Acute and sub-chronic oral toxicities of DA.AMLODEPON HVD hard capsule in experimental animals

2021 ◽  
Vol 148 (12) ◽  
pp. 58-67
Author(s):  
Pham Thi Van Anh ◽  
Nguyen Van Dam ◽  
Nguyen Van Dat ◽  
Pham Thanh Ky ◽  
Nguyen Trong Thong ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Chronic Toxicity ◽  
The Body ◽  
Toxicity Study ◽  
World Health ◽  
Histopathological Analysis ◽  
Experimental Animals ◽  
Health Organization ◽  
General Conditions

Assessment of toxicities of DA.AMLODEPON HVD hard capsule on experimental animals. The acute toxicity of DA.AMLODEPON HVD was assessed on Swiss mice according to World Health Organization Guidance, and LD50 determination according to the method of Litchfield – Wilcoxon. The sub-chronic toxicity study of DA.AMLODEPON HVD at two doses (0.42 g/kg/day and 1.26g/kg/day) was conducted in rats for four consecutive weeks. After administration, general conditions and the body weight of rats were evaluated. Blood samples were collected for analyzing serum parameters before treatment (T0), second week (T1), and fourth week (T2). Histopathological analysis of livers and kidneys was observed at the end of the experiment. The results revealed that mice were taken up to a maximum dose of 39.15 g/kg with no symptoms of acute toxicity, LD50 of DA.AMLODEPON HVD has not been determined. The sub-chronic toxicity study at two doses did not change the body weight of rats, general conditions. The parameters for structures and functions of livers and kidneys and microscopic of the livers and kidneys are in a normal range during the study period.

scholarly journals Acute and subchronic oral toxicities of “Da day An Chau” tablets in experimental animals

2021 ◽  
Vol 141 (5) ◽  
pp. 1-9
Author(s):  
Tran Thanh Tung ◽  
Dao Viet Hoang ◽  
Pham Thi Van Anh ◽  
Dang Thi Thu Hien
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
World Health Organization ◽  
Biochemical Parameters ◽  
Maximum Dose ◽  
Toxicity Study ◽  
World Health ◽  
Subchronic Toxicity ◽  
Experimental Animals ◽  
Health Organization

In this study, the toxicities of “Da day An Chau” tablets (DDAC) were assessed on experimental animals. To evaluate the acute toxicity on Swiss mice according to World Health Organization Guidance and to determine LD50 refer to the method of Litchfield – Wilcoxon. The subchronic toxicity study of DDAC at two doses (0.58 g/kg/day and 1.74 g/kg/day) was conducted in rats for four consecutive weeks. Evaluation of general conditions and weight of rats during the study period. Rat’s blood was taken for hematological and biochemical evaluations. The livers and kidneys microscopes were evaluated at the end of the experiment. The result revealed that mice were taken up to a maximum dose of 25.71 g/kg with no symptoms of acute toxicity; LD50 of DDAC has not been determined. At two doses, the subchronic toxicity study did not change rats’ body weight, hematological, biochemical parameters, and microscopic of the livers and kidneys during the study period.

scholarly journals Acute and Sub-chronic Toxicity Studies on Methanol Stem Bark Extract of Frankincense Tree (Boswellia dalzielii) and Leaves Extract of Kenaf (Hibiscus cannabinus)

2021 ◽  
pp. 33-38
Author(s):  
S. Salihu ◽  
C. A. Otitolaiye ◽  
M. U. Hizbullah
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Chronic Toxicity ◽  
Stem Bark ◽  
Toxicity Study ◽  
Bark Extract ◽  
Albino Rats ◽  
Liver And Kidney ◽  
Stem Bark Extract ◽  
Oral Acute Toxicity

Aim: Frankincense tree (Boswellia dalzielii) and Kenaf (H. cannabinus) are plants abundantly found in north-western Nigeria. These plants are very popular among the locals as potent sources of ethno medicine. The present study investigates the oral acute toxicity potentials of methanolic stem bark extract of frankincense tree and Kenaf leaves, as well as sub-chronic toxicity potentials of the plants extracts on the kidney and liver of Albino rats. Study Design: Laboratory-experimental design was used for this study. Place and Duration of Study: This study was carried out between September 2019 and November 2019 at Biochemistry laboratory, Sokoto State University, Sokoto, Nigeria. Methodology: For the oral acute toxicity study, the revised “Up and Down” test (Limit Dose Test) was used to determine the LD50 of the extracts. For sub-chronic toxicity study, twenty albino rats were used for each plant, and were divided into four groups of five animals each. Group I (control), Group II (received 200 mg extract/kg body weight), Group III (received 400 mg extract/kg body weight) and Group IV (received 800 mg extract/kg body weight). All administrations were given orally for 28 days. Liver and kidney markers were determined using standard methods. Result: The oral acute toxicity test of the plant extracts at 3000 mg/kg body weight showed no mortality for 24 hours and subsequent 14days of administration. LD50 for both plants is therefore greater than 3000 mg/kg. The result shows no significant differences (p > 0.05) on liver and kidney function biomarkers investigated when Group II, III and IV are compared with control. Conclusion: This suggests that Frankincense stem bark and kenaf leaves extracts may be safe in rats at doses less than or equal 3000 mg/kg.

