A traditional Chinese medicine composition for dissolving urate crystals and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for dissolving urate crystals and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: Radix Tripetali 30-50 parts, Smilax Glabra 40-70 parts, Chicken Gizzard Mucosa 20-40 parts, Arisaema Cum Bile 20-40 parts, Plantago 20-35 parts, Coix Seed 25-45 parts, Poria 15-30 parts and Salvia Miltiorrhiza 15-25 parts. The composition takes Radix Tripteryglli and Smilax Glabra as monarch drugs, and takes Chicken Gizzard Mucosa and Arisaema Cum Bile as minister drugs, and has the effect of actively dissolving the deposited urate crystals in the body. According to the monitoring of the double-source CT three-dimensional reconstruction technology, the volume of urate crystals in the body of early-stage gout patients can be reduced by 30-40% after continuously taking the composition for 3-6 months, can be reduced by 50-60% after taking the composition for 6-12 months, and can be reduced by more than 90% in combination with the treatment of local tophi. The application further provides a water-overflowing pill preparation of the composition and a preparation method thereof, and the composition has the characteristics of active crystal dissolution, definite curative effect and high safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for dissolving urate crystals and its preparation method. Background Technology

[0002] Gout is a metabolic disease caused by purine metabolism disorders and / or impaired uric acid excretion. Clinically, it is characterized by hyperuricemia, recurrent acute arthritis, and tophi formation. With improved living standards and changes in dietary structure, the incidence of gout is increasing year by year, and it has become a common metabolic disease that seriously endangers human health.

[0003] Currently, Western medicine mainly uses the following types of drugs to treat gout: (1) drugs that inhibit uric acid production, such as allopurinol and febuxostat; (2) drugs that promote uric acid excretion, such as benzbromarone and probenecid; (3) anti-inflammatory drugs for acute attacks, such as colchicine and nonsteroidal anti-inflammatory drugs. However, the existing Western medicine treatment has the following shortcomings: First, the above-mentioned drugs mainly focus on controlling blood uric acid levels and lack the active dissolving effect on urate crystals that have been deposited in joints and soft tissues; Second, long-term use can lead to adverse reactions such as liver and kidney toxicity and gastrointestinal reactions, affecting patients' medication compliance; Third, blood uric acid is prone to rebound after discontinuation of the drug, making it difficult to achieve long-term stable control of gout.

[0004] Traditional Chinese medicine (TCM) has unique advantages in the treatment of gout. Existing TCM patents mostly formulate prescriptions from the perspectives of "clearing heat and dampness," "activating blood circulation and removing blood stasis," and "tonifying the liver and kidneys." For example, patent CN116726117B discloses a TCM composition for treating gouty arthritis, composed of chicory, poria cocos, smilax glabra, sophora japonica, and gentiana macrophylla, which can reduce uric acid crystals in the joints. Patent CN200510200502.X discloses a TCM composition composed of smilax glabra, clematis chinensis, and other medicinal herbs. However, these patents all use "lowering uric acid" or "anti-inflammatory" as their main mechanisms of action, lacking direct evidence of "active dissolution" of already deposited urate crystals, and lacking quantitative efficacy verification using modern detection methods such as dual-source CT three-dimensional reconstruction.

[0005] Therefore, developing a traditional Chinese medicine composition for dissolving urate crystals and its preparation method is of great clinical significance and social value. Summary of the Invention

[0006] In order to overcome the above-mentioned defects of the prior art, the embodiments of the present invention provide a traditional Chinese medicine composition for dissolving urate crystals and a method for preparing the same, so as to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine composition for dissolving urate crystals, made from the following raw materials in parts by weight: Clematis chinensis 30-50 parts, Smilax glabra 40-70 parts, chicken gizzard lining 20-40 parts, Arisaema cum bile 20-40 parts, Plantago asiatica 20-35 parts, Coix lacryma-jobi 25-45 parts, Poria cocos 15-30 parts, Salvia miltiorrhiza 15-25 parts.

[0008] Preferably, it is made from the following raw materials in parts by weight: Clematis chinensis 35-45 parts, Smilax glabra 50-60 parts, chicken gizzard lining 25-35 parts, Arisaema cum bile 25-35 parts, Plantago asiatica 25-30 parts, Coix lacryma-jobi 30-40 parts, Poria cocos 20-25 parts, and Salvia miltiorrhiza 18-22 parts.

[0009] More preferably, it is made from the following raw materials in parts by weight: 40 parts Clematis chinensis, 55 parts Smilax glabra, 30 parts chicken gizzard lining, 30 parts Arisaema cum bile, 28 parts Plantago asiatica, 35 parts Coix lacryma-jobi, 22 parts Poria cocos, and 20 parts Salvia miltiorrhiza.

