错位双链聚核苷酸注射液的质控方法研究

Quality control methods for mismatched double-stranded polynucleotide injection

目的:研究建立错位双链聚核苷酸(polyI:C12U)注射液的质控方法。方法:采用反相高效液相色谱(RP-HPLC)法测定碱基比例;采用紫外吸收光谱法测定样品的增色效应、最大吸收波长、OD250/OD260和OD280/OD260;采用琼脂糖电泳法测定相对分子质量范围;其余项目按中国药典三部进行测定。结果:建立了该产品的质量检测方法,测得样品的碱基比例C/U为15.8,I/C为1.11;增色效应为63.5%,最大吸收波长为263 nm,OD250/OD260为0.98,OD280/OD260为0.60;相对分子质量分布在100～1000bp范围内。其余各项指标均符合规定。结论:建立的检验方法和质量标准为有效地控制错位双链聚核苷酸注射液的质量奠定良好基础。

Objective：To establish the quality control methods for mismatched double-stranded polynucleotide（poly I：C12U） injection.Methods：The base ratio of poly I：C12U was determined by a reverse phase HPLC（RP-HPLC） method.The hyperchromicity,maximum absorption wavelength,OD250/OD260 ratio and OD280/OD260 ratio was analyzed by ultraviolet absorption spectrometry.The molecular weight range was determined using agarose gel electrophoresis method.Other tests were done according to the ChP.Results：Quality test methods of the product were established.When base ratio of the sample was tested,C/U ratio was 15.8,and I/C ratio was 1.11.The hyperchromicity was 63.5%,maximum absorption wavelength was 263 nm,OD250/OD260was 0.98,and OD280/OD260was 0.60.The molecular weight range distributed in 100-1000 bp.The remaining tests all conformed to its specification.Conclusion：The established test methods and quality standard lay a good foundation to effectively control the quality of poly I：C12U.