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目的 评价健脾生血颗粒对大鼠生殖能力及早期胚胎发育的影响.方法 将176只SD大鼠按性别分层,采用随机数字表法分为对照组及健脾生血颗粒低、中、高剂量组,分别以健脾生血颗粒0、1.16、3.48、5.80 g/(kg·d)给予雌鼠2周及雄鼠4周连续灌胃给药后,雌雄大鼠以1∶1合笼,雌鼠持续给药至妊娠第7天,雄鼠持续给药至剖检前,雄鼠整个给药周期为59 ～63天.剖检所有亲代动物,观察亲代动物体征形态,检查组织病理情况进行一般毒性检测;称重睾丸、附睾,计数附睾尾精子数并行精子活力检查检测生殖力毒性;计数黄体、活胎、死胎、吸收胎并计算着床数以观察早期胚胎发育毒性.结果 (1)一般毒性:健脾生血颗粒高剂量组雄鼠体重增长减缓.中低剂量组则无异常;(2)生育力毒性:健脾生血颗粒各剂量对雄鼠睾丸、附睾及附睾尾精子数量均无明显影响;(3)早期胚胎发育毒性:健脾生血颗粒各剂量组对早期胚胎形成未见明显影响.结论 健脾生血颗粒一般毒性方面可能存在一定的胃肠毒性作用,未见毒性反应剂量为3.48 g/(kg·d).健脾生血颗粒各剂量组均未见明显生育力及早期胚胎发育毒性反应.“,”Objective To assess the effects of Jianpi Shengxue Granule (JSG) on the fertility and early embryo development in rats.Methods Totally 176 SD rats were stratified by sex,and divided into 4 groups,i.e.,the control group,low,medium,high dose JSG treatment groups.Rats in the 3 JSG treatment groups were administered with JSG at 0,1.16,3.48,5.80 g/kg per day by gastrogavage,respectively.After 2 weeks of administration for females and 4 weeks of administration for males,males and females were caged in the ratio of 1 ∶ 1.Females were administered to the gestation day 7.Males were administered for 59-63 days until the day before anatomy.All parental generations were anatomized to observe signs and morphologies.Pathological examination was performed.General toxicity was detected.The testis and epididymis were weighed.Spermatozoa number was counted from epididymis,and reproduction toxicity of sperm motility was checked.The numbers of corpus luteum,live fetus,dead fetus,and absorbed fetus were counted.The implantation number was calculated to observe early embryo development toxicity.Results (1)General toxicity:The body weight growth slowed down in male rats of the high dose JSG treatment group.No abnormality was found in low and medium dose JSG treatment groups.(2)Fertility toxicity:There was no obvious toxic effect on testis,epididymis,and spermatozoa number from epididymis sperm in all JSG treatment groups.(3)Early embryo development toxicity:No significant effect on the formation of early embryos was found in all JSG treatment groups.Conclusions Certain gastrointestinal toxicity of JSG might exist to some extent.The dose for non-adverse effect of JSG on fertility and early embryo development was 3.38 g/kg per day.No obvious fertility or early embryo development toxicity occurred in each JSG treatment group.