This document outlines protocols for conducting toxicity studies of herbal medicines. It discusses various types of toxicity studies including acute, sub-acute, chronic, and subchronic studies. It provides details on commonly used laboratory animals, testing parameters, dosages, and observations for each type of study. The goal is to safely assess herbal medicines and determine appropriate dosage levels for clinical use by evaluating toxicity signs and examining tissue samples.
toxicology study according to OECD guidelines, organisation for economic co-orporation and developement, jasdeep singh , maharaja ranjit singh punjab technical university bathinda
toxicology study according to OECD guidelines, organisation for economic co-orporation and developement, jasdeep singh , maharaja ranjit singh punjab technical university bathinda
Presentation on all the evaluation methods in animals for anti diabetics. It includes methods for insulin dependant and insulin independent diabetes mellitus!
Presentation on all the evaluation methods in animals for anti diabetics. It includes methods for insulin dependant and insulin independent diabetes mellitus!
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
The Organization for Economical and Co-operation Development was used for testing of chemicals.
The original OECD guideline 451 for carcinogenecity study was adopted in 1981.
A Major carcinogenicity study is done on rodents
Mainly there routes of administration: oral, dermal, and inhalation.
animal toxicity tests are useful in finding the right dose for drugs to be used in humans. this ppt contains the method of toxicity studies and different types of toxicity studies.
Preclinical ToxPathology is often considered as an hidden scientific field in Pathology and it offers a lot of complexity. When implementing Digital Pathology strategies within translational workflows it is crucial to understand the basics of ToxPathology.
So, let's start with the introduction !
yantropakaranaani 1
. Choose and record contemporary machines used in Ayurvedic
drug preparation
. Discuss the pharmaceutical use of Distillation apparatus, Ball
Mill, Pulveriser, End Runner, Edge Runner, Tablet compression machine, Capsule filling machine, Pouch filling machine, Liquid filling machine in Ayurvediya Aushadhi Nirmana
. Enlist categorical information about the following Yantras in the charts- Ulukhal Yantra, Patan Yantra, Jarana Yantra, Patala
Yantra and Swedana Yantra.
. Enlist Ayurvediya aushadhi kalpana and equipments/yantras/
machines used for preparation of each kalpana.
• Rasashastra deals with metallic, mineral and poisonous drugs.
• These drugs are pharmaceutically processed and rendered fit for internal administration.
• For the various processing of rasa uparasadi dhatus and for the preparation of medicines, specific apparatuses called ‘Yantras’ are needed.
• Metals and minerals are required to undergo certain processes like shodhana, jarana, marana, satwapatana etc before they could be administered into the body and all these processes could only be achieved with the help of yantras.
• For exploring and utilizing the knowledge of Rasasastra, a better understanding of yantras is needed.
• Textbooks of Ayurvediya Rasasastra including Rasatarangini, Rasaratna samuchaya, Rasarnavam and Rasendra Choodamani have been the sources of literature along with other published works on Rasasastra.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
2. PROTOCOL FOR TOXICITY
STUDY
Presenter:
Dr.SARANYA SASI
2nd Year PG Scholar
Guide:
Dr.GOVINDA SHARMA K
Asso:Professor
Department Of RASASASHTRA & BHAISHAJYA KALPANA
Sri Dharmasthala Manjunatheswara College of Ayurveda & Hospital
Hassan 08-Feb-17 2PROTOCOL FOR TOXICITY STUDIES
3. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 3
• INTRODUCTION
•TYPES
•COMMONLY USED LABORATORY
ANIMALS
• ACUTE TOXICTY STUDIES
• SUB ACUTE TOXICITY STUDIES
• CHRONIC STUDIES
• SUBCHRONIC STUDIES
• TEST REPORT
• ASSESSMENT OF HERBAL MEDICINE
•ARTICLE
• CCRAS RESEARCH REPORT
• DISCUSSION
•CONCLUSION
• REFERENCE
4. •Toxicology is classically defined as the study of poisons.
•It is concerned mainly with the study of adverse effects of
xenobiotics.
•Casarett 1996 defined it as a science that defines the
limits of safety of chemical agents for human and
animal population.
