硼硅玻璃管制注射剂瓶内表面耐水性能评价与影响因素探究

Evaluation of Hydrolytic Resistance of Inner Surfaces of Injection Vials Made of Borosilicate Glass and Its Influencing Factors

目的考察我国硼硅玻璃管制注射剂瓶内表面耐水性能,探究其对药品质量的影响及其影响因素。方法测定58批样品内表面耐水性,通过相容性研究分析内表面耐水性对药品质量的影响,玻璃成分分析与扫描电镜法研究其影响因素。结果中硼硅玻璃管制注射剂瓶内表面耐水性均为HC1级,合格率100%,低硼硅玻璃管制注射剂瓶合格率97.4%,其中HC1级38.5%,HCB级58.9%。内表面耐水性能差会导致药品pH值升高,且更易发生玻璃脱片。玻璃组分碱金属氧化物含量偏高、二次成型过程碱硼相大量挥发、内表面处理为影响内表面耐水性的主要因素。结论我国中硼硅玻璃管制注射剂瓶内表面耐水性能较好,低硼硅玻璃管制注射剂瓶内表面耐水性参差不齐,性能差的样品存在与药品不相容的风险,建议企业优化产品配方、改进二次成型工艺参数以提升产品质量。

OBJECTIVE To investigate the hydrolytic resistance of the inner surfaces of injection vials made of borosilicate glass in China,and explore its influence on drug quality and its influencing factors.METHODS The hydrolytic resistance of the inner surfaces of 58 batches of samples were determined.The influence on drug quality was explored through compatibility study.The influencing factors were studied by glass composition analysis and scanning electron microscope.RESULTS The hydrolytic resistance of the inner surfaces of injection vials made of middle borosilicate glass was HC1 grade and the qualified rate was 100%.The qualified rate of injection vials made of low borosilicate glass was 97.4%,including HC1 grade accounting for 38.5% and HCB grade for 58.9%.The poor hydrolytic resistance of inner surfaces would lead to increase of the pH value of drugs and glass delamination.The main factors affecting the hydrolytic resistance of inner surfaces were the high content of alkali metal oxides in glass components,the volatilization of alkali boron phase during the secondary molding process and the treatment of inner surfaces.CONCLUSION The inner surfaces of the injection bottles made of middle borosilicate glass in China have good hydrolytic resistance.However,the hydrolytic resistance of injection bottles made of low borosilicate glass in China is uneven.The samples with poor performance are at risk of incompatibility with drugs.It is suggested that enterprises optimize product formula and improve secondary molding process parameters to improve product quality.