3种方法测定玻璃酸钠的分子量比较

Comparison of Three Methods for Determining Molecular Weight of Sodium Hyaluronate

目的:比较3种方法测定玻璃酸钠注射液中玻璃酸钠分子量的结果。方法:采用黏度法测定玻璃酸钠注射液中玻璃酸钠的分子量,并采用体积排阻色谱法(SEC)及多角度激光光散射仪与体积排阻色谱法联用(MALLS-SEC)对其分子量及分子量分布(Mw/Mn)进行测定。结果:MALLS-SEC法与黏度法的测定结果较为接近,且同时可测定样品的Mw/Mn。3批样品分子量4次测定的平均值分别为991 962,1 007 438,990 232;RSD分别为6.5%,4.6%,2.2%(n=4)。分子量分布4次测定的平均值为1.6,1.6,1.6;RSD为7.2%,3.2%,3.2%(n=4)。结论:MALLS-SEC法测定准确度及精密度较好,可用于玻璃酸钠样品的质量控制。

Objective： To compare the molecular weight of sodium hyaluronate in the injection determined by three methods. Methods： Viscometry was used to determine the molecular weight of sodium hyaluronato. The molecular weight and its distribution （Mw/Mn） was measured by size exclusion chromatography （SEC） and the combination of multi-angle laser light scattering instrument and size exclusion chromatography （MALLS-SEC）. Results： The results of MALLS-SEC were close to those of viscometry, and Mw/Mn was obtained simultaneously. The average value of molecular weight of three batches of samples was 991962, 1007438 and 990232 with RSD of 6.5% , 4.6% and 2.2%, respectively（n =4）. The average value of gw/Mn was 1.6, 1.6 and 1.6 with RSD of 7.2%, 3.2% and 3.2%, respectively（ n = 4）. Conclusion： MALLS-SEC shows better accuracy and precision, and can be used in the quality control Of sodium hyaluronate samples.