مكونات الرعاية الصحية والأدوية, مستخلصات نباتية طبيعية

كامبتوثيسين

Camptothecin supplier bulk factory Wholesale buy Extract factory

الاسم الانجليزي: Camptothecin

مواصفة

- نقاء: Camptothecin ≥ 98% (HPLC); High – purity grade: ≥ 99% (HPLC)

- الذوبانية: Sparingly soluble in water (approx. 0.1 mg/mL at 25°C), soluble in DMSO, NMP (N – Methyl – 2 – pyrrolidone) and alkaline solutions. Water – soluble derivatives (e.g., sodium salt) have improved solubility.

- نقطة الانصهار: 260 – 264°C (decomposes)

- المذيبات المتبقية: DMSO ≤ 0.5%, NMP ≤ 0.5%

- المعادن الثقيلة: ≤ 10 جزء في المليون

- حجم الجسيمات: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for enhanced bioavailability in formulations

مظهر

- Pale yellow to yellowish – green crystalline powder, odorless

رقم CAS：7689 – 03 – 4

مهلة: 7 – 10 Working Days

طَرد

- 100 mg/vial (sterile glass vial), 1 g/aluminum foil – lined bag; stored under nitrogen to prevent oxidation

السوق الرئيسي: Global pharmaceutical and research markets, with significant demand in North America, Europe, and Asia, especially in oncology research and drug development

سيناريوهات التطبيق

الخصائص الأساسية

الصيغة الجزيئية: C₂₀H₁₆N₂O₄

التركيب الكيميائي: A pentacyclic quinoline alkaloid, featuring a unique camptothecin ring system with a lactone moiety, which is crucial for its biological activity.

الميزات الرئيسية

- Topoisomerase Inhibitor: Specifically targets DNA topoisomerase I, preventing the religation of DNA strands during replication, leading to DNA damage and cell death in rapidly dividing cells.

- Antitumor Activity: Potent cytotoxic effects against a wide range of cancer cell lines, including colorectal, lung, ovarian, and pancreatic cancers.

- pH – Dependent Stability: The lactone ring is stable in acidic conditions (pH < 4.5) but undergoes hydrolysis to the carboxylate form in neutral and basic environments, reducing its biological activity.

- High Potency: Low therapeutic doses are required due to its strong inhibitory effect on DNA replication, but this also necessitates careful handling to manage potential toxicity.

سيناريوهات التطبيق

1. أبحاث الأورام

Pre – clinical Studies:

- Widely used in in – vitro cell culture experiments and in – vivo animal models to study the mechanism of action of topoisomerase I inhibitors, screen for new anticancer drugs, and evaluate the efficacy of combination therapies.

تطوير الأدوية:

- Serves as a lead compound for the development of second – generation and third – generation camptothecin – based drugs. Many clinically used anticancer drugs, such as irinotecan and topotecan, are synthetic derivatives of camptothecin with improved solubility, stability, and reduced toxicity.

2. صناعة الأدوية

Anticancer Drug Synthesis:

- As an intermediate in the production of camptothecin – derived drugs. Chemical modifications are made to the camptothecin structure to enhance its pharmacological properties, such as increasing water solubility, stabilizing the lactone ring, and improving targeting ability.

ضبط الجودة:

- Used as a reference standard for the analysis and quality control of camptothecin – based drugs, ensuring the consistency and purity of pharmaceutical products.

3. البحث الطبي الحيوي

DNA Replication and Repair Studies:

- Helps researchers understand the processes of DNA replication, repair, and the role of topoisomerases in maintaining genomic stability. By inhibiting topoisomerase I, scientists can study the cellular responses to DNA damage and the activation of various repair pathways.

Drug Resistance Research:

- Investigated to understand the mechanisms of drug resistance in cancer cells towards camptothecin and its derivatives. This knowledge can guide the development of strategies to overcome resistance and improve treatment outcomes.

طرق الكشف

كروماتوغرافيا السائل عالية الأداء (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: 254 nm for quantification.

كروماتوغرافيا السوائل فائقة الأداء - مطيافية الكتلة (UPLC – MS):

- Used for the identification and quantification of camptothecin and its metabolites in biological samples. It provides high – sensitivity and high – resolution analysis, crucial for pharmacokinetic and pharmacodynamic studies.

مطيافية تحويل فورييه بالأشعة تحت الحمراء (FTIR):

- Helps in confirming the chemical structure of camptothecin by analyzing the characteristic absorption peaks of its functional groups, ensuring the integrity of the compound during production and storage.

