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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 study the quality control method of establishing polyI: C12U injection. Methods: The RP-HPLC method was used to determine the base ratio. The enhancement effect, the maximum absorption wavelength, OD250 / OD260 and OD280 / OD260 of the samples were determined by UV-Vis absorption spectroscopy. Molecular weight range; the remaining items were determined by the three Chinese Pharmacopoeia. Results: The quality test method was established. The ratio of base to base C / U was 15.8, I / C was 1.11, the enhancement effect was 63.5%, the maximum absorption wavelength was 263 nm, OD250 / OD260 was 0.98, OD280 / OD260 of 0.60; relative molecular mass distribution in the range of 100 ~ 1000bp. The rest of the indicators are in line with the provisions. Conclusion: The established test methods and quality standards provide a good foundation for effectively controlling the quality of misplaced double-stranded polynucleotide injection.