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وینبلاستین

Vinblastine supplier bulk factory Wholesale buy Extract factory

  1. نام انگلیسی: Vinblastine
  1. مشخصات
    • خلوص: Vinblastine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • حلالیت: Soluble in water (as sulfate salt, ~50 mg/mL), methanol, and ethanol; insoluble in non – polar solvents
    • ظاهر - مرتبط: افت در هنگام خشک شدن ≤ 1.0%، فلزات سنگین ≤ 10 ppm، حلال‌های باقیمانده ≤ 0.5%
    • اندازه ذرات: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in formulations
  1. ظاهر
    • White to off – white crystalline powder (sulfate salt form), odorless
  1. شماره CAS：143-67-9 (Vinblastine); 2068 – 78 – 2 (Vinblastine sulfate)
  1. زمان سرب: ۷ تا ۱۰ روز کاری
  1. بسته
    • 10 mg/vial (sterile glass vial), sealed under nitrogen; 100 mg/aluminum foil – lined bag for research – grade products
  1. بازار اصلی: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, mainly for oncology treatment and biomedical research
  1. سناریوهای کاربردی

خواص هسته

  • فرمول مولکولی: C₄₆H₅₈N₄O₉ (Vinblastine); C₄₆H₅₈N₄O₉·2H₂SO₄ (Vinblastine sulfate)
  • ساختار شیمیایی: An indole – alkaloid derived from Catharanthus roseus (Madagascar periwinkle), consisting of a complex dimeric structure with two linked indole rings.
  • ویژگی‌های کلیدی
    • 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.
    • فراهمی زیستی کم: Oral absorption is poor; typically administered intravenously for therapeutic use.
    • قدرت بالا: Requires careful dosage control due to significant toxicity to rapidly dividing normal cells (e.g., bone marrow, gastrointestinal tract).

سناریوهای کاربردی

1. درمان سرطان

  • 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.
  • درمان کمکی:
    • Given after surgery or radiation to reduce the risk of cancer recurrence by targeting remaining cancer cells.

2. تحقیقات زیست پزشکی

  • مطالعات زیست‌شناسی سلولی:
    • 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.
  • توسعه دارو:
    • 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. انکولوژی دامپزشکی

  • 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.

روش‌های تشخیص

  • کروماتوگرافی مایع با کارایی بالا (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.
  • کروماتوگرافی مایع - طیف‌سنجی جرمی (LC - MS):
    • Used for identifying vinblastine and its metabolites in biological samples, providing high – sensitivity detection and confirmation of the compound’s structure.
  • طیف‌سنجی فرابنفش-مرئی:
    • Quick – screening method to estimate vinblastine concentration based on its characteristic absorption peak at 262 nm, useful for initial quality control and batch analysis.

منبع و مزایا

  • منبع طبیعی: 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.
  • اهمیت درمانی: A cornerstone in cancer chemotherapy, having significantly improved survival rates for several types of cancer since its discovery.
  • ارزش تحقیق: A fundamental tool in biological research, facilitating the understanding of basic cellular processes and driving innovation in cancer treatment strategies.

انطباق با مقررات

  • سازمان غذا و داروی آمریکا (FDA): 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 (آژانس دارویی اروپا): Licensed for use in oncology, with continuous pharmacovigilance to monitor adverse effects and ensure patient safety.
  • چین NMPA: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections.
دسته: ,

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 دستگیری در حالت G2/M و mitotic disaster in quickly proliferating cells. Acknowledged as an داروهای مهم by WHO, it is clinically indispensable for treating Hodgkin lymphoma, testicular most cancers, and superior breast carcinoma.

۲. تامین، خواص شیمیایی و شناسایی‌ها

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

  • خواص شیمیایی:

    • نام شیمیایی: 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

    • وزن مولکولی: 909.06 g/mol

    • ظاهر: White to off-white hygroscopic crystalline powder

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

    • پایداری: Mild-sensitive; oxidizes beneath alkaline situations

  • شناسه‌های کلیدی:

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

    • مقدار EC (EINECS): 205-620-3

    • م.ف: C₄₆H₆₀N₄O₁₃S

    • مگاوات: 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:

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

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

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

  • مقدار مصرف:

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

  • Vital Security Profile:

    • Hematologic: افراطی 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.

    • موارد منع مصرف: Energetic infections, bone marrow suppression, being pregnant (FDA Class D).

4. Shaanxi Zhonghong: Pioneering Vinca Alkaloid Manufacturing
با 28+ years in plant-derived oncology APIs, we ship cGMP vinblastine sulfate assembly مونوگراف‌های USP/EP. 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 بیش از ۸۰ مکان بین‌المللی beneath cold-chain protocols.

۵. مشخصات دقیق و با کیفیت بالا

کلاس پارامتر مشخصات تکنیک
آفت‌کش‌ها دیکلوروس ≤0.01 میلی‌گرم بر کیلوگرم GC-MS/MS (EU 2021/601)
مالاتیون ≤0.05 میلی‌گرم بر کیلوگرم کروماتوگرافی گازی-طیف‌سنجی جرمی/طیف‌سنجی جرمی
فلزات سنگین سرب ≤1 پی پی ام دستگاه ICP-MS (USP <232>)
همانطور که ≤0.5 پی پی ام ICP-MS
میکروبیولوژی تامک ≤10² CFU/g USP <61>
Bile-tolerant GNR غایب/10 گرم USP <62>
Vital Attributes Vinblastine Sulfate ≥99.5% HPLC-ELSD (USP <621>)
وینکریستین ≤0.1% UPLC-PDA
محتوای آب ≤5.0% Karl Fischer
اندوتوکسین‌ها <0.25 اتحادیه اروپا/میلی گرم 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. جداسازی کروماتوگرافی: Flash chromatography → HPLC purification (vindoline/catharanthine).

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

  5. Sulfation: Response with sulfur trioxide advanced.

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

  7. لیوفیلیزاسیون: خشک کردن انجمادی beneath argon ambiance.

7. Scientific & Analysis Purposes

  • انکولوژی: 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:

  • شناسه: ¹H/¹³C NMR spectral match (δ 0.98 ppm, 3H, t; δ 3.70 ppm, 3H, s).

  • خلوص: 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), نازایی (membrane filtration USP <71>), حلال‌های باقیمانده (GC-HS).

  • پایداری: 36-month shelf-life at ۲-۸ درجه سانتی‌گراد (validated per ICH Q1A(R2)).

9. Chilly-Chain Logistics

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

  • بسته ثانویه: Vacuum-sealed Alu-bags در UN-certified shippers with temperature loggers.

  • ذخیره سازی: 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%)

  • مرزهای تحلیل:

    • Oral formulations (P-glycoprotein inhibitors)

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

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

۱۱. سوالات متداول

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:
✉️ ایمیل: liaodaohai@gmail.com
🌐 خالص: www.aiherba.com
Request: COA, DMF, CEP, and customized synthesis quotations.

۱۳. نتیجه‌گیری
Vinblastine sulfate stays a cornerstone antineoplastic agent with irreplaceable scientific worth. Its efficacy hinges on خلوص فوق العاده بالا (>99.5%), stringent impurity management (vincristine ≤0.1%)، و temperature-controlled dealing with. Shaanxi Zhonghong ترکیب می کند 28 years of vinca alkaloid experience, patented purification expertise، و انطباق با cGMP to ship oncology APIs that meet world pharmacopeial requirements. Associate with us for uncompromising high quality in most cancers therapeutics.

۱۴. منابع

  1. Noble RL, et al. (1958). انجمن شیمی آمریکا (J Am Chem Soc). 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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