Silymarin

Silymarin BP
Milk Thistle Extract
Silibinin
Silybin

Written by

Reviewed by

Picture of Gaurav Sood
Gaurav Sood

Partner - HimPharm

Picture of Dr B M Sood
Dr B M Sood

Chairman - HimPharm

Silymarin Manufactured by HimPharm

Category: Phytochemical
Trade Names: Silymarin, Milk thistle extract, Flavonolignans, Silibinin, Silybin​ Legalon, Thistle extracts
Routes of Administration: Oral, Topical, Inhalation
ATC Code: Not applicable

Identifiers

  • CAS Number: 22888-70-6
  • PubChem CID: 314011
  • ChemSpider ID: 278436
  • DrugBank ID: DB01322
  • UNII: T2M04GYY7K
  • KEGG ID: D08521
  • ChEBI ID: 9241
  • ChEMBL ID: CHEMBL341481
  • CompTox Dashboard (EPA): DTXSID7048942
  • ECHA InfoCard: 100.040.445

Chemical and Physical Data

  • Molecular Formula C25H22O10
  • Molar Mass 482.44 g/mol

SMILES: O=C(O)[C@H]1Oc2c(oc3cc(O)c(O)c(O)c3C2=O)cc1O)C

InChI: InChI=1S/C25H22O10/c1-10-4-11-12-7-20(32-23(31)6-5-22(30)29-12)24(33-13(2)26)18(28)9-19-25(10,34-19)8-21(27)14(3)17(9)15(11)16(10)20/h4-7,9,14-15,17,21,26-28H,8H2,1-3H3,(H,29,30)/t9-,10-,14+,15+,16+,17+,20+,21-,25+/m0/s1

Introduction

Silymarin

Silymarin, derived from the seeds of the milk thistle plant (Silybum marianum), holds a significant place in alternative medicine and pharmaceuticals.

Renowned for its purported benefits in liver health and beyond, Silymarin has garnered attention for its diverse therapeutic properties and potential applications. In this comprehensive guide, we dive into the nature of Silymarin, exploring its origins, uses, and manufacturing standards set by HimPharm.

Silymarin

Impact of Silymarin on Pharmaceutical, Drug, and Natural Products Industry

The impact of Silymarin reverberates across the pharmaceutical, drug, and natural products industry, offering a beacon of hope for individuals grappling with liver disorders, oxidative stress, and inflammatory conditions.

Understanding the intricacies of Silymarin production and its pharmacological properties is important in harnessing its full potential for human health and well-being.

Understanding Silymarin

What is Silymarin?

Silymarin represents a standardized extract derived from the seeds of the milk thistle plant (Silybum marianum). This complex mixture comprises flavonolignans, including silibinin A and B, isosilibinin A and B, silicristin, and silidianin, each contributing to its therapeutic efficacy.

Uses of Silymarin, Silymarin Benefits

Silymarin finds extensive use in the treatment of liver diseases, including chronic liver disease, liver cirrhosis, and hepatitis. Its hepatoprotective, antioxidant, and anti-inflammatory properties make it a valuable asset in combating oxidative stress, promoting liver regeneration, and mitigating the progression of liver disorders.

Physical Characteristics of Silymarin

Silymarin typically appears as a fine powder, varying in color from pale yellow to light brown. Its characteristic bitter taste and distinctive odor distinguish it as a potent phytochemical with a huge therapeutic potential.

Source of Extraction

The extraction of Silymarin primarily involves the collection and processing of milk thistle seeds. Through solvent-based extraction methods, the active compounds are isolated and concentrated to yield pharmaceutical-grade Silymarin formulations.

Significance of Silymarin, Milk Thistle Benefits

Silymarin’s & importance lies in its ability to safeguard liver health, combat oxidative stress, and alleviate inflammation. Beyond its hepatoprotective properties, Silymarin exhibits promise in diverse therapeutic applications, ranging from cancer treatment to neuroprotection.

