摘要
目的:探讨含多肽类药物的检验方法。方法:采用乙腈/水(含0.19％TFA)多肽淋洗系统分析了脑活素注射液的肽谱,进而用PICO-TAG氨基酸分析法分析了该药品水解前、后总氨基酸含量,两者的差值即为肽的含量。结果:本法结果可靠,专属性强。结论:试验结果反映了该药品的内在质量,为脑活素的全面质控提供了可靠的方法依据。
Objective: Discovering analytical method of the peptides. Method: The peptides map of Cerebrolysin was studied by using CH_3CN/H_2O(including 0.1％ TFA) peptides elution system, The to tal conteuts of amino acids in Cerebrolysin before hydrolysis, after hydrolysis were determined by Waters Pico Tag amino acid analysis system, The balance of theirs is the content of peptides. Result: The result is applicable for the production and the quality control of Cerebrolysin. Conclude: The result reflects Cerebrolysin quality, The method may be used to Cerebrolysin analysis.
出处
《中国药品标准》
CAS
2000年第2期47-49,共3页
Drug Standards of China
