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  1. نام انگلیسی: Vincristine
  1. مشخصات
    • خلوص: Vincristine sulfate ≥ 98% (HPLC); high – purity grade: ≥ 99% (HPLC)
    • حلالیت: Soluble in water (as sulfate salt, approximately 10 mg/mL), ethanol; insoluble in non – polar solvents like chloroform
    • مربوط به ظاهر: 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 parenteral formulations
  1. ظاهر
    • White to off – white crystalline powder (sulfate salt form), odorless
  1. شماره CAS：2068 – 78 – 2 (Vincristine sulfate); 57 – 22 – 7 (Vincristine base)
  1. زمان سرب: ۷ تا ۱۰ روز کاری
  1. بسته
    • 1 mg/vial (sterile glass vial), sealed under nitrogen; 10 mg/aluminum foil – lined bag for research – grade products
  1. بازار اصلی: Global pharmaceutical market, especially in North America, Europe, and Asia, predominantly used in oncology treatment and biomedical research
  1. سناریوهای کاربردی

خواص هسته

  • فرمول مولکولی: C₄₇H₅₅N₅O₁₁ (Vincristine); C₄₇H₅₅N₅O₁₁·H₂SO₄ (Vincristine sulfate)
  • ساختار شیمیایی: An indole – alkaloid derived from Catharanthus roseus (Madagascar periwinkle), featuring a complex dimeric structure with a unique arrangement of indole and vindoline moieties.
  • ویژگی‌های کلیدی
    • Antimitotic Agent: Binds to tubulin subunits, inhibiting microtubule polymerization. This disrupts the formation of the mitotic spindle during cell division, leading to cell cycle arrest at the metaphase stage and subsequent apoptosis of rapidly dividing cells.
    • High Selectivity for Neurons: While effective against cancer cells, it also has significant neurotoxicity due to its affinity for microtubules in neurons, affecting axonal transport and leading to peripheral neuropathy.
    • فراهمی زیستی کم: Oral absorption is negligible, thus it is primarily administered intravenously for therapeutic use.
    • Potent Cytotoxicity: Even at low doses, it exhibits strong antitumor activity, but careful dosing is required to balance efficacy and minimize side effects.

سناریوهای کاربردی

1. درمان سرطان

  • Pediatric Cancers:
    • A crucial component in the treatment of acute lymphoblastic leukemia (ALL) in children, often used in combination regimens like VDLP (vincristine, daunorubicin, L – asparaginase, prednisone). It significantly improves remission rates, with cure rates for pediatric ALL exceeding 80% in many cases.
  • Adult Hematological Malignancies:
    • Used in the treatment of Hodgkin’s lymphoma and non – Hodgkin’s lymphoma, commonly included in combination chemotherapy protocols such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) for non – Hodgkin’s lymphoma, enhancing treatment efficacy.
  • Solid Tumors:
    • Applied as part of adjuvant or palliative therapy for solid tumors like neuroblastoma, rhabdomyosarcoma, and Wilms’ tumor, either alone or in combination with other chemotherapeutic agents to control tumor growth and improve patient prognosis.

2. تحقیقات زیست پزشکی

  • مطالعات زیست‌شناسی سلولی:
    • Serves as a valuable tool for studying microtubule – dependent cellular processes, including cell division, intracellular transport, and cell motility. By disrupting microtubule dynamics, researchers can observe the impact on various cellular functions and signaling pathways.
  • توسعه دارو:
    • Used as a reference compound for developing novel antimitotic drugs. Its structure and mechanism of action inspire the design of analogs with potentially improved therapeutic indices, reduced toxicity, and enhanced selectivity for cancer cells.
  • Neurotoxicity Research:
    • Investigated to understand the mechanisms of chemotherapy – induced peripheral neuropathy. Studying vincristine – induced neurotoxicity helps in developing strategies to prevent or mitigate this common and debilitating side effect of cancer treatment.

روش‌های تشخیص

  • کروماتوگرافی مایع با کارایی بالا (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% formic acid (gradient elution), Flow Rate: 1.0 mL/min, Detection Wavelength: 297 nm for quantification.
  • کروماتوگرافی مایع - طیف‌سنجی جرمی (LC - MS):
    • Employed for identifying vincristine and its metabolites in biological samples with high sensitivity. It provides detailed information about the compound’s structure and enables accurate quantification even at trace levels.
  • طیف‌سنجی فرابنفش-مرئی:
    • Utilized as a rapid screening method to estimate vincristine concentration based on its characteristic absorption peak at 297 nm, useful for initial quality control and batch analysis during manufacturing.

منبع و مزایا

  • منبع طبیعی: Initially isolated from the leaves and stems of Catharanthus roseus. Due to the low natural yield (about 0.0001 – 0.001% dry weight) and environmental concerns, semi – synthetic and synthetic production methods are now predominantly used to meet the global demand.
  • Therapeutic Importance: A cornerstone in cancer chemotherapy, especially for hematological malignancies and certain pediatric cancers, where it has significantly improved survival rates and patient outcomes.
  • Research Significance: Facilitates fundamental research in cell biology and oncology, driving advancements in understanding cancer mechanisms and the development of more effective cancer treatments.

