Subacute Toxicity Study Research Articles

Toxicological evaluation of banana and milk combination as incompatible diet - An experimental exploration of Samyoga viruddha concept

BackgroundFood is the basic requirement and an essential part of all living beings which sustains life. A lot of emphasize has been given to food in the classics of Ayurveda and a detailed description of food which are both wholesome and unwholesome have been described. Viruddhahara (incompatible food) is a unique concept explained in Ayurveda which, in long run, may be harmful to the body. Objective(s)Intake of Kadaliphala (Musa paradisiaca. Linn, a variety of banana) and cow milk is an example of Samyoga Viruddha (incompatibility with reference to combination of things). This combination is routinely consumed by people. The present study was planned to evaluate the toxicological implication of their combination on wistar rats. Materials and methodsA subacute toxicity study was conducted on Wistar rats following the repeated dose 28-day oral toxicity study in rodents, 407 - OECD guidelines. Different haematological and biochemical parameters along with histopathology of important organs were carried out to assess the toxicological implication of the combination. ResultsRepeated administration of the combination of Kadaliphala (Banana) and cow milk showed statistically significant increase in SGOT & urea and statistically significant decrease in creatinine. Significant decrease was observed in the food intake, faecal wet weight and faecal water in the 7th day of study, food conversion ratio in the 14th day of study, in the food intake, faecal wet weight and faecal water in the 21st day of study and significant decrease in the food conversion ratio in the 28th day of study. In histopathological examination, the test drug administered group showed mild to moderate myocarditis in the sections from heart. In sections from liver of two rats of test group, diffused micro fatty changes were observed. In sections from spleen; mild to moderate increase in the white pulp portion was observed. ConclusionMarked variation in SGOT, urea and creatinine levels and alteration in sections of heart, liver and spleen are indicative of mild toxicological implications of the combination of banana and milk. Continuous intake of this incompatible combination may hence prove harmful to the body.

Toxicological Assessment of Ethanolic Leaves Extract of Kalanchoe pinnata in Rats

Kalanchoe pinnata is a perennial plant that is widely used in the folklore treatment of kidney and gallstones and urinary insufficiency. The present study aims to evaluate the potential toxicity of the leaf extractof this plant upon acute and sub-acute (28 day) exposure in Wistar rats when administered orally. In acuteoral toxicity(n=3) female Wistar rats were treated with a single dose of 2000mg/kg b.wt and observed for14 days and sub-acute toxicity(n=6) male and female Wistar rats were treated with the dose of 500 and1000mg/kg b.wt of leaf extract for 28 days consecutively. No mortality, morbidity or adverse clinical signsof toxicity were observed during the experimental period. No significant changes in the body weight wasobserved. Gross necropsy did not indicate any treatment-related pathological changes in any of the animalsin the acute and sub-acute toxicity studies. Histopathology of the liver, heart and kidney did not show anyremarkable lesions that could be related to the administration of the leaf extract. Ethanolic leaf extract ofKalanchoe pinnata is relatively safe with an LD50 value greater than 2000 mg/kg. From the sub-acute study,the no-observed adverse effects level (NOAEL) of the extract can be derived as 1000 mg/kg b.wt in maleand female Wistar rats.

Toxicological Assessment of Ethanolic Leaves Extract of Kalanchoe pinnata in Rats

Kalanchoe pinnata is a perennial plant that is widely used in the folklore treatment of kidney and gallstones and urinary insufficiency. The present study aims to evaluate the potential toxicity of the leaf extractof this plant upon acute and sub-acute (28 day) exposure in Wistar rats when administered orally. In Acuteoral toxicity(n=3) Female Wistar rats were treated with a single dose of 2000mg/kg b.wt and observed for14 days and Sub-acute toxicity(n=6) Male and Female Wistar rats were treated with the dose of 500 and1000mg/kg b.wt of leaf extract for 28 days consecutively. No mortality, morbidity or adverse clinical signsof toxicity were observed during the experimental period. No significant changes in the body weight wasobserved. Gross necropsy did not indicate any treatment-related pathological changes in any of the animalsin the acute and sub-acute toxicity studies. Histopathology of the Liver, Heart and Kidney did not show anyremarkable lesions that could be related to the administration of the leaf extract. Ethanolic leaf extract ofKalanchoe pinnata is relatively safe with an LD50 value greater than 2000 mg/kg. From the sub-acute study,the no-observed adverse effects level (NOAEL) of the extract can be derived as 1000 mg/kg b.wt in maleand female Wistar rats.

