四逆汤煎剂和缓释片剂的毒性比较

目的比较四逆汤煎剂和缓释片两种剂型的毒性。方法通过动物的急性毒性和亚急性毒性试验,考察四逆汤煎剂和片剂的毒性。结果四逆汤煎剂MTD>222.00g生药/kg体重;四逆汤缓释片MTD>8.50g生药/kg体重。亚急性毒性试验中,各项生化指标均在正常范围内,且各组间差异无显著性;缓释片组未见明显毒副作用;煎剂组肝脏脏器系数与正常对照组和缓释片组相比显著增加,病理切片显示两只大鼠肝脏可见弥漫水样变性,汇管区炎细胞浸润,假胆管增生,一只大鼠心脏有轻度心内膜炎和键索变性。结论四逆汤传统煎剂经过剂型改良,从毒性角度来看,缓释片剂明显优于煎剂,更为安全可行。

Objective To compare the toxicity of Sini decoction with the toxicity of Sini Sustained Release Tablets. Methods Using the experiment of acute toxicity and subacute toxicity, we explored the toxicity of Sini decoction and Sustained Release Tablets. Results The Maximum Tolerated Dose(MTD) of Sini tablets was more than 8.50g·kg-1 and the MTD of Sini decoction was more than 222.00g·kg-1. All the biochemical indexes were normal in subacute toxicity test and no significant differences among the groups were seen. Hepatic biopsy specimens revealed mild abnormality, including hepatocellular vacuolar degeneration and pseudohepatobiliary formation, and cardiac biopsy specimens revealed mild endocarditis in Sini decoction group. However, Sini Sustained Release Tablets have no toxicity under our experimental condition. Conclusions It is suggested that Sini sustained release tablets are more safe than Sini decoction.