摘要
向来自2个厂家的药用玻璃容器中加入含或不含乙二胺四乙酸(EDTA)的0.9%氯化钾溶液,灭菌(121℃、1 h)后进行加速试验(60℃贮存30 d)。在不同时间点取样,通过目检、微粒分析、测定硅离子浓度、扫描电镜观察等手段,考察介质对药用玻璃容器可能形成脱片的影响。同时,考察玻璃内表面耐水性测定结果 [照美国药典(USP)操作]是否与玻璃形成脱片的风险相关。结果表明,含EDTA的介质对2个厂家的玻璃容器内表面均产生了不同程度的侵蚀。耐水性测定结果不能成为预测玻璃容器发生脱片风险的指标。
Different extraction media [0.9% KC1 solution with or without edetate （EDTA）] were added into pharmaceutical glass containers provided by two manufacturers. After sterilization （121 ℃, 1 h） and accelerated test （stored at 60 ℃ for 30 d）, the effect of media on delamination propensity of pharmaceutical glass containers was investigated with the results of visual inspection, particle analysis, determination of Si ion concentration and scanning electron microscopy as indexes. Meanwhile, the hydrolytic resistance test of inner surface according to US pharmacopoeia （USP） was also performed to investigate whether there was a correlation between the results of hydrolytic resistance determined with the USP method and evidence of delamination. The results showed that the EDTA-containing medium caused different degrees of erosion of inner surface of vials provided by two manufacturers. The results of hydrolytic resistance test could not be used as indicators of the chemical durability of the glass containers.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2015年第3期293-298,共6页
Chinese Journal of Pharmaceuticals
关键词
加速试验
提取介质
EDTA
玻璃容器
玻璃脱片
耐受性
accelerated test
extraction medium
edetate
glass container
delamination
durability