INTRODUCTION
08-Feb-17PROTOCOL FOR TOXICITY STUDIES 4
6. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 6
COMMONLY USED LABORATORY ANIMALS
FOR RESEARCH PURPOSE *
Animals Purpose
Laboratory Mouse
(Mus musculusdomesticus)
Cancer research
Diabetes
Arthrosclerosis
Epilepsy
Autoimmune disease
Laboratory Rat (Rattusnorvegicus)
Biochemistry
Nutrition
Toxicology
Oncology
Pharmacology
Endrocrinology
Neurophysiology
Mastomys (Pramyscoucha)
Routine testing of plague suspect
material
Protozological and helminthological
Research
RODENTS
7. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 7
Gerbil (Merioneshurrianae)
Behavioral
Cancer
Epilepsy
Neurological Experiments
Hamster (Mesocricetusauratus) Cancer
Guinea pig
(Caviaporcellus)
Delayed hypersensivity
Biochemistry
Toxicology
Physiology
Pharmacology
Oncology
Vit C Metabolism
Rabbit (Oryctolaguscuniculus)
Immunology
Hypertension
Infectious disease
Virology
Embryology
Toxicology
Teratology
atherosclerosis
8. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 8
NON-RODENTS
Animals Purpose
Monkeys
Virology
Toxicolgy
Reproductive physiology
Contraceptive biology
Endocrinology
Immunology
Dogs (Canisfamiliaris)
Chronic arterial disease
Congestive heart failure
DM
Ulcerative colitis
Lymphocytic leukemia
Glaucoma
Cats (Feliscatus)
Neurophysiology
Reflexes
Synoptic transmission
Perception of light and sound
*Girish B.C, C.Ravikumar, C.R Santosh, V.T Shilpa
Department of Veterinary Pathology Veterinary college Hassan
10. 08-Feb-17 10PROTOCOL FOR TOXICITY STUDIES
Sl.No. Test Groups No. of Animals
1. Control group 10
(5M + 5F)
2. Therapeutic Dose
(TD)
10
(5M + 5F)
3. Average Dose
(TD x 5)
10
(5M + 5F)
4. Highest Dose
(TD x 10)
10
(5M + 5F)
Test dose : Single dose
Route of administration : Oral
Duration : 10 days
11. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 11
a) Mortality : To be observed on 24, 48 & 72 hours
b) Clinical signs: Monitoring of convulsions, lethargy, sleep, coma,
salivation, diarrhoea
•Cage side examination (daily)
•Skin colour, fur, eyes & mucous membrane (daily)
•Spontaneous and voluntary motor activity on every ½ hour, 1 hour,
2 hours, 4 hours and 24 hours after drug administration.
•0,1,7th day spontaneous motor activity
•Necropsy - In case of animal dies
12. 08-Feb-17 12PROTOCOL FOR TOXICITY STUDIES
Species Animals No. Age
(wks)
Weight
(gms)
Duration of experiment
Male Female TC
Exp.
Imm.
Exp.
Post
Exp.
Mice
(Swiss)
24
6x4*
24
6x4*
4-6 18-20 15 days
oral
50%
15th
day
50%
30th
day
Rat
Wistar
24
6x4*
24
6x4*
4-6 60-90 15 days
oral
50%
15th
day
50%
30th
day
TC-Test compound exposure
Imm Exp – Immediate (48 hours) after last exposure – instant effect
Post exp – Post-exposure (15 days) after last exposure – reversibility
of toxicity if any
13. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 13
Pre-experimentation phase
I. Acclimatization of animals
•Period – 7 days (Recording of body weight and food intake twice in
a week)
•Urine qualitative test
•Fecal consistency
14. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 14
Experimentation phase
I)Test compound exposure multiple dose (once daily for 15 days) and
dosage schedule (as recommended by sponsor)
II)Mortality 6/12/24 hours
III)Body weight (Twice in a week)
I)Food consumption (Daily)
II)Fecal consistency
III)Cage side activity
IV)Neurological examination
V)Urine qualitative test
16. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 16
Observations:
a. Mortality: To be observed on 24, 48 and 72 hrs.
b. Clinical Signs:
• A careful cage side examination will be made daily.
changes in:
- Skin, fur, eyes and mucous membrane.
