Regulatory Toxicology and Pharmacology (original) (raw)
Related papers
Safety and tolerability of a dried aqueous spearmint extract
Regulatory Toxicology and Pharmacology, 2017
Spearmint (Mentha spicata L.) and spearmint extracts are Generally Recognized as Safe (GRAS) for use as flavoring in beverages, pharmaceuticals, and confectionaries. Studies of spearmint extracts in humans and animals have reported conflicting results with respect to toxicity. Since the chemical composition of these extracts was not reported and the spearmint source material was different, the relevance of these existing data to evaluating the risks associated with ingestion of a dried aqueous spearmint extract standardized to rosmarinic acid is not clear. Hence, the safety and tolerability of the dried aqueous spearmint extract was evaluated as part of a double-blind, randomized, placebo-controlled trial in healthy adults with age-associated memory impairment. Ingestion of both 600 and 900 mg/day for 90 days had no effect on plasma levels of follicular stimulating hormone, luteinizing hormone, or thyroid stimulating hormone, or other safety parameters including vital signs, plasma chemistry or whole blood hematology values. Additionally, there were no reported severe adverse events, no significant betweengroup differences in the number of subjects reporting adverse effects and the adverse events reported could not be attributed to ingestion of the extract. These results therefore show that ingestion of the aqueous dried spearmint extract is safe and well-tolerated.
Background: Cognitive function can decline during the aging process and significantly reduce quality of life. Although a number of interventions have been investigated for cognitive dysfunction, including antioxidants, this prominent health concern emphasizes a need to explore methods to support cognitive health later in the life span. An aqueous extract from a proprietary spearmint line has been developed which contains a number of antioxidant compounds, including rosmarinic acid, at levels that are higher than found in commercially-bred spearmint. Therefore, this pilot trial assessed the tolerance, bioavailability, and potential cognitive health implications of a proprietary spearmint extract in men and women with self-reported memory impairment. Methods: Subjects consumed 900 mg/day spearmint extract for 30 days. The sample population (N = 11) was 73% female and 27% male with a mean age of 58.7 ± 1.6 y. Tolerability parameters were assessed at baseline and end of treatment visits. Computerized cognitive function tests were completed and blood was drawn at pre- and post-dose (0.5 to 4 h) timepoints during baseline and end of treatment visits. Subjective cognition was also assessed at end of treatment. Results: No serious adverse events or clinically relevant findings were observed in any tolerability parameters. Plasma vanillic, caffeic, and ferulic acid sulfates, rosmarinic acid, and methyl rosmarinic acid glucuronide were detected in plasma following acute administration of the spearmint extract. Computerized cognitive function scores improved in reasoning (P = 0.023) and attention/concentration (P = 0.002) after 30 days of supplementation. After acute administration, subjects had improved attention/concentration in two tests at 2 (P = 0.042 and P = 0.025) and 4 h (P = 0.001 and P = 0.002). Conclusions: The results from this pilot trial suggest that the spearmint extract, which contains higher rosmarinic acid content relative to extracts from typical commercial lines, was welltolerated at 900 mg/day. In addition, the extract was bioavailable and further investigation is warranted regarding its potential for supporting cognitive health
Peppermint and spearmint, both members of the Lamiaceae family, have been used in the form of extracts, infusions, and decoctions, because of their health benefits. Consumers are looking for functional food products which not only provide health benefits but also necessitate less preparation time. Therefore, this study aimed to investigate the bioactive properties of powdered peppermint and spearmint extracts. Peppermint and spearmint extracts obtained using pressurized water extraction were made into powder forms with a spray dryer using the air inlet temperature of 140°C. Powdered peppermint extract (PPE) and powdered spearmint extract (PSE) showed significant inhibition against key enzymes of type 2 diabetes (α-glucosidase) and hypertension (angiotensin 1-converting enzyme, ACE). Alpha glucosidase inhibition degree of PPE and PSE as IC 50 values was 0.6 and 1.2 mg/mL, respectively, while IC 50 values for the ACE inhibition test were 4.5 mg for PPE and 5.8 mg for PSE. The HPLC-DAD method for ACE inhibition activity showed the suitability of this method for plant extracts high in phenolics which had no interference effects on the results. There were no differences between PPE and PSE in the DPPH test. However, PPE had higher Trolox equivalent antioxidant capacity (190 mg/g) with the ABTS test than PSE (170 mg/g). The predominant phenolics of PPE and PSE were found to be eriocitrin (47 mg/ g) and rosmarinic acid (27 mg/g), respectively.
Acute Oral Safety Study of Rosemary Extracts in Rats
Journal of Food Protection, 2008
Increasing interest in rosemary plants is due to their antioxidant and health-enhancing properties. The aim of this study was to evaluate the potential acute toxicity of two supercritical fluid extracts of rosemary. An acute safety study of rosemary extracts was conducted in Wistar rats at a single oral gavage dosage of 2,000 mg/kg of body weight. Rosemary extracts were well tolerated; no adverse effects or mortality were observed during the 2-week observation period. No abnormal signs, behavioral changes, body weight changes, or change in food and water consumption occurred. Two weeks after a single oral rosemary extract dose of 2,000 mg/kg of body weight, there were no changes in hematological and serum chemistry values, organ weights, or gross or histological characteristics. Rosemary extracts appear to have low acute toxicity, and the oral lethal doses (LD50) for male and female rats are greater than 2,000 mg/kg of body weight.
