注射用重组人生长激素中卤化丁基胶塞镁、钛元素的迁移研究

目的:建立电感耦合等离子发射光谱法(ICP-OES)法进行注射用重组人生长激素中卤化丁基胶塞镁、钛元素的迁移量测定方法。方法:采用ICP-OES法,测定波长为镁279.553 nm,钛336.122 nm。结果:镁、钛元素质量浓度在0.02~0.5 μg·mL^-1范围内,与发射强度均呈良好的线性关系,相关系数大于0.999 8,加标回收率介于90.2%~98.4%,RSD小于5.0%。5批样品倒置放置1周后镁元素迁移量含量为0.5~0.6 μg·支^-1,而钛均为未检出;正置样品,镁元素的含量均小于0.08 μg·支^-1,钛均为未检出。结论:本法经方法学验证,可用于镁、钛元素的迁移量测定。

Objective: To establish an ICP-OES method for the determination of Mg and Ti that migrate from the butyl rubber closures to recombinant human growth hormone for injection.Method:The ICP-OES method was adopted with the wavelength at 279.553 nm for Mg and 336.122 nm for Ti.Results: A good linear relationship was observed between the emission intensity of spectral line of both Mg and Ti and their concentrations in the range of 0.02-0.5 μg·mL^-1,and the correlation coefficients were all above 0.999 8.The average recoveries were between 90.2% and 98.4%,with RSD less than 5.0%.For 5 batches of samples,the leachable Mg were between 0.5 and 0.6 μg per vial after being placed upside down for one week,while the migration quantity were lower than 0.08 μg per vial after being placed upright for one week.The leachable Ti were not detected either after being placed upside down or upright for one week.Conclusion:The validation results show that the established method is suitable for determination of Mg and Ti migration.

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