摘要
目的观察封管用两种枸橼酸钠注射液配方在体外对新西兰大白兔有无溶血、凝集作用。方法依照《化学药物刺激性、过敏性和溶血性研究技术指导原则》,取规定量受试药加入2%兔血生理盐水混悬液中,观察溶血和凝集情况,并用分光光度计测定吸光度值,计算溶血率。结果Ⅰ型封管用枸橼酸钠注射液(含枸橼酸0.3%)与Ⅱ型封管用枸橼酸钠注射液(含枸橼酸4%)在药物浓度10%时的溶血率分别为3.3%与13.4%,在药物浓度2%时的溶血率分别为1.1%与8.3%。结论含枸橼酸0.3%的封管用枸橼酸钠注射液对兔红细胞无明显溶血和凝集现象,溶血率小于5%,符合注射剂要求;而含枸橼酸4%的封管用枸橼酸钠注射液的溶血率大于5%,静脉注射会有溶血倾向。
Objective To observe whether two kinds of sodium citrate injection for catheter locking can cause haemolysis and coagulation in vitro. Methods According to Guideline for Research Technique on Irritation, Allergia and Hemolysis of Chemicals, prescriptive dose of sodium citrate injection for catheter locking was added to rabbit blood of 2% （diluted by salt solution） to observe the effects of haemolysis and coagulation. Then the absorbency was determined by spectrophotometer and the rate of haemolysis was calculated. Results The rate of haemolysis of Sodium citrate injection for catheter locking Ⅰ （containing 0.3% citric acid） and Sodium citrate injection for catheter locking Ⅱ （containing 4% citric acid） was 3.3% and 13.4% at the concentration of 10% and 1.1% and 8.3% at 2% respectively. Conclusion Sodium citrate injection for catheter locking containing 0.3% citric acid can cause haemolysis and coagulation on red blood cells of rabbits in vitro with the rate of haemolysis less than 5% which accords with the criterion of injection. Sodium citrate injection for catheter locking contained 4% citric acid shows the tendency of haemolysis with the rate of haemolysis more than 5%.
出处
《中国血液净化》
2007年第9期517-518,共2页
Chinese Journal of Blood Purification
关键词
封管
枸橼酸钠注射液
溶血性试验
Catheter locking
Sodium citrate injection
Hemdytic effect studies
