A traditional Chinese medicine composition for treating hyperuricemia combined with metabolic syndrome, and a preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome, its preparation method, and its application. The traditional Chinese medicine composition comprises the following components in parts by weight: Codonopsis pilosula 3-6 parts, Astragalus membranaceus 12-18 parts, Bupleurum chinense 1-5 parts, Citrus reticulata peel 1-5 parts, Citrus aurantium peel 3-6 parts, Scutellaria baicalensis 1-5 parts, Nelumbo nucifera leaf 3-6 parts, Crataegus pinnatifida 3-6 parts, Anemarrhena asphodeloides 12-18 parts, Coptis chinensis 1-3 parts, Polygonatum sibiricum 3-6 parts, Pueraria lobata 28-35 parts, Schisandra chinensis 1-5 parts, Smilax glabra 28-35 parts, Cimicifuga foetida 1-5 parts, processed chicken gizzard lining 5-10 parts, Lycopus lucidus 3-6 parts, Atractylodes lancea 3-6 parts, Phellodendron chinense 3-6 parts, and Liquidambar formosana 3-6 parts. The traditional Chinese medicine composition of this invention follows the theory of traditional Chinese medicine compatibility, and synergistically achieves the effects of strengthening the spleen and soothing the liver, resolving phlegm and drying dampness, clearing heat and removing blood stasis. By effectively reducing the levels of blood uric acid, triglycerides, systolic blood pressure and diastolic blood pressure, and regulating key indicators such as high-density lipoprotein, it significantly improves the clinical symptoms of patients with hyperuricemia and metabolic syndrome. Moreover, it has good safety in clinical application and no obvious adverse reactions.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome, its preparation method, and its application. Background Technology

[0002] Hyperuricemia (HUA) is a metabolic disorder characterized by serum uric acid levels exceeding 360 μmol / L due to excessive uric acid production or reduced excretion. Its core pathological mechanism lies in purine metabolism disorders leading to uric acid accumulation. Recent clinical studies have confirmed that hyperuricemia is not an isolated metabolic abnormality, but rather a key initiating factor in the occurrence and development of metabolic syndrome (MS), demonstrating a clear causal relationship and a cumulative pathophysiological effect between the two. Uric acid, as an important endogenous pro-inflammatory factor in the body, can induce metabolic disorders of blood pressure, blood lipids, and blood glucose through multiple mechanisms when serum uric acid levels remain elevated. Firstly, uric acid crystals deposit in the vascular endothelium, damaging endothelial cell function and activating the renin-angiotensin-aldosterone system, leading to vasoconstriction, sodium and water retention, and consequently hypertension. Secondly, uric acid can inhibit adipocyte differentiation, promote inflammatory responses in adipose tissue, reduce insulin sensitivity, and simultaneously promote hepatic fat synthesis and lipid deposition, resulting in elevated triglycerides and decreased high-density lipoprotein cholesterol, leading to abnormal lipid metabolism. Thirdly, a hyperuricemic state can interfere with pancreatic β-cell function through oxidative stress and inflammatory pathways, reducing insulin secretion and exacerbating insulin resistance, ultimately inducing or aggravating glucose metabolism disorders. Conversely, symptoms of metabolic syndrome such as obesity and insulin resistance further reduce the efficiency of renal uric acid excretion, forming a vicious cycle of "hyperuricemia-metabolic disorder," significantly increasing the risk of complications such as cardiovascular disease and diabetic nephropathy, posing a serious threat to patients' health.