المصدر والمزايا

مصدر طبيعي: Originally isolated from the bark and wood of the Chinese tree Camptotheca acuminata. However, due to the low content of camptothecin in the plant (0.01 – 0.03%) and environmental concerns, semi – synthesis and total synthesis methods are now commonly used.

الإمكانات العلاجية: Its unique mechanism of action makes it a valuable starting point for the development of highly effective anticancer drugs, contributing significantly to the field of oncology.

أداة البحث: A crucial tool in biomedical research, enabling a deeper understanding of fundamental biological processes related to DNA metabolism and cancer biology.

الامتثال التنظيمي

إدارة الغذاء والدواء الأمريكية: Regulated as an investigational new drug (IND) for research purposes and as a pharmaceutical ingredient for approved camptothecin – based drugs. Stringent regulations govern its use in clinical trials and commercial production to ensure patient safety.

لائحة الاتحاد الأوروبي: Subject to strict regulations under the European Medicines Agency (EMA). Clinical trials involving camptothecin and its derivatives must comply with Good Clinical Practice (GCP) guidelines, and marketing authorization is required for commercial use.

الصين NMPA: Monitored closely in China, especially for drugs derived from camptothecin. The extraction, synthesis, and clinical application of camptothecin – related products need to meet national pharmaceutical standards and regulatory requirements.

القسم: مكونات الرعاية الصحية والأدوية, مستخلصات نباتية طبيعية

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Camptothecin: Nature’s Potent Topoisomerase Inhibitor for Oncology & Analysis | Supplier & Manufacturer

1. What is Camptothecin?

Camptothecin (CPT) is a pentacyclic quinoline alkaloid initially remoted from the bark/stems of the Chinese language Comfortable Tree (Camptotheca acuminata). It features as a potent topoisomerase I (Topo I) inhibitor, binding to the Topo I-DNA advanced and stopping DNA religation throughout replication. This triggers replication fork collapse, double-strand DNA breaks، و S-phase selective apoptosis in quickly dividing cells. Its distinctive mechanism underpins its significance in oncology therapeutics و most cancers biology analysis.

2. Supply, Chemical Properties & Identifiers

إمداد: مستخرجة في المقام الأول من Camptotheca acuminata bark/seeds. Semi-synthesis from plant precursors is widespread.
الخصائص الكيميائية:
- الاسم الكيميائي: (S)-4-Ethyl-4-hydroxy-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione
- المكونات الجزيئية: C₂₀H₁₆N₂O₄
- الوزن الجزيئي: 348.36 g/mol
- مظهر: Pale yellow to gentle inexperienced crystalline powder
- الذوبان: Lactone ring pH-dependence – Soluble in DMSO, DMF, chloroform (closed lactone kind, energetic); hydrolyzes to inactive carboxylate kind in aqueous pH >7.
- استقرار: Mild and pH-sensitive. Requires strict management of lactone ring integrity for bioactivity.
معرفات رئيسية:
- كاس: 7689-03-4
- كمية EC (EINECS): 231-684-4
- م ف: C₂₀H₁₆N₂O₄
- م و: 348.36

3. Purity, Efficacy, Security & Dosage

Optimum Product: The “finest” camptothecin options >99% HPLC purity, >95% lactone kind content material (important for exercise), and undetectable contaminants. Shaanxi Zhonghong achieves this by way of proprietary pH-controlled crystallization و التجميد بالتجفيف.
Well being Benefits & Functions:
- Anticancer Exercise: Core mechanism: Topo I inhibition → DNA harm → S-phase apoptosis. Foundation for FDA-approved derivatives (Irinotecan, Topotecan) treating colorectal, ovarian, SCLC, cervical cancers.
- Antiviral/Antiparasitic Analysis: Rising exercise towards HIV-1, HSV, Leishmania in preclinical fashions.
- (Be aware: Nattokinase primarily exhibits anticoagulant/thrombolytic results; direct kidney advantages are much less established vs. potential CPT nephrotoxicity issues).
Dosage & Administration:
- NOT a dietary complement. Used clinically as IV derivatives below strict medical supervision.
- Analysis doses differ (usually 0.1-100 µM في المختبر; mg/kg ranges في الجسم الحي). No secure each day consumption for self-administration exists.
Important Precautions & Aspect Results:
- Extreme Toxicity: Myelosuppression (neutropenia, thrombocytopenia), extreme diarrhea (cholinergic & delayed), hemorrhagic cystitis, hepatotoxicity.
- Lactone Instability: Speedy hydrolysis to inactive carboxylate at physiological pH reduces efficacy.
- موانع الاستعمال: Being pregnant/lactation (teratogenic), pre-existing bone marrow melancholy, energetic infections.
- التعامل مع: Cytotoxic – Requires PPE (gloves, masks, lab coat). Keep away from inhalation/pores and skin contact.

