硝酸益康唑纳米微乳气雾剂的稳定性试验

Stability Testing of Econazole Nitrate Microemulsion Aerosol

目的：考察硝酸益康唑微乳气雾剂的稳定性，为其生产、包装、贮藏运输条件以及制订有效期提供科学依据。方法：根据《药物稳定性研究技术指导原则》和硝酸益康唑微乳气雾剂的质量标准，对该品进行影响因素试验、加速试验和长期试验。结果：在影响因素试验、加速试验和长期试验条件下．样品的各项指标均无明显变化。结论：硝酸益康唑微乳气雾剂的稳定性较好，有效期可暂定为两年。

Objective ：To investigate the stability of Econazole Nitrate Microemulsion Aerosol to provide scientific basis for its production ,packaging,storage and transportation conditions,and formulate and the period of validity. Methods ：According to the principles referring to the drug stability and its quality standard ,we carried out the stress testing ,accelerated testing and long-term testing. Results ：Under the conditions of the stress test- ing,accelerated testing and long-term testing,there were no obvious changes of all quality indexes. Conclusion Econazole Nitrate Microemulsion Aerosol has good stability under the experimental conditions. The period of validity can be tentatively set for two years.