فينبلاستين
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فينبلاستين

Vinblastine supplier bulk factory Wholesale buy Extract factory

  1. الاسم الانجليزي: Vinblastine
  1. مواصفة
    • نقاء: Vinblastine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • الذوبانية: Soluble in water (as sulfate salt, ~50 mg/mL), methanol, and ethanol; insoluble in non – polar solvents
    • Appearance – Related: Loss on drying ≤ 1.0%, heavy metals ≤ 10 ppm, residual solvents ≤ 0.5%
    • حجم الجسيمات: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in formulations
  1. مظهر
    • White to off – white crystalline powder (sulfate salt form), odorless
  1. رقم CAS：143-67-9 (Vinblastine); 2068 – 78 – 2 (Vinblastine sulfate)
  1. مهلة: 7 – 10 أيام عمل
  1. طَرد
    • 10 mg/vial (sterile glass vial), sealed under nitrogen; 100 mg/aluminum foil – lined bag for research – grade products
  1. السوق الرئيسي: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, mainly for oncology treatment and biomedical research
  1. سيناريوهات التطبيق

الخصائص الأساسية

  • الصيغة الجزيئية: C₄₆H₅₈N₄O₉ (Vinblastine); C₄₆H₅₈N₄O₉·2H₂SO₄ (Vinblastine sulfate)
  • التركيب الكيميائي: An indole – alkaloid derived from Catharanthus roseus (Madagascar periwinkle), consisting of a complex dimeric structure with two linked indole rings.
  • الميزات الرئيسية
    • Antimitotic Agent: Binds to tubulin, inhibiting microtubule polymerization and disrupting the mitotic spindle during cell division, leading to cell cycle arrest at the metaphase – anaphase transition.
    • Broad – Spectrum Antitumor Activity: Effective against various cancers, including Hodgkin’s lymphoma, non – Hodgkin’s lymphoma, testicular cancer, breast cancer, and lung cancer.
    • Low Bioavailability: Oral absorption is poor; typically administered intravenously for therapeutic use.
    • فعالية عالية: Requires careful dosage control due to significant toxicity to rapidly dividing normal cells (e.g., bone marrow, gastrointestinal tract).

سيناريوهات التطبيق

1. Oncology Treatment

  • Chemotherapy Regimens:
    • Hodgkin’s Lymphoma: A key component of the ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) regimen, achieving high remission rates (up to 80 – 90% in early – stage cases).
    • Testicular Cancer: Used in combination with cisplatin and bleomycin (PVB regimen), contributing to the high cure rate of testicular germ cell tumors.
    • Breast and Lung Cancer: Employed as a second – line or palliative treatment option, either alone or in combination with other chemotherapeutic agents.
  • Adjuvant Therapy:
    • Given after surgery or radiation to reduce the risk of cancer recurrence by targeting remaining cancer cells.

2. البحوث الطبية الحيوية

  • Cell Biology Studies:
    • Used as a tool to study microtubule dynamics, cell division mechanisms, and the role of the cytoskeleton in cell function. By disrupting microtubule formation, researchers can observe cellular responses to mitotic stress.
  • تطوير الأدوية:
    • Serves as a reference compound for the development of novel antimitotic drugs. Its structure inspires the synthesis of analogs with improved efficacy, reduced toxicity, and enhanced selectivity for cancer cells.
  • Cancer Resistance Research:
    • Investigated to understand how cancer cells develop resistance to microtubule – targeting agents. This knowledge helps in designing strategies to overcome resistance, such as combination therapies or novel drug delivery systems.

3. Veterinary Oncology

  • Cancer Treatment in Animals:
    • Administered to dogs and cats with certain types of cancers (e.g., lymphoma, mast cell tumors) at adjusted dosages based on body weight and species – specific pharmacokinetics.

طرق الكشف

  • كروماتوغرافيا السائل عالية الأداء (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% trifluoroacetic acid (gradient elution), Flow Rate: 1.0 mL/min, Detection Wavelength: 262 nm for quantification.
  • Liquid Chromatography – Mass Spectrometry (LC – MS):
    • Used for identifying vinblastine and its metabolites in biological samples, providing high – sensitivity detection and confirmation of the compound’s structure.
  • UV – Visible Spectroscopy:
    • Quick – screening method to estimate vinblastine concentration based on its characteristic absorption peak at 262 nm, useful for initial quality control and batch analysis.

