目的：评价灌胃给予健脾生血颗粒对大鼠胚胎-胎仔发毒性作用。方法：孕鼠随机分为阴性对照、阳性对照和低、中、高剂量试验组，分别于孕期第6至第15天连续灌胃给药。其中，低、中、高剂量试验组分别灌胃健脾生血颗粒浸膏1．16、3．48、10．44 g／kg／d，阳性对照组灌胃维生素 A 醋酸酯0．08 g／kg／d，阴性对照组给予同样体积的纯净水。记录孕鼠的体重、身长、摄食量及临床表现。于妊娠第20天剖检孕鼠，观察胎盘和胎鼠外观形态，记录黄体数、活胎数、死胎数、吸收胎、着床数及胎盘质量，制作骨骼和内脏标本，以作进一步检查。结果：阳性对照组出现了明显的致畸作用，证明本试验系统结果可靠。试验组大鼠经给药后，均未见明显异常临床症状，各剂量组对胚胎的形成均无明显影响，且黄体数、植入数、死胎、活胎以及吸收胎与阴性对照组比较差异均无统计学意义。此外，低、中剂量的浸膏对亲代大鼠未见明显一般毒性，但高剂量浸膏可致亲代大鼠体重和摄食量下降，影响部分胎鼠的发育，主要表现为体重减轻，少数动物关节畸形等。结论：在本试验条件下，健脾生血颗粒浸膏对大鼠胚胎-胎仔发育毒性的无不良反应剂量为3．48 g／kg，相当于成人临床最大用量的42倍。%Objective:To investigate the effects of Invigorating Spleen-Generating Blood Granule on embryo-fetal development of rats after intragastric administration.Methods:Pregnant rats were randomly divided into five groups:negative control,positive control,treatment groups with low,medium,or high dosage.The control groups were given oral administration with extract of the granule at 1.16、3.48、10.44 g/kg/d respectively for 10 days after six days’pregnancy.The positive control group were given Vita-min A acetate at 0.08 g/kg/d;the negative group were given pure water with same volume.Then the weight,body length,food consumption,and clinical features of pregnant rats were recorded.Pregnant rats were dissected at their 20 days’pregnancy.Then placentas,fetal rat appearances,skeleton,viscera,and numbers of corpus luteum,live fetus,dying fetus,absorbed fetus,im-plantation and other factors were recorded.Results:Obvious teratogenesis appeared in positive control rats,showed the reliability of the experiment.No abnormal clinical symptoms were observed in the rats of all treatment groups.There were no statistical differ-ences of numbers of corpus luteum,live fetus,dying fetus,absorbed fetus,and implantation among the rats of all treatment groups and negative control.No general toxicity was found from rats with low or medium dosage.But high dosage of extract may result in a decline of weight,and food consumption.Furthermore,the development of fetal rats was also affected.Conclusion:The safe dosage of Invigorating Spleen-Generating Blood Granule on embryo-fetal development of rats was under 3.48 g/kg,42 times of clinical dosage on human.
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