羟丙基甲基纤维素琥珀酸酯对大鼠生育力的研究。

Studies of hydroxypropylmethylcellulose acetate succinate on fertility 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 2:187-201. doi: 10.2131/jts.10.supplementii_187.

DOI:10.2131/jts.10.supplementii_187

Abstract

A fertility study was carried out in Slc: 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. Male rats were treated with HPMCAS from 60 days before pairing until the completion of mating. Female rats received HPMCAS for 22 days, from 14 days prior to mating up to Day 7 of gestation. All pregnant females were sacrificed on Day 21 of gestation and all fetuses were examined for abnormalities. No abnormal signs were seen in mating or fertility in the rat treated with HPMCAS. No external, internal and skeletal anomalies attributable to HPMCAS were observed in the fetuses. It was concluded that HPMCAS had no harmful effect on mating, fertilization, implantation, or embryonic development.

摘要

在对Slc:SD大鼠进行的一项生育力研究中，大鼠口服给予药用辅料羟丙基甲基纤维素琥珀酸酯（HPMCAS），剂量水平分别为625、1250和2500mg/kg/天。雄性大鼠在配对前60天开始接受HPMCAS处理，直至交配完成。雌性大鼠在交配前14天至妊娠第7天接受HPMCAS处理22天。所有怀孕雌性大鼠在妊娠第21天处死，检查所有胎儿是否存在异常。接受HPMCAS处理的大鼠在交配或生育力方面未观察到异常迹象。在胎儿中未观察到可归因于HPMCAS的外部、内部和骨骼异常。结论是，HPMCAS对交配、受精、着床或胚胎发育没有有害影响。