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目的:观察阿魏酸钠氯化钠注射液是否有过敏性、注射部位刺激性和溶血性反应。方法:全身主动过敏反应:豚鼠分别静脉注射原药低剂量和高剂量,以5%卵蛋白溶液为阳性对照,0.9%氯化钠注射液为阴性对照;注射部位刺激性:家兔左右耳静脉分别滴注原液(100 ml:阿魏酸钠0.3 g与氯化钠0.9 g),0.9%氯化钠注射液(阴性对照),20 D·min~(-1),qd,每次30min,4 d;体外溶血试验:原液(100 ml:阿魏酸钠0.3 g与氯化钠0.9 g)体外试管法(目测法)及比色法。结果:全身主动过敏反应:除阳性对照组外,各组均未出现过敏反应症状;注射部位刺激性:肉眼观察及切片镜检,与阴性对照部位相比未见明显的注射部位刺激性;体外溶血试验:观察3 h未见明显的溶血和红细胞凝集反应,取上清液在545nm处测定吸光度5管试样溶血率均小于5%。结论:阿魏酸钠氯化钠注射液未出现全身主动过敏反应、无明显的注射部位血管刺激及无明显的溶血和红细胞凝集反应。
Objective: To observe whether sodium ferulate sodium and sodium chloride injection is allergic, injection site irritation and hemolytic reaction. Methods: Systemic active anaphylaxis: guinea pigs were intravenous injection of low and high doses of the original drug, 5% ovalbumin solution as a positive control, 0.9% sodium chloride injection as a negative control; injection site irritation: rabbit left and right ear vein (100 ml: sodium ferulate 0.3 g and sodium chloride 0.9 g), 0.9% sodium chloride injection (negative control), 20 D · min -1, qd for 30 min, 4 d; In vitro hemolysis test: In vitro (100 ml: sodium ferulate 0.3 g and sodium chloride 0.9 g) in vitro tube method (visual method) and colorimetric method. RESULTS: Systemic active anaphylaxis: No allergic reaction was observed in all groups except for the positive control group. Irritation of injection site: Macroscopic observation and biopsy showed no obvious injection site irritation compared with negative control site. In vitro Hemolysis test: No obvious hemolytic and hemagglutination reaction was observed after 3 h. The supernatant was measured at 545 nm for absorbance. The hemolysis rates of 5 tubes were less than 5%. Conclusion: Sodium ferulate sodium chloride injection did not appear systemic active allergic reaction, no significant injection site of vascular irritation and no obvious hemolysis and hemagglutination reaction.