Jilin University Announces Exclusive Licensing of a Novel TCM Formulation for Acute Pancreatitis Treatment
Recently, the Technology Development Office of the Scientific Research Academy of Jilin University released a public notice on the transformation of scientific and technological achievements, proposing toExclusive Licensein the manner of,“A Traditional Chinese Medicine Composition for Pancreatic Clearance and Its Preparation Process”The patent rights are granted to China-Japan Union Hospital of Jilin University, with a licensing term extending up to17 years, the contract amount shall be settled based on a sales commission model.
The inventor of this patented technology is from the Third Hospital of Jilin University's Clinical Medical College.Professor Yu Qian and her team。
Yu Qian:Member of the Committee on Pharmacy Administration and Pharmacotherapeutics, National Health Commission of the People’s Republic of China; Vice Chairperson of the Professional Committee on Drug Evaluation, Chinese Research Hospital Association; Member of the Clinical Pharmacy Professional Committee, Chinese Medical Association; Member of the Pharmacy Administration Professional Committee, Chinese Hospital Association; Member of the Hospital Pharmacy Professional Committee, Chinese Pharmaceutical Association; Chairperson of the Clinical Pharmacy Branch, Jilin Provincial Pharmaceutical Association; Chairperson of the Medical Institutions Professional Committee, Jilin Provincial Drug Re-evaluation Association. Research achievements: Serves as an editorial board member for national-level journals such as the Annals of Pharmacotherapy (Chinese Edition). Has presided over more than 20 research projects, including those funded by the Jilin Provincial Department of Science and Technology, the Jilin Provincial Health Research Talent Special Project, the Wu Jieping Medical Foundation, and multicenter studies on post-marketing drug safety re-evaluation. Has published 13 SCI-indexed papers, including four in Q2 journals, with one paper rated asHighly Cited Papers in the Field of Pharmacology & Toxicology. Granted one invention patent; served as editor-in-chief for one textbook included in the “13th Five-Year Plan” curriculum.
Assignee of This Patent TechnologyChina-Japan Union Hospital of Jilin University, is a large comprehensive Grade A tertiary hospital directly affiliated with Jilin University, integrating medical care, teaching, scientific research, prevention, healthcare, and rehabilitation.
The patent proposed for conversion is titled “A Traditional Chinese Medicine Composition for Pancreatic Clearance and Its Preparation Process,” which falls within the field of traditional Chinese medicine (TCM) technology. This invention introduces a composition formulated from seven TCM ingredients—Bupleuri Radix (Chaihu), Corydalis Rhizoma (Yanhusuo), Toosendan Fructus (Chuanlianzi), Rhei Radix et Rhizoma (Dahuang), Scutellariae Radix (Huangqin), Aucklandiae Radix (Muxiang), and Paeoniae Radix Rubra (Chishao)—in specific weight ratios. It also provides a corresponding preparation process involving steps such as extraction, concentration, and granulation. The TCM composition exhibits efficacies in clearing heat and detoxifying, soothing the liver and regulating qi, activating blood circulation to relieve pain, and clearing damp-heat from the liver and spleen. It is indicated for symptoms such as fever, abdominal pain and distension, nausea and vomiting, jaundice, and constipation caused by disharmony of liver-spleen qi mechanism, or invasion by heat-toxin or damp-heat.
The disease addressed by this patent primarily involves pancreatitis triggered by disharmony in the qi dynamics of the liver and spleen, with adverse effects invading the spleen and stomach, or by invasion of heat-toxin and damp-heat. Based on its clinical manifestations, this condition can be categorized under traditional Chinese medicine (TCM) concepts such as “abdominal pain,” “spleen heat disease,” or “epigastric pain.” TCM practitioners throughout history have attributed its etiology frequently to emotional stagnation, dietary irregularities, or exogenous pathogenic factors. TCM emphasizes “restoring flow as the therapeutic principle,” as stated in Zhang’s Medical Compendium: “Epigastric pain is mostly caused by stagnation,” highlighting that qi stagnation and obstruction are the key pathological mechanisms.