[0003] Currently, modern medicine primarily treats hyperuricemia complicated by metabolic syndrome with symptomatic treatment. The core goals are to control uric acid, blood pressure, blood lipids, and blood glucose levels respectively: Uric acid-lowering drugs include those that inhibit uric acid production (such as allopurinol and febuxostat) and those that promote uric acid excretion (such as benzbromarone), which directly intervene in the uric acid metabolism process to reduce serum uric acid levels; Antihypertensive drugs commonly used include angiotensin-converting enzyme inhibitors (such as benazepril), angiotensin II receptor antagonists (such as valsartan), and calcium channel blockers (such as amlodipine) to control blood pressure to target levels; Lipid-lowering drugs mainly consist of statins (such as atorvastatin) and fibrates (such as fenofibrate), used to regulate the lipid profile and reduce the risk of cardiovascular disease; Hypoglycemic drugs include metformin, sulfonylureas (such as gliclazide), and dipeptidyl peptidase-4 inhibitors (such as sitagliptin) to maintain stable blood glucose levels. Meanwhile, lifestyle interventions, such as low-purine diets, weight control, regular exercise, and smoking cessation and alcohol limitation, are emphasized as adjunctive measures to drug therapy. However, there are certain limitations: First, the treatment targets are singular and lack a holistic approach: Modern medicine uses a "multi-drug combination" model to control various metabolic indicators separately, but it does not intervene in the core causal relationship of "hyperuricemia inducing metabolic disorders," and cannot fundamentally break the vicious cycle between the two. It can only achieve "indicator control" rather than "etiological treatment," and patients need to take medication for a long time or even for life, and the indicators are prone to rebound after stopping medication. Second, the risk of adverse reactions is high: Long-term use of multiple drugs will significantly increase the incidence of adverse reactions. For example, allopurinol may cause severe skin allergic reactions, febuxostat has controversial cardiovascular risks, statins may cause liver damage, and benzbromarone may affect kidney function. Some patients discontinue treatment because they cannot tolerate the adverse reactions. Third, the intervention for complications is limited: Although modern medicine can control a single indicator, its effect on improving potential pathological changes such as insulin resistance and vascular endothelial damage caused by metabolic syndrome is limited, and it is difficult to effectively reduce the risk of long-term complications. Based on the clinical characteristics of hyperuricemia complicated with metabolic syndrome, traditional Chinese medicine classifies it into categories such as "turbidity and blood stasis," "dizziness," and "diabetes." It believes that the core pathogenesis is mainly spleen and kidney deficiency, internal accumulation of phlegm and dampness, and obstruction by turbid toxins and blood stasis. Common treatment methods include strengthening the spleen and kidney, resolving dampness and eliminating turbidity, and promoting blood circulation and removing blood stasis. These methods have certain advantages in terms of efficacy and safety, but there is still no specific drug for treating this disease, making it difficult to achieve a breakthrough in efficacy. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome, so as to solve the problems of single target, difficulty in treating the root cause, high adverse drug reactions, and insufficient intervention in long-term complications in the existing treatment of hyperuricemia complicated with metabolic syndrome.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0006] A traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome, the composition comprising the following components in parts by weight: Codonopsis pilosula 3-6 parts, Astragalus membranaceus 12-18 parts, Bupleurum chinense 1-5 parts, Citrus reticulata peel 1-5 parts, Citrus reticulata peel 3-6 parts, Scutellaria baicalensis 1-5 parts, Nelumbo nucifera leaf 3-6 parts, Crataegus pinnatifida 3-6 parts, Anemarrhena asphodeloides 12-18 parts, Coptis chinensis 1-3 parts, Polygonatum sibiricum 3-6 parts, Pueraria lobata 28-35 parts, Schisandra chinensis 1-5 parts, Smilax glabra 28-35 parts, Cimicifuga foetida 1-5 parts, processed chicken gizzard lining 5-10 parts, Lycopus lucidus 3-6 parts, Atractylodes lancea 3-6 parts, Phellodendron chinense 3-6 parts, and Liquidambar formosana 3-6 parts.

[0007] In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: Codonopsis pilosula 4-5 parts, Astragalus membranaceus 14-16 parts, Bupleurum chinense 2-4 parts, Citrus reticulata 2-4 parts, Citrus reticulata 4-5 parts, Scutellaria baicalensis 2-4 parts, Nelumbo nucifera leaf 4-5 parts, Crataegus pinnatifida 4-5 parts, Anemarrhena asphodeloides 14-16 parts, Coptis chinensis 1-3 parts, Polygonatum sibiricum 4-5 parts, Pueraria lobata 28-32 parts, Schisandra chinensis 2-4 parts, Smilax glabra 28-32 parts, Cimicifuga foetida 2-4 parts, processed chicken gizzard lining 6-9 parts, Lycopus lucidus 4-5 parts, Atractylodes lancea 4-5 parts, Phellodendron chinense 4-5 parts, and Liquidambar formosana 4-5 parts.

[0008] In some embodiments, the traditional Chinese medicine composition comprises the following components in parts by weight: Codonopsis pilosula 5 parts, Astragalus membranaceus 15 parts, Bupleurum chinense 3 parts, Citrus reticulata 3 parts, Citrus reticulata 5 parts, Scutellaria baicalensis 3 parts, Nelumbo nucifera leaf 5 parts, Crataegus pinnatifida 5 parts, Anemarrhena asphodeloides 15 parts, Coptis chinensis 1.5 parts, Polygonatum sibiricum 5 parts, Pueraria lobata 30 parts, Schisandra chinensis 3 parts, Smilax glabra 30 parts, Cimicifuga foetida 3 parts, processed chicken gizzard lining 7.5 parts, Lycopus lucidus 5 parts, Atractylodes lancea 5 parts, Phellodendron chinense 5 parts, and Liquidambar formosana 5 parts.

[0009] In some embodiments, the preparation method of the traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome includes the following steps: taking Codonopsis pilosula, Astragalus membranaceus, Bupleurum chinense, Citrus reticulata peel, Citrus reticulata peel, Scutellaria baicalensis, Nelumbo nucifera leaf, Crataegus pinnatifida, Anemarrhena asphodeloides, Coptis chinensis, Polygonatum sibiricum, Pueraria lobata, Schisandra chinensis, Smilax glabra, Cimicifuga foetida, processed chicken gizzard lining, Lycopus lucidus, Atractylodes lancea, Phellodendron chinense, and Liquidambar formosana according to the weight proportions, soaking and decocting with 3 to 5 times the amount of water, and combining the filtrates to obtain the final product.

[0010] In some embodiments, the soaking time is 30-50 minutes; and / or the decocting is performed 2-3 times, each decocting consisting of first bringing it to a boil over high heat, and then simmering it over low heat for 30-50 minutes.

[0011] Preferably, the soaking is carried out with 4 times the amount of water for 30 minutes; and / or, the decocting is carried out twice, each time including first boiling over high heat and then simmering over low heat for 30 minutes.

[0012] This invention also protects a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition; wherein the traditional Chinese medicine composition is an extract; and wherein the extract is an aqueous extract.

