摘要
本文对奥地利 EBEWE公司及国内8家药厂生产的脑活素类注射液的肽色谱图及分子量分布进行分析比较。结果表明,该产品的分子量都低于1万,其组成及分布情况各不相同。由此反映出各厂家工艺的不同,建议有关部门应组织统一的考察并制订出相应的质量标准。
In this article the peptide chromatograms and molecular weight distribution of Cerebrolysis Injection from the EBEWE CO in Austria and 8 domestic manufactures were analyzed and compared with. The result indicated that all the molecular weights were less than 10000,their composition and distribution were different. It has been shown that the technology used by those factories was different , so it is recommended that the relevant Units should organize unified inspection and formulate corresponding quality standard.