Shanxi Medical University Announces $89,000 Technology Package Transfer for Codonopsis Pilosula Polysaccharide Preparation

Recently, Shanxi Medical UniversityFour Codonopsis pilosula PolysaccharidesPublic notice has been issued regarding the transfer of relevant invention patents, with a proposed total transfer amount ofRMB 620,000. This patent transaction adopts the form of patent right assignment, with Shanxi Medical University as the assignor and Shanxi Zhenglai Pharmaceutical Co., Ltd. as the assignee. The invention patents covered in the transaction are as follows:

Proposed Transfer of Four Patents by Shanxi Medical University: Patent Names

The technical innovations of these four patents lie inActive polysaccharide components with well-defined structures and uniform molecular weights were isolated and identified from Codonopsis pilosula, a traditional Chinese medicinal herb, and their specific pharmacological functions were systematically elucidated for the first time.—The former is a linear β-(2→1)-fructofuranan with a low molecular weight (approximately 3,000 Da), exhibiting significant anti-gastric ulcer effects, with its mechanism closely related to the regulation of oxidative stress pathways; the latter is an oligoglucan (molecular weight 1,500–2,000 Da) featuring both an α-(1→4) main chain and β-(6→1) side chains, which can effectively activate macrophages and exert potent immunomodulatory activity. This series of achievements has realized a breakthrough in transforming traditional medicinal materials into raw materials for modern pharmaceuticals and health products with high added value and well-defined functions.

Although Codonopsis pilosula, as a key traditional herb for replenishing qi, is widely used in clinical Traditional Chinese Medicine to treat conditions such as spleen and stomach deficiency, poor appetite, and fatigue, and is believed to have potential gastroprotective and immunoenhancing effects, its modern application faces significant challenges.

First,In the Field of Gastric Ulcer Treatment, although mainstream drugs such as proton pump inhibitors (PPIs) can effectively suppress acid secretion, they are unable to directly promote the repair of damaged mucosa, and long-term use may lead to adverse effects such as osteoporosis and gut microbiota dysbiosis. More importantly, one of the core mechanisms underlying gastric mucosal injury is oxidative stress imbalance, yet existing therapies have limited capacity to target this pathway, resulting in suboptimal efficacy or high recurrence rates in some patients.

Secondly,In the field of immunomodulation,There is an urgent clinical need for safe and effective immunoenhancers to address infections, adjuvant cancer therapy, and states of immunodeficiency. However, many synthetic or biological agents are associated with high costs, significant side effects, or poor stability. Although natural products are considered an ideal source, their complex composition, undefined active constituents, and substantial batch-to-batch variability severely hinder their development and application as standardized pharmaceuticals.

Existing Codonopsis pilosula extracts are precisely in this state: their polysaccharide components are complex, with a broad molecular weight distribution and heterogeneous structures, leading to unstable efficacy and unclear mechanisms of action. Consequently, they fail to meet the core requirements of modern pharmaceuticals for quality controllability, well-defined targets, and reproducible therapeutic effects.

Therefore,Precisely isolate active polysaccharide monomers with clear structures, uniform molecular weights, and specific functions from Codonopsis pilosula, and scientifically validate their therapeutic value for specific clinical pain points (such as oxidative damage to the gastric mucosa and impaired macrophage function).It has become a key breakthrough in bridging the gap between traditional Chinese medicine experience and modern evidence-based medicine, and also addresses the market’s urgent demand for novel, safe, and highly effective natural drugs.

This series of patented technologies centers on the active polysaccharide components of Codonopsis pilosula, a traditional tonic Chinese herbal medicine. By employing interdisciplinary approaches involving modern natural product chemistry, molecular pharmacology, and microbiomics, we have successfully established a comprehensive research system that spans from precise structural elucidation and targeted functional screening to in-depth mechanistic interpretation. Its core advantages and innovations are reflected in the following aspects:

First, we achieved precise decoupling of the "structure-function" relationship of Codonopsis pilosula polysaccharides and a breakthrough in their monomerization.Traditional Codonopsis pilosula extracts are difficult to standardize due to their complex composition and high polysaccharide heterogeneity, which severely restricts their modern applications.