[0013] The application of the aforementioned traditional Chinese medicine composition or pharmaceutical preparation in the preparation of drugs for treating hyperuricemia complicated with metabolic syndrome is also within the scope of protection of this invention.

[0014] In some embodiments, the traditional Chinese medicine combination treats hyperuricemia complicated with metabolic syndrome by lowering uric acid, blood glucose, blood lipid and blood pressure levels.

[0015] The relationship between ruler, minister, assistant, and envoy:

[0016] Based on the pathogenesis of hyperuricemia complicated with metabolic syndrome, characterized by "spleen deficiency and liver stagnation, phlegm and dampness obstruction," the traditional Chinese medicine compound of this invention has the effects of strengthening the spleen and soothing the liver, resolving phlegm and drying dampness, clearing heat and removing blood stasis. With the goal of treating both the root cause and the symptoms, the compound is prepared from the following raw materials: Codonopsis pilosula, Astragalus membranaceus, Bupleurum chinense, Citrus reticulata peel, Citrus reticulata peel, Scutellaria baicalensis, Nelumbo nucifera leaf, Crataegus pinnatifida, Anemarrhena asphodeloides, Coptis chinensis, Polygonatum sibiricum, Pueraria lobata, Schisandra chinensis, Smilax glabra, Cimicifuga foetida, processed chicken gizzard lining, Lycopus lucidus, Atractylodes lancea, Phellodendron chinense, and Liquidambar formosana.

[0017] The raw materials selected in this invention are based on the following: Codonopsis pilosula, Astragalus membranaceus, and Bupleurum chinense are the principal herbs in the formula. Codonopsis pilosula and Astragalus membranaceus invigorate the spleen and replenish qi, while Bupleurum chinense soothes the liver, relieves stagnation, and regulates qi. Together, they work synergistically to treat the root cause of spleen deficiency and liver stagnation. The assistant herbs work in two directions: Citrus reticulata peel and Citrus aurantium peel regulate qi and invigorate the spleen, drying dampness and resolving phlegm; Scutellaria baicalensis, Coptis chinensis, Phellodendron chinense, and Atractylodes lancea clear heat and dry dampness, dispersing stagnation of heat in the three jiaos; Smilax glabra clears heat and promotes diuresis; Lycopus lucidus invigorates blood and promotes diuresis; Crataegus pinnatifida and Gallus gallus domesticus promote digestion, eliminate stagnation, and disperse blood stasis. These three groups of herbs work together to treat the symptoms of phlegm, dry dampness, clear heat, and remove blood stasis. Anemarrhena asphodeloides, Polygonatum sibiricum, and Schisandra chinensis nourish yin and moisten dryness, preventing the principal and assistant herbs from being too pungent, dry, bitter, and cold, thus damaging yin; Cimicifuga foetida, Pueraria lobata, and Nelumbo nucifera leaf raise clear yang, resolve dampness, and descend turbidity, restoring the normal ascending and descending of qi amidst a large amount of clearing and diuretic herbs, serving as adjuvant herbs. Using *Luffa cylindrica* as the guiding herb, due to its penetrating nature, it can traverse the twelve meridians, enhancing the effects of dispelling dampness and unblocking the meridians, and guiding the power of other herbs directly to the affected area. The entire formula, with its principal, assistant, adjuvant, and guiding herbs, each plays its specific role, forming a comprehensive system that addresses the root cause by strengthening the spleen and soothing the liver, resolving phlegm and drying dampness, clearing heat and removing blood stasis to treat the symptoms, assisting yin in raising clear qi to regulate the body's balance, and unblocking the meridians to achieve therapeutic effects. This reflects a comprehensive treatment approach targeting complex pathogenesis at multiple levels and multiple targets. Based on scientifically selected and proportioned raw materials, the above-mentioned traditional Chinese medicine formula achieves synergistic effects through mutual coordination and promotion among its components. It effectively strengthens the spleen and soothes the liver, resolves phlegm and dries dampness, clears heat and removes blood stasis, improving the clinical symptoms of patients with hyperuricemia and metabolic syndrome, and lowering indicators such as uric acid, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure, thereby effectively controlling the condition with no significant adverse reactions.

[0018] Beneficial effects:

[0019] Based on the pathogenesis of hyperuricemia complicated with metabolic syndrome, this invention proposes "spleen deficiency and liver stagnation, phlegm-dampness and blood stasis" as the basic pathogenesis according to the theory of the Five Elements in Traditional Chinese Medicine. It establishes strengthening the spleen and soothing the liver, resolving phlegm and drying dampness, and clearing heat and removing blood stasis as the main treatment principles. A compound Chinese medicine formula is created to treat this disease, which not only improves the patient's clinical symptoms but also lowers indicators such as uric acid, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure, thereby effectively controlling the condition with no significant adverse reactions. The entire formula, with its principal, assistant, and adjuvant herbs, each plays a specific role: strengthening the spleen and soothing the liver to treat the root cause; resolving phlegm and drying dampness, clearing heat and removing blood stasis to treat the symptoms; assisting yin to raise clear qi to regulate the body's balance; and unblocking the meridians to achieve efficacy. This comprehensive treatment approach addresses the complex pathogenesis at multiple levels and with multiple targets. Detailed Implementation

[0020] The present invention will be further described in detail below with reference to specific embodiments, and the advantages of the present invention in the above and / or other aspects will become clearer.

