Effect of a novel antiinflammatory polyherbal preparation (Sudarshanam oil) on hematological parameters in Wistar rats.

The present investigation was an attempt to evaluate the anti-inflammatory effect of a polyherbal preparation (Sudarshanam Oil) on hematological parameters in Wistar rats. This polyherbal formula contains main ingredients of Tinaspora Cordifolia, Curcuma longa, Terminalia chebula, Emblica officinalis, Andrographis paniculata and Terminalia belerica. The active phytochemicals such as tannins, glycosides, flavonoids and triterpenoids are extracted from these herbal plants. And extract was prepared in corn oil. Young adult Wistar rats of either sex were divided into 4 groups and each group having 6 males and 6 females were dosed for 28 days. First group was the control group which was dosed with corn oil as vehicle (15 mL/kg body weight). Groups II, III and IV were treated with different doses of Sudarshanam oil, viz. as 5 mL/kg, 10 mL/kg and 15 mL/kg body weight respectively. On 29th day, after overnight fasting, the blood samples were collected through cardiac puncture under CO2 anaesthesia. The blood samples were collected and transferred into prelabelled vaccutainer coated with EDTA for hematological parameters investigation by using Advia-120 hematology analyser. The results revealed that no treatment related adverse effects in any of the hematological parameters. Thus, Sudarshanam oil proves to be highly potent, novel anti-inflammatory preparation which can be a challenge against allopathic anti-inflammatory drug.

Safety assessment of pomegranate fruit extract: acute and subchronic toxicity studies.

Pomegranate (Punica granatum L.) fruit is widely consumed as fresh fruit and juice. Because of its potential for health benefits, pomegranate fruit extracts have been commonly marketed as dietary supplements in recent years. The objective of the present study was to investigate potential adverse effects, if any, of a standardized pomegranate fruit extract in rats following subchronic administration. The extract was standardized to 30% punicalagins, the active anomeric ellagitannins responsible for over 50% of the antioxidant potential of the juice. The oral LD(50) of the extract in rats and mice was found to be greater than 5 g/kg body weight. The intraperitoneal LD(50) in rats and mice was determined as 217 and 187 mg/kg body weight, respectively. In the subchronic study, Wistar strain rats (10/sex/group) were administered via gavage 0 (control), 60, 240 and 600 mg/kg body weight/day of the extract for 90 days. Two additional groups received 0 and 600 mg/kg/day of the extract for 90 days, followed by a 28 day recovery phase. Compared to the control group, administration of the extract did not result in any toxicologically significant treatment-related changes in clinical observations, ophthalmic examinations, body weights, body weight gains, feed consumption, clinical pathology evaluations and organ weights. The hematology and serum chemistry parameters that showed statistical significant changes compared to control group were within the normal laboratory limits and were considered as biological variations and not the toxic effect of the extract. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. Based on the results of this study, the no observed-adverse-effect level (NOAEL) for this standardized pomegranate fruit extract was determined as 600 mg/kg body weight/day, the highest dose tested.

Safety assessment of a solid lipid curcumin particle preparation: acute and subchronic toxicity studies.

Curcumin, a polyphenol, is obtained from turmeric, the ground rhizomes of Curcuma longa L. Extensive research over the past half century has revealed several health benefits of curcumin. The objective of the present study was to investigate potential adverse effects, if any, of a novel solid lipid curcumin particle (SLCP) preparation in rats following acute and subchronic administration. The oral LD50 of the preparation in rats as well as in mice was found to be greater than 2000 mg/kg body weight (bw). In the subchronic toxicity study, Wistar rats (10/sex/group) were administered via oral gavage 0 (control), 180, 360, and 720 mg/kg bw/day of SLCP preparation for 90 days. Administration of the curcumin preparation did not result in any toxicologically significant treatment-related changes in clinical (including behavioral) observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No adverse effects of the curcumin preparation were noted on the hematology, serum chemistry parameters, and urinalysis. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for this standardized novel curcumin preparation was determined as 720 mg/kg bw/day, the highest dose tested.