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引用本文:申国华,刘晓普,董培智,王慧.中成药中非法添加他达拉非新型衍生物的检测及结构鉴定[J].中国现代应用药学,2020,37(2):192-196.
SHEN Guohua,LIU Xiaopu,DONG Peizhi,WANG Hui.Detection and Characterize of a Novel Tadalafil Derivatives Added Illegally into Traditional Chinese Medicines[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(2):192-196.
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中成药中非法添加他达拉非新型衍生物的检测及结构鉴定
申国华1, 刘晓普1, 董培智1, 王慧2
1.山西省食品药品检验所, 太原 030031;2.中国食品药品检定研究院, 北京 102629
摘要:
目的 对中成药中非法添加的一种新型他达拉非类衍生物进行结构确证。方法 采用制备液相分离、纯化目标物,采用高效液相色谱法、液相色谱-质谱联用技术、核磁共振氢谱技术等手段对其结构进行表征,并结合文献报道,推断该化合物的结构。结果 通过数据分析与文献报道,确定该化合物为一种新型的他达拉非类衍生物。结论 该化合物为一种新型的他达拉非衍生物,在国内现行的PDE5型抑制剂检测标准中均未收载。本研究为进一步完善PDE5型抑制剂检测标准提供了科学依据。
关键词:  中成药  非法添加  他达拉非衍生物
DOI:10.13748/j.cnki.issn1007-7693.2020.02.013
分类号:R917.101
基金项目:山西省重点研发计划项目(201903D321011)
Detection and Characterize of a Novel Tadalafil Derivatives Added Illegally into Traditional Chinese Medicines
SHEN Guohua1, LIU Xiaopu1, DONG Peizhi1, WANG Hui2
1.Shanxi Provincial Institute for Food and Drug Control, Taiyuan 030031, China;2.National Institutes for Food and Drug Control, Beijing 102629, China
Abstract:
OBJECTIVE To confirm a novel tadalafil derivatives added illegally into the traditional Chinese medicines. METHODS The target compound was separated and purified by preparative liquid phase, characterized by high performance liquid chromatography, liquid chromatography-mass spectrometry, nuclear magnetic resonance hydrogen spectrometry and other means, and its structure was concluded based on the literature reported. RESULTS The new compound was identified as a novel derivatived tadalafil based on the data analysis and literature reported. CONCLUSION The compound has not been in the scope of current detection range of PDE5 inhibitor illegally added in traditional Chinese medicines, as a newly derivatived tadalafil. This work provides a basis for further improving the quality control of PDE5 inhibitors.
Key words:  traditional Chinese medicines  illegally  tadalafil analogue
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