Feletti F, Tripodi A S, Germogli R
Institute of Pharmacology II, University of Pavia, Italy.
Arzneimittelforschung. 1993 Aug;43(8):894-7.
The reproductive toxicity of taurohyodeoxycholic acid (3 alpha, 6 alpha-dihydroxy-5-beta-cholanoyl-2-amino-ethyl-sulfonic acid, THDCA, Io, Praxis, CAS 2958-04-5), a new synthetized biliary acid patented in Europe, Japan and the United States for prevention and therapy of gallstones and related symptoms, was assayed by performing segment I (fertility and general reproductive performance) and segment II (teratology) studies. In the first study THDCA was administered (100, 220 or 500 mg/kg by oral route) to male and female rats prior to and in the early stage of pregnancy. No adverse effects or dose-related abnormalities were observed in the reproductive performance of either sex; no death or evidence of teratogenicity in fetuses were also observed. In the second study THDCA was administered (100, 220 or 500 mg/kg by oral route) to rats and rabbits during the fetal organogenesis period. No maternal toxicity, teratogenicity or adverse effects on growth of embryos and fetuses and no reduction of the viability index were observed. From these studies the no-effect dose can be estimated at 500 mg/kg.
牛磺猪去氧胆酸（3α，6α - 二羟基 - 5 - β - 胆酰基 - 2 - 氨基乙磺酸，THDCA，Io，Praxis，CAS 2958 - 04 - 5）是一种新合成的胆汁酸，在欧洲、日本和美国均已获得专利，用于预防和治疗胆结石及相关症状。通过进行第一阶段（生育力和一般生殖性能）和第二阶段（致畸学）研究，对其生殖毒性进行了测定。在第一项研究中，在妊娠前及妊娠早期，给雄性和雌性大鼠口服给予THDCA（100、220或500mg/kg）。在任何一性别的生殖性能方面均未观察到不良反应或剂量相关异常；也未观察到胎儿死亡或致畸迹象。在第二项研究中，在胎儿器官形成期给大鼠和家兔口服给予THDCA（100、220或500mg/kg）。未观察到母体毒性、致畸性或对胚胎和胎儿生长的不良反应，也未观察到活力指数降低。从这些研究中可以估计无作用剂量为500mg/kg。
