基于UHPLC-Q-TOF-MS技术探究脾肾两助丸钴-60辐照灭菌前后化学差异  

Investigation of Chemical Differences between Pishenliangzhu Pills before and after Sterilization by Cobalt-60 Irradiation Based on UHPLC-Q-TOF-MS Technique

作　　者：王雅婷 曹林旭 许信学 吕王伟 秦雪梅[1,2] 李震宇 WANG Yating;CAO Linxu;XU Xinxue;LÜWangwei;QIN Xuemei;LI Zhenyu(Modern Research Center for Traditional Chinese Medicine,Shanxi University,Taiyuan 030006,China;The Key Laboratory of Chemical Biology and Molecular Engineering of Ministry of Education,Taiyuan 030006,China;Shanxi Huakang Pharmaceutical Co.,Ltd.,Taiyuan 030006,China)

机构地区：[1]山西大学中医药现代研究中心,太原030006 [2]化学生物学与分子工程教育部重点实验室,太原030006 [3]山西华康药业股份有限公司,山西运城044200

出　　处：《中国药学杂志》2025年第4期394-406,共13页Chinese Pharmaceutical Journal

基　　金：国家中医药管理局青年岐黄学者培养项目资助(2022-256)。

摘　　要：目的 辐照灭菌广泛应用于中药制剂领域,但辐照灭菌对中药化学组成是否产生影响需要深入研究,尤其是针对组方复杂的丸剂类中成药。方法 本研究以处方30味药材的脾肾两助丸为例,首先采用超高效液相色谱-四极杆飞行时间质谱(UHPLC-Q-TOF-MS)高分辨质谱技术对脾肾两助丸化学成分进行解析,然后利用所得到的数据对脾肾两助丸成分进行多元统计分析,最后对比《中国药典》2020年版中15味药22个指标成分辐照前后的含量,同时分析其余质谱鉴定化合物的差异,全面探究辐照灭菌化学差异。结果 共鉴定出260个化合物,包括45个黄酮类化合物,28个三萜类化合物,24个苯丙素类化合物以及糖苷类、有机酸类、脂类、氨基酸类、生物碱类等其他类化合物163个。主成分分析、聚类分析均表明脾肾两助丸在钴-60辐照[剂量(2.5±0.5)kGy]前后整体化学组成没有显著差异,所鉴定的成分中仅有13个成分发生变化,且变化率较小。结论 钴-60辐照灭菌对脾肾两助丸整体化学组成影响不大。本研究以脾肾两助丸为例,证明了高分辨质谱在中药辐照灭菌所致化学差异研究中的应用前景,也为辐照灭菌技术在中成药生产中的应用提供了科学依据。OBJECTIVE To investigate the effect of this tratitional Chinese medicine irradiation sterilization on the chemical composition,especially pills with complex herb composition.METHODS The chemical composition of Pishenliangzhu Pills was examined using high-resolution mass spectrometry.Then,the obtained data were used for the multivariate statistical analysis of the components of Pishenliangzhu Pills and finally,the contents of 22 index components of 15 medicines in the Chinese Pharmacopoeia 2020 were compared before and after irradiation,and the rest of the compounds were analyzed by mass spectrometry,so as to comprehensively investigate the differences in the chemistry of the irradiated sterilizers.RESULTS A total of 260 compounds were identified,including 45 flavonoids,28 triterpenoids,24 phenylpropanoid compounds,and 163 glycosides,organic acids,lipids,amino acids,and alkaloids.Principal component analysis and cluster analysis revealed that there were no significant changes in the chemical composition of Pishenliangzhu Pills after Cobalt-60 irradiation at a dose of(2.5±0.5)kGy,with only 13 components showing minor alterations.CONCLUSION This study demonstrates the potential of high-resolution mass spectrometry in investigating chemical differences induced by irradiation sterilization in traditional Chinese medicine using Pishenliangzhu Pills as an example,which providing scientific evidence for the utilization of irradiation sterilization technology in producing Chinese patent medicines.

关 键 词：高分辨质谱 脾肾两助丸 钴-60辐照灭菌 化学差异 

分 类 号：R917[医药卫生—药物分析学]