Milk Thistle Extract(Silymarin 80%) Dossier

• Milk Thistle origin is from central Asia and the Mediterranean region. After it has introduced in China, it is mainly cultivated in Liaoning, Inner Mongolia, Jiangsu, and Hebei province. These areas have quite similar, natural and geographical condition as its origin.
• Milk Thistle is an annual, or biennial herbaceous plant with erect stems in total 30 ~ 200cm of height. It has many branches, blooming in May until June, and fruiting period starts from June until July.

• Milk Thistle extraction is formulated from the achene extracted and from the Silybum marianum (L.) Gaertn. The main active ingredients include: Silybin (Silybin A & Silybin B), Isosilybin (Isosilybin A & Isosilybin B), Silydianin, Silychristin.
• Milk Thistle is a flavonoid extracted and has various functions including protecting and stabilizing hepatocyte membrane, which can improve hepatic function and produce the effect of reducing enzyme, and it is not easy for the enzyme to rebound. Silybin can stabilize the hepatic cell membrane and maintain its integrity, and can promote the ultrastructural restoration of hepatocytes, which promotes the division and growth of normal hepatocytes, also improve the ability of hepatocytes to synthesize RNA and protein, along with increase the production of reticuloendothelial systems.
• The ability to phagocytize cells can enhance macrophage activity to accelerate virus clearance. At the same time, Silybin can promote fat transfer and anti-oxidation, helps to prevent excessive oxidation and infiltration of fat, which eventually reduce hepatic steatosis, and promote the metabolism of the liver, enhance its detoxification, and reduce the damage of toxic substances of liver cells.
• Since the extraction has an outstanding effect of protecting normal liver cells and increase the recovery of damaged cell membranes, it’s highly applied in food, healthcare and pharmaceutical industries. The dosage forms include capsule, tablets, injection and so on.
• The formulation is a highly sensitive process only to be done by a professional. The harvested silymarin seeds generally need to be shelled, deoiled etc. to start and ready the formulation. The extraction will proceed under the precise condition control with acetone, ethanol, ethyl acetate and other different extraction solvents. After concentrating and drying, different specifications of extracts can be obtained as result.
• Some of the extractions will also need to be deoiled twice before being finally crushed. All the materials are delivered in the market after passing quality check.

• There are impurities that may impact the product quality and different countries issue the different requirements on those materials.
• Heavy metals compants and residual limitation:
• Pb & As < 2PPM      Cd, Hg <1PPM
• Microorganisms: The total number of microbial colonies < 10,000/1g.
• Among them, the number of yeasts < 1000/1g, and the number of enterobacteriaceae < 1000/1 g. Salmonella and colibacillosis cannot be detected.
• Pesticides residue: organic chlorine, organic phosphorus and aromatics are not required.
• Moisture: Loss on drying < 5%.
• Residual solvent components: ethanol, ethyl acetate ethanol, acetone, n-hexane, benzene, etc.

• There are several ways to category Silymarin products
• Category by Silybin content percentage
  • Double Silibinin 30% products: Products include Silybin A + B and Isosilybin A+B. The sum of content determined by HPLC≥ 30%, and other quality aspects can meet the requirements.
• Single Silibinin 30% products: Products include Silybin A + B. The sum of content determined by HPLC≥ 30%, and other quality aspects can meet the requirements.
• Category by Silymarin (by HPLC): The sum of Silymarin (HPLC) include Silybin (Silybin A & Silybin B), Isosilybin (Isosilybin A & Isosilybin B), Silydianin, Silychristin.
  • Silymarin 40% by HPLC:  Silybin (Silybin A & Silybin B), Isosilybin (Isosilybin A & Isosilybin B), Silydianin, Silychristin, the sum of those contents determined by HPLC≥40%.
• Silymarin 50% by HPLC: The sum of contents determined by HPLC≥ 50%.
• Silymarin 55% by HPLC: The sum of contents determined by HPLC≥ 55%.
• Silymarin 60% by HPLC: The sum of contents determined by HPLC ≥ 60%
• Category by Silymarin (by UV):

UV-VIS. (Ultraviolet and visible spectrophotometry) is a method for determining the absorbance of substances in the wavelength range of 190 to 800 nm, for material identification, impurity inspection, and quantitative determination. By this method, Silymarin (by UV) can be divided into 80% product and the others.

• Single Silibinin product category: Single Silibinin product is a silymarin product containing merely, or with Silibinin A + B as the main active ingredients.
  • 80% single Silibinin product: Silymarin (by HPLC) ≥80%, and other quality aspects can meet the requirements.
• 90% single Silibinin product: Silymarin (by HPLC) ≥90%, and other quality aspects can meet the requirements.
• 95% single Silibinin product: Silymarin (by HPLC) ≥95%, and other quality aspects can meet the requirements.
• 98% single Silibinin product: Silymarin (by HPLC) ≥95%, and other quality aspects can meet the requirements.

1. The insolubility of silymarin products give the great challenges in terms of usage and development of diverse products.
2. Thus water-soluble silymarin products come to take up the market. The water-soluble products have the following advantages:
3. － Solubility in water from 0.001g/100ml raise to 1g/100ml, and even maximum  to 10g/100ml.
4. － Silymarin(by HPLC) by all content can reach above 80%.