目的 觀察補血益母丸對哺乳期的親代母鼠及子代生長發(fā)育的影響，探討其安全性。方法 妊娠大鼠100只，隨機分為4組，即對照組（去離子水）和補血益母丸低、中、高劑量（3.8、11.4、34.2 g生藥/kg）組，每組25只。F₀母鼠于哺乳期第0天開始ig給藥，連續(xù)給藥至哺乳期結束，每日l次。F₀母鼠觀察一般狀況、體質量、攝食量、分娩及哺乳情況；F1代大鼠觀察仔鼠的外觀、體質量、生理發(fā)育、神經反射、行為及生殖功能等。結果 未發(fā)現(xiàn)補血益母丸對F₀母鼠哺乳期以及胚胎和F1代大鼠生長發(fā)育有明顯毒性和干擾作用。結論 補血益母丸對F₀代母鼠哺乳期及F1子代均無明顯毒性，未見毒性反應的劑量（NOAEL）為34.2 g生藥/kg，相當于臨床人用劑量的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