摘要
目的通过小鼠类过敏实验,对注射用益气复脉(冻干)(YQFM)与9种临床常用药物配伍的类过敏安全性进行评估。方法①小鼠耳廓蓝染类过敏实验,尾iv含有0.4%伊文思蓝(EB)的受试物:阳性对照组给予Compound 48/80-0.4%伊文思蓝(EB)的生理盐水溶液,阴性对照组给予0.4%EB生理盐水溶液,单独药物组给予"药物-0.4%EB的生理盐水溶液"(包括注射用辅酶A、注射用环磷酰胺、维生素C、维生素B6、奥扎格雷注射液、氨茶碱注射液、呋塞米注射液、注射用盐酸纳洛酮、注射用泮托拉唑钠9种药物),配伍药物组给予用"药物-0.4%EB的生理盐水溶液"配制的YQFM。对小鼠耳廓蓝染面积进行评估,并测定小鼠耳廓EB渗出量。②小鼠血液组胺检测实验,除0.4%EB生理盐水溶液均换做生理盐水外,分组给药方法与耳廓蓝染实验均相同。给药30 min后取血,化学法测定小鼠血液组胺释放率。结果①阳性对照、单独给药的维生素B6、注射用辅酶A、注射用盐酸纳洛酮、呋塞米注射液,配伍给药的维生素B6、注射用盐酸纳洛酮、呋塞米注射液小鼠耳廓蓝染类过敏实验结果为阳性,其他结果均为阴性,且9种药物配伍给药的EB含量升高率较单独给药有下降的趋势,②小鼠血液中的组胺的释放在配伍前后也无明显变化。结论 YQFM与9种临床常用药物配伍给药组分别与单独给药组比较,小鼠耳廓蓝染类过敏考察指标和组胺检测指标无增加类过敏发生的风险。
Objective To evaluate the pseudo-allergic safety of Yiqi Fumai Lyophilized Injection(YQFM) in combination with nine common injections by pseudo-allergic test in mouse.Methods ① The mouse pseudo-allergic reaction model was developed by injecting test substance in 0.4% Evans blue(EB) solutions via tail vein.The positive control group was given Compound 48/80-0.4% EB saline solution,the negative control group was given 0.4% EB saline solution,and the drug compatibility group was given "drug-0.4% EB" saline solution.According to the standard of mice ear blue staining test,the scores of ear blue staining was evaluated,and the EB exudation of mice ear was measured.② In the concentration test of histamine in mice,except that 0.4% EB saline solution was replaced by saline solution,the administration method was the same as that of mice with ear blue staining test.Blood was collected after 30 min,and the histamine content in blood of mice was determined by chemical method.The histamine content in blood of mice was determined by a similar method.Result ① Positive drug,vitamin B6,coenzyme A for injection,naloxone hydrochloride for injection,and furosemide injection in single dose groups,and vitamin B6,furosemide injection and naloxone hydrochloride for injection administered in combination with YQFM showed positive results in ear blue staining test in mice;the other results were negative.Moreover,the increase rate of EB content in nine drug compatibility group was lower than that in the single administration.② There was no significant change in histamine content in the blood of mice before and after compatibility.Conclusion Comparing nine kinds of commonly used drugs in combination group with single group respectively,there was no increase in the risk of pseudo-allergic reaction in mice with mice ear blue staining test and histamine detection.
作者
赵志宇
万梅绪
李智
李德坤
宋美珍
侯健
徐亮
鞠爱春
ZHAO Zhiyu;WAN Meixu;LI Zhi;LI Dekun;SONG Meizhen;HOU Jian;XU Liang;JU Aichun(School of Pharmacy, Tianjin Medical University, Tianjin 300070, China;Tianjin Tasly Pride Pharmaceutical Co, Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections, Tianjin 300410, China;Tasly Holding Group Co., Ltd., Tianjin 300410, China;Tianjin Clinical Drug Key Technology Laboratory, Tianjin 300070, China)
出处
《药物评价研究》
CAS
2019年第7期1324-1329,共6页
Drug Evaluation Research
基金
天津市中药注射剂关键技术校企协同创新实验室建设项目(17PTSYJC00090)
关键词
注射用益气复脉(冻干)
药物配伍
类过敏:安全性
耳廓蓝染
组胺
Yiqi Fumai Lyophilized Injection
compatibility
pseudo-allergic test
safety
blue staining of auricle
histamine
