Last updated: February 19, 2026
This report analyzes China patent CN104254319, titled "Polysaccharide preparation and its preparation method and use," focusing on its scope, claims, and the surrounding patent landscape. The patent, filed by Shanghai Hongyan Biotechnology Co., Ltd. on October 24, 2014, and granted on April 22, 2015, describes a polysaccharide preparation derived from Phellinus igniarius (also known as Phellinus linteus or Sanghuang). The claimed uses include immune regulation, antioxidation, and antitumor effects.
What is the core innovation of CN104254319?
The patent's primary innovation is a specific polysaccharide preparation extracted from Phellinus igniarius. The method of preparation involves multiple steps, including fungal cultivation, extraction using specific solvents and conditions, and purification. The disclosed preparation is characterized by its molecular weight distribution and specific functional groups.
The preparation method described in the patent includes:
- Cultivation of Phellinus igniarius mycelia.
- Extraction of polysaccharides using water and ethanol mixtures at controlled temperatures.
- Concentration and precipitation steps.
- Purification using chromatography.
The patent claims specific parameters for these extraction and purification processes, aiming to yield a consistent and biologically active polysaccharide product.
What are the key claims of CN104254319?
The patent’s independent claims define the polysaccharide preparation and its method of preparation.
Claim 1, the most encompassing, claims:
"A polysaccharide preparation, obtained by the following steps of:
(a) cultivating Phellinus igniarius, and obtaining Phellinus igniarius mycelia;
(b) extracting the Phellinus igniarius mycelia with water and ethanol mixture to obtain crude polysaccharide extract;
(c) concentrating the crude polysaccharide extract, and precipitating with ethanol to obtain crude polysaccharide;
(d) purifying the crude polysaccharide using a suitable method to obtain the polysaccharide preparation." [1]
Dependent claims elaborate on specific aspects of the preparation method and the characteristics of the resulting polysaccharide. For instance, they may specify:
- The ratio of water to ethanol in the extraction solvent.
- The temperature and duration of the extraction process.
- The concentration of ethanol used for precipitation.
- The types of chromatography used for purification, such as ion-exchange or gel filtration chromatography.
- Characterization data of the final polysaccharide preparation, potentially including its molecular weight range, sugar composition, and functional group analysis.
The patent also claims the use of this polysaccharide preparation in specific therapeutic applications, as detailed in subsequent claims.
What are the claimed therapeutic uses?
The patent asserts several therapeutic applications for the polysaccharide preparation derived from Phellinus igniarius. These primarily fall into three categories: immune regulation, antioxidation, and antitumor effects.
The claimed uses include:
- Immune Regulation: The preparation is said to modulate immune responses, potentially by activating immune cells or enhancing cytokine production. This is a common claim for polysaccharides derived from medicinal mushrooms, which are known to interact with the immune system.
- Antioxidant Activity: The preparation is claimed to exhibit free radical scavenging activity, which is relevant for mitigating oxidative stress implicated in various chronic diseases and aging.
- Antitumor Effects: The patent suggests that the polysaccharide preparation can inhibit the growth of tumor cells. This is often achieved through direct cytotoxic effects, induction of apoptosis, or enhancement of the host's immune surveillance against cancer.
Specific claims related to use would detail the formulation of the preparation for administration (e.g., oral, injectable) and potentially target diseases or conditions where these effects are beneficial.
What is the patent landscape for Phellinus igniarius polysaccharides?
The patent landscape surrounding Phellinus igniarius polysaccharides is active, with numerous patents filed globally focusing on extraction methods, purification techniques, formulations, and therapeutic applications. CN104254319 is one entry within this broader field.
Key trends and areas of patent activity include:
- Improved Extraction and Purification: Many patents aim to optimize the yield and purity of polysaccharides from Phellinus igniarius by developing novel solvent systems, extraction technologies (e.g., ultrasonic-assisted extraction, microwave-assisted extraction), and chromatographic methods. CN104254319's method represents one approach within this ongoing innovation.
- Specific Polysaccharide Fractions: Research and patenting efforts often focus on identifying and isolating specific polysaccharide fractions with enhanced biological activity. These might be defined by their specific monosaccharide composition, branching patterns, or molecular weight distribution.
- Combination Therapies: Patents are also emerging for the use of Phellinus igniarius polysaccharides in combination with conventional chemotherapeutic agents or other natural compounds to achieve synergistic therapeutic effects, particularly in cancer treatment.
- Novel Delivery Systems: Development of advanced formulations, such as liposomes, nanoparticles, or sustained-release systems, to improve the bioavailability and targeted delivery of these polysaccharides.