- Convulsions, lethargy, sleep, coma, salivation, diarrhoea and
date of death.
17. 08-Feb-17 17PROTOCOL FOR TOXICITY STUDIES
Species No. of Animals Age
(wks)
Weight
(gms)
Duration of
experiment
Male Female TC Exp. Term.
Exp.
Mice
(Swiss)
40
10 x 4*
40
10 x 4*
4 15-18 90 days 100%
Rat
Wistar
40
10 x 4*
40
10 x 4*
4 60-80 90 days 100%
TC-Test compound exposure
Term. Exp – Termination of experiment immediately after last
exposure (48 hours) euthanization of animals for collection of vital
organs.
18. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 18
Pre-experimentation phase
I. Acclimatization of animals
•Period – 7 days (Recording of body weight and food intake twice in
a week)
•Urine qualitative test (Ames multiple sticks)
•Fecal consistency (Filter paper technique)
19. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 19
Experimentation phase
I)Test compound exposure - multiple dose (once daily for 90 days)
and dosage schedule (as recommended by sponsor)
II)Mortality 6/12/24 hours
III)Body weight (Twice in a week)
IV)Food consumption (Twice/weekly)
V)Fecal consistency
VI)Cage side activity
VII)Neurological examination
21. 13 week study +/- 4 wk recovery (3 doses and
control)
Species 2 species – rodents, dogs
In-life observations (+/- ophthamology)
Clinical pathology
Necropsy
Histopathology
Used to set doses for carcinogenicity studies
08-Feb-17 21PROTOCOL FOR TOXICITY STUDIES
22. TEST REPORT
Test substance:
•Physical nature
•Purity
•Physicochemical
properties
•Identification data
•Source of substance
•Batch number
Vehicle (if appropriate):
•Justification for choice of vehicle (if other than water)
Test animals:
•Species/strain used and justification for
choice made;
•Number, age, and sex of animals at start
of test;
•Source, housing conditions, diet, etc.;
•Individual weights of animals at the start
of the test.
The test report should include the following information:
08-Feb-17PROTOCOL FOR TOXICITY STUDIES 22
23. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 23
ASSESSMENT OF HERBAL MEDICINES
WHO - published guidelines for the assessment and evaluation of
toxicities of herbal medicines
These guidelines can be utilized in testing of Ayurvedic medicines
These guidelines are intended to indicate the standard methods of non-clinical
toxicological studies related to assessing the safety of herbal medicines.
ACUTE TOXICITY
Species : 2(1 rodent & 1 non-rodent)
Sex : male/female
No : rodent – 5 animal per sex at least (each group)
non-rodent – 2 animal at least
ROA : ordinarily, the oral route of clinical administration
Parenteral route
Dose : a sufficient dose levels should be used in rodents to determine the
approximate lethal dose
sufficient dose level should be used for the observation of overt toxic signs
24. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 24
Frequency of administration : one or more doses – 24 hr period
Observation : toxic sign
• severity
• onset
• progression and reversibility of signs should observed and
• recorded in relation to dose and time
(animal should be observed for at least 7 to 14 days – general rule)
• animals dying during the observation period, as well as rodent surviving
• to the end of observation period should be autopsied.
• histopathological examination should conducted - if necessary
LONG TERM TOXICITY STUDY
Species : 2(1 rodent & 1 non-rodent)
Sex : male/female
No : rodent – 10 male & 10 female(each group)
non-rodent – 3 male & 3 female
ROA : the oral route of clinical administration
25. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 25
Administration period: depend on expected period of clinical use.
Expected period of clinical use Administration period for toxicity study
Single/repeated for Less than 1 week 2 weeks – 1 month
Repeated
Btwn 1 week to 4 wk
4 wk – 3 months
Repeated
Btwn 1 – 6 months
3 – 6 months
Long term repeated
More than 6 months
9- 12 months
Dose levels –
• groups receiving at least 3 different dose levels should be used.
