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中华医学会肠外肠内营养学分会药学协作组. 规范肠外营养液配制[J]. 协和医学杂志, 2018, 9(4): 320-331. doi: 10.3969/j.issn.1674-9081.2018.04.007
引用本文: 中华医学会肠外肠内营养学分会药学协作组. 规范肠外营养液配制[J]. 协和医学杂志, 2018, 9(4): 320-331. doi: 10.3969/j.issn.1674-9081.2018.04.007
Pharmacy Cooperative Group. Consensus for Parenteral Nutrition Solutions Compounding[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(4): 320-331. doi: 10.3969/j.issn.1674-9081.2018.04.007
Citation: Pharmacy Cooperative Group. Consensus for Parenteral Nutrition Solutions Compounding[J]. Medical Journal of Peking Union Medical College Hospital, 2018, 9(4): 320-331. doi: 10.3969/j.issn.1674-9081.2018.04.007

规范肠外营养液配制

doi: 10.3969/j.issn.1674-9081.2018.04.007
详细信息
    通讯作者:

    梅丹 电话:010-69156514,E-mail:meidanpumch@163.com

  • 中图分类号: R459.3

Consensus for Parenteral Nutrition Solutions Compounding

More Information
  • 摘要: 国内不同地区、不同医院肠外营养混合液处方组成和配制方法差别较大。为改善国内肠外营养液配制认知、减少不当配制、降低患者相关风险, 中华医学会肠外肠内营养学分会药学协作组组织专家, 按目前中国当前实际情况及国际上发表的研究结果及循证医学证据, 结合配制方面有关专家的经验, 形成《规范肠外营养液配制》专家共识, 为国内肠外营养液配制的规范化和标准化提供推荐意见。
  • 表  1  肠外营养液组成成分

    药物类别 上市品种
    碳水化合物 葡萄糖注射液
    脂肪乳 脂肪乳注射液、中/长链脂肪乳、结构脂肪乳、ω-3鱼油脂肪乳、多种油脂肪乳
    氨基酸 复方氨基酸注射液(3AA、6AA、9AA、15HBC、18AA、20AA等)、小儿复方氨基酸、丙氨酰谷氨酰胺
    电解质 氯化钾注射液、氯化钠注射液、葡萄糖酸钙注射液、氯化钙注射液、硫酸镁注射液、门冬氨酸钾镁注射液、甘油磷酸钠注射液、复合磷酸氢钾注射液
    微量营养素 水溶性维生素、脂溶性维生素、复合维生素、多种微量元素
    灭菌注射用水(或通过0.9%氯化钠、5%葡萄糖、葡萄糖氯化钠注射液等补充)
    下载: 导出CSV

    表  2  各功能室洁净度级别要求

    各功能室 GMP ISO 悬浮粒子最大允许数(m3)
    ≥0.5 μm ≥5 μm
    一次更衣室 D级(静态) 8 3 520 000 29 000
    洗衣洁具间 D级(静态) 8 3 520 000 29 000
    二次更衣室 C级(静态) 7 352 000 2 900
    配制间 C级(静态) 7 352 000 2 900
    层流洁净工作台 B级(静态) 5 3 520 29
    GMP:药品生产质量管理规范; ISO:国际标准化组织
    下载: 导出CSV

    表  3  各功能室微生物限度要求

    各功能室 GMP ISO 微生物最大允许数
    沉降菌(φ90 mm)
    (cfu/0.5 h)
    浮游菌
    (cfu/m3)
    一次更衣室 D级 8 10 200
    洗衣洁具间 D级 8 10 200
    二次更衣室 C级 7 3 100
    配制间 C级 7 3 100
    层流洁净工作台 B级 5 1 10
    GMP、ISO:同表 2
    下载: 导出CSV
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  • 收稿日期:  2018-06-27
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