EVALUATION OF TOXICITY AND ANTIASTHMATIC POTENTIAL OF AN AYURVEDIC FORMULATION ON EXPERIMENTAL ANIMALS

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (02) ◽  
pp. 61-67
Author(s):  
Manisha Sahu ◽  
Raj K. Tiwari ◽  
Vikas Sharma ◽  
Shiv S. Shukla ◽  
Ravindra K. Pandey ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Chronic Toxicity ◽  
Marked Decrease ◽  
Signs And Symptoms ◽  
Toxicity Study ◽  
Experimental Animals ◽  
Acute Toxicity Study ◽  
Guinea Pig Model ◽  
Dose Levels ◽  
Oral Acute Toxicity

The aim of this study was to explore acute and chronic toxicity as well as antiasthmatic potential of the ayurvedic formulation Nayopayam Kashayam on experimental animals. The present study was targeted for the study of its toxicity profile along with its antiasthmatic activity. The acute toxicity study was carried out using OECD 425 CPCSEA guideline in albino wistar rats. Oral acute toxicity study was performed at 2000mg/kg orally, which was considered as limit dose. The chronic toxicity study was carried out with administration of Nayopayam Kashayam at three therapeutic equivalent doses i.e. TED (45mg/kg, orally), TEDx5 (225 mg/kg, orally) and TEDx10 (450 mg/kg, orally) for 90 days. Further, antiasthmatic study was carried out using histamine-induced bronchospasm in guinea pig model. The results of acute toxicity studies showed that drug did not create any signs and symptoms of toxicity and no mortality was shown to an oral dose of 2000 mg/kg in rats. The results of chronic toxicity study showed that the drug even at level as high as dose of TEDx10 had no significant effect at all on hematological and body weight parameters, however mild to moderate unfavorable changes in kidney and liver were indicated. The experiential changes were not seen at the lower dose levels. The drug also showed a marked decrease in hiccups of asthma during antiasthmatic study. Hence, it is suggested that the Nayopayam Kashayam, prepared as per the traditional method, is secured/safe for utilization and treatment of asthma at the therapeutic dose level.

scholarly journals Dose and time-dependent acute and subchronic oral toxicity study of propoxazepam in mice and rats

2020 ◽  
Vol 8 (1) ◽  
pp. 1 ◽  
Author(s):  
Nikolay Yakovlevich Golovenko ◽  
Valentina Nikolayevna Kovalenko ◽  
Vitalii Borisovich Larionov ◽  
Аnatoliy Semenovich Reder
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Oral Administration ◽  
The Body ◽  
Toxicity Study ◽  
Male Rats ◽  
Toxicity Tests ◽  
Male And Female ◽  
Organ Weights ◽  
Female Mice

Propoxazepam, 7-bromo-5 - (o-chlorophenyl)-3-propoxy - 1,2-dihydro - 3H-1,4-benzodiazepin-2-one, in the models of nociceptive and neuropathic pain showed significant analgesic activity. In order to explore clinical potential of propoxazepam for long term human consumption, toxicology testing in laboratory animals using well-accepted international guidelines is required. Acute toxicity tests were conducted by the oral administration of 2500; 3500; 4000; 4500 and 5000 mg/kg body weight to male and female mice and rats for a period of 3, 7 and 14 day. In subacute study, male rats were administered with various doses of propoxazepam (0.9, 4.5, and 9.0 mg/kg) to evaluate its toxicity for a period of 90 days. The effect of propoxazepam on body weight gain and organ weights, food and water consumptions were analyzed. From the present study, it can be concluded that the acute (3, 7 and 14 days) and subchronic (90 days) oral administrations of propoxazepam did not produce any clinical signs of toxicity or mortality of the male and female mice and rats. These results revealed that the LD50 of propoxazepam is greater than 5000 mg/kg and it therefore, belongs to the category V of relatively non-toxic substances according to the GHS. In the acute toxicity study, neither mortality no significant change in the body weight and the relative organ weights were recorded in all treated mice and rats. Present data set revealed that there wasn`t a strong correlation between body weight with food and water consumptions. The result indicates that the oral administration of propoxazepam did not produce any significant toxic effect in mice and rats and the substance can be safely used for therapeutic use in pharmaceutical formulations.  

