清开灵注射液类过敏反应特点及致敏物质初步筛选研究

Pseudoallergic reaction characteristics of Qingkailing injection and preliminary screening of allergic substances

采用小鼠类过敏实验模型,研究清开灵注射液（Qingkailing injection,QKLI）的类过敏反应特点以及影响其类过敏反应的因素,并对其致敏物质初步筛选。结果显示,不同品系的小鼠（ICR,昆明,BALB/c,C57）在静脉注射QKLI后产生的类过敏反应有所不同,其中ICR和昆明小鼠的类过敏反应较BALB/c,C57强。用生理盐水配制的QKLI较5%葡萄糖注射液配制的QKLI诱导ICR小鼠产生的类过敏反应更强。当其剂量为临床2倍剂量时,部分批号QKLI可诱发明显或可疑类过敏反应,当剂量降低至临床等倍剂量时,所有批号QKLI均不诱发小鼠类过敏反应。不同批号的QKLI诱发的小鼠类过敏反应程度有所不同。因此QKLI的类过敏反应发生可能与机体不同体质有一定联系。不同溶媒可能影响QKLI的安全性。QKIL诱发类过敏反应具有批间差异性。另外临床使用时也应严格控制剂量。最后通过比较QKLI中不同成分和中间体诱发的小鼠类过敏反应,初步认为致类过敏物质可能主要存在于中间体板蓝根提取物和栀子提取物中。

This study aimed to explore the characteristics and the influencing factors of Qingkailing injection（QKLI） pseudoallergic reaction,and screen out the possible pseudoallergenic substances.The results showed that ICR and Kunming mice had stronger pseudoallergic reactions than BALB/c and C57 mice after being injected with the same dose of QKLI.The pseudoallergic reaction induced by QKLI that was prepared with 0.9% saline was stronger than that prepared with 5% glucose.When the dose was twice of the clinical dose,some batches of QKLI could cause significant or suspected pseudoallergic reactions;when the dose dropped to clinically equal times,all of the batches did not induce pseudoallergic reactions in mice.Different batches of QKLI induced different pseudoallergic reactions in mice.Therefore,QKLI＇s pseudoallergic reactions might have a certain relationship with different body constitutions.Different solvents might affect the safety of QKLI.QKIL-induced pseudoallergic reactions had the different characteristics between batches,and the dosage should be strictly controlled in clinical use.After the comparison of pseudoallergic reactions induced by different components and different intermediates of QKLI in mice,it was preliminary believed that pseudoallergenic substances might exist in intermediate Isatidis Radix extracts and Gardenia extracts,but specific pseudoallergens shall be furthered studied in subsequent experiences.