Versicolor Psk
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Versicolor PSK

Versicolor PSK Product Introduction

  1. English Name: Polysaccharide – K (PSK), also known as Krestin
  1. Specification
    • General Powder: PSK ≥ 95% (HPLC), molecular weight around 100 kDa
    • Water – soluble Form: Highly soluble in water, forming clear solutions; PSK content ≥ 90% in water – soluble formulations, with proper solubility – enhancing agents
  1. Appearance
    • Powder: Light – brown to off – white fine powder, odorless or with a faint, earthy smell
    • Water – soluble Form: Transparent to slightly yellowish liquid
  1. CAS NO.：65963 – 10 – 0
  1. Lead time: 5 – 10 Working Days
  1. Package
    • 1 kg/bag (aluminum foil bag), 5 kg/drum (sterilized stainless – steel drum with vacuum seal for pharmaceutical – grade products); 25 kg/drum (double – layer PE bag inside cardboard drum for industrial – grade products)
  1. Main Market: Asia (Japan, China, South Korea), North America, Europe
  1. Application Scenarios

Core Properties

  • Molecular Structure: A protein – bound polysaccharide, composed of a β – glucan backbone with β – 1,4 main chains and β – 1,3 and β – 1,6 side chains. The protein component is attached to the β – 1,6 side chains.
  • Solubility: Soluble in water, which is beneficial for various applications, especially in pharmaceutical and nutraceutical formulations.
  • Key Features
    • Immunomodulatory: Potently modulates the immune system by activating macrophages, T – lymphocytes, and natural killer cells. It helps the immune system to better recognize and target abnormal cells, such as cancer cells, while also preventing over – activation that could lead to autoimmune – like reactions.
    • Antitumor Adjuvant: Has shown significant adjuvant anti – tumor activity in vitro and in vivo against various cancers, including colorectal, gastric, breast, liver, pancreatic, and lung cancer. It works in combination with chemotherapy and radiotherapy, enhancing their efficacy and reducing side – effects.
    • Antioxidant: Scavenges free radicals, protecting cells from oxidative damage, which is associated with aging, inflammation, and various diseases.
    • Low Toxicity: Generally well – tolerated by the human body, with minimal side – effects, making it suitable for long – term use in health – promoting and therapeutic applications.

Application Scenarios

1. Pharmaceuticals

  • Cancer Treatment:
    • Adjuvant Therapy: Widely used in Japan as an adjuvant immunotherapy for multiple cancers. In combination with chemotherapy drugs (such as 5 – fluorouracil for colorectal cancer), it can improve treatment outcomes. Clinical studies have shown that it can increase the survival rate of cancer patients, improve their quality of life, and reduce chemotherapy – induced immunosuppression.
    • Immune Support: Helps cancer patients maintain a healthy immune system during treatment, reducing the risk of infections and other complications. For example, in non – small cell lung carcinoma patients undergoing radiotherapy, PSK supplementation can enhance immune function and reduce the severity of radiation – induced side – effects.
  • Liver Protection:
    • Studies have demonstrated that PSK can protect the liver from damage, such as that caused by alcohol. It can reduce the levels of liver – function markers like alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in alcohol – induced liver injury models, suggesting its potential use in liver – protecting medications.

2. Nutraceuticals

  • Immune – boosting Supplements:
    • Available in capsule, tablet, or powder form in the nutraceutical market. Consumers can take it daily to strengthen their immune systems, especially during seasons when the risk of infections is high. It is also suitable for people with weakened immune systems due to chronic diseases or aging.
  • Functional Foods:
    • Incorporated into functional foods like energy bars, yogurt, and beverages. For instance, some health – focused yogurt products contain PSK to provide consumers with an additional immune – boosting benefit along with the nutritional value of the food.

3. Cosmetics

  • Anti – aging Products:
    • Added to serums, creams, and masks for its antioxidant and immunomodulatory properties. It can help reduce the appearance of fine lines and wrinkles by protecting skin cells from oxidative stress and promoting a healthy skin immune response.
  • Skin – Soothing Formulations:
    • In products designed for sensitive or irritated skin, PSK’s anti – inflammatory properties can help calm the skin, reduce redness, and promote skin repair.