[0010] Formula analysis The formulation principle of the traditional Chinese medicine composition of this invention is as follows: The principal herbs are Clematis chinensis and Smilax glabra. Clematis chinensis is pungent and salty in taste, warm in nature, and enters the bladder meridian. It has the effects of dispelling wind and dampness and clearing the meridians, making it a key herb for clearing and dissolving urate crystals. It effectively unblocks the twelve meridians, promoting the loosening and separation of urate crystals from joints and soft tissue deposits. Smilax glabra is sweet and bland in taste, neutral in nature, and enters the liver and stomach meridians. It has the effects of detoxifying, removing dampness, and promoting joint mobility. In large doses, it can promote the elimination of dampness and turbidity and dissolve blood stasis. Together, these two herbs serve as the principal herbs, synergistically exerting their core role in actively dissolving urate crystals.

[0011] Assistant herbs: Chicken gizzard lining and Arisaema cum Bile. Chicken gizzard lining is sweet in taste and neutral in nature, entering the spleen, stomach, small intestine, and bladder meridians. It has the effects of strengthening the stomach and promoting digestion, dissolving urate crystals, and relieving urinary tract infections. Its "dissolving" ability helps dissolve urate crystals. Arisaema cum Bile is bitter and slightly pungent in taste and cool in nature, entering the lung, liver, and spleen meridians. It has the effects of clearing heat and resolving phlegm, calming wind and relieving convulsions. It specifically targets the meridians and is good at treating bone pain. Targeting the pathogenesis of urate crystal deposition in the joints and meridians, it resolves phlegm and disperses nodules to help dissolve crystals. Together, these two herbs enhance the crystal-dissolving power of the principal herb.

[0012] Adjuvant herbs: Plantain, Coix seed, and Poria. Plantain is sweet and cold in nature, entering the liver, kidney, lung, and small intestine meridians. It has diuretic and urinary tract clearing effects, promoting the excretion of dissolved uric acid from the kidneys. Coix seed is sweet and bland in taste, cool in nature, entering the spleen, stomach, and lung meridians. It has diuretic and dampness-removing effects, strengthening the spleen without harming the body's vital energy. Poria is sweet and bland in taste, neutral in nature, entering the heart, lung, spleen, and kidney meridians. It has diuretic and dampness-removing effects, strengthening the spleen and calming the mind, addressing the root cause. These three herbs work together as adjuvant herbs to ensure a smooth "dissolution → excretion" pathway.

[0013] Used herb: Danshen (Salvia miltiorrhiza). Danshen is bitter and slightly cold in nature. It enters the heart and liver meridians and has the effects of promoting blood circulation, removing blood stasis, regulating menstruation, and relieving pain. It promotes blood circulation and removes blood stasis, helping the dissolved urate crystals to be transported smoothly to the excretion channels with the blood and preventing redeposition.

[0014] The entire formula is based on "unblocking the channels and dissolving stones" and "eliminating turbidity and detoxifying", supplemented by "eliminating dampness and removing acid" and "activating blood circulation and unblocking the channels", forming a complete treatment chain of "actively dissolving crystals → accelerating excretion → preventing re-deposition".

[0015] Preparation method This invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: (1) Weigh each raw material according to the weight, clean and dry them, mix and pulverize them, and pass them through an 80-120 mesh sieve to obtain a fine mixed powder; (2) Add excipients to the mixed fine powder and mix well. The mass ratio of the mixed fine powder to the excipient is 5-10:1. Preferably, the excipient is starch and the mass ratio of the mixed fine powder to the starch is 5:1. (3) Water-coated pills are made by using water or medicinal juice as a binder and a coating method. Preferably, a process of starch molding and drug coating is adopted, which specifically includes: taking part of starch and placing it in a coating pot, using syrup as a binder to mold it, obtaining starch masterbatch, and then adding the mixed powder obtained in step (2) to coat the pills. (4) Dry the water-coated pills at 50-65℃ to constant weight, sterilize, and package them to obtain the final product.

[0016] Dosage and usage The method of administration for the water-based pill preparation of the traditional Chinese medicine composition of this invention is as follows: (1) Initial period (days 1-3): Take one pill once a day, around 9 a.m., with warm water. (2) Adaptation period (days 4-6): If there is no obvious discomfort or the crystal dissolution reaction is mild, change to taking 1 pill twice a day, at 9 am and 3 pm; (3) Maintenance period (starting from day 7): Change to twice a day, 2 pills at 9 am and 3 pm. After that, the dosage can be dynamically adjusted according to individual response, gradually increasing to 10-30 pills each time, twice a day, with a maximum daily dose not exceeding 60 pills.

