硫酸软骨素钠含量测定用国家对照品的研制

Study on Preparation and Standardization of Reference Standard of Chondroitin Substance Sodium

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 reference substance tot chondroitin sulfate sodium. METHODS Identification of ehondroitin sulfate sodium was carried out by infrared（IR） and high performance liquid chromatography（HPLC）. A high perform- ante size exclusion chromatography in conjunction with refraetive index detector and multi-angle laser light scatter（MALLS） was used to determine the molecular weight and molecular weight distribution of chondroitin sulfate sodium. The content of chondroitin sulfate sodi- um was calculated by mass balance method. RESULTS The content of chondroitin sulfate sodium reference substance was 99. 1% . CONCLUSION The establishment of national reference substance of chondroitin sulfate sodium can effectively control the quality of the product.