本文選題：雌鼠 + 生育力與早期胚胎發(fā)育��； 參考：《中國新藥雜志》2017年01期

【摘要】：目的:觀察紅花如意丸對SD雌鼠生育力與早期胚胎發(fā)育的影響,評價(jià)其對動物生殖的毒性或干擾作用,為臨床用藥提供參考。方法:SD雌鼠按體重隨機(jī)分為溶媒對照組(純化水)、陽性對照組(環(huán)磷酰胺80 mg·kg~(-1))、紅花如意丸1,5和15 g·kg~(-1)共5組。溶媒對照組和受試物組雌鼠交配前連續(xù)灌胃(ig)給藥14 d至妊娠D7(GD7),陽性對照組雌鼠于交配前14 d腹腔注射給予環(huán)磷酰胺。檢測并記錄體重、攝食量、生育相關(guān)指標(biāo)、性激素和早期胚胎發(fā)育情況。結(jié)果:與溶媒對照組比較,15 g·kg~(-1)劑量組動物的體重和宮外增重降低,動情間期延長,平均黃體數(shù)、平均著床數(shù)和平均活胎數(shù)均有降低的趨勢。結(jié)論:在本實(shí)驗(yàn)所確定的條件下,紅花如意丸對SD大鼠生育力與早期胚胎發(fā)育毒性的最大無毒性反應(yīng)劑量(no observed adverse effect level,NOAEL)為5 g·kg~(-1),是大鼠等效劑量的10.4倍,臨床劑量的62.5倍。
[Abstract]:Objective: To observe the effect of Honghua Ruiyi Pill on the fertility and early embryo development of SD female rats, evaluate its toxic or interference effect on animal reproduction, and provide reference for clinical use. Methods: SD female rats were randomly divided into the dissolvent control group (purified water), the positive control group (80 mg kg~ (-1)), the safflower pill 1,5 and the 15 g kg~ (-1). A total of 5 groups. The dissolvent control group and the female rats were given a continuous intragastric injection (Ig) for 14 d to pregnancy D7 (GD7), and the female rats in the positive control group were given cyclophosphamide by intraperitoneal injection of 14 d before mating. The weight, food intake, fertility related indexes, sex hormones and early embryonic development were recorded and 15 g. Kg~ (-1) were compared with the control group. The weight and extrauterine weight gain of the animals in the dose group decreased, the interval of estrus prolonged, the average number of corpus luteum, the average number of implantation and the average number of live births decreased. Conclusion: under the conditions determined by this experiment, the largest non-toxic reaction dose (no observed adverse effect LE) for the SD rats' fertility and the early embryonic developmental toxicity (observed adverse effect LE) Vel, NOAEL) was 5 g. Kg~ (-1), 10.4 times the equivalent dose of rats and 62.5 times of the clinical dose.
【作者單位】： 上海市計(jì)劃生育科學(xué)研究所藥理毒理學(xué)研究室中國生育調(diào)節(jié)藥物毒理檢測中心;國家人口和計(jì)劃生育委員會計(jì)劃生育藥具重點(diǎn)實(shí)驗(yàn)室;復(fù)旦大學(xué)生殖與發(fā)育研究院;甘南佛閣藏藥有限公司;
【基金】：上海市實(shí)驗(yàn)動物創(chuàng)新行動計(jì)劃項(xiàng)目(14140901302) 上海市男性生殖與泌尿疾病藥物非臨床評價(jià)專業(yè)技術(shù)服務(wù)平臺(15DZ2290400)
【分類號】：R29

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