From the perspective of Traditional Chinese Medicine (TCM) pathogenesis, the core of this disease lies inDysfunction of Qi MechanismThe liver governs coursing and discharge, while the spleen governs the ascending of clear qi; only through their mutual coordination can the normal ascending and descending functions of the spleen and stomach be maintained. If emotional depression leads to stagnation of liver qi, this stagnation may transversely invade the spleen, thereby weakening the spleen’s function of transportation and transformation. Traditional Chinese Medicine holds that “qi is the commander of blood”; when qi moves, blood moves. If qi mechanism is obstructed, blood circulation will also be impeded, leading to the formation of blood stasis, which in turn causes abdominal pain. Meanwhile, the spleen prefers dryness and dislikes dampness. If damp turbidity accumulates internally and encumbers the spleen and stomach, it will prevent clear qi from ascending and turbid qi from descending, further obstructing the qi mechanism. Huang Yuanyu, a physician of the Qing Dynasty, pointed out in Si Sheng Xin Yuan (Source of the Four Sages) that the prevalence of dampness is often related to insufficient yang qi in the human body. When spleen yang is deficient, damp pathogen cannot be properly transformed and transported, resulting in stagnation of qi mechanism in the middle jiao, impairment of fluid distribution, accumulation of phlegm-dampness, and obstruction of qi and blood, ultimately leading to visceral dysfunction and disease onset.
Currently, several traditional Chinese medicine (TCM) formulations are available for the treatment of acute pancreatitis. However, their pharmacological properties are often excessively potent, frequently necessitating concurrent enema administration, which involves cumbersome procedures and is less patient-friendly. Furthermore, TCM products for pancreatitis currently on the market remain predominantly in the form of traditional decoction pieces, which present several notable drawbacks. First, quality control is difficult to standardize, as the medicinal materials are susceptible to environmental factors during storage, leading to deterioration. Second, the dispensing process relies on manual handling and weighing, which is prone to dosage errors. Third, self-decoction by patients is inconvenient, making it difficult to precisely control dosage and administration.
Addressing the numerous pain points of complex procedures, inconsistent quality control, and inconvenient medication administration, this inventionEstablished a full-process standardized management system from the source of medicinal materials to the finished pharmaceutical products, achieving a key breakthrough from experience-based compounding to standardized production.
The primary advantage of the traditional Chinese medicine composition provided by this patent lies inRigorous formulation design and clear hierarchical compatibility relationships among sovereign, minister, assistant, and envoy herbs. The prescription is based onRadix Aucklandiae as the sovereign drug, its pungent and warming properties excel at regulating qi movement in the triple burner. Modern studies have confirmed that costunolide and other constituents found in Aucklandia root can effectively promote gastrointestinal motility and bile secretion, directly addressing the core pathogenesis of abdominal pain due to qi stagnation.
Deputy Herbs: Rhubarb and Red Peony RootRhubarb, bitter and cold in nature, acts synergistically to clear heat and eliminate stagnation, facilitating the downward expulsion of damp-heat toxins. Red Peony Root enters the blood level to drain liver fire, resolve stasis, and alleviate pain; together, these two herbs target the pathological mechanisms of heat toxicity and blood stasis. As assistant herbs, Corydalis Rhizome, Sichuan Chinaberry Fruit, and Scutellaria Root enhance the effects of promoting qi circulation and blood activation, soothing the liver and draining fire, and clearing heat while drying dampness, respectively. Bupleurum Root serves as the guiding herb, directing the other ingredients into the Liver and Gallbladder meridians and playing a key role in soothing the liver and relieving depression. This formula is not a mere aggregation of herbs but a multi-target, synergistic compound system established on the therapeutic principle of “soothing the liver and regulating qi, clearing heat and activating blood.”
In terms of formulation technology, this patentAchieved the leap from traditional experience-based decoction to modern standardized production, which represents its core advancement. This process involves meticulous validation and locking of every critical parameter.
For instance, the 40-minute soaking time set prior to extraction is determined based on the water absorption saturation point of the medicinal herbs derived from experiments, ensuring the full dissolution of active ingredients during the subsequent decoction process. The regimen employing an “8-6-6” fold water volume with three extractions represents the optimal choice for balancing extraction efficiency and cost. The selection of a 100-mesh screen for filtration is a rational decision that balances filtrate clarity with filtration efficiency, effectively retaining impurities while avoiding the reduced efficiency associated with finer meshes.
