摘要
目的测定注射用核糖核酸中核糖核酸的分子量及其分布。方法采用分子排阻色谱-多角度激光散射联用技术,以含0.02%叠氮钠的0.1 mol·L-1氯化钠溶液为流动相,流速0.5 m L·min-1,采用TSKgel G2000SWXL色谱柱,柱温为30℃。结果获得了样品的dn/dc值、分子量与分子量分布等分子特征参数。测得样品dn/dc值为0.1547,分子量（Mw）在4.6-234.2 k Da,分子量分布系数（Mw/Mn）在1.3-2.9。结论本文尝试以新的思路建立测定生物大分子核糖核酸分子量的方法,该方法快速、简便,可用于核酸类药物分子量及其分布的测定。实际样品检测结果表明,市售的注射用核糖核酸的分子量及分布差异均较大,原料及生产工艺有待进一步规范,加强质量控制。
Objective To determine the molecular weight and molecular distribution in ribonucleic acid for injection. Methods A size exclusion chromatography was performed on a TSKgel G2000 SWXL column maintained at 30 ℃ with the refractive index detector and muti-angle laser light scatter. Na Cl（0.1 mol·L-1） in 0.02% sodium azide（Na N3） aqueous solution was used as the mobile phase and the flow rate was 0.5 m L·min-1. Results Molecular characteristic parameters such as specific refractive index increment（dn/dc）, weight-average molecular weight（Mw） and polydispersity（Mw/Mn） were obtained. The dn/dc value was 0.1547. The Mw of the samples were between 4.6-234.2 k Da, with the Mw/Mn range at 1.3-2.9. Conclusion This method can determine the absolute molecular weight and distribution in ribonucleic acid directly and rapidly without molecular calibrants, and provide a new means to characterize nucleic acid drugs. Big difference is seen in the molecular weight and distribution among products from different manufacturers, the indicating the need for further improvment and standardization in quality.
作者
张再平
吴小曼
张锐
王玉
ZHANG Zai-ping WU Xiao-man ZHANG Rui WANG Yu(Jiangsu Institute for Food and Drug Control, Nanjing 210008 Jiangxi University of Traditional Chinese Medicine, Nanchang 330004)
出处
《中南药学》
CAS
2016年第11期1241-1244,共4页
Central South Pharmacy
关键词
注射用核糖核酸
分子量
分子量分布
多角度激光光散射
分子排阻色谱法
ribonucleic acid for injection
molecular weight
molecular distribution
muti-angle laser light scatter
size exclusion chromatography
