Rodríguez M D, García H
Department of Pharmacology and Toxicology, National Center for Scientific Research, Havana, Cuba.
Teratog Carcinog Mutagen. 1994;14(3):107-13. doi: 10.1002/tcm.1770140302.
The present studies evaluated the teratogenic potential and reproductive toxicity of Policosanol, a new hypocholesterolemic drug. Policosanol was administered by oral gavage to Sprague-Dawley rats and New Zealand White rabbits during the period of organogenesis at dosages up to 500 and 1,000 mg/kg/day, respectively. There was no evidence of teratogenicity or any other embryonal toxicity. In a fertility and reproductive study female rats were treated with Policosanol by oral gavage at dosages up to 500 mg/kg/day, 2 weeks prior to mating and throughout mating and pregnancy to day 21 of lactation. Males were given treatment 60 days before and during mating. Reproductive parameters of mothers were normal. There was no evidence that treatment affected the survival, postnatal growth, or behavior of the offspring. No maternal treatment-related adverse side effects occurred in these studies. It is concluded that Policosanol was not teratogenic in either rats or rabbits, nor did it induce reproductive toxicity in rats.
本研究评估了新型降胆固醇药物聚多卡醇的致畸潜力和生殖毒性。在器官形成期，分别以高达500和1000毫克/千克/天的剂量通过口服灌胃给予Sprague-Dawley大鼠和新西兰白兔聚多卡醇。没有致畸性或任何其他胚胎毒性的证据。在一项生育力和生殖研究中，雌性大鼠在交配前2周以及整个交配和妊娠期直至哺乳期第21天，通过口服灌胃给予聚多卡醇，剂量高达500毫克/千克/天。雄性大鼠在交配前60天和交配期间接受治疗。母亲的生殖参数正常。没有证据表明治疗会影响后代的存活、出生后生长或行为。在这些研究中未出现与母体治疗相关的不良副作用。结论是，聚多卡醇对大鼠和兔子均无致畸性，对大鼠也未诱发生殖毒性。
