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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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垂体后叶注射液中主成分和杂蛋白谱的生物质谱研究

Profiling of key components and impurity proteins of posterior pituitary injection by mass spectrometry

分类号:
出版年·卷·期(页码):2014,34 (3):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:垂体后叶注射液是国家基本药物,其主成分为缩宫素和升压素。本品工艺简单,成分复杂而风险较大,对其主成分和杂蛋白谱进行分析,可为生产工艺监督提供新视角。方法:4个企业共77份样品用MALDI-TOF/TOF质谱进行主成分鉴定,还采用HPLC-Q-TOF质谱对垂体后叶国家标准品和4个企业杂蛋白进行了鉴定、相对含量与差异分析。结果:77份样品均检出缩宫素与猪源升压素,均未检出牛源升压素。标准品和样品中共鉴定到274个杂蛋白。企业2杂蛋白相对含量及种类存在显著变化。结论:MALDI-TOF/TOF测定可有效地用于本品的种属快速筛查。利用HPLC-Q-TOF获得4个企业的杂蛋白谱与相对含量结果,其中,杂蛋白相对含量的变化为药品的质量监督提供了新的分析视角。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: Posterior pituitary injection is one of the essential drugs in China. The key components of the injection are oxytocin and vasopressin. However,due to its high complexity of components and simple production process,this product is at high risk. Therefore,it is necessary to analyze the key components and impurity proteins,and the data will provide a new insight into the supervision of the production of posterior pituitary injection. Methods: MALDI-TOF/TOF was used to analyze the key components of 77 batches of samples from 4 different manufacturers. Impurity proteins of the national standard sample and the 77 batches of samples were profiled by HPLC-Q-TOF. Relative contents and differences of impurity proteins in samples from 4 manufacturers were revealed. Results: Swine vasopressin and oxytocin were detected in the 77 batches of samples,but bovine vasopressin was not detected. Moreover,a total of 274 proteins were identified from the tested samples of the standard and the 77 batches of products. Significant changes in the relative contents and variety of impurity proteins were observed in the samples from manufacturer No.2. Conclusion: As a high efficient tool,MALDI-TOF/TOF can be used for rapid species screening. Impurity protein and relative abundances dataset were obtained by HPLC-Q-TOF. Moreover,the change of relative contents of impurity proteins can serve as a powerful resource for the supervision of medicine quality.

-----参考文献:---------------------------------------------------------------------------------------
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[4] WANG Xiao-ping(王小平), RONG Rong(容蓉), TIAN Jing-zhen(田景振). Progress on analytical methods for polypeptide drugs(多肽类药物分析的研究进展)[J]. Food Drug(食品与药品), 2009, 11(9):55
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