Abstract: Objective To establish a standard operating procedure (SOP) for the detection of TCMI allergic-like reactions in order to provide a reference for related testing. Methods By taking TCMI A, the effects of such factors as the gender and age of experimental animals, administration methods (vehicle, dosage, injection speed), laboratory temperatures, and batches of production on allergic-like reactions were investigated. The number of animals with scores of blue staining of ear auricles in each group was used to assess the severity of reactions. The Technical Specifications for Testing Anaphy-lactoid Reactions of Intravenous Traditional Chinese Medicine Injections and the Guidelines 9105: Principles for Bioactivity Testing of Traditional Chinese Medicine were referenced. Results At a laboratory temperature of 23-26°C and by using male juvenile and adult ICR mice as subjects, the test article was prepared immediately before use by mixing with Evans blue, and administered via tail vein injection at a rate of 0.2 mL per 10 seconds. Physiological saline or a 5% glucose solution served as both the vehicle and the negative control. This procedure could be adopted as a standard operating procedure (SOP) for testing TCMI A for allergic-like reactions. Conclusion An internal control standard for testing TCMI allergic-like reactions enables rapid detection of the reactions, which can contribute to quick identification, risk control and clinical safety.

Key words: Traditional Chinese Medicine Injection, Pseudo-Allergic Reaction, Methodological Study, Standard Operating Procedure(SOP), Mice