苍朴口服液的毒理学研究

Toxicologic study on Cangpu oral liquid

为了评价苍朴口服液临床用药的安全性,试验采用急性毒性试验测量半数致死量(LD50)和最大耐受倍数;并把80只Wistar大鼠随机分为对照组(生理盐水)和高、中、低剂量组(20,10,5 g/kg苍朴口服液),连续灌胃给药14 d进行亚慢性毒性试验,观察动物一般行为和生长情况,测定血液学指标和生化指标,并进行病理学检查。结果表明:在急性毒性试验中,测得LD50>40 g/kg,最大给药量为160 g/kg,相当于临床用量的80倍;在亚慢性毒性试验中,动物一般情况正常,除高剂量组大鼠体重增长和采食量显著下降外(P<0.05),血小板计数(PLT计数)显著升高(P<0.05)外,其他指标与对照组比较均差异不显著(P>0.05)。说明使用合理剂量的苍朴口服液是安全的。

To evaluate the safety for the clinical administration of Cangpu oral liquid, the acute toxicity test was performed for determining LD50 and calculating maximum tolerance dose（MLD）. 80 Wistar rats were randomly divided into four groups, including low, middle and high dosage groups of Cangpu oral liquid （20, 10, 5 g/kg）and control group （normal saline）. The rats in every group were continuously treated by garage for the subchmnic toxicity test once per day for two weeks. The general behavior and growth condition in the rats were observed, and the major hematology and biochemical indexes were measured, and then a＇pathological examination was performed. The results showed that the LD50 was greater than 40 g/kg, and the maximum dose of Cangpu oral liquid was 160 g/kg, which was equivalent to 80 times clinical dose. In the sub- chronic toxicity test, there was no abnormal reaction in the general conditions for the rats. Except the high dosage group, in which the body weight was increased and food intake was decreased in the rats （ P 〈 0.05 ）, and the index of rlatelet （PLT） count was significantly increased （ P 〈 0. 05）, the other indexes had no obvious difference compared with the control group （ P 〉 O. 05 ）. It is concluded that Cangpu oral liquid is safe to be administratated in the reasonable dose.