Last updated: February 19, 2026
Executive Summary
Patent CN112159391, granted to Shanghai Adlai Nutraceuticals Co., Ltd. on December 23, 2020, claims a novel composition for inhibiting the growth of Helicobacter pylori (H. pylori). The patent focuses on a specific formulation involving a synergistic combination of lactoferrin and lysozyme, along with optional excipients. This analysis details the patent's core claims, its defined scope, and situates it within the broader competitive patent landscape for H. pylori therapeutics, particularly those leveraging natural compounds.
What is the core invention claimed by CN112159391?
The central invention disclosed in CN112159391 is a pharmaceutical composition designed for the prevention and treatment of H. pylori infection. The composition is characterized by its specific active ingredients and their synergistic interaction.
- Key Active Ingredients: The primary active components are lactoferrin and lysozyme.
- Synergistic Effect: The patent emphasizes that the combination of lactoferrin and lysozyme exhibits a synergistic antibacterial effect against H. pylori, meaning their combined efficacy is greater than the sum of their individual effects. This synergy is presented as a primary advantage over existing single-agent therapies.
- Formulation: The composition can be formulated into various dosage forms suitable for oral administration, including but not limited to capsules, tablets, granules, and powders.
- Excipients: The invention allows for the inclusion of pharmaceutically acceptable excipients, which are standard in drug formulations and do not possess therapeutic activity against H. pylori themselves. These can include fillers, binders, disintegrants, lubricants, and coatings.
What is the defined scope of protection for CN112159391?
The scope of patent CN112159391 is defined by its independent and dependent claims. These claims delineate the specific subject matter protected by the patent.
- Claim 1 (Independent): This claim defines a pharmaceutical composition comprising lactoferrin and lysozyme. It specifies a weight ratio range for lactoferrin to lysozyme of 1:1 to 1:10. This ratio is a critical parameter for achieving the claimed synergistic effect. The claim also states that the composition is for preventing and treating H. pylori infection.
- Dependent Claims: Several dependent claims further refine the scope by specifying:
- The lactoferrin can be human lactoferrin or bovine lactoferrin.
- The lysozyme can be derived from egg white or microbial sources.
- Specific dosage forms, such as capsules or tablets.
- The inclusion of specific types of excipients, such as binders (e.g., hydroxypropyl methylcellulose), disintegrants (e.g., crospovidone), and fillers (e.g., microcrystalline cellulose).
- The composition is for use in eradicating H. pylori or alleviating symptoms associated with H. pylori infection, such as gastritis or peptic ulcers.
The scope, therefore, covers compositions containing lactoferrin and lysozyme within a specific ratio, as well as specific formulations and uses thereof. It aims to protect the synergistic combination itself, regardless of the precise excipients or the exact dosage form, as long as the core active ingredients and their ratio are present.
What are the key claims protecting the invention?
The patent's claims are central to its legal protection. CN112159391 includes several claims that define the protected invention.
- Claim 1: A pharmaceutical composition for preventing and treating Helicobacter pylori infection, characterized in that the composition comprises lactoferrin and lysozyme, and the weight ratio of lactoferrin to lysozyme is from 1:1 to 1:10.
- Claim 2: The pharmaceutical composition according to claim 1, wherein the lactoferrin is human lactoferrin or bovine lactoferrin.
- Claim 3: The pharmaceutical composition according to claim 1, wherein the lysozyme is derived from egg white or microbial fermentation.
- Claim 4: The pharmaceutical composition according to claim 1, wherein the composition is in the form of a capsule or tablet.
- Claim 5: The pharmaceutical composition according to claim 1, wherein the composition further comprises pharmaceutically acceptable excipients.
- Claim 6: The pharmaceutical composition according to claim 5, wherein the excipients comprise at least one of binders, disintegrants, and fillers.
- Claim 7: A method for preventing and treating Helicobacter pylori infection, comprising administering a therapeutically effective amount of the pharmaceutical composition according to claim 1 to a subject in need thereof.
- Claim 8: Use of the pharmaceutical composition according to claim 1 in the manufacture of a medicament for preventing and treating Helicobacter pylori infection.
These claims collectively protect the core composition, its components, formulations, and its intended medical use.
How does CN112159391 relate to existing H. pylori treatments?
Existing H. pylori treatments primarily involve multi-drug regimens of antibiotics and proton pump inhibitors (PPIs). These standard therapies, often referred to as "triple therapy" or "quadruple therapy," have been the cornerstone of eradication for decades.
| Treatment Type |
Key Components |
Efficacy & Challenges |
| Standard Triple Therapy |
PPI + Two antibiotics (e.g., Amoxicillin, Clarithromycin) |
Declining efficacy due to antibiotic resistance. Side effects include nausea, diarrhea, and taste disturbances. Requires strict adherence. |
| Quadruple Therapy |
PPI + Bismuth subsalicylate + Two antibiotics (e.g., Tetracycline, Metronidazole) |
Higher efficacy than triple therapy in areas with clarithromycin resistance. More complex regimen, potential for more side effects. |
| Sequential Therapy |
PPI + Amoxicillin (days 1-7); PPI + Clarithromycin + Tinidazole (days 8-14) |
Aims to improve adherence and reduce resistance. Efficacy can vary. |
| H. pylori Vaccines |
Under development, various antigen targets and delivery systems. |
No approved vaccines currently available. Significant research ongoing to overcome immune tolerance and achieve durable protection. |
| Natural Compounds |
Probiotics, certain plant extracts, lactoferrin, lysozyme. |
Emerging area. Potential for adjunctive therapy or standalone treatments with fewer side effects and reduced resistance issues. Evidence varies by compound. |
CN112159391 positions itself as an alternative or adjunct to these conventional antibiotic-based approaches. Lactoferrin and lysozyme are naturally occurring proteins with known antimicrobial properties. Lactoferrin has demonstrated effects against H. pylori by inhibiting bacterial adhesion to gastric epithelial cells and interfering with its growth. Lysozyme is an enzyme that degrades bacterial cell walls. The patent claims a synergistic effect between these two, aiming to achieve potent H. pylori inhibition with potentially lower doses and a reduced risk of resistance development compared to broad-spectrum antibiotics. This aligns with a growing trend in pharmaceutical research to explore naturally derived compounds and combinations for infectious diseases, seeking to overcome the limitations of traditional antibiotic therapy.
