目的 評價幼齡大鼠重復ig給予參苓健脾胃顆粒后的毒性反應，為兒童的用藥安全劑量及臨床不良反應監(jiān)測范圍提供參考。方法 176只幼齡SD大鼠隨機分為4組，即對照組和參苓健脾胃顆粒低、中、高劑量（3.3、9.9和22.2 g生藥/kg）組，每天ig給藥1次，連續(xù)給藥3個月，停藥恢復1個月；檢查指標包括臨床觀察、體質量、攝食量、血液學、血液生化學、凝血功能、尿液生化、生長發(fā)育、自主活動、學習記憶能力、血清激素、臟器質量及系數(shù)、解剖檢查和組織病理學檢查。結果 參苓健脾胃顆粒連續(xù)ig給藥1個月及3個月檢查，與對照組比較，除22.2 g生藥/kg組雄性大鼠自給藥21 d起至給藥結束，大部分檢測時間點平均攝食量明顯降低（P<0.05、0.01）外，各劑量組其它各項指標未見與藥物相關的毒性反應。結論 參苓健脾胃顆粒重復ig給藥3個月，對幼齡大鼠未觀察到毒性反應的劑量（NOAEL）為22.2 g生藥/kg，為5～14歲兒童臨床最大擬用劑量（0.56 g生藥/kg）的40倍，提示臨床長期使用的安全性較好。

Objective To investigate the toxic effect of Shenling Jianpiwei Particles (SLJPWP) in juvenile rats for evaluating its safe dosage in children and providing reference for monitoring its clinical adverse reaction. Methods Totally 176 juvenile SD rats (males and females) were randomly divided into four groups, control group and SLJPWP high, medium, and low dose (0, 3.3, 9.9, and 22.2 g crude drug/kg) groups. All animals were ig administered once daily for three months continuously, and then recovered for one month with no dosing. Parameters were examined including general condition, body weight, food intake, hematological and biochemical index, blood coagulation parameter, urine biochemical parameters, growing development, autonomous activity, learning and memory ability, hormone, organ coefficient, anatomic examination, and histopathological examination. Results Compared with control group, the average amount of food intake was decreased in 22.2 g crude drug/kg SLJPWP group in male rats from 21 d to the end of administration. No other drug-related toxic reaction was found in other indexes of SLJPWP granules. Conclusion After rats were ig administered with SLJPWP for three months continuously, the no-observed-adverse-effect level (NOAEL) in juvenile rats was 22.2 g crude drug/kg, amount to 40 times the recommended dose (0.56 g crude drug/kg) for children aged 5-14, which suggested that the safety of long-term clinical use is fine.