[0021] In this embodiment of the invention, the experimental methods described are conventional methods unless otherwise specified; the reagents described are commercially available unless otherwise specified.

[0022] Example 1

[0023] Take 10g of Codonopsis pilosula, 30g of Astragalus membranaceus, 6g of Bupleurum chinense, 6g of Citrus reticulata peel, 10g of Citrus reticulata peel, 6g of Scutellaria baicalensis, 10g of Nelumbo nucifera leaf, 10g of Crataegus pinnatifida, 30g of Anemarrhena asphodeloides, 3g of Coptis chinensis, 10g of Polygonatum sibiricum, 60g of Pueraria lobata, 6g of Schisandra chinensis, 60g of Smilax glabra, 6g of Cimicifuga foetida, 15g of processed chicken gizzard lining, 10g of Lycopus lucidus, 10g of Atractylodes lancea, 10g of Phellodendron chinense, and 10g of Liquidambar formosana. Add water equivalent to 4 times the total weight of the herbs and soak for 30 minutes. First, bring to a boil over high heat, then simmer over low heat for 30 minutes. Repeat the decoction twice. After filtering the dregs, obtain 400 mL of liquid.

[0024] Example 2

[0025] Take 12 g of Codonopsis pilosula, 34 g of Astragalus membranaceus, 8 g of Bupleurum chinense, 8 g of Citrus reticulata peel, 12 g of Citrus reticulata peel, 6 g of Scutellaria baicalensis, 10 g of Nelumbo nucifera leaf, 10 g of Crataegus pinnatifida, 30 g of Anemarrhena asphodeloides, 3 g of Coptis chinensis, 10 g of Polygonatum sibiricum, 60 g of Pueraria lobata, 6 g of Schisandra chinensis, 60 g of Smilax glabra, 6 g of Cimicifuga foetida, 15 g of processed chicken gizzard lining, 10 g of Lycopus lucidus, 10 g of Atractylodes lancea, 10 g of Phellodendron chinense, and 10 g of Liquidambar formosana. Add water equivalent to 4 times the total weight of the herbs and soak for 30 minutes. First, bring to a boil over high heat, then simmer over low heat for 30 minutes. Repeat the decoction twice. After filtering the dregs, obtain 400 mL of liquid.

[0026] Example 3

[0027] Take 8 g of Codonopsis pilosula, 26 g of Astragalus membranaceus, 4 g of Bupleurum chinense, 4 g of Citrus reticulata peel, 8 g of Citrus reticulata peel, 4 g of Scutellaria baicalensis, 10 g of Nelumbo nucifera leaf, 10 g of Crataegus pinnatifida, 30 g of Anemarrhena asphodeloides, 3 g of Coptis chinensis, 10 g of Polygonatum sibiricum, 60 g of Pueraria lobata, 6 g of Schisandra chinensis, 60 g of Smilax glabra, 6 g of Cimicifuga foetida, 15 g of processed chicken gizzard lining, 10 g of Lycopus lucidus, 10 g of Atractylodes lancea, 10 g of Phellodendron chinense, and 10 g of Liquidambar formosana. Add water equivalent to 4 times the total weight of the herbs and soak for 30 minutes. First, bring to a boil over high heat, then simmer over low heat for 30 minutes. Repeat the decoction twice. After filtering the dregs, obtain 400 mL of liquid.

[0028] Example 4

[0029] Take 10g of Codonopsis pilosula, 30g of Astragalus membranaceus, 6g of Bupleurum chinense, 6g of Citrus reticulata peel, 10g of Citrus reticulata peel, 6g of Scutellaria baicalensis, 10g of Nelumbo nucifera leaf, 10g of Crataegus pinnatifida, 30g of Anemarrhena asphodeloides, 3g of Coptis chinensis, 8g of Polygonatum sibiricum, 60g of Pueraria lobata, 6g of Schisandra chinensis, 60g of Smilax glabra, 6g of Cimicifuga foetida, 15g of processed chicken gizzard lining, 8g of Lycopus lucidus, 8g of Atractylodes lancea, 8g of Phellodendron chinense, and 8g of Liquidambar formosana. Add water equivalent to 4 times the total weight of the herbs and soak for 30 minutes. First, bring to a boil over high heat, then simmer over low heat for 30 minutes. Repeat the simmering process twice. After filtering the dregs, obtain 400 mL of the decoction.

[0030] Example 5 Clinical Data

[0031] (I) Research Methods

[0032] 1. Research Content

[0033] Patients who visited the outpatient departments of general internal medicine, rheumatology, and endocrinology at Jiangsu Provincial Hospital of Traditional Chinese Medicine and met the inclusion criteria were selected and randomly divided into a treatment group and a control group. Statistical methods were used to analyze the data of various indicators before and after treatment in the treatment group and the control group to objectively evaluate the efficacy and safety of the Xie Tu He Mu Xie Zhuo formula.