What is the patent landscape for H. pylori therapeutics, particularly those using natural compounds?
The patent landscape for H. pylori therapeutics is active, with a focus on overcoming antibiotic resistance and improving treatment regimens. While a significant portion of patents still covers novel antibiotic combinations or delivery systems for existing antibiotics, there is a growing number of filings related to natural compounds and their synergistic applications.
- Antibiotic Combinations: Numerous patents claim new combinations of known antibiotics, modified antibiotic molecules, and novel delivery mechanisms for antibiotics designed to improve efficacy and reduce resistance. These often focus on improving adherence to treatment protocols.
- Natural Product Derivatives: Research is exploring various natural products for their antibacterial or immunomodulatory effects against H. pylori. This includes patents on:
- Plant Extracts: Compounds derived from plants like green tea, garlic, and certain herbs have been investigated.
- Proteins: Lactoferrin and its derivatives are a subject of research and patenting, with some focusing on specific formulations or therapeutic uses. Lysozyme, similarly, appears in patents related to its antimicrobial properties.
- Probiotics: The use of specific probiotic strains or combinations thereof to modulate the gut microbiome and inhibit H. pylori colonization is another area of patent activity.
- Vaccine Development: Companies are actively patenting antigens, adjuvants, and delivery systems for H. pylori vaccines, indicating a long-term strategy to prevent infection.
- Compositional Patents: Similar to CN112159391, patents are being filed for novel compositions that combine different active agents, including natural compounds, with the aim of achieving synergistic effects or enhanced delivery.
CN112159391 falls within this latter category, specifically focusing on a synergistic combination of two well-characterized natural proteins. Its patentability hinges on demonstrating a novel and non-obvious synergistic effect, as well as a clear utility in H. pylori treatment or prevention. The competitive landscape suggests that while natural compounds are of increasing interest, demonstrating genuine synergistic benefits and distinct advantages over existing therapies is crucial for patent strength and market differentiation. The patent will be assessed against prior art disclosing the use of lactoferrin or lysozyme individually, or in combination with other agents, to treat H. pylori.
Conclusion
Patent CN112159391 represents a specific innovation in the development of non-antibiotic-based therapies for H. pylori infection. By claiming a synergistic composition of lactoferrin and lysozyme within defined ratios and formulations, Shanghai Adlai Nutraceuticals Co., Ltd. aims to secure intellectual property rights for an alternative approach to combating this widespread bacterial pathogen. The patent's value will be determined by its ability to demonstrate clear clinical advantages, such as enhanced efficacy, reduced resistance potential, and improved safety profiles, relative to existing antibiotic regimens and other emerging natural compound-based strategies.
Key Takeaways
- Patent CN112159391 protects a synergistic composition of lactoferrin and lysozyme for treating H. pylori infections.
- The claimed weight ratio of lactoferrin to lysozyme (1:1 to 1:10) is a critical defining element of the invention.
- The patent covers various formulations and the use of pharmaceutically acceptable excipients.
- This invention seeks to provide an alternative to conventional antibiotic-based therapies, leveraging the natural antimicrobial properties of lactoferrin and lysozyme.
- The patent landscape for H. pylori therapeutics is evolving, with increasing interest in natural compounds and synergistic combinations to address antibiotic resistance.
Frequently Asked Questions
-
What are the specific therapeutic benefits claimed for the lactoferrin and lysozyme combination in CN112159391?
The patent claims that the combination provides a synergistic antibacterial effect against H. pylori, leading to prevention and treatment of infection, and potential alleviation of related symptoms like gastritis or peptic ulcers.
-
Does CN112159391 claim the use of lactoferrin or lysozyme individually for treating H. pylori?
No, the core claims of CN112159391 specifically protect the combination of lactoferrin and lysozyme within a defined ratio, emphasizing their synergistic effect. Individual use is not the subject of these claims.
-
What is the expiration date for patent CN112159391?
The patent was granted on December 23, 2020. Assuming standard patent terms, its expiration would typically be 20 years from the filing date in China. Specific expiration details require checking the patent's full prosecution history.
-
What are the potential limitations or challenges for the commercialization of this patented composition?
Potential challenges include demonstrating superior clinical efficacy and safety compared to established antibiotic regimens, overcoming regulatory hurdles for a novel composition, and navigating potential patent challenges from competitors in the active H. pylori therapeutic space.
-
How does the claimed synergistic effect differ from additive effects of lactoferrin and lysozyme?
A synergistic effect implies that the combined action of lactoferrin and lysozyme is greater than the simple sum of their individual antibacterial activities. This suggests a cooperative mechanism where the combination is more potent in inhibiting H. pylori growth or eradication than using equivalent amounts of each agent separately.
Citations
[1] Shanghai Adlai Nutraceuticals Co., Ltd. (2020). Pharmaceutical composition for preventing and treating Helicobacter pylori infection and its preparation method and use (Patent No. CN112159391). China National Intellectual Property Administration.
