烟酸注射液血管刺激性和类过敏反应研究  

Study on vascular irritation and anaphylactoid reaction of niacin injection

作　　者：潘碧妍 赖国彬 颜慷祺 陈红英 PAN Bi-yan;LAI Guo-bin;YAN Kang-qi(Guangzhou Baiyunshan Mingxing pharmaceutical Co.,LTD,Guangzhou 510250,China;不详)

机构地区：[1]广州白云山明兴制药有限公司,广州510250 [2]广州市越秀区大东街社区卫生服务中心,广州510055

出　　处：《中国处方药》2024年第10期47-50,共4页Journal of China Prescription Drug

基　　金：广州市科技计划项目产学研协同创新重大专项(201604046024)。

摘　　要：目的评估仿制药烟酸注射液对实验动物的血管刺激性及类过敏反应,为该药物临床安全用药提供参考。方法予日本大耳白兔耳缘静脉注射烟酸注射液,每日1次,连续5 d,观察血管刺激性症状,末次给药后72 h、14 d取耳缘静脉及周围组织进行病理制片和组织病理学检查。予SD大鼠尾静脉注射烟酸注射液,以全身类过敏反应行为学表现为评分标准,判断类过敏反应程度,并采血进行组胺和免疫球蛋白(IgE)检测。结果实验兔耳缘静脉注射烟酸注射液,在给药期间和停药期间均未见明显血管刺激性症状。SD大鼠尾静脉注射烟酸注射液未引起类过敏反应。结论仿制药烟酸注射液对兔耳血管无明显刺激性作用,亦未引起大鼠的类过敏反应,建议规范临床用药,减少不良反应的发生。Objective To evaluate the vascular irritation and anaphylactoid reaction of generic drug niacin injection on experimental animals,and provide reference for safe drug usage in clinical practice.Methods Niacin injection was injected into the ear vein of Japanese white rabbits once a day for 5 consecutive days to observe the vascular irritation symptoms,pathological preparations and histopathological examination of the marginal ear vein and surrounding tissues were taken at 72 h and 14 d after the last administration.Niacin injection was injected into the tail vein of SD rats.The degree of anaphylactoid reaction was judged by evaluation criterion of systemic anaphylactoid reaction behavioral performance.Blood samples were collected for histamine and IgE detection.Results Niacin injection didn’t present obviously irritating symptoms on the ear veins of rabbits during the administration period and the withdrawal period.Intravenous injection of niacin in SD rats did not cause anaphylactoid reaction.Conclusion The generic drug niacin injection has no obvious stimulating effect on blood vessels of rabbit ear,nor does it cause anaphylactoid reaction in rats.It is recommended to standardize clinical medication and reduce the occurrence of adverse reactions.

关 键 词：烟酸注射液 血管刺激性 类过敏反应 一致性评价 安全用药 

分 类 号：R969.3[医药卫生—药理学]