Evaluation of Safety Profiles of a Herbal Wound Healing Formulation in Laboratory Animals

The present study reported an acute, Sub acute dermal safety and Mucus membrane irritation profile of AO and AO11 in laboratory animals. This is a very effective wound healing oil formulation developed in house. We have systematically studied the effect of the oil in Laboratory Animal for its hematological parameters and found no hepato or renal toxicity associated with the sub-chronic dermal exposure of investigational product and investigational product11 in the animals. Wound is demarcated as the breakdown of community tissues by violence or trauma. The restoration of wounded or inflamed tissues back to normal condition is regarded as healing.

Theformulations were derived from Curcuma longa Linn and Glycyrrhiza glabra Linn rhizomes, Hamiltonia suaveolens Roxb bark, Typha angustifolia Linn flowers, Azadirachta indica A.Juss leaveswithout/ with pig fat (AO and AO11 respectively) mixed in certain proportion using Sesamum indicum Linn oil as a base, manufactured at a GMP certified facility. Acute, sub-acute dermal safety, mucus membrane irritation profiles were studied by OECD guidelines number 434, 410 and 405 in Wistar rats and New Zealand rabbits respectively.This study was conducted using 10 males and 10 females Wistar rats employing OECD guideline number 410. For acute study dermal application of 2000 mg/kg single dose and for sub-acute study limit dose protocol of 1000 mg/kg for 28 days was used. For mucus membrane irritation test0.10ml dose was used.

In an acute study no local reaction, behavioral changes and mortality was observed at 2000 mg/kg by dermal route till 14 days. In sub-acute study with dermal application of 1000 mg/kg for 28 days, there were no abnormal signs/symptoms at the application site, no difference inbody weight, food consumption, hematology/enzyme profiles, urine analysis, relative organ weights and histopathological observations of vital organs in comparison to control animals. Mucus membrane of rabbits showed no evidence of irritation for both formulations.