果糖注射剂的处方工艺研究及质量控制

Studies on Fructose Injection Prescription Process and Quality Control

目的对果糖注射液的制备工艺和灭菌工艺及果糖注射液的质量控制方法进行探讨。方法采用加入和不加抗氧化剂的制备工艺,考察其灭菌前后变化及抗氧化剂的抗氧效果。对制备过程中不同的p H值及灭菌温度对所制果糖注射液的主要质量指标5-羟甲基糠醛的考察。采用旋光法探讨果糖注射液的质量控制方法。结果在90℃保温,介质的p H值和温度对果糖分解的影响较小,p H值调至4~5,0.7kg·cm-2的灭菌压力条件下,加入亚硫酸氢钠,对果糖的p H值影响较小,吸光度较低。果糖浓度在20.0130~100.0648mg·m L-1范围内旋光度与溶液浓度呈线性关系(r=0.99989,n=5),回收率为99.84%,RSD为0.26%(n=3)。结论该实验得出的处方的制备工艺完全符合药典标准。灭菌工艺的效果可靠,可以保证质量。该制剂稳定,方法稳定,简便易行,快速准确,质量控制方法可行。

OBJECTIVE Preparation of fructose and fructose injection sterilization process and quality control methods are discussed. METHODS Adding antioxidants or not,we investigate their changes before and after sterilization and antioxidants in the antioxidant effect. We also examine different p H value of the preparation and sterilization temperature in the fructose injection system of a main quality indicator— 5-HMF. We use polarimetric method as quality control. RESULTS At 90℃,medium p H value and temperature has little effect on the decomposition of fructose,PH value is adjusted to 4 to 5,0. 7 kg·cm-2 pressure sterilization under the conditions of addition of sodium bisulfate,there is little impact on p H value and low absorbance. Fructose concentration range from 20. 0130 to100. 0648 mg·m L-1 was linear（ r = 0. 99989,n = 5）,recovery was 99. 84%,RSD was 0. 26%（ n = 3）. CONCLUSION The prescription from the experiment fits Pharmacopoeia standards. The effect of sterilization processes can ensure quality and reliable. The preparation is stable,method is stable,simple,fast and accurate,quality control method is feasible.