论文部分内容阅读
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 results of three methods for determining the molecular weight of sodium hyaluronate in sodium hyaluronate injection. Methods: The molecular weight of sodium hyaluronate in sodium hyaluronate injection was determined by viscosity method. The molecular weight was determined by size exclusion chromatography (SEC) and multi-angle laser light scattering with size exclusion chromatography (MALLS-SEC) Molecular weight and molecular weight distribution (Mw / Mn) were measured. Results: The results of the MALLS-SEC method and the viscometry method are close, and the Mw / Mn of the sample can be determined at the same time. The average of four determinations of the molecular weight of the three batches of samples was 991 962, 1007 438 and 990 232, respectively; RSD was 6.5%, 4.6% and 2.2% respectively (n = 4). The average of 4 determinations of molecular weight distribution was 1.6, 1.6, 1.6; RSD was 7.2%, 3.2%, 3.2% (n = 4). Conclusion: The MALLS-SEC method has good accuracy and precision, and can be used for the quality control of sodium hyaluronate samples.