scholarly journals Safety assessment of subtilisin QK in rats

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shuai Xiao ◽  
Dingbang Hu ◽  
Ya Gao ◽  
Yang Ai ◽  
Sang Luo ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Adverse Effects ◽  
Oral Dose ◽  
Fibrinolytic Activity ◽  
Toxicity Study ◽  
Subchronic Toxicity ◽  
Safety Pharmacology ◽  
Sd Rats ◽  
Acute Toxicity Study ◽  
Safety Pharmacology Study

Abstract Background Subtilisin QK is a serine protease in the subtilisin family, and is fermented by Bacillus subtilis QK02. The fibrinolytic activity of subtilisin QK was measured by detecting low molecular weight degradation products using a spectrophotometric method developed by Japan Bio Science Laboratory Co., Ltd. Subtilisin QK powder can maintain its fibrinolytic activity for more than 24 months when it is stored at room temperature and protected from light. Our previous results showed that subtlisin QK directly degraded cross-linked fibrins in the fibrin plate assay and effectively inhibited thrombosis in the mouse thrombus model. The aim of this study was to determine the acute toxicity, potential subchronic toxicity, and safety pharmacology of subtilisin QK in Sprague–Dawley (SD) rats. Methods In the acute toxicity study, a single oral dose of 100,000 FU/kg was administered to 10 female and 10 male SD rats. In the 28-day subchronic toxicity, 60 female and 60 male SD rats were randomly assigned to four experimental groups (daily oral dose of 0, 2500, 7500 and 25,000 FU/kg). In the safety pharmacology study, 20 female and 20 male SD rats were randomly assigned to four experimental groups (single oral dose of 0, 500, 1500 and 5000 FU/kg). Results No death occurred and no adverse effects were observed in the acute toxicity study at a dose of 100,000 FU/kg. In the 28-day subchronic toxicity study, several hematological and blood biochemical parameters showed increases or decreases; however, due to the lack of a dose–response relationship, these differences were considered unrelated to treatment. In the safety pharmacology study, no adverse effects were observed on the central nervous of SD rats post-administration up to a dose of 5000 FU/kg subtilisin QK. Conclusion The results showed that oral consumption of subtilisin QK is of low toxicological concern. No adverse effects were observed at doses of 2500, 7500, and 25,000 FU/kg in the 28-day subchronic toxicity, and the no-observed-adverse-effect level (NOAEL) of subtilisin QK was 25,000 FU/kg.

scholarly journals Acute and subacute toxicity evaluation of hydroalcoholic extract from the stem bark of Bois Bande (Parinari campestris Aubl.1772) in rats

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Venkatesan Sundaram ◽  
Stephanie Mohammed ◽  
M. R. Srinivasan ◽  
Jenelle Johnson ◽  
Rod Suepaul ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Oral Dose ◽  
Conventional Medicine ◽  
Sperm Count ◽  
Scientific Data ◽  
The Body ◽  
Toxicity Study ◽  
Hydroalcoholic Extract ◽  
Subacute Toxicity ◽  
Acute Toxicity Study

Abstract Introduction The bark of Bois Bande (Parinari campestris) is a popular aphrodisiac in the Caribbean that has been traditionally used for many years to restore sexual vitality, increase sperm count, and treat erectile dysfunction, without valid scientific data. Acute and 28-day subacute toxicity studies were conducted to evaluate the safety of the hydroalcoholic extract of P.campestris bark and to find a safe dose for human use in conventional medicine. Methods The acute toxicity study used a single oral dose of P.campestris extract at four separate doses, 5, 50, 300, and 2,000 mg/kg, and was seen for 14 days, while the subacute toxicity study used a daily oral dose of P.campestris extract at 3 different doses, 100, 300, and 1000 mg/kg/day for 28 days. Results The LD50 of P.campestris extract was found to be greater than 2000 mg/kg in the acute toxicity study. P.campestris extract did not show toxicity at 1000 mg/kg/day in subacute toxicity trial; NOAEL was 1000 mg/kg/day in rats. However, the body weight was increased in males. Conclusion In conclusion, 1000 mg/kg P.campestris extract can be considered safe and non-toxic in males.

scholarly journals Acute and Subchronic (28-day) Oral Toxicity Studies on the Film Formulation of k-Carrageenan and Konjac Glucomannan for Soft Capsule Application

2019 ◽  
Vol 87 (2) ◽  
pp. 9 ◽  
Author(s):  
Ni Sutrisni ◽  
Sundani Soewandhi ◽  
I Adnyana ◽  
Lucy Sasongko
Keyword(s):  
Acute Toxicity ◽  
Experimental Period ◽  
Konjac Glucomannan ◽  
Toxicity Study ◽  
Oral Toxicity ◽  
Subchronic Toxicity ◽  
Acute Toxicity Study ◽  
Relative Organ Weight ◽  
Film Formulation ◽  
Safe Dose