scholarly journals Evaluation of acute and sub-acute oral toxicity of the aqueous extract of Aquilaria malaccensis leaves in Sprague Dawley rats

2019 ◽  
pp. 20-32
Author(s):  
Redzuan Nul Hakim Abdul Razak ◽  
Suzanah Abdul Rahman ◽  
Asmah Hanim Hamdan ◽  
Roszaman Ramli ◽  
Muhammad Lokman Md Isa ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Lethal Dose ◽  
The Body ◽  
Female Rats ◽  
Male Rats ◽  
Histopathological Analysis ◽  
Sprague Dawley ◽  
Aquilaria Malaccensis ◽  
Sprague Dawley Rats

Aquilaria malaccensis or commonly known as ‘gaharu’ is a species of Aquilaria genus and belongs to the Thymelaeaceae family. It is widely distributed in Malaysia, Indonesia, and the Borneo Islands. Traditionally, its leaves were used to relieve bruises and studies have shown that they function as an antioxidant, aphrodisiac, and tranquilizer. Despite its proven beneficial medicinal properties, information regarding its toxicity is limited. Therefore, we performed a safety evaluation on the aqueous A. malaccensis leaves extract (AMAE) in Sprague Dawley rats. The assessment of acute toxicity based on the Organization for Economic Cooperation and Development (OECD) Guideline 420 revealed that AMAE did not influence mortality, clinical appearance, body weight gain, or necropsy findings at a dose of 2000 mg/kg body weight. In the sub-acute toxicity, all doses did not significantly modify the body weight and food and water intake. In male rats treated with 2000 mg/kg, there was a significant reduction in the relative weight of liver. Not only that, an increase in alkaline phosphatase and alanine transaminase was also observed in different groups among the female rats. A significant decrease in the creatinine level was also seen among male rats administered with different doses of AMAE. In both sexes, histopathological analysis had shown abnormalities in the liver and kidney of rats treated at the dose of 2000 mg/kg. In conclusion, the 50% lethal dose (LD50) of AMAE was estimated to be greater than 2000 mg/kg. In sub-acute duration, the findings suggested that AMAE administered orally is slightly toxic at higher doses (2000 mg/kg) and could provoke functional and structural changes in the kidney and liver of rats. Thus, the extract should be used with caution.

scholarly journals Toxicity Study of 1-(2, 5-Dihidroxyphenil)-3-Pyridine-2-Il-Propenone In Adult Female Mice

2021 ◽  
Author(s):  
Ika Puspitasari ◽  
Ratna Asmah Susidarti
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Toxicity Test ◽  
Biochemical Parameters ◽  
Chronic Toxicity ◽  
Histological Analysis ◽  
Lymphocytic Infiltration ◽  
Experimental Animals ◽  
Female Mice ◽  
Chronic Toxicity Test

This research aimed to evaluate the toxicity of 1-(2, 5-dihidroxyphenil)-3-pyridine-2-il-propenone (DPP) after 24 hours and 90-day administration in female mice. Acute toxicity test was performed using the OECD 423 method, and DPP was administered once a day at doses of 300, 2000, and 5000 mg/kg body weight (BW). Toxic symptoms were observed after 24 hours of administration, and this continued until the 14th day. The experimental animals were dissected and examined for histological organs on the 15th day. The sub-chronic toxicity test was performed using the OECD 408 method, and DPP at 14, 28, and 56 mg/kg/day was administered for 90 days. Toxic symptoms were observed every day, and the amount of food and water intakes were also measured. Furthermore, statistical analysis was performed, and changes in body weight as well as routine blood checks and biochemistry were observed. At the end of the study, experimental animals were killed and the vital organs' weights were examined before their histological analysis. The results showed that DPP at 300-5000 mg/kg/day and 14-56 mg/kg/day for 90 days did not show any toxic symptom respectively. In the sub-chronic toxicity test, no change was observed in blood and urine biochemical parameters (p≥0.05). However, lymphocytic infiltration in the liver and congested vessel in the kidney occurred after administration at 56 mg/kg / day. The results showed that the acute toxicity of DPP is at category 5 according to Globally Harmonized Classification System and sub-chronic toxicity is at a dose below 56 mg/kg/day.

