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目的:研究阿奇霉素缓释阴道栓的局部刺激性和急性毒性,旨在为该制剂用于临床提供理论依据。方法:根据临床推荐用药方案计算新西兰兔的阴道给药量和疗程。末次给药后24h处死动物,解剖取出阴道组织进行肉眼观察和病理组织检查;新西兰兔一日内阴道给予大剂量阿奇霉素缓释阴道栓(140mg·kg-1.d-1),观察给药后2周内动物的情况。结果:新西兰兔连续阴道给予阿奇霉素缓释阴道栓7d,食欲、精神和活动正常;病理组织检查发现阿奇霉素缓释阴道栓组和基质空白栓组均未出现黏膜层细胞坏死脱落及固有层多量炎性细胞浸润现象。大剂量阿奇霉素缓释阴道栓给药后2周内无动物死亡。结论:阿奇霉素缓释阴道栓阴道局部用药无明显毒性及刺激性,其临床使用安全可靠。
Objective: To study the local irritation and acute toxicity of azithromycin sustained release vaginal suppository, aiming to provide a theoretical basis for the clinical application of this preparation. Methods: According to the clinical recommended dosage regimen New Zealand rabbit vaginal administration and treatment. The animals were sacrificed 24 h after the last administration, and the vaginal tissues were dissected out for visual observation and histopathology examination. New Zealand rabbits were given high dose azithromycin vaginally suppositories (140 mg · kg-1.d-1) Week animal situation. Results: New Zealand rabbits were given continuous vaginal administration of azithromycin for 7 days, their appetite, mental and activity were normal. Pathological examination showed no necrosis of mucosal cells and a large amount of inflammation in lamina propria Cell infiltration. No dose of azithromycin sustained release vaginal suppository within 2 weeks after the death of animals. Conclusion: Azithromycin vaginal suppository vaginal vaginal administration without obvious toxicity and irritation, its clinical safe and reliable.