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作 者:朱玉平[1] 朱江波[1] 马玺里[1] 田逸君[1] 万旭英[1] 张天宝[1]
机构地区:[1]第二军医大学卫生毒理学教研室,上海200433
出 处:《中国新药杂志》2009年第21期2068-2071,共4页Chinese Journal of New Drugs
摘 要:目的:评价红景天苷注射液对SD大鼠有无发育毒性作用。方法:采用大鼠标准致畸性(Ⅱ段)试验,孕SD大鼠随机分为4组,每组20只。实验组剂量分别为0.5,0.25,0.125 g.kg-1(分别约相当于最大耐受剂量的1/3,1/6,1/12),对照组0.9%NS。孕期6~15 d尾静脉注射给药,qd。孕期20 d处死孕鼠,检查母体妊娠与胎鼠畸形情况。结果:各实验组对母鼠增重、活胎率、死胎率、吸收胎率及胎鼠外观畸形、内脏畸形和骨骼畸形率无显著影响。在较高剂量时,对胸骨节数、远端指骨数和远端跖骨数、骶椎骨数等骨化有一定的影响。在低剂量下如0.125 g.kg-1对胎儿的生长发育有促进作用,表现为活胎体重、胎盘重和活胎身长增高。结论:红景天苷注射液在受试剂量下无明显的母体毒性、胚胎毒性和致畸作用,但对胎鼠有轻度的骨化迟缓;同时在低剂量下对胎鼠的生长发育有促进作用。Objective: To evaluate the developmental toxicity of rhodioside injection in rats. Methods: In the present study, developmental toxicity in Sprague-Dawley rats was induced by intravenous injection of rhodioside (0, 0. 125, 0.25 and 0.5 g·kg^-1 ) daily on gestation day 6 - 15. Pregnant rats were sacrificed on 20th day of gestation. Reproductive indices were determined and fetuses were examined for external, visceral and skeletal malformations. Results: There were no significant differences between three treatment groups and control group in weigh gain, live fetus rate, dead fetus rate, absorbed fetus rate, external malformations rate, viscera malformations rate and skeletal malformations rate. In larger doses, abnormality of sternal vertebra, distal pha]anges, distal metatarsal bone and sacral vertebra were found in some rats. In smaller doses (such as 0. 125 g·kg^-1) , growth and development of fetus were even promoted, i.e. the body length, placenta weight and fetus body weight were larger than that of control group. Conclusion: Rhodioside does not show conspicuous parent toxicity, teratogenic effect, embryotoxicity in SD rats are found at the dose levels of 0. 125, 0.25 and 0.5 g·kg^-1. The larger doses induce lowgrade retardation of calcification effect on skeleton development and smaller doses promote growth and development of fetus somewhat.
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