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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 ampicillin hydrochloride injection and provide a scientific basis for its production, packaging, storage, transport conditions and the validity period. Methods According to the “Technical Guiding Principles of Drug Stability Study” and the quality standard of Anshuxingsun Hydrochloride Injection, the influencing factors test, accelerated test and long-term test were carried out. Results In the influencing factors test, accelerated test and long-term test conditions, no significant changes in the indicators of the sample. Conclusion The stability of ampicillin hydrochloride injection is good, the validity period can be tentatively scheduled for two years.