Subacute oral toxicity study of maxing Kugan decoction on rats.

Abstract

The Maxing Kugan Decoction (MKD) is a traditional Chinese medicine prescription specifically designed for respiratory infectious diseases in the northwest region, particularly targeting influenza during the winter and spring seasons. While its clinical efficacy has been established, there is a significant gap in its toxicological safety. This study aims to evaluate the subacute oral toxicity of MKD in rats, focusing on its effects on food consumption, weight, vital signs, haematological parameters, and organ histology. To determine subacute oral toxicity, MKD was administered by gavage at 12.6, 25.2, or 50.4 g/kg/day to male and female rats for 90 days. Meanwhile, the general behavior, body weight, food intake, urine routine parameters, blood biochemical, hematological parameters, coagulation parameters, organ coefficients and organ histopathology were recorded and analyzed. The results showed that experimental rats were healthy and displayed no evidence of toxicity. Furthermore, no mortality or abnormalities in general conditions, including diet and weight, were noted. While the levels of a few indicators changed during administration, their levels remained within the normal range and were not correlated with dose or gender. Overall, no toxicological significance was recorded. Meanwhile, histopathological analysis did not identify abnormal pathological changes in tissue structure and cell morphology across organs, and no significant delayed toxic reactions were detected during the remission period. Overall, our results indicated that oral administration of 50.4 g/kg (60 times the clinical dose in humans) of MKD for three months is safe for SD rats and is not associated with toxic side effects.