注射用甲磺酸胺银杏内酯B对围产期仔鼠生长及组织器官发育的影响  

Effects of XQ-1H for injection on the growth and tissues ' development of F1 rats in perinatal period

作　　者：乔红群[1] 李红沙 岳鹏[2] 蔡鸣[2] 毛黎顺 邵卿[2] 

机构地区：[1]南京工业大学,江苏南京210009 [2]江苏省药物研究所,江苏南京210009 [3]江苏柯菲平医药有限公司,江苏南京210016

出　　处：《华西药学杂志》2016年第2期165-168,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的观察注射用甲磺酸胺银杏内酯B(XQ-1H)对哺乳期仔鼠的一般生长状况以及对仔鼠组织器官发育的影响,研究其伴随的毒代动力学,为XQ-1H围产期安全性评价提供依据。方法将108只受精SD大鼠随机均分为溶媒对照组和3个给药(20、10、5 mg·m L-1)实验组。对照组大鼠给予0.9%氯化钠溶液,实验组给药剂量分别为100、50、25 mg·kg-1·d-1。于妊娠期第15天开始给药,每天1次,连续给药至哺乳期结束(出生后第21天),于尾静脉注射,给药容积为5 m L·kg-1。实验组取3只孕鼠于妊娠20 d进行剖宫,取各给药组仔鼠进行解剖,检查XQ-1H是否可通过胎盘屏障进入仔鼠。仔鼠出生4d后,每窝留10只,各给药组选择2只剔除仔鼠进行解剖,检查XQ-1H是否可通过乳汁分泌进入仔鼠。给药组24只孕鼠于哺乳期结束时处死母鼠,观察指标包括仔鼠的一般观察、出生畸形、体重、摄食量及解剖后观察组织器官的发育情况。结果XQ-1H可通过母体胎盘屏障,不可由哺乳通过乳汁传递给子代;与对照组相比,各给药组仔鼠一般生长状况未出现统计学差异;子代各组织器官发育良好,与对照组比较无统计学差异。结论 XQ-1H对子代生长及组织器官发育无不良影响。OBJECTIVE To observe the effects on growth and tissues＇ development of newborn rats in lactation period and research the concomitant toxic kinetics,further to provid a safety evaluation for XQ- 1H. METHODS 108 pregnant SD rats were divided into4 groups randomly. Solvent control group were injected with 0. 9% Na Cl and test groups were injected with XQ- 1H in dose of 100,50,25 mg·kg^-1·d^-1from E15 to PNG21. The daily application volume（ 5 m L·kg^-1body weight） was calculated according to the latest body weight. Three pregnant rats from each group were killed at E20,further dissecting the fetal rats to test if XQ- 1H passed through the placenta barrier. At PNG4,every litter kept 10 fetal rats and 2 other rats were chosen from each group to dissect. Whether XQ- 1H passed through breast milk was tested. 24 pregnant rats were sacrificed at the end of lactation period. General conditions of newborn rats,food intake,malformation,body weights were observed. Tissue＇s development was observed after anatomy. RESULTS XQ- 1H passed through placenta barrier instead of breastmilk. However,compared with solvent control group,there were no significant differences inbody weight and general conditions. No toxic clinical symptoms were observed in newborn rats＇ organs. CONCLUSION XQ- 1H has no effects on the growth and tissues＇ development of F1 tats.

关 键 词：甲磺酸胺银杏内酯B 围产期 胎盘屏障 妊娠 乳汁 畸形 生殖毒性 

分 类 号：R96[医药卫生—药理学]