Applications of Silymarin or Milk Thistle Liver Usage

Silymarin finds widespread use in the pharmaceutical, nutraceutical, and dietary supplement industries. Its versatility allows for oral ingestion, intravenous administration, and topical application, catering to diverse consumer preferences and medical requirements.

Exploring Silymarin and its Use in Pharmaceuticals and Healthcare

Pharmacological Actions of Silymarin

Silymarin exerts its pharmacological effects through various mechanisms, including antioxidant activity, modulation of inflammatory pathways, and enhancement of liver function. By scavenging free radicals, inhibiting lipid peroxidation, and promoting hepatocellular regeneration, Silymarin offers a different approach to liver protection and overall health maintenance.

Clinical Efficacy of Silymarin, Liver Health with Silymarin

Clinical studies have demonstrated the efficacy of Silymarin in treating a large number of liver disorders, including alcoholic liver disease, non-alcoholic fatty liver disease (NAFLD), and drug-induced hepatotoxicity. Its ability to improve liver enzyme levels, reduce hepatic inflammation, and enhance liver function tests underscores its therapeutic potential in clinical settings.

Safety Profile of Silymarin

Silymarin exhibits an excellent safety profile, with minimal adverse effects reported in clinical trials and observational studies. Common side effects, such as gastrointestinal discomfort and allergic reactions, are rare and generally mild in nature. 

However, caution should be exercised in individuals with known allergies to Asteraceae family plants or those with pre-existing medical conditions.

The Raw Material from which Silymarin is Obtained

Raw Material Overview

Milk Thistle: Nature’s Gift to Liver Health

Milk thistle (Silybum marianum) serves as the primary source of Silymarin, offering a rich reservoir of bioactive compounds with therapeutic potential. Indigenous to the Mediterranean region, milk thistle has been revered for centuries for its medicinal properties and hepatoprotective effects.

Composition of Milk Thistle Seeds

Milk thistle seeds contain a complex array of phytochemicals, including flavonolignans, flavonoids, fatty acids, and essential oils. Among these constituents, flavonolignans, represented by silymarin, emerge as the principal bioactive agents responsible for the plant’s therapeutic efficacy.

Harvesting and Processing of Milk Thistle Seeds

The harvesting of milk thistle seeds typically occurs during the flowering stage, when the seeds are fully matured. Following harvest, the seeds undergo cleaning, drying, and milling to ensure optimal extraction of Silymarin and other bioactive compounds.

Quality Assurance in Silymarin Raw Material Sourcing & Raw Material Procurement

HimPharm places great importance on sourcing premium-quality milk thistle seeds from reputable suppliers and certified organic farms. Stringent quality control measures are implemented to verify the authenticity, purity, and potency of the raw materials, ensuring compliance with regulatory standards and customer expectations.

HimPharm Manufacturing Standards as Milk Thistle Manufacturers

HimPharm’s Role in Silymarin Production

HimPharm stands as a pioneering force in the production of Silymarin, epitomizing excellence and innovation in pharmaceutical manufacturing. With a rich legacy spanning over four decades, HimPharm has been instrumental in setting industry benchmarks for quality and reliability as Silymarin manufacturers. 

Through state-of-the-art facilities and cutting-edge technology, HimPharm ensures the seamless production of pharmaceutical-grade Silymarin, adhering to stringent quality standards and regulatory requirements. Because of these advantages, HimPharm ranks high amongst Silymarin suppliers worldwide. 

Upholding International Quality Standards

At HimPharm, quality is not just a commitment but a way of life. Every stage of the manufacturing process, from raw material procurement to product formulation, undergoes rigorous quality control measures to ensure consistency and efficacy. 

HimPharm’s adherence to international quality standards, including Good Manufacturing Practices (GMP) and ISO certifications, underscores its unwavering dedication to product excellence and customer satisfaction.

HimPharm’s Commitment to Fulfilling Your Bulk Requirements for Silymarin

HimPharm understands the diverse needs of its clients and prides itself on its ability to cater to bulk requirements with precision and efficiency. Whether it’s supplying Silymarin for pharmaceutical formulations, dietary supplements, or herbal remedies, HimPharm’s scalable production capabilities ensure timely delivery and seamless integration into clients’ manufacturing processes. 

