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International Journal of Clinical Pharmacology &
Toxicology (IJCPT)
http://scidoc.org/IJCPT.php ISSN-2167-910X
Article name:
Acute and Sub acute Toxicity studies on Siddha Herbo-mineral Anti-arthritic formulation "Pooneeru
Diravagam" in experimental animal models:
Ethno pharmacological Relevance: 60% of the world's population depends on traditional medicine . It is in use for primary
health care and general health care among rural, urban, semi urban in both developed and developing countries parallel to
the usage of western medicines. Pooneeru diravagam is an indigenous Siddha medicine . There is a huge cry, tall fake claims
regarding the safety and efficacy of Siddha formulations. The present study is aimed to evaluate the safety of Pooneeru
diravagam by determining any toxicity changes through acute and sub-acute toxicity studies per oral administration in
Swiss albino rats.
Materials and Methods: Acute toxicity study was carried out as per OECD Guideline-423 in healthy Swiss albino female rat
weighing 200–245 gm. The Study was carried out in three female rats under fasting condition; signs of toxicity were
observed for every one hour for first 24 hours and every day for fortnight from the beginning of the study. Sub acute
toxicity study was carried out as per OECD guidelines-407 in Swiss albino rats of either sex weighing 220–245 gm of three
groups of 6 rats each (Three male and three female) at two dosage levels 0.2 ml and 0.4 ml of 28 days continuous drug
administration (oral route).
Results: The animals were sacrificed on the 29th day and various blood biochemical parameters haematological and clinical
signs were measured. The organ morphology such as kidney, liver, heart, lungs, spleen, pancreas, brain, ovaries and testes
were processed for Histopathological study. The results of sub-acute toxicity on 29th day did not show any evidence of
changes. Physiological, Hematological as well as Histopathological parameters remained unaltered when compared with
control animals throughout the dosing period.
Conclusions: From the results it is concluded that usage of pooneeru diravagam at the dosage of 0.4 ml/kg p.o is safe for
the population suffering from rheumatoid arthritis.
Link: http://scidoc.org/IJCPT-2167-910X-04-101.php
Article name:
PPAR α/γ Agonist in Management of Diabetic Dyslipidemia: A Review
Cardiovascular diseases are major contributors of mortality and morbidity in patients with type 2 diabetes mellitus (T2DM),
while dyslipidemia and hyperglycemia are key modifiable risk factors to prevent coronary artery disease (CAD). Although
healthy diet, regular physical activity and maintaining a normal body weight are advised, patients generally require single or
multiple drugs to treat T2DM. Moreover, patients with T2DM are prone to atherogenic diabetic dyslipidemia (ADD), which
is characterized by elevated triglyceride, small dense LDL particles and low High-density lipoprotein (HDL) cholesterol. Even
though low-density lipoprotein cholesterol (LDL) remains the primary target of therapy, non-high density lipoprotein (non-
HDL) cholesterol is as an important parameter to be considered in clinical practice. Unfortunately, high-dose statin therapy
is not advised for long term, as it can increase risk of new onset T2DM. On the other hand, glitazars are newer molecules
having dual peroxisome proliferator-activated receptors (PPAR) α/γ agonistic action that can improve lipid profile with
improvement of insulin sensitivity. In conclusion, the overall safety of saroglitazar is acceptable due to minimal side effects,
but improvement of β cell function, effect on insulin sensitivity by analysis of insulin resistance index by using the
homeostatic model assessment (HOMAIR) and long term cardiovascular benefits like atherosclerotic plaque stabilization or
regression need to be confirmed.
Link : http://scidoc.org/IJCPT-2167-910X-04-102.php
Article name:
Body Fluid Extraction of Toxic Dental Materials Made From Methyl Methacrylate And HPLC
Analysis Combined With Automated SPE
Methyl methacrylate polymer (PolyMMA) is widely used as the composite resin for the dental plate. During the
preparation process of PolyMMA by the polymerization reaction, benzoylperoxide (BPO) and N,N’-dimethyl P-
toluidine (DMPT) are added as the initiator and the stimulator, respectively. These compounds exhibit toxicity as
well as a residue potential, their use raises concerns regarding human safety. The degree of elution into serum or
saliva was determined to evaluate risk to the user. Analysis was done by HPLC combined with solid-phase
extraction using a C-18 column. The eluted compounds were found to be in the order of 10 to 70 ppm .
Link : http://scidoc.org/IJCPT-2167-910X-03-401.php
Article name:
Toxic Compounds Analysis With High Performance Liquid Chromatography Detected By Electro
Chemical Detector (Ecd)
The principal area of application of high performance liquid chromatography-electrochemical detector
(HPLC-ECD) has been in the analysis of naturally-occurring analytes, such as catecholamines, and
pharmaceuticals in biological samples, HPLC-ECD has also applied to the analysis of pesticides and other
analytes of interest to the toxicologist. In this paper, toxic area is described. In these, ammatoxins,
aromatic amine, nitro-compounds, algal toxins, fungal toxins, pesticides, veterinary drug and food
residues will be concretely described.
