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复方环丙沙星注射液的稳定性研究
李引乾1, 黄勇旗1, 吴秋侠1
西北农林科林科技大学 动物医学院
摘要:
[目的]为复方环丙沙星注射液的临床应用提供科学依据.[方法]以272 nm为测定波长,紫外分光光度法测定复方环丙沙星注射液中盐酸环丙沙星的含量.进行光加速试验和经典恒温热加速试验,计算药物降解10%的时间,即药物有效期.[结果]复方环丙沙星注射液对光不稳定.经计算求得室温25 ℃,时复方环丙沙星注射液的分解速率常数K为9.9×10-8 min-1,其分解10%的时间为2.025年.[结论]复方环丙沙星注射液在避光、室温条件下贮存的有效期为2年.
关键词:  复方环丙沙星注射液  紫外分光光度法  稳定性  有效期
DOI:
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基金项目:
Studies on sability of Compound Ciprofloxacin Injection
Abstract:
【Objective】 Stability of the Compound Ciprofloxacin Injection was observed and its period of validity was determined so as to supply scientific proof to the clinical application of the preparation.【Method】 The content of Ciprofloxacin Hydrochloride in Compound Ciprofloxacin Injection was measured by Uv-Vis at 272 nm.Light stability experiments and classical heat stability experiments were taken.The time that content of the preparation was decomposed that of the initial 10% is period of validity of the preparation.【Result】 The Compound Ciprofloxacin Injection is unstable to light.The resoluble rate constant K is 9.9×10-8 min-1 at room temperature(25 ℃),and the content of Ciprofloxacin Hydrochloride in Compound Ciprofloxacin Injection was reduced that of the initial 10% is 2.025 years.【Conclusion】 The period of validity of the Compound Ciprofloxacin Injection is 2 years stored under room-temperature (25 ℃) without light.
Key words:  Compound Ciprofloxacin Injection  UV-Vis  stability  period of validity