精制胃乐胶囊长期毒性实验研究

Chronic toxicity experimental study of refined wei le capsule in rats

目的通过SD大鼠长期毒性实验观察精制胃乐胶囊(r WLC)可能产生的毒性反应,以评价r WLC的安全性,为临床安全用药提供依据。方法 120只SD大鼠随机分为4组(空白组、r WLC高、中、低剂量组),每组30只,3个给药剂量组分别为4.00、1.41和0.50 g·kg-1·d-1(分别是成人临床日用量50 mg·kg-1·d-1的80、28和10倍),每天灌胃1次,连续给药90 d。停药日及14 d后,分别检测大鼠体重、血液学和血液生化指标,计算重要脏器指数,并进行组织病理检查。结果与空白组比较,r WLC 3个剂量组对大鼠的一般状况、体重、血液学、血液生化指标、重要脏器指数和脏器组织结构等均未见明显改变。停药14 d后,检测r WLC 3个组大鼠上述各项指标也未见明显异常。结论长期大剂量连续灌胃给予r WLC,对大鼠无明显毒性作用,停药14 d后也未见药物的延迟性毒性反应,表明该药临床拟用剂量安全,未见明显长期毒性。

Objective To evaluate the safety of refined wei le capsule （rWLC） and to provide evidence for the clinical safely drug - use through long - term toxicity test in rats . Methods 120 SD rats were randomly divided into 4 groups （control group, high, middle and low dosage of rWLC groups） , 30 rats in each group. Rats were treated with rWLC at three doses of 4.00, 1.41, and 0.50 g · kg-1· d-1（ equivalent to 80, 28 and 10 times of adult clinic daily dose of 0.05 g · kg- 1 · d- 1 ） by gavage, once a day for 90 days. The body weights, the inde- xes of hematology and biochemistry, organ weight index, and the pathological examination were measured at 90 days of administration and 14 days after stopping the medicine, respectively . Results The general animal health body weights ,the indexes of hematology and biochemistry, organ weight index, and pathological examination of major organs of rats had no significant difference comparing with control group after 90 days of administration ; 14 days after stopping the medicine, no evident abnormal changes of above indexes were observed in administration groups. Conclusion rWLC has no significant toxicity or delayed toxicity after long - term of high dosage continu- ous oral gavage in rats, which indicates that the clinic dose is safe.