Bitter sophora Root extract 519-02-8 Manufacturer, supplier, exporter by MEDIOCON INC

 

 

 

Bitter sophora Root extract Manufactured by MEDIOCON INC

 

   Name: Bitter sophora Root extract

CAS No:   519-02-8

Molecular Weight:  248.36 g/mol

Molecular formula:  : C₁₅H₂₄N₂O

Synonyms: Matrine, (+)-Matrine, Matridin-15-one, Ku Shen Extract, Sophora Flavescens Root Extract 

Appearance:  Light yellow to brownish-yellow powder (crude extract); White needle crystal or white powder (high-purity 98% extract)

 Solubility :  Soluble in water, ethanol, chloroform, benzene, and acetone; low solubility in petroleum ether

Use :

Bitter Sophora Root extract is utilized across several fields, including pharmaceuticals, cosmetics, and agriculture. 

·       Pharmaceutical/Traditional Medicine: Used to clear heat, dry dampness, kill parasites (antipruritic), and promote diuresis. It treats skin disorders (eczema, psoriasis, acne), vaginal itching, jaundice, and bacillary dysentery.

·       Anti-tumor & Immunomodulator: Used in cancer treatments to induce apoptosis, inhibit tumor angiogenesis, and reverse multidrug resistance in cancers like liver and lung cancer.

·       Skincare & Cosmetics: Included in products to balance oil, tighten pores, reduce inflammation, and repair skin due to its anti-bacterial and soothing properties.

·       Agriculture: Acts as a botanical pesticide (low-toxicity, low-residue) to control pests like cabbage caterpillars, tea caterpillars, and mites. 

4. Other Constituents

Besides matrine, the extract contains oxymatrine (antiviral)

 How is  Bitter sophora Root extract manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC likely manufactures Bitter Sophora Root Extract (from Sophora flavescens) using standard natural product extraction and purification, involving raw root preparation (cleaning, drying, grinding), solvent extraction (often ethanol/water), concentration, and purification via chromatography, focusing on key compounds like matrine and oxymatrine, rather than full chemical synthesis, though research explores biosynthetic pathways in microbes for specific compounds. 

General Manufacturing Process for Sophora Flavescens Extract:

1.    Raw Material Sourcing & Authentication: High-quality Sophora flavescens roots are selected, botanically verified, and tested for purity and active compound levels (alkaloids like matrine).

2.    Preparation: Roots are cleaned, dried (to 8-12% moisture), and ground into a uniform powder to maximize extraction efficiency.

3.    Extraction: The powdered root is typically extracted using a solvent, often an ethanol-water mixture (50-80% ethanol), to pull out the target alkaloids and flavonoids.

4.    Concentration: The liquid extract is concentrated by removing the solvent, often through evaporation, to create a crude extract.

5.    Purification: Further purification uses methods like column chromatography (e.g., Sephadex LH-20, silica gel) to isolate and concentrate specific active compounds, achieving high purity (e.g., >80%).

6.    Drying & Standardization: The final extract is dried (e.g., spray drying) into a powder, standardized to contain specific percentages of active ingredients like matrine and oxymatrine. 

What are the different  dosage forms  of   Bitter sophora Root extract Manufactured  by  MEDIOCON INC?

While specific product lines for MEDIOCON INC weren't found, Bitter Sophora Root Extract (Sophora flavescens) is generally available as a powder (used in capsules, tablets, or bulk), sometimes as a standardized liquid extract, and traditionally prepared as decoctions (teas) or pastes, with clinical forms including injections, but MEDIOCON INC's offerings likely focus on the common powder/extract forms for nutraceuticals. 

Common Forms for Sophora flavescens Extracts:

·       Powder: The most common raw material form, often standardized for key compounds like matrine, used in capsules, tablets, or mixed into drinks.

·       Capsules/Tablets: The powdered extract is encapsulated or pressed into tablets for convenient oral dosing.

·       Liquid Extracts/Tinctures: Concentrated liquid forms for easier absorption or specific applications.

·       Injections: Used in clinical settings, particularly in China, for treating cancer and infections, though this requires pharmaceutical-grade processing.

·       Traditional Preparations: Decoctions (brewed teas) and topical pastes are used traditionally. 

