Skip to content
2000
Volume 15, Issue 4
  • ISSN: 2210-3155
  • E-ISSN: 2210-3163

Abstract

Introduction

Milk thistle extract is widely used in dietary supplements due to its strong hepatoprotective effect. There are some differences in the quality characteristics and standard values of milk thistle extract set by pharmacopoeias and standards in various countries and regions.

Methods

To promote the standardization of quality standards for milk thistle extract, this paper summarized and compared the standard characteristics and related values settings in four different standards. At the same time, actual samples were tested for the characteristics that appeared more frequently in standard. We found that the ratio algorithm of silymarin set in the pharmacopoeia standards was not reasonable and could blur the quality of related products from the test results, especially without limiting the total amount of silymarin in the standard.

Results

We suggested setting standard values for all six silymarin characteristics, establishing more universal detection methods, and preparing relevant reference materials to match the detection methods. Based on the comparison of standards and test data, the characteristics of the ethanol content, ethyl acetate content, methanol insoluble substances, heavy metal content, and microbial characteristics should draw more attention and should be considered in the future for setting newly formulated standards.

Conclusion

This paper lays the data foundation for developing higher quality standards for milk thistle extract, which plays an important role in promoting the international trade of milk thistle extract.

Loading

Article metrics loading...

/content/journals/npj/10.2174/0122103155315751240711060456
2024-07-18
2025-03-30
Loading full text...

Full text loading...

