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预装式注射器与药物相容性的研究进展

刘小慧, 印晖, 严方, 狄斌

刘小慧, 印晖, 严方, 狄斌. 预装式注射器与药物相容性的研究进展[J]. 中国药科大学学报, 2016, 47(3): 275-281. DOI: 10.11665/j.issn.1000-5048.20160304
引用本文: 刘小慧, 印晖, 严方, 狄斌. 预装式注射器与药物相容性的研究进展[J]. 中国药科大学学报, 2016, 47(3): 275-281. DOI: 10.11665/j.issn.1000-5048.20160304
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LIU Xiaohui, YIN Hui, YAN Fang, DI Bin. Compatibility of pre-filled syringes with pharmaceutical products[J]. Journal of China Pharmaceutical University, 2016, 47(3): 275-281. DOI: 10.11665/j.issn.1000-5048.20160304
Citation: LIU Xiaohui, YIN Hui, YAN Fang, DI Bin. Compatibility of pre-filled syringes with pharmaceutical products[J]. Journal of China Pharmaceutical University, 2016, 47(3): 275-281. DOI: 10.11665/j.issn.1000-5048.20160304
shu

预装式注射器与药物相容性的研究进展

  • 1.

    中国药科大学药学院药物分析系

  • 2.

    江苏省医疗器械检验所

  • 3.

    中国药科大学药物质量与安全预警教育部重点实验室

基金项目: 国家自然科学基金资助项目(No.81202500)

Compatibility of pre-filled syringes with pharmaceutical products

摘要

    摘要
  • 摘要: 预装式注射器(PFS)包装的注射液作为一种药械组合产品，近几年得到了迅速的发展。但是，其包装材料与生物药物发生相互作用的可能性很高，因此，有关二者的相容性也成为研究热点。本文就PFS的可提取物和浸出物、安全性评价和相关分析方法等方面的研究进展进行了综述。
    Abstract: Pre-filled syringes are becoming increasingly popular for packaging and delivering system of pharmaceutical products. However, their compatibility with biotherapeutics needs to be carefully assessed. This review highlights and makes critically review on the extractables and leachables, the safety evaluation and analytical methods related to the compatibility study.
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    • 参考文献(50)
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  • 刊出日期:  2016-06-24

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