护肝片大鼠长期毒性试验研究

Long Term Toxicity Test of Hugan Tablets

目的研究大鼠服用护肝片90d的安全性。方法将SD大鼠按体重随机分为低、中、高剂量组(1.25g/(kg·bw)、2.50g/(kg·bw)和5.0g/(kg·bw))和空白对照组,分别给予不同浓度样品和蒸馏水,每日1次,连续90d。实验期间观察大鼠一般状况和体重的增长、血常规、生化指标及组织器官等方面的变化。结果试验中各组大鼠生长活动均正常。试验结束时各剂量组大鼠体重、体重增重及脏体比与对照组比较差异无显著性(P>0.05),各剂量组大鼠生化指标和血常规值均在正常范围内,且与对照组比较差异无显著性(P>0.05)。各组大鼠大体检查未见异常,对受检脏器做组织病理学检查,给药组与对照组无明显差别。结论护肝片未见明显毒性反应,临床长期服用较为安全。

OBJECTIVE To study the safety of rats using tablets for 90 days. METHDOS SD rats were randomly divided into low,medium,high dosage groups（ 1. 25 g /（ kg·bw） 、2. 50 g /（ kg·bw）,5. 0g /（ kg·bw）） and blank control group according to their weight. Rats in three dosage groups were given different concentrations of samples,while the rats in blank control group were given with distilled water,once per day for 90 successive days. During the experiment,observing the general condition of rats and the growth of the body weigh,blood routine and biochemical indexes and the change of the respect such as tissues and organs. RESULTS The growth activities were normal in all the rats in the experiment. Test at the end of the experiment,rat body weight,weight gain and organ / body weight ratio of each dosage group had no significant difference compared with control group（ p〈0. 05）,blood biochemical indices and value of routine blood in each dosage group rats were within the normal range,and there was no significant difference compared with control group（ p〈0. 05）. All groups of rats in general exception,no abnormality was found,histopathological examination tested viscera had no specific lesions,and dosage groups and control group had no significant difference. CONCLUSION Hugan tablets have no obvious adverse reaction,clinical long-term use is safe.