Toxicological Evaluation of the Repeated Dose Administration of the Ethanolic Extract of <i>Azolla microphylla</i> in Wistar Albino Rats

Azolla microphylla is an easily cultivable aquatic plant with the commendable nutritious property. Recent reports on Azolla species emphasize the therapeutic potential of the plant extracts. Moreover, the same genus of plant also had displayed antioxidant potential owing to its free radical scavenging tendency. Although these attributes were identified, a study investigating the toxicological property of different dosages of ethanolic extract of A. microphylla (EAM) is not yet reported. Thus the present study aims for the in vivo toxicological evaluation of the EAM in Wistar strain of rats. Daily doses of 0, 250, 500, 1000 and 2000 mg/kg body weight of EAM were administered orally to group-I, group-II, group-III, group-IV & group-V rats, respectively for 14 days. Biochemical and histopathological studies were established through standard methods. The acute toxicity results suggest the non-toxic nature of the extract supported with the absence of mortality and toxic symptoms until 72 h of observation. The results of sub-acute toxicity study in the extract-treated rats (group-II to group-IV) indicate non-significant changes to the biochemical (total protein, AST, ALT, LDH, albumin, globulin, urea, creatinine, cholesterol, & triglycerides), hematological (Hemoglobin, RBCs, WBCs, platelets, monocytes, lymphocytes, & neutrophils), and histopathological observations when compared to the control group of rats. However, group-V rats were treated with 2000 mg/kg b.w. exhibited statistically significant variations to most of the biochemical and hematological parameters although no mortality/physical toxic signs were reported till the end of the experimental period. Thus, the sub-acute toxicity results suggest that the extracts were non-toxic and safe to rats between 250-2000 mg/kg b.w. concentration under 14 days observational period. Moreover, as there was no mortality upto 2000 mg/kg b.w., 50% lethal dose (LD50) could not be determined, and hence it is considered to be greater than 2000 mg/kg/day.

Hepatoprotective effect of selected isoandrographolide derivatives on steatotic HepG2 cells and High Fat Diet fed rats

Non-alcoholic Fatty Liver Disease (NAFLD) is one of the growing epidemics of the globe. This study was aimed to evaluate the anti-NAFLD effect of selected IAN derivatives using in silico, in vitro and in vivo models. In silico tools viz., DataWarrior, SwissADME and Gaussian 09 were used to predict the pharmacokinetic properties and electronic distribution patterns of the derivatives; docking analysis was done with Autodock against PPARα. Toxicities of the derivatives were assessed in HepG2 cells using MTT assay. Anti-NAFLD efficacies of the derivatives were assessed in free fatty acid induced steatotic HepG2 cells. In vivo anti-NAFLD effect of active isoandrographolide (IAN) derivative, 19-propionyl isoandrographolide (IAN-19P) was assessed in High Fat Diet fed rats. In silico and in vitro studies indicated that IAN-19P showed improved drug-likeness and drug score. The toxicity of IAN-19P to HepG2 cells was comparatively less than IAN and other derivatives. In free fatty acid induced steatotic HepG2 cells, treatment with IAN-19P significantly lowered intracellular triglyceride content and leakage of LDH and transaminases. Treating High Fat Diet fed animals with IAN-19P significantly lowered plasma lipids, transaminases, LDH and GGT levels. The treatment with IAN-19P upregulated the expressions of PPARα and CPT-1. IAN-19P did not produce any noticeable adverse effect till 2 g/kg concentration in acute and 250 mg/kg concentration in subacute toxicity studies. This study indicated the beneficial effect of IAN-19P for the treatment of NAFLD; however robust investigations are needed to establish the potential of IAN-19P to treat NAFLD.