The aim of this study was to investigate the acute and subchronic toxicity of a film formulation that combines κ-Carrageenan and konjac glucomannan for soft capsule application. For the acute toxicity study, a dose of 2000 mg/kg body weight (bw) of the film suspension was administered orally to rats. The animals were observed for toxic symptoms and mortality daily for 14 days. In a subchronic toxicity study, the film suspension, at doses of 10, 30 and 75 mg/kg bw for 28 days, were orally administered to rats. After 28 days, the rats were sacrificed for hematological, biochemical and histological examination. In the acute toxicity study, neither signs of toxicity nor death among the rats were observed for up to 14 days of the experimental period. The results of the subchronic toxicity study show that there were no significant changes observed in the hematology and organ histology. Some alterations to the relative organ weight and blood biochemistry were observed, but they were considered to be temporary effects and not an indication of toxic effects. The overall findings of this study indicate that the film formulation of κ-Carrageenan and konjac glucomannan is non-toxic up to a dose of 75 mg/kg bw, which could be considered a safe dose for soft capsule application.

Oral Toxicological Studies ofPuerariaFlower Extract: Acute Toxicity Study in Mice and Subchronic Toxicity Study in Rats

2013 ◽  
Vol 78 (11) ◽  
pp. T1814-T1821 ◽  
Author(s):  
Akira Takano ◽  
Tomoyasu Kamiya ◽  
Masahito Tsubata ◽  
Motoya Ikeguchi ◽  
Kinya Takagaki ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Toxicity Study ◽  
Subchronic Toxicity ◽  
Acute Toxicity Study ◽  
Toxicological Studies

An experiemental study to evaluate the principle Trini Dravyani Nati Upayunjita w.s.r. to Kshara (Alkali)

2019 ◽  
Vol 4 (04) ◽  
Author(s):  
Amrita Paul ◽  
Umapati C. Baragi ◽  
Kashinath Hadimur ◽  
R. A. Deshmukh
Keyword(s):  
Acute Toxicity ◽  
Adverse Effects ◽  
Dose Level ◽  
Behavioral Changes ◽  
Toxicity Study ◽  
Fixed Dose ◽  
Albino Rats ◽  
Acute Administration ◽  
Acute Toxicity Study ◽  
Acute Study

Background: In Charaka Samhita it has been mentioned that three medicinal substances viz. Pippali (Piper longum), Kshara (alkali) and Lavana (salt) can be used as emergency medicine, but they should not be consumed in excess (Ati Upayunjita). If they are consumed in excess quantity they will cause several adverse effects in the body. Hence in the present study Kshara has been evaluated in experimental animals in two different phases viz. acute administration at graded doses as part of acute toxicity study and sub-acute administration at fixed dose level, as part of sub-acute toxicity study, to assess the possible adverse effects if any. Objectives: To evaluate the acute and sub-acute toxic effect of Kshara in albino rats to establish the principle of Trini Dravyani Nati Upayunjita. Materials and Methods: Wister strain albino rats of either sex weighing between 150 - 200g body weights were used for experimental study. The experiment was carried out as per ‘Ayush Guidelines’ after the IAEC clearance. For Acute Toxicity - 9 Albino rats were used and for Sub-Acute Toxicity - 12 Albino rats were used. The dose calculation was done on the basis of body surface area ratio using the table of ‘Paget and Barnes rule’. Results: In Acute toxicity study no mortality and behavioral changes were observed when the drug Kshara was studied after two dose level i.e. TED X 5 and TED X 10. In Sub-acute study some behavioral changes (including cage side behavior) were observed. No mortality was observed in any of the groups. Discussion: Acute toxicity study of Kshara showed no immediate and evident toxic signs and mortality within 24 hours of observation. In Sub-acute toxicity study in all four groups, no mortality or evident toxic effects were observed, however some mild histopathological changes were observed in sub-acute study.

Absence of Detectable Toxicity in Rats Fed Partially Hydrolyzed Guar Gum (K-13) for 13 Weeks

1997 ◽  
Vol 16 (6) ◽  
pp. 611-623 ◽  
Author(s):  
Takatoshi Koujitani ◽  
Hidetoshi Oishi ◽  
Yuji Kubo ◽  
Toshihiro Maeda ◽  
Keiji Sekiya ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Guar Gum ◽  
Toxicity Study ◽  
Oral Toxicity ◽  
Subchronic Toxicity ◽  
Mutagenic Potential ◽  
Reverse Mutation ◽  
Acute Toxicity Study ◽  
K 13 ◽  
Partially Hydrolyzed Guar Gum

