论文部分内容阅读
目的:评价冠心宁注射液制备过程中果糖和葡萄糖的变化规律。方法采用HPLC-ELSD法分别测定不同工艺步骤葡萄糖和果糖的含量。结果:果糖和葡萄糖峰分离良好,果糖的线性范围为0.063 mg/m L~2.014 mg/m L(r=0.999 9),平均回收率为100.93%(n=6);葡萄糖的线性范围为0.065 mg/m L~2.083 mg/m L(r=0.999 7),平均回收率为100.06%(n=6)。结论:HPLC-ELSD法可用于冠心宁注射液制备过程中果糖和葡萄糖的含量测定,影响冠心宁注射液果糖和葡萄糖含量的关键步骤为两次醇沉,过程质量检测数据可指导生产过程控制同时也可为质量标准制定的合理性提供理论依据。
Objective: To evaluate the changes of fructose and glucose during the preparation of Guanxinning injection. Methods The contents of glucose and fructose in different technological steps were determined by HPLC-ELSD. RESULTS: The fructose and glucose peaks were well separated. The linear range of fructose ranged from 0.063 mg / m L to 2.014 mg / m L (r = 0.999 9) and the average recovery was 100.93% (n = 6). The linear range of glucose was 0.065 mg / m L ~ 2.083 mg / m L (r = 0.999 7) with an average recovery of 100.06% (n = 6). Conclusion: HPLC-ELSD method can be used for the determination of fructose and glucose in the preparation of Guanxinning injection. The key step affecting the content of fructose and glucose in Guanxinning injection is two alcohol precipitation. The quality inspection data of the process can guide the production process Control also provides a theoretical basis for the rationality of quality standards.