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目的:对清开灵注射液不良反应的物质基础进行初步研究,以探讨其机制。方法:获得发生临床不良反应批号的清开灵注射液。采用免疫接种激发和被动皮肤过敏反应实验,观察特异性免疫反应;SDS-PAGE凝胶电泳检测大分子蛋白,琼脂糖凝胶电泳检测大分子核酸,HPLC/MS判断药物分子量范围。结果:实验动物有药物毒性反应表现:立毛、抽搐、自主活动减少,甚至死亡;特异性免疫激发实验未产生特异性抗体;清开灵注射液药物成分的分子量小于2 kD,不含有蛋白质和核酸类大分子物质。结论:清开灵注射液易引发药物毒性反应;药物直接过敏实验无抗体产生表明清开灵注射液变态反应的过敏原很可能为半抗原类化合物。
Objective: To study the material basis of adverse reactions of Qingkailing injection to explore its mechanism. Methods: Qingkailing injection with clinical adverse reaction batch number was obtained. Immune challenge and passive cutaneous anaphylaxis tests were used to observe specific immune responses. Large-molecule proteins were detected by SDS-PAGE gel electrophoresis. Macromolecular nucleic acids were detected by agarose gel electrophoresis. The range of drug molecular weight was determined by HPLC/MS. RESULTS: The experimental animals had drug toxicity: hair growth, convulsions, decreased autonomic activity, and even death; specific immune challenge test did not produce specific antibodies; Qing Kai Ling injection drug component has a molecular weight of less than 2 kD and does not contain proteins and nucleic acids. Macromolecular substances. Conclusion: Qingkailing injection is prone to induce drug toxicity; no direct antibody allergy test results indicate that allergens of Qingkailing injection allergy are likely to be hapten compounds.