This study, throughSystematic Isolation and Purification Strategy(including hot water extraction, graded alcohol precipitation, ultrafiltration, anion/cation exchange chromatography, and gel filtration chromatography, etc.),First isolation of four active polysaccharide monomers with well-defined structures and highly homogeneous molecular weights from Codonopsis pilosula:

(1) A linear β-D-fructofuranan (CPS-A, ~3 kDa), with a backbone linked by (2→1)-glycosidic bonds;

(2) A glucan (CPC, 1.5–2 kDa) featuring both an α-(1→4) backbone and β-(6→1) side chains;

(3) A high-molecular-weight (~1700 kDa) fructan with α-(2→3) side chains (CPPS);

(4) A complex composed of two fructans with different configurations (with molecular weights of 2–2.5 kDa and 1–1.5 kDa, respectively). These structures were confirmed by modern analytical techniques such as HPGPC, FT-IR, NMR, and GC-MS, providing a molecular basis for subsequent functional studies and quality control.

Second, a “multi-target, multi-dimensional” functional validation system has been established.Reveals the unique value of Codonopsis pilosula polysaccharides in three major areas: gastrointestinal protection, immunomodulation, and gut microbiota regulation.

Among them,CPS-AIt demonstrated significant mucosal protective effects in an ethanol-induced rat gastric ulcer model. The underlying mechanism is closely associated with the upregulation of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities, concomitant with the downregulation of malondialdehyde (MDA) and myeloperoxidase (MPO) levels, indicating that it exerts anti-ulcer effects by modulating the oxidative stress pathway.

CPCIt significantly activated RAW264.7 macrophages in vitro, promoting cell proliferation and phagocytic activity, and dose-dependently enhancing the secretion and mRNA expression of NO, ROS, and inflammatory/regulatory cytokines (such as TNF-α, IL-6, and IL-10), thereby confirming its bidirectional immunomodulatory potential.

Notably, two additional patents further expand the application boundaries of Codonopsis pilosula polysaccharides:CPPSIt has been confirmed to act as a broad-spectrum prebiotic, significantly enriching beneficial short-chain fatty acid (SCFA)-producing gut microbiota such as *Prevotella*, *Faecalibacterium*, and *Phascolarctobacterium*, and holds great promise for interventions in ulcerative colitis, metabolic syndrome, and even neurodegenerative diseases; whereasFructan Complexesdemonstrate a response to specific probiotics—Pediococcus pentosaceusThe selective growth-promoting effect of *Pediococcus pentosaceus* provides a new raw material for the development of targeted prebiotics or functional fermented foods.

Third, it possesses significant advantages in industrialization and high potential for commercial translation.All active polysaccharides are derived from Codonopsis pilosula, a substance recognized as both food and medicine in Traditional Chinese Medicine, ensuring a high safety profile. The preparation process is based on aqueous extraction, membrane separation, and conventional chromatography techniques, eliminating the need for toxic reagents. This controlled and cost-effective workflow facilitates scalable production. Furthermore, the resulting products are well-defined single components or polysaccharide complexes with excellent batch-to-batch consistency, meeting the stringent modern pharmaceutical and functional food requirements for “Quality by Design” and “traceable standards.”

In summary, this series of patents not only elucidates the material basis and mechanisms of action underlying the traditional efficacy of Codonopsis pilosula in “tonifying qi and strengthening the spleen” from a scientific perspective, but also successfully transforms traditional Chinese medicine experience into modern bioactive ingredients with clear clinical indications and market positioning through structural precision, functional specificity, and process standardization. This represents a significant paradigm shift in the research on traditional Chinese medicine polysaccharides, moving from “empirical application of crude extracts” to “precise development of individual compounds,” and demonstrates outstanding originality, systematic rigor, and industrialization value.

