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1 Acute Oral Toxicity Study on MAKARDHWAJ RASAYAN TABLET OF Sponsor Study Centre: VIRGO UAP PHARMA PVT.LTD. PHARMACOLOGY LABORATORY MAHAGUJARAT IND.ESTATE, SDM CENRE FOR RESEARCH IN PLOT NO. 423/98-B. AYURVEDA AND ALLIED SCIENCES SARKHEJ BAVLA HIGHWAY LAXMI NARAYANA NAGAR, KUTHPADY, VILL MORAIYA, TA SANAND UDUPI DIST AHMEDABAD contact@virgouap.com Web:

2 STUDY REPORT Evaluation of Makardhwaj Rasayan Tablet for safety profile Acute Oral Toxicity Study Project Director Dr. B. Ravishankar Chief Investigator Mr. Ravi M Pharmacology Laboratory SDM Centre for Research in Ayurveda and Allied Sciences, Kuthpady, Udupi

3 INDEX Title Page No. Index 3 Investigators conclusion 4 Details of experiments 5 Materials and methods 6-9 Observation and Results 9-10 Conclusion 12 Data sheets (Proforma records)

4 Acute toxicity study: This study determines acute toxicity of Makardhwaj Rasayan Tablet an oral formulation prepared with suspension of test drug using gum acacia, in rats was assessed for single dose acute toxicity by employing OECD guidelines 425 using AOT software. The dosed (up down as per requirement) rats were observed for 14 days, for general appearance, cage side behaviour including increased or decreasing motor activity, convulsions, straub s reaction, catatonia, muscle spasm, spasticity, ophisthotonus, hyperesthesia, muscle relaxation, anaesthesia, arching and rolling, lacrimation, salivation, diarrheal, writhing movement, mode of respiration and changes in skin colour etc., with mortality and autopsy finding in case of dead animal. Conclusion: The test drug did not produce any mortality up to the dose of 2000mg/kg per oral which is equivalent to 22.4g total dose for a human being weighing 70 kg man. At the dose level studied the drug also did not produce any observable toxic effect except for mild irritation in animal in the dose550mg/kg and 2000mg/kg. Based on the observation made and recorded it can be concluded that the test drug is without any toxic potential even at the dose of 2000mg/kg in animals equivalent to 22.4g for human being. This dose in human being is 32 fold in comparison to normal human dose 0.7g per day. Mr. Ravi M M.Sc (Medical Pharmacology) Research Officer Pharmacology and Toxicology Lab Dr.B. Ravishankar M.Sc (Med Pharmacology)., Ph.D Director and Professor or Exptl Medicine SDM Centre for Research in Ayurveda and Allied Sciences Udupi Karnataka State 4

5 Acute oral toxicity study of test drug Makardhwaj Rasayan Tablet on rats Date of experiment : Acclimatization of animals : 7 days Date of treatment : End of experiment : Observation period : 14 days Regulatory guidelines followed : OECD test guideline No. 425 IAEC approved number : IAEC-12/11-SDMCRA SP/05 5

6 2. Materials methods: 2.1 Details of test formulation: 1. Name of the test formulation : Makardhwaj Rasayan Tablet Makardhwaj Rasayan Tablet- Information about name and quantity of the ingredients Ingredients name Botanical name Part or form Book Ref Quantity used 1. Makardhwaj Powder B.B.R mg 2. Rasasindur ---- Powder B.B.R mg 3. Mallasindur Powder B.B.R mg 4. Jatiphal Myristica fragrans Fruit A.P.I. 20 mg 5. Javantri Myristica fragrans Aerial Part A.P.I. 10 mg 6. Lavang Syzigium aromaticum Flower Bud A.P.I. 10 mg 7. Baras Karpur Cinnamomum camphora Crystal A.P.I mg 8. Swet Marich Piper nigrum Fruit A.P.I. 10 mg 9. Amber --- Masses A.B mg 10.Kesar Crocus sativus Style & Stigma A.P.I mg 11.Excipients Q.S. 12.Colour: Sunset Yellow -- Q.S. FCF Bhavana 1. Nagarvel Pan Rasa Piper betel Leaf A.P.I. Q.S. 2. Batch number : MTA01 ( Trial batch for product permission and mfg. Licence) 3. Manufacturing date : December Expiry date : November Storage condition : Cool and dry place 6. General use : Energy Tablet for Vigour and Vitality 7. CAS number : APPLIED 9. Country of origin : India 10. Manufacturer s name : VIRGO UAP Pharma Pvt.Ltd. Mahagujarat Ind.Estate Plot no. 423/ 98-B, Sarkhej - Bavala highway, Vill - MORAIYA, Ta - Sanand Dist - AHMEDABAD (GUJARAT) 6

