摘要
目的:建立医用透明质酸钠凝胶的绝对分子量及其分布的测定方法。方法:采用多角度激光光散射仪与体积排阻色谱法联用(MALLS-GPC)测定医用透明质酸钠凝胶的绝对分子量及其分布。根据透明质酸钠特有的绝对折射率增量(dn/dc)和样品示差信号强度求得透明质酸钠含量。通过数据分析得到医用透明质酸钠凝胶的结构特性。结果:本方法测得聚乙二醇(PEG)标准品重均分子量(Mw)与标示值的相对偏差为4.7%,医用透明质酸钠凝胶样品分散度接近于1,分子量大于100万,所得的均方根半径(RMS radius)约为140 nm。本方法测得的透明质酸钠含量和糖醛酸法所得结果相差不大。结论:该方法准确性及精密度较好,在实验过程中可同时得到均方根旋转半径、聚集态及样品中的透明质酸钠含量等信息,可用于医用透明质酸钠凝胶的质量控制和应用研究。
Objective: To establish a new method for the determination of the absolute molecular weight and molecular weight distribution in medical sodium hyaluronate gel.Methods: A multi angle light scatterer and a gel permeation chromatograph(MALLS-GPC) was used to determine the molecular weight and the distribution of medical sodium hyaluronate gel.The contents of sodium hyaluronate were calculated by the specific refractive index increment(dn/dc) of sodium hyaluronate and signal strength of sample.The structural properties of medical sodium hyaluronate gel were obtained through statistical analysis.Results: The relative deviation of the measured value and the nominal value(by measuring Polyethylene Glycol standard) was 4.7%.The dispersity of the samples were about 1,the weight-average molecular weight(Mw) of the samples were greater than 1 million,and their RMS radius were about 140 nm.The sodium hyaluronate contents measured by MALLS-GPC method are similar to the uronic acid content method.Conclusion: The accuracy and precision obtained by this method were proved to be reliable.Data such as the gel’s RMS radius,conformational status,and the sodium hyaluronate content in samples and etc can be obtained simultaneously.The MALLS-GPC method can be used for the quality control and application study of the medical sodium hyaluronate gel.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第8期1435-1438,共4页
Chinese Journal of Pharmaceutical Analysis