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 are enforced to ensure the quality and efficacy of vincristine – based products.
  • EMA (آژانس دارویی اروپا): Licensed for use in oncology, with continuous pharmacovigilance programs in place to monitor adverse effects and ensure patient safety throughout the product lifecycle.
  • چین NMPA: Registered for clinical use in cancer treatment, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections to comply with national pharmaceutical standards.
دسته: ,

Vincristine Sulfate: The Microtubule-Concentrating on Chemotherapy Agent Revolutionizing Oncology | Supplier & Manufacturer

1. What is Vincristine?

Vincristine sulfate is a dimeric Catharanthus alkaloid derived from the Madagascar periwinkle (Catharanthus roseus). As a microtubule-disrupting agent, it binds with excessive affinity to β-tubulin on the vinca area, inhibiting microtubule polymerization and disrupting mitotic spindle meeting. This triggers metaphase arrest و آپوپتوز in quickly dividing cells. Labeled as a WHO Important Medication, it is clinically indispensable for treating acute leukemias, lymphomas, and strong tumors via its potent antimitotic exercise.

۲. تامین، خواص شیمیایی و شناسایی‌ها

  • عرضه: Remoted from Catharanthus roseus leaves; semi-synthesized from precursors catharanthine and vindoline

  • خواص شیمیایی:

    • نام شیمیایی: Methyl (2β,3β,4β,5α,12β,19α)-15-[(5S,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]-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylate sulfate

    • روش مولکولی: C₄₆H₅₆N₄O₁₀·H₂SO₄

    • وزن مولکولی: 923.04 g/mol

    • ظاهر: White to off-white hygroscopic powder

    • حلالیت: Freely soluble in water (30 mg/mL), sparingly soluble in ethanol

    • پایداری: Gentle-sensitive; degrades above pH 5.5

  • شناسه‌های کلیدی:

    • CAS: 2068-78-2 (vincristine sulfate)

    • EC Quantity (EINECS): 218-216-0

    • م.ف: C₄₆H₅₈N₄O₁₄S

    • مگاوات: 923.04

3. Pharmaceutical-Grade Specs & Scientific Profile

  • Optimum Product: Requires >99.5% HPLC purity, <0.1% vinblastine (poisonous analog), and endotoxin-free (<0.25 EU/mg)شانشی ژونگ‌هونگ از طریق ... به این مهم دست می‌یابد. countercurrent chromatography و lyophilization stabilization.

  • Therapeutic Purposes:

    • انکولوژی: First-line for ALL (induction remedy), Hodgkin/non-Hodgkin lymphoma, neuroblastoma, Wilm’s tumor

    • مکانیسم: Binds tubulin dimer (Kd=85 nM) → suppresses microtubule dynamics → mitotic disaster

    • (Observe: Nattokinase demonstrates fibrinolytic exercise; no medical proof helps nephroprotective advantages)

  • مقدار مصرف:

    • IV Administration Solely: 1.4-2.0 mg/m² weekly (max 2 mg/dose)

    • No oral bioavailability; by no means self-administer

  • Crucial Security Profile:

    • Neurotoxicity: Dose-limiting peripheral neuropathy (sensory > motor)

    • Hematologic: Delicate myelosuppression (in contrast to vinblastine)

    • Autonomic Results: Ileus, bladder atony, orthostatic hypotension

    • Extravasation Threat: Extreme tissue necrosis requiring central line

    • موارد منع مصرف: Charcot-Marie-Tooth illness, intrathecal administration (deadly)

4. Shaanxi Zhonghong: cGMP Vinca Alkaloid Specialist
با 28+ years in plant-derived oncology APIs, we produce EP/USP-compliant vincristine sulfate:

  • Scientific Infrastructure:

    • 5 College Joint Labs (Tubulin binding analysis)

    • Patented Tech: CN202310XXXXXX (Vindoline stabilization)

  • قابلیت‌های تحلیلی:

    • UPLC-MS/MS (purity/impurities)

    • 600MHz NMR (structural affirmation)

    • ICP-MS (elemental impurities)

    • LAL Chromogenic (endotoxins)

  • World Distribution: API shipments to بیش از ۸۰ مکان بین‌المللی with cold-chain compliance

5. Pharmaceutical High quality Specs

کلاس پارامتر مشخصات تکنیک
آفت‌کش‌ها کلرپیریفوس ≤0.01 میلی‌گرم بر کیلوگرم کروماتوگرافی گازی-طیف‌سنجی جرمی/طیف‌سنجی جرمی
Dimethoate ≤0.02 mg/kg LC-MS/MS
فلزات سنگین سرب ≤1.0 ppm دستگاه ICP-MS (USP <232>)
سی دی ≤0.5 پی پی ام ICP-MS
میکروبیولوژی تامک ≤10² CFU/g USP <61>
ای. کولی غایب/10 گرم USP <62>
Crucial Attributes Vincristine Sulfate ≥99.5% HPLC-PDA (USP <621>)
وینبلاستین ≤0.1% UPLC-MS
محتوای آب ≤4.0% Karl Fischer
اندوتوکسین‌ها <0.25 اتحادیه اروپا/میلی گرم LAL (USP <85>)

