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人类辅助生殖技术用液中铵离子含量影响因素分析

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目的 为人类辅助生殖技术(ART)用液产品中铵离子含量的控制及储存条件提供参考。方法 选择市场上 6 个厂家 17 批不同作用的ART用液,使用离子色谱法测定铵离子含量,并分析储存温度和储存时间对铵离子含量的影响。结果 货架有效期内,冷冻液套装、解冻液套装、培养液、处理液中铵离子含量分别为 0。89~3。34 μg/mL,0。88~4。68 μg/mL,0。75~1。45 μg/mL,0。38~3。89 μg/mL。胚胎培养液中铵离子含量,37℃储存时30d内从0。9μg/mL升至3。1μg/mL,4℃储存时240 d内从0。6μg/mL升至 1。7 μg/mL。结论 不同作用ART用液中铵离子含量存在差异,且与产品的储存温度、储存时间呈正相关。在进行货架有效期制订时,应考虑产品中铵离子含量。
Analysis of Factors Affecting the Content of Ammonium Ions in Fluids for Assisted Reproductive Technology
Objective To provide a reference for the control of ammonium ion content and storage of fluids for assisted reproductive technology(ART).Methods Seventeen batches of ART fluids with different functions from six manufacturers on the market were selected,the ion chromatography(IC)method was used to determine the ammonium ion content,and the effects of storage temperature and storage time on the ammonium ion content were analyzed.Results During the shelf-life,the ammonium ion contents of refrigerant kit,thawing fluid kit,medium and handling fluids were in the range of 0.89 to 3.34 μg/mL,0.88 to 4.68 μg/mL,0.75 to 1.45 μg/mL,0.38 to 3.89 μg/mL respectively.The content of ammonium ions in embryo culture fluids increased from 0.9 μg/mL to 3.1 μg/mL stored at 37℃within 30 d,and from 0.6 μg/mL to 1.7 μg/mL stored at 4℃within 240 d.Conclusion The contents of ammonium ions in ART fluids with different functions are diverse,and they are positively correlated with the storage temperature and storage time of the products.The ammonium ion content in the products should be considered when formulating the shelf-life.

assisted reproductive technologyfluid production chromatographyammonium ioncontent determinationquality controlstorage temperaturestorage time

管瑞芹、赵丹妹、姜爱莉、柯林楠、王召旭

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中国食品药品检定研究院,北京 102629

烟台大学,山东 烟台 264005

人类辅助生殖技术 液体类产品 离子色谱法 铵离子 含量测定 质量控制 储存温度 储存时间

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(12)