中文摘要：

生育调节药物是指能够改变人类生殖过程从而达到调节生育目的的物质。由于该类药物的应用对象多数是健康的育龄男女,长期用药者居多,其毒性作用具有蓄积性、迁延性和整体性,又经常脱离临床监控,因此,对其评价要则也有其独特的一面,如：①性别选择性用药,在选择动物时,通常无须♀♂各半,而是要结合临床用药性别特征;②多数激素类药物,特别是孕激素类药物,不宜采用大鼠或Beagle犬作实验动物,而采用猴;③在长期毒性试验中,对动物的激素水平检测应作为必备指标,对动物的性周期和全身性器官观察应作为常规指标;④长期毒性试验周期一般建议超过半年;⑤在安全药理学试验中,常常应开展激素样活性、子宫肌条收缩或阴茎勃起等补充安全药理学试验;⑥生殖毒性伴随毒代动力学研究应对精、血和乳汁药物浓度逐步开展检测,以研究生育调节药物是否能够通过血睾、胎盘和血乳屏障,分别对♂动物、胚胎和子代产生毒副作用;⑦生殖毒性试验除了按常规要求进行外,还要具体问题具体对待;⑧常常需要开展生殖、遗传毒性和致癌试验。

英文摘要：

Fertility regulation drugs are the substances which can regulate human fertility via altering the reproductive process.With the characteristics of long term applying to healthy people and those of childbearing age,toxicity accumulation,persistency and integrity,and usually being out of the clinical monitoring,the evaluation of fertility regulation drugs has some special aspects,such as：① For the sex-selective drugs,the selection of gender of laboratory animals depends on the characteristics of clinical medication;② Monkey is more appropriate laboratory animal than rats or Beagle dogs for most hormonal drugs,especially progesterone drugs;③ In the repeated-dose toxicity tests,the detection of the animal hormones is an essential index,the animal sex cycle and systemic organ observation are conventional indexes;④ Over 6 months are required for repeated-dose toxicity tests;⑤ To evaluate the safety of fertility regulation drugs,it is often required to carry out hormone-kind activity,uterine muscle contraction or penile erectile and other tests in general pharmacology studies;⑥ To evaluate whether the fertility regulation drugs can pass the blood-testis,placenta and milk barrier,and further to evaluate the toxic side effects to males,embryos and offsprings,the sperm drug concentration,blood concentration and milky juice drug concentration assays are required to carry out according to reproductive toxicokinetic studies;⑦ The test of reproductive toxicity should be considered on a case by case basis,because it is difficult to carry out this study in the conventional way;⑧ It is mandatory to take reproductive,carcinogenic and genetic toxicity tests.