摘要
目的:探讨血必净注射液(XBJJ)不良反应是否以类过敏反应为主,并挖掘其可能引起类过敏反应的影响因素。方法:借助小鼠类过敏反应模型,分别选取XBJJ临床最高浓度的0.5,1,2倍进行类过敏反应研究,以判断不同浓度XBJJ是否诱发小鼠类过敏反应;比较配制后存放不同时间的XBJJ诱发小鼠类过敏反应是否存在差异,具体为配制XBJJ到不同浓度后,分别存放10 min,2.5 h,6 h,24 h后再给小鼠尾静脉注射;最后取选3 s,45 s,90 s 3个推注时间进行XBJJ注射,再对不同注射速度的XBJJ诱发小鼠类过敏反应差异进行比较。结果:XBJJ在药物浓度高于临床推荐浓度时会诱发小鼠类过敏反应;与配制后存放10 min比较,随着存放时间的延长,相同浓度XBJJ诱发小鼠类过敏反应的程度加重;另外,当XBJJ以3 s注射完时(注射速度达0.083 mL·s^(-1)),其产生的类过敏反应最强。结论:XBJJ诱发的不良反应以类过敏反应为主。XBJJ配制后存放时间过长和注射速度过快,都会导致其诱发小鼠类过敏反应加重。XBJJ临床使用时,应严格按照药品使用说明书推荐的用法、用量、配制浓度、滴注速度,并现用现配,合理用药,对于提高XBJJ的用药安全性具有积极意义。
Objective: To investigate whether the adverse reactions of Xuebijing injection(XBJJ) are mainly pseudoallergic reactions and explore the influencing factors of its pseudoallergic reactions. Method:Mouse model of pseudoallergic reaction was used to study the anaphylactoid reaction of XBJJ which at 0.5, 1 and2 times of the highest clinical concentration. Next, we compared the differences in pseudoallergic reactions caused by XBJJ for different storage times after preparation. Specifically, XBJJ was prepared into different concentrations, stored for 10 minutes, 2.5 hours, 6 hours and 24 hours, and then injected into the tail vein of mice.Finally, three different injection speeds of 3 seconds, 45 seconds and 90 seconds were selected for XBJJ injection,and then the differences in the paeudoallergic reactions induced by XBJJ in mice under different injection speeds were compared. Result: XBJJ induces pseudoallergic reactions in mice when the drug concentration is higher than the clinically recommended concentration. Compared with storage for 10 minutes after preparation, the degree of pseudoallergic reaction in mice induced by the same concentration of XBJJ increased with the extension of storage time. In addition, when XBJJ was injected in 3 s(the injection rate was 0.083 mL·s^(-1)), it produced the strongest pseudoallergic reaction. Conclusion: The adverse reactions induced by XBJJ are mainly pseudoallergic reactions. Excessive storage time after preparation and fast injection speed of XBJJ will lead to aggravation of pseudoallergic reactions in mice. When XBJJ is used clinically, it should strictly follow the usage,dosage, concentration, and drip rate recommended in the drug instruction manual. Rational drug use is of positive significance for improving the safety of XBJJ.
作者
易艳
李春英
张宇实
赵雍
张桂萍
韩佳寅
田婧卓
王连嵋
潘辰
刘素彦
梁爱华
YI Yan;LI Chun-ying;ZHANG Yu-shi;ZHAO Yong;ZHANG Gui-ping;HAN Jia-yin;TIAN Jing-zhuo;WANG Lian-mei;PAN Chen;LIU Su-yan;LIANG Ai-hua(State Key Laboratory of Innovative Natural Medicine and Traditional Chinese Medicine(TCM)Injections,Key Laboratory of Beiing for Identification and Safety of TCM,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Tianjin Chase Sun PharmaceuticalCo.Ltd.,Tianjin 301700,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2021年第5期77-83,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家“重大新药创制”科技重大专项(2014ZX09201022-004,2015ZX09501004-003-001,2018ZX09101002-003)
中国中医科学院自选课题项目(Z2014036,ZZ2014023,ZXKT15031)
中国中医科学院中医药“一带一路”合作专项(GH201919)。
关键词
血必净注射液
不良反应
类过敏反应
合理用药
Xuebijing injection
adverse reaction
pseudoallergic reaction
rational administration of drug
