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作 者:许丽丽 徐兴燕 汪冰 崔伟亮 林永强 林慧彬[3] 王明耿 崔巧红 XU Li-li;XU Xing-yan;WANG Bing;CUI Wei-liang;LIN Yong-qiang;LIN Hui-bin;WANG Ming-geng;CUI Qiao-hong(Shandong Institute for Food and Drug Control,Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM,Jinan 250101,China;Shandong University of Traditional Chinese Medicine,Jinan 250355,China;Shandong Academy of Chinese Medicine,Jinan 250014,China;Shandong Buchang Shenzhou Pharmaceutical Co.,Ltd.,Heze 274000,China)
机构地区:[1]山东省食品药品检验研究院,中药标准创新与质量评价工程实验室,济南250101 [2]山东中医药大学,济南250355 [3]山东省中医药研究院,济南250014 [4]山东步长神州制药有限公司,菏泽274000
出 处:《中华中医药杂志》2021年第12期7302-7305,共4页China Journal of Traditional Chinese Medicine and Pharmacy
基 金:国家重点研发计划“中医药现代化研究”(No.2017YFC1701500,No.2017YFC1701502,No.2017YFC1701504,No.2017YFC1702700,No.2017YFC1702701);山东省自然科学基金项目(No.ZR2017MH023,No.ZR2018PH040);泰山学者工程(No.ts201511107);2018年国家中医药管理局全国中药资源普查项目(No.GZY-KJS-2018-004);山东省中医药科技发展计划(No.2017-519,No.2019-0988,No.2019-0987);中央本级重大增减支项目(No.2060302);国家科技重大专项重大新药创制课题子课题(No.2017ZX09301064010)。
摘 要:目的:探索电子束射线辐照灭菌对蓬莪术有效成分的影响,为蓬莪术辐照灭菌提供指导依据。方法:采用Kromasil 100-5-C_(18)色谱柱(250mm×4.6mm,5μm),流动相为乙腈(A)-0.5%磷酸溶液(B),梯度洗脱,切换检测波长为426nm、216nm。结果:蓬莪术HPLC共有模式确定了14个共有峰,各批次蓬莪术辐照前后相似度均>0.85;0、3、6个月时双去甲氧基姜黄素、去甲氧基姜黄素、姜黄素、莪术烯醇、呋喃二烯酮、牻牛儿酮和呋喃二烯的含量,经SPSS 19.0软件成组t检验无显著性差异;同批次样品辐照前与辐照后样品聚类一致性较好,6个月内各成分辐照前后变化趋势一致。结论:本研究建立的波长切换法符合方法学验证要求,电子束辐照对蓬莪术整体化学成分基本无影响,且不影响其稳定性,首次为蓬莪术辐照灭菌方式的选择提供了实验依据。Objective: To investigate the effects of electron beam irradiation sterilization on the effective components before and after the irradiation, so as to provide guide for the sterilization of the Curcuma phaeocaulis. Methods: The analysis was carried out on an analytical column Kromasil 100-5-C_(18)(250 mm×4.6 mm, 5μm) with gradient elution of acetonitrile(A) and 0.5%phosphoric acid solution(B) at the detection wavelength of 426 nm and 216 nm. Results: The common pattern was established and 14 peaks were identified as the common peaks. The similarity of each batch before and after irradiation was more than 0.85. After group t-test by SPSS 19.0 software, the content change of bisdemethoxycurcumin, demethoxycurcumin, curcumin, curcumenol,furanodienone, germacrone and furanodiene was not significantly after irradiation. The same batch before and after electron beam irradiation sterilization had better clustering consistency and the identical change trend of each component. Conclusion: The established method is consistent with the method validation requirements. Electron beam irradiation sterilizationsterilization has no significant effect on the chemical composition consistency and its stability. This method can provide reference for the sterilization of Curcuma phaeocaulis.
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