大鼠中羟丙基甲基纤维素琥珀酸酯的致畸学研究。

Teratological studies of hydroxypropylmethylcellulose acetate succinate in rats.

作者信息

Hoshi N, Ueno K, Igarashi T, Kitagawa H, Fujita T, Ichikawa N, Kondo Y, Isoda M

出版信息

J Toxicol Sci. 1985 Oct;10 Suppl 2:203-26. doi: 10.2131/jts.10.supplementii_203.

DOI:10.2131/jts.10.supplementii_203

Abstract

A teratogenicity study was carried out in S1c: SD rats orally administered Hydroxypropylmethylcellulose acetate succinate (HPMCAS), a useful pharmaceutical excipient, at dose levels of 625, 1,250 and 2,500 mg/kg/day for a period of 11 days from day 7 to day 17 of gestation. Two-thirds of the pregnant females in each group were sacrificed on Day 21 of gestation and their fetuses were examined. The remaining dams were allowed to litter naturally, and the postnatal development of the offsprings was observed. The incidences of external, internal, and skeletal anomalies were not significantly increased in the fetuses of any treated groups. HPMCAS caused no effects on parturition, lactation, postnatal growth and reproductive ability of the male and female offspring.

摘要

在S1c:SD大鼠中进行了一项致畸性研究，在妊娠第7天至第17天期间，以625、1250和2500mg/kg/天的剂量水平口服给予一种有用的药用辅料醋酸羟丙甲纤维素琥珀酸酯（HPMCAS），持续11天。每组三分之二的怀孕雌性大鼠在妊娠第21天处死，并检查其胎儿。其余的母鼠自然产仔，并观察后代的产后发育情况。任何处理组的胎儿中，外部、内部和骨骼异常的发生率均未显著增加。HPMCAS对雄性和雌性后代的分娩、哺乳、产后生长和生殖能力均无影响。