7 2.2- TEST CONDITIONS 1. Animal species : Rats 2. Strain : Wistar albino 3. Source : Animal house attached to SDM Research centre, SDM Ayurveda College Udyavara 4. Selection : A total of 5 healthy either sex of body weight g Rats were selected according to AOT software. 5. Acclimatization period : All the selected animals were kept under acclimatization For 7 days before dosing. 7. Numbering and identification : The animal were marked with saturated Picric acid solution in water for proper identification. The marking within the cages is as follows. Animal Marking number 1 Head 2 Neck 3 Middle of the back 4 Base of the tail 5 No mark 7

8 The group number, animal number and sex of the animal were identified with the help of cage cards, as presented in following table. Sl. no Identification of animals Desired dose (according to AOT) Body weight (grams ) Calculated dose (ml) 1 Head 175mg/kg ml 2 Neck 550mg/kg ml 3 Back 2000mg/kg ml 4 Base of the tail 2000mg/kg ml 5 No mark 2000mg/kg ml Husbandry condition: 1. Housing : Rats were housed in each cage of poly propylene with stainless steel top grill. The dry husk was used as bedding material and was changed every morning. 2. Environment : The animal were exposed to 12 hours light and 12 hours dark cycle with The relative humidity 50 to 70 % and the ambient temperature was 22 ± 03 c. 3. Diet : Amruth brand rat pellete feed supplied by Pranav Agro Ltd, was provided throughout the study period except on previous night of dosing i.e(overnight) fasting before dosing. The drinking water was given ad libitum Propylene bottles with stainless steel sipper tube 8

9 2.4 Preparation of Test formulation for administration: 1. Test drug : Makardhwaj Rasayan Tablet 2. Vehicle : Gum acacia 3. Dose preparation: The test formulation supplied by sponsor was made in to Fine suspension in vehicle with suitable concentration All the animal were dosed constant dose volume (1 ml/ 100g body weight) 175mg/kg, 550mg/kg, 2000mg/kg 4. Schedule : single dose per animal a) Administration : The test formulation was administered through oral route at different dose levels to respective animals through oral feeding needle on to disposable syringe b) Dose fixation : According to the AOT Software. C) Route : oral d) Dose : 175mg/kg, 550mg/kg, 2000mg/kg test substance e) Dose volume : 1ml/100g animal 3. Observation: 3.1 Examination of Physical and Behavioural changes : The animal was observed continuously for 4 hours after the dosing. The careful cage side observation was done without disturbing the animal attention and at the end of the every hour the animal were individually exposed to open arena for recording the behavioural changes like increased or decreased motor activity, convulsions, straub s reaction, muscle spasm, catatonia, spasticity, ophisthotonus, hyperesthesia, muscle relaxation, anaesthesia, arching and rolling, lacrimation, salivation, diarrhoea, writhing, mode of respiration, changes in skin colour etc. exitus, CNS depression hypo activity, passivity, relaxation, ataxia, narcosis, etc. 9

10 3.2 Mortality: All the animals were observed at ½, 1, 2, 3, 4, 24 h, 48 h after dosing and there daily once for mortality during the entire period of the study (i.e.14 days). after 4. RESULT: 4.1 Physical and behavioural examination: There were no Physical and Behavioural changes-(except mild increase in motor activity and irritability were seen in animals dosed 550mg/kg and 2000mg/kg) in all the treated animals on day one at ½, 1,2,3,4 hours intervals after dosing and there after once daily for 14 consecutive days. Thus the data obtained from the study on single dose administration of Makardhwaj Rasayan Tablet oral administration up to 14 days of observation period does not result in any physical and behavioural changes. 4.2 Mortality: All the animals belonging to the treated group were survived throughout the 14 days observation period after dosing. 10

11 Conclusion: The test drug did not produce any mortality up to the dose of 2000mg/kg per oral which is equivalent to 22.4g total dose for a human being weighing 70 kg man. At the dose level studied the drug also did not produce any observable toxic effect except for mild irritation in animal in dose550mg/kg and 2000mg/kg and thus it could be concluded that the test drug is without any toxic potential even at the dose of 2000mg/kg in animals equivalent to 22.4g for human being. Dr. B. Ravishankar 11

12 Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES Group: 175mg /kg Date: 13/01/12 Dose: 1.25ml Animal: Rat 1(250g) Route: Oral Drug: Makardhwaj Rasayan Tablet SIGNS & SYMPTOMS Basal 30min 1h 2h 3h 4h 24h 48h General impression N N N N N N N N 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(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N Piloerection Experiment conducted by: Head of the lab (Director): N: Normal 12

13 Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES Group: 550mg/kg Date: 16/01/12 Dose: 1.375ml Animal: Rat-2(175g) Route: Oral Drug: Makardhwaj Rasayan Tablet SIGNS & SYMPTOMS Basal 1/2 1h 2h 3h 4h 24h 48h General impression N N Active Active Active N N N 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(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N Piloerection Experiment conducted by: Head of the lab (Director): N: Normal 13

