基于物质基础评价不同干燥工艺对天舒胶囊质量的影响  

Evaluate effects of different drying methods on quality of Tianshu capsule on substance basis

作　　者：张梦婷 毕宇安[3,2] 张欣 徐桂红[3,2] 黄文哲[3,2] 王振中[3,2] 萧伟[1,3,2] 

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]中药制药过程新技术国家重点实验室,江苏连云港222001 [3]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中国中药杂志》2017年第18期3537-3545,共9页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2013ZX09402203)

摘　　要：从天舒胶囊所含化学成分的角度,考察热风循环干燥、喷雾干燥2种干燥方式对天舒胶囊质量的影响,运用UPLCDAD技术首次建立天舒胶囊UPLC指纹图谱,并通过UPLC-Q-TOF-MS/MS技术对其主要成分进行鉴定,共鉴定出62个化合物,其中21个化合物为首次在天舒胶囊中被报道。实验表明这2种干燥方式对天舒胶囊中化学成分的种类无影响,但在部分成分的含量上有差别;且以10批热风循环干燥样品生成的共有模式作为对照图谱,喷雾干燥样品的指纹图谱相似度为0.877,2种干燥方式样品的指纹图谱相似程度很高。该研究首次采用UPLC-DAD技术结合UPLC-Q-TOF-MS/MS技术快速、全面、准确评价不同干燥方式下天舒胶囊化学成分的差异,为天舒胶囊质量评价提供依据。Abstract：To investigate the effect of hot air circulation drying and spray drying on the quality of Tianshu capsule from the view point of chemical compositions. UPLC-DAD was used to establish the fingerprint of Tianshu capsules for the first time, and the main chemical constituents were identified by UPLC-Q-TOF-MS/MS. A total of 62 compounds were identified in this method, 21 of which were reported in Tianshu capsules for the first time. The results showed that there were no significant differences in the identification of the chemical constituents types between these two methods, but the contents of some constituents were different. The common patterns generated by the 10 batches of hot air cycle drying samples were used as the control fingerprint, and the similarity of the spray drying samples fingerprints was 0.877, with high similarity of the fingerprints between these two methods. UPLC-DAD combined with UPLC-Q-TOF-MS/MS technology was used for the first time to evaluate the chemical constituents of Tianshu capsule rapidly, comprehensively and accurately, providing technical support for the quality evaluation of Tianshu capsule.

关 键 词：天舒胶囊 热风循环干燥 喷雾干燥 指纹图谱 UPLC-ESI-MS/MS 化学成分 

分 类 号：R283.6[医药卫生—中药学]