Detection of a Tadalafil Analogue as an Adulterant in a Dietary Supplement for Erectile Dysfunction

作者: Jeronimo Ulloa , Luis Sambrotta , Flavia Redko , Osvaldo Nestor Mazza , Gustavo Garrido

DOI: 10.1111/JSM.12759

关键词:

摘要: Introduction. Several cases of adulteration dietary supplements with tadalafil, sildenafil, and vardenafil, or their unapproved analogues have been reported worldwide. Mainly, the presence latter represents a serious health risk to consumers as efficacy toxic effects not assessed may result in unpredictable adverse effects. Aim. To investigate suspected synthetic phosphodiesterase type 5 (PDE-5) inhibitors supplement marketed Argentina for treatment erectile dysfunction (ED). Methods. The content capsules (sample A) was analyzed by thin layer chromatog- raphy (TLC) high-performance liquid chromatography (HPLC) diode-array detection. From organic extract sample A, major compound purified column (CC). isolated identified proton nuclear magnetic resonance (1H NMR) carbon NMR (13C NMR), heteronuclear single quantum coherence, distortionless enhancement polarization transfer (DEPT 135), electrospray ionization mass spectrometry, ultraviolet, infrared (Fourier transform spectroscopy) spectroscopy. Main Outcome Measure. Proof herbal products PDE-5 inhibitors. Results. By TLC HPLC analysis, detected A extract. purification this CC led isolation pure which according its spectral data (6R,12aR)-2-amino-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino (1',2':1,6) pyrido (3,4-b) indole- 1,4-dione aminotadalafil. Conclusions. An inhibitor analogue, aminotadalafil, has supplement. This study first report Latin America one few independent studies an product ED treatment. Ulloa J, Sambrotta L, Redko F, Mazza ON, Garrido G, Becher EF, Muschietti L. Detection tadalafil analogue adulterant dysfunction. J Sex Med 2015;12:152-157.

参考文章(14)
Ronald W Lewis, Kerstin S Fugl-Meyer, Giovanni Corona, Richard D Hayes, Edward O Laumann, Edson D Moreira Jr, Alessandra H Rellini, Taylor Segraves, None, Definitions/epidemiology/risk factors for sexual dysfunction The Journal of Sexual Medicine. ,vol. 7, pp. 1598- 1607 ,(2010) , 10.1111/J.1743-6109.2010.01778.X
M.-C. Lin, Y.-C. Liu, Y.-L. Lin, J.-H. Lin, Identification of a Tadalafil Analogue Adulterated in a Dietary Supplement Journal of Food and Drug Analysis. ,vol. 17, pp. 451- 458 ,(2020) , 10.38212/2224-6614.2584
Sharon Sze-Yin Oh, Peng Zou, Min-Yong Low, Hwee-Ling Koh, Detection of Sildenafil Analogues in Herbal Products for Erectile Dysfunction Journal of Toxicology and Environmental Health. ,vol. 69, pp. 1951- 1958 ,(2006) , 10.1080/15287390600751355
Eung-Sun Lee, Ji Won Kim, Ji Hyun Lee, Kyoung Moon Han, Sooyeul Cho, Insun Hwang, Soon Young Han, Kabyong Chae, Jinho Kim, Identification of a new tadalafil analogue found in a dietary supplement. Food Additives and Contaminants Part A-chemistry Analysis Control Exposure & Risk Assessment. ,vol. 30, pp. 621- 626 ,(2013) , 10.1080/19440049.2013.766766
Peng Zou, Peiling Hou, Min-Yong Low, Hwee-Ling Koh, Structural elucidation of a tadalafil analogue found as an adulterant of a herbal product. Food Additives and Contaminants Part A-chemistry Analysis Control Exposure & Risk Assessment. ,vol. 23, pp. 446- 451 ,(2006) , 10.1080/02652030500479690
Ming-Thau Sheu, An-Bang Wu, Geng-Cheng Yeh, Angel Hsia, Hsiu-O Ho, Development of a liquid chromatographic method for bioanalytical applications with sildenafil. Journal of Chromatography B. ,vol. 791, pp. 255- 262 ,(2003) , 10.1016/S1570-0232(03)00223-X
Neil Campbell, John P. Clark, Vera J. Stecher, John W. Thomas, Amy C. Callanan, Brian F. Donnelly, Irwin Goldstein, Jed C. Kaminetsky, Adulteration of Purported Herbal and Natural Sexual Performance Enhancement Dietary Supplements with Synthetic Phosphodiesterase Type 5 Inhibitors The Journal of Sexual Medicine. ,vol. 10, pp. 1842- 1849 ,(2013) , 10.1111/JSM.12172