In vitro cytotoxicity and in vivo sub-acute toxicity studies on Vitex doniana (Verbenaceae) leaves extract in MCF-7 breast cancer cells and female Wistar rats

In vitro cytotoxicity and in vivo sub-acute toxicity studies on Vitex doniana (Verbenaceae) leaves extract in MCF-7 breast cancer cells and female Wistar rats

Acute and Subacute Toxicity Assessment of Ethyl Acetate Extracts from Aerial Parts of Clerodendrum thomsoniae Balf.f in Rodents

Clerodendrum is a genus of about 500 species belongs to the family Lamiaceae. Several species of this genus have been proved for the treatment of various diseases. Clerodendrum thomsoniae Balf.f were selected in this study; according to the literature available, there is no systematic toxicity studies for this plant were described. The current study was therefore carried out to evaluate the acute and sub-acute toxicity in mice and rats. The acute oral toxicity study was performed in mice following OECD guidelines 425, and the sub-acute toxicity was performed in male and female rats following OECD guidelines 407. The results showed that mice given a single dose of up to 2000 mg/kg orally did not show any toxicity signs or mortality. In the sub-acute toxicity analysis in rats, 3 specific daily doses of 150, 300, and 600 mg/kg for 28 days did not induce any major changes to the hematological and biochemical parameters. Histopathological studies revealed normal architecture that did not indicate any morphological disturbances. In our study, no deaths or any signs of toxicity were found in acute and subacute toxicity studies after oral administration according to OECD guidelines, which concluded that ethyl acetate extract of Clerodendrum thomsoniae Balf (EACT) could use for in vivo biological activity studies in laboratory animals to explore its various medicinal activity before study in human subjects.

Oral toxicity evaluation of gokshuradi guggulu, an ayurvedic formulation

Gokshuradi guggulu is an important classical polyherbal formulation used in Ayurvedic system of medicine for the treatment of various chronic diseases like kidney stones and diabetes. However, no scientific attempts were made to evaluate its oral toxicity. Hence, the present study evaluated the acute and 28 days repeated dose sub-acute oral toxicities of gokshuradi guggulu in rats. Gokshuradi guggulu was tested for its compliance using physicochemical and analytical parameters as per standards prescribed in Ayurvedic Pharmacopeia of India. In acute oral toxicity study, Wistar rats were orally administered a single dose of gokshuradi guggulu (2700 mg/kg) and clinical signs and mortality or moribund stage were observed for 14 days along with weekly body weight. On day 15, the rats were euthanized and the gross morphology was carried out during necropsy. In sub-acute (repeated dose) oral toxicity study, the rats were orally administered gokshuradi guggulu (270, 1350 and 2700 mg/kg) once daily up to 28 days. Clinical signs and mortality or moribund stage, weekly body weight, weekly feed and water consumptions, biochemical and hematological investigations, urine analysis, and major organ weights and histopathology were carried out. In acute and sub-acute toxicity studies, gokshuradi guggulu administration did not show any alteration in parameters or any adverse effect as compared to vehicle treated group. There was no mortality or moribund state observed in any group in both studies. Administration of gokshuradi guggulu in acute and 28 days repeated doses did not exhibit any toxicity or adverse effect at the doses used and NOAEL was found to be 2700 mg/kg.

Toxicological evaluation of aqueous extract of the traditional Chinese formula Qing Hao Gan Cao.

Qing Hao Gan Cao (QHGC), a Chinese medicinal formula containing Artemisia annua and Glycyrrhizae Radix et Rhizoma, has been used to treat sunstroke and as an antiviral agent for more than 800 years. It has not previously been subject to a toxicological safety evaluation in acute and subacute (28days) studies. Therefore, the acute and subacute toxicity of an aqueous extract of QHGC were evaluated in vivo. For the QHGC preparation, the botanical raw materials were crushed into pieces and mixed in the ratio of 10:1 in distilled water for 12 h, then boiling three times for 2 h each time. The three decoctions were mixed and filtered, then spray-dried with hot air at 160°C for 30 min, and stored at room temperature. For the acute toxicity test, 72.0 g/kg of QHGC extract was administered by gavage to male and female mice. Body weight, general observations, and autopsy results were recorded. No mortality or toxicity signs were observed during the studies. For the subacute toxicity test, 4.0, 8.0, or 16.0 g/kg/day of QHGC extract was administered to rats for 28 days. General observations and mortality, body weight, biochemical and hematological parameters, organ weight, and pathological morphology were analyzed. The acute and subacute toxicity studies did not show significant changes in body weight, general observations, hematology and biochemical parameters, organ weight, and liver, spleen, stomach, duodenum, testis, ovary, lung, heart, and kidney histopathological analyses. The consumption of QHGC aqueous extract can be considered safe within the conditions of this study.