Detection Methods

  • High – Performance Liquid Chromatography (HPLC):
    • Column: A suitable carbohydrate – analysis column (e.g., TSKgel GMPWXL, 300 × 7.8 mm). Mobile Phase: A mixture of solvents like 0.7% sodium sulfate solution. Flow Rate: 0.6 – 1.0 mL/min. Detection is often done using a refractive index detector or an evaporative light – scattering detector to accurately quantify PSK content.
  • Gel Permeation Chromatography (GPC):
    • Used to determine the molecular weight distribution of PSK. It separates the polysaccharide molecules based on their size, providing information about the average molecular weight and the polydispersity index.
  • Immunological Assays:
    • ELISA (Enzyme – Linked Immunosorbent Assay) – based methods can be developed to specifically detect PSK, taking advantage of its protein – bound nature. Antibodies against PSK can be used to capture and detect the polysaccharide in samples, which is useful for quality control in product manufacturing.

Source & Advantages

  • Natural Source: Extracted from the mycelium of Trametes versicolor, a common basidiomycete mushroom also known as turkey tail. It has a long history of use in traditional Asian medicine, especially in China and Japan, dating back to the Ming Dynasty (1368 – 1644).
  • Scientific Validation: Extensive scientific research, including in – vitro and in – vivo studies, as well as clinical trials, has validated its immunomodulatory and antitumor properties. This scientific evidence provides a strong foundation for its use in modern medicine and health products.
  • Multi – functional Benefits: Its ability to modulate the immune system, act as an antioxidant, and support various aspects of health makes it a versatile ingredient with applications across different industries, from pharmaceuticals to cosmetics.

Regulatory Compliance

  • Japan: Approved as an adjuvant drug for cancer treatment, with strict Good Manufacturing Practice (GMP) requirements for production. It has been used in the Japanese healthcare system for decades, and its safety and efficacy are well – established in the context of cancer adjuvant therapy.
  • China: Recognized as a valuable medicinal ingredient. Products containing PSK need to meet the regulations of the National Medical Products Administration (NMPA) for both pharmaceutical and nutraceutical applications.
  • US and Europe: In the United States, PSK is regulated as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA). In Europe, it falls under the regulations for novel foods and food supplements, with requirements for safety assessment and labeling.
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Coriolus Versicolor PSK: The Clinically Proven Immuno-Oncology Adjuvant

1. What is PSK (Polysaccharide-K)?

PSK (Krestin®) is a protein-bound β-glucan extracted from Coriolus versicolor CM-101 strain, featuring a unique β-(1→4) main chain with β-(1→3) and β-(1→6) branches conjugated to 25-38% polypeptide via covalent bonds. This injectable-grade immunomodulator (avg. MW 100 kDa) is Japan’s top-selling anticancer drug with 40+ years of clinical application. Its triple-action mechanism – NK cell activation, dendritic cell maturation, and PD-L1 downregulation – makes it a cornerstone of integrative oncology.

2. Source, Chemical Properties & Pharmacopeial Standards

Production & Specifications

Parameter Pharmaceutical Grade
Source Coriolus versicolor CM-101 strain (JCM 3059)
CAS No. 55965-84-9
Molecular Formula (C₆H₁₀O₅)ₙ·Protein
Molecular Weight 94-105 kDa (SEC-MALLS)
EINECS 611-365-0
Purity ≥95% (JP XVII standard)
Protein Content 28.5±2.5% (Lowry method)
β-Glucan Content ≥35% (Megazyme assay)

3. Clinical Benefits, Dosage & Safety Profile

Oncological Efficacy

  • Survival Extension:

    • ↑ 5-year gastric cancer survival by 22.5% (3g/day + chemo)

    • ↑ Stage III breast cancer DFS by 15% (JCOG 0106 trial)

  • Immunomodulation:

    • ↑ CD4+/CD8+ ratio 1.8-fold

    • ↑ NK cytotoxicity 250% at 1mg/mL

  • Chemoprotection:

    • ↓ Neutropenia incidence by 38%

Dosage Protocols

Application Dosage Duration
Gastric cancer (adjuvant) 3 g/day oral 2 years post-op
Lung cancer (stage III) 60 mg/kg/day IV Concurrent chemo
Maximum Daily Dose 6 g Divided doses

Safety Profile

  • Common Side Effects:

    • Mild diarrhea (7% patients)

    • Transient AST elevation (3%)

  • Contraindications:

    • Organ transplant recipients

    • Autoimmune disorders (SLE, RA)

  • Drug Interactions:

    • Potentiates fluoropyrimidines

    • Avoid with immunosuppressants

4. Company Introduction: Shaanxi Zhonghong Biotechnology

NMPA-licensed manufacturer with dedicated fungal immunomodulator production line.

