Oral Bioavailability is the Key to Efficacy of Milk Thistle (Silymarin)


Oral Bioavailability is the Key to Efficacy of Milk Thistle (Silymarin)


Silymarin is extracted from milk thistle plant, and the origin of milk thistle is from the Mediterranean. As early as ancient Greece and early A.D. of Europe, they already had records of the use of milk thistle to treat disease and subside jaundice. Thus, European countries have utilized milk thistle to treat liver disease for thousands of years. Now, silymarin is well recognized as a liver protective ingredient by the academic researchers, and has been published more than 4000 international papers to prove the safest and most effective liver protective ingredient of silymarin. At present, various silymarin products are sold in the world's drug store, supermarket, and wholesale food markets.

 

Silymarin first certified as a medicine was derived from a German pharmaceutical company in decades ago, and consequently in the name of advanced country’s medicine and registered in Taiwan and mainland China. Therefore, the silymarin products are sold as a medicine only in Germany, Taiwan and mainland China, and the rest of the countries such as United States, Japan, South Korea, Australia, New Zealand, Southeast Asia etc. all are food supplement. Although the U.S. Pharmacopeia includes the standard requirement  of silymarin, various silymarin products are sold as food supplement in the US markets. The reason may be from the oral absorption rate of commercially available silymarin is low (i.e., low body bioavailability), resulting in ambiguous efficacy and thus cannot approved silymarin as a treatment medicine. Many industrial and academic researchers are trying to solve the "low body bioavailability" bottleneck, and have published hundreds of papers of techniques or formulations tend to improve the silymarin oral absorption rate in academic research journals. But the improvements are still limited.

 

All countries must have their pharmacopeia specifications  for qualified drugs in pharmaceuticals. Milk thistle (Silymarin) has also in the US Pharmacopeia and Taiwan's latest eighth edition of Pharmacopeia, and has its standardized and qualified inspection specifications. Drugs must be dissolved before they can be absorbed. To estimate the body bioavailability, pharmacopeia has a minimum requirement for the dissolving rate of silymarin. That is, after the solubility test is performed in accordance with the method contained in the pharmacopeia, the minimum dissolution rate of silymarin must be higher than 75% to meet the requirements of the Pharmacopeia. By the company's collection of silymarin products from the markets of United States, Germany, Japan, Taiwan, Singapore, the results of analysis of the dissolution rate of silymarin products according to the US Pharmacopeia are compared in the following table:

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According to the U.S. Pharmacopeia analysis, data show that only the original Germany pharmaceutical and G&E Hepanamin have the capabilities to pass the Pharmacopeia dissolution specification. Hepanamin has the highest body bioavailability in the same ingredient of silymarin products, and meet the requirements of US Pharmacopeia and the latest Chinese Pharmacopeia of Taiwan. Hepanamin is the best silymarin liver medicine in the world!

2020-07-01