血根碱安全性试验研究

Safety Test of Sanguinarine

为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、10.5、2.1 mg/(kg·d)]给大鼠连续灌胃给药30d,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依据。

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 21, 10.5 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 14 d recovery（P〉0.05）. The safety evaluation of sanguinarine laid a theoretical foundation for its clinical application.