The concentration step precisely controls the relative density of the extract toBetween 1.25 and 1.30 at 60°C, this standard is crucial. A density that is too low indicates high moisture content, which would significantly increase energy consumption and time in subsequent drying processes; conversely, a density that is too high renders the extract overly viscous, making it difficult to pour from containers, leading to waste and disrupting production continuity. The density range established by this patent ensures the extract maintains good fluidity for easy transfer, while laying an ideal material foundation for the next granulation step.
In terms of the molding process, the patent adoptsWet Granulation Technology, and precisely optimized the excipient ratio. The extract was determined to be mixed with excipients (corn starch and sucrose) at a ratio of 1:2.8, using 75% ethanol as a wetting agent, so that the resulting soft mass reached“Clumps when grasped, disperses upon touch”state.
This state is key to successful granulation, ensuring that after passing through a 12-mesh sieve, the resulting granules are uniform in size, have a high formation rate, and exhibit good flowability. The final granular dosage form itself represents a significant advantage, as it overcomes the inconveniences of traditional decoctions, such as difficult preparation and portability, while maximally retaining the rapid onset of action characteristic of decoctions. Quantitatively packaged granules offer accurate dosing, good stability, and convenient administration, better aligning with modern medication habits.
In summary, the advantages of this patent span“Theory - Formula - Process - Dosage Form - Clinical”a complete chain. It starts from clear TCM pathogenesis theory, deduces sophisticated compatibility; through a series of quantifiable and reproducible standardized production processes, it stably and efficiently transfers the active ingredients of medicinal materials to the final product; and uses granule dosage forms convenient for clinical use as carriers.
This systematic innovation, which closely integrates the wisdom of traditional Chinese medicine with modern pharmaceutical technology, ensures uniform product quality, reliable therapeutic efficacy, and convenient application.
Guided by this paradigm, research enterprises and institutions both in China and abroad are expanding their focus to broader fields. Centering on digestive system diseases as well as other common and chronic conditions, they have established multiple pipelines under development, continuously driving the translation of more original scientific achievements into clinical and market value.
In the international market,32 Biosciencesis a U.S. biotechnology company focused on the field of gastrointestinal (GI) mucosal immunology, with its primary achievements centered on first-in-classMucosal Immune Modulator (MIM) CS-0003. This drug is designed to exert synergistic effects through multiple mechanisms: providing a coating protection for the intestinal mucosal barrier at the physical level, inhibiting the virulence of pathogenic bacteria, and precisely modulating local mucosal immune responses, thereby offering comprehensive buffering and protection for the gastrointestinal tract. Its first target indication is the prevention of gastrointestinal surgical site infections (GI SSI), with plans to expand its application in the future to areas with significant unmet needs, such as inflammatory bowel disease (IBD) and the prevention of colorectal cancer recurrence.
Currently, CS-0003 is in a critical transitional phase from preclinical to clinical development. Studies to support an Investigational New Drug (IND) application are underway, with plans to subsequently initiate Phase I clinical trials.
In China,Department of Pancreatic Surgery, The First Affiliated Hospital of Dalian Medical UniversityofProfessor Shang DongThe team is one of the leading authorities in China in the field of integrated traditional Chinese and Western medicine for the treatment and research of severe acute pancreatitis (SAP).
The General Program Project of the National Natural Science Foundation of China for 2023 undertaken by this team“Mechanistic Study on Qingyi Granules Regulating Acinar Cell Fate in Severe Acute Pancreatitis Based on Lipid Metabolism Remodeling”Among the core achievements is the revelation, from a novel perspective of lipid metabolism remodeling in acinar cells, of its independently developed“Qingyi Granules” for Disease Interventionkey underlying mechanisms. Studies have shown that during the onset of severe acute pancreatitis, abnormal reprogramming of lipid metabolism occurs within pancreatic acinar cells. This "lipid metabolic remodeling" is a critical factor contributing to cellular injury, inflammatory cascades, and even organ failure. Qingyi Granules exert their therapeutic effects by modulating this specific metabolic pathway, thereby influencing the fate (i.e., survival or death) of acinar cells. This approach alleviates pancreatic self-injury at its source and suppresses subsequent systemic inflammation.
Currently, this research remains in the basic research stage, representing a preclinical mechanistic exploration aimed at elucidating the drug’s mechanism of action, with the project scheduled to run through 2027. Subsequent rigorous formulation development, pharmacological and toxicological studies, and clinical trials are required before it can ultimately be translated into a marketed pharmaceutical product.