药物非临床生殖毒性实验中优选阳性对照药的探索

Optimal positive control drug in non-clinical reproductive toxicity test

目的探索在药物非临床生殖毒性实验中,选择较为适宜的阳性对照药。方法选择本实验室不同阶段开展的生殖毒性实验结果,采用列表对比方式汇总和分析。结果生育力与早期胚胎发育毒性实验、胚胎-胎仔发育毒性实验、围产期毒性实验结果均出现阳性反应。结论在大鼠生育力与早期胚胎发育毒性实验中选择环磷酰胺,在大鼠胚胎-胎仔发育毒性实验中选敌枯双和环磷酰胺,在兔胚胎-胎仔发育毒性实验中选反应停和环磷酰胺,在围产期毒性实验中选择丙基硫氧嘧啶为阳性对照药都是较为适宜的。

Objective To select more appropriate positive control drug in non-clinical reproductive toxicity test. Methods The reproductive toxicity test results in the laboratory at different stages were summarized. Results The results of fertility and early embryonic development toxicity test, embryo-fetal developmental toxicity study and pre- and postnatal toxicity test showed positive reaction. Conclusion Cyclophosphamide is proper in rat fertility and early embryonic development toxicity test（section Ⅰ）. Cyclophosphamide and Bis-A-TDA for rat embryo-fetal developmental toxicity study（section Ⅱ）, thalidomide and cyclophosphamide for rabbit embryo-fetal developmental toxicity study（sectionⅡ） are appropriate positive control drug. Propylthiouracil is suitable in pre- and postnatal toxicity test（section Ⅲ）.