中国药物警戒 ›› 2015, Vol. 12 ›› Issue (10): 611-613.

• 质量与工艺研究 • 上一篇    下一篇

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

郭欢迎, 耿庆光, 王嫦鹤   

  1. 陕西省食品药品检验所，陕西 西安 71006
  • 收稿日期:2015-08-26 修回日期:2015-12-07 出版日期:2015-10-08 发布日期:2015-12-07
  • 通讯作者: 耿庆光，女，本科，副主任药师，药物分析与检验。E-mail: 554310029@qq.com
  • 作者简介:郭欢迎，女，本科，主管药师，药物分析与检验。
  • 基金资助:
    陕西省社会科学基金(13G020)

Correlation Analysis of Furfural, 5-hydroxymethylfurfural Content and pH Value of Dextran 40 and Glucose Injection

GUO Huan-ying, GENG Qing-guang, WANG Chang-he   

  1. Shanxi Institute for Food and Drug Control, Shanxi Xi'an 710061, China
  • Received:2015-08-26 Revised:2015-12-07 Online:2015-10-08 Published:2015-12-07

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摘要： 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。

关键词: 右旋糖酐40葡萄糖注射液, pH值, 5-羟甲基糠醛, 糠醛, 相关性分析

Abstract: 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.

Key words: dextran 40 and glucose injection, pH value, 5-hydroxymethylfurfural, furfural, correlation analysis

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