摘要
快速筛查常用中药注射液中有害物质5-羟甲基糠醛,并以其含量为指标进行质量评价。利用LC-MS/MS分析方法,对56批市售的23种常用中药注射液和葡萄糖注射液中的5-羟甲基糠醛进行定量分析,在52批中检出5-羟甲基糠醛。在所检的样品中5-羟甲基糠醛的最低含量为0.003 8μg·mL 1,最高含量为1 420μg·mL 1;不同种类、不同厂家、同一厂家不同批次生产的中药注射液中5-羟甲基糠醛的含量差异很大。结果表明,以5-羟甲基糠醛含量为指标,市售的中药注射液质量良莠不齐;需要对中药注射液中5-羟甲基糠醛的安全性予以关注,并制定统一的限量标准,以提高中药注射液的用药安全。
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 0.003 8 μtg＇mL-1 and the maximum content was 1 420 μg.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-hydroxymetbyl 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.
出处
《药学学报》
CAS
CSCD
北大核心
2013年第11期1705-1709,共5页
Acta Pharmaceutica Sinica
基金
科技部创新方法工作专项资助项目(2011IM030200)
关键词
中药注射液
5-羟甲基糠醛
LC—MS
MS
质量评价
traditional Chinese medicine injection
5-hydroxymethyl furfural
LC-MS/MS
quality evaluation
