Stephania Cepharantha Extract 481-49-2 Manufacturer Exporter MEDIOCON INC

 

 

Stephania Cepharantha Extract Manufactured by MEDIOCON INC     

 

   Name: Stephania Cepharantha Extract

CAS No:  481-49-2

Molecular Weight:  606.70g/mol

Molecular formula:   C₃₇H₃₈N₂O₆

Synonyms: Stephania cephalantha root extract, Extract of the roots of the Stephania cepharantha, Menispermaceae, Stephania Cepharantha Root Extract.

Appearance:  Brown fine powder.

 Solubility :  soluble in DMSO  water.

Use :

- Cosmetic Uses:

    - Skin Conditioning: Improves skin texture and appearance by enhancing moisture retention and reducing inflammation.

    - Antioxidant Properties: Protects skin cells from oxidative stress, preventing premature aging and maintaining skin elasticity.

    - Detoxifying Effects: Helps remove toxins and impurities from the skin, contributing to a clearer complexion.

- Therapeutic Uses:

    - Anti-Inflammatory Agent: Reduces inflammation and pain, making it useful for treating conditions like arthritis and rheumatism.

    - Antiviral Properties: Shows potential in treating viral infections, including herpes simplex virus and SARS-CoV-2.

    - Anticancer Properties: May inhibit tumor cell growth, induce apoptosis, and reverse multidrug resistance in cancer cells.

    - Immunomodulation: Regulates immune responses, potentially treating autoimmune diseases and allergies.

- Pharmaceutical Applications:

    - Bacteriostatic Agent: Inhibits bacterial growth, making it useful for treating infectious diseases.

    - Pain Relief: Provides analgesic effects, reducing pain and discomfort.

- Other Potential Uses:

    - Treating Alopecia: May be used to treat hair loss conditions like alopecia areata.

    - Radiation-Induced Leukopenia: Helps prevent or treat decreased white blood cell count caused by radiation therapy.

 How is  Stephania Cepharantha Extract manufactured by MEDIOCON INC Synthesized?

Stephania Cepharantha Extract is synthesized through a multi-step process that involves optimization of extraction conditions to maximize the yield of active compounds, particularly cepharanthine. Here's an overview of the synthesis process:

Extraction Process1. Solvent Selection: The extraction process starts with selecting an appropriate solvent, typically ethanol-water mixtures, with 80% ethanol-water (v/v) being optimal for extracting antitumor agents.

2. Ratio of Liquid to Raw Material: A ratio of 10:1 (g/mL) is used to achieve the best extraction yield and cepharanthine content.

3. Extraction Duration: Heat reflux extraction is performed for 2 hours, repeated three times, to ensure maximum extraction efficiency.

4. Particle Size: The particle size of the raw material is optimized to achieve the best extraction yield, with coarse powder being more effective than finer or larger particles.

Purification Process1. Macroporous Adsorption Resins (MR): The crude extract is purified using MR, specifically D101 resin, to enrich cepharanthine.

2. Elution Solvent: Ethanol-water-triethylamine or ethanol-water-formic acid mixtures are used as elution solvents to achieve optimal separation of cepharanthine.

3. Volume of Elution Solvent: The volume of the elution solvent is optimized to achieve the best yield and purity of cepharanthine.¹

Optimization Techniques1. Single-Factor Experiment: Single-factor experiments are conducted to study the effect of various factors on extraction yield and cepharanthine content.

2. Orthogonal Design: Orthogonal design (L9, 3^4) is used to determine the optimal extraction conditions and to study the interactions between different factors.

By optimizing these conditions, the yield of total alkaloids can reach 3.4%, with a cepharanthine content of 2.9%, exhibiting significant anti-proliferative activities in A549 cells.

What are the different  dosage forms  of   Stephania Cepharantha Extract Manufactured  by  MEDIOCON INC?

Stephania Cepharantha Extract comes in various dosage forms, each with its benefits and limitations:

- Oral Formulations:

    - Oral Disintegrating Tablets: Convenient, fast-acting, and avoids liver first-pass effect, but can be fragile.

    - Dropping Pills: Small dosage, fast dissolution, high bioavailability, and easy administration.

    - Conventional Tablets: Ordinary tablets with larger granules, slow dissolution, and diffusion rates.

- Injectable Formulations:

    - Injections: Rapid efficacy, direct entry into bloodstream, improved bioavailability, and targeted efficacy.

- Pulmonary Delivery Systems:

    - Dry Powder Inhalers (DPIs): Fast-acting, safe, and environmentally friendly, ideal for treating respiratory issues like COVID-19.

- Nanoformulations:

    - Liposomes: Improved solubility, bioavailability, and targeted delivery.