4. Shaanxi Zhonghong: Your Premier Camptothecin Supply

Shaanxi Zhonghong Investment Technology Co., Ltd. is a cGMP/ISO-certified chief in high-purity plant-derived APIs. With 28+ years in bioactive phytochemistry, we focus on:

Core Capabilities:
- التميز العلمي: 5 College Joint Labs, 20+ Patents (incl. CPT stabilization tech), Unique Natural Compound Library.
- Slicing-Edge Analytics: HPLC-PDA/ELSD (purity), UPLC-QTOF-MS (impurity profiling), Superconducting FT-NMR (construction ID), ICP-MS (المعادن الثقيلة)، كروماتوغرافيا الغاز-مطياف الكتلة/مطياف الكتلة (residual solvents). Purity >99%, exceeding USP by 20%.
- تحقيق دولي: يوفر أكثر من 80 دولة – Pharma, Biotech, Tutorial Analysis.
- التكامل الرأسي: مصادر مستدامة → GMP Extraction → pH-Managed Purification → التجميد بالتجميد.

5. Rigorous Product Specs

فئة الملوثات	المعلمة	تقييد المواصفات	ألق نظرة على التقنية
المبيدات الحشرية	الكلوربيريفوس	≤ 0.01 ملغ/كغ	كروماتوغرافيا الغاز-مطياف الكتلة/مطياف الكتلة
	سايبرمثرين	≤ 0.05 ملغ/كغ	GC-ECD
	Whole Different Pesticides	≤ 0.1 mg/kg (every)	EU 2021/601
المعادن الثقيلة	الرصاص	≤ 1.0 ملغ/كغ	ICP-MS (USP <232>)
	مثل	≤ 0.5 ملغ/كغ	ICP-MS (USP <232>)
	قرص مضغوط	≤ 0.5 ملغ/كغ	ICP-MS (USP <232>)
	الزئبق	≤ 0.1 ملغ/كغ	CVAAS (USP <232>)
ميكروبيولوجي	مركز تامك	≤ 10³ وحدة تشكيل مستعمرة/جم	جامعة ساو باولو <61>
	TYMC	≤ 10² وحدة تشكيل مستعمرة/جم	جامعة ساو باولو <61>
	الإشريكية القولونية	غائب في 10 جرام	جامعة ساو باولو <62>
	السالمونيلا أنواع	Absent in 375g	جامعة ساو باولو <62>
Important High quality	Camptothecin Purity	≥ 99.0% (HPLC)	HPLC-PDA (USP <621>)
	Lactone Kind	≥ 95.0%	pH-Particular HPLC
	Water Content	≤ 2.0%	Karl Fischer (USP <921>)
	المذيبات المتبقية	Class 1/2 Solvents: Undetected	GC-FID (ICH Q3C)

6. سير عمل تصنيع متفوق

الحصاد المستدام: Camptotheca acuminata cultivated below GACP tips.
الاستخراج الانتقائي: Ethanol/Water أو ثاني أكسيد الكربون فوق الحرج extraction of bark/seeds.
التطهير الرئيسي: تقسيم السائل-السائل (CH₂Cl₂/H₂O), adsorbent chromatography (SiO₂, polyamide).
Lactone Stabilization: pH-controlled crystallization (pH 3.5-4.5) to maximise lactone yield.
Last Purification: HPLC التحضيري (C18 column, MeOH/H₂O/TFA cell section).
تجفيف: التجميد بالتجميد (-50°C, <10 Pa) to protect lactone ring & stability.
إطلاق مراقبة الجودة: ممتلىء شهادة التحليل verifying identification, purity, lactone content material, contaminants.

7. Key Application Areas

Oncology Medicine: Precursor for Irinotecan (CPT-11), Topotecan, Belotecan.
Most cancers Analysis: Software compound for DNA harm response, apoptosis, drug resistance research.
Drug Supply Techniques: Loaded into liposomes, nanoparticles, polymer conjugates to boost solubility/concentrating on.
Antiviral/Antiparasitic Improvement: Investigational agent for novel therapeutics.

