摘要
目的 研究法莫替丁氯化钠注射液的稳定性及其贮存期。方法 以HPLC法测定法莫替丁及其有关物质的含量 ,分别用加速实验法、室温留样观察法和强光照射法对法莫替丁进行稳定性实验。结果 法莫替丁的含量随温度的升高和时间的延长逐渐下降 ,但有关物质的含量均小于 2 %。加速实验法结果 :温度 4 0℃ ,湿度 75 %条件下 ,法莫替丁氯化钠放置 1个月、3个月和 6个月时 ,法莫替丁的含量依次为标示量的 10 1.9%、10 1.3%和 10 1.2 %。室温留样观察法 :法莫替丁氯化钠注射液放置 1年含量为 10 0 .8%。强光照射法 :在 4 5 0 0Lx光照下第 1d、第 5d和第 10d法莫替丁的含量依次为标示量的 10 2 .6 %、10 2 .1%和 10 1.3%。结论 3种实验方法测得的数据基本一致。法莫替丁氯化钠注射液的有效期可暂定为
Aim To study the stability and expiration of famotidine sodium chloride injection.Methods The contents of famotidine and its related substances were determined by means of HPLC.The samples were tested by accelerating experiment,room temperature storage and strong light exposure experiment, respectively.Results The content of famotidine was slowly reduced while temperature rising and time prolonging.The content of related substances was smaller than 2%.The content of famotidine was 101.9%,101.3% and 101.2% at the end of the 1st,3rd and 6th month respectively at 40℃ and the humidity 75% with accelerating experiment.Its content was 100.8% for 1 year under room temperature storage.Its content was 102.6%?102.1% and 101.3% at the end of the 1st,5th and 10th day respectively at 4500Lx light with accelerating experiment.Conclusion The data obtained from the three experiments were similar,so that famotidine sodium chloride injection may be stored for 1 year at room temperature.
出处
《解放军药学学报》
CAS
2002年第2期83-85,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
