血卟啉单甲醚对SD大鼠的致畸学研究

A Teratological Study of Sprague-Dawley Rats with 3 (or 8)-(l-Methoxyethyl)-8 (or 3)-hydroxyethyl-deuteroporphyrin

用传统致畸学试验研究了血卟啉单甲醚(PSD-044)的潜在胚胎毒性、生长毒性和致畸作用。试验参照推荐的临床使用剂量,分别设PsD-044 20、10、5mg/kg 3个剂量组和阴性对照(生理盐水)和阳性对照(五氯酚钠)。于孕期第10天静脉注射给药,共检查了81只孕鼠和803只胎鼠。结果表明:PsD-044对孕鼠无母体毒性效应,胚胎毒性和致畸作用。而在同一实验条件下的阳性对照物诱发胎鼠的致畸率高达14.1％。

The potential embryotoxicity, developmental toxicity and teratogenic effects of (3 or 8)-(l-methoxyethyl)-8 (or3)-hydroxyethyl-deuteroporphyrin (PsD-044) were investigated in Sprague-Dawley rats with the conventional teratological method in vivo. According to the recommending clinical dosage, PsD-044 was administered intravenously at 20, 10 and 5mg/kg, as compared to the negative control with saline and the positive control with sodium pentachlorophenolate, respectively on the 10th day of the gestation. Eighty-one pregnant rats and 803 fetuses were examined. The results suggest that the maternal toxicity, embryotoxicity and teratogenic effects of PsD-044 were not found, however, the malformation induced by known teratogen was as high as 14.1%.