• one dose level should not cause toxic changes and one dose level that
produces overt toxic effects should be included
26. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 26
Observations and examinations:
1. General signs, body weight and food and water intake
2. Hematological examination
3. Renal and hepatic function tests
4. Other function tests
5. Animal found dead during the examination should be
autopsied as soon as possible
27. Journal of Pharmacology and pharmacotherapeutics
April-June 2011 Vol 2 Issue 2
08-Feb-17PROTOCOL FOR TOXICITY STUDIES 27
28. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 28
Conclusion
Naga bhasma has got no acute
toxic effect as on GIT, liver, testis,
kidney, and seminal vesicle in the
dose upto 416mg/100 gm body
weight. Whereas for a period of 60
days study shows, no toxic effect
has been observed in therapeutic
dose and intermediate dose.
But in higher dose significant toxicity has
been attributable to naga bhasma.
However, further giving haritaki churna
and swarna bhasma to the highest dose
animals seems lesser amount of toxicity. So
the concept of bhasma vikara shanti upaya
described by different autors in different
RS literatures proves significance.
29. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 29
RESEARCH - CCRAS
1. Chronic Toxicity study of Mahalaxmivilasa Rasa with Gold in rats.
conclusion :
The test drug has no serious toxicity potential. Though some changes were observed
in spleen and lungs on histopathological examination they were not consistent and dose
dependent. At high dose level the drug has the proclivity to depress WBC formation
especially lymphocyte formation and cause hypertriglyceridemia
2. Acute Toxicity study of Mahasudarshan Ghan Vati in mice
Coclusion:
Effect of test drug was studied after a single administration up to eight dose levels with
3000mg/kg as the maximum dose in rats. The animals were observed for 72 hrs
periodically for general behavioral changes to screen its effect on CNS and mortality
was observed up to 7 days. No mortality and behavioral changes was observed during
the study.
30. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 30
1. Pharmaceutico – analytical study of NARADIYA LAKSHMI VILASA RASA &
its toxicological evaluation (2016)
Dr.Patel Manjit Dhirubhai
Dept. Of RASASHASTRAAlva's Ayurvedic Medical College Moodbidiri Karnataka
RTESULT
By observing the haematological, bio chemical and food concersion parameters,
Naradiya lakshmi vilasa rasa is safe at therapeutic dose, 5 times therapeutic dose and
upto the 10 times of therapeutic dose. Its careful administration is not likely to cause
any serious toxic outcome at the therapeutic dose level
31. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 31
•Acute toxicity is involved in estimation of LD50 (the dose which has
proved to be lethal (causing death) to 50% of the tested group of
animals).
•Determination of acute oral toxicity is usually an initial screening step
in the assessment and evaluation of the toxic characteristics of all
compounds
•The methods so far utilized for the determination of median lethal dose
(LD50) and the new changes which could be made.
•Sub acute and chronic toxicity studies are designed to characterize the
toxic effects of drugs upon repeated daily administration for periods of
time ranging from 2 weeks to 1 year and to determine no-toxic-effect
dosage levels for short to long-term repeated dosing.
DISCUSSION
32. 08-Feb-17PROTOCOL FOR TOXICITY STUDIES 32
• The presence of heavy metals by chemical analysis - above the
permissible limits in some drugs - may be in different
forms by which the elements are bound.
• Since these elements could be chelated in the formulation either
hydrolytic or nonhydrolytic form of the metal will be safe to use.
• The results of the researches by CCRAS also confirms the nontoxic
nature of the drug as the final product in bhasma/rasakalpas are
different from the raw materials since they would be transformed to
therapeutic compounds by different processes like detoxification,
titration, heating etc.
• Hence it is suggested that any claim made on safety of ayurvedic herbo
mineral/ metallic preparations should be made only after the toxicity
clinical studies
33. REFERENCE
•CRC hand book of toxicology
• Safety/Toxicity study report of some ayurvedic drugs
(CCRAS Department of AYUSH India)
•www.Oecd-library.org.cited
•www.http://toxipedia.org.
08-Feb-17PROTOCOL FOR TOXICITY STUDIES 33