With a customer-centric approach and a focus on reliability, HimPharm emerges as the preferred partner for sourcing high-quality Silymarin in bulk quantities.

Silymarin Production Processes

Details of the Step-by-Step Manufacturing Process of Silymarin

The production of Silymarin at HimPharm entails a meticulously orchestrated series of steps, each designed to maximize potency, purity, and efficacy. From raw material extraction to final product formulation, every stage reflects HimPharm’s unwavering commitment to quality and innovation.

Step 1: Raw Material Extraction The process begins with the selection of premium milk thistle seeds, which undergo solvent-based extraction to isolate the active compounds, including silibinin, silicristin, and silidianin.

Step 2: Purification and Concentration The extracted material undergoes purification to remove impurities and unwanted substances, followed by concentration to enhance the potency and efficacy of the active compounds.

Step 3: Formulation and Standardization The concentrated extract is formulated into standardized Silymarin preparations, ensuring consistency and uniformity in every batch. HimPharm employs cutting-edge analytical techniques to verify the quality and purity of the final product.

Step 4: Quality Control Testing Rigorous quality control testing is conducted throughout the manufacturing process to assess the identity, purity, and potency of Silymarin. Each batch undergoes comprehensive analysis to meet the highest quality standards and regulatory requirements.

Testing in Silymarin Manufacturing

Quality control serves as the cornerstone of Silymarin manufacturing at HimPharm, with stringent testing protocols ensuring product integrity and compliance. From identity verification to potency assays, HimPharm employs state-of-the-art analytical techniques to uphold quality standards and customer expectations.

  • Identity Testing: Utilizing macroscopic and microscopic examination to verify the authenticity and botanical identity of raw materials.
  • Purity Analysis: Conducting chemical analysis to assess the purity of the extracted compounds and eliminate contaminants.
  • Potency Assay: Determining the concentration of active compounds to ensure therapeutic efficacy and consistency across batches.
  • Microbiological Testing: Screening for microbial contaminants to maintain product safety and compliance with regulatory standards.
  • Stability Testing: Evaluating the stability of the final product under various storage conditions to ensure shelf-life and product integrity over time.

Navigating Production Bottlenecks in Silymarin Manufacturing

In the dynamic landscape of pharmaceutical manufacturing of liver health supplements including Silymarin, production bottlenecks pose inherent challenges requiring proactive management and innovative solutions. HimPharm remains vigilant in identifying and addressing potential bottlenecks to ensure seamless workflow and optimal resource utilization.

  • Raw Material Sourcing: Ensuring a consistent and reliable supply of high-quality milk thistle seeds to sustain manufacturing operations.
  • Process Optimization: Streamlining manufacturing processes to enhance efficiency and throughput without compromising product quality.
  • Regulatory Compliance: Navigating complex regulatory requirements and ensuring adherence to international quality standards and GMP guidelines.
  • Supply Chain Logistics: Managing logistics and distribution channels to minimize lead times and ensure timely delivery of finished products to customers.

Conclusion

Recap of Key Insights

In conclusion, Silymarin stands as a testament to nature’s therapeutic bounty, offering benefits for liver health and overall well-being. HimPharm’s unwavering commitment to excellence and innovation has positioned it as a trusted leader of Silymarin manufacturers in India, catering to the diverse needs of its global clientele.

Leveraging HimPharm's Expertise in Silymarin Manufacturing

As the demand for natural remedies and pharmaceutical-grade supplements continues to soar, HimPharm remains dedicated to advancing the science of Silymarin production and meeting the evolving needs of the healthcare industry. With a legacy built on integrity, quality, and innovation, HimPharm invites you to embark on a journey of health and vitality with Silymarin, nature’s gift to liver health.

Write to or Call HimPharm to Request a Quote, COA, and MSDS.

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These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

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