Toxicity studies were conducted to evaluate acute and subchronic oral toxicity and mutagenicity of partially hydrolyzed guar gum (K-13). In an acute toxicity study, mice and rats were treated with K-13 at a dose of 6000 mg/ kg. There were no deaths, so the LD50s were >6000 mg/ kg in both species. In a subchronic toxicity study, K-13 was given to rats as a dietary admixture at concentrations of 0.2. 1.0 and 5.0% for 13 weeks. There were no effects attributable to K-13 in any examinations. K-13 proved to have no mutagenic potential in a reverse mutation test using bacteria.

scholarly journals An exploratory analysis on the toxicity & safety profile of Polyherbal combination of curcumin, quercetin and rutin

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Reshu Tiwari ◽  
Mohammed Haris Siddiqui ◽  
Tarique Mahmood ◽  
Alvina Farooqui ◽  
Paramdeep Bagga ◽  
...  
Keyword(s):  
Body Weight ◽  
Acute Toxicity ◽  
Adverse Effects ◽  
Lipid Profile ◽  
Biochemical Parameter ◽  
Normal Group ◽  
Toxicity Study ◽  
General Behaviour ◽  
Swiss Albino Mice ◽  
Acute Toxicity Study

Abstract Background Curcumin, quercetin and rutin are flavonoids having strong antioxidant potential, individually used in treatment of numerous ailments. The safety assessment of each of them is already established but no toxicological assessment has been done that would guarantee the safe use of these three flavonoids when used as a polyherbal combination (PHC). The aim of this study to evaluate the possible toxicological effect of polyherbal combination of these three flavonoids in female Swiss albino mice. Methods In acute toxicity study, the oral dose of poly herbal combination was administered to four groups stepwise in single dose and general behaviour, adverse effects and mortality were determined up to 14 days and compared to normal group. In sub-acute study, the tested poly herbal combination was administered orally for 28 days to the four experimental groups and their body weight was measured each alternate day from the first day of dosing. On 29th day the final body weight was recorded and euthanized by using thiopentone sodium, blood was collected and later haematological, lipid profile, biochemical parameter was evaluated and compared to normal group. Result In acute toxicity study, no abnormal general behaviour, adverse effects were reported. No significant changes were reported in body weight, haematological, lipid profile, biochemical parameter in sub-acute toxicity study. No mortality was reported in both the study. Histopathological examination revealed no alterations in clinical signs or organ weight at any dose. Conclusion The result concludes that the oral administration of Polyherbal combination did not produce any significant toxic effect in swiss albino mice. Hence, the Polyherbal combination can be utilized safely for therapeutic 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

In-vitro and in-vivo evaluation of antidiabetic activity of Withania coagulans extract

2019 ◽  
Vol 09 ◽  
Author(s):  
Tejas Patel ◽  
B.N. Suhagia
Keyword(s):  
Blood Glucose ◽  
Acute Toxicity ◽  
Aqueous Extract ◽  
Pancreatic Beta Cell ◽  
Toxicity Study ◽  
Acute Toxicity Study ◽  
Withania Coagulans ◽  
Study Results

Background: Diabetes mellitus is major issue to public health as its prevalence is rising day by day. Synthetic agents available for the diabetic treatment are expensive or produce undesirable side effect on chronic use and some of them are not suitable during pregnancy. Herbal medicines accepted widely due to side effects and low cost. Objective: The aim of present study was to evaluate the activity of Withania coagulans extract using In-vitro and In-vivo model. Methods: Different three types of Withania coagulans extract were prepared using aqueous (W1), Alcohol (W2) and hydro-alcoholic (50:50) mixture (W3). In-vitro Anti-diabetic activity of the all three extracts evaluated using RINm5F Pancreatic beta cells.Further, n-vivo anti-diabetic evaluation performed by administering 50 mg/kg (p.o) aqueous extract for 7 days in Streptozotocin (STZ)-induced mice. Body weight of the animals was also determined to perform acute toxicity study. Results: The results of in –vitro cell based study indicated that among all three extract, aqueous extract (W1) of Withania coagulans showed potential increase in inulin release. The EC50 of the W1 (249.6 µg/L) which is compared with standard (Glibenclamide) EC50. From the results of In-vitro study, W1 subjected for acute toxicity study and the acute toxicity study results indicated LD50 of 50mg/kg. Diabetic rats treated with W1 extract at oral dose of 50 mg/kg for 7 days showed 34.17% reduction in blood glucose in comparison to untreated diabetic (STZ-induced) rats. Blood glucose levels of Standard treated (Glibenclamide) and control untreated. Conclusion: In conclusion, results of pancreatic beta cell based study showed increase in insulin release by administration of extract. Further aqueous extract (W1) was potentially reduced blood glucose level in STZ induced diabetic mice.

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