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目的:建立甘精胰岛素国家对照品。方法:用质谱测定分子量、HPLC法肽图鉴别及测定纯度。结果:以氮含量、纯度扣除法以及外标法结果综合考虑,最终确定首批甘精胰岛素国家对照品的含量为93.7%。即每1mg含甘精胰岛素0.937mg。结论:建立的甘精胰岛素国家对照品可用于国内同类药物的研究和检定以及该进口药品的质控
Objective: To establish insulin glargine national standard. Methods: The molecular weight was determined by mass spectrometry. The peptide map was identified by HPLC and the purity was determined. Results: Based on the nitrogen content, the deduction of purity and the results of external standard method, the content of the first national standard of insulin glargine was 93.7%. That is, each mg of insulin glargine 0.937mg. Conclusion: The established insulin glargine reference substance can be used for the research and verification of similar drugs in the country and the quality control of imported drugs