Toxicological evaluations of betulinic acid and ursolic acid; common constituents of Houttuynia cordata used as an anthelmintic by the Naga tribes in North-east India

BackgroundBetulinic acid (BA) and ursolic acid (UA) are two major phytoconstituents of Houttuynia cordata Thunb., (Saururaceae) which is used as an anthelmintic in the traditional medicine system of the Nagas in Nagaland, India. This study evaluates their toxic potentials using rodent models (Swiss albino mice and Wistar rats) according to the OECD (Organization for Economic Cooperation and Development) guidelines. Acute and 28-day sub-acute oral toxicity studies were conducted, and evaluations were made based on biochemical, hematological, and histopathological observations.ResultsAcute oral toxicity study revealed the oral LD50 of both the test compounds to be > 2000 mg/kg in mice. Sub-acute administration of BA at 10 mg/kg body weight (b.w.) revealed a significant increase in serum glutamic oxaloacetic transaminase (SGOT), alkaline phosphatase (ALP), urea concentrations and eosinophil and lymphocyte counts in rats. Animals administered with 10 mg/kg b.w. UA revealed elevated neutrophil count, SGOT, ALP, and urea concentrations, whereas white blood cells (WBC), lymphocyte, and platelet counts were found to be low. Histopathological examinations of body organs revealed alterations in the architecture of the liver, kidney, and spleen tissues. Notably, all these alterations were recoverable as evident in the satellite group, indicating a recovering pattern from the toxic effects caused by the oral administration of these phytocompounds.ConclusionAlthough UA and BA possess several therapeutic properties, their long-term usage can cause mild toxicity in their users. This study also paves way for evaluating the optimum effective and safe dose of these phytocompounds.

Thiazolidine Derivatives Attenuate Carrageenan-Induced Inflammatory Pain in Mice.

BackgroundPeripheral inflammation leads to the development of persistent thermal hyperalgesia and mechanical allodynia associated with increased expression of interleukin-1β (IL-1β) in the spinal cord. The aim of the present study was to investigate the effects of thiazolidine derivatives, 1b ([2-(2-hydroxyphenyl)-1,3-thiazolidin-4-yl](morpholin-4-yl)methanone) and 1d (2-hydroxy-4-{[2-(2-hydroxyphenyl)-1,3-thiazolidine-4-carbonyl]amino}benzoic acid), on thermal hyperalgesia, mechanical allodynia and on IL-1β expression during carrageenan-induced inflammation in the spinal cord in mice. Inflammatory pain was induced by injecting 1% carrageenan into the right hind paw of the mice.MethodsThe animals were administered thiazolidine derivatives, 1b and 1d (1 mg/kg, 3 mg/kg, or 10 mg/kg), intraperitoneally 30 minutes before carrageenan administration. The animals’ behavior was evaluated by measuring thermal hyperalgesia, mechanical allodynia, and motor coordination. The IL-1β expression was measured by enzyme-linked immunosorbent assay. Acute and sub-acute toxicity studies were conducted to evaluate the toxicity profile of compounds.ResultsTreatment with the thiazolidine derivative, 1b and 1d, attenuated carrageenan-induced thermal hyperalgesia and mechanical allodynia at doses of 1 mg/kg, 3 mg/kg, and 10 mg/kg. No motor coordination deficits were observed in animals. The compounds also reduced IL-1β expression in the spinal cord of mice. Acute and sub-acute toxicity studies revealed that both compounds were safe.ConclusionThe compounds exhibit promising activity against inflammatory pain due to their ability to produce anti-hyperalgesic and anti-allodynic effects and to inhibit IL-1β expression in the spinal cord.

