荧光染色法测定生物制品中DNA残留量的研究

摘要

目的：对荧光染色法测定生物制品中的 DNA残留量进行初步的研究和分析，确定该方法用于 DNA质量控制的可行性。方法依据《中国药典》2010年版三部附录ⅨB《外源性DNA残留量测定法》之荧光染色法。结果该方法的线性、重复性、回收率均能满足生物制品中DNA残留量检测的要求，如果用作生物制品行业适用的检测方法，应制备统一的DNA标准品。结论该方法具有简便、快速、可定量分析等优点，可基本满足生物制品行业对DNA残留量质量控制的要求。%OBJECTIVE Preliminary research and analysis of fluorescence staining method for the determina-tion of residual DNA in biological products , determine the feasibility of this method used in the quality control of DNA.METHODS According to the Chinese Pharmacopoeia 2010 edition three appendix IX B the exogenous DNA residues determination by fluorescent staining method .RESULTS The method was linear ,repeatability and recovery rate can meet the biological products in residual DNA detection requirements ,if used as the test methods applicable in biological products industry ,should prepare a unified standard DNA .CONCLUSION The method has the ad-vantages of simple ,rapid and quantitative analysis ,and it can basically meet the requirements of the quality control of residual DNA in the biological products industry .