注射用灯盏花素主动全身过敏反应评价指标的探索

Exploration on Evaluation of Active Systemic Anaphylaxis Induced by Breviscapine Injection

目的观察豚鼠及大鼠对注射用灯盏花素诱导的主动全身过敏反应(ASA)的表现,增加与过敏反应相关指标的检测,探索从多层次、多方面评价中药注射剂潜在的过敏性。方法将Hartley豚鼠及BN大鼠分别随机分为卵蛋白(OVA)组、注射用灯盏花素组、阴性对照组,给予相应的药物或生理盐水,进行ASA实验,观察药物激发后30 min动物ASA。取肺组织HE染色观察病理改变。采用放免法检测BN大鼠在致敏前、致敏第18日以及激发后血清总IgE水平的变化。结果对Hartley豚鼠或BN大鼠,OVA组均呈现阳性过敏反应症状,注射用灯盏花素组则为阴性。肺组织病理切片显示,OVA组或灯盏花素组肺组织血管周围均有明显淋巴细胞浸润等免疫病理表现。与阴性对照组或药物致敏前比较,OVA组或灯盏花素组大鼠给药后血清总IgE水平显著升高(P<0.05或P<0.01)。结论增加不同品种动物及指标,能更全面评价注射用灯盏花素的潜在致敏性。

Objective To set up multiple criterions of active systemic anaphylaxis（ASA） induced by Breviscapine and other traditional Chinese medicine injections by observing ASA of guinea pigs and rats.Methods Hartley guinea pigs or BN rats were randomly divided into OVA group,Breviscapine injection group and negative control group.Animals were injected with different drugs or saline at 0.5 mL each on the first,third,fifth day and repeated on nineteenth day.The usual systemic symptoms of ASA test were observed within 30 min after the last injection.The lung tissue pathological examination was performed with HE staining.Serum IgE levels were determined before,18 days and 19 days after the first injection by radioimmunoassay.Results Hartley guinea pigs or BN rats in OVA group showed positive systemic allergy symptoms,while Breviscapine injection group demonstrated negative symptoms.However,pathological changes of the lung tissue with perivascular lymphocyte infiltration and higher levels of serum IgE were found both in OVA group and Breviscapine group of guinea pigs or BN rats（P〈0.05,P〈0.01）.Conclusion The multiple criterions of evaluation with different animal species and increased observation targets for the potential ASA detection induced by Breviscapine injection are more comprehensive and acceptable.