To find MEDIOCON INC's specific forms:
You would need to check their official product catalog or contact them directly for details on their Bitter Sophora Root Extract offerings

 How Bitter sophora Root extract Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Bitter Sophora Root Extract (derived from Sophora flavescens or "Ku Shen") is manufactured through a multi-stage process of extraction, purification, and drying to produce a standardized powder, often targeting matrine or oxymatrine alkaloids. These extracts are used to formulate various dosage forms, including capsules, tablets, injections, lotions, and pastes. 

Manufacturing and Preparation Process
The production of Bitter Sophora Root extract typically involves the following stages:

·       Raw Material Selection and Preparation: Authenticated Sophora flavescens roots are cleaned to remove debris and then crushed/ground into a coarse powder to increase surface area for extraction.

·       Extraction: The powder is extracted using heated water or ethanol-water mixtures (typically 50-80% ethanol). Other methods include:

o   Reflux Extraction: The powder is refluxed with 95% alcohol (3 times, 1.5–2 hours each) to extract total flavonoids.

o   Microwave-Assisted Extraction (MAE): A modern, high-efficiency method using 60% ethanol at 50°C for 10 minutes.

·       Filtration and Concentration: The extract is filtered to remove solid residue and then concentrated using vacuum evaporation at reduced temperatures (40-60°C) to prevent thermal degradation of the alkaloids.

·       Purification: The concentrate is purified using methods such as column chromatography (polyamide or macroporous resin) to separate specific alkaloids (matrine/oxymatrine) and remove impurities.

·       Drying: The purified extract is dried using spray drying, vacuum drying, or freeze drying to achieve a stable powder with a moisture content of less than 5%.

·       Standardization: The final powder is tested (using HPLC or UV) to ensure it meets specific concentrations of matrine or oxymatrine (e.g., 1–5% in general extracts, up to 98% in high-purity extracts). 

What are the appropriate Dosage forms of Bitter sophora Root extract Manufactured  by  MEDIOCON   INC?                

Based on the product portfolio of Mediocon Inc, which includes herbal extracts, API powders, and nutraceutical ingredients, the appropriate dosage forms for Bitter Sophora Root Extract (Sophora flavescens) manufactured or supplied by them are generally: 

·       Extract Powders: Often supplied in bulk (e.g., 25 kg drums) as raw material for further formulation.

·       Capsules: For oral administration.

·       Tablets: For oral administration.

·       Liquid Extracts/Decoctions: Utilized in traditional medicine practices. 

Product Characteristics and Usage:

·       Active Ingredients: The extract is usually standardized for high matrine or oxymatrine content.

·       Industry Application: These products are used in nutraceuticals, pharmaceuticals, and sometimes as botanical pesticides. 

When should Bitter sophora Root extract Manufactured by MEDIOCON INC be taken?

Information regarding the consumption of Sophora flavescens (Bitter Sophora Root) extract suggests general guidelines. It is important to adhere to the specific instructions provided on the label of the MEDIOCON INC product, as dosages can vary depending on the concentration and intended use. 

·       Bitter Sophora root extract may be consumed at different times throughout the day.

·       Dividing the daily amount into separate servings is a common practice to potentially improve tolerance.

·       Taking the extract with meals may help to reduce the likelihood of potential stomach discomfort, such as nausea, which can sometimes occur with herbal extracts.

·       It is used in traditional practices for managing conditions associated with "damp-heat," including skin irritations like itching or eczema, or digestive issues such as diarrhea. 

Important Considerations:

·       Safety Warning: Given its potential effects, consulting a healthcare provider before using this extract is advisable, especially if you have pre-existing health conditions or are using other medications.

·       Avoid if Pregnant/Nursing: Use of this extract is generally not recommended for individuals who are pregnant or nursing, or those with hormone-sensitive conditions.

·       Storage: The extract typically has a shelf life of 2 years and should be stored in a tightly sealed container in a cool, dry place. 

Disclaimer: This information is for general knowledge and should not be considered medical advice. Always consult with a healthcare professional before starting any new supplement regimen.

 What are the effects And Side effects of Bitter sophora Root extract Manufactured by MEDIOCON INC?

Bitter Sophora Root Extract (from Sophora flavescens) offers anti-inflammatory, antimicrobial, and potential anti-cancer effects, used in TCM for skin issues, infections, and as a diuretic, but high doses or prolonged use can cause liver toxicity, gastrointestinal distress, dizziness, and allergic reactions, potentially interacting with medications like blood thinners and immunosuppressants. Specific effects and safety of a MEDIOCON INC product would depend on its formulation, so always follow their directions and consult a healthcare professional, especially if pregnant, breastfeeding, or on other medications. 