    - Nanoparticles: Enhanced delivery, potential for treating various diseases.¹

These dosage forms aim to improve the bioavailability and efficacy of Stephania Cepharantha Extract, which has poor water solubility. Researchers continue to explore new formulations to widen its clinical applications.

 How Stephania Cepharantha Extract Manufactured by MEDIOCON INC   Dosage Forms are prepared?

The preparation of Stephania Cepharantha Extract dosage forms involves various methods depending on the desired formulation. Here's an overview of the preparation process for different dosage forms:

 

Oral Formulations1. Oral Disintegrating Tablets: The extract is mixed with excipients, compressed into tablets, and designed to disintegrate quickly in the mouth.

2. Dropping Pills: The extract is dissolved in a solvent, mixed with a carrier, and formed into small pills.

3. Conventional Tablets: The extract is mixed with excipients, granulated, and compressed into tablets.

 

Injectable Formulations1. Injections: The extract is dissolved in a solvent, sterilized, and filled into vials or ampoules.

Pulmonary Delivery Systems1. Dry Powder Inhalers (DPIs): The extract is mixed with excipients, processed into a dry powder, and packaged in inhalation devices.

Nanoformulations1. Liposomes: The extract is encapsulated in liposomes using techniques like thin-film hydration or solvent injection.

2. Nanoparticles: The extract is formulated into nanoparticles using methods like nanoprecipitation or emulsion polymerization.

The preparation process typically involves [1]:

- Extraction: The plant material is extracted using solvents like ethanol or water.

- Purification: The extract is purified using techniques like chromatography or crystallization.

- Formulation: The purified extract is formulated into the desired dosage form.

- Quality Control: The final product is tested for quality, purity, and potency.

The specific preparation method may vary depending on the manufacturer and the intended use of the product.

What are the appropriate Dosage forms of Stephania Cepharantha Extract Manufactured  by  MEDIOCON   INC?                

The appropriate dosage forms of Stephania Cepharantha Extract depend on the intended use and therapeutic goals. Some potential dosage forms include:

Dosage Forms1. Oral Tablets or Capsules: Suitable for systemic effects, such as anti-inflammatory or immunomodulatory effects.

2. Injectable Formulations: May be used for severe or acute conditions, such as cancer treatment or severe infections.

3. Topical Formulations: Creams, ointments, or gels for localized effects, such as skin conditions or wound healing.

4. Dry Powder Inhalers (DPIs): Potential for treating respiratory issues, such as COVID-19 or other pulmonary diseases.

Dosage Considerations1. Dosage Strength: Varies depending on the specific application and patient population.

2. Dosing Frequency: May be once or multiple times daily, depending on the condition being treated.

3. Route of Administration: Chosen based on the desired therapeutic effect and patient needs.

Specific Dosage Information1. Cepharanthine Dosage: Typically ranges from 1-20 mg/kg body weight, depending on the study and application.

2. Extract Dosage: May vary depending on the extract's potency and standardization [1][2].

It's essential to consult with a healthcare professional to determine the most appropriate dosage form and regimen for a specific condition or patient.

When should Stephania Cepharantha Extract Manufactured by MEDIOCON INC be taken?

The timing of taking Stephania Cepharantha Extract depends on various factors, including:

Factors Influencing Timing1. Condition being treated: Different conditions may require different dosing schedules.

2. Dosage form: Oral, injectable, or topical formulations may have different administration times.

3. Individual patient needs: Healthcare providers may adjust timing based on patient response and needs.

General Guidelines1. With meals: Some oral formulations may be taken with meals to enhance absorption or reduce gastrointestinal side effects.

2. As directed by a healthcare provider: It's essential to follow the recommended dosing schedule and guidelines provided by a healthcare professional.

Specific Timing InformationLimited information is available on specific timing for Stephania Cepharantha Extract. Consult with a healthcare professional for personalized guidance on when to take the extract

 What are the effects And Side effects of Stephania Cepharantha Extract Manufactured by MEDIOCON INC?

Stephania Cepharantha Extract, specifically its active compound cepharanthine, has various effects and potential side effects:

 

Effects- Anti-inflammatory: Reduces inflammation and swelling, making it beneficial for conditions like arthritis and skin issues.

- Antiviral: Shows promise in treating viral infections, including COVID-19, HIV, and herpesviruses.

- Anticancer: May inhibit tumor cell growth, induce apoptosis, and enhance chemotherapy efficacy.

- Immunomodulation: Regulates immune responses, potentially treating autoimmune diseases and allergies.

- Antioxidant: Protects cells from oxidative stress, promoting overall wellness.

Side Effects- Mild gastrointestinal upset: Nausea, diarrhea, abdominal discomfort

- Headache or dizziness: Particularly when taken on an empty stomach or at higher doses

- Allergic reactions: Rare but possible, including skin rashes, itching, and swelling

- Transient fatigue or malaise: More likely in sensitive individuals

Precautions- Pregnancy and breastfeeding: Consult a healthcare provider before use.

