法莫替丁氯化钠注射液的研制及临床疗效观察  

Preparation and Clinical Therapeutic Efficacy of Famotidine Sodium Chloride Injection

作　　者：文爱东[1] 毛幼桦[2] 赵磊[1] 杨志福[1] 蒋永培[1] 

机构地区：[1]第四军医大学西京医院药剂科,西安市710032 [2]陕西省人民医院药剂科,西安市710032

出　　处：《中国药房》2002年第2期84-86,共3页China Pharmacy

摘　　要：目的 :研制法莫替丁氯化钠注射液。方法 :以门冬氨酸为助溶剂 ,以生理盐水为溶媒制备法莫替丁氯化钠注射液。用HPLC法测定法莫替丁及其有关物质的含量 ,同时考察其稳定性和影响因素 ,并观察其临床疗效。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。加速实验法 :40℃条件下 ,法莫替丁氯化钠注射液放置6mo时 ,法莫替丁的含量为98 6 % ;室温留样观察法 :法莫替丁氯化钠注射液放置1y,法莫替丁的含量为98 4 % ;强光照射法 :在4500Lx光照下d10法莫替丁含量为98 5 % ,但有关物质的含量均小于2 %。法莫替丁氯化钠注射液临床总有效率为93 75 %。结论 :法莫替丁氯化钠注射液性质稳定 ,临床应用简便 ,无污染 。OBJECTIVE:To prepare famotidine sodium chloride injection METHODS:The famotidine sodium chloride injection was prepared with aspartic acid as solutizing agent and sodium chloride injection as solvent The contents of famotidine and its related substances were determined by means of HPLC Influencing factor and the stability of famotidine were studied and the therapeutic effect was observed RESULTS:The content of famotidine was slowly reduced while temperature rising and time prolongine The content of famotidine was 98 6% at the end of the 6th month at 40℃ with accelerating experiment Its content was 98 4% after one year storage under room temperature Its content was 98 5% at the 10th day after illumination with 4 500Lx light in accelerating experiment The content of related substances was less than 2% The total effective rate was 93 75% CONCLUSION:Famotidine sodium chloride injection was stable in property and had definite therapeutic effect,and its clinical application was simple and free from contamination

关 键 词：法莫替丁 氯化钠注射液 制备 临床应用 疗效观察 

分 类 号：R975.6[医药卫生—药品]