Link : http://scidoc.org/IJCPT-2167-910X-03-301.php
Article name:
Simulated Evaluation of Drug-Impaired Psychomotor Performance
The purpose of this placebo-controlled, randomized-crossover study was to evaluate a computer-based divided-attention
task as a method for measure impaired human psychomotor performance. The ability of the divided-attention task to
detect and differentiate was evaluated using single oral doses of placebo, caffeine and diphenhydramine. Ten healthy men
were the subjects of the study. Subject performance on divided-attention was compared with tests of short-term memory
and a set of visual analogue scales. The study also assessed potential learning and boredom effects associated with the
testing procedures. The results indicate a divided-attention task can detect and differentiate effects of diphenhydramine
from those of caffeine and placebo; however, it cannot differentiate effects of caffeine at the doses utilized from that of
placebo. Visual analogue scale results corroborated these findings. Observations show that the short-term memory test
was not sensitive to the effects of study medication. While the results observed with this convenient, computer-based
divided-attention task are promising, additional studies need to be conducted with other classes of CNS-active drugs and
over a range of doses.
Link: http://scidoc.org/IJCPT-2167-910X-03-201.php
Article name:
A Possible Association of Sex Hormone-Binding Globulin with Weight Gain in
the Valproic Acid-Treated Female Patients with Epilepsy
Weight gain is a common adverse consequence of treatment with valproic acid. Although a low sex
hormone-binding globulin (SHBG) level was shown to be an independent risk factor for the development
of metabolic syndrome and type 2 diabetes in the general population, there is presently no data available
regarding the association between the SHBG level and valproic acid-induced weight gain. The association
between the plasma SHBG level and being overweight was retrospectively investigated in 46 valproic acid-
treated and 59 carbamazepine-treated patients with epilepsy. Among the female patients treated with
valproic acid, the plasma SHBG levels tended to be negatively correlated with the gap between the body
mass index value for each patient and the upper limit of the normal range (adjusted partial regression
coefficient = -6.86, P = 0.041), and the SHBG levels were significantly lower in the overweight subjects
than in the normal weight subjects (P = 0.001). These associations were not observed among the valproic
acid-treated male patients or the carbamazepine-treated male and female patients. The plasma SHBG
levels may be therefore associated with being overweight in the valproic acid-treated female patients.
Link: http://scidoc.org/IJCPT-2167-910X-03-101.php

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Clinical pharmacy journal

  • 1. International Journal of Clinical Pharmacology & Toxicology (IJCPT) http://scidoc.org/IJCPT.php ISSN-2167-910X
  • 2. Article name: Acute and Sub acute Toxicity studies on Siddha Herbo-mineral Anti-arthritic formulation "Pooneeru Diravagam" in experimental animal models: Ethno pharmacological Relevance: 60% of the world's population depends on traditional medicine . It is in use for primary health care and general health care among rural, urban, semi urban in both developed and developing countries parallel to the usage of western medicines. Pooneeru diravagam is an indigenous Siddha medicine . There is a huge cry, tall fake claims regarding the safety and efficacy of Siddha formulations. The present study is aimed to evaluate the safety of Pooneeru diravagam by determining any toxicity changes through acute and sub-acute toxicity studies per oral administration in Swiss albino rats. Materials and Methods: Acute toxicity study was carried out as per OECD Guideline-423 in healthy Swiss albino female rat weighing 200–245 gm. The Study was carried out in three female rats under fasting condition; signs of toxicity were observed for every one hour for first 24 hours and every day for fortnight from the beginning of the study. Sub acute toxicity study was carried out as per OECD guidelines-407 in Swiss albino rats of either sex weighing 220–245 gm of three groups of 6 rats each (Three male and three female) at two dosage levels 0.2 ml and 0.4 ml of 28 days continuous drug administration (oral route). Results: The animals were sacrificed on the 29th day and various blood biochemical parameters haematological and clinical signs were measured. The organ morphology such as kidney, liver, heart, lungs, spleen, pancreas, brain, ovaries and testes were processed for Histopathological study. The results of sub-acute toxicity on 29th day did not show any evidence of changes. Physiological, Hematological as well as Histopathological parameters remained unaltered when compared with control animals throughout the dosing period. Conclusions: From the results it is concluded that usage of pooneeru diravagam at the dosage of 0.4 ml/kg p.o is safe for the population suffering from rheumatoid arthritis. Link: http://scidoc.org/IJCPT-2167-910X-04-101.php Article name: PPAR α/γ Agonist in Management of Diabetic Dyslipidemia: A Review Cardiovascular diseases are major contributors of mortality and morbidity in patients with type 2 diabetes mellitus (T2DM), while dyslipidemia and hyperglycemia are key modifiable risk factors to prevent coronary artery disease (CAD). Although healthy diet, regular physical activity and maintaining a normal body weight