Potential Effects & Benefits (General)

·       Anti-inflammatory & Antimicrobial: Contains matrine and oxymatrine, used for infections, eczema, and sores.

·       Diuretic & Detoxifying: Helps clear "hot air" and dampness in the body.

·       Skin Health: Balances oil, tightens pores, and helps repair skin cells (cosmetic use).

·       Anticancer Potential: Studied for suppressing tumors, but more research is needed.

·       Cardiovascular: May lower blood pressure and improve circulation. 

Potential Side Effects & Risks (General)

·       Liver Toxicity (Hepatotoxicity): High doses or prolonged use, especially of concentrated extracts, can harm the liver.

·       Neurological Effects: Dizziness, fatigue, and in rare cases, neurotoxicity.

·       Digestive Issues: Nausea, vomiting, gastric discomfort, especially at high doses.

·       Allergic Reactions: Skin redness, itching, swelling, or even anaphylaxis in sensitive individuals.

·       Drug Interactions: May increase bleeding risk with blood thinners and interfere with immunosuppressants or blood pressure drugs. 

  How is Bitter sophora Root extract Manufactured by MEDIOCON  INC  Tested Qualitatively?

 

MEDIOCON INC likely tests Bitter Sophora Root Extract qualitatively by verifying the presence and purity of key compounds like flavonoids (matrine, oxymatrine, trifolirhizin) and other phytochemicals, using methods such as chromatography (TLC, HPLC, GC/MS) and spectroscopic analysis (UV-Vis, MS) for identification, alongside physical checks (moisture, particle size) and safety tests (heavy metals, microbes, pesticides) to ensure it meets quality standards. 

General Qualitative Testing for Sophora Flavescens Extract
While specific details for MEDIOCON INC aren't public, manufacturers follow industry-standard qualitative and quantitative tests:

1.    Phytochemical Screening (Presence of Compounds):

·       Reagent Tests: Using reagents like Mayer's, Dragendorff's (for alkaloids) or Molisch's (for carbohydrates) on extracts to observe color changes or precipitates.

·       Chromatography (TLC/Paper Chromatography): Separating components and comparing them to known standards for identification.

2.    Chromatographic Analysis (Identification & Purity):

·       HPLC (High-Performance Liquid Chromatography): Quantifies and identifies flavonoids (like matrine, oxymatrine) and other active ingredients, ensuring consistency.

·       GC/MS (Gas Chromatography/Mass Spectrometry): Identifies volatile compounds and provides structural information.

3.    Spectroscopic Techniques:

·       UV-Vis Spectroscopy: Checks for characteristic absorption patterns of flavonoids.

·       LC/MS (Liquid Chromatography/Mass Spectrometry): Used for detailed structural analysis of complex mixtures.

4.    Physicochemical Properties:

·       Moisture Content: Checked (often <5%) via drying methods.

·       Loss on Drying (LOD): Measures volatile matter.

·       Particle Size & Flowability: Optimized for downstream processing.

5.    Safety & Contaminant Testing:

·       Heavy Metals: Screening for lead, mercury, arsenic, cadmium.

·       Microbiological Tests: Checks for bacteria, yeast, mold.

·       Pesticide Residue Analysis: Ensures levels are below regulatory limits. 

   Which tests are performed on Bitter sophora Root extract Manufactured by  MEDIOCON INC ?

Based on the product portfolio of Mediocon Inc, which specializes in supplying herbal extracts, phytochemicals, and pharmaceutical chemicals, the tests performed on their Bitter Sophora Root Extract (typically derived from Sophora flavescens or Ku Shen) generally conform to rigorous quality assurance standards. 

While specific lot-by-lot,, results vary, typical tests for this ingredient include:

·       Assay Method (Quantification of Actives): High-Performance Liquid Chromatography (HPLC) is used to determine the concentration of primary active components, specifically Matrine and Oxymatrine (often in concentrations of 4%, 5%, 70%, or 98%).

·       Identification (Thin Layer Chromatography - TLC): Used for verifying the botanical origin of the root extract.

·       Physical Properties:

o   Appearance: Visual analysis (e.g., white crystalline powder, or white-to-brownish yellow powder).

o   Solubility: Tested for solubility in water and alcohol.

o   pH: Measured in solution (typically 4.0-7.0).

o   Particle Size/Density: Bulk density measurements.

