ICP法测定预灌封注射器中的可提取总钨量
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摘要
建立电感耦合等离子体发射光谱仪(ICP)法测定预灌封注射器(PFS)中钨的提取量和迁移量的方法。分别对提取溶剂(4%乙酸溶液、水和0.5%氨水溶液)、提取部位(不锈钢针头、针头连接玻璃尖端和整支注射器)和提取条件(高压灭菌和超声)进行考察,确定提取溶剂为0.5%氨水溶液,对整支注射器进行灌装提取且121℃高压灭菌1 h时,钨提取效率最高。用pH 4.0和pH 7.0乙酸铵缓冲液作为介质模拟迁移试验,测定迁移溶液中的钨含量。本研究建立的方法简单易行且准确可靠,可作为PFS中钨总量的测定方法。
An inductively coupled plasma spectrometry(ICP) method was established for the determination of tungsten which was extracted and migrated from prefilled syringes(PFS). The extraction solvents(4% acetic acid solution, water and 0.5% ammonia solution), extraction sites(stainless steel needle, needle connected with the glass tip and the whole syringe) and extraction conditions(sterilized in the autoclave and ultrasound) were investigated respectively. The results showed the efficiency of tungsten extraction was the highest when extracted with 0.5% ammonia solution to fill the whole syringe and sterilized at the condition of 121 ℃ for 1 h. The tungsten contents in the migration solutions were determined with pH 4.0 and pH 7.0 ammonium acetate buffer as the media for migration test. The method was simple, feasible, accurate, reliable and suitable for the detection of tungsten in PFS.
An inductively coupled plasma spectrometry(ICP) method was established for the determination of tungsten which was extracted and migrated from prefilled syringes(PFS). The extraction solvents(4% acetic acid solution, water and 0.5% ammonia solution), extraction sites(stainless steel needle, needle connected with the glass tip and the whole syringe) and extraction conditions(sterilized in the autoclave and ultrasound) were investigated respectively. The results showed the efficiency of tungsten extraction was the highest when extracted with 0.5% ammonia solution to fill the whole syringe and sterilized at the condition of 121 ℃ for 1 h. The tungsten contents in the migration solutions were determined with pH 4.0 and pH 7.0 ammonium acetate buffer as the media for migration test. The method was simple, feasible, accurate, reliable and suitable for the detection of tungsten in PFS.
引文
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[2]张广湘.重组人促红素注射液与预灌封注射器相容性研究[D].广州:华南理工大学硕士学位论文,2016.
[3] GERHARDT A, MCGRAW N R, SCHWARTZ D K, et al.Protein aggregation and particle formation in prefilled glass syringes[J]. J Pharm Sci, 2014,103(6):1601-1612.
[4] JONES L S, KAUFMANN A, MIDDAUGH C R, et al.Silicone oil induced aggregation of proteins[J]. J Pharm Sci, 2005,94(4):918-927.
[5] THIRUMANGALATHU R,KRISHNAN S,RICCI M S,et al. Silicone oil and agitation induced aggregation of a monoclonal antibody in aqueous solution[J]. J Pharm Sci,2009, 98(9):3167-3181.
[6] ADLER M. Challenges in the development of prefilled syringes for biologics from a fonnulationscientist's point of view[EB/OL].[2012-02-11]. https://www. americanpharmaceuticalreview. com.
[7]张广湘,蓝建华,徐苏华,等.ICP-MS测定预灌封注射器中的可提取钨[J].中国医疗器械杂志,2016, 40(2):137-139.
[8] RONK M, LEE H, FUJIMORI K, et al. Characterization of protein aggregating tungstates:electrospray mass spectrometry analysis of extracts from prefilled syringes and from tungsten pins used in the manufacture of syringes[J].PDA J Pharm Sci Tech, 2016, 70(1):51-61.
[9] MORANDOTTI A, SWIFT R. Nexa注射器-苛刻产品的最佳选择[J].医药包装,2015, 38(2):38-42.
[10] SEIDL A, HAINZL O, RICHTER M, et al. Tungsten induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity[J].Pharm Res, 2012, 29(6):1454-1467.
[2]张广湘.重组人促红素注射液与预灌封注射器相容性研究[D].广州:华南理工大学硕士学位论文,2016.
[3] GERHARDT A, MCGRAW N R, SCHWARTZ D K, et al.Protein aggregation and particle formation in prefilled glass syringes[J]. J Pharm Sci, 2014,103(6):1601-1612.
[4] JONES L S, KAUFMANN A, MIDDAUGH C R, et al.Silicone oil induced aggregation of proteins[J]. J Pharm Sci, 2005,94(4):918-927.
[5] THIRUMANGALATHU R,KRISHNAN S,RICCI M S,et al. Silicone oil and agitation induced aggregation of a monoclonal antibody in aqueous solution[J]. J Pharm Sci,2009, 98(9):3167-3181.
[6] ADLER M. Challenges in the development of prefilled syringes for biologics from a fonnulationscientist's point of view[EB/OL].[2012-02-11]. https://www. americanpharmaceuticalreview. com.
[7]张广湘,蓝建华,徐苏华,等.ICP-MS测定预灌封注射器中的可提取钨[J].中国医疗器械杂志,2016, 40(2):137-139.
[8] RONK M, LEE H, FUJIMORI K, et al. Characterization of protein aggregating tungstates:electrospray mass spectrometry analysis of extracts from prefilled syringes and from tungsten pins used in the manufacture of syringes[J].PDA J Pharm Sci Tech, 2016, 70(1):51-61.
[9] MORANDOTTI A, SWIFT R. Nexa注射器-苛刻产品的最佳选择[J].医药包装,2015, 38(2):38-42.
[10] SEIDL A, HAINZL O, RICHTER M, et al. Tungsten induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity[J].Pharm Res, 2012, 29(6):1454-1467.