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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 general growth status of neonatal gonadotrophs B (XQ-1H) for injection and its effect on the development of the tissues and organs of pups. The toxicokinetics of the compound ginkgolide B (XQ-1H) Provide a basis for the safety assessment during delivery. Methods A total of 108 fertilized SD rats were randomly divided into a vehicle control group and three experimental groups (20, 10, and 5 mg · mL -1). The control group rats were given 0.9% sodium chloride solution, the experimental group doses were 100,50,25 mg · kg-1 · d-1. Administered on the 15th day of gestation, once daily, and continuously administered until the end of lactation (21 days after birth), and injected into the tail vein at a volume of 5 m L · kg-1. In the experimental group, 3 pregnant rats were cesarean at 20 days of gestation and the pups in each group were dissected to check if XQ-1H could pass through the placental barrier. Four pups were born after 4d, leaving 10 per litter, each treatment group choose 2 remove the offspring for anatomy, check XQ-1H whether the secretion of milk into the offspring. Twenty-four pregnant rats in the drug-treated group were sacrificed at the end of lactation. The observation included the general observation, birth deformity, body weight, food intake and anatomical observation of the development of tissues and organs. Results XQ-1H could pass the maternal placental barrier and could not be passed from breastfeeding to offspring through breast milk. Compared with the control group, there was no statistical difference in the growth status of the offspring in the offsprings. The offspring tissues and organs developed well, There was no significant difference in the control group. Conclusion XQ-1H has no adverse effect on the growth of offspring and the development of tissues and organs.