are advised, patients generally require single or multiple drugs to treat T2DM. Moreover, patients with T2DM are prone to atherogenic diabetic dyslipidemia (ADD), which is characterized by elevated triglyceride, small dense LDL particles and low High-density lipoprotein (HDL) cholesterol. Even though low-density lipoprotein cholesterol (LDL) remains the primary target of therapy, non-high density lipoprotein (non- HDL) cholesterol is as an important parameter to be considered in clinical practice. Unfortunately, high-dose statin therapy is not advised for long term, as it can increase risk of new onset T2DM. On the other hand, glitazars are newer molecules having dual peroxisome proliferator-activated receptors (PPAR) α/γ agonistic action that can improve lipid profile with improvement of insulin sensitivity. In conclusion, the overall safety of saroglitazar is acceptable due to minimal side effects, but improvement of β cell function, effect on insulin sensitivity by analysis of insulin resistance index by using the homeostatic model assessment (HOMAIR) and long term cardiovascular benefits like atherosclerotic plaque stabilization or regression need to be confirmed. Link : http://scidoc.org/IJCPT-2167-910X-04-102.php
  • 3. Article name: Body Fluid Extraction of Toxic Dental Materials Made From Methyl Methacrylate And HPLC Analysis Combined With Automated SPE Methyl methacrylate polymer (PolyMMA) is widely used as the composite resin for the dental plate. During the preparation process of PolyMMA by the polymerization reaction, benzoylperoxide (BPO) and N,N’-dimethyl P- toluidine (DMPT) are added as the initiator and the stimulator, respectively. These compounds exhibit toxicity as well as a residue potential, their use raises concerns regarding human safety. The degree of elution into serum or saliva was determined to evaluate risk to the user. Analysis was done by HPLC combined with solid-phase extraction using a C-18 column. The eluted compounds were found to be in the order of 10 to 70 ppm . Link : http://scidoc.org/IJCPT-2167-910X-03-401.php Article name: Toxic Compounds Analysis With High Performance Liquid Chromatography Detected By Electro Chemical Detector (Ecd) The principal area of application of high performance liquid chromatography-electrochemical detector (HPLC-ECD) has been in the analysis of naturally-occurring analytes, such as catecholamines, and pharmaceuticals in biological samples, HPLC-ECD has also applied to the analysis of pesticides and other analytes of interest to the toxicologist. In this paper, toxic area is described. In these, ammatoxins, aromatic amine, nitro-compounds, algal toxins, fungal toxins, pesticides, veterinary drug and food residues will be concretely described. Link : http://scidoc.org/IJCPT-2167-910X-03-301.php
  • 4. Article name: Simulated Evaluation of Drug-Impaired Psychomotor Performance The purpose of this placebo-controlled, randomized-crossover study was to evaluate a computer-based divided-attention task as a method for measure impaired human psychomotor performance. The ability of the divided-attention task to detect and differentiate was evaluated using single oral doses of placebo, caffeine and diphenhydramine. Ten healthy men were the subjects of the study. Subject performance on divided-attention was compared with tests of short-term memory and a set of visual analogue scales. The study also assessed potential learning and boredom effects associated with the testing procedures. The results indicate a divided-attention task can detect and differentiate effects of diphenhydramine from those of caffeine and placebo; however, it cannot differentiate effects of caffeine at the doses utilized from that of placebo. Visual analogue scale results corroborated these findings. Observations show that the short-term memory test was not sensitive to the effects of study medication. While the results observed with this convenient, computer-based divided-attention task are promising, additional studies need to be conducted with other classes of CNS-active drugs and over a range of doses. Link: http://scidoc.org/IJCPT-2167-910X-03-201.php Article name: A Possible Association of Sex Hormone-Binding Globulin with Weight Gain in the Valproic Acid-Treated Female Patients with Epilepsy Weight gain is a common adverse consequence of treatment with valproic acid. Although a low sex hormone-binding globulin (SHBG) level was shown to be an independent risk factor for the development of metabolic syndrome and type 2 diabetes in the general population, there is presently no data available regarding the association between the SHBG level and valproic acid-induced weight gain. The association between the plasma SHBG level and being overweight was retrospectively investigated in 46 valproic acid- treated and 59 carbamazepine-treated patients with epilepsy. Among the female patients treated with valproic acid, the plasma SHBG levels tended to be negatively correlated with the gap between the body mass index value for each patient and the upper limit of the normal range (adjusted partial regression coefficient = -6.86, P = 0.041), and the SHBG levels were significantly lower in the overweight subjects than in the normal weight subjects (P = 0.001). These associations were not observed among the valproic acid-treated male patients or the carbamazepine-treated male and female patients. The plasma SHBG levels may be therefore associated with being overweight in the valproic acid-treated female patients. Link: http://scidoc.org/IJCPT-2167-910X-03-101.php