FREE RADICALS SCAVENGING ACTIVITY OF SPEARMINT METHANOLIC EXTRACT
Plant kingdom contains about 620 families. One of them is family lamiaceae which has spearmint plant. This plant has a pungent taste with digestive effects. Phytochemical screening, chemical composition and antioxidant activity of spearmint aerial parts methanolic extract were investigated. Phytochemical analysis indicated the presence of terpenes, tanins, flavonoids, saponins, glycosides, alkaloids and phenolic glycosides. Total phenolic and flavonoids contents of the methanolic extract were found to be 35.65mg gallic acid equivalent (GAE)/g and 27.47mg quercetin equivalent (QE)/g respectively. Different antioxidant procedures were used to determine the activity of spearmint as antioxidant such as: DPPH, antioxidant capacity, nitric oxide radical scavenging, superoxide dismutase activity, hydroxyl radical scavenging and reducing power assay.
Report: Safety and toxicological evaluation of herbal formulation on rodents
Pakistan journal of pharmaceutical sciences, 2018
Herbal medicines are still most popular, abundant and affordable remedies for curing various ailments. Garlina is one of the herbal formulations of Hamdard Laboratories (waqf) Pakistan used to treat cardiovascular diseases and elevated sugar level. However, there is no scientific data available regarding the potential toxicity. Therefore, the present study was to assess the acute and sub-chronic toxicity in rats. The single dose of Garlina 5000mg/kg were administered orally and observed for 14 days. A sub-chronic toxicity test was performed at 2000mg/kg of Garlina daily for 30 days. Control rats received saline. The biochemical, hematological and histopathological analysis was carried out. The acute toxicity LD50 was determined to be <5000mg/kg. The result of acute and sub-chronic toxicity revealed no mortality and sign of toxicity. Garlina did not elicit any significant change in body weight, hematological and histopathology analysis when compared to saline treated rats. The rel...
Analysis of Peppermint Leaf and Spearmint Leaf Extracts by Thin-Layer Chromatography
Journal of Chemical Education, 2008
Spearmint (Mentha spicata L.) is a short-term perennial herb in Lamiaceae family. Mint production is affected by many diseases among which being highly susceptible to leaf rust (Puccinia menthae) that causes up to 70% yield loss in the study area. The present study was undertaken to investigate the potential efficacy of various botanicals for the control of spearmint leaf rust. Crude acetone extract of Lantana camara L., Milletia ferruginea L., Eucalyptus globules L., Maesa lanceolata L, Ruta chalapensis L., Vernonia amygdalina L., Datura stramonium L. and C. citrates (DC) Stapf were investigated in greenhouse and field conditions. Plants sprayed with propiconazole were used as standard check and untreated plants as control. The experiment was arranged in completely randomized design (CRD) and randomized complete block design (RCBD) both for in vivo and field experiments, respectively. Spore suspension of the pathogen containing 10 spores/ml was sprayed on two-month-old spearmint seedlings. Filtered extract of each plant was sprayed-6 separately on infected plants in greenhouse as different treatment. For field experiment, botanicals were sprayed on well established plants before disease occurrence and continued for two months at 15 day interval. Data was recorded on Fresh leaf yield (kg ha), dry leaf yield (kg ha), fresh stem wt (kg/plot), essential oil contents,-1-1 essential oil yield, disease severity and disease control. D. stramonium, M. lanceolata and M. ferruginea were found significantly effective botanical extracts both in green house and field condition for the control of spearmint leaf rust.
Environmental Analysis Health and Toxicology
The use of home remedies for medicinal purposes, most of which are edible plants has continued to be a practice in many homes. However, there has been an increasing report of chronic use with lethal effect. Among the commonly used herbal/ medicinal plants were ginger, garlic and lemon. These were seen to be prevalent across continents with brewing and crude extraction being the most means of consumption. This study investigated the organ wide toxicity of this extract following chronic consumption of crude extract. Twenty-five albino Wister rats, five in each group were used for this experiment. Each animal received 0.5ml/kg body weight of either ginger extract, garlic extract, lemon juice, or a mixture of equal volumes of all three extract (v/v) respectively twice daily for seven (7) days. Statistics were represented as ±SE; P≤0.05 was considered significant. Previous studies have shown that moderate consumption of these medicinal plants were beneficial and have shown no deleterious...
Acute and Sub Acute Safety Studies of Herbmed Plus-A Herbal Formulation in Laboratory Animals
International Journal of Pharmacy and Pharmaceutical Sciences, 2014
Objective: To study Acute, sub-acute oral toxicity profile of Herbmed plus (HP)-A herbal formulation. Methods: HP was derived from Crataeva nurvala Buch-Ham (Varun) bark, Musa paradisiaca Linn (Kadali/Banana) stem and roots, Achyranthes aspera Linn (Aghada) whole plant and Hordeum vulgare Linn (Yav) seeds. Above materials were converted into Varun bhavit kadali bhavit, kshars of Kadali, Aghada and Yav respectively and were mixed in certain proportions in GMP certified manufacturing facility to formulate HP capsules form. Acute and sub-acute safety profiles of HP was studied by OECD guidelines Number 423 and FDA guidelines in Swiss albino mice and Wistar rats respectively. For the acute study, HP was administered orally in a single dose of 2000mg/kg and for sub-acute study HP was administered orally using 90,180 and 450 mg/kg doses for 90 days. Results: In an acute study there were no behavioral changes and mortality at 2000 mg/kg by the oral route in mice up to 14 days. In sub-acute study after administration of various doses of HP for 90 days to various groups; there was no significant difference in body weight, food consumption, hematology / enzyme profiles, relative organ weights and histological observations of vital organs in comparison to control animals. Conclusion: The acute LD50 cut off for HP was found to be > 2000mg/kg in mice and No Observed Adverse Effect Level (NOAEL) for HP was found to be > 450 mg/kg by oral route for 90 days in Wistar rats.