As state support for the development of classical Traditional Chinese Medicine (TCM) formulas and active ingredient monomers intensifies, and consumer recognition of concepts such as “scientific TCM” and “precision nutrition” deepens, this technology has established a solid foundation for transitioning from laboratory research to industrialization and from the domestic market to the international arena. It boasts broad market prospects and significant strategic value.

Currently, there is a wide variety of proprietary Chinese medicines and prepared herbal slices containing Codonopsis pilosula (Dangshen) as the main ingredient on the market. Representative products include Sijunzi Pills, Buzhong Yiqi Pills, Shengmai Yin, and various Dangshen oral liquids. These products are widely used in clinical Traditional Chinese Medicine practice and the health supplement market for"Strengthen the spleen and replenish qi," "Enhance physical stamina"for such purposes, with particularly high acceptance among middle-aged and elderly individuals as well as those in a sub-health state.

However,Its core defect lies in the undefined active substance:Most products are mixtures obtained through aqueous decoction or alcohol extraction, containing various components such as saponins, alkaloids, polysaccharides, and volatile oils. Among these, the polysaccharide fraction constitutes a complex system characterized by a broad molecular weight distribution and high structural heterogeneity. This complexity makes product standardization difficult, leads to significant batch-to-batch variability in efficacy, and prevents the elucidation of which specific components exert which biological effects, thereby severely hindering their acceptance within the evidence-based medicine framework and their internationalization. Despite their favorable safety profiles and low costs, the lack of support from modern scientific validation makes it challenging for them to enter the mainstream high-end markets for functional foods or pharmaceuticals.

In the field of anti-gastric ulcer treatment,Mainstream products include proton pump inhibitors (e.g., omeprazole, pantoprazole) and H₂ receptor antagonists (e.g., ranitidine), representing a substantial global market size;In terms of immunomodulation,These include prescription drugs such as thymosin alpha-1, interferon, and levamisole, as well as nutritional supplements like glutamine and beta-glucan (yeast-derived). The advantages of these products lie in their relatively clear mechanisms of action, robust clinical evidence, and rapid onset of efficacy; they have been incorporated into multiple clinical practice guidelines.

However, its limitations are equally prominent:Long-term use of proton pump inhibitors (PPIs) can lead to gut microbiota dysbiosis, vitamin B12 deficiency, and an increased risk of fractures; synthetic immunomodulators are often associated with adverse reactions such as fever, allergies, and hepatic and renal burden, in addition to their high cost. Furthermore, most Western medicines target only a single pathological link (such as acid suppression or direct stimulation of immune cells) and lack the capacity for comprehensive regulation of the body’s overall homeostasis (e.g., oxidative-antioxidative balance and the gut-immune axis). In contrast, Codonopsis pilosula polysaccharide monomers, which are naturally derived, exhibit multi-target synergistic effects, and have minimal side effects, hold unique potential for chronic disease management and health maintenance scenarios that prioritize “safe, long-term intervention.”

In recent years, plant polysaccharide health supplements, represented by Ganoderma lucidum polysaccharide capsules, Lentinan tablets, Astragalus polysaccharide oral liquids, and Lycium barbarum polysaccharide powders, have expanded rapidly in both domestic and international markets, primarily promoting concepts such as “immune enhancement,” “anti-fatigue,” and “antioxidant” effects. These products are typically manufactured from crude polysaccharide extracts subjected to simple purification processes, offering moderate pricing and gradually increasing consumer awareness. In contrast, the precise Codonopsis pilosula polysaccharide monomers represented by this series of patented technologies possess significant differentiated advantages:Well-defined structure, uniform molecular weight, and strong functional targeting (specifically focusing on anti-ulcer activity, immune activation, broad-spectrum prebiotic effects, and specific prebiotic effects); in-depth mechanistic studies; derived from medicinal and edible homologous herbs, ensuring high safety and acceptability.

Looking ahead, high-purity plant-derived active polysaccharides that combine robust scientific evidence with traditional medical wisdom will usher in significant development opportunities, driven by the advancement of the “Healthy China” strategy, an aging population, and the sustained rise in consumer demand for natural, safe, and functional health products.