盐酸安妥沙星注射液的稳定性试验

Stability Testing of Antofloxacin Hydrochloride Injection

目的考察盐酸安妥沙星注射液的稳定性,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》和盐酸安妥沙星注射液的质量标准,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。结论盐酸安妥沙星注射液的稳定性较好,有效期可暂定为两年。

Objective To investigate the stability of Antofloxacin Hydrochloride Injection 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-tern testing. Results Under the conditions of the stress testing, accelerated testing and long-term testing, there were no obvious changes of all quality indexes. Conclusion Antofloxacin Hydrochloride Injection has good stability under the experimental conditions. The period of validity can be tentatively set for two years.