In Vivo and In Vitro Toxicity Profiles of Hexane Extract of Alpinia malaccensis Rhizome in Rat and Cell Line Models.

The objective of the study was to evaluate the potential toxicity of crude n-hexane extract of Alpinia malaccensis rhizome. The in vivo acute oral toxicity was evaluated by administering a single oral dose of the extract at 0, 300, or 2000 mg/kg body weight to female Wistar rats according to modified OECD Test Guideline 423. For the in vitro cytotoxicity study, A549, HepG2, 3T3, and COS-7 cell lines were exposed to different doses of A. malaccensis extract and cell viability was assessed adopting MTT assay followed by AO/EB staining, Hoechst staining, and comet assay with a view to compare the cellular and molecular mechanisms underlying the toxicity, if any. It was found that administration of 2000 mg/kg bw dose in in vivo oral acute toxicity study did not produce significant toxicity or mortality. No significant (p < 0.05) differences were observed for body weight and hematological and biochemical parameters compared to control after 14 days of treatment. No changes in behavior, body weight, hematological and biochemical parameters, and aspects of histopathology were observed when compared to the control. Thus, the possible oral lethal dose for A. malaccensis extract is above 2000 mg/kg body weight. The in vitro cytotoxicity analysis showed nontoxicity concentrations of the extract to be 2, 1.4, 30, and 1.4 µg/mL for A549, HepG2, 3T3, and COS-7 cells, respectively, where no apoptotic/necrotic cell death and DNA damage were observed. In conclusion, the extract of rhizome of A. malaccensis did not produce apparent cytotoxicity or acute oral toxicity, confirming the scope to use A. malaccensis as a safe food preservative and a natural therapeutic product after further subacute and chronic toxicity studies.

Acute and subacute (28 days) oral toxicity studies of tucum almond oil (Bactris Setosa Mart.) in mice

Oils extracted from almonds are often used with particular interest due to their prospective health effects and benefits. Tucum is a Pantanal fruit widely consumed by local population and no in vivo toxicity studies regarding its safety are available in the literature to date. This study investigated the acute and subacute toxicity of tucum almond oil (TAO) in mice by evaluating its safety profile. For the acute (2000 mg/kg) and subacute (250, 500 and 1000 mg/kg) toxicity studies, TAO was administered orally to mice according to 425 and 407 Organization for Economic Cooperation and Development Guidelines, respectively. Food intake, body, and organ weight of animals were recorded. Signs of toxicity were assessed, and hematological, biochemical and histopathological analyses were performed. In the acute toxicity study, no mortality or behavioral changes were observed in mice treated with 2000 mg/kg, indicating that LD50 is higher than this dose. In the subacute toxicity test, the doses evaluated did not produce relevant changes in hematological, biochemical or histopathological parameters in the exposed animals. The data obtained suggest that TAO did not induce toxicity after exposure to a single or repeated doses and LD50 value may be considered to be more than 2000 mg/kg body weight.

Sub-acute oral toxicity study of aqueous extract of tobacco leaves (Nicotiana tabacum L.) on lipid profile, the tissue, and serum of the liver and kidney of male Wistar rats

Context Tobacco consumption may pose a very serious threat to the physiological state of the body; yet, fewer records have been documented in that regard. Objective We investigated the impact of aqueous extract of tobacco leaves on the lipid profile, the tissue, and serum levels of the liver and kidney of male Wister rats. Materials and methods Rats (n = 52; weight = 33 − 47 g; ∼ 2½ weeks old) were acclimatised for 7 days and administered aqueous extract of tobacco leaves at 100, 200, 400, 0 mg/kg of body weight (to group A, B, C, D) for 30 days. Results Compared with the control group, the kidney tissue and serum (i.e., urea and creatinine) were not influenced, in contrast, indices of the liver such as AST, ALT, and ALP, dose-dependently increased. Changes such as coagulative necrosis resulted in the infiltration of mononuclear inflammatory cells and the vacuolar degeneration of the liver. Beside the reduction in the high-density lipoprotein of the rats, there was an increase in the concentration of triglycerides, very low-density lipoprotein, low-density lipoprotein, and the total cholesterol. Conclusion Thus, extract of tobacco leaves can greatly influence the body lipid profile, beside the serum and tissues of the liver.

