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目的:观察滋肾育胎丸对SD大鼠胚胎-胎仔发育的影响,为临床用药提供参考。方法:在着床至硬腭闭合期间(GD6~15)灌胃(ig)给予SD妊娠大鼠不同剂量(6,12和24 g·kg~(-1))的滋肾育胎丸,溶媒对照组和阳性对照组动物分别给予纯化水和环磷酰胺。其中,阳性对照组于GD12皮下注射环磷酰胺(15mg·kg~(-1))。检测并记录母鼠体重、摄食量、胚胎着床、胎仔吸收、雌二醇(E2)、孕酮(P)和睾酮(T)激素,检测胎仔生长发育和畸形等情况。结果:滋肾育胎丸对孕鼠的妊娠结局(平均黄体数、平均着床数、平均活胎数、活胎率、吸收胎率和死胎率等)、对胎仔的外观、内脏和体格生长发育(窝均体重、身长、尾长和胎盘重)均未见明显影响;滋肾育胎丸各剂量组睾酮、孕酮和雌二醇水平均在正常范围内波动。结论:滋肾育胎丸对SD大鼠胚胎-胎仔发育毒性的未见不良反应水平(NOAEL)为12 g·kg~(-1),是大鼠等效剂量的8倍,临床人用剂量的48倍。剂量达24 g·kg~(-1)时可使母鼠宫外增重减少。
Objective: To observe the influence of Zishen Yutai Pill on embryonic-fetal development in SD rats and provide reference for clinical use. METHODS: Zishen Yu fetal pills (6,12 and 24 g · kg ~ (-1)) were given intragastrically (ig) to SD pregnant rats during implants until the closure of the hard palate (GD6 ~ 15) Groups and positive control animals were given purified water and cyclophosphamide. Among them, the positive control group was injected cyclophosphamide (15 mg · kg -1) into GD12 subcutaneously. The body weight, food intake, embryo implantation, fetal absorption, estradiol (E2), progesterone (P) and testosterone (T) hormones were detected and recorded. The fetal growth and deformity were detected. Results: The pregnancy outcome (mean luteal number, average number of implants, average number of live fetus, live fetus rate, absorbed fetus rate and stillbirth rate) of Zishen Yutai Pills on pregnant rats, appearance, internal organs and physical growth (Body weight, length, tail length and weight of placenta) were not significantly affected. The levels of testosterone, progesterone and estradiol in each dose group of Zishen Yutai Wan fluctuated within the normal range. Conclusion: The NOAEL of Zishen Yutai Pill to embryo - fetal developmental toxicity of SD rats is 12 g · kg ~ (-1), which is 8 times of the equivalent dose in rats. The clinical dosage 48 times. The dose of 24 g · kg ~ (-1) can reduce the extrauterine weight gain.