目的考察国药集团兰州生物制药有限公司人血白蛋白与其内包装材料的相容性。方法采用4种提取溶剂对1批内包装材料(中硼硅玻璃模制注射剂瓶和注射液用卤化丁基橡胶塞)进行提取试验,对内包装潜在的浸出物进行毒理学评估。通过模拟加速试验...目的考察国药集团兰州生物制药有限公司人血白蛋白与其内包装材料的相容性。方法采用4种提取溶剂对1批内包装材料(中硼硅玻璃模制注射剂瓶和注射液用卤化丁基橡胶塞)进行提取试验,对内包装潜在的浸出物进行毒理学评估。通过模拟加速试验,对样品中的元素进行趋势分析以及玻璃瓶内表面观察;并测定长期稳定性试验过程药物常规检查项目。结果内包装材料浸出元素检出结果均≤50%的限值,有机物安全阈值(margin of safety,MOS)均>1.0,表明浸出元素及有机物在当前的暴露量下均不会对使用者有安全风险。模拟加速试验结果表明药品在长期稳定性条件放置一段时间后不会有脱片风险,长期稳定性试验药物常规检查项目均符合药典要求。结论内包材对药品质量无明显影响,总体相容性良好,可用于人血白蛋白的包装。展开更多
A new method for determination of 2,6-ditertbutyl-p-cresol in medical rubber plug by gas chromatography/mass spectrometry was developed.Analytical method and extraction conditions were optimized. Retention time and ma...A new method for determination of 2,6-ditertbutyl-p-cresol in medical rubber plug by gas chromatography/mass spectrometry was developed.Analytical method and extraction conditions were optimized. Retention time and mass spectra of total ion chromatography were used for qualitative analysis. The m/z 205 was quantitative ion for BHT by gas chromatography/mass spectrometry/selected ion storage. The method is simple, rapid and accurate. The detection limit of BHT was 0.01mg/L,the recovery was 90.18~96.64% and the RSD(n=7) was 1.34%.展开更多
文摘在管道封堵机器人中大变形橡胶筒是实现密封的核心部件,其在使用中常出现密封失效和撕裂失效等问题.为了明晰上述原因和解决问题,本文中研究了不同橡胶材料以及不同橡胶筒轴向长度、径向长度和倾斜边角等结构参数对管道封堵机器人的静态密封特性影响.基于橡胶材料的高弹性和大变形特性,进行了橡胶筒的多阶段变形力学分析.对橡胶材料进行单轴拉伸压缩试验,得到橡胶材料的本构关系参数.建立管道封堵机器人橡胶筒密封特性分析的有限元计算模型,通过多因素分析方法,获得橡胶筒关键结构参数的最优方案.并设计了室内试验来进一步确定最优橡胶筒材料.研究结果表明集中在橡胶筒肩部的应力直接影响橡胶筒的形变损伤.经过橡胶筒的密封效果对比分析后得出最优的橡胶筒结构为轴向长度180 mm、径向厚度55 mm、倾斜边角28°,橡胶材料硬度为85 HA.
文摘目的考察国药集团兰州生物制药有限公司人血白蛋白与其内包装材料的相容性。方法采用4种提取溶剂对1批内包装材料(中硼硅玻璃模制注射剂瓶和注射液用卤化丁基橡胶塞)进行提取试验,对内包装潜在的浸出物进行毒理学评估。通过模拟加速试验,对样品中的元素进行趋势分析以及玻璃瓶内表面观察;并测定长期稳定性试验过程药物常规检查项目。结果内包装材料浸出元素检出结果均≤50%的限值,有机物安全阈值(margin of safety,MOS)均>1.0,表明浸出元素及有机物在当前的暴露量下均不会对使用者有安全风险。模拟加速试验结果表明药品在长期稳定性条件放置一段时间后不会有脱片风险,长期稳定性试验药物常规检查项目均符合药典要求。结论内包材对药品质量无明显影响,总体相容性良好,可用于人血白蛋白的包装。
文摘A new method for determination of 2,6-ditertbutyl-p-cresol in medical rubber plug by gas chromatography/mass spectrometry was developed.Analytical method and extraction conditions were optimized. Retention time and mass spectra of total ion chromatography were used for qualitative analysis. The m/z 205 was quantitative ion for BHT by gas chromatography/mass spectrometry/selected ion storage. The method is simple, rapid and accurate. The detection limit of BHT was 0.01mg/L,the recovery was 90.18~96.64% and the RSD(n=7) was 1.34%.