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The safety,efficacy and pharmaceutical quality of male enhancement nutraceuticals bought online:Truth versus claim

Journal of Integrative Medicine 2021年第3期19卷 232-242页

作者： Mohamed Ismail Nounou Heba AEassa Nada AHelal Khaled Aboul Fotouh Ihab Mansoor Isabel KLatz Cindy Zheng Hadeer AEassa Dina Mohamed Diana MHuynh abigail rwiss Jessica Sweeney Monica TOakes Mark MMikhail Nadine Amine Harshvir Kaur Natalia Echeverry Kamila Orzechowski Doreen Szollosi Department of Pharmaceutical Sciences School of Pharmacy&Physician Assistant Studies(SOPPAS)University of Saint Joseph(USJ)HartfordConnecticut 06103USA Department of Pharmaceutics and Industrial Pharmacy Faculty of PharmacyAL-Azhar UniversityCairo 11651Egypt Pharmaceutical Sciences Department Irma Lerma Rangel College of PharmacyTexas A&M Health Science CenterTexas A&M UniversityCollege StationTexas 77843USA Division of Molecular Pharmaceutics and Drug Delivery College of PharmacyThe University of Texas at AustinTexas 78712USA Department of Pharmaceutics Faculty of PharmacyAssiut UniversityAssiut 71526Egypt Department of Pharmaceutics Faculty of PharmacyAlexandria UniversityAlexandria 21521Egypt Department of Public Health Sciences College of Health SciencesThe University of Texas at El PasoTX 79968USA Genetic Engineering and Biotechnology Research Institute University of Sadat CitySadat 32897Egypt Department of Industrial Pharmacy Faculty of PharmacyAlexandria UniversityAlexandria 21521Egypt

Objective:Nutraceutical products are widely used for their claimed therapeutic benefits.However,falsified or adulterated nutraceuticals present a major health threat to consumers.This study investigates the pharmaceutical quality,safety and anti-inflammatory effects of six male enhancement nutraceuticals that claim to be 100%natural.Methods:Three batches of six male enhancement products were tested to detect the presence and levels of adulterants via high-performance liquid chromatography(HPLC).The pharmaceutical quality of the selected nutraceuticals was tested with near infrared spectroscopy(NIR)and Se De M.The cytotoxic effects of these products on HepG2 cells were determined through cell proliferation(XTT)and lactate dehydrogenase(LDH)cytotoxicity assays.Lastly,the in vitro inflammatory effects of these products were investigated using murine J774 macrophages through cytokine release analysis.Results:HPLC analysis detected the presence of sildenafil citrate,a vasodilator,and the active ingredient in Viagra and Revatio,in all batches of the products we analyzed.Amount of sildenafil citrate ranged from 0.45 mg to 51.85 mg among different batches.NIR assessment showed inter-and intra-batch heterogeneity in product composition.Results of the XTT and LDH assays showed significant cytotoxic effects of the analyzed products.XTT analysis revealed that the viability of HepG2 treated with tested products varied from 27.57%to 41.43%.Interestingly,the male enhancement products also showed anti-inflammatory effects.Conclusion:Despite their labeling as 100%natural,all products tested in this study contained levels of sildenafil citrate,which was not reported on the packaging.There was a lack of pharmaceutical uniformity among products of the same batch and across different batches.Additionally,the products we tested had cytotoxic effects.These study findings highlight the adulteration,poor quality and hazard of these nutraceuticals.Therefore,strict regulation of these products and standardization of the definition of nutra

关键词： Nutraceuticals Adulteration Erectile dysfunction Sildenafil citrate Online market

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