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目的：通过对眼用诺氟沙星毫微粒的形态、大小及分布，载药性质，体外释药性质，初步稳定性和安全性的考察，对其质量进行评价。方法：以透射电镜和激光粒度分析仪考察形态性质；紫外分光光度法测定包封率和载药量；动态透析法考察体外释药性质；通过药物含量及卫生学指标变化评价其稳定性；眼刺激试验考察其刺激性。结果与结论：毫微粒大小均匀、外形圆整、不粘连，平均粒径dav=553um，包封率=90．14％，载药量=22．70％；体外释药性质符合双相动力学规律；室温放置3月药物含量无变化，卫生学指标符合规定；眼刺激试验经单次、多次给药，证实对眼无刺激性。
OBJECTIVE: To assess the quality of norfloxacin nanoparticles by investigating the morphology, size, distribution, drug-loading properties, in vitro release properties, initial stability and safety of norfloxacin nanoparticles. METHODS: Morphological properties were examined by transmission electron microscopy and laser particle size analyzer. The encapsulation efficiency and drug loading were determined by ultraviolet spectrophotometry. The dynamic drug-dialysis method was used to investigate the drug release properties in vitro. The stability of the drug was evaluated by the change of drug content and hygienic index. Irritation test examines its irritation. RESULTS AND CONCLUSION: The nanoparticle size was uniform, the shape was round, non-blocking, the average particle size dav = 553um, encapsulation efficiency = 90.14%, drug loading = 22.70% The results showed that there was no change in the drug content at room temperature in March, and the hygienic indexes were in conformity with the regulations. The eye irritation test was given once and repeatedly and proved to be non-irritating to eyes.