Toxicity profiling of the ethanolic extract of Citrullus lanatus seed in rats: behavioral, biochemical and histopathological aspects.

Citrullus lanatus (Cucurbitaceae) is conventionally used for the treatment of urinary tract infection, renal stones, hypertension, diabetes and diarrhoea. Current study evaluates acute and 28 days repeated toxicity ethanolic extract of C. lanatus seed (EECLS) in Wistar rats to measure its safety profile. The single dose (2000 mg/kg BW) of EECLS was administered while in 28 days repeated study 250, 500 and 1000 mg/kg BW were administered orally in rats. Parameters such as biochemical, haematological and histopathological were analysed in subacute toxicity study. During study, no apparent sign of toxicity, behavioural changes and mortality were detected in acutely exposed animals. In 28 days repeated toxicity study, rats did not show significant changes in behaviour, gross pathology, body weight, biochemical and haematological parameters. Abridged serum glucose and cholesterol levels during the study designate their roles in treatment of hyperglycaemic and hyperlipidaemic conditions. No significant difference was observed in histopathology of liver and kidneys of treated rats. The current investigation demonstrated that EECLS is non-toxic below 1000 mg/kg BW and provides protection to some body organs. The data propose that LD50 of EECLS was greater than 2000 mg/kg BW and the no observed adverse effect level (NOAEL) of EECLS was at the dose of 1000 mg/kg in rats. Taken together, our finding suggests that, EECLS is safe and provides some protection to body organs; also, its extract can be used for further preclinical and clinical evaluation for its therapeutic activity.

Acute, sub-acute, sub-chronic and chronic toxicity studies of four important Nigerian ethnomedicinal plants in rats

BackgroundAzadirachta indica, Khaya senegalensis, Anogeissus leiocarpus and Tamarindus indica are important ethnomedicinal plants used for health mitigation since the history of mankind. They are used discretionarily in folkloric medicine on the premise that they are natural products devoid of synthetic preservatives. However, nature endows plants with metabolites for warding off potential attacks from animals and the environment. Some of these metabolites are responsible for toxicity of some plants. Furthermore, drug-induced liver injuries and nephrotoxicity are the leading causes of pharmaceutical attrition of promising drug candidates in clinical trials. Thus, we aimed to evaluate the safety of four ethnomedicinal plants in short-, medium- and long-term usage.MethodsRats dosed once with 5000 mg/kg extracts of each of these plants served as acute study (AS) while rats dosed daily with 2000 mg/kg for 2, 12 and 14 weeks served as sub-acute (SAS), sub-chronic (SCS) and chronic (CS) studies, respectively. Rats administered distilled water served as the negative control (NC).ResultsA. leiocarpus and T. indica significantly reduced percentage weight gain in the SCS compared to the NC. A. leiocarpus significantly (P< 0.05) increased transaminases and alkaline phosphatase in the AS only; and total protein (TP) in the AS, SAS, SCS and CS compared to the NC. K. senegalensis significantly (P< 0.05) increased alanine aminotransferase but significantly (P< 0.05) decreased TP in the AS only compared to the NC. However, A. indica and T. indica significantly (P< 0.05) increased globulin and aspartate transaminase in the CS only. Whereas A. leiocarpus and K. senegalensis significantly (P< 0.05) increased urea and creatinine in the AS than SAS, SCS and CS; Na+ and K+ were significantly higher in the SCS and CS studies compared to the NC. The histological lesions seen ranged from cellular degeneration, congestion, fibrosis to necrosis.ConclusionThus, nonlethal, reversible toxic insults occur in short-term usage (AS); while, insidious lethal toxic effects occur in medium-term (SAS) and long-term usage (SCS and CS). The ability of these plant to maintain adequate hematological parameters, bodyweight and absence of mortality may explain free usage of preparations made from these plants in folkloric medicine.

