注射用间苯三酚的非临床安全性评价  

Nonclinical Safety Evaluation of Phloroglucinol Dehydrate Injection

作　　者：王欣[1] 周继春[1] 景爱华[2] 雷万军[2] 

机构地区：[1]河南省食品药品检验所,河南郑州450008 [2]河南科技大学医学技术与工程学院,河南洛阳471023

出　　处：《河南科技大学学报（医学版）》2017年第2期100-103,共4页Journal of Henan University of Science & Technology:Medical Science

摘　　要：目的对注射用间苯三酚进行临床前动物安全性评价试验。方法豚鼠全身主动过敏性试验(ASA):在首次注射后第14天、第21天由耳缘静脉注射供试品,观察30 min后动物过敏反应;豚鼠被动皮肤过敏性试验(PCA):皮内注射抗血清被动致敏,24 h后注射伊文思兰,测量蓝色反应斑;体外溶血试验:观察供试品3 h内有无溶血和凝聚现象;血管刺激性试验:家兔连续5 d耳缘静脉注射供试品,观察其对注射局部血管的刺激;肌肉刺激性试验:家兔后肢股四头肌内注射供试品,观察其对肌肉组织的刺激。结果注射用间苯三酚豚鼠过敏性试验中均未发生过敏反应,溶血性试验3 h内未发生溶血和凝聚现象,血管刺激性试验和肌肉刺激性试验均未出现刺激性反应。结论注射用间苯三酚无过敏性反应、刺激性反应及溶血性,使用安全可靠。Objective To evaluate the preclinica] animal safety of phloroglucinol dehydrate injection. Methods Active systemic anaphylaxis was investigated in guinea pigs when phloroglueinol dehydrate injection was injected on 14 d and 21 d after the first treatment. Passive cutaneous anaphylaxis was investigated in guinea pigs by intravenous injection of evans blue at 24 h after intracutaneous injection of serum antibodies for observing blue reaction spots. In the in vitro hemolytic test, hemolysis and coagulation were observed in 3 h. In the vessel stimulation test, the local blood vessel stimulation was observed after injecting phloroglueinol dehydrate injection for successively 5 d. In the muscle stimulation test, the muscular tissue stimulation was observed after injecting phloroglucinol dehydrate injection in the rabbit hind leg quadriceps. Results There was no allergic reaction to the guinea pigs, no hemolytic and coagulation reaction in the hemolytic test and no stimulation to ear vein and muscular tissue in the vessel and muscle stimulation test. Conclusion Phloroglucinol dehydrate injection was safe and reliable without allergic reaction, stimulation response and haemolyticus.

关 键 词：注射用间苯三酚 安全性试验 过敏反应 溶血试验 刺激性试验 

分 类 号：R965.3[医药卫生—药理学]