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Subacute oral toxicity study of maxing Kugan decoction on rats
Taiqiang Jiao1,2,3, Ling Yuan4, Jiaqing Li1,2
1College of Traditional Chinese Medicine, Ningxia Medical University, Yinchuan, 750004, Ningxia, China.
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.
Insights
Maxing Kugan Decoction (MKD), a traditional Chinese medicine for respiratory infections, showed no toxic side effects in rats during a 90-day oral toxicity study. This safety evaluation supports its clinical use for influenza and other respiratory illnesses.
Area of Science:
- Traditional Chinese Medicine
- Pharmacology
- Toxicology
Background:
- Maxing Kugan Decoction (MKD) is a traditional Chinese medicine (TCM) used for respiratory infectious diseases, particularly influenza.
- Clinical efficacy of MKD is recognized, but its toxicological safety profile requires thorough investigation.
- Evaluating the safety of TCMs is crucial for their continued clinical application and regulatory approval.
Purpose of the Study:
- To assess the subacute oral toxicity of Maxing Kugan Decoction (MKD) in Sprague-Dawley rats.
- To investigate the effects of MKD on general health, hematological parameters, and organ histology.
- To establish a safety profile for MKD at doses significantly exceeding human clinical use.
Main Methods:
- Subacute oral toxicity study involving 90-day gavage administration of MKD to male and female rats at varying doses (12.6, 25.2, 50.4 g/kg/day).
- Comprehensive monitoring of animal behavior, body weight, food intake, urine analysis, blood biochemistry, hematology, and coagulation parameters.
- Post-study analysis included organ coefficient measurements and detailed histopathological examination of major organs.
Main Results:
- No mortality or adverse effects on general condition, body weight, or food intake were observed in any treatment group.
- Hematological and biochemical parameters remained within normal ranges, showing no dose- or gender-dependent toxicological significance.
- Histopathological analysis revealed no abnormal pathological changes in organ tissues, and no delayed toxic reactions were detected post-administration.
Conclusions:
- Oral administration of Maxing Kugan Decoction (MKD) up to 50.4 g/kg/day for 90 days is safe in Sprague-Dawley rats.
- MKD does not exhibit significant subacute oral toxicity, even at doses 60 times the human clinical dose.
- The findings support the safety of MKD for treating respiratory infectious diseases.
