利用欧洲药典方法评价国产重组人粒细胞集落刺激因子原液中的制品相关蛋白含量

目的：分析评价国产重组人粒细胞集落刺激因子原液中的制品相关蛋白含量，为《中华人民共和国药典》（简称《中国药典》）标准提高提供依据。方法：对比国际主流药典，选择其中最为通用的制品相关蛋白含量分析方法；用该方法对征集的国产重组人粒细胞集落刺激因子原液进行分析检测及结果判定。结果：欧洲药典（EP）所列方法最为通用，用该方法对12家生产企业的33批原液进行了检测；结果显示，5家企业的13批原液符合EP标准，其余厂家及批次不符合EP标准。结论：我国已有相当数量的重组人粒细胞集落刺激因子产品符合EP的制品相关蛋白含量标准，可以考虑将该方法纳入新版《中国药典》，以促进该制品质量的提高并与国际接轨。

Objective: To analyze and evaluate the content of product related proteins in the bulk of recombinant human granulocyte colony-stimulating factor produced in China,and also to provide the basis for improving the standard of Chinese Pharmacopoeia. Methods: After a comparison of the international primary pharmacopoeias,the most commonly used method was selected to analyze the content of product related proteins in the collected samples. Results: The method in European Pharmacopoeia (EP) is the most general method,and it was used to analyze the 33 lots of bulk produced by 12 manufacturers. Results showed that 13 lots of bulk produced by five manufacturers met the EP standard,and the rest of samples were not in conformity with it. Conclusion: In China, there are a considerable number of recombinant human granulocyte colony stimulating factor products that meet the EP standard. It is reasonable to incorporate the EP method into the new version of Chinese Pharmacopoeia in order to improve the quality of the products and to integrate with international standard.

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