ABSTRACT
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.