8. cGMP High quality Management Protocol
توظف شنشي تشونغ هونغ أ tiered QC technique:

تعريف: الرنين المغناطيسي النووي بتقنية تحويل فورييه (¹H/¹³C), HPLC-UV/PDA spectral match vs. USP reference customary.
Assay & Impurities: HPLC-ELSD/PDA quantifies CPT (≥99.0%) and detects ≤0.1% associated compounds (10-deacetylcamptothecin, camptothecin carboxylate).
Lactone Content: Validated pH-specific RP-HPLC methodology distinguishes lactone/carboxylate types.
الملوثات: ICP-MS for heavy metals (USP <232>), كروماتوغرافيا الغاز-مطياف الكتلة/مطياف الكتلة for 500+ pesticides (EU 2021/601), LC-MS/MS for mycotoxins, جامعة ساو باولو <61>/<62> for microbiology.
استقرار: Actual-time & accelerated ICH Q1A(R2) research verify 24-month shelf-life at -20°C (desiccated, argon ambiance).

9. Safe Packaging & Logistics

Major Pack: Amber glass vials sealed below argon, full of desiccant.
Secondary Pack: Vacuum-sealed aluminum luggage داخل UN-certified HDPE containers.
تخزين: -20 درجة مئوية ± 5 درجة مئوية; defend from gentle/moisture.
توصيل: International cold-chain logistics (-15°C to -25°C) by way of DHL FedEx UltraCold.

10. Mechanisms, Functions & Challenges

الآلية: Traps Topo I-DNA cleavable complexes → Collision with replication forks → DSBs → ATR/Chk1 activation → p53-mediated apoptosis.
ابتكار: تشونغهونغ PEGylated liposomal CPT (Patent: CN202210XXXXXX) enhances tumor concentrating on.
حدود التحليل:
- Novel Analogues: 7-Silylcamptothecins (improved lactone stability).
- العلاجات المختلطة: With PARP inhibitors, immunotherapy.
- Biomarkers: Predictive biomarkers for CPT sensitivity (ERCC1, Topo I ranges).
التحديات: Lactone instability, myelosuppression, ABCG2-mediated drug resistance, tumor heterogeneity.

11. Steadily Requested Questions (FAQ)

Q1: Can I take Camptothecin as a complement?
- A: Completely NOT. CPT is a potent cytotoxic compound with extreme unintended effects. Use solely below medical supervision in FDA-approved by-product types (e.g., Irinotecan) or for managed analysis.
Q2: Why is lactone kind important?
- أ: Solely the closed lactone ring binds Topo I. The open carboxylate kind is inactive and will trigger renal toxicity. Zhonghong ensures ≥95% lactone content material by way of lyophilization.
Q3: How does Camptothecin differ from Nattokinase for kidneys?
- أ: CPT carries nephrotoxicity dangers (tubular harm). Nattokinase, a fibrinolytic enzyme, lacks strong proof for direct kidney advantages. Neither is nephroprotective.
This autumn: What analytical strategies verify Zhonghong’s CPT purity?
- أ: HPLC-PDA/ELSD (purity), UPLC-QTOF-MS (impurities), الرنين المغناطيسي النووي بتقنية تحويل فورييه (construction), pH-HPLC (lactone quantification), ICP-MS (heavy metals).
Q5: Do you supply Camptothecin derivatives?
- أ: Sure. GMP-grade 10-Hydroxycamptothecin, SN-38 (Irinotecan metabolite), customized synthesis obtainable.

12. The place to Purchase?
Supply research-grade & GMP Camptothecin:

بريد إلكتروني: liaodaohai@gmail.com
إنترنت: www.aiherba.com
طلب: COA, MSDS, customized synthesis quotes.

13. الخاتمة
Camptothecin stays a cornerstone of topoisomerase-targeted oncology. Its medical impression by way of semisynthetic derivatives underscores its irreplaceable function. Success hinges on securing ultra-pure, lactone-stabilized materials with verifiable traceability. Shaanxi Zhonghong delivers >99% HPLC purity CPT عبر patented stabilization expertise, cGMP compliance، و unmatched analytical rigor – empowering drug discovery and superior therapeutics.

14. المراجع

Wall ME, et al. (1966). مجلة الكيمياء الأمريكية. 88:3888–3890. [DOI:10.1021/ja00968a057]
Hsiang YH, et al. (1985). J Biol Chem. 260:14873–14878. [PMID:2997227]
Pommier Y. (2006). Nat Rev Most cancers. 6:789–802. [DOI:10.1038/nrc1977]
USP-NF Monograph: Camptothecin. USP44-NF39.
ICH Q3C (R8): Residual Solvents. (2021).
FDA Steerage: Irinotecan Label. (2023).
Thomas CJ, et al. (2004). J Med Chem. 47:3972–3981. [DOI:10.1021/jm030660+]
Du W, et al. (2022). Acta Pharm Sin B. 12:3006–3025. [DOI:10.1016/j.apsb.2022.03.011]
GLS-010-IPHASE Research Protocol (NCT04501563).
EMA Evaluation Report: Topotecan (2020). EMA/CHMP/89262/2020.

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