·       Purity and Contaminant Testing:

o   Loss on Drying/Moisture Content: To ensure stability and prevent microbial growth.

o   Ash Content: To determine inorganic impurities.

o   Heavy Metals: Testing for lead, arsenic, mercury, and cadmium.

o   Microbiological Tests: Total plate count, yeast, and mold tests.

·       Chemical Profiling: Sometimes includes Ultraviolet-Visible Spectroscopy (UV) to assess total flavonoid content. 

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

Manufacturing banana extract as an API (Active Pharmaceutical Ingredient) for MEDIOCON INC, like any API, faces challenges in regulatory compliance, complex extraction chemistry, supply chain consistency (raw banana quality/availability), ensuring purity & stability (avoiding impurities/degradation), scaling up processes, quality control, and environmental sustainability, especially managing banana waste biomass and solvent use, requiring advanced green chemistry and process optimization. 

Key Challenges in Banana API Manufacturing:

1.    Raw Material Variability: Bananas are natural products; inconsistent quality, ripeness, and pest issues affect extract yield and composition, making standardized sourcing difficult.

2.    Extraction Complexity: Isolating specific bioactive compounds (flavonoids, phenolics) from complex banana biomass (pulp, peel) requires efficient, selective, and scalable extraction methods, often using solvents.

3.    Purity & Impurity Control: Preventing unwanted compounds from being extracted and ensuring the final API meets strict purity standards (e.g., absence of contaminants, degradation products) is crucial.

4.    Scale-Up Issues: Lab-scale extraction methods may not translate well to large volumes, potentially introducing new impurities or reducing efficiency.

5.    Stability & Degradation: Bioactive compounds in banana extract can degrade over time or with improper handling, impacting shelf-life and efficacy.

6.    Regulatory Hurdles: Meeting stringent pharmaceutical regulations (FDA, WHO-GMP) for natural product APIs requires extensive documentation and validation.

7.    Waste Management: Processing bananas generates significant biomass waste (peels, stems) that needs sustainable handling to avoid environmental issues like odor and greenhouse gases.

8.    Sustainability: Balancing extraction efficiency with green chemistry principles (reducing solvent use, energy, waste) is a growing demand. 

How These Apply to MEDIOCON INC (Hypothetical):
For MEDIOCON INC, these general API challenges would specifically relate to:

·       Securing consistent banana supply for their API.

·       Developing robust extraction/purification methods to isolate desired compounds from the fruit matrix.

·       Innovating waste valorization to create value from biomass, turning a problem into a resource.

·       Implementing green solvents and processes to meet sustainability goals

What are the challenges in manufacturing of Bitter sophora Root extract Manufactured by MEDIOCON  INC ’s Dosage forms?

Manufacturing challenges for Bitter Sophora Root Extract (like Sophora flavescens) dosage forms involve raw material variability, ensuring consistent active compound potency, overcoming poor flowability and compressibility in dried extracts for tablets, stabilizing the complex mixture, potential toxicity/side effects (like CYP3A activation), and ensuring regulatory compliance, with issues like adulteration and inconsistent harvesting adding layers of complexity. Specific to Sophora, sourcing adequate roots, managing their potent alkaloids (like matrine), and ensuring extract quality for effective delivery pose significant hurdles for dosage forms like tablets or capsules. 

Key Manufacturing Challenges

1.    Raw Material Inconsistency:

·       Variability: Biochemical properties differ based on plant part (root vs. seed), growing conditions (drought resistance is a factor), harvest time, and geographical origin, affecting active ingredient levels.

·       Sourcing: Insufficient supply of Sophora roots due to high demand and cultivation challenges.

2.    Extraction & Formulation Issues:

·       Chemical Complexity: Complex mixtures of compounds, making standardization difficult.

·       Poor Physical Properties: Dried extracts often have low flowability, poor compressibility, and hygroscopicity, challenging tablet manufacturing.

·       Bioavailability: Ensuring active compounds are effectively absorbed by the body.

3.    Stability & Shelf-Life:

·       Chemical Degradation: Herbal products are prone to degradation from light, oxygen, heat, and humidity, impacting quality over time.

·       Enzymatic Activity: Plant enzymes can break down active ingredients.

4.    Quality & Safety Concerns:

·       Standardization: Difficulty in selecting proper marker compounds for consistent quality control.

·       Adulteration: Risk of mixing with inferior or different plant parts/species.

·       Potential Toxicity: Sophora contains potent compounds (alkaloids) that can interact with drug metabolism (e.g., activating CYP3A enzymes), requiring careful dosage control.

