双氯芬酸钠注射液的溶血性及主动全身过敏反应试验

Experiment of diclofenac sodium injection on hemolysis and active systemic anaphylaxis

为评价双氯芬酸钠注射液的溶血性及其对豚鼠主动全身过敏反应,采用体外试管法观察试验24 h内药物致溶血与红细胞凝集现象。豚鼠主动全身过敏反应试验通过3次腹腔注射致敏,于末次致敏后第14天及第21天,以2倍致敏剂量肌肉注射进行激发,观察各组动物的过敏反应症状,计算过敏反应发生率。溶血试验结果显示,4℃静置过夜,供试品低剂量组无溶血现象,其余各组均呈完全溶血现象。豚鼠主动全身过敏反应试验筛选出药物的致敏注射剂量为0.0625 mL/kg·bw,阳性对照药可引起豚鼠发生过敏反应,发生率为33.3%。药物及药物溶剂均未引起豚鼠的过敏反应。表明双氯芬酸钠注射液不会引起豚鼠全身主动过敏反应,但其可导致红细胞溶解,不宜用作静脉注射。

To investigate the effect of diclofenac sodium injection on hemolysis and active systemic anaphylaxis(ASA),hemolytic effect of diclofenac sodium was evaluated through observing hemolysis and agglutination of red blood cells in 24 hours by in vitro test.In ASA,guinea pigs were injected intraperitoneally every other day for 3 times.On the 14th day and 21st day,post the last sensitization,guinea pigs were injected with the same medicine in the dosage of twice as much as sensitization dose through intramuscular injection.The symptoms and the incidence of allergic response were assessed according to ASA symptom scale and evaluation criteria.Results of hemolysis test showed that after overnight at 4℃,there were no hemolytic reaction in the group of diclofenac sodium diluents 0.1 mL and normal saline group,while other groups showed completely hemolysis.The optimum sensitized dosage of diclofenac sodium injection was 0.0625 mL/kg.The guinea pigs showed positive allergic response to BSA with 33.3%incidence.However,guinea pigs had negative reaction on either diclofenac sodium injection and its solvent.The conclusions were that diclofenac sodium injection does not ASA in guinea pigs,while it could induce hemolysis,and should not be used intravenously.