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目的建立硫酸软骨素钠含量测定用国家对照品。方法以红外光谱法(IR)和高效液相色谱法(HPLC)进行鉴别,采用尺寸排阻色谱和多角度激光光散射联用方法(SEC-MALLS)测定绝对分子质量和分子量分布,采用质量平衡法计算硫酸软骨素钠待标对照品的含量。结果用药典新增订的含量测定方法对硫酸软骨素钠的原料进行测定,最终确定首批硫酸软骨素钠对照品的含量为99.1%。结论硫酸软骨素钠含量测定用国家对照品的建立可有效的控制产品质量。
Objective To establish a national standard for the determination of sodium chondroitin sulfate. Methods The compounds were identified by infrared spectroscopy (IR) and high performance liquid chromatography (HPLC). The absolute molecular mass and molecular weight distribution were determined by size exclusion chromatography and multi-angle laser light scattering (SEC-MALLS) Calculate the content of sodium chondroitin sulfate standard to be labeled. Results The content of Chondroitin Sulfate Sodium was determined by the newly-added content determination method of Pharmacopeia, and the first batch of Chondroitin Sulfate reference substance was finally determined to be 99.1%. Conclusion The determination of sodium chondroitin sulfate content with the establishment of the national reference substance can effectively control product quality.