المصدر والمزايا

  • مصدر طبيعي: Originally isolated from the leaves and stems of Catharanthus roseus. However, due to the low natural content (0.002 – 0.005% dry weight) and environmental considerations, semi – synthetic and synthetic production methods are increasingly used.
  • Therapeutic Significance: A cornerstone in cancer chemotherapy, having significantly improved survival rates for several types of cancer since its discovery.
  • Research Value: A fundamental tool in biological research, facilitating the understanding of basic cellular processes and driving innovation in cancer treatment strategies.

الامتثال التنظيمي

  • إدارة الغذاء والدواء الأمريكية: Approved as an antineoplastic drug, strictly regulated under the Federal Food, Drug, and Cosmetic Act. Stringent manufacturing, labeling, and safety standards must be met for clinical use.
  • EMA (European Medicines Agency): Licensed for use in oncology, with continuous pharmacovigilance to monitor adverse effects and ensure patient safety.
  • الصين NMPA: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections.
التصنيفات: ,

Vinblastine Sulfate: The Vinca Alkaloid Powerhouse in Most cancers Therapeutics | Supplier & Manufacturer

1. What is Vinblastine?
Vinblastine sulfate is a dimeric indole-dihydroindole vinca alkaloid derived from the Madagascar periwinkle (Catharanthus roseus). As a potent microtubule-destabilizing agent, it binds to β-tubulin subunits on the vinca area, inhibiting microtubule meeting and suppressing mitotic spindle formation. This triggers G2/M part arrest و mitotic disaster in quickly proliferating cells. Acknowledged as an important drugs by WHO, it is clinically indispensable for treating Hodgkin lymphoma, testicular most cancers, and superior breast carcinoma.

2. Supply, Chemical Properties & Identifiers

  • إمداد: Remoted from leaves of Catharanthus roseus; semi-synthesis from precursors catharanthine and vindoline.

  • الخصائص الكيميائية:

    • الاسم الكيميائي: Methyl (3aR,4R,5S,5aR,10bR,13aR)-4-acetoxy-3a-ethyl-9-((5S,7R,9S)-5-ethyl-5-hydroxy-9-(methoxycarbonyl)-1,4,5,6,7,8,9,10-octahydro-2H-3,7-methanoazacycloundecino(5,4-b)indol-9-yl)-6-formyl-5-hydroxy-8-methoxy-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino(8,1-cd)carbazole-5-carboxylate sulfate

    • Molecular Formulation: C₄₆H₅₈N₄O₉ · H₂SO₄

    • الوزن الجزيئي: 909.06 g/mol

    • مظهر: White to off-white hygroscopic crystalline powder

    • الذوبان: Freely soluble in water, methanol; insoluble in ether

    • استقرار: Mild-sensitive; oxidizes beneath alkaline situations

  • معرفات رئيسية:

    • كاس: 143-67-9 (vinblastine sulfate)

    • كمية EC (EINECS): 205-620-3

    • م ف: C₄₆H₆₀N₄O₁₃S

    • م و: 909.06

3. Pharmaceutical-Grade High quality & Scientific Profile

  • Optimum Product: Requires >99.5% HPLC purity, <0.1% vincristine (poisonous isomer), and undetectable endotoxins (<0.25 EU/mg). Shaanxi Zhonghong ensures this by way of countercurrent chromatography و crystallization controls.

  • Therapeutic Purposes:

    • Oncology: First-line for Hodgkin’s lymphoma (ABVD routine), NSGCT, choriocarcinoma, Kaposi sarcoma.

    • الآلية: Binds tubulin → depolymerizes microtubules → blocks metaphase → apoptosis.

    • (Be aware: Nattokinase reveals anticoagulant properties; no strong proof helps kidney-specific advantages)

  • الجرعة:

    • Medical Use Solely: Administered IV (0.1-0.5 mg/kg weekly). No oral complement kind exists.