- Liver disease: Potential liver toxicity; consult a healthcare provider before use.

- Interactions with medications: May interact with blood thinners, antihypertensive drugs, and antidiabetic medications.

Topical UseWhen applied topically, Stephania Cephalantha Root Extract may cause:

- Redness or irritation: At the application site

- Itching or discomfort: Possible allergic dermatitis

- Dryness or peeling: Of the skin

It's essential to consult with a healthcare professional before using Stephania Cepharantha Extract, especially if you have underlying medical conditions or take medications.

  How is Stephania Cepharantha Extract Manufactured by MEDIOCON  INC  Tested Qualitatively?

Stephania Cepharantha Extract is tested qualitatively using various methods to ensure its quality, purity, and potency. Some of these methods include:

 

Qualitative Testing Methods1. High-Performance Liquid Chromatography (HPLC): Used to identify and quantify specific compounds, such as cepharanthine.

2. Thin-Layer Chromatography (TLC): A simple and rapid method for identifying compounds and detecting impurities.

3. Gas Chromatography-Mass Spectrometry (GC-MS): Used to analyze the extract's chemical composition and identify specific compounds.

4. Spectroscopic Methods: Techniques like UV-Vis spectroscopy and infrared spectroscopy can provide information about the extract's chemical structure and composition.

Quality Control Parameters1. Purity: Testing for contaminants, heavy metals, and other impurities.

2. Potency: Measuring the extract's bioactive compound content, such as cepharanthine.

3. Identity: Verifying the extract's botanical origin and chemical composition.

Standardization1. Standardized Extracts: Ensuring consistent levels of bioactive compounds.

2. Marker Compounds: Identifying specific compounds, like cepharanthine, to standardize the extract.

These qualitative testing methods help ensure the quality and efficacy of Stephania Cepharantha Extract for various applications

 Which tests are performed on Stephania Cepharantha Extract Manufactured by  MEDIOCON INC ?

Tests performed on Stephania Cepharantha Extract include:

- High-Performance Liquid Chromatography (HPLC): To identify and quantify specific compounds like cepharanthine.

- Thin-Layer Chromatography (TLC): A simple and rapid method for identifying compounds and detecting impurities.

- Gas Chromatography-Mass Spectrometry (GC-MS): Analyzes the extract's chemical composition and identifies specific compounds.

- Cytotoxicity Assay: Evaluates the extract's anti-proliferative activity in cancer cells.

- Antimicrobial Testing: Determines the extract's bacteriostatic activity against gram-positive and gram-negative bacteria.

- Anti-Inflammatory and Analgesic Testing: Assesses the extract's effectiveness in reducing inflammation and pain.

- Toxicity Testing: Determines the extract's safety profile, including acute toxicity and maximum non-lethal dose.

- Physical and Chemical Index Testing: Evaluates the extract's physical and chemical properties, such as appearance, solubility, and pH.

- Hazardous Substance Testing: Checks for heavy metals, arsenic, and other contaminants.

- Quality Control Testing: Ensures the extract meets quality standards, including purity, potency, and consistency.

What are the challenges in Manufacturing of Stephania Cepharantha Extract Manufactured by MEDIOCON   INC API?

Manufacturing Stephania Cepharantha Extract API poses several challenges, including:

- Extraction Efficiency: Optimizing extraction conditions to maximize yield and purity of cepharanthine, a key alkaloid in Stephania Cepharantha.

- Solvent Selection: Choosing suitable solvents that can effectively extract the desired compounds while minimizing impurities.

- Scalability: Scaling up extraction processes from laboratory to industrial levels while maintaining consistency and quality.

- Purification: Effectively purifying the extract to meet pharmaceutical standards, which can be time-consuming and costly.

- Quality Control: Ensuring batch-to-batch consistency and quality of the extract, which requires robust testing and validation protocols.

- Regulatory Compliance: Meeting regulatory requirements for pharmaceutical ingredients, including documentation, testing, and validation.

- Environmental Impact: Minimizing the environmental footprint of the extraction process by reducing solvent usage and waste generation.

- Cost-Effectiveness: Balancing the cost of production with the need for high-quality extracts, which can be a challenge in industrial-scale manufacturing.

 

Some specific challenges in the extraction process include¹:

- Particle Size: Finding the optimal particle size for extraction, as smaller particles can increase extraction efficiency but may also lead to filtration difficulties.

- Extraction Time: Determining the ideal extraction time to balance yield and purity with production efficiency.

- Solvent Ratio: Optimizing the solvent-to-raw material ratio to achieve maximum extraction efficiency.

- Macerating Time: Identifying the optimal macerating time to enhance extraction yield and purity.