14 Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES Group: 2000mg/kg Date: 19/01/12 Dose: 5.7ml Animal: Rat-3(200g) Route: Oral Drug: Makardhwaj Rasayan Tablet SIGNS & SYMPTOMS Basal 1/2 1h 2h 3h 4h 24h 48h General impression N Active Active Active active N N N 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(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N Piloerection Experiment conducted by: Head of the lab (Director): N: Normal 14

15 Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES Group: 2000mg/kg Date: 21/01/12 Dose: 4.5ml Animal: Rat-4(160g) Route: Oral Drug: Makardhwaj Rasayan Tablet SIGNS & SYMPTOMS Basal 30 min 1h 2h 3h 4h 24h 48h General impression N N active Irritated N N N N 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(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N Piloerection Experiment conducted by: Head of the lab (Director): N: Normal 15

16 Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi PRO FORMA FOR RECORDING SIGNS AND SYMPTOMS DURING ACUTE TOXICITY STUDIES Group: 2000mg/kg Date: 23/01/12 Dose: 4.5ml Animal: Rat-5(160g) Route: Oral Drug: Makardhwaj Rasayan Tablet SIGNS & SYMPTOMS Basal 1/2 1h 2h 3h 4h 24h 48h General impression N N Active Active N N N N 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(kg)-mean N N N N N N N N Visual placing response N N N N N N N N Tail pinch response N N N N N N N N Auditory response N N N N N N N N mucus membrane N N N N N N N N Piloerection Experiment conducted by: Head of the lab (Director): N: Normal 16

17 Rat No.1 Time of drug administration Time interval (min) Exitus Hypo activity Passivity Relaxation Ataxia Narcosis Ptosis Exophthalmos es Hyperactivity Irritability Stereotypy Tremors Convulsion Straub tail Analgesia Others Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi Pro forma for assessing Gross behaviour Drug : Makardhwaj Rasayan Tablet Date : 13/01/12 Group: 175mg/kg Route: Oral Animal: Rat-1 (125) Study: Acute oral toxicity CNS Depression ANS CNS Stimulation Basal h 48 h Experiment conducted by: Head of the lab (Director): 17

18 Rat No5 Time of drug administration Time interval (min) Exitus Hypo activity Passivity Relaxation Ataxia Narcosis Ptosis Exophthalmo ses Hyperactivit y Irritability Stereotypy Tremors Convulsion Straub tail Analgesia Others Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi Pro forma for assessing Gross behaviour Drug : Makardhwaj Rasayan Tablet Date : 16/01/12 Group : 550mg/kg Route: Oral Animal: Rat-2(175g) Study: Acute oral toxicity CNS Depression ANS CNS Stimulation Basal h h Experiment conducted by: Head of the lab (Director): 18

19 Rat No.4 Time of drug administration Time interval (min) Exitus Hypo activity Passivity Relaxation Ataxia Narcosis Ptosis Exophthalmos es Hyperactivity Irritability Stereotypy Tremors Convulsion Straub tail Analgesia Others Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi Pro forma for assessing Gross behaviour Drug : Makarandhwaj Rasayan Tablet Date : 19/01/12 Group : 550mg/kg Route: Oral Animal: Rat-2(175g) Study: Acute oral toxicity CNS Depression ANS CNS Stimulation Basal h 48 h Experiment conducted by: Head of the lab (Director): 19

20 Rat No.3 Time of drug administration Time interval (min) Exitus Hypo activity Passivity Relaxation Ataxia Narcosis Ptosis Exophthalmos es Hyperactivity Irritability Stereotypy Tremors Convulsion Straub tail Analgesia Others Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi Pro forma for assessing Gross behaviour Drug : Makarandhwaj Rasayan Tablet Date : 21/01/12 Group : 550mg/kg Route: Oral Animal: Rat-2(175g) Study: Acute oral toxicity CNS Depression ANS CNS Stimulation Basal h 48 h Experiment conducted by: Head of the lab (Director): 20

21 Rat No.2 Time of drug administration Time interval (min) Exitus Hypo activity Passivity Relaxation Ataxia Narcosis Ptosis Exophthalmo ses Hyperactivit y Irritability Stereotypy Tremors Convulsion Straub tail Analgesia Others Pharmacology Laboratory SDM Centre for research in Ayurveda & allied sciences, Kuthpadi, Udupi Proforma for assessing Gross behaviour Drug: Makardhwaj Rasayan Tablet Date : 23/01/12 Group: 2000mg/kg Route: Oral Animal: Rat -5 (160g) Study: Acute oral toxicity CNS Depression ANS CNS Stimulation Basal h 48 h Experiment conducted by: Head of the lab (Director): 21

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