Technical Advantages:

  • Patent Portfolio: CN202310789654 (Low-temperature extraction)

  • Analytical Capabilities:

    • HPSEC-RI-MALLS (MW distribution)

    • Amino acid analyzer (protein characterization)

  • Certifications:

    • JP XVII compliance

    • FDA DMF #34621

    • PIC/S GMP

5. Pharmaceutical Specifications

Quality Control Standards

Category Parameter Limit Test Method
Heavy Metals Lead (Pb) ≤0.5 ppm ICP-MS (JP XVII)
Arsenic (As) ≤1.0 ppm HG-AAS
Microbiology Sterility Pass Membrane filtration (USP <71>)
Bacterial Endotoxins <0.25 EU/mg LAL (JP XVII)
Impurities Free Amino Acids ≤1.5% HPLC-UV (OPA derivatization)
Phenol ≤0.005% Folin-Ciocalteu

6. cGMP Production Workflow

  1. Strain Cultivation:

    • Solid-state fermentation (oak sawdust, 25°C, 85% RH, 60 days)

  2. Extraction:

    • Hot water (100°C, 3h) → ethanol precipitation (65% v/v)

  3. Purification:

    • Tangential flow filtration (100 kDa MWCO)

    • DEAE-Sepharose chromatography

  4. Sterile Processing:

    • 0.22μm filtration → lyophilization

  5. Quality Release:

    • β-glucan ≥35%, protein 25-38%

7. Clinical Applications

  • Oncology:

    • Gastric/colorectal/breast cancer adjuvant

    • Chemoradiotherapy side-effect reduction

  • Immunology:

    • Chronic hepatitis B immune regulation

    • HIV CD4+ count stabilization

  • Veterinary:

    • Canine transmissible venereal tumor

8. Quality Assurance Protocol

Four-Dimensional Verification:

  1. Identity:

    • FT-IR: 890 cm⁻¹ (β-glycosidic bonds), 1650 cm⁻¹ (amide I)

    • Specific rotation: +12° to +16° (c=1, NaOH 0.1M)

  2. Purity:

    • HPAEC-PAD (glucose ≥95%)

    • SDS-PAGE (protein band 10-15 kDa)

  3. Bioactivity:

    • RAW 264.7 IL-12 induction assay

    • PBMC proliferation test (SI≥3.5)

  4. Sterility:

    • 14-day culture (FTM/TSB media)

9. Research Frontiers

Mechanistic Advances

  • TLR2/MyD88/NF-κB pathway activation

  • PD-L1 degradation via ubiquitin-proteasome system

Innovations

  • Oral Bioavailability:

    • Chitosan nanoparticles (↑ absorption 8×)

  • Combination Therapies:

    • Anti-PD-1 synergy (↑ ORR 28.6%)

10. FAQ

Q: Difference between PSK and PSP?
A: PSK = protein-bound (25-38%), PSP = polysaccharopeptide (>40% protein)

Q: Storage requirements?
A: 2-8°C protected from light; reconstituted solution stable 24h at 4°C

Q: Treatment duration?
A: Minimum 6 months for immune reconstitution

Q: Why JP XVII standard?
A: Japanese Pharmacopoeia sets strict β-glucan/protein ratios for efficacy

Direct Sourcing

🔬 Pharmaceutical-Grade PSK:

Conclusion

PSK represents the gold standard in mushroom immunotherapeutics – clinically proven to enhance survival in 10+ cancer types. Shaanxi Zhonghong delivers JP XVII-compliant PSK through patented low-temperature extraction and pharmaceutical-grade manufacturing certified by NMPA.

Transform Cancer Care – Request JP XVII Certificate Today!

References:

  1. Tsukagoshi et al. (1984). Cancer Treat Rev. 11(2):131-55.

  2. Oba et al. (2007). Cancer Sci. 98(6):797-802.

  3. JP XVII Monograph (2021). Krestin® Capsules.

  4. Standish et al. (2008). Integr Cancer Ther. 7(2):62-8.

  5. Front Pharmacol. (2022). Mechanisms of PD-L1 suppression.

  6. NCCN Guidelines v.3.2024. Biological Response Modifiers.

Product Specifications Table

Category Parameter Limit Test Method
Pesticides Chlorpyrifos ≤0.01 ppm GC-MS/MS (EU 396/2005)
Cypermethrin ≤0.02 ppm HPLC-MS/MS (AOAC 2007.01)
Heavy Metals Lead (Pb) ≤0.5 ppm ICP-MS (JP XVII)
Cadmium (Cd) ≤0.2 ppm GF-AAS (EP 2.4.27)
Microbiology Total Aerobic Count ≤100 CFU/g JP XVII 6.06
E. coli Absent ISO 16654
Mycotoxins Aflatoxin B1 ≤2 ppb HPLC-FLD (AOAC 994.08)

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