补血益母丸哺乳期暴露对大鼠亲代和子代发育毒性的研究

目的 观察补血益母丸对哺乳期的亲代母鼠及子代生长发育的影响，探讨其安全性。方法 妊娠大鼠100只，随机分为4组，即对照组（去离子水）和补血益母丸低、中、高剂量（3.8、11.4、34.2 g生药/kg）组，每组25只。F₀母鼠于哺乳期第0天开始ig给药，连续给药至哺乳期结束，每日l次。F₀母鼠观察一般状况、体质量、摄食量、分娩及哺乳情况；F1代大鼠观察仔鼠的外观、体质量、生理发育、神经反射、行为及生殖功能等。结果 未发现补血益母丸对F₀母鼠哺乳期以及胚胎和F1代大鼠生长发育有明显毒性和干扰作用。结论 补血益母丸对F₀代母鼠哺乳期及F1子代均无明显毒性，未见毒性反应的剂量（NOAEL）为34.2 g生药/kg，相当于临床人用剂量的53倍。

Toxicity of lactation exposure to Buxue Yimu Pills on maternal rats and their offsprings

Objective To observe the toxic effects of Buxue Yimu Pills on maternal rats during lactation period, the growth and development of their offsprings to determine its safety. Methods A total of 100 pregnant rats were divided into the following 4 groups:control group (deionized water), low, medium, and high dose (3.8, 11.4, and 34.2 g crude drug/kg) group of Buxue Yimu Pills, with 25 female rats in each group. Female rats were administered by intragastric method one time everyday from day 0 of lactation through weaning. F₀ pregnant rats were observed for body weight, food intake, childbirth and lactation. The appearance, body weight, physiological development, nerve reflex, behavior and fertility detected were observed in F₁ rats as well. Results No distinct toxicological nor interference effects were observed in the study of lactational rats, embryos they gestated and their F 1 offsprings. Conclusion Buxue Yimu Pills showed no obvious toxicity effect on the indexes of F₀ and F₁. The no toxic dose of Buxue Yimu Pills is 34.2 g crude drug/kg, which is 53 times the clinical dose.