pH值对注射用雷贝拉唑钠有关物质影响的研究

Study on the Influence of pH Value to the Related Substance of Rabeprazole Sodium for Injection

目的 研究p H值对注射用雷贝拉唑钠有关物质的影响。方法 将雷贝拉唑钠溶液和冻干制剂进行强制加热破坏,采用高效液相色谱法测定各处方有关物质的含量,并以此作评价指标进行p H值筛选。结果 p H值在11.50~13.00范围内,雷贝拉唑钠溶液p H值越高溶液越稳定;而将样品冻干后,p H值在12.00~12.25时样品最稳定。结论 注射用雷贝拉唑钠冻干制剂并非碱度越大越稳定,其适宜的p H值为12.00~12.25,本研究可为该制剂p H值的选择提供科学依据。

OBJECTIVE To study on the influence of pH value on the related substances of Rabeprazole Sodium for Injection. METHODS HPLC was adopted to measure the related substance content of rabeprazole sodium solution and its lyophilized preparation treated by forced heat damage, and it was as an evaluation index for pH value screening. RESULTS In the range of pH value 11.50 - 13.00, it was more stable with the increasing of pH value of rabeprazole sodium solution. The most stable pH value was 12.00 - 12. 25 with respect to its lyophilized preparation. CONCLUSION It wasn＇t more stable with the increasing of alkalinity of Rabeprazole Sodium for Injection. Its suitable pH value was 12.00 - 12.25. This study provided the scientific basis for pH screening of Rabeprazole Sodium for Injection.