5.    Regulatory & Analytical Hurdles:

·       Complex Analysis: Difficult to analytically test complex herbal extracts.

·       Regulatory Compliance: Meeting stringent quality guidelines (WHO, FDA) for complex natural products is challenging. 

What is the Packing for Bitter sophora Root extract Manufactured by MEDIOCON INC?

MEDIOCON INC's Bitter Sophora Root Extract is typically packed in inner double plastic bags inside fiber drums, with common bulk sizes being 25kg, but they also offer smaller packs like 5kg or 1kg aluminum foil bags, with specifications often including food/pharma grade, and can be customized per buyer demand, often featuring HDPE drums for larger orders. 

Standard Packaging Options:

·       Bulk: 25kg in a fiber drum (with inner double plastic bags).

·       Smaller Quantities: 5kg or 1kg in aluminum foil bags (with inner double plastic bags).

·       Custom: As per demand, possibly in HDPE drums. 

Key Features:

·       Grades: Available in food grade, pharmaceutical grade, and for veterinary use.

·       Material: Uses food-grade inner plastic bags for hygiene, sealed within outer containers like drums or foil bags.

·       Customization: Packaging can often be adjusted based on specific customer needs, notes Tradeindia. 

What is shelf life Of Bitter sophora Root extract Manufactured by MEDIOCON INC? 

While specific data for MEDIOCON INC. isn't available in the snippets, typical shelf life for high-quality Bitter Sophora Root Extract (Ku Shen) powders, often containing active compounds like Matrine, is generally 2 years, provided it's stored in a cool, dry, well-ventilated place as a powder. Storage conditions, like refrigeration for solvents or freezing for powders, can extend this, but 2 years is a common guideline for manufacturers. 

Key Factors for Shelf Life:

·       Form: Powders generally last longer than liquid extracts.

·       Purity & Standardization: Extracts with higher standardized content (e.g., 90% Total Matrines) often have stable shelf lives.

·       Storage: Keeping it dry, away from light, and at appropriate temperatures (often room temp for powder, cooler for liquids) is crucial. 

To Confirm for MEDIOCON INC.:

·       Check the Product Label: The most accurate shelf life will be printed on the product packaging.

·       Contact the Manufacturer: Reach out to MEDIOCON INC. directly for their official specifications. 

What should the label claim for Bitter sophora Root extract Manufactured by MEDIOCON INC   Include?

For a label claim for Bitter Sophora Root Extract from MEDIOCON INC, include the ingredient name (Sophora flavescens Root Extract), key active compounds like Matrine and Oxymatrine (often standardized), origin, extraction method, benefits (anti-inflammatory, antibacterial, liver support), certifications (USDA Organic, ISO), and storage info, ensuring compliance with relevant regulations (e.g., FDA for supplements/cosmetics) for specific claims. 

Key Label Components

1.    Product Name: Bitter Sophora Root Extract (or Sophora flavescens Root Extract).

2.    Manufacturer: Manufactured by MEDIOCON INC.

3.    Ingredient Details:

1.    Botanical Name: Sophora flavescens Ait..

2.    Key Compounds: Highlight standardized alkaloids (Matrine, Oxymatrine) if applicable, often with percentage content (e.g., Matrine 10%).

3.    Extraction Ratio: (e.g., 10:1 extract, meaning 10 parts root to 1 part extract).

4.    Benefits/Uses (Claims):

0.    Cosmetic: Anti-inflammatory, antibacterial, soothing for skin, helps with redness/eczema (especially topical).

1.    Nutraceutical: Supports liver health, digestive comfort, immune response, antioxidant, clearing internal heat (Traditional Chinese Medicine basis).

2.    Ensure claims are substantiated and follow regulatory guidelines (e.g., FDA for supplements, specific cosmetic regulations for skincare).

5.    Certifications: USDA Organic, CNAS, ISO (9001, 22000) if held.

6.    Quality Assurance: Certificate of Analysis (CoA) reference, batch number.

7.    Usage & Storage: Shelf life (e.g., 2 years), storage conditions, suggested use (e.g., topical, dietary supplement).

8.    Warnings: Potential interactions (immunosuppressants, blood thinners) or side effects (skin irritation). 

Where can Bitter sophora Root extract Manufactured by MEDIOCON INC are procured?

Bitter sophora Root 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 Bitter sophora Root 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 Bitter sophora Root extract Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Bitter sophora Root extract Manufactured by MEDIOCON INC product, regardless of the procurement source.