张梦婷 毕宇安 张欣 徐桂红 黄文哲 王振中 萧伟

[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UPLCQTOFMS/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0877，2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UPLCDAD技术结合UPLCQTOFMS/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。

[关键词]天舒胶囊； 热风循环干燥； 喷雾干燥； 指纹图谱； UPLCESIMS/MS； 化学成分

Evaluate effects of different drying methods on quality of

Tianshu capsule on substance basis

ZHANG Mengting1，3， BI Yuan2，3， ZHANG Xin2，3， XU Guihong2，3， HUANG Wenzhe2，3， WANG Zhenzhong2，3， XIAO Wei 1，2，3*

（1. College of Pharmacy， Nanjing University of Chinese Medicine， Nanjing 210023， China；

2. Jiangsu Kanion Pharmaceutical Co.， Ltd.， Lianyungang 222001， China；

3. State Key Laboratory of Pharmaceutical Process Newtech for Traditional Chinese Medicine， Lianyungang 222001， China）

[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 UPLCDAD was used to establish the fingerprint of Tianshu capsules for the first time， and the main chemical constituents were identified by UPLCQTOFMS/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 0877， with high similarity of the fingerprints between these two methods UPLCDAD combined with UPLCQTOFMS/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

[Key words]Tianshu capsule； hot air circulation drying； spray drying； fingerprint； UPLCESIMS/MS； chemical components

天舒膠囊作为江苏康缘药业股份有限公司独家生产的中药六类新药，来源于金·刘完素《宣明论方》卷二的大川芎方，由天麻、川芎两味药材组成，方中川芎和天麻配伍，共奏活血化癖、平肝息风、镇定止痛之效[1]。临床主要用于血癖所致血管神经性头痛，证见头痛日久，痛有定处，或兼头晕，夜寐不安，舌质暗或有癖斑。

喷雾干燥及热风循环干燥作为实际生产中广泛使用的干燥方式，与热风循环干燥相比，喷雾干燥的物料受热时间短、干燥迅速、干燥产物有较好的流动性和分散性[2]。

本实验首次采用UPLCDAD结合UPLCQTOFMS/MS技术建立一种全面系统的化学评价体系，用指纹图谱结合化学成分定性研究评价不同干燥方式对天舒胶囊质量的影响，考察不同干燥方式对天舒胶囊化学成分的影响。……