目的 考察皮内注射用卡介苗与其直接接触的包装容器的相容性，评估疫苗现用包装容器低硼硅玻璃安瓿的适宜性。方法 分别检测已包装的皮内注射用卡介苗在加速条件及长期规定储存条件下，疫苗及低硼硅玻璃安瓿的外观、安瓿中有毒有害金属离子（As、Sb、Pb、Cd） 迁移量、安瓿内表面脱片风险等，同时分析安瓿对疫苗质量的影响程度及安瓿是否被疫苗腐蚀受损。结果 3 批皮内注射用卡介苗在23~27 ℃放置 6个月，2～8 ℃放置30个月，安瓿中有毒有害金属离子迁移至疫苗中的量远低于安全限值，As迁移量为0.001~0.006 μg/支、Sb迁移量≤0.005 μg/支、Pb迁移量为0.028~0.080 μg/支、Cd迁移量为0.007~0.018 μg/支，低硼硅玻璃安瓿内表面被疫苗腐蚀脱片的风险较低。3批皮内注射用卡介苗在23~27 ℃放置6个月和2~8 ℃放置27个月，疫苗及低硼硅玻璃安瓿外观与0个月一致；关键质量检定结果水分为1.5%~-2.4%、渗透压摩尔浓度为342~378 mOsmol/kg、活菌数为（3.61~7.75）×10⁶  CFU/mg、效力为15~20 mm，均合格。结论 皮内注射用卡介苗与低硼硅玻璃安瓿发生相互作用的风险可接受，相容性良好，表明现用低硼硅玻璃安瓿是适宜的。

 Objective   To investigate the compatibility of packaging materials to BCG vaccine for intradermal injection and to evaluate the suitability of current low borosilicate glass ampoule container. Methods  After packaged BCG vaccines were stored under accelerated condition or long-time storage condition, the appearance of vaccines and low borosilicate glass ampoules were boserced,the release of harmful metal ions such as As, Sb, Pb and Cd from glass and the risk of ampoules inner surface adscission were evaluated,and the effect of ampoules on vaccine quality and containers corrsion by vaccine were analyzed. Results  After storage at 23-27 ℃ for 6 months and at 2-8 ℃ for 30 months,the content of harmful metal ions migrated from ampoules to vaccines were below safety limit,with As at 0.001~0.006 μg/vial,Sb≤0.005 μg/vial, Pb at 0.028~0.080 μg/vial, Cd at 0.007~0.018 μg/vial.The abscission risk of inner surface due to corrosion by the vaccine was low. The quality of 3 batches packaged vaccines storage at 23-27 ℃ for 6 months and at 2-8 ℃ for 27 months were qualified and the appearances of 3 batches of BCG vaccines and ampoules were consistent with those before storage,with moisture 1.5%-2.4%, osmotic pressure molar concentration 342-378 mOsmol/kg, living bactera of (3.61-7.75)×10⁶ CFU/mg, and effectiveness of 15-20 mm. Conclusion  The risk of interaction between BCG and low borosilicate glass ampoules is acceptable with good compatibility.,confirming that the current containers is suitable for BCG.