CAJ | 학술논문

目的对注射用兰索拉唑与4种常用输液配伍的稳定性进行研究，研究对象采用该品种原研企业日本武田公司与江苏奥赛康药业股份有限公司生产的产品共3批。方法将两个厂家生产的注射用兰索拉唑与4种输液按临床应用配伍，在室温条件下，观察溶液颜色及pH值并采用HPLC法测定配伍后12h内不同时间点的含量及有关物质。结果结合注射用兰索拉唑临床使用方法，在室温条件下，注射用兰索拉唑与0.9%氯化钠溶液配伍后，6h内颜色无变化，pH值可维持在较高的水平，含量＞99.3%高于其他配伍溶液，有关物质在1%以下低于其他配伍溶液。结论临床使用注射用兰索拉唑时，最好与0.9%氯化钠配伍使用，在6h内使用完毕。
목적대주사용란색랍서여4충상용수액배오적은정성진행연구，연구대상채용해품충원연기업일본무전공사여강소오새강약업고빈유한공사생산적산품공3비。방법장량개엄가생산적주사용란색랍서여4충수액안림상응용배오，재실온조건하，관찰용액안색급pH치병채용HPLC법측정배오후12h내불동시간점적함량급유관물질。결과결합주사용란색랍서림상사용방법，재실온조건하，주사용란색랍서여0.9%록화납용액배오후，6h내안색무변화，pH치가유지재교고적수평，함량＞99.3%고우기타배오용액，유관물질재1%이하저우기타배오용액。결론림상사용주사용란색랍서시，최호여0.9%록화납배오사용，재6h내사용완필。
Objective To evaluate the compatibility of lansoprazole for injection totally 3 batches from Jiangsu Aosaikang Pharmaceutical Co., Ltd and Takeda Pharmceutical Company Limited with four kinds of infusion solution. Methods Lansoprazole for injection from two different company were compounded with four infusion solutions respectively. The stability of the mixture was then characterized in respect of the color, clarity, pH and concentration at room temperature for 12h by HPLC. Results Combined with the clinical application of lansoprazole for injection, at room temperature, lansoprazole for injection in normal saline solution was colorless for 6h, pH could maintain a high level, the contend was more than 99.3%, which was higher than other compatibility solution and the related substance was lower than 1%,which was also lower than other compatibility solution. Conclusion Lansoprazole for injection had better compound with normal saline solution and use in 6h.