A pH-sensitive, stimuli-responsive, superabsorbent, smart hydrogel from psyllium (Plantago ovata) for intelligent drug delivery.

Herein, we report a polysaccharide-based hydrogel isolated from psyllium husk (a well-known dietary fiber) and evaluated for its swelling properties in deionized water (DW) at different physiological pH values, i.e., 1.2, 6.8 and 7.4. Swelling of psyllium hydrogel (PSH) in DW under the influence of temperature and at different concentrations of NaCl and KCl solutions was also examined. A pH-dependent swelling pattern of PSH was observed following the order DW > pH 7.4 > pH 6.8 > pH 1.2. Stimuli-responsive swelling and deswelling (on–off switching) behavior of PSH was observed in DW and ethanol, DW and normal saline, at pH 7.4 and pH 1.2 environments, respectively. Similar swelling behavior and on–off switching attribute of PSH-containing tablets indicated the unaltered nature of PSH even after compression. Scanning electron micrographs of swollen and then freeze-dried PSH via transverse and longitudinal cross-sections revealed hollow channels with an average pore size of 6 ± 2 μm. Furthermore, PSH concentration-dependent sustained release of theophylline from tablet formulation was witnessed for >15 h following the non-Fickian diffusion mechanism. Subacute toxicity studies revealed the non-toxic nature of PSH. Therefore, dietary fiber-based material, i.e., PSH could be a valuable pharmaceutical excipient for intelligent and targeted drug delivery.

Subacute Toxicity Study and Clinical Trials for Ziziphus spina-christi Leaves Extract as an Anti-dandruff Shampoo

Subacute Toxicity Study and Clinical Trials for Ziziphus spina-christi Leaves Extract as an Anti-dandruff Shampoo

Toxicopathological, proinflammatory and stress response evaluation of Terminalia catappa extract in male Wistar rats.

The present study was carried out to assess the oral safety, proinflammatory and stress response effect of Terminalia catappa aqueous leaf extract (TCA) in male Wistar rats. The acute and sub-acute oral toxicity of TCA was assessed using guidelines 423 and 407 of the Organisation for Economic Co-operation and Development (OECD), respectively. Signs of clinical toxicity, morbidity and mortality were observed. The biochemical, haematological, proinflammatory, stress response and histopathological indices were assessed. In the acute toxicity study, no sign of clinical toxicity, morbidity, and mortality was observed for TCA treatment, up to 5000 mg/kg bwt. However, in the sub-acute toxicity study, repeated daily TCA treatment significantly (p<0.05) altered the body weight gain, plasma alkaline phosphatase activity and albumin concentration. There were no obvious morphological and macroscopic alterations in the organs investigated. TCA appear not to elicit any proinflammatory, stress, systemic and organ toxic effect when utilised at the reported dose and time frame.

Acute and sub-acute toxicity studies of aqueous leaf extract of launaea taraxacifolia (willd.) in wistar rats

Aim: This study aim to evaluate the acute and sub-acute toxicity profile of aqueous leaf extract of Launaea taraxacifolia (LT) in Wistar rats. Methods: Acute toxicity was investigated using Lorke’s method, while sub-acute toxicity was assessed using OECD guideline. The first phase of the acute toxicity study had nine Wistar rats randomly divided into three groups (n=3) and administered doses of 10mg/kg, 100mg/kg and 1000mg/kg (po) leaf extract of LT, respectively. In the second phase, four groups animals (n=1) received doses of 1200mg/kg, 1600mg/kg, 2900mg/kg and 5000 mg/kg (po) of the extract, respectively. For the sub-acute toxicity study, twenty rats were randomly divided into four groups (n=5). Group 1 received 10ml/kg distilled water, while Groups 2-4 received 250mg/kg, 500mg/kg and 1000mg/kg (po) of the extract, respectively for 28 days. Results: Acute toxicity result showed no mortality in both phases of study. In the sub-acute studies, significant increases in platelets in all treatment groups and RBC at the highest dose (1000 mg/kg) of the extract were observed (p