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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 evaluate the effects of Jianpi Shengxue Granule on reproductive capacity and early embryonic development in rats. Methods Seventy-six SD rats were stratified by gender. The rats were randomly divided into control group, Jianpi Shengxue Granule group (low, middle and high dose), and spleen and kidney blood granules (0,1.16,3.48,5.80 g / kg · d) given female mice for 2 weeks and male rats for 4 weeks after continuous oral administration, male and female rats to 1: 1 cage, females continued administration until 7 days of gestation, male rats continued administration until the pre-test, Male rats throughout the drug delivery cycle of 59 to 63 days. All the animals were necropsied to observe the signs and symptoms of the parent animals and the histopathology was checked for general toxicity. The testicular and epididymis were counted and the number of spermatozoa in the epididymis was counted. Simultaneous sperm motility test was used to detect genital toxicity. The corpus luteum, live fetus, stillbirth, absorption Fetuses were counted and the number of implants counted to observe early embryonic developmental toxicity. Results (1) General Toxicity: The body weight of male rats in Jianpi Shengxue Granule high dose group slowed down. (2) fertility toxicity: each dose of Jianpi Shengxue granule had no significant effect on sperm count of testis, epididymis and epididymal sperm in male rats; (3) early embryonic developmental toxicity: The dose group had no significant effect on the formation of early embryo. Conclusion The general toxicity of Jianpi Shengxue Granules may have certain gastrointestinal toxic effects, and no toxic reaction dose is 3.48 g / (kg · d). No significant fertility and early embryonic developmental toxicity were observed in each group of Jianpi Shengxue Granules.