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基于血红蛋白的血液替代品的质量控制。

Quality control of hemoglobin-based blood substitutes.

作者信息

Hsia J C, Er S S

机构信息

Biosciences Division, Defence and Civil Institute of Environmental Medicine, Downsview, Ontario, Canada.

出版信息

Biomater Artif Cells Artif Organs. 1988;16(1-3):105-11. doi: 10.3109/10731198809132560.

DOI:10.3109/10731198809132560
PMID:3179461
Abstract

Preparation and use of hemoglobin-based blood substitutes, from stroma-free hemoglobin (SFH or Hb) and its DPG analogue-modified derivatives (PLP-Hb, ATP-Hb etc.) without thorough characterization and quality control in animal or human testing have produced, and may continue to produce, artifacts in the finished product. Thus the development of such a natural substitute for the volume expansion and oxygen delivery functions of the blood will be impeded. A case is made for the use of affinity purified hemoglobin and modified hemoglobin as standard starting materials for the preparation of Hb-based blood substitute(s) in general, and in particular poly PLP-Hb. Development of a commercial scale blood-substitute is only possible after the safety and toxicity issues of substitutes have been resolved by applying rigorous quality control.

摘要

基于血红蛋白的血液替代品的制备与使用,若使用无基质血红蛋白(SFH或Hb)及其二磷酸甘油酸(DPG)类似物修饰的衍生物(PLP-Hb、ATP-Hb等),而在动物或人体试验中未进行全面表征和质量控制,已产生且可能继续在成品中产生假象。因此,这种用于血液容量扩充和氧气输送功能的天然替代品的开发将会受阻。有人主张,一般而言,应使用亲和纯化的血红蛋白和修饰血红蛋白作为制备基于血红蛋白的血液替代品的标准起始材料,尤其是聚PLP-Hb。只有在通过严格的质量控制解决了替代品的安全性和毒性问题之后,才有可能开发出商业规模的血液替代品。

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