scholarly journals Acute and Subchronic Oral Toxicity Studies of an Ethanol/Water Extract of Euphorbia scordifolia Jacq (Euphorbiaceae) in Mice and in Rats

2017 ◽  
Vol 7 ◽  
pp. 18-29 ◽  
Author(s):  
Michel Archange Tagne Fokam ◽  
Paul Aimé Noubissi ◽  
René Kamgang
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Oral Administration ◽  
Blood Cells ◽  
Water Extract ◽  
The Body ◽  
Toxicity Study ◽  
Control Group ◽  
Acute Toxicity Study ◽  
Hematological Analysis

Euphorbia scordifolia is used in Cameroon as galactagogue and in the treatment of gastrointestinal disorders. This work was undertaken to evaluate the acute and subchronic toxicities of ethanol/water extract of Euphorbia scordifolia (EWEs). Acute toxicity study was carried out by oral administration of 1, 2, 3, 4 and 5 g/kg body weight of EWEs to mice in the respective groups. Subchronic toxicity study was conducted by oral administration of the extract at daily doses of 50, 75 and 100 mg/kg body weight to another group of rats for 28 days, while rats in the control group received 10 mL/kg body weight of distilled water. Following the 28-day treatment, the rats were sacrificed for hematological, biochemical and histopathology studies. In the acute toxicity study, EWEs was found to be non-toxic at a dose of 5000 mg/kg body weight. The subchronic treatment with EWEs did not alter either the body weight gain or the food and water consumption. Biochemical analysis did not show any significant differences in any of the parameters examined in males or females. Hematological analysis showed a significant decrease (P<0.01) in white blood cells and red blood cells in males treated with 100 mg/kg bw and a significant (P<0.01) decrease in hemoglobin and hemoglobin hematocrit in all treated females. Necropsy and histopathological examination revealed some slight hepatic necrosis with the dose 100 mg/kg bw. It would be necessary to use the ethanol/water extract for short periods (<4 weeks). Thus, the plant, at least its ethanol/water extract, could be considered with a wide margin of safety for short-term oral use.

PHARMACOGNOSTIC, ANTIOXIDANT AND ACUTE TOXICITY STUDY OF Ficus sycomorus (Linn) (Moraceae) ROOT AND STEM BARK

2020 ◽  
Vol 4 (2) ◽  
pp. 605-614
Author(s):  
Murtala M. Namadina ◽  
H. Haruna ◽  
U. Sanusi
Keyword(s):  
Acute Toxicity ◽  
Radical Scavenging ◽  
Stem Bark ◽  
The Body ◽  
Toxicity Study ◽  
Bark Extract ◽  
Root Extract ◽  
Acute Toxicity Study ◽  
Radical Scavenging Ability ◽  
Phytochemical Components

Most of biochemical reactions in the body generates Reactive Oxygen Species (ROS), which are involved in the pathogenesis of oxidative stress-related disorders like diabetes, nephrotoxicity, cancer, cardiovascular disorders, inflammation and neurological disorders when they attack biochemical molecules like proteins, lipids and nucleic acid. Antioxidants are used to protect the cells or tissues against potential attack by ROS. Most medicinal plants possess a rich source of antioxidants such as flavonoids, phenols, tannins, alkaloids among others. These phytochemicals are currently pursued as an alternative and complimentary drug. In this study, phytochemical components, antioxidant and acute toxicity study of the methanol extract of stem bark and root of F. sycomorus were carried out using standard methods. Findings from this study revealed the presence of some diagnostic microscopical features such as calcium oxalate, starch, gum/mucilage, lignin, Aleurone grain, suberized/Cuticular cell wall and inulin but calcium carbonate was absent in stem bark but present in the powdered root. Quantitative physical constants include moisture contents (6.40% and 7.82%), ash value (7.20% and 9.30 %) in stem bark and root respectively. Carbohydrates, alkaloid, flavonoids, saponins, tannins, glycoside, steroid, triterpenes and phenols were present in all the extracts. They were found to exhibit potent 1,1,-diphenyl 2-picryl hydrazyl (DPPH) free scavenging activity. The DPPH radical scavenging ability of the extracts showed the following trend Ascorbic acid < stem bark extract˃ root extract. The LD50 of the methanolic stem bark and root extracts were found to be greater than 5000 mg /kg and is considered safe for use. Nonetheless, further

scholarly journals Secular Trends of Underweight, Overweight, and Obesity in Children and Adolescents from Ukraine

