舒乳通口服液毒理学实验研究

STUDY ON TOXICITY OF SHURUTONG ORAL LIQUOR

目的 :观察舒乳通口服液急慢性毒性反应。方法 :在预试基础上测小鼠 1日最大给药量 ;大鼠给药 12周 ,每 2周测一次体重 ,12周末称重后处死一半动物 ,其余动物停药后观察 2周 ,分别于用药 12周和停药 2周取血测血液生化、血象、肝肾功能 ,取主要脏器称重 ,并制作病理切片。结果 :小鼠灌服舒乳通口服液 2 .75g kg后 7日内 ,大鼠灌服舒乳通口服液 0 .75g kg、0 .375g kg、0 .1895g kg连续 12周及停药 2周均无一例动物死亡和异常反应 ;大鼠体重增加、外周血象、血液生化均末见异常 ,与对照组比较无显著性差异 (P >0 .0 5 ) ,病理组织学检查无异常。结论 :小鼠灌服舒乳通口服液 180倍临床剂量 ,大鼠连续 12周灌服舒乳通口服液 5 0、2 5、12 .5倍临床剂量并停药观察2周 ,均未显示毒性反应 ,可认为其临床使用是安全的。

Objective:To study the acute and the long-term toxicity of ShuRuTong oral liquor(SRT) on mice and rats. Methods: Based on experiment performed beforehand, acute toxicity was carried out to obtain the maximum drug dose (MDD) in mice. The long-term toxicity test was carried out in rats. SRT was given once daily for 12 successive weeks. Common behaviors and growth of body weight were observed. After the last dose, half of the rats in each groups were killed, the rest were remained for further observation 2 weeks. Hematology, blood biochemistry, histopathology, weights and weight exponent of major viscera were tested. Results: Neither mice nor rats had died or showed any abnormal signs within the examination terms. Body weight gain, hematology, blood biochemistry, histopathology, weights and weight exponent of major viscera were all verified in normal ranges, and showed no statistical significance (P>0.05) compared with blank control group; No pathological changes were found in major organs by pathologicoanatomic examination. Conclusion: These results suggested that SRT is safe to be used in clinic and has no acute and chronic toxicity.