6. cGMP Manufacturing Course of

  1. Botanical Sourcing: C. roseus cultivated underneath GACP tips

  2. Alkaloid Extraction: Ethanol/water gradient extraction (pH 4.0)

  3. Precursor Isolation: کروماتوگرافی تبادل یونی (vindoline)

  4. Oxidative Coupling: Fe³⁺/H₂O₂-mediated dimerization

  5. Sulfation: Response with SO₃-pyridine complicated

  6. تبلور: Managed polymorph formation (Type II crystals)

  7. لیوفیلیزاسیون: -50°C freeze-drying underneath nitrogen environment

  8. فیلتراسیون استریل: 0.22 µm membrane filtration

7. Scientific & Analysis Purposes

  • Oncology Protocols:

    • R-CHOP (lymphoma)

    • VDCLP (pediatric ALL)

  • Drug Supply Methods:

    • Liposomal encapsulation (Marqibo®)

    • Peptide-drug conjugates (tumor-targeted supply)

  • Neuroscience Analysis:

    • Axonal transport research

    • Neurotoxicity modeling

8. cGMP High quality Management Protocol
Zhonghong’s 360° QC consists of:

  • شناسایی: ¹³C NMR (C-18/C-19 carbonyl resonance at 175.2 ppm)

  • خلوص: HPLC-ELSD quantifies vincristine (≥99.5%) and vinblastine (≤0.1%)

  • Efficiency: Tubulin polymerization assay (IC₅₀ 0.1-0.3 μM)

  • Security: Bacterial endotoxins (kinetic chromogenic LAL), sterility testing (USP <71>)

  • پایداری: 24-month shelf-life at ۲-۸ درجه سانتی‌گراد (ICH Q1A validated)

9. Chilly-Chain Packaging & Logistics

  • Main Container: Sort I amber vials (nitrogen headspace)

  • بسته بندی ثانویه: Vacuum-sealed Alu-PET pouches with desiccant

  • ذخیره سازی: 2-8°C shielded from gentle

  • تحویل: World cold-chain transport (2-8°C) by way of DHL Thermonet

10. Mechanism & Improvements

  • Molecular Motion:

    • Excessive-affinity binding to βIII-tubulin isotype

    • Suppresses microtubule dynamic instability by 95%

    • القا می‌کند Bim-mediated apoptosis

  • Zhonghong Improvements:

    • Enzymatic dimerization (yield ↑35%)

    • Cryogenic milling for particle dimension management

  • مرزهای تحلیل:

    • Tubulin isotype-specific analogs

    • Neuroprotective co-administration (glutamate antagonists)

  • چالش‌ها:

    • Neurotoxicity administration

    • ABC transporter-mediated resistance

۱۱. سوالات متداول

Q1: Can vincristine be used as a dietary complement?
A: Completely not. Vincristine is a cytotoxic chemotherapy agent requiring medical supervision. Unauthorized use causes extreme neurotoxicity.

Q2: Does nattokinase profit kidney sufferers?
*A: No medical proof helps nattokinase for kidney illness. Vincristine requires dose adjustment in renal impairment (CrCl <30 mL/min).*

Q3: Why is vinblastine impurity managed?
*A: Vinblastine causes distinct myelotoxicity. Our UPLC-MS detects ≤0.05% impurity (ICH Q3A limits).*

This autumn: What distinguishes Zhonghong’s vincristine?
*A: cGMP manufacturing, ≥99.5% purity, endotoxin management (<0.25 EU/mg), and patented lyophilization expertise.*

Q5: Do you provide vincristine for ADCs?
*A: Sure. GMP-grade maleimide-activated vincristine accessible for antibody-drug conjugates (DAR 4-8).*

12. World Procurement
Supply cGMP vincristine sulfate:
✉️ ایمیل: liaodaohai@gmail.com
🌐 خالص: www.aiherba.com
Request: COA, DMF, regulatory help, and customized synthesis choices.

۱۳. نتیجه‌گیری
Vincristine sulfate stays a cornerstone of pediatric and hematologic oncology with distinctive microtubule-targeting properties. Its medical utility is dependent upon خلوص فوق العاده بالا (>99.5%), stringent neurotoxic impurity management، و temperature-managed distribution. Shaanxi Zhonghong ترکیب می کند three many years of vinca alkaloid experience, patented stabilization expertise، و انطباق با cGMP to ship APIs assembly international 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. (1985). مجله بیول شیمی. 260:14608. [PMID:2995464]

  3. WHO EML (2023): Vincristine sulfate injection

  4. USP Monograph: Vincristine Sulfate. USP44-NF39

  5. EMA Guideline CPMP/QWP/1850/04

  6. Lobert S, et al. (1996). Biochemistry. 35:6806. [DOI:10.1021/bi952483n]

  7. Zhonghong Patent: CN202310XXXXXX (Cryo-milling course of)

  8. ICH Q3D (R2): Elemental Impurities

  9. FDA Label: Vincristine Sulfate Injection

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

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