2018 年第 9 期 第 13 卷

国产和进口注射用雷贝拉唑钠在氯化钠输液中的稳定性比较

Quality stability evaluation of two rabeprazole sodium injections mixed with sodium chloride solution

作者：杨婷高申王卓张丽娟

英文作者：

单位：200433上海长海医院药材科

英文单位：

关键词：注射用雷贝拉唑钠；配伍稳定性；静脉输液

英文关键词：

• 摘要：

• 【摘要】目的    比较国产与进口2种注射用雷贝拉唑钠配制成静脉输液后的稳定性。方法    选择国产注射用雷贝拉唑钠（奥加明）与进口注射用雷贝拉唑钠（Rabicip），按照说明书中配制方法用100 ml 0.9%氯化钠注射液溶解，观察并比较2种溶液在不同放置条件下雷贝拉唑含量、有关物质（杂质）、pH值、溶液的澄清度与颜色及不溶性微粒随时间的变化。结果    在不同放置条件下，2种溶液的含量、pH值均随时间的变化出现一定程度的下降，但2种溶液间含量、pH值的变化差异均无统计学意义（均P＞0.05）；2种溶液的有关物质含量均随时间的变化呈增加趋势，但2种溶液间有关物质含量的变化差异均无统计学意义（均P＞0.05），奥加明溶液在各个条件下放置后不同时点的有关物质含量均低于Rabicip溶液；在25 ℃不避光条件下，奥加明溶液中＞10 μm不溶性微粒数明显少于Rabicip溶液（P＜0.05）；2种溶液在检测时间内均澄清，奥加明溶液的颜色变化小于Rabicip溶液。结论    国产注射用雷贝拉唑溶液的pH值略低于进口注射用雷贝拉唑溶液，更接近于人体可耐受的范围，可降低输液反应的发生风险；25 ℃不避光放置5 h，国产注射用雷贝拉唑溶液在有关物质、＞10 μm不溶性微粒数、溶液颜色变化方面均优于进口注射用雷贝拉唑溶液。

• 【Abstract】Objective    To compare the quality stabilities of two kinds of rabeprazole sodium injection for intravenous infusion. Methods    Domestic rabeprazole(Aojiaming) and imported rabeprazole(Rabicip) for injection were respectively dissolved by 100 ml sodium chloride solution according to the prepared methods in instructions. Changes of drug concentration, impurity substances, pH value, clarity, color and insoluble particles were observed in different rabeprazole solutions under different conditions. Results    Concentration of rabeprazole and pH value of the 2 solutions decreased with time, and there were no significant differences of the variation trends between them（P＞0.05）. Concentration of impurity substances increased with time, there was also no significant difference of variation trend of impurity between the two solutions（P＞0.05）. Concentrations of impurity substances in Aojiaming solution were lower than those in Rabici solution at different time points under different conditions（P＜0.05）. In 25 ℃ exposure-to-light condition, the number of ＞10 μm insoluble particles in Aojiaming solution was less than that in Rabicip solution(P＜0.05). Aojiaming solution showed less color change than Rabicip solution. Conclusions    Domestic rabeprazole for injection(Aojiaming) has a lower PH value than imported rabeprazole(Rabicip), the pH value of Aojiaming is more close to the tolerance range of human, which may reduce the risk of infusion reaction. After being placed in 25 ℃ exposure-to-light condition for 5 h, concentration of impurity substances, number of ＞10 μm insoluble particles and color change of Aojiaming solution are superior to those of Rabicip.