{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T08:08:39Z","timestamp":1794557319535,"version":"4.9.1"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,1,11]],"date-time":"2019-01-11T00:00:00Z","timestamp":1547164800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2019,1,11]],"date-time":"2019-01-11T00:00:00Z","timestamp":1547164800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Italmex"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Pharmacol Toxicol"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Fibrosis is a response to chronic liver disease that results in excessive accumulation of extracellular matrix proteins and formation of scar tissue. Fibrosis represents a clinical challenge of worldwide significance. Several studies have demonstrated that many natural products and herbal medicines have activity against liver fibrosis, and extracts of milk thistle such as silymarin and silybin are the natural compounds most commonly prescribed for liver diseases. Therefore, we sought to assess and compare the pharmacokinetic properties and bioavailability of silybin\u2013phosphatidylcholine complex in oily-medium soft-gel capsules and conventional silymarin tablets in healthy Mexican volunteers.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We enrolled 23 healthy volunteers to participate in a prospective, balanced, blind, single-dose, two-way crossover study with a one-week washout period. Fasting participants received either 45\u2009mg silybin\u2013phosphatidylcholine complex or 70\u2009mg silymarin to assess which formulation provided better bioavailability of silybin. Plasma was obtained and analysed for silybin concentration using a validated ultra-performance liquid chromatography\u2013tandem mass spectroscopy method. Pharmacokinetic parameters were obtained by non-compartmental analysis and values were compared by analysis of variance for a crossover design. Ratios of maximum plasma drug concentration and area under the curve (AUC) were obtained and 90% confidence intervals were calculated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The 23 healthy subjects (11 women, 12 men) who participated in the study were aged 22\u201331\u2009years old (average: 28), average weight 64.8\u2009kg, height 1.65\u2009m and body mass index 23.5\u2009kg\/m<jats:sup>2<\/jats:sup>. Plasma levels of silybin were higher after the administration of silybin\u2013phosphatidylcholine complex capsules compared with that after conventional silymarin tablets (<jats:italic>P<\/jats:italic>\u2009&lt;\u2009\u00a00.0001).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The silybin\u2013phosphatidylcholine complex in oily-medium soft-gel capsules seems to provide superior bioavailability. However, clinical studies must be performed to demonstrate its clinical relevance in the treatment of liver diseases.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03440164\">NCT03440164<\/jats:ext-link>; registered on November 11, 2016.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40360-018-0280-8","type":"journal-article","created":{"date-parts":[[2019,1,11]],"date-time":"2019-01-11T12:10:08Z","timestamp":1547208608000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Superior silybin bioavailability of silybin\u2013phosphatidylcholine complex in oily-medium soft-gel capsules versus conventional silymarin tablets in healthy volunteers*"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5257-8048","authenticated-orcid":false,"given":"Nahum","family":"M\u00e9ndez-S\u00e1nchez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Dibildox-Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jahir","family":"Sosa-Noguera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram\u00f3n","family":"S\u00e1nchez-Medal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco J.","family":"Flores-Murrieta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,1,11]]},"reference":[{"issue":"3","key":"280_CR1","doi-asserted-by":"publisher","first-page":"315","DOI":"10.2174\/092986707779941159","volume":"14","author":"R Gaz\u00e1k","year":"2007","unstructured":"Gaz\u00e1k R, Walterov\u00e1 D, Kren V. 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(NABIO) and the Mexican Health Authority (COFEPRIS). The study was conducted in accordance with the provisions of the Declaration of Helsinki (2013), General Health Law in Mexico and ICH Good Clinical Practice procedures (2005).The participants granted the written consent to participate in the study. The signed form was approved by NABIO and COFEPRIS.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MDM is a member of research group from ITALMEX SA, He was declare no competing interests. JSN \u2013 Is a member of research group from ITALMEX SA, He was declare no competing interests. RSM \u2013 Is a member of research group from ITALMEX SA, he was declare no competing interests. All other authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"5"}}