血根碱安全性试验研究

Thirty Days Feeding Experiment of Sanguinarine in Rats

关键词:  血根碱  大鼠  毒性  安全性评价

Key words:  sanguinarine  rat  toxicity  safety evaluation

摘要:

本试验旨在观察大鼠连续给予血根碱30 d所产生的毒性反应及停药后恢复情况，为临床应用提供理论依据。将血根碱分别按高、中、低剂量 [21 mg／(kg?d)、10.5 mg／(kg?d)、2.1 mg／(kg?d)]给大鼠连续灌胃给药30 d，观察给药期间及停药后14 d大鼠的临床体征、血液常规和生化指标、脏器指数等方面的变化。结果表明，连续给药30 d后与对照组比较，高、中剂量组体重明显增加（p<0.05），高剂量组的谷丙转氨酶、谷草转氨酶水平升高（p<0.05），其他剂量组的血液生化指标，各剂量组的血液常规、脏器指数均未见显著性变化（p>0.05）；停药后14 d，高、中剂量组比对照组体重明显增加（p<0.05），其他各项检查指标无显著差异性（p>0.05）。本研究对血根碱的安全性进行了初步评价，结果可为血根碱的临床应用提供理论基础。

Abstract:

To provide theoretical evidence for clinical applications, the toxicity of sanguinarine in rats after feeding the drug for 30 d and the recovery after drug withdrawal was observed．Three treatment groups and control group were divided up. Rats in high-dose, middle-dose and low-dose groups were respectively administrated sanguinarine at 21mg／(kg?d), 10.5 mg／(kg?d) and 2.1 mg／(kg?d) orally for 30 consecutive days. The clinical signs, hematological index, blood biochemical index and organ index of rats were investigated during 30-d drug administration period and 14 d after drug withdrawal. The results indicated that sanguinarine in high-dose and middle-dose could induce body weight increasing in rats compared with control group (p<0.05). The level of alanine aminotrans ferase(ALT) and partate aminotransferase(AST) in rats from high-dose group was higher than those from control group (p<0.05). Compared with control group, there was no evident effect in hematological index, and organ index （p>0.05）. The body weight of rats from the high-dose group and middle-dose group had significant difference compared with control group（p<0.05），but the other indexes had no significant difference after another 14d recovery（p>0.05）. The safety evaluation of sanguinarine laid a theoretical foundation for its clinical application.