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

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。

Detection and Characterize of a Novel Tadalafil Derivatives Added Illegally into Traditional Chinese Medicines

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.