[0034] 2. Source of cases

[0035] The cases in this study were collected from the outpatient clinics of the Department of General Internal Medicine, Department of Rheumatology, and Department of Endocrinology of Jiangsu Provincial Hospital of Traditional Chinese Medicine from September 2024 to March 2025. All patients met the diagnostic criteria for hyperuricemia and metabolic syndrome, and also met the inclusion criteria for this study. The initial enrollment target was 100 patients, but 91 were actually enrolled. In the treatment group, 3 patients were lost to follow-up, and 1 patient was excluded due to failure to take medication on time. In the control group, 3 patients were lost to follow-up, and 2 patients were excluded due to failure to take medication on time. Ultimately, 46 patients were included in the treatment group and 45 in the control group.

[0036] 3. Case selection criteria

[0037] 3.1 Diagnostic criteria

[0038] 3.1.1 Diagnostic criteria for hyperuricemia

[0039] According to the "Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout in China (2019)" formulated by the Endocrinology Branch of the Chinese Medical Association, the diagnostic criteria for hyperuricemia are: regardless of whether a person is male or female, a blood uric acid level exceeding 420 μmol / L on two separate occasions is sufficient for diagnosis.

[0040] 3.1.2 Diagnostic criteria for metabolic syndrome

[0041] A diagnosis can be made if three or more of the following criteria are met.

[0042] (1) Abdominal obesity (i.e., central obesity): waist circumference ≥90 cm for men and ≥85 cm for women;

[0043] (2) Hyperglycemia: fasting blood glucose ≥6.1 mmol / L or blood glucose ≥7.8 mmol / L 2 hours after glucose load and / or has been diagnosed with diabetes and is under treatment;

[0044] (3) Hypertension: Blood pressure ≥130 / 85 mmHg (1 mmHg=0.133 kPa) and / or has been diagnosed with hypertension and is under treatment;

[0045] (4) Fasting triglyceride (TG) ≥1.70 mmol / L;

[0046] (5) Fasting high-density lipoprotein (HDL-C) <1.04 mmol / L. The waist circumference cutoff for central obesity was determined according to the standard set forth in the "Health Industry Standard of the People's Republic of China - Adult Weight Determination" (Standard No. WS / T428-2013) issued by the National Health and Family Planning Commission in 2013.

[0047] 3.1.3 Diagnostic Criteria for Traditional Chinese Medicine Syndromes

[0048] The TCM syndrome diagnosis criteria for "spleen deficiency and liver stagnation with phlegm-dampness and blood stasis" described in this invention refer to the descriptions of related syndromes in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and, combined with the characteristics of this disease, the specific criteria are as follows:

[0049] Main symptoms: discomfort in the hypochondrium, abdominal distension, dizziness, and weakness in the limbs.

[0050] Secondary symptoms: depression or irritability, joint pain, and loose or dry stools.

[0051] Tongue and pulse: The tongue is pale and dark in color or has ecchymosis and petechiae, the tongue coating is white and greasy or yellow and greasy, and the pulse is thin, wiry and slippery or thin, wiry and hesitant.

[0052] A diagnosis can be made based on the presence of all primary symptoms and at least one secondary symptom, combined with tongue and pulse examination.

[0053] 3.2 Inclusion criteria

[0054] ① Meets the diagnostic criteria for hyperuricemia complicated with metabolic syndrome.

[0055] ② Those who meet the diagnostic criteria for liver and spleen disharmony and dampness stagnation in traditional Chinese medicine.

[0056] ③ Informed consent and voluntary participation.

[0057] ④ Age 20-75 years old.

[0058] 3.3 Exclusion Criteria

[0059] ① Creatinine clearance (CCr) ≤ 30 ml / min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 1.5 times the upper limit of normal;

[0060] ② Patients with secondary hyperuricemia and abnormal renal function caused by other kidney diseases, tumors, etc.;

[0061] ③ Individuals with a recent history of taking thiazide diuretics, aspirin, or other medications that can affect uric acid excretion;

[0062] ④ Those who are unable to cooperate with treatment due to mental or psychological illness;

[0063] ⑤ Individuals prone to allergies, especially those allergic to the control drug or with contraindications specified in the instructions;

[0064] ⑥ Pregnant and lactating women, or those who tested positive for HCG in their urine before enrollment, or those who are planning to conceive.

[0065] 3.4 Termination of Test Criteria

[0066] If, during the clinical trial, the treatment plan needs to be adjusted due to a rapid increase in uric acid, blood pressure, blood sugar, or blood lipids, or if the patient experiences severe adverse reactions or rapid deterioration of their condition due to taking the investigational drug, or exhibits signs of serious complications, the trial should be terminated immediately.

[0067] 3.5 Standards for shedding and rejection

[0068] Case dropout criteria: those lost to follow-up during observation or those who naturally dropped out.

[0069] Exclusion criteria: Subjects who were found to have poor adherence to the established treatment protocol after being included in the trial.

[0070] 4 Research Methods

[0071] 4.1 Sample size calculation and grouping method

[0072] Based on existing research findings and references, and guided by the "Methods for Estimating Sample Size of Study Subjects" in *Clinical Epidemiology*, this study used the overall effective rate as the primary outcome measure. The effective rate was set at p1 = 70% for the control group and p2 = 96.67% for the treatment group. The probability of Type I error was taken as α = 0.05, and the probability of Type II error as β = 0.1. This determined an appropriate sample size to ensure that the number of cases remained statistically valid until the end of the trial. (The formula is:)

[0073] ;

[0074] Assuming a dropout rate of 15%, a total of 70 cases were required. Based on the time of initial visit, patients meeting the inclusion criteria were assigned a unique number and randomly assigned to a treatment group and a control group, with 35 patients in each group. This study actually included 91 patients, with 46 in the treatment group and 45 in the control group.

