注射用兰索拉唑与0.9%氯化钠注射液的配伍变化  

Compatibility of Lansoprazole for Injection with 0.9% Sodium Chloride Injections

作　　者：张萍萍[1] 李秋影[1] 扈文礼[1] 高声传[1] 隋因[1] 史国兵[1] 

机构地区：[1]沈阳军区总医院药剂科,沈阳110840

出　　处：《中国药师》2014年第6期1054-1057,共4页China Pharmacist

摘　　要：目的：探讨注射用兰索拉唑与0.9％氯化钠注射液配伍液分别在室温、光照、4 ～8℃条件下放置不同时间溶液的变化.方法：模拟临床用药,参照2010年版《中国药典》,对五厂家生产的15批次注射用兰索拉唑与0.9％氯化钠注射液100 ml配伍后在三种条件下放置,对兰索拉唑含量、pH、澄清度和不溶性微粒数进行测定,对含量、pH采用SAS软件进行统计分析.结果：五厂家15批次的注射用兰索拉唑配伍溶液在三种条件放置8h后含量均在90％以上;pH随时间逐渐减小,8h均能维持在pH 9左右;室温光照条件下配伍溶液8h出现浑浊;10 μm和25μm微粒数4h内基本符合《中国药典》要求.结论：注射用兰索拉唑临床上可按说明书配伍使用,但建议与0.9％氯化钠注射液配伍后放置在阴凉处并尽快使用.Objective：To investigate the compatibility of lansoprazole for injection with 0.9% sodium chloride injections under the conditions of room temperature,light and 4-8℃.Methods：The solutions of lansoprazole for injection of 15 batches from five manufacturers in 100 ml 0.9% sodium chloride injections were prepared by simulating the drug concentration in the clinical use and stored under the experimental conditions.The content,pH value,clarity and insoluble particles were detected by the methods specified in ChP （2010 edition）,and the results were statistically analyzed by SAS software.Results：The content of the solutions were above 90% after the 8-hour storage under the conditions.The pH value was decreased slightly with time went by and could maintain approximately 9 after the 8-hour storage.The solutions became turbid after the 8-hour storage under light.The 10μm and 25μm particles were within the acceptable range specified in ChP （2010 edition） in 4 hours under the conditions.Conclusion：Lansoprazole for injections can be used according to the instructions.The solution of lansoprazole for injection in 0.9% sodium chloride injections should be stored in cool place and used up as soon as possible.

关 键 词：注射用兰索拉唑 配伍 含量 澄清度 不溶性微粒 

分 类 号：R942[医药卫生—药剂学]