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研制一种以纳米乳为载体的新型罗红霉素制剂。通过伪三元相图确定最佳配方;通过温度、光稳定性、加速离心、HPLC试验考察其稳定性;通过粒度测定仪测定其粒径分布;通过体外抑菌试验考察其药效。罗红霉素纳米乳由乙酸乙酯、Tween-80、乙醇、罗红霉素、蒸馏水组成;各种稳定性试验证实纳米乳体系稳定;平均粒径10.6 nm;对金黄色葡萄球菌、无乳链球菌、副鸡嗜血杆菌MIC值分别为≤0.125、≤0.125和4μg/mL。结果表明,罗红霉素纳米乳是一种质量稳定、抑菌效果好的药物传递系统。
Development of a new type of roxithromycin nanoemulsion carrier. Through the pseudo-ternary phase diagram to determine the best formula; by temperature, light stability, accelerated centrifugation, HPLC test to investigate the stability; particle size distribution analyzer to determine its distribution; antibacterial test in vitro efficacy. Roxithromycin nanoemulsion is composed of ethyl acetate, Tween-80, ethanol, roxithromycin and distilled water. The stability of the nanoemulsion system is confirmed by various stability tests; the average particle size is 10.6 nm; for Staphylococcus aureus, Streptococcus, Haemophilus paragallinarum MIC values were ≤ 0.125, ≤ 0.125 and 4μg / mL. The results showed that roxithromycin nanoemulsion is a kind of drug delivery system with stable quality and good antibacterial activity.