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作 者:杨伟峰[1,2] 余学钊[1,2] 何萍[1] 郝伟[1] 李贻奎[1]
机构地区:[1]中国中医科学院西苑医院实验研究中心,北京100091 [2]湖北中医药大学药学院,湖北武汉430065
出 处:《中国中药杂志》2012年第13期1894-1897,共4页China Journal of Chinese Materia Medica
基 金:国家"重大新药创制"科技重大专项(2009ZX09301-005)
摘 要:目的:采用豚鼠过敏试验研究丹参滴注液及其组分的致敏性,为改进该药,提高临床用药安全性提供参考。方法:采用全身主动过敏试验方法,豚鼠腹腔注射各组受试药物以致敏,致敏期间每日观察动物状态。在末次致敏后的第11天用致敏量的2倍量进行激发,观察激发前15 min及激发后40 min豚鼠反应,评价动物反应症状。激发后40 min采血制备血清,ELISA检测血清IgE,组胺含量,并结合反应症状结果综合评价药物致敏性。结果:各组豚鼠致敏期间无异常反应,激发后综合判定致敏性,丹参滴注液、丹参精制液为可疑,辅料组为阴性。结论:丹参滴注液在除去大分子成分后,其余成分仍可能导致机体出现过敏反应。Objective: To compare the anaphylactoid effect of Danshen injection and its components on guinea pig. Method: Applying active systemic anaphylaxis (ASA) tests, the corresponding experimental injections were administrated to guinea pigs to sen- sitized, and allergen with double doses was injected to stimulate in the 11 days after the last sensitized. The anaphylaxis situation of guinea pigs was observed. Result: Danshen injection and its components are suspicion on guinea pigs, while negative reaction was ob- served on guinea pigs which injected by the liquid excipients of Danshen injection. Conclusion: Danshen injection using the ultrafiltra- tion method still have some antigenic impurities which cannot be removed completely, and this may be one of the reasons for anaphylac- tic reaction.
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