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目的 :建立阿奇霉素凝胶的制备及质量控制方法。方法 :用卡波姆 940作凝胶基质制备阿奇霉素凝胶。进行了酸碱度及卫生学、稳定性、透皮吸收、皮肤刺激性等试验及含量测定。结果 :pH值 6 .5～ 7.5 ,卫生学检查符合规定 ,凝胶稳定无变化无刺激性 ,含量测定平均回收率为 1 0 0 .7%。结论 :本方法设计合理 ,稳定性好 ,可满足临床需要
Objective: To establish the method of preparation and quality control of azithromycin gel. METHODS: Azithromycin gels were prepared using carbomer 940 as a gel matrix. Conducted the pH and hygiene, stability, transdermal absorption, skin irritation and other tests and content determination. Results: The pH values ranged from 6.5 to 7.5. Hygienic examination accorded with the regulations. The gel was stable and non-irritating. The average recovery was 100.7%. Conclusion: The method is reasonable in design and good in stability to meet clinical needs