中药注射液中5-羟甲基糠醛来源探讨

目的:通过对中药注射液中的5-羟甲基糠醛(5-HMF,5-Hydroxymethylfurfural)来源的初步探讨,为提高中药注射液的质量控制水平提供参考依据.方法:利用HPLC方法对注射液、中间体中的5-HMF和寡糖(葡萄糖、果糖及蔗糖)分别进行含量测定,确定5-HMF的来源；通过模拟生产过程考察不同寡糖的受热不稳定情况,来探讨5-HMF的生成机制.结果:只有在含有果糖的中间体中含有5 -HMF.模拟高温灭菌过程发现仅有果糖受热后转化生成5-羟甲基糠醛及其相关物质,而葡萄糖和蔗糖均没有转化.结论:并不是所有的寡糖在高温下都易转化5-HMF.在常见的三种糖中,只有果糖在高温下易转化生成5-HMF,而葡萄糖和蔗糖不易转化.建议对含果糖的中药注射液进行5-HMF的限度检查,而含葡萄糖和蔗糖的可以不控制该项目.

Study on the Generation of 5-Hydroxymethylfurfural in Chinese Medicine Injection

Objective：To improve the quality control of Chinese medicine injection, the preliminary study on the generation of 5- hydroxymethylfurfural in Chinese medicine injection was discussed. Methods： Finding the formation mechanism of 5-hydroxymethylfurfural, the HPLC was used to determine 5-hydroxymethylfurfural in products, intermediates and sugars （glucose, sucrose, fructose ） , and the simulation of high-temperature sterilization was used to study the instability to heat of different sugars. Results ： The 5-hydroxy- methyffurfural was detected in the intermediates of fructose. And only fructose generated 5-hydroxymethyffurfural after the simulation of high-temperature sterilization. Conclusion ： Compared with glucose and sucrose, fructose generated 5-hydroxymethylfurfural much more easilier. Therefore, detecting 5-hydroxymethylfurfural is recommended for the Chinese medicine injection with fructose instead of glu- cose and sucrose.