乳糖酸阿奇霉素缓释阴道栓的研制

Preparation lactose-azithromycin sustained release suppository

目的:制备乳糖酸阿奇霉素缓释阴道栓。方法:以硬脂酸聚烃氧酯(S-40)为基质,羟丙基甲基纤维素(HPMC)为缓释材料采用热熔法制备栓剂,建立了性状、鉴别、含量测定等质控方法,并进行了稳定性试验、黏膜刺激性试验。结果:以硫酸呈色分光光度法测定乳糖酸阿奇霉素的含量平均回收率为99.60%,RSD为1.96%(n=9),栓剂稳定,无变化,黏膜刺激性小。结论:该制剂制备工艺可行,性质稳定,测定方法简便准确。

OBJECTIVE To prepare lactose-azithromycin sustained release suppository. METHODS Using S-40 as stroma and using HPMC as sustained release material to prepare suppository with fusion method. To establish the quality standard including appearance identification and assay. The stability test and the irritation test were conducted. RESULTS The spetrophotometry of sulfuric acid visual ization was used for the assay. The average recovery was 99.60% （1.96%）. The suppository was stable with little irritation of mucous. CONCLUSION The preparation of suppository is feasible. The quality is stable and testing method is accurate.