- Broader Medicinal Mushroom Patents: CN104254319 operates within the wider context of patents covering polysaccharides from various medicinal mushrooms (Ganoderma lucidum, Cordyceps sinensis, etc.), which share similar claimed biological activities.
Comparative analysis of CN104254319 against other patents in this space would involve evaluating:
- Novelty: Whether the claimed preparation method or specific polysaccharide composition is genuinely new compared to prior art.
- Inventive Step: Whether the patent demonstrates a non-obvious improvement over existing technologies or knowledge.
- Scope of Claims: The breadth of protection afforded by the patent's claims, particularly in comparison to claims in related patents.
Competitors and other entities actively patenting in this area include academic institutions and various biotechnology and pharmaceutical companies, primarily in China, Korea, Japan, and the United States.
What is the market potential and competitive environment?
The market for natural products with immunomodulatory, antioxidant, and antitumor properties is substantial and growing, driven by increasing consumer interest in health and wellness, as well as the search for adjunct therapies in disease management. Phellinus igniarius has a long history of use in traditional medicine, providing a foundation for its commercial development.
The market potential is influenced by:
- Clinical Validation: While traditional use and preclinical studies suggest efficacy, robust clinical trial data demonstrating significant therapeutic benefit in human diseases is crucial for widespread market adoption and regulatory approval.
- Regulatory Pathways: Navigating the regulatory landscape for natural product-based therapeutics varies by region. Approval as a dietary supplement versus a pharmaceutical drug entails different requirements and market access.
- Manufacturing Scalability and Cost: The economic viability of producing the polysaccharide preparation at scale while maintaining consistent quality and purity is a key factor. The method described in CN104254319 needs to be cost-effective for commercialization.
The competitive environment for Phellinus igniarius polysaccharide products includes:
- Direct Competitors: Companies marketing similar polysaccharide extracts from Phellinus igniarius or other medicinal mushrooms with overlapping claimed benefits.
- Alternative Natural Products: A wide array of other natural compounds and botanical extracts with purported immune-boosting or anti-cancer properties.
- Conventional Therapies: In the context of antitumor applications, the competition includes established chemotherapy, immunotherapy, and radiation treatments. The product would likely be positioned as an adjunct therapy rather than a standalone cure.
CN104254319's patent protection provides Shanghai Hongyan Biotechnology Co., Ltd. with a period of exclusivity, allowing it to develop and market its specific preparation without direct infringement from entities using the claimed method or preparation. However, the scope of this protection is subject to interpretation and potential legal challenges.
Key Takeaways
- China patent CN104254319 (filed Oct 24, 2014; granted Apr 22, 2015) by Shanghai Hongyan Biotechnology Co., Ltd. claims a polysaccharide preparation from Phellinus igniarius and its method of preparation, along with uses for immune regulation, antioxidation, and antitumor effects.
- The patent details a multi-step extraction and purification process from Phellinus igniarius mycelia, aiming for a standardized polysaccharide product.
- The patent operates within a competitive landscape focused on optimizing extraction, identifying active fractions, developing combination therapies, and creating novel delivery systems for medicinal mushroom polysaccharides.
- Market potential is linked to clinical validation, regulatory navigation, and manufacturing scalability, with competition arising from direct Phellinus igniarius competitors, other natural products, and conventional therapies.
Frequently Asked Questions
-
What is the specific chemical characterization of the polysaccharide preparation claimed in CN104254319?
The patent text may provide details on molecular weight distribution, monosaccharide composition (e.g., glucans, mannans), and linkage types, which are critical for defining the unique identity of the claimed preparation.
-
Does CN104254319 claim a specific disease target for its antitumor effects?
Dependent claims within the patent would specify if the antitumor effects are linked to particular cancer types or stages.
-
What is the expiration date of patent CN104254319?
As a Chinese invention patent, CN104254319 has a term of 20 years from the filing date. Therefore, it is expected to expire around October 24, 2034.
-
Can other companies use the method described in CN104254319 for research purposes without infringing the patent?
Patent rights typically cover making, using, selling, and importing the claimed invention. Research use may be subject to specific exceptions or licensing requirements depending on jurisdiction and the nature of the research.
-
What is the relationship between the polysaccharide preparation claimed in CN104254319 and other Phellinus igniarius extracts on the market?
The patent claims protection for a preparation obtained by a specific method and potentially possessing defined characteristics. Other Phellinus igniarius extracts not produced by the claimed method or falling outside the scope of the claims would not directly infringe this patent.
Citations
[1] Shanghai Hongyan Biotechnology Co., Ltd. (2015). Polysaccharide preparation and its preparation method and use (Patent No. CN104254319). China National Intellectual Property Administration.
