中草药复合添加剂的小鼠急性毒性试验

An Experimental of Mice Acute Toxicological Test of Chinese Herbal Medicine Compound Additive

为研究补气血、补肝肾中草药复合添加剂的急性毒性,试验采用灌胃法,选取SPF级昆明小鼠40只,雌雄各半,随机均分为4组(对照组、低剂量组、中剂量组和高剂量组),以0.86g/mL的中草药混悬液,每次0.4mL/10g灌胃,24h内,高剂量组灌胃2次,每次0.4mL;中剂量组灌胃2次,每次0.3mL;对照组灌胃0.4mL蒸馏水2次;低剂量组灌胃1次,0.2mL。连续7d,每天观察小鼠的精神状况和死亡情况。试验结束后,小鼠眼球采血,检测血液生理及生化指标;剖解小鼠,取心脏、肝脏、脾脏、肺脏、肾脏称重,计算脏器指数,制作病理组织切片,观察各脏器病理变化。结果显示,试验期间各组小鼠未见异常;中、高剂量组小鼠体重极显著高于对照组(P<0.01);高剂量组肝脏指数、脾脏指数均极显著高于其他组(P<0.01);试验组小鼠白细胞总数较对照组极显著升高(P<0.01),但仍处在正常范围内;试验组小鼠血液肌酐显著降低(P<0.05),中剂量组尿素氮显著低于对照组(P<0.05);各组间其他生化指标均差异不显著(P>0.05);病理组织切片结果显示,各组肝脏、脾脏和肾脏均无任何病理变化。综上所述,中草药复合添加剂对蛋白质代谢有明显的促进作用,可提高机体免疫力和肾脏功能,其最大给药量(34.4g/kg生药)是临床成人每天用药(0.371g/kg)的92.7倍,证明该药物无毒性,安全性好。

To study the acute toxicity of Chinese herbal medicine compound additive for invigorating qi-blood,liver and kidney,the intragastric administration was adopted in this study,40 SPF Kunming mice were divided into four groups:Control group,low dose group,middle dose group and high dose group,and supplemented with the concentration 0.86 g/mL of Chinese herbal medicine compound additive.The suspension was administered intragastrically at a volume of0.4 mL/10 g per gavage,twice within 24 hin high dose group(0.4 mL each time)and middle dose group(0.3 mL each time)for 7 d,the control group was given intragastrically 0.4 mL distilled water twice within 24 hfor 7 d,and the low dose group was given 0.2 mL,once within24 hfor 7 d.The general condition and death of mice were observed daily.At end of the test,blood was collected from the eyeballs of mice to detect physiological and biochemical indicators.The mice were anatomized,and the organ index was calculated by weighing the heart,liver,spleen,lung and kidney,and pathological sections were made to observe the pathological changes.The results showed that there was no abnormality in mice of experimental groups.Compared with the blank control group,the body weight of mice in middle dose group and high dose group was extremely significantly increased(P<0.01).The liver index and spleen index of the high dose group were extremely significantly higher than other groups(P<0.01).The total number of white blood cells of mice in Chinese herbal medicine compound additive groups were extremely significantly increased(P<0.01),but it was still within the normal range.The blood creatinine was significantly decreased in Chinese herbal medicine compound additive groups(P<0.05),and the urea nitrogen of middle dose group was significantly increased(P<0.05);There was no significant difference in other biochemical indexes among all groups(P>0.05).The results of pathological tissue sections showed that there was no pathological changes in liver,spleen and kidney in all groups.In conclusion,Chinese herbal medicine of invigorating qi-blood,liver and kidney played a significant role in promoting protein metabolism which could significantly improve the body immunity and kidney function.The maximum dose(34.4 g/kg,crude drug)was 92.7 times as much as the amount of clinical adult(0.371 g/kg)daily,proving that the drug was non-toxic and safe.