[国产白蛋白溶液与国外同类产品质量的比较研究]
[Comparative study of the quality of domestic albumin solution and foreign analogs].
作者信息
Prokhorova N I, Galkin V V, Rusanov V M, Kuzmichev V A, Sarafanova L N, Khromova G M, Migunov V N, Pozina I M, Semenov M V, Ivanova V S
出版信息
Gematol Transfuziol. 1993 Jun;38(6):7-10.
The quality and standards of albumin solutions (5, 10 and 20%) made in this country meet the requirements of national specification documentation. This, however, lacks some standards included into European Pharmacopoeia and mandatory for foreign manufacturers (Na and K ions, hemipigments, polymers, thermostability). The comparative tests of the albumin solutions made in Russia and abroad by conventional European standards showed that Russian solutions by some parameters are inferior to foreign samples. This urges improvement of the solution production technology as well as updating technical documents regulating the product quality.
该国生产的白蛋白溶液（5%、10%和20%）的质量和标准符合国家规范文件的要求。然而，这缺乏一些纳入欧洲药典且对外商制造商具有强制性的标准（钠和钾离子、半色素、聚合物、热稳定性）。按照欧洲常规标准对俄罗斯和国外生产的白蛋白溶液进行的对比测试表明，俄罗斯的溶液在某些参数上不如国外样品。这促使改进溶液生产技术以及更新规范产品质量的技术文件。
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