[0075] 4.2 Treatment methods

[0076] 4.2.1 Basic Treatment

[0077] ① Provide health education for patients with hyperuricemia and metabolic syndrome.

[0078] ② Guide patients to adjust their lifestyle, including a low-salt, low-fat, low-purine, and low-sugar diet, quitting smoking and alcohol, drinking more than 2000mL of purified water daily, and arranging appropriate exercise methods and amounts according to the patient's individual situation to maintain an effective exercise amount of more than 30 minutes per day.

[0079] ③ Patients with diabetes, hyperlipidemia, and hypertension who are regularly taking Western medicine should continue to maintain their basic treatment plan.

[0080] 4.2.2 Control group treatment

[0081] The patient was given basic treatment combined with oral febuxostat to lower uric acid, 40 mg once daily.

[0082] 4.2.3 Treatment Group

[0083] Basic treatment combined with traditional Chinese medicine compound: The traditional Chinese medicine composition prepared in Example 1 is taken orally at 200 mL each half an hour after breakfast and dinner, once a day.

[0084] 4.2.4 Treatment Course

[0085] One course of treatment lasts 12 weeks, and relevant indicators are rechecked after one course of treatment.

[0086] 4.3 Observation Content

[0087] 4.3.1 Efficacy observation indicators

[0088] ① Uric acid, waist circumference, fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure levels.

[0089] ② Traditional Chinese Medicine (TCM) syndromes: discomfort in the hypochondrium, abdominal distension, dizziness, heaviness and weakness in the limbs, depression or irritability, joint pain, and changes in symptom scores before and after TCM syndrome treatment, such as loose or dry stools.

[0090] The primary symptoms are rib discomfort, abdominal distension, dizziness, and weakness in the limbs, scored as 0, 2, 4, and 6 points respectively, according to four levels: normal, mild, moderate, and severe. Secondary symptoms include emotional depression or irritability, joint pain, and loose or dry stools, scored as 0, 1, 2, and 3 points respectively, according to four levels: normal, mild, moderate, and severe. See Table 1 for specific scoring criteria.

[0091] Table 1. Scoring Criteria for Traditional Chinese Medicine Syndrome Differentiation

[0092] ;

[0093] 4.3.2 Safety Indicators

[0094] Monitor routine blood, urine, and stool tests, as well as liver and kidney function, and record any adverse events to conduct a systematic assessment of its safety.

[0095] 4.4 Evaluation criteria for efficacy and safety

[0096] 4.4.1 Traditional Chinese Medicine Syndrome Therapy Evaluation Criteria

[0097] Refer to the efficacy evaluation criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines":

[0098] The overall therapeutic effect index n = (pre-treatment score - post-treatment score) ÷ pre-treatment score × 100%.

[0099] ① Clinical cure: All or almost all TCM clinical symptoms have disappeared, and the syndrome score has decreased by ≥95%.

[0100] ② Significant effect: Clinical symptoms in TCM are significantly improved, and the syndrome score is reduced by ≥70%.

[0101] ③ Effective: All clinical symptoms in TCM improved, and the syndrome score decreased by ≥30% and <70%.

[0102] ④ Ineffective: No significant improvement or aggravation of clinical symptoms in traditional Chinese medicine, and a decrease of <30% in syndrome score.

[0103] 4.4.2 Criteria for Judging the Severity of Adverse Events

[0104] Mild: The subjects can tolerate it, the treatment plan does not need to be adjusted, and it does not affect the subjects' recovery and prognosis.

[0105] Moderate: Subjects cannot tolerate it, requiring adjustments to the treatment plan, which may affect the subject's recovery and prognosis.

[0106] Severe: Life-threatening, with a risk of death or disability. The medication should be stopped immediately and the condition reassessed.

[0107] 4.5 Statistical Methods

[0108] SPSS 28.0 statistical analysis software was used. Count data were expressed as frequencies, and χ² was used as the statistical metric. 2 Tests. For continuous data, t-tests or non-parametric tests are used depending on whether the data are normally distributed. A p-value <0.05 indicates a statistically significant difference, a p-value <0.01 indicates a statistically significant difference, and a p-value >0.05 indicates no statistically significant difference.

[0109] (II) Research Results

[0110] Analysis of general condition before treatment

[0111] Before treatment, the two groups of patients were compared in terms of gender, age, uric acid, waist circumference, fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, high-density lipoprotein, systolic blood pressure, diastolic blood pressure, and TCM syndrome scores. The results of chi-square test, t-test, and non-parametric test were all P>0.05, indicating no statistical significance. This shows that there was no significant difference between the treatment group and the control group before treatment, and they were comparable. See Table 2-4 for details.

[0112] Table 2 Comparison between the two groups of patients in terms of gender and age.

[0113]

[0114] Note: Gender and age were compared between the two groups of patients before treatment. Count data (gender) were analyzed using the chi-square test. Measurement data (age) that conformed to a normal distribution and had homogeneous variance were analyzed using an independent samples t-test, expressed as mean ± standard deviation; non-normally distributed or heterogeneous variance data were analyzed using a non-parametric test, expressed as median (interquartile range).