[0017] During medication, you may experience a crystal-dissolving reaction such as itchy skin, increased foam in urine, dry mouth, joint pain and swelling, and a transient increase in blood uric acid. These are normal treatment reactions and will gradually subside with continued medication.

[0018] The technical effects and advantages of the traditional Chinese medicine composition for dissolving urate crystals and its preparation method of the present invention are as follows: (1) It has a direct effect of actively dissolving deposited urate crystals. This invention utilizes "active crystal dissolution" as its core mechanism. The synergistic combination of herbs such as Clematis chinensis and chicken gizzard membrane, which promote blood circulation and dissolve stones, with herbs like Smilax glabra and Arisaema cum Bile, which clear turbidity and disperse nodules, allows it to directly act on monosodium urate crystals already deposited in joints and soft tissues, promoting their transformation from the solid phase to the liquid phase. Clinical dual-source CT scans provide objective evidence for this. This is fundamentally different from existing technologies that indirectly reduce crystal formation by inhibiting uric acid production or promoting uric acid excretion.

[0019] (2) The efficacy was quantitatively verified using dual-source CT three-dimensional reconstruction technology. This invention introduces dual-source CT dual-energy imaging technology into the evaluation system of traditional Chinese medicine's crystal-dissolving efficacy. It employs intelligent gout volume statistics technology to obtain the total volume (cm³) of urate crystals as the core efficacy indicator, achieving precise quantification of the crystal-dissolving effect. Unlike existing patents that rely on indirect indicators such as blood uric acid, this invention provides objective data support of "crystal volume reduction of X%".

[0020] (3) The therapeutic effect is definite and the crystal dissolution effect is significant. Clinical observations show that after 3-6 months of continuous use, the volume of urate crystals in the body of patients with early-stage gout decreases by 30-40%; after 6-12 months of continuous use, the volume of crystals decreases by 50-60%; and after combined treatment with local tophi, the crystal reduction can reach more than 90%.

[0021] (4) High safety, suitable for long-term use No serious liver or kidney damage or other significant toxic side effects were observed after continuous use of this composition for 6-12 months, providing a safe and feasible medication regimen for the long-term maintenance treatment of gout, a chronic metabolic disease. Attached Figure Description

[0022] Figure 1 The image shows a three-dimensional reconstruction of urate crystals in the left foot of a patient before and after treatment using dual-source CT scans in Case 1 of this invention. Figure 2 The image shows a three-dimensional reconstruction of urate crystals in the right foot of a patient before and after treatment using dual-source CT scans in Case 2 of this invention. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention. Example 1: Traditional Chinese Medicine Composition Formulation

[0024] Formula (by weight): Clematis chinensis 40 parts, Smilax glabra 55 parts, chicken gizzard lining 30 parts, Arisaema cum bile 30 parts, Plantago asiatica 28 parts, Coix lacryma-jobi 35 parts, Poria cocos 22 parts, Salvia miltiorrhiza 20 parts.

[0025] Weigh each raw material according to the above ratio, clean, dry, mix and pulverize, and pass through a 100-mesh sieve to obtain a fine powder. Add an appropriate amount of starch (powder:starch = 5:1) and mix well. Use a water-based pill-forming process, using starch as a mold and syrup as a binder, to form pills, dry at 60℃, sterilize, and package, each pill weighing approximately 0.1g. Example 2: Traditional Chinese Medicine Composition Formulation

[0026] Formula (by weight): Clematis chinensis 35 parts, Smilax glabra 60 parts, chicken gizzard lining 25 parts, Arisaema cum bile 25 parts, Plantago asiatica 25 parts, Coix lacryma-jobi 40 parts, Poria cocos 25 parts, Salvia miltiorrhiza 18 parts.

[0027] The preparation method is the same as in Example 1. Example 3: Traditional Chinese Medicine Composition Formulation

[0028] Formula (by weight): Clematis chinensis 45 parts, Smilax glabra 50 parts, chicken gizzard lining 35 parts, Arisaema cum bile 35 parts, Plantago asiatica 30 parts, Coix lacryma-jobi 30 parts, Poria cocos 20 parts, Salvia miltiorrhiza 22 parts.

[0029] The preparation method is the same as in Example 1. Example 4: Clinical Case

[0030] Case 1, see appendix Figure 1 The dual-energy CT scan showed urate crystal deposition in gouty tophi (green marked area). Prior to treatment in June 2024, a dual-energy CT scan showed a total volume of urate crystals in the left ankle joint of 3.25 cm³. In January 2025, after treatment, a dual-energy CT scan showed that the total volume of urate crystals in the left ankle joint was 0.25 cm³, a reduction of nearly 92%.

