[關(guān)鍵詞]
[摘要]
目的 對蘇蘇小兒止咳顆粒進(jìn)行幼齡SD大鼠長期毒性試驗研究,為其提供臨床前安全性評價。方法 蘇蘇小兒止咳顆粒高、中、低劑量(以生藥計30、15、5 g/kg)連續(xù)ig給藥30 d。觀察指標(biāo)包括一般觀察、體質(zhì)量、攝食量、行為學(xué)測試、雌二醇、睪酮、脛骨長度、尿液、血液學(xué)、凝血指標(biāo)、血液生化、電解質(zhì)、臟器質(zhì)量、臟器系數(shù)及組織病理學(xué)檢查等。結(jié)果 30 g/kg劑量組雄鼠給藥期間出現(xiàn)體質(zhì)量增長緩慢,恢復(fù)期可恢復(fù)正常。其余動物未見明顯藥物相關(guān)毒性反應(yīng),停藥后未見遲緩毒性發(fā)生。結(jié)論 在本試驗條件下,蘇蘇小兒止咳顆粒對幼齡大鼠的無毒反應(yīng)劑量為15 g/kg,相當(dāng)于臨床擬用劑量的22倍。
[Key word]
[Abstract]
Objective Preclinical safety study was conducted to assess the long-term toxicity effects of Susu Xiao'er Zhike (SSXEZK) Granules in juvenile rats, and provide preclinical safety evaluation for clinic. Methods Daily ig administration of SSXEZK Granules at 30, 15, and 5 g/kg for 30 d was used in high, medium, and low dose groups, respectively. The long-term toxicity effects of SSXEZK Granules was determined by general observation of the animals, and monitoring the changes of their body weight, food intake, behavioral test, estradiol, testosterone, tibial length,urine, faeces, hematology, blood coagulation, blood biochemistry, electrolyte, organ weight and organ index. Histopathological examination was conducted after sacrifice. Results All animals had no significant toxicity and no delayed toxicity occurred after treatment with various doses, except that the body weight growth of male rats was retarded treated with 30 g/kg dose. Conclusion In the situation of this experiment, the NOAEL of SSXEZK Granules in rats was 15 g/kg, which was equivalent to 22 times of the suggested dose in clinical use.
[中圖分類號]
[基金項目]