【摘要】 目的观察天麻细粉片在实验动物中的毒性和安全性。方法急性毒性试验采用昆明种小鼠和SD大鼠各20只,雌雄各半,天麻细粉片剂量为15.0 g/kg体重,观察14 d,记录中毒表现。Ames试验采用了菌株TA97、TA98、TA100和TA102,在加S9与不加S9的条件下加入天麻细粉片,剂量分别为8、40、200、1000、5000μg/皿。小鼠骨髓细胞微核试验和精子畸变试验均采用昆明种小鼠,天麻细粉片剂量为1.25、2.50、5.00 g/kg体重,用环磷酰胺40 mg/kg体重为阳性对照。30 d喂养试验采用SD大鼠,雌、雄各40只,天麻细粉片剂量为2.81、5.62、11.25 g/kg体重,连续给予30 d,观察动物一般状况和体重,测定血液学及血液生化学指标、脏器系数,并进行组织病理学检查。结果急性毒性试验结果显示天麻细粉片在小鼠和大鼠中的最大耐受剂量(MTD)均>15.0 g/kg体重,属无毒级。天麻细粉片的Ames试验、小鼠骨髓细胞微核试验和精子畸变试验结果均为阴性。30 d喂养试验显示动物一般状况良好,各剂量天麻细粉片对动物的体重、进食量、食物利用率以及脏器重量和脏器系数均无明显影响,对动物的血常规和血清生化指标也无明显影响。病理检查显示高剂量天麻细粉片对动物的肝、肾、胃肠、脾、卵巢(睾丸)等组织无明显毒性。结论本实验条件下天麻细粉片未见明显毒性或致畸和致突变作用。更多还原

【Abstract】 Objective To study the toxicity and safety of Gastrodina elata powder tablets in laboratory animals. Methods There were 20(male/female: 10/10) Kunming mice or SD rats involved in the acute toxicity test.The dose of Gastrodina elata powder tablets was 15.0 g/kg body weight(BW).The animals were observed for 14 days after administration to record the toxicity.In Ames test,bacterial strains TA97,TA98,TA100 and TA102 were used;8 μg/plate,40 μg/plate,200 μg/plate,1000 μg/plate or 5000 μg/plate of Gastrodina elata powder tablets were added to the strains with or without S9.In the micronucleus test of bone marrow cells and spermatic aberration test,Kunming mice were used;the doses of Gastrodina elata powder tablets were 1.25 g/kg BW,2.50 g/kg BW and 5.00 g/kg BW,respectively;and cyclophosphamide was used as a positive control at a dose of 40 mg/kg BW.In the 30 day-feeding experiment,SD rats were used(male/female: 40/40);the doses of Gastrodina elata powder tablets were 2.81 g/kg BW,5.62 g/kg BW and11.25 g/kg BW,respectively.The animals were treated continuously for 30 days and their general conditions as well as body weights were determined.The hematology and blood biochemical indexes and organ coefficients of the animals were measured,as well.In addition,pathological examinations were performed. Results In the acute toxicity test,Gastrodina elata powder tablets was no toxic with a maximal tolerable dose(MTD) of more than 15.0 g/kg BW in the mice and rats.The results for the Ames test,micronucleus test of bone marrow cells and spermatic aberration test of Gastrodina elata powder tablets were negative.During the 30 day-feeding experiment,the animals were in good general conditions;and Gastrodina elata powder tablets at each dose did not have any influence on the body weights,food-intake amount,food utilization rate,as well as organ weights and organ coefficients of the animals.In addition,Gastrodina elata powder tablets had no influence on blood count and serum biochemical indexes of the animals,as well.Pathological examinations showed that Gastrodina elata powder tablets at highest dose did not have obvious toxicity in tissues like the liver,kidney,stomach,intestine,spleen,ovary and testis. Conclusion Gastrodina elata powder tablets had no obvious toxicity or teratogenic/mutagenic activities under the experimental conditions described in the paper.更多还原