疏风解毒胶囊对大鼠胚胎-胎仔发育毒性的研究  

Embryo-fetal developmental toxicity study with Shufeng Jiedu Capsule in rats

作　　者：刘妍[1,2] 温和 唐桂毅 段蕊[1,2] 黄妍 张海娇[1,2] 张春云 胡金芳 曹勇[3] 李文军 翟永林[3] LIU Yan;WEN He;TANG Gui-yi;DUAN Rui;HUAN Yan;ZHANG Hai-jiao;ZHANG Chun-yun;HU Jin-fang;CAO Yong;LI Wen-jun;ZHAI Yong-lin(Tianjin Institute of Pharmaceutical Research Drug Assessment Co.Ltd,Tianjin 300301,China;Tianjin Engineering Research Center of Drug Preclinical Assessment Techology,Tianjin 300301,China;Anhui Technology Innovation Center for Traditional Chinese Medicine Extraction,Bozhou 236800,China)

机构地区：[1]天津药物研究院新药评价有限公司,天津300301 [2]天津市新药非临床评价技术工程中心,天津300301 [3]中药提取安徽省技术创新中心,亳州236800

出　　处：《中华中医药杂志》2018年第12期5596-5600,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家科技重大专项重大新药创制项目(No.2015ZX09501004)~~

摘　　要：目的:评价疏风解毒胶囊对妊娠大鼠及胚胎-胎仔发育的影响。方法:每组25只雌性SD大鼠从妊娠第6～15天每天灌胃给予疏风解毒胶囊(4.15、12.46、37.37g生药/kg)或去离子水1次,评价妊娠母鼠的状态、体质量和体质量增长、摄食量、生殖能力及胎仔的体质量、性别、顶臀长、尾长和外观、内脏、骨胳发育的畸形或变异。结果:母鼠第1天给药时出现体质量增长减少(P<0.01),此后体质量增长正常。母鼠给药后的摄食量和生殖能力,胎仔的生长和发育均正常。结论:本实验条件下,母体及胚胎发育的安全剂量均为37.37g/kg,按照体质量计算,该剂量相当于人用最大临床使用剂量的81倍。Objective:To evaluate the effects of Shufeng Jiedu Capsule on pregnant rats and embryo-fetal development. Methods:A total of 25 female SD rats per group were intragastric administrated daily with deionized water or Shufeng Jiedu Capsule (crude drug 4.15,12.46,37.37g/kg)from GD 6 to 15.Pregnant dams were evaluated for clinical signs,body weight and body weight gain,food consumption,reproductive performance.Fetuses were weighed,sexed,lengths of crown-rump and tail measured and examined for external,visceral,and skeletal malformations/variations.Results:Decrease in body weight gain were observed on the first day of administration (P<0.01),and then the body weight gain increased normally.The food consumption and reproductive performance of dams,and growth and development of their offspring were normal.Conclusion:Under the condition of the experiment,the no observable adverse effect level (NOAEL)for maternal toxicity and embryo-fetal developmental toxicity is preparation 37.37g/kg,equal to 81 times the maximum recommended human daily dose based on weight.

关 键 词：疏风解毒胶囊 母体毒性 发育毒性 

分 类 号：R285.5[医药卫生—中药学]