Allergic test of azithromycin for injection in guinea pigs in non-clinical safety evaluation

doi:10.19803/j.1672-8629.20220377

Abstract

Abstract: Objective To evaluate the allergic test methods in non-clinical safety evaluation by investigating allergic reaction of guinea pigs induced by azithromycin for injection. Methods The active systemic anaphylaxis(ASA): Guinea pigs were randomly divided into negative control group, positive control group, low-dose group(2.5 mg·kg^-1) and high-dose group(10 mg·kg^-1) in experiment I．The intraperitoneal injections of azithromycin for injection were administrated to guinea pigs once every other day for three times. On the 14th and 21st days after the last sensitization, the symptom of allergic reaction was observed by intravenous administration of azithromycin for injection. The other methods were same as the experiment I, except the dose of high-dose group was set at 5 mg·kg^-1 in experiment II.The doses of passive cutaneous anaphylaxis (PCA) were as same as the ASA. On the 11th day after the last sensitization, antiserums were prepared. Guinea pigs of each group were injected intradermally by diluted antiserum. The blue spot diameter in skin was measured after intravenous administration of the same doses after 24 hours. Results No systemic allergic reaction was observed on guinea pigs administrated of azithromycin on the 14th day after the last sensitization in experiment I of ASA. The symptom of nose-scratching or wheezing sound was observed in high-dose group after intravenous administration of azithromycin on the 21st day in experiment I of ASA. No systemic hypersensitive reaction was observed both on the 14th and 21st days in experiment II of ASA. The positive reaction was observed in positive control group, while no allergic reaction was observed in the azithromycin administration group of PCA. Conclusion The occurrence of allergic reactions may be related with the dose and the sensitization time. The method has its own limitations. More focus may be given to the allergic test in non-clinical safety evaluation, because even if it meets the guiding principles, allergic reactions may also be caused.

Key words: azithromycin, injection, active systemic anaphylaxis, passive cutaneous anaphylaxis, allergic reaction, evaluation of the method

CLC Number:

R965

LIU Chun, WANG Jucai, HUANG Yuchang, YE Xiaoqing, ZHAO Yingshu, ZHAN Meimei, WANG Chen. Allergic test of azithromycin for injection in guinea pigs in non-clinical safety evaluation[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1161-1164.

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