新型辅料——泊洛沙姆108毒性及一般药理研究

A TOXIC AND PHARMACOLOGICAL STUDY OF A NEW ADDITIVE——POLOXAMER108

泊洛沙姆108(Poloxamer 108)为制药用新型辅料。小白鼠灌胃LD_(50)>30g/kg;静脉注射LD_(50)为6.56±0.31g/kg;腹腔注射LD_(50)为6.68±0.38g/kg.亚急性毒性表明正常犬静脉注射0.05g/kg和0.15g/kg连续4周对血象、血脂、肾功能均无影响。低剂量对部分肝细胞有极轻微浊肿,大剂量组部分细胞浊肿增强。本品在红细胞混悬液中10%浓度不溶血。腹腔注射本品2g/kg对小鼠自发活动及皮下注射2g/kg对小鼠戊巴比妥钠催眠作用均无影响。0.4g/kg对犬呼吸、血压、心电图及家兔颈总动脉血流量均无明显影响。对家兔阴道粘膜和皮肤无刺激性。

Poloxamer 108 is a new additive used in pharmaceutical industry Its acute toxicity is low: oral LD50>30g/kg;the intravenous administration LD50> 6.56±0.31g/kg and abdominal cavity administration LD50>6.68±0.38gk/g in mice. The subacute toxicity did not show any effects on the blood biochemical compositions in dogs. Tissue samples were normal except for light waterswelling of liver cells. Poloxamer(10%)did not cause hemolysis in the solution of red blood cell(2%).Data of the respiration, blood pressure, ECG in dogs and ECG, blood pressure, bood flow volume of the carotid artery in rabbits suggested no statistical significance. It had no irritant effect on the vaginal mucous membrane and skin.