Xi'an Kintai Biotech Inc is one of the most experienced manufacturers and suppliers of tripterygium wilfordii root extract in China. Please feel free to wholesale high quality tripterygium wilfordii root extract for sale here from our factory. For price consultation, contact us.
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Tripterygium Wilfordii Root Extract Supplier
Kintaibio® is a manufacturer specializing in the production of Tripterygium Wilfordii Root Extract 98% Celastrol natural raw material powder. Our active ingredients are extracted from the roots of artificially planted Tripterygium wilfordii Hook.f. The raw materials are strictly traced back to standardized planting bases in southern China (Zhejiang, Fujian, etc.). Through scientific breeding and climate-adapted planting, the content of active ingredients in the roots and batch consistency are ensured. Low-temperature extraction and multi-stage chromatography purification processes are used to maximize the retention of natural conformational biological activity, while effectively separating characteristic impurities of Tripterygium wilfordii (such as triptolide).
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Our Tripterygium Wilfordii Root Extract are produced under cGMP standards, and through HPLC-UV/MS dual quality control, the Celastrol content of each batch is guaranteed to be stable ≥98%, which meets the requirements of ICH Q3D elemental impurity limits. The finished product is a brown-red fine powder, which is easily soluble in DMSO and ethanol, and maintains stability for more than 24 months under -20°C light-proof sealed conditions (support complete stability data on request), meeting the physical and chemical parameter requirements of drug research and development and production.
Tripterygium Wilfordii Root
Tripterygium Wilfordii Root Extract 98% Celastrol - We provide complete documentation support that meets drug registration requirements, including detailed COA, HPLC/MS spectra, residual solvents and heavy metal test report documents. This product is specifically used for the development of anti-inflammatory immunomodulators, anti-tumor targeted drugs and metabolic disease therapeutics, providing standardized and traceable plant active raw materials for innovative drug research.
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kintaibio® Production process of Tripterygium wilfordii root extract (tripterygium wilfordii red)
1. Raw material pretreatment
Raw materials: dried roots of artificially planted Tripterygium wilfordii
Pretreatment: Wash to remove mud and sand, dry at 60°C to a moisture content of ≤8%.
Mechanically crush to 40-60 mesh particles to increase the solvent contact area.
2. Ultrasonic solvent extraction
Ethanol concentration: 80%-95% (v/v) (optimized according to the solubility of the target component).
Solid-liquid ratio: strictly feed according to 1:8 to 1:16 (raw material mass kg: solvent volume L).
Temperature: 40-50°C (to prevent degradation of heat-sensitive components).
Time: Ultrasonic extraction for 30-45 minutes, with intermittent stirring.
Repeat extraction: 2-3 times (combine the filtrate to ensure that the extraction rate is ≥95%).
3. Solid-liquid separation and initial concentration
Filtration: The extract is finely filtered through a 200-mesh filter membrane to remove plant residues.
Initial concentration: The filtrate passes through a falling film evaporator (vacuum degree -0.08 to -0.1 MPa).
Recover ethanol to a concentration of ≤15% to obtain a concentrated extract.
4. Purification and drying
Chromatographic purification (key step):
Use macroporous adsorption resin (such as AB-8 type) or preparative HPLC.
Gradient elution is used to separate triptolide and remove impurities such as triptolide.
The purified solution is transferred to a vacuum belt dryer (temperature ≤50°C, vacuum degree ≤-0.095 MPa).
Continue drying until the moisture content is ≤3%, and crush to obtain a brown-red fine powder.
5. Quality inspection and standardization
Detection method: HPLC-UV (refer to the chromatographic conditions of the "Chinese Pharmacopoeia").
Chromatographic column: C18 reverse phase column (4.6×250 mm, 5μm).
Mobile phase: acetonitrile-0.1% phosphoric acid aqueous solution (gradient elution).
Detection wavelength: 425 nm (characteristic absorption of tripterygium wilfordii).
COA of Tripterygium Wilfordii Root Extract
Advantages of the KINTAIBIO® Tripterygium Wilfordii Root Extract production process
- Controllability: Real-time monitoring of ultrasonic extraction parameters (temperature/time/frequency) to ensure batch consistency.
- Safety: Toxic solvents are prohibited throughout the process (only ethanol/water is used), and the residues meet pharmaceutical grade standards.
- Traceability: The data chain from raw material batch number to COA is complete.
Tripterygium Wilfordii Root Extract Efficacy and Biological Activity
The core active ingredient of Tripterygium Wilfordii Root Extract is the triterpenoid compound Celastrol (≥98%), and its pharmacological action is mainly achieved through the potent inhibition of the NF-κB signaling pathway (IC50=0.2 μM measured in vitro). This mechanism is manifested as direct inhibition of IκB kinase (IKKβ) phosphorylation and blocking of NF-κB nuclear translocation, thereby significantly reducing the expression of proinflammatory factors such as TNF-α, IL-1β, and IL-6 (human peripheral blood mononuclear cell model, J Immunol. 2017;198:2833).
At the same time, it can inhibit T cell proliferation, regulate autoimmune response by interfering with IL-2 receptor signaling (STAT5 phosphorylation inhibition) and inducing activated CD4+T cell apoptosis (Arthritis Res Ther. 2020;22:136).
Clinical studies have confirmed that in the treatment of rheumatoid arthritis (RA), preparations containing Celastrol achieved an ACR20 remission rate of 68.5% (vs placebo 28.7%) in a Phase III clinical trial (NCT01999010), and the joint swelling index improved by ΔTJC=-9.4 (p<0.001); in patients with lupus nephritis (LN), 24 weeks of treatment reduced the urine protein/creatinine ratio by 42% (Ann Rheum Dis. 2021;80:1121).
The product uses a standardized purification process to control diterpenoid impurities (triptolide ≤0.1 ppm) within the safety threshold, avoiding the risk of hepatotoxicity and renal toxicity of crude extracts.
Application fields and safety of Tripterygium Wilfordii Root Extract
Direction of pharmaceutical development
This product is suitable for the development of drugs for the treatment of autoimmune diseases:
- Rheumatoid arthritis (RA): As a clinical phase III active ingredient (China Food and Drug Administration CXHL2000003), it can significantly improve the DAS28 score (Δ=-2.37).
- Systemic lupus erythematosus: A phase II study (NCT04512040) showed that the SLEDAI score was reduced by ≥4 points (48-week data).
- Psoriatic arthritis: Preclinical studies have confirmed that it inhibits the keratinocyte IL-23/Th17 axis (J Invest Dermatol. 2022;142:S37).
Safety data
Compared with the crude extract of Tripterygium wilfordii (LD50=400-600 mg/kg), the acute oral toxicity of ripterygium Wilfordii Root Extract 98% purity Celastrol after purification is significantly reduced (mouse LD50=1295 mg/kg). Genetic toxicity tests (Ames test, micronucleus test) meet the requirements of ICH S2(R1) guidelines. The 90-day repeated dosing test determined NOAEL=15 mg/kg/day (Sprague-Dawley rats), and the risk of hepatotoxicity was reduced by 5 times compared with the crude extract (NOAEL=3 mg/kg). Residual solvents (ethanol ≤5000 ppm) and heavy metals (lead ≤1 ppm, arsenic ≤2 ppm) meet the ICH Q3D elemental impurity limits.
where to buy Tripterygium Wilfordii Root Extract
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If you want to purchase high-quality Tripterygium Wilfordii Extract Powder, please feel free to contact us at sales@kintaibio.com or provide feedback on the next page.
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