[0115] The results showed that the gender difference between the two groups was statistically significant (P=0.759>0.05) according to the chi-square test. 2 =0.094), the difference was not statistically significant, and the two groups were comparable; the mean age of the two groups was not statistically significant, and the difference was not statistically significant, and the two groups were comparable.

[0116] Table 3 Comparison of metabolic indicators such as uric acid between the two groups before treatment

[0117]

[0118] Note: Before treatment, the following parameters were compared between the two groups: uric acid, waist circumference, fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure. Indicators that were normally distributed and homogeneous in variance were analyzed using independent samples t-tests and expressed as mean ± standard deviation. Indicators that were not normally distributed or had unequal variances were analyzed using non-parametric tests and expressed as median (interquartile range).

[0119] The results showed that the pre-treatment results for metabolic indicators such as uric acid were all P>0.05, indicating no statistically significant difference between the treatment group and the control group before treatment, and thus they were comparable.

[0120] Table 4 Comparison of TCM syndrome scores (individual scores) between the two groups before treatment

[0121]

[0122] Note: Before treatment, the two groups of patients were compared in terms of symptoms such as hypochondriac discomfort, abdominal distension, dizziness, weakness and fatigue in the limbs, depression or irritability, joint pain, and whether their stool was loose or dry. Traditional Chinese medicine syndrome indicators (hypochondriac discomfort, abdominal distension, etc.) were presented as ordinal data, expressed as median (interquartile range), and nonparametric tests were used for comparisons between groups.

[0123] The results showed that the TCM syndrome score indicators were all P>0.05, indicating no statistically significant difference between the treatment group and the control group before treatment, and thus they were comparable.

[0124] 2. Analysis of Experimental Results

[0125] 2.1 Comparison of metabolic indicators such as uric acid between the two groups after treatment

[0126] Table 5 Comparison of metabolic indicators such as uric acid between the two groups after treatment.

[0127]

[0128] Note: Intergroup comparisons were made between the two groups of patients after treatment for uric acid, waist circumference, fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure. Indicators that conformed to a normal distribution and homogeneous variance were analyzed using independent samples t-tests, and expressed as mean ± standard deviation; indicators that were not normally distributed or had unequal variances were analyzed using nonparametric tests, and expressed as median (interquartile range).

[0129] The results showed that after treatment, there were no statistically significant differences in uric acid, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure between the two groups (P<0.05), indicating that there were differences in uric acid, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure between the treatment group and the control group. There were no statistically significant differences in other metabolic indicators (waist circumference, fasting blood glucose, and 2-hour postprandial blood glucose) (P>0.05). The results indicate that, compared with the control group, treatment with the compound formula of this invention can more effectively reduce serum uric acid levels in patients with hyperuricemia and metabolic syndrome, while also showing effects in improving lipid metabolism disorders (reducing triglycerides and increasing high-density lipoprotein) and assisting in lowering blood pressure.

[0130] Table 6. Comparison of metabolic indicators such as uric acid after treatment between the two groups.

[0131]

[0132] Note: Within-group comparisons were made of uric acid, waist circumference, fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure in the two groups of patients after treatment. Data are expressed as mean ± standard deviation. Paired t-tests were used to determine if the data were normally distributed and homogeneous in variance; otherwise, non-parametric tests were used.

[0133] The results showed that after treatment, the levels of uric acid and other indicators in both groups were significantly different from those before treatment (P<0.05), indicating that both treatment methods could reduce the patients' blood uric acid levels and other metabolic indicators.

[0134] 2.2 Comparison of TCM syndrome scores before and after treatment in the two groups

[0135] Table 7 Comparison of TCM syndrome (item) scores between the two groups of patients after treatment.

[0136]

[0137] Note: The following comparisons were made between the two groups of patients regarding post-treatment symptoms: hypochondriac discomfort, abdominal distension, dizziness, weakness and fatigue in the limbs, depression or irritability, joint pain, and stool consistency (loose or dry). Traditional Chinese medicine syndrome indicators (hypochondriac discomfort, abdominal distension, etc.) were presented as ordinal data, expressed as median (interquartile range). Non-parametric tests were used for inter-group comparisons.

[0138] The results showed that the scores of TCM syndromes (items) in the two groups after treatment were significantly different (P<0.05), indicating that there were significant differences in the scores of each item between the treatment group and the control group after treatment.

[0139] Table 8. Comparison of TCM syndrome (item) scores between the two groups of patients after treatment.

[0140]

[0141] Note: Within-group comparisons were made of indicators such as hypochondriac discomfort, abdominal distension, dizziness, weakness and fatigue of limbs, depression or irritability, joint pain, and stool consistency (loose or dry) before and after treatment in both groups of patients. TCM syndrome indicators (hypochondriac discomfort, abdominal distension, etc.) were presented as ordinal data, expressed as median (interquartile range), and changes in TCM syndrome indicators were analyzed using paired nonparametric tests.

[0142] The results showed that after treatment, the TCM syndrome indicators such as hypochondriac discomfort and abdominal distension in both groups were significantly different from those before treatment (P<0.05), indicating that the TCM syndrome indicators changed before and after treatment in both groups.

