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目的:对血栓通注射制剂进行非临床安全性检查。方法:对血栓通注射制剂进行了小鼠半数致死量(LD50)测定,并对三个厂家的血栓通注射制剂进行血管刺激性、溶血性及过敏试验研究。结果:血栓通注射制剂的小鼠LD50为(419.351±22.605)mg·kg-1;临床使用最大浓度对新西兰兔耳缘静脉无明显刺激作用;溶血试验结果显示三个厂家的溶血率有较大不同;豚鼠全身主动过敏试验显示血栓通注射制剂在该实验条件下静脉注入豚鼠体内会出现类似过敏反应症状;在本实验条件下血栓通注射液和注射用血栓通注入豚鼠体内后,没有引发被动皮肤过敏反应。结论:血栓通注射制剂小鼠LD50为(419.351±22.605)mg·kg-1;血栓通注射制剂临床使用最大浓度对新西兰兔耳缘静脉无明显刺激作用;其不同厂家的溶血率明显不同;可引发豚鼠类似过敏反应的症状。
Objective: To study the non-clinical safety of Xueshuantong injection. Methods: LD50 of Xueshuantong injection was tested. The irritation, hemolytic and allergic effects of Xueshuantong injection in three factories were studied. Results: The LD50 of mice injected with Xuesaitong was (419.351 ± 22.605) mg · kg-1. No significant stimulation was observed in the ear vein of New Zealand rabbits at maximum concentration. The results of hemolysis showed that the hemolysis rates of the three manufacturers were larger Different; guinea pig whole body active allergy test showed that Xuesaitong injection preparation under the experimental conditions intravenous injection of guinea pigs will appear similar symptoms of allergic reactions; under the experimental conditions, Xuesaitong injection and injection of thrombosis through guinea pigs, did not trigger passive Skin allergies. Conclusion: The LD50 of Xuesaitong injection in mice was (419.351 ± 22.605) mg · kg-1. The maximum clinical concentration of Xuesaitong injection did not significantly stimulate the New Zealand rabbits’ ear veins. The hemolysis rates of different manufacturers were significantly different Trigger the symptoms of a guinea pig-like allergic reaction.