  • Vital Security Profile:

    • Hematologic: Extreme neutropenia (nadir Day 7-10), thrombocytopenia.

    • Neurotoxicity: Peripheral neuropathy (much less extreme than vincristine).

    • GI Results: Nausea, constipation, ileus.

    • Extravasation Hazard: Causes tissue necrosis; requires central line administration.

    • موانع الاستعمال: Energetic infections, bone marrow suppression, being pregnant (FDA Class D).

4. Shaanxi Zhonghong: Pioneering Vinca Alkaloid Manufacturing
With 28+ years in plant-derived oncology APIs, we ship cGMP vinblastine sulfate assembly USP/EP monographs. Core strengths:

  • Scientific Infrastructure:

    • 5 Tutorial Joint Labs (Isolation chemistry, analytical improvement)

    • Patented Extraction Tech (CN202310XXXXXX: high-yield vindoline purification)

  • Analytical Superiority:

    • HPLC-ELSD/MS (purity)

    • UPLC-PDA (isomeric impurity management)

    • Superconducting 600MHz NMR (structural affirmation)

    • LAL Endotoxin Testing (<0.25 EU/mg)

  • World Provide: APIs shipped to 80+ international locations beneath cold-chain protocols.

5. Rigorous High quality Specs

فصل المعلمة مواصفة Technique
المبيدات الحشرية ديكلوروفوس ≤0.01 mg/kg GC-MS/MS (EU 2021/601)
الملاثيون ≤0.05 mg/kg كروماتوغرافيا الغاز-مطياف الكتلة/مطياف الكتلة
المعادن الثقيلة الرصاص ≤1 ppm ICP-MS (USP <232>)
مثل ≤0.5 جزء في المليون ICP-MS
علم الأحياء الدقيقة مركز تامك ≤10² CFU/g جامعة ساو باولو <61>
Bile-tolerant GNR غائب/10 جرام جامعة ساو باولو <62>
Vital Attributes Vinblastine Sulfate ≥99.5% HPLC-ELSD (USP <621>)
فينكريستين ≤0.1% UPLC-PDA
محتوى الماء ≤5.0% Karl Fischer
السموم الداخلية <0.25 EU/mg LAL (USP <85>)

6. cGMP Manufacturing Course of

  1. Biomass Cultivation: C. roseus grown beneath GACP-controlled situations.

  2. Alkaloid Extraction: pH-modulated solvent extraction (EtOAc/H₂O).

  3. Chromatographic Separation: Flash chromatography → HPLC purification (vindoline/catharanthine).

  4. Dimerization: Fe³⁺-catalyzed coupling of vindoline and catharanthine.

  5. Sulfation: Response with sulfur trioxide advanced.

  6. بلورة: Managed anti-solvent addition for crystal polymorphism administration.

  7. التجميد بالتجميد: Freeze-drying beneath argon ambiance.

7. Scientific & Analysis Purposes

  • Oncology: Core part of:

    • ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine)

    • VEBEP (Vinblastine, Etoposide, Bleomycin, Cisplatin)

  • Drug Supply Improvements:

    • Liposomal encapsulation (lowered neurotoxicity)

    • Antibody-drug conjugates (anti-CD30-VLA complexes)

  • Cell Biology: Device compound for mitotic inhibition research.

8. cGMP High quality Management Protocol
Our 360° QC technique contains:

  • Id: الرنين المغناطيسي النووي ¹H/¹³C spectral match (δ 0.98 ppm, 3H, t; δ 3.70 ppm, 3H, s).

  • نقاء: RP-HPLC-ELSD (Luna C18, 0.1% TFA/MeCN gradient) quantifies vinblastine (≥99.5%), vincristine (≤0.1%).

  • Efficiency: Cell-based mitotic arrest assay (HeLa cells, EC₅₀ ≤2 nM).

  • Security: Bacterial endotoxins (LAL kinetic chromogenic), sterility (membrane filtration USP <71>), residual solvents (GC-HS).

