Zang Qing-ce, He Jing-jing, Bai Jin-fa, Zheng Ya-jie, Zhang Rui-ping, Li Tie-gang, Wang Zhong-hua, He Jiu-ming, Abliz Zeper
State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.
Yao Xue Xue Bao. 2013 Nov;48(11):1705-9.
To screen the harmful substance 5-hydroxymethyl furfural content in commercially available traditional Chinese medicine injection which are commonly used, and to preliminarily evaluate the quality of these injections, 5-hydroxymethyl furfural was taken as an index. The contents of 5-hydroxymethyl furfural in 56 samples which consist of 23 kinds of traditional Chinese medicine injections and glucose injection were determined using LC-MS/MS, and 5-hydroxymethyl furfural was detected in 52 of these samples. The minimal content was 0.0038 microg x L(-1) and the maximum content was 1420 microg x mL(-1). The contents of 5-hydroxymethyl furfural were significantly different in traditional Chinese medicine injection which came from different kinds, manufacturers or batches. The results showed the quality difference of commercially available traditional Chinese medicine injection is significant taking 5-hydroxymethyl furfural content as assessment index. More attention should be paid to the safety of 5-hydroxymethyl furfural in traditional Chinese medicine injection, and unified limitation standard should be set to improve medication safety of traditional Chinese medicine injection.
以5-羟甲基糠醛为指标，筛选常用的市售中药注射剂中的有害物质5-羟甲基糠醛含量，并对这些注射剂的质量进行初步评价。采用液相色谱-串联质谱法测定了由23种中药注射剂和葡萄糖注射液组成的56个样品中5-羟甲基糠醛的含量，其中52个样品检测到5-羟甲基糠醛。最低含量为0.0038μg·L⁻¹，最高含量为1420μg·mL⁻¹。不同种类、厂家或批次的中药注射剂中5-羟甲基糠醛的含量存在显著差异。结果表明，以5-羟甲基糠醛含量为评价指标，市售中药注射剂的质量差异显著。应更加关注中药注射剂中5-羟甲基糠醛的安全性，并制定统一的限量标准，以提高中药注射剂的用药安全性。
