目的   比较西林瓶和预灌封注射器包装灭菌注射用水的稳定性和相容性。方法 采用2种包装形式各连续生产3批灭菌注射用水，根据《国家药包材标准》和中国药典2015年版二部的相关要求，同时对西林瓶和预灌封装灭菌注射用水进行稳定性和相容性的加速试验研究。 结果   2种包装形式各3个批次的灭菌注射用水，所有项目的检测均符合相关要求。西林瓶（pH值：6.1~6.7，电导率：4~7 μS/cm）和预灌封注射器装灭菌注射用水（pH值：6.1~6.7，电导率：1~5 μS/cm）同期结果差别较小，所测物质的迁移水平均在安全范围内，玻璃制品无显著脱片现象。 结论   预灌封注射器对灭菌注射用水稳定性和相容性的影响与西林瓶包装相似，可作为灭菌注射用水的包装材料。

Objective  To compare the stability and compatibility of sterilized water for injection packaged in penicillin bottle and prefilled syringes. Methods  Three batches of sterilized water for injection were continuously produced with two packaging forms, respectively. The products were assessed for accelerated stability and compatibility according to standards in National Standards for Pharmaceutical Packaging Materials and Chinese pharmacopeia 2015 (VolumeⅡ). Results  All test items of six batches of sterilized water for injection met the requirements. Products in forms of penicillin bottle（pH：6.1~6.7，comducttivity：4~7 μS/cm ）and prefilled syringes （pH：6.1~6.7，comducttivity：1~5 μS/cm ）showed similar results. The migration levels of substances tested were all within the safe range, and there was no significant delamination of glass materials. Conclusion  Sterilized water for injection in prefilled syringes has similar stability and compatibility with that in penicillin bottle, thus prefilled syringes can be used as packaging materials for sterilized water for injection.