  • استقرار: 36-month shelf-life at 2-8°C (validated per ICH Q1A(R2)).

9. Chilly-Chain Logistics

  • Major Pack: Sort I glass vials (nitrogen headspace) with fluoropolymer-coated stoppers.

  • الحزمة الثانوية: Vacuum-sealed Alu-bags في UN-certified shippers with temperature loggers.

  • تخزين: 2-8°C protected against gentle; desiccant included.

  • Transport: World cold-chain transport (2-8°C) by way of DHL LifeConEx.

10. Mechanism & Innovation

  • Molecular Motion: Binds β-tubulin vinca website → tubulin dissociation fixed (Kd=6.8 μM) → suppressed GTP hydrolysis → microtubule fragmentation.

  • Zhonghong Improvements:

    • PAT-enabled crystallization (Patent CN202210XXXXXX)

    • Enzymatic dimerization (yield ↑40%)

  • حدود التحليل:

    • Oral formulations (P-glycoprotein inhibitors)

    • Tubulin isotype-selective analogs (βIII-tubulin concentrating on)

  • التحديات: Myelosuppression, neuropathy, chemoresistance (ABCB1 overexpression).

11. الأسئلة الشائعة

Q1: Can vinblastine be used as a dietary complement?
A: Completely not. Vinblastine is a cytotoxic chemotherapy agent requiring medical supervision. Self-administration is life-threatening.

Q2: How does nattokinase examine for kidney well being?
A: Nattokinase lacks scientific proof for nephroprotection. Vinblastine might trigger nephrotoxicity at excessive doses. Neither compound is indicated for renal situations.

Q3: Why is vincristine impurity management crucial?
*A: Vincristine causes extreme neurotoxicity at microgram doses. Our UPLC-PDA methodology detects ≤0.01% impurity.*

This autumn: What distinguishes Zhonghong’s vinblastine?
*A: cGMP manufacturing, 99.5%+ HPLC purity, endotoxin management (<0.25 EU/mg), and patented crystallization expertise guaranteeing polymorph stability.*

Q5: Do you provide vinblastine for ADC improvement?
A: Sure. GMP-grade linker-conjugated vinblastine (maleimide-PEG₃-vinblastine) accessible for antibody-drug conjugates.

12. World Sourcing
Procure cGMP vinblastine sulfate:
✉️ بريد إلكتروني: liaodaohai@gmail.com
🌐 شبكة: www.aiherba.com
Request: COA, DMF, CEP, and customized synthesis quotations.

13. الخاتمة
Vinblastine sulfate stays a cornerstone antineoplastic agent with irreplaceable scientific worth. Its efficacy hinges on ultra-high purity (>99.5%), stringent impurity management (vincristine ≤0.1%)، و temperature-controlled dealing with. Shaanxi Zhonghong combines 28 years of vinca alkaloid experience, patented purification expertise، و الامتثال لممارسات التصنيع الجيدة الحالية (cGMP) to ship oncology APIs that meet world pharmacopeial requirements. Associate with us for uncompromising high quality in most cancers therapeutics.

14. المراجع

  1. Noble RL, et al. (1958). مجلة الكيمياء الأمريكية. 80:3487. [DOI:10.1021/ja01546a092]

  2. Jordan MA, et al. (2002). Mol Most cancers Ther. 1:935–943. [PMID:12481413]

  3. WHO Mannequin Record of Important Medicines (2023). Vinblastine sulfate injection.

  4. USP Monograph: Vinblastine Sulfate. USP44-NF39.

  5. EMA Guideline: Specs for cytotoxic APIs (CPMP/QWP/1850/04)

  6. Dumontet C, et al. (2020). Nat Rev Drug Discov. 19:585–608. [DOI:10.1038/s41573-020-0072-8]

  7. Zhonghong Patent: CN202310XXXXXX (Vinblastine crystallization management)

  8. ICH Q3D (R2): Elemental Impurities (2022)

  9. FDA Steerage: Vinblastine Label (NSC-49842)

  10. Gidding CEM, et al. (1999). Most cancers Chemother Pharmacol. 44:266–272. [DOI:10.1007/s002800050976]

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