坤泰胶囊对大鼠胚胎和胎仔的发育毒性研究.PDFVIP

Drug Evaluation Research 第 35 卷 第 5 期 2012 年 10 月 - 337 - 坤泰胶囊对大鼠胚胎和胎仔的发育毒性研究 龚 立，刘 昆，张 云，龚华云，王 玮* 四川抗菌素工业研究所 中国医药集团安全性评价研究中心，四川 成都 610052 摘 要：目的 评价 SD 孕鼠在致畸敏感期（怀孕第 6～15 天）ig 给予坤泰胶囊溶液对 SD 大鼠的母体毒性、胚胎-胎仔毒性 和致畸性。方法 雌性 SD 大鼠低、中、高剂量组在怀孕第 6～15 天内分别 ig 给予 2.5 、5、10 g/(kg·d) 坤泰胶囊成品粉溶液， 对照组给予双蒸水。试验期内每天观察动物的一般情况和临床毒性表现；记录孕鼠的体质量；在怀孕第 20 天进行剖腹检查， 摘取卵巢和子宫，观察黄体数、着床数、胚胎生存及死亡情况、生存胎仔的外观、性别、体质量、骨骼及脏器发育等指标。 结果 孕鼠及胚胎、胎仔发育的上述各观察指标未见明显异常，与对照组比较无显著差异。结论 在本实验条件下，坤泰胶 囊成品粉未见明显的母体毒性与胚胎和胎儿发育毒性。 关键词：坤泰胶囊成品粉；SD 大鼠；胚胎-胎仔毒性；致畸性 中图分类号：R965.3 文献标志码：A 文章编号：1674 - 6376 (2012) 05 - 0337 - 06 Development toxicity of Kuntai Capsule powder on embryo and fetus of rats GONG Li, LIU Kun, ZHANG Yun, GONG Hua-yun, WANG Wei Sichuan Industrial Institute of Antibiotics, Sinopharm Center for Safety Evaluation, Chengdu 610052, China Abstract: Objective To evaluate the matrix toxicity, embryo-fetal toxicity, and teratogenicity of ig administration with Kuntai Capsule powder on SD rats in sensitive period to teratogenic agent (day 6 ―15 of pregnancy). Methods Female rats were administrated with Kuntai Capsule powder solution [2.5, 5, 10 g/(kg·d)] at day 6―15 of pregnancy, while the rats in control group were given double distilled water. In the trial period, general conditions and clinical toxicity performance of the animals were observed daily, and body weight of rats was recorded. SD rats were sacrificed at day 20 after pregnancy. The luteal number, nidation sites, embryo survival and death, the appearance, sex, weight, bone and organ development indicators of survival fetus were observed. Results There were no statistical significance between Kuntai Capsule group and control group in above indexes. Conclusion Kuntai Capsule does not have obvious toxicity on embryo and fetus of rats under the conditions in th