右旋糖酐40葡萄糖注射液 pH 值与5-羟甲基糠醛、糠醛含量的相关性分析

摘要

Objective To analyze the correlation of furfural, 5-hydroxymethylfurfural (5-HMF) content and pH value of dextran 40 and glucose injection, and to provide reasonable suggestions for the production, transportation and use. Methods High performance liquid chromatography method was used to determine the content of 5- HMF and furfural of 90 batches of dextran 40 and glucose Injection. The pH value of the solution was determined by acidometer. Correlation of furfural, 5-HMF content and pH value was analyzed by SPASS 17.0. The destructive tests were carried out to verify the conclusion. Results There is a negative correlation between the value of pH and content of 5- HMF, and the content of furfural was positively correlated with 5- HMF. Destructive test results show that, the decrease of pH value will lead to the generation of 5- HMF and furfural. Conclusion Through the strict control of pH value, the stability of dextran 40 and glucose injection can be increased. And the increase 5- HMF and furfural content of the preparation could be suppressed too.%目的：对右旋糖酐40葡萄糖注射液的 pH 值与5-羟甲基糠醛、糠醛含量进行相关性分析，为其生产、运输和使用提供合理化建议。方法采用高效液相色谱法对所有90批右旋糖酐40葡萄糖注射液中的5-羟甲基糠醛、糠醛进行测定，同时采用酸度计测定溶液的 pH 值，并用 SPASS 17.0对测定结果的 pH 值与5-羟甲基糠醛、糠醛进行相关性分析，并采用破坏性试验对结论进行验证。结果右旋糖酐40葡萄糖注射液的 pH 值与5-羟甲基糠醛的含量负相关，5-羟甲基糠醛的含量与糠醛的含量呈正相关。破坏性试验结果证明，pH 值的降低会导致5-羟甲基糠醛和糠醛的生成。结论通过严格控制该制剂的 pH 值，可以增加右旋糖酐40葡萄糖注射液的稳定性，抑制制剂中5-羟甲基糠醛和糠醛含量的增加。