摘要
目的找出静脉注射人血白蛋白辛酸钠大鼠未出现急性症状的辛酸钠最大用量及毒效应特征。方法对110只SD大鼠经静脉分别一次性注射辛酸钠5.3、10.6、21.2、42.4、84.8 mg/ml(相当于临床使用的1、2、4、8、16倍)的人血白蛋白溶液[辛酸钠白蛋白组1～5(实验组1～5)]和水溶液(辛酸钠对照组)[2种溶液的每种辛酸钠浓度(组)各注射10只],注射剂量分别为50、100、200、400、800 mg/kg,另10只注射0.9%NaCl作为阴性对照,于注射后d3、d7、d14称体重、每天观察死亡等毒性表现和行为特征,14 d后解剖大鼠,观察其内脏器官病变。结果无论是辛酸钠白蛋白组还是辛酸钠对照组,当辛酸钠为42.4、84.8 mg/ml(临床使用的8、16倍)时均造成了大鼠注射后的应激反应,而辛酸钠为5.3、10.6和21.2 mg/ml(临床使用的1、2、4倍)时未对大鼠造成任何急性毒性作用。结论人血白蛋白中辛酸钠增加至21.2 mg/ml(临床使用浓度的4倍)时不会对大鼠造成任何急性毒性作用。
Abstract：Objective Research on the maximum safety volume and toxicity effect of sodium caprylate in the rats that did not appear the acute toxicity symptoms after injected different sodium caprylate concentrations of human albumin solu- tion. Methods The sodium caprylate concentrations respectively 5.3,10.6,21.2,42.4,84. 8 rag/m1 （ equivalent to 1,2,4, 8,16 times of clinical usage concentration） in albumin solution and aqueous solution were injected into 100 SD rats only once. The rats which injected sodium caprylate albumin solution were included in the 5 test groups （ sodium caprylate albumin groups）, the others which injected sodium caprylate aqueous solution were included in 5 corresponds sodium caprylate control groups, 10 rats for each concentration as a group. The administration doses were 50,100,200,400,800 mg/kg for each group respectively. The other 10 rats not injected as negative control group. Weigh the rats in the 3rd,Tth and 14th days respective- ly,observe the toxicity phenomena, behavior characteristics and death of rats etc. every day. The observation lasted for 14 days. The rats were dissected after 14 days to observe the lesions of internal organs. Results Whether sodium caprylate con- trol group or sodium caprylate albumin group,when sodium caprylate concentrations were 42.4 mg/ml and 84. 8 mg/ml （8, 16 times of clinical usage concentration）, they all caused the stress reaction of rats after injection. When sodium caprylate concentrations were 5.3 mg/ml, 10.6 mg/ml and 21.2 mg/ml （1,2,4 times of chnical usage concentration） , they did not cause any acute toxicity effects to the rats. Conclusion When the sodium caprylate concentration in human albumin in- creased to 21.2 mg/ml （4 times of clinical usage concentration） ,it will not cause any acute toxicity effect to rats.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2012年第12期1276-1279,共4页
Chinese Journal of Blood Transfusion
基金
国家科技支撑计划--生物制品安全性评价技术及原辅料安全性研究(2008BAI54B00)
