首页|静注人免疫球蛋白(pH4)内包装材料相容性考察

静注人免疫球蛋白(pH4)内包装材料相容性考察

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考察了静注人免疫球蛋白(pH 4)(1)与其内包装材料(中硼硅玻璃模制注射剂瓶和注射液用卤化丁基橡胶塞)的相容性.采用5种提取溶剂对内包装材料进行提取试验,并对可提取物进行毒理学风险评估.通过模拟加速试验,对样品中的Si、B、Al元素进行趋势分析,采用扫描电镜观察玻璃瓶内表面,预测注射剂瓶脱片情况,并测定1长期稳定性试验的常规检查项目.结果表明,内包装材料中的提取元素检出结果均小于控制阈值,有机物安全阈值均大于1.0,表明在当前的暴露量下,可提取物不会对使用者有安全风险.模拟加速试验结果预测,药品在长期稳定性条件放置36个月不会有脱片风险,长期稳定性试验结果显示药物常规检查项目均符合药典要求.上述结果说明内包装材料对药品质量无明显影响,总体相容性好,可用于1的内包装系统.
Material Compatibility of Human Immunoglobulin(pH 4)for Intravenous Injection
The compatibility of human immunoglobulin(pH 4)(1)for intravenous injection with its internal packaging materials(medium borosilicate glass molded injection bottle and halogenated butyl rubber plug for injection)was investigated.Five extraction solvents were used for the extraction test of the internal packaging materials and the toxicological risk assessment of the extracts was carried out.By simulating accelerated testing,trend analysis was conducted on Si,B,and Al elements in the samples.Scanning electron microscopy was used to observe the inner surface of the glass bottle in order to predict the detachment of the injection bottle.Meanwhile,the routine inspection items for long-term stability testing of 1 were determined.The results showed that the detection results of extracted elements from the inner packaging materials were all below the control thresholds,and the organic safety thresholds were all greater than 1.0.The results indicated that under the current exposure level,the extractable substances do not pose a safety risk to users.The simulation acceleration test results predicted that the drug will not have the risk of detachment after being stored under long-term stability conditions for 36 months.The long-term stability test results showed that all routine inspection items of the drug met the requirements of the pharmacopoeia.The internal packaging material has no significant impact on the quality of the drug and has good compatibility,which can be used for the internal packaging system of 1.

human immunoglobulin for intravenous injectionmedium borosilicate glass molded injection bottlehalogenated butyl rubber plug for injectioncompatibility

杨晓东、魏君慧、霍雨晨、崔岩、刘琛、谢楠

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国药集团兰州生物制药有限公司,甘肃兰州 730046

甘肃省药品检验研究院,甘肃兰州 730070

静注人免疫球蛋白 中硼硅玻璃模制注射剂瓶 注射液用卤化丁基橡胶塞 相容性

甘肃省药品监督管理局2021年药品安全监管专项"揭榜挂帅"项目甘肃省药品监督管理局2022年度科研计划项目

2021GSMPA0022022GSMPA0029

2024

10.16522/j.cnki.cjph.2024.09.013

中国医药工业杂志
上海医药工业研究院,中国化学制药工业协会

中国医药工业杂志

CSTPCD
影响因子：0.487
ISSN：1001-8255
年,卷(期)：2024.55(9)
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