2021 ◽  
Vol 18 (6) ◽  
pp. 3302
Author(s):  
Katarzyna Dereń ◽  
Justyna Wyszyńska ◽  
Serhiy Nyankovskyy ◽  
Olena Nyankovska ◽  
Marta Yatsula ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Age Groups ◽  
Overweight And Obesity ◽  
The Body ◽  
World Health ◽  
Public Health Issue ◽  
Significant Difference ◽  
Significant Public Health ◽  
Health Organization ◽  
Obesity In Children

Overweight and obesity, as well as underweight in children and adolescents, pose a significant public health issue. This study aimed to investigate the secular trend of the incidence of underweight, overweight, and obesity in children from Ukraine in 2013/2014 and 2018/2019. The studies were conducted in randomly selected primary and secondary schools in Ukraine. In total, 13,447 children (6468 boys and 6979 girls) participated in the study in 2013/2014 and 18,144 children (8717 boys and 9427 girls) participated in 2018/2019. Measurements of body weight and height were performed in triplicate. Underweight, overweight, and obesity were diagnosed according to the standards of the World Health Organization (WHO). In the group of girls, a significant difference between 2013/2014 and 2018/2019 measurements was found only among 7-year-olds. The percentage of girls at this age exceeding the body mass index (BMI) norm was lower in the 2018/2019 study. In boys, a significant difference was also found in 7-year-olds, and, as in girls, a lower share of overweight and obesity was found in 2018/2019. But for the ages of 12, 13, and 15, the significant differences had a different character—more overweight or obese boys were found in the 2018/2019 study. The proportion of underweight children was similar for the majority of age groups in both genders and did not differ in a statistically significant way.

Acute and subacute toxicity assessment of Madhulai Manappagu (Siddha herbal syrup formulation) in animal model

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Meenakshi Sundaram Malayappan ◽  
Gayathri Natarajan ◽  
Logamanian Mockaiyathevar ◽  
Meenakumari Ramasamy
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Oral Route ◽  
Toxicity Assessment ◽  
Toxicity Study ◽  
Female Rats ◽  
Albino Rats ◽  
Oral Toxicity ◽  
Gross Pathology ◽  
Toxicity Studies

Abstract Objectives Madhulai Manappagu – a well-known sastric and widely prescribed Siddha herbal syrup formulation indicated for treating Veluppu Noi (Anaemia especially Iron deficiency Anaemia) has been in day today practice in Tamil Nadu for a quite longer decades. The syrup is a herbal preparation which has a sweet pleasant odour and a palatable taste, contain the juice of pomegranate (Punica granatum L.) as the main ingredient. Though the formulation is a fruit juice, the safety profile of the syrup is not established and is being marketed without toxicological evaluation. The study is aimed at ascertaining the acute and sub-acute toxicity assessment of Madhulai Manappagu in Wistar Albino rats. Methods The acute and sub-acute (28day repeated oral) toxicity studies were performed as per the guidelines mentioned in the Organization for Economic Cooperation and Development (OECD) 423 (adopted on December 2001) and TG 407 (adopted on October 2008) with slight modifications respectively. For acute toxicity study, three female rats were randomly selected as control; three female rats were randomly selected and were administered a single dose of 5,000 mg/kg body weight per oral route. For sub-acute (28day repeated oral) toxicity studies, three doses of test drug MM of 500 mg/kg/day (low dose), 750 mg/kg/day (intermittent dose) and 1,000 mg/kg/day (high dose) were selected for administration. Both sexes of Wistar Albino rats were randomized into four groups of 10 animals each (five males, five females). Group I was kept as control group. Group II, III and IV served as low, intermittent and high doses of MM respectively. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed. Results In the acute toxicity study, rats showed no toxicological signs on behavior, gross pathology and body weight of rats when treated with a single dose of 5,000 mg/kg body weight per oral route. In the subacute (28 days repeated oral) toxicity study, rats have showed no significant changes on behavior, gross pathology, body weight, and hematological and biochemical parameters when treated with Madhulai Manappagu in three different doses. Conclusions The toxicity studies which include both acute and 28 days repeated (subacute) oral toxicity studies, revealed no observed adverse effect level (NOAEL) of Madhulai Manappagu in animals. Thus the safety of the drug in human usage was ensured.

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