摘要
目的应用类过敏体内外评价体系,初步对注射用曲札茋苷进行安全性评价。方法采用RBL-2H3细胞模型和小鼠体内模型(ICR及昆明种),以Compound48/80和清开灵注射液为阳性对照组,体外采用MTT法检测细胞活力,以组胺和β-氨基己糖苷酶的释放率为检测指标;体内通过尾静脉注射含伊文思蓝的受试物,检测小鼠耳廓蓝染发生率,伊文思蓝渗出量,血液中组胺、免疫球蛋白IgE(IgE)及细胞内皮生长因子含量。结果 RBL-2H3细胞体外检测显示,200 μg·mL^(-1)注射用曲札茋苷与阴性对照组比较,组胺和β-氨基己糖苷酶释放率差异无统计学意义;相当于临床剂量50倍(1.75 mg·mL^(-1))的注射用曲札茋苷未引起小鼠发生类过敏反应。结论初步建立的类过敏反应体内外检测体系,适用于中药注射剂类过敏反应的快速筛查,注射用曲札茋苷在该体系中未见类过敏反应发生,初步说明具有较高的安全性。
Objective To evaluate the safety of piceatannol-3’-O-β-D-glucopyranoside for injection with an in vivo and in vitro allergy evaluation system.Methods RBL-2H3 cell models and in vivo mouse models (ICR and Kunming species) were used.Compound48/80 and Qingkailing injection were used as the positive control group.MTT method was used in vitro to detect the cell viability,and the release rate of histamine and β-aminoglycosidase was used as the detection index.The test substance containing Evans blue was injected through the tail vein to detect the incidence of blue staining of the ears of mice,the amount of EB exudation,and the levels of histamine,IgE and VEGF in the blood.Results In vitro detection of RBL-2H3 cells showed that compared with the negative control group,the release rates of histamine and β-aminoglycosidase were not significantly different.Piceatannol-3’-O-β-D-glucopyranoside for injection equivalent to 50 times (1.75 mg·mL^(-1)) the clinical dose did not cause any allergic reactions in mice.Conclusion The in vivo and in vitro detection system for allergic reactions is suitable for the rapid screening of allergic reactions to Chinese medicine injections.Piceatannol-3’-O-β-D-glucopyranoside for injection is safe without any allergic reactions.
作者
杨炳治
杨旭娟
黄茜
曹亚茹
刘国光
刘一丹
YANG Bing-zhi;YANG Xu-juan;HUANG Xi;CAO Ya-ru;LIU Guo-guang;LIU Yi-dan(Lijiang Culture and Tourism College,Lijiang Yunnan 674100;Institute of Medicine,Kunming Pharmaceutical Group Co.,Ltd.,Kunming 650100)
出处
《中南药学》
CAS
2021年第12期2525-2530,共6页
Central South Pharmacy
关键词
曲札茋苷
类过敏反应
安全性评价
piceatannol-3’-O-β-D-glucopyranoside
allergic reaction
safety evaluation
