注射用兰索拉唑在木糖醇和果糖注射液中的配伍稳定性研究

目的考察注射用兰索拉唑在木糖醇和果糖注射液中的配伍稳定性。方法将临床常规剂量注射用兰索拉唑分别加入木糖醇和果糖注射液中,室温下放置6 h,观察外观,测定pH值及不溶性微粒数,并采用高效液相色谱法测定配伍后不同时间点溶液中兰索拉唑及有关物质含量。结果 6 h内2种配伍液的外观、pH值无明显改变,不溶性微粒数符合中国药典规定。木糖醇配伍液中兰索拉唑含量稳定,6 h时兰索拉唑含量仍有99.56%,有关物质含量<0.50%;果糖配伍液中兰索拉唑含量6 h时为95.01%,有关物质较木糖醇配伍液明显增多,2 h时为1.15%,6 h时达2.94%。结论室温状态下,注射用兰索拉唑与木糖醇注射液配伍较果糖注射液更加稳定,可在临床中应用。

Compatibility of lansoprazole in xylitol injection and fructose injection

Objective To investigate the compatibility of lansoprazole in xylitol injection and fructose injection. Methods A clinical routine dose of lansoprazole was added to xylitol injection or fructose injection and the mixtures were kept at room temperature respectively. High-performance liquid chromatography was used to determine the content of lansoprazole and the related substance in the fl uid at 0, 1, 2, 3, 4 and 6 h after the preparation. The appearance, pH value and insoluble particles were observed. Results In the 2 mixtures, no remarkable changes in the appearance were observed, pH value and the insoluble particles varied slightly. Lansoprazole was stable in xylitol injection, the content was 99.56% of the initial concentration 6 h after the drug was mixed, and the related substance was lower than 0.5%. The concentration of lansoprazole in fructose injection dropped to 95.01% of the initial concentration at 6 h; more related substance was found in xylitol injection, reaching 1.15% at 2 h and 2.94% at 6 h. Conclusion At room temperature, lansoprazole is compatible with xylitol injection, and it is more stable in xylitol injection than in fructose injection.