大鼠皮肤类过敏试验评定标准的探讨

Evaluation criteria for rat skin anaphylactoid test

该研究通过对大鼠皮肤类过敏试验各项特征指标的研究,选定同只动物给药部位皮肤蓝斑OD与对照部位皮肤蓝斑OD比值(K)作为新的评定标准。并以有临床类过敏反应报道的常用造影剂、中药注射剂和注射剂原料药或辅料为受试药物进行大鼠皮肤类过敏试验,以对K进行界定:K>2为类过敏反应阳性;1.2≤K≤2为类过敏性可疑;K<1.2为类过敏反应阴性。以此标准对受试药物的类过敏性进行评定。评定结果与经典标准的评定结果进行比较,以考察K的适用性。比较结果显示,以K作为大鼠皮肤类过敏试验的评定标准,可更真实地反映皮肤蓝染的实际情况,同时将因动物个体因素造成的误差降到最低。其阳性、可疑、阴性3级标准相对蓝斑直径阳性、阴性2级标准,具有更为客观、准确的特点,建议尝试选择K作为药物致大鼠皮肤类过敏反应的评定标准。

This study is to explore characteristic indexes in evaluation criteria for rat skin anaphylactoid test comparing skin blue spot OD values at the treated position and the control position in the same animal. Common contrast agents,traditional Chinese medicine injections and injections＇ active pharmaceutical ingredients or excipients in the existing clinical anaphylactoid reaction reports were taken as test drugs in the rat skin anaphylactoid test to define the K value： K〉2 represents positive anaphylactoid reaction,1. 2≤K≤2 represent doubtable anaphylactoid; K〈 1. 2 represents negative anaphylactoid reaction,which were taken as the criteria for evaluating anaphylactoid of tested drugs. The evaluation result and that for classic criteria were compared to study the applicability of K value. According to the comparison,K value,as the evaluation criteria in the rat skin anaphylactoid test,can more truly reflect the actual situation of skin aizen and minimize the error caused by animal individual factors. Compared with positive and negative two-level criteria for blue spot diameter,K value＇s positive,doubtable and negative three-level criteria are more objective and accurate. Therefore,K value can be used as the evaluation criteria in the rat skin anaphylactoid test.