超清版 GB/T 44209-2024 纳米技术 多聚糖超顺磁氧化铁溶液铁含量测量 电感耦合等离子体发射光谱法
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资料介绍
ICS 07.120
CCS L 04
中华人民共和国国家标准
GB/T 44209—2024
纳米技术 多聚糖超顺磁氧化铁溶液
铁含量测量 电感耦合等离子体
发射光谱法
Nanotechnologies—Measurement of iron content in polysaccharide coated super﹘
paramagnetic iron oxide solution—Inductively coupled plasma atomic emission
spectrometry
2024-07-24 发布2025-02-01 实施
国家市场监督管理总局
国家标准化管理委员会发 布
目 次
前言 ····································································································· Ⅲ
引言 ····································································································· Ⅳ
1 范围 ·································································································· 1
2 规范性引用文件 ······················································································ 1
3 术语和定义 ··························································································· 1
4 测量原理 ······························································································ 2
5 仪器、器具与试剂 ···················································································· 2
6 溶液配制 ······························································································ 2
7 测量步骤 ······························································································ 3
8 结果计算 ······························································································ 4
9 不确定度分析 ························································································· 4
10 测量报告 ···························································································· 4
附录A （资料性） 多聚糖超顺磁氧化铁溶液铁含量的测量及不确定度分析示例 ····················· 5
参考文献 ·································································································· 8
前 言
本文件按照GB/T 1.1—2020《标准化工作导则 第1 部分：标准化文件的结构和起草规则》的规
定起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。
本文件由中国科学院提出。
本文件由全国纳米技术标准化技术委员会（SAC/TC 279）归口。
本文件起草单位：东南大学、南京大学、正大天晴药业集团股份有限公司、苏州科技大学。
本文件主要起草人：顾宁、朱金蕾、陆成晖、张喜全、陈智林、孙兴华、陈博、张宇、陆颖琪、
沈艳。
引 言
多聚糖超顺磁氧化铁是由高生物相容性的多聚糖修饰于纳米氧化铁表面形成的具有超顺磁性的纳米
颗粒。其灭菌水溶液已在包括磁共振成像、磁致热疗、干细胞标记示踪等疾病诊疗领域开展了临床前以
及临床研究。此外，由于其具备极佳的生物安全性与磁响应性能，在生命科学、环境治理、工农业生产
等多个国计民生领域也得到了广泛应用。因此，深入研究多聚糖超顺磁氧化铁溶液的性能指标、建立高
效的测量方法与稳定的质量控制体系，将大力推动该类纳米药物的发展。
多聚糖超顺磁氧化铁溶液的铁含量是其质量控制体系中最为关键的一项指标。铁含量的精确测量直
接决定该类药物的使用剂量，进而影响包括补铁、磁共振成像、磁热治疗、模拟酶催化在内的多项医疗
效果。然而，不同于传统的小分子药物，该类溶液的铁含量测量受到自身纳米结构的影响，使用常规方
法难以实现精确的测量。因此，制定多聚糖超顺磁氧化铁溶液铁含量测量方法的国家标准对该类药物的
发展意义重大。
目前国内尚无针对多聚糖超顺磁氧化铁类纳米药物铁含量的测量标准。电感耦合等离子体发射光谱
法是金属元素（包括铁）测量的通用技术，为《中国药典》（2020 年版）所规定。为满足质量控制以及
医学新技术研究等需要，在原有药典方法基础上结合纳米技术进行了拓展与完善，特制定本文件。
1 范围
本文件描述了多聚糖超顺磁氧化铁溶液中铁含量的测量方法，包括测量原理，仪器、器具与试剂，
溶液配制，测量步骤，结果计算，不确定度分析和测量报告。
本文件适用于采用电感耦合等离子体发射光谱法对水溶液体系下氧化铁类纳米颗粒铁含量的测量。
2 规范性引用文件
下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文
件，仅该日期对应
CCS L 04
中华人民共和国国家标准
GB/T 44209—2024
纳米技术 多聚糖超顺磁氧化铁溶液
铁含量测量 电感耦合等离子体
发射光谱法
Nanotechnologies—Measurement of iron content in polysaccharide coated super﹘
paramagnetic iron oxide solution—Inductively coupled plasma atomic emission
spectrometry
2024-07-24 发布2025-02-01 实施
国家市场监督管理总局
国家标准化管理委员会发 布
目 次
前言 ····································································································· Ⅲ
引言 ····································································································· Ⅳ
1 范围 ·································································································· 1
2 规范性引用文件 ······················································································ 1
3 术语和定义 ··························································································· 1
4 测量原理 ······························································································ 2
5 仪器、器具与试剂 ···················································································· 2
6 溶液配制 ······························································································ 2
7 测量步骤 ······························································································ 3
8 结果计算 ······························································································ 4
9 不确定度分析 ························································································· 4
10 测量报告 ···························································································· 4
附录A （资料性） 多聚糖超顺磁氧化铁溶液铁含量的测量及不确定度分析示例 ····················· 5
参考文献 ·································································································· 8
前 言
本文件按照GB/T 1.1—2020《标准化工作导则 第1 部分：标准化文件的结构和起草规则》的规
定起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。
本文件由中国科学院提出。
本文件由全国纳米技术标准化技术委员会（SAC/TC 279）归口。
本文件起草单位：东南大学、南京大学、正大天晴药业集团股份有限公司、苏州科技大学。
本文件主要起草人：顾宁、朱金蕾、陆成晖、张喜全、陈智林、孙兴华、陈博、张宇、陆颖琪、
沈艳。
引 言
多聚糖超顺磁氧化铁是由高生物相容性的多聚糖修饰于纳米氧化铁表面形成的具有超顺磁性的纳米
颗粒。其灭菌水溶液已在包括磁共振成像、磁致热疗、干细胞标记示踪等疾病诊疗领域开展了临床前以
及临床研究。此外，由于其具备极佳的生物安全性与磁响应性能，在生命科学、环境治理、工农业生产
等多个国计民生领域也得到了广泛应用。因此，深入研究多聚糖超顺磁氧化铁溶液的性能指标、建立高
效的测量方法与稳定的质量控制体系，将大力推动该类纳米药物的发展。
多聚糖超顺磁氧化铁溶液的铁含量是其质量控制体系中最为关键的一项指标。铁含量的精确测量直
接决定该类药物的使用剂量，进而影响包括补铁、磁共振成像、磁热治疗、模拟酶催化在内的多项医疗
效果。然而，不同于传统的小分子药物，该类溶液的铁含量测量受到自身纳米结构的影响，使用常规方
法难以实现精确的测量。因此，制定多聚糖超顺磁氧化铁溶液铁含量测量方法的国家标准对该类药物的
发展意义重大。
目前国内尚无针对多聚糖超顺磁氧化铁类纳米药物铁含量的测量标准。电感耦合等离子体发射光谱
法是金属元素（包括铁）测量的通用技术，为《中国药典》（2020 年版）所规定。为满足质量控制以及
医学新技术研究等需要，在原有药典方法基础上结合纳米技术进行了拓展与完善，特制定本文件。
1 范围
本文件描述了多聚糖超顺磁氧化铁溶液中铁含量的测量方法，包括测量原理，仪器、器具与试剂，
溶液配制，测量步骤，结果计算，不确定度分析和测量报告。
本文件适用于采用电感耦合等离子体发射光谱法对水溶液体系下氧化铁类纳米颗粒铁含量的测量。
2 规范性引用文件
下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注日期的引用文
件，仅该日期对应