那曲肝素钙的紫外光谱法检测与应用

Determination of Nadroparin Calcium by UV Spectrophotometry and its Application in Production Process

研究发现以1mol／L乙酸钠（NaAc）溶液为介质，那曲肝素钙（NadroparinCalcium，NC）在邻菲哕啉．硫酸锌（phen—ZnSO4）体系中有显著的紫外吸收峰（λmax为302nm），其吸光度与Nc溶液的浓度成线性正比关系，由此建立了一种新的测定Nc的分析方法。该方法的线性范围为5．38×10^-3～3．87×10^-2mol／L，检出限为2．06×10^-3mol／L。干扰实验结果表明，所得方法对钙离子具有很强的抗干扰能力。将所建立的方法应用于NC的实际生产工艺过程中，结果令人满意。同时，对其机理进行了探究。这些结果为NC的药品生产工艺提供了一种监控技术。

To establish a simple and correct detection method of Nadroparin calcium （NC） in its practical production process, a new UV spectrophotometry based on the system of 1,10-phenanthroline monohydrate and Zinc sulfate （phen-ZnSO4 ） is developed. The results showed that NC has a significant UV absorption peak （hmax =302 rim） in the system of phen-ZnSO4 with 1 mol/L NaAc as buffer,and there is a linear proportional relationship between the absorbance and the concentration of NC solution. In order to optimize the detection method,effects of the amount of NaAc solution, the amount of ZnSO4 solution and the color time have been studied. The further research resuhs indicated that the resulting method had a linear range of 5.38 ~ 10 -3 - 3.87 ~ 10 -2 mol/L and a detection limit oF 2.06 ~ 10-z mob＇L. It has been applied in the practical production process of NC, and the analysis results are satisfied and useful in process monitoring. Furthermore, the detection mechanism of this method has been explored by the test of the detection of unfractionated heparin（UFH） and the study of the effect of additional NaNO2 solution. The results suggested that the hydroxyl groups on the pentasaccharidic antithrombin-binding sequence of the NC structure take part in the formation of the color system. These findings provide a basis for the establishment of a new type of process control technology in the pharmaceutical produc- tion process of NC.