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。

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.

R965.3