1st ed. Delhi: Ahuja Publishing House; 2005:193.

  5. Pulak. K.Mukherjee. Qualitity control of Herbal drugs An approach to evaluation of botanical.Pharmacological Screening of herbal drugs:562-571.

  6. WHO Monographs On Selected Medicinal Plants.1st ed. Aitbs Publishers, India; 2005: 277-287.

  7. Hyun Sook Lee, Eum Young Seo, Nam E Kong, Wao Kyung Kin. Gingerol inhibits metastasis of MDA-MB-231 human breast cancer cells. The Journal of Nutritional Biochemistry August 1 2007. Available from URL:http://www.science direct.com.

  8. T.A. Ajith, U. Hema, M.S. Aswath, Zingiber officinale Roscoe prevents acetaminophen-induced acute hepatotoxicity by enhancing hepatic antioxidant status. Food and Chemical Toxicology June 9 2007. Available from URL:http://www.science direct.com.

  9. T.A. Ajith, V. Nivitha, S. Usha, Zingiber officinale Roscoe alone and in combination with α-tocopherol protect the kidney against cisplatin-induced acute renal failure. Food and Chemical Toxicology June 2007; 45(6): 

921-927.

  1. Supinya Tewtrakul and Sanan Subhadhirasakul. Anti-allergic activity of some selected plants in the Zingiberaceae family. Journal of Ethnopharmacology February 12 2007; 109(3):535-538.

  2. I. Stoilova, A.Krastanor, A.Stoyanova, P.Denev, S.Gargova. Antioxidant activity of a ginger extract (Zingiber officinale). Food Chemistry 2007; 102(3):764-770.

  3. Zafar Iqbal, Muhammed Lateen, Muhammed Shoji Akthar, Muhammed Nabeel Ghayur, Anwarul Hassan Gilani. In vivo anthelmintic activity of ginger against gastrointestinal nematodes of sheep. Journal of Ethnopharmacology June 30 2006;106(2):285-287.

  4. Hua-li Zhou, Yang-mei Deng, Qiang-min Xiem. The modulatory effects of the volatile oil of ginger on the cellular immune response in vitro and in vivo in mice. Journal of Ethnopharmacology April 21 2006;105(1-2):301-305.

  5. Ramesh K. Goyal and Sanjay V. Kadnur. Beneficial effects of Zingiber officinale on goldthioglucose induced obesity. Fitoterapia April 2006;108(2):160-163.

  6. Nathorn Chaiyakunapruk, Nantawarn kitikannallorn, Surakit Nathisuwan, Kittiboon Leeprakobboon, Chutchai Leelasettagool. The efficacy of ginger for the prevention of postoperative nausea and vomiting: A meta-analysis. American Journal of Obstetrics and Gynecology January 2006;194(1):95-99.

  7. Uma Bhandari, Raman kanojia and K.K. Pillai. Effect of ethanolic extract of Zingiber officinale on dyslipidaemia in diabetic rats. Journal of Ethnopharmacology February 28 2005;97(2):227-230.

  8. Ajit Kar, B. K. Choudhary and N. G. Bandyopadhyaym. Comparative evaluation of hypoglycaemic activity of some Indian medicinal plants in alloxan diabetic rats. Journal of Ethnopharmacology January 2003;84(1):

105-108.

  1. S. S. Sharma, V.Kochupillai, S.K Gupta, S.D.Seth, Y.K.Gupta. Antiemetic efficacy of ginger (Zingiber officinale) against cisplatin-induced emesis in dogs. Journal of Ethnopharmacology July 1997;57(2):93-96.

  2. A. Bordia, S. K. Verma and K. C. Srivastava. Effect of ginger (Zingiber officinale Rosc.) and fenugreek (Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients with coronary artery disease. Prostaglandins,Leukotrienes and Essential Fatty Acids May 1997; 56(5):379-384.

  3. Wiggo Fischer-Rasmussen, Susanne K Kjaer, Claus Daul, Ulla Asping. Ginger treatment of hyperemesis gravidarum. European Journal of Obstetrics & Gynecology and Reproductive Biology January 4 1991;38(1):19-24.

  4. T. Mustafa and K. C. Srivastava. Ginger (zingiber officinale) in migraine headache. Journal of Ethnopharmacology July 1990;29(3):267-273.

  5. Ghayur, Muhammed Nabeel, Anwarul Hassan. Ginger Lowers Blood Pressure Through Blockade of Voltage-Dependent Calcium Channels. Journal Of Cardiovascular Pharmacology January 2005;45(1):74-80.

  6. John A. O. Ojewole. Analgesic, antiinflammatory and hypoglycaemic effects of ethanol extract of Zingiber officinale (roscoe) rhizomes (zingiberaceae) in mice and rats. Phisiotherapy research June 28 2006;20(9):764-772. Available from URL:http://www.pubmed.com.

  7. Kokate C.K, Purohit A.P, Gokhale S.B. Pharmacognosy. 8th ed. Nirma Prakasan;2002:395-397.

  8. H.Gehard vogel(Ed). Drug discovery and evaluation. 2nd ed. Springer; 2002: 947-1051.

  9. T.Dimo, A.Rakotonirina, P.V.Tan, E.Dongo, A.B.Dongmo, P.Kantchouing

et al. Antihypertensive effects of Dorstenia psilurus extract in rructose-fed hypeinsulinemic, hypertensive rats. Phytomedicine 2001;8(2):101-106.

  1. Anjaneyulu, M., Ramarao, P. Protective effect of pioglitazone against multiple low-dose streptozotocin-induced diabetes in rats. 2007; Available from URL:http://Prous Science.com.

  2. Li-Ping Xu, Fu-Ming Shen, He Shu, Chao-Yu Miao, Yúan-Ying Jiang, Ding-Feng Su. Synergism of atenolol and amlodipine on lowering and stabilizing blood pressure in spontaneously hypertensive rats. Available online:
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