[0031] Case 2, see appendix Figure 2 The dual-energy CT scan showed urate crystal deposition in gouty tophi (green marked area). Prior to treatment in June 2024, a dual-energy CT scan showed a total volume of urate crystals in the right ankle joint of 3.11 cm³. In January 2025, after treatment, a dual-energy CT scan showed that the total volume of urate crystals in the right ankle joint was 0.27 cm³, a reduction of nearly 91%.

[0032] The above formulas are all dimensionless calculations. The formulas are derived from software simulations based on a large amount of collected data to obtain the most recent real-world results. The preset parameters and thresholds in the formulas are set by those skilled in the art according to the actual situation.

[0033] The above embodiments can be implemented, in whole or in part, by software, hardware, firmware, or any other combination thereof. When implemented using software, the above embodiments can be implemented, in whole or in part, as a computer program product. The computer program product includes one or more computer instructions or computer programs. When the computer instructions or computer programs are loaded or executed on a computer, all or part of the processes or functions described in the embodiments of this application are generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired (e.g., infrared, wireless, microwave, etc.) means. The computer-readable storage medium can be any available medium that a computer can access or a data storage device such as a server or data center that includes one or more sets of available media. The available medium can be a magnetic medium (e.g., floppy disk, hard disk, magnetic tape), an optical medium (e.g., DVD), or a semiconductor medium. The semiconductor medium can be a solid-state drive.

[0034] Those skilled in the art will recognize that the modules and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of this application.

[0035] Those skilled in the art will understand that, for the sake of convenience and brevity, the specific working processes of the systems, devices, and modules described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0036] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of modules is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple modules or components may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between apparatuses or modules may be electrical, mechanical, or other forms.

[0037] The modules described as separate components may or may not be physically separate. The components shown as modules may or may not be physical modules; they may be located in one place or distributed across multiple network modules. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs.

[0038] In addition, the functional modules in the various embodiments of this application can be integrated into one processing module, or each module can exist physically separately, or two or more modules can be integrated into one module.

[0039] If the aforementioned functions are implemented as software functional modules and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, or a portion of the technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0040] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0041] In conclusion, the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for dissolving urate crystals, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient: Clematis chinensis 30-50 parts, Smilax glabra 40-70 parts, chicken gizzard lining 20-40 parts, Arisaema cum bile 20-40 parts, Plantago asiatica 20-35 parts, Coix lacryma-jobi 25-45 parts, Poria cocos 15-30 parts, Salvia miltiorrhiza 15-25 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient: Clematis chinensis 35-45 parts, Smilax glabra 50-60 parts, chicken gizzard lining 25-35 parts, Arisaema cum bile 25-35 parts, Plantago asiatica 25-30 parts, Coix lacryma-jobi 30-40 parts, Poria cocos 20-25 parts, Salvia miltiorrhiza 18-22 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient: Clematis chinensis 40 parts, Smilax glabra 55 parts, chicken gizzard lining 30 parts, Arisaema cum bile 30 parts, Plantago asiatica 28 parts, Coix lacryma-jobi 35 parts, Poria cocos 22 parts, Salvia miltiorrhiza 20 parts.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is an oral preparation, which is any one of pills, powders, granules, capsules or tablets.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The oral preparation is a water-based pill preparation.

6. A method for preparing a traditional Chinese medicine composition for dissolving urate crystals according to any one of claims 1-5, characterized in that, Includes the following steps: (1) Weigh each raw material according to the weight, mix them, pulverize them, and pass them through an 80-120 mesh sieve to obtain a fine mixed powder; (2) Add excipients to the mixed fine powder and mix well. The mass ratio of the mixed fine powder to the excipients is 5-10:

1. (3) Using water or medicinal juice as a binder, water-coated pills are made by the coating method; (4) Dry the water-coated pills at 50-65℃ to constant weight, sterilize, and package them to obtain the final product.

7. The preparation method according to claim 6, characterized in that, The excipient in step (2) is starch, and the mass ratio of the mixed fine powder to starch is 5:

1.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for dissolving urate crystals deposited in the body.

9. The application according to claim 8, characterized in that, The drug was detected using dual-source CT dual-energy imaging technology, and after 3-6 months of use, the volume of urate crystals decreased by 30-40%.

10. The application according to claim 8, characterized in that, The drug was detected using dual-source CT dual-energy imaging technology. After 6-12 months of use, the volume of urate crystals decreased by 50-60%, and the crystal reduction in local tophi treatment could reach more than 90%.

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