孕妇金花胶囊对孕鼠胚胎生长发育致畸实验研究

目的通过对孕鼠胚胎生长发育致畸试验;观察检测孕妇金花胶囊的致突变毒性反应,并对该供试品的致突变毒性反应发生的危害程度进行安全性评价,为临床孕妇使用孕妇金花胶囊提供安全用药剂量的参考范围;方法通过给妊娠7 d的SD品系孕鼠ig孕妇金花胶囊药液三个不同剂量(10.0 g、5.0 g、2.5 g/kg.d,1次/d),连续10 d;观察和病检该供试品对孕鼠生殖期胚胎各项生长发育指标,即(1)孕鼠检查、(2)胚胎数与胚胎生长发育外观检查、(3)胚胎骨骼生长发育状况检查、(4)胚胎各重要脏器形态及部分脏器的组织病理切片镜检等;与空白对照组比较,检测孕鼠及胚胎的上述各项指标致畸变毒性反应发生的影响;结果孕妇金花胶囊ig给药对孕鼠胚胎生长发育即:(1)孕鼠检查、(2)胚胎数与胚胎生长发育外观检查、(3)胚胎骨骼生长发育状况检查、(4)胚胎各重要脏器形态及部分脏器的组织病理切片镜检等,与空白对照组比较未见有致畸毒性反应发生。结论孕妇金花胶囊致畸试验各项观测指标检测显示:对孕鼠胚胎生长发育未见有致畸毒性反应发生。

Experimental Study on Teratogenicity of Gravida Jin Hua Capsule on the Development of Mouse Embryos Growth

Objective through the tests on the growth and development of mouse embryos; mutagenic toxicity observed Gravida Jin Hua Capsule, and the test of mutagenicity hazard toxicity reaction for the safety evaluation for clinical use in pregnant women, Gravida Jin Hua Capsule provides safe dose reference range; Methods by 7 d SD lines to pregnancy pregnant rats Ig Gravida Jin Hua Capsule liquid three different doses （10.0 g, 5.0 g, 2.5 g/kg. d, l/d）, continuous 10 d; observation and pathological examination of the specimen of the pregnant rat embryo development indexes of reproduc- tive growth period, i.e. （ 1 ）, 2 （ cheek pregnant rats） appearance inspection growth of embryo and embryonic, （ 3 ） check the status of growth and development of embryonic skeletal, （4） embryos the major organ morphology and some organ histopathology examinations; compared with the blank control group, the indexes of pregnant rats and embryo teratogenic effects of toxic reaction; Results Ig Gravida Jin Hua Capsule administered to pregnant rats embryonic growth and development： （ 1 ） check pregnant rats （2）, visual inspection of the number of embryos and embryo growth and development, （3） check the status of growth and development of embryonic skeletal, （4） embryos the major organ morphology and some organs pathological examinations, and the blank compared to the control group there was no occurrence of terato- genie toxicity. Displays the test; Conclusion of Gravida Jin Hua Capsule teratogenicity test the observed indexes： on pregnant rats embryonic growth there is no teratogenic toxicity reaction occurred.