 

Addressing these challenges requires careful optimization of extraction conditions, purification protocols, and quality control measures to ensure the production of high-quality Stephania Cepharantha Extract API.

What are the challenges in manufacturing of Stephania Cepharantha Extract Manufactured by MEDIOCON  INC ’s Dosage forms?

Manufacturing Stephania Cepharantha Extract dosage forms poses several challenges, including:

 

Formulation Challenges- Standardization and Quality Control: Ensuring consistency in the quality and potency of herbal extracts due to natural variations in plant constituents.

- Bioavailability and Stability: Optimizing formulations for bioavailability and stability, considering factors like solubility and degradation.

Manufacturing Challenges- Scalability: Scaling up extraction processes while maintaining consistency and quality.

- Equipment Selection: Choosing suitable equipment for various dosage forms, such as tablets, capsules, or creams.

- Process Optimization: Optimizing process parameters, like temperature and pressure, to ensure efficient extraction and product quality.

Regulatory Challenges- Compliance with GMP: Adhering to Good Manufacturing Practices (GMP) standards to ensure product quality and safety.

- Regulatory Documentation: Maintaining thorough documentation for regulatory compliance, including batch records and testing results.

Quality Assurance Challenges- Raw Material Sourcing: Ensuring a consistent and high-quality supply of raw materials.

- Testing and Validation: Conducting rigorous testing and validation to ensure product quality and efficacy.¹

Research and Development Challenges- Novel Formulations: Developing innovative dosage forms, such as orodispersible tablets or implantable dosages.

- Pharmacological Studies: Conducting pharmacological studies to validate efficacy and safety.

What is the Packing for Stephania Cepharantha Extract Manufactured by MEDIOCON INC?

Stephania Cepharantha Extract comes in various packaging options, including¹ ² ³:

- Tablets: 60 tablets or 180 tablets per pack, available on Amazon.in

- Powder: 100gm or 200gm packs, available on Flipkart and Amazon.in, with prices ranging from ₹2,700 for 100gm or 200gm packs

- Pure Natural and Organic: Some products are labeled as pure natural and organic, emphasizing their herbal and chemical-free composition

Some popular brands offering Stephania Cepharantha Extract products include:

- Shree Herbal: Offers tablets and powder forms

- Shri: Provides powder forms with free shipping and cash-on-delivery options

- JSR Herbal: Offers powder forms with free shipping and cash-on-delivery options

These products are available on online marketplaces like Amazon.in and Flipkart, with options for home delivery and cash on delivery.

What is shelf life Of Stephania Cepharantha Extract Manufactured by MEDIOCON INC? 

The shelf life of Stephania Cepharantha Extract is typically 2 years when stored properly. To maintain its potency and quality, it's essential to store it in¹ ²:

- Cool and dry place: Away from direct sunlight and heat sources.

- Well-closed container: Protecting it from moisture and contaminants.

Some key factors to consider when storing Stephania Cepharantha Extract include:

- Temperature: Store at room temperature or in a cool, dry place.

- Light protection: Keep it away from direct sunlight.

- Humidity control: Store in a dry environment to prevent moisture absorption.

By following these storage guidelines, you can help ensure the extract remains effective and safe for use within its 2-year shelf life.

What should the label claim for Stephania Cepharantha Extract Manufactured by MEDIOCON INC   Include?

The label claim for Stephania Cepharantha Extract should include:

- Product Name: Stephania Cepharantha Extract or specific product name

- Active Ingredients: Cepharanthine or other specified alkaloids

- Concentration: Percentage or amount of active ingredients (e.g., 90% cepharanthine)

- Dosage Instructions: Recommended dosage and administration

- Storage Conditions: Instructions for storage (e.g., cool, dry place; away from sunlight)

- Shelf Life: Expiration date or shelf life (e.g., 2 years)

- Manufacturer Information: Name and contact details of the manufacturer

- Batch Number: Unique batch number for traceability

- CAUTION: Any relevant warnings or cautions for use

- Intended Use: Statement of intended use (e.g., dietary supplement, traditional herbal remedy)

Additionally, labels may include claims related to:

- Traditional Use: Statement of traditional use in herbal medicine

- Health Benefits: Claims related to immune support, anti-inflammatory effects, or other benefits

- Quality Assurance: Statements about quality control, purity, or standardization

Where can Stephania Cepharantha Extract Manufactured by MEDIOCON INC are procured?

Stephania Cepharantha Extract Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

FOR API

MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/Whatsapp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

GST No: 27DHUPM2366D1ZZ

For Dosage Forms :

- Online Marketplaces: You can find Stephania Cepharantha Extract Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Stephania Cepharantha Extract Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Stephania Cepharantha Extract Manufactured by MEDIOCON INC product, regardless of the procurement source.