20140709(定稿)玻璃酸钠及制剂分子量与分子量分布测定方法研究.docxVIP

修改内容：4.小结中的2个“分子量”改为“分子质量”。其它未修改。玻璃酸钠及制剂分子质量与分子质量分布测定方法研究*宋玉娟，李颖颖，范慧红**(中国食品药品检定研究院，北京 100050)摘要目的:分析玻璃酸钠(SH)及制剂分子质量和分子质量分布测定不同模式的特点，重点研究折光指数增量(dn/dc值)、对照品等对测定结果的影响。方法:采用凝胶色谱法(SEC)，色谱柱为ShodexSB806HQ(300 mm×8 mm)，流动相为0.2 moL·L-1的氯化钠溶液(含0.02％叠氮化钠)，流速为0.5mL?min-1，柱温为35℃，进样量100μL，检测采用2种方法，单一示差折光检测器及采用示差折光检测器和激光光散射仪(MALLS)联用。结果:玻璃酸钠及制剂相对分子质量和绝对分子质量测定结果存在约30%的误差，dn/dc值、对照品等对测定结果产生一定影响。结论:凝胶色谱示差折光检测法和凝胶色谱激光光散射联用法，2种方法均可用于玻璃酸钠及制剂分子质量控制。关键词：玻璃酸钠(SH)；分子质量；分子质量分布;凝胶色谱法(SEC)；凝胶色谱激光光散射联用法(SEC-MALLS)；折光指数增量(dn/dc)中图分类号：R917 文献标识码：A 文章编号：0254-1793(2014)08Determination of molecular weight and molecular weight distribution of sodium hyaluronate and its preparations*SONG Yu-juan, LI Ying-ying, FAN Hui-hong**(National Institutes for Food and Drug Control, Beijing 100050，China)Abstract Objective: To analyze the different determination modes of molecular weight and molecular weight distribution of sodium hyaluronate(SH) and its preparations, especially the influence of dn/dc value and standards on the determination results. Methods: UsingSEC method，samples were analyzed on aShodexSB806HQ column(300 mm×8 mm)，the mobile phase was 0.2 moL?L-1 sodium chloride(containing 0.2％sodium azide) at a flow rate of 0.5mL?min-1, the injection was 100μL, the column temperature was 35 °C, and the signals were detected by RI detector (used by SEC method) or RI coupled with MALLS detectors(used by SEC-MALLS method). Results: The results showed that there were about 30% differences between the molecular weight and molecular weight distribution results determined by SEC-RI and SEC-MALLS methods, and thedn/dcvalue and standards had certain influences on the determination results. Conclusion:SEC-RI and SEC-MALLS methods could both be used for quality control of SH and its preparations. Key words: sodium hyaluronate(SH); molecular weight; distribution of molecular weight;size exclusion chromatography(SEC)；size exclusion chromatography–multi angle laser light scattering(SEC－MALLS)；refractive index incre