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      Determination of synthetic pharmaceutical adulterants in herbal weight gain supplements sold in herb shops, Tehran, Iran

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          Abstract

          Background

          Nowadays with the growing popularity of herbal remedies across the world, large sections of population rely on herbal drug practitioners for their primary care. Therefore there is a need to ensure about the safety of herbal drugs and to detect adulteration with undeclared active pharmaceutical ingredients. Herbal drugs are used as first-line drug therapy in some instances. Unfortunately even if there are claims as to be natural, undeclared active pharmaceutical ingredients have been detected in these supplements.

          Objectives

          The purpose of the present study was to analyse herbal weight gain drugs collected from herb shops located in Tehran, Iran to detect hidden pharmaceutical ingredients using UHPLC and GC/MS instrumentations.

          Methods

          Sixty herbal drugs advertised as weight gain supplements were gathered from herb shops Tehran province, Iran. All samples were analysed from analytical toxicology point of view to detect undeclared active pharmaceutical ingredients. Method was validated for quantitative analysis of cyproheptadine and dexamethasone.

          Results

          Method validity parameters showed good results for quantitative analysis of pharmaceutical ingredients. Cyproheptadine, dexamethasone, sildenafil, tramadol, caffeine and acetaminophen were detected in herbal weight gain drugs. Analysed dosage forms contained cyproheptadine and dexamethasone in concentrations higher than therapeutic doses. Quantitative analysis of contaminated drugs showed that the content of pharmacologic ingredients were 0.2–67 and 5.5–10.1 mg/tablet or capsule for cyproheptadine and dexamethasone respectively.

          Conclusions

          Despite natural supplements producers’ claim, herbal weight gain drugs were not natural at all. Undeclared active pharmaceutical ingredients can predispose patients to health problems and even life-threatening situations.

          Graphical Abstract

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          Most cited references29

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          Weight gain as an adverse effect of some commonly prescribed drugs: a systematic review.

          Several drugs, or categories of drugs, listed by the WHO and other writers and used in the treatment of chronic disease, are consistently associated with weight gain as a side effect and considered 'obesogenic'. The extent to which they may contribute to the multifactorial process behind obesity is not well documented. We systematically reviewed papers from Medline 1966-2004, Embase 1980-2004, PsycINFO 1967-2004, and Cochrane Register of Controlled Trials, to determine the effect on body weight of some drugs that are believed to favour weight gain. We included randomized controlled studies of adult participants (>18 years) prescribed a drug considered obesogenic, that compared the 'obesogenic' drug with placebo, an alternative drug or other treatment, and that had a duration of at least 3 months: 43 studies totalling 25,663 subjects met these criteria. The main objective of the majority of studies was to compare the efficacy and safety of drug therapy, with weight change recorded under safety outcomes; weight change was a primary outcome measure in only six studies. There was evidence of weight gain for all drugs included, up to 10 kg at 52 weeks. Differences in dosage, patient population, duration of treatment and dietary advice make generalization of the results difficult. Data on body weight are often not recorded in published clinical trials or is reported in insufficient detail. This side-effect has potentially serious consequences, and should be mentioned to patients. Weight management measures should be routinely considered when prescribing drugs known to promote weight gain. Future clinical trials should always document weight changes.
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            Is Open Access

            Combined DNA, toxicological and heavy metal analyses provides an auditing toolkit to improve pharmacovigilance of traditional Chinese medicine (TCM)

            Globally, there has been an increase in the use of herbal remedies including traditional Chinese medicine (TCM). There is a perception that products are natural, safe and effectively regulated, however, regulatory agencies are hampered by a lack of a toolkit to audit ingredient lists, adulterants and constituent active compounds. Here, for the first time, a multidisciplinary approach to assessing the molecular content of 26 TCMs is described. Next generation DNA sequencing is combined with toxicological and heavy metal screening by separation techniques and mass spectrometry (MS) to provide a comprehensive audit. Genetic analysis revealed that 50% of samples contained DNA of undeclared plant or animal taxa, including an endangered species of Panthera (snow leopard). In 50% of the TCMs, an undeclared pharmaceutical agent was detected including warfarin, dexamethasone, diclofenac, cyproheptadine and paracetamol. Mass spectrometry revealed heavy metals including arsenic, lead and cadmium, one with a level of arsenic >10 times the acceptable limit. The study showed 92% of the TCMs examined were found to have some form of contamination and/or substitution. This study demonstrates that a combination of molecular methodologies can provide an effective means by which to audit complementary and alternative medicines.
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              Adulteration of Dietary Supplements by the Illegal Addition of Synthetic Drugs: A Review

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                Author and article information

                Contributors
                akhgari1349@yahoo.com
                Journal
                Daru
                Daru
                DARU Journal of Pharmaceutical Sciences
                Springer International Publishing (Cham )
                1560-8115
                2008-2231
                21 September 2018
                December 2018
                : 26
                : 2
                : 117-127
                Affiliations
                [1 ]ISNI 0000 0001 0706 2472, GRID grid.411463.5, Department of Toxicology & Pharmacology, Faculty of Pharmacy, Pharmaceutical Sciences Branch, , Islamic Azad University (IAUPS), ; Tehran, Iran
                [2 ]Legal Medicine Research Center, Legal Medicine Organization, Tehran, Iran
                Article
                216
                10.1007/s40199-018-0216-2
                6279663
                30242673
                ec69e363-a94a-4377-98eb-7193275e5c21
                © Springer Nature Switzerland AG 2018
                History
                : 4 July 2018
                : 4 September 2018
                Categories
                Research Article
                Custom metadata
                © Springer Nature Switzerland AG 2018

                Pharmacology & Pharmaceutical medicine
                herbal drugs,adulteration,weight gain,analytical toxicology,cyproheptadine,dexamethasone

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