摘要
目的:预测盐酸洛美沙星滴耳剂有效期,用以扩大洛美沙星的临床应用,增加耳科用药。方法:采用紫外分光光度法测定制剂含量,用经典恒温法和Weibul概率法探讨其稳定性。结果:紫外分光光度法测定制剂含量平均回收率为99.80%,RSD为0.66%。经典恒温法预测本制剂在pH为5~6,25℃贮存时有效期为5.16年,Weibul概率法预测其有效期为4.98年。结论:紫外分光光度法测定盐酸洛美沙星滴耳剂快速简便,精密度好,可靠性高。在无阳光直射条件下室温贮存本制剂稳定性好。
OBJECTIVE: To predict the stability of lomefloxacin hydrochloride ear drops. METHODS: The drops were determined using UV spectrophotometry. Classical isothermal method and Weibull probability paper method were used to determine the stability of the ear drops. RESULTS: The average recovery of lomefloxacin from the ear drops was 99.80%, and the average relative standard deviation (RSD) was 0.66%. After using classical isothermal method and Weibull probability paper method, the shelf life of the lomefloxacin ear drops was 5.16 years and 4.98 years respectively. CONCLUSION: The analysis method of UV spectrometry was rapid and precise. Being stored away from direct sunlight, the stability of lomefloxacin ear drops is good.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1997年第5期284-287,共4页
Chinese Pharmaceutical Journal
关键词
盐酸洛美沙星
滴耳剂
稳定性
lomefloxacin hydrochloride, ear drops, stability