References

  1. SulasL. ReG.A. BullittaS. PiluzzaG. Chemical and productive properties of two Sardinian milk thistle (Silybum marianum (L.) Gaertn.) populations as sources of nutrients and antioxidants.Genet. Resour. Crop Evol.201663231532610.1007/s10722‑015‑0251‑5
    [Google Scholar]
  2. KarkanisA. BilalisD. EfthimiadouA. Cultivation of milk thistle (Silybum marianum L. Gaertn.), a medicinal weed.Ind. Crops Prod.201134182583010.1016/j.indcrop.2011.03.027
    [Google Scholar]
  3. ValkováV. ĎúranováH. BilčíkováJ. HabánM. Milk thistle (Silybum marianum): A valuable medicinal plant with several therapeutic purposes.J. Microbiol. Biotechnol. Food Sci.20209483684310.15414/jmbfs.2020.9.4.836‑843
    [Google Scholar]
  4. MarcedduR. DinolfoL. CarrubbaA. SarnoM. Di MiceliG. Milk thistle (Silybum Marianum L.) as a novel multipurpose crop for agriculture in marginal environments: a review.Agronomy202212372910.3390/agronomy12030729
    [Google Scholar]
  5. AbenavoliL. CapassoR. MilicN. CapassoF. Milk thistle in liver diseases: past, present, future.Phytother. Res.201024101423143210.1002/ptr.3207 20564545
    [Google Scholar]
  6. FloraK. HahnM. RosenH. BennerK. Milk thistle (Silybum marianum) for the therapy of liver disease.Am. J. Gastroenterol.199893213914310.1111/j.1572‑0241.1998.00139.x 9468229
    [Google Scholar]
  7. BijakM. Silybin, a major bioactive component of milk thistle (Silybum marianum L. Gaernt.): Chemistry, bioavailability, and metabolism.Molecules20172211194210.3390/molecules22111942 29125572
    [Google Scholar]
  8. FallahM. DavoodvandiA. NikmanzarS. AghiliS. MirazimiS.M.A. AschnerM. RashidianA. HamblinM.R. ChamanaraM. NaghshN. MirzaeiH. Silymarin (milk thistle extract) as a therapeutic agent in gastrointestinal cancer.Biomed. Pharmacother.202114211202410.1016/j.biopha.2021.112024 34399200
    [Google Scholar]
  9. ViktorovaJ. Stranska-ZachariasovaM. FenclovaM. VitekL. HajslovaJ. KrenV. RumlT. Complex evaluation of antioxidant capacity of milk thistle dietary supplements.Antioxidants20198831710.3390/antiox8080317 31426591
    [Google Scholar]
  10. LiW.Y. YuG. HoganR.M. MohandasR. FryeR.F. GumprichtE. MarkowitzJ.S. Relative bioavailability of silybin A and silybin B From 2 multiconstituent dietary supplement formulations containing milk thistle extract: A single-dose study.Clin. Ther.2018401103113.e110.1016/j.clinthera.2017.11.013 29273470
    [Google Scholar]
  11. DrouetS. LeclercE.A. GarrosL. TungmunnithumD. KabraA. AbbasiB.H. LainéÉ. HanoC. A green ultrasound-assisted extraction optimization of the natural antioxidant and anti-aging flavonolignans from milk thistle Silybum marianum (L.) gaertn. fruits for cosmetic applications.Antioxidants20198830410.3390/antiox8080304 31416140
    [Google Scholar]
  12. TewfikS. TewfikI. Nutraceuticals, functional foods and botanical dietary supplements; promote wellbeing and underpin public health.World Rev. Sci. Technol. Sustain. Dev.20085210412310.1504/WRSTSD.2008.018552
    [Google Scholar]
  13. Milk Thistle Market Outlook.2023Available from: https://www.futuremarketinsights.com/reports/milk-thistle-market
  14. BhattacharyaS. Milk Thistle Seeds in Health.2nd edNuts and Seeds in Health and Disease Prevention202042943810.1016/B978‑0‑12‑818553‑7.00030‑9
    [Google Scholar]
  15. Milk Thistle Dry Extract, Refined and Standardised (Silybi mariani extractum siccum raffinatum et normatum). European Pharmacopoeia 10.6.2022Available from: http://www.uspbpep.com/ep60/milk%20thistle%20dry%20extract%20refined%20and%20standardised%202071e.pdf
  16. Powdered Milk Thistle Extract. United States Pharmacopoeia. USP35–NF30, 1387.Available from: https://ouci.dntb.gov.ua/en/works/4ONVVQO7/
  17. Quality Requirements of Milk Thistle Extract. (T/CAB 0277-2023). Association Standards Committee of China Industry-University-Research Institute Collaboration Association.BeijingStandards Press of China2023
    [Google Scholar]
  18. Plant Extract-Milk thistle extract (Active Pharmaceutical Ingredient) (T/CCCMHPIE 1.21—2016). Association Standards Committee of China Chamber of Commerce of Medicine &Health Products Importers & Exporters; Standards Press of China: Beijing2016
    [Google Scholar]
  19. Chinese National Food Safety Standard : Determination of ash content in food (GB 5009.4-2016). Chinese National Standard.BeijingStandards Press of China2016
    [Google Scholar]
  20. Chinese National Food Safety Standard -: Determination of moisture in food (GB 5009.3-2016). Chinese National Standard;Standards Press of China: Beijing, 2016
    [Google Scholar]
  21. Residual solvent determination method. Chinese Pharmacopoeia.2020Part Four : General Rules 0861. Available from: https://www.cisema.com/en/chinese-pharmacopoeia-2020-edition-official-english-translation/
  22. Chinese National Food Safety Standard : Determination of lead in food (GB 5009.12-2023). Chinese National StandardBeijingStandards Press of China2023
    [Google Scholar]
  23. Chinese National Food Safety Standard : Determination of multi-element in food (GB 5009.268-2016). Chinese National Standard.BeijingStandards Press of China2016
    [Google Scholar]
  24. Chinese National Food Safety Standard : Determination of total arsenic and inorganic arsenic in food (GB 5009.11-2024). Chinese National Standard.BeijingStandards Press of China2024
    [Google Scholar]
  25. Chinese National Food Safety Standard : Determination of total mercury and organic mercury in food (GB 5009.17-2021). Chinese National Standard.BeijingStandards Press of China2021
    [Google Scholar]
  26. Chinese National Food Safety Standard : Determination of cadmium in food (GB 5009.15-2023). Chinese National Standard.BeijingStandards Press of China2023
    [Google Scholar]
  27. Chinese National Food Safety Standard : Microbiological testing of food: Determination of aerobic plate count (GB 4789.2-2022). Chinese National Standard.BeijingStandards Press of China2022
    [Google Scholar]
  28. (aChinese National Food Safety Standard : Microbiological testing of food - Determination of coliform count (GB 4789.3-2016). Chinese National Standard.BeijingStandards Press of China2016
    [Google Scholar]
  29. (bChinese National Food Safety Standard : Microbiological testing of food - Determination of mold and yeast count (GB 4789.15-2016). Chinese National Standard.BeijingStandards Press of China2016
    [Google Scholar]
  30. Chinese National Food Safety Standard : Microbiological testing of food - Determination of mold and yeast count (GB 4789.15- 2016). Chinese National Standard.BeijingStandards Press of China2016
    [Google Scholar]
  31. Chinese National Food Safety Standard - Microbiological testing of food - Determination of salmonella (GB 4789.4-2024). Chinese National StandardStandards Press of China: Beijing2024
    [Google Scholar]
  32. Chinese National Food Safety Standard - Microbiological testing of food - Determination of salmonella (GB 4789.4-2024). Chinese National StandardStandards Press of China: Beijing2024
    [Google Scholar]
/content/journals/npj/10.2174/0122103155315751240711060456
Loading
/content/journals/npj/10.2174/0122103155315751240711060456
Loading

Data & Media loading...


  • Article Type:
    Research Article
Keyword(s): characteristics; detection; Milk thistle extract; pharmaceuticals; silymarin; standard
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test