[0143] 2.3 Comparison of the improvement in the total score of TCM syndrome in the two groups

[0144] Table 9 Comparison of total TCM syndrome scores before and after treatment in the two groups of patients.

[0145]

[0146] Note: The total scores of TCM syndromes before and after treatment were compared within the two groups, and between the groups were compared after treatment. For indices that conform to normal distribution and homogeneity of variance, independent samples t-tests were used for comparisons between groups, and the results were expressed as mean ± standard deviation; for indices that are not normally distributed or have unequal variances, nonparametric tests were used, and the results were expressed as median (interquartile range).

[0147] Within-group comparisons are expressed as mean ± standard deviation; paired t-tests are used to determine if the data are normally distributed and homogeneous in variance, otherwise nonparametric tests are used.

[0148] The results showed that the total TCM syndrome scores in both groups after treatment were significantly different from those before treatment (P<0.05), indicating that the total TCM syndrome scores changed in both groups after treatment. The treatment group was also significantly different from the control group after treatment (P<0.05), indicating a significant difference in the total TCM syndrome scores between the two groups after treatment.

[0149] After treatment, the total scores of TCM syndromes in both groups decreased significantly compared to before treatment (both P<0.0001), indicating that both treatment methods could improve the patients' TCM clinical symptoms. However, the degree of improvement in the treatment group was much greater than that in the control group: the total score in the treatment group decreased from (28.78 ± 1.92) to (5.04 ± 2.41), while the control group only decreased from (28.64 ± 2.11) to (20.67 ± 2.62). The inter-group comparison showed that the difference in total scores between the two groups after treatment was statistically significant (P<0.0001). This indicates that the treatment regimen was significantly more effective than the control group in relieving the syndrome of "spleen deficiency and liver stagnation with phlegm and dampness obstruction".

[0150] Table 10 Comparison of TCM syndrome efficacy between the two groups of patients

[0151]

[0152] Note: The efficacy of TCM syndromes is used as ordinal data, and nonparametric tests are used for intergroup comparisons.

[0153] The results showed that compared with the control group, P<0.001, the difference was statistically significant, and the TCM syndrome efficacy in the treatment group was better than that in the control group.

[0154] In summary, the treatment group showed significant improvements in metabolic indicators such as uric acid, waist circumference, fasting blood glucose, 2-hour postprandial blood glucose, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure before and after treatment (P<0.05), indicating that the treatment regimen effectively regulates multiple laboratory indicators in patients with hyperuricemia and metabolic syndrome. Regarding TCM syndrome differentiation, the treatment group showed significant reductions in symptom scores (discomfort in the hypochondrium, abdominal distension, dizziness, weakness and fatigue in the limbs, depression or irritability, joint pain, and loose or dry stools) after treatment, with statistically significant differences within the group (P<0.05). Furthermore, the total TCM syndrome score decreased significantly compared to before treatment, indicating that the formula significantly improves symptoms of liver-spleen disharmony and dampness-stasis obstruction. Compared with the control group, the treatment group showed more significant improvements in uric acid, triglycerides, high-density lipoprotein, systolic blood pressure, and diastolic blood pressure (P<0.05), suggesting that the formula is superior to febuxostat in regulating key metabolic indicators. In terms of TCM syndrome efficacy, the treatment group showed significantly better results than the control group in terms of symptom scores and overall efficacy (P<0.001), with a total effective rate of 100%, compared to 42.22% in the control group. These results indicate that the formula is superior to the control drug in overall clinical efficacy.

[0155] (III) Security Analysis

[0156] During the 12-week follow-up period after treatment, no abnormalities were observed in any of the safety indicators in either group, and no adverse reactions were reported.

[0157] Safety was evaluated during the study through regular examinations (blood, urine, and stool routine tests, liver and kidney function tests, and electrocardiograms) and proactive recording of adverse events. At the end of the 12-week follow-up, all safety indicators in both groups were normal, and no treatment-related adverse reactions were observed. The treatment regimen used in this invention demonstrates good safety.

[0158] This invention provides a traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome, its preparation method, and its application. Many methods and approaches exist for implementing this technical solution; the above description is merely a preferred embodiment of the invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention. All components not explicitly stated in this embodiment can be implemented using existing technologies.

Claims

1. A traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Codonopsis pilosula 3-6 parts, Astragalus membranaceus 12-18 parts, Bupleurum chinense 1-5 parts, Citrus reticulata 1-5 parts, Citrus reticulata 3-6 parts, Scutellaria baicalensis 1-5 parts, Nelumbo nucifera leaf 3-6 parts, Crataegus pinnatifida 3-6 parts, Anemarrhena asphodeloides 12-18 parts, Coptis chinensis 1-3 parts, Polygonatum sibiricum 3-6 parts, Pueraria lobata 28-35 parts, Schisandra chinensis 1-5 parts, Smilax glabra 28-35 parts, Cimicifuga foetida 1-5 parts, processed chicken gizzard lining 5-10 parts, Lycopus lucidus 3-6 parts, Atractylodes lancea 3-6 parts, Phellodendron chinense 3-6 parts, and Liquidambar formosana 3-6 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Codonopsis pilosula 4-5 parts, Astragalus membranaceus 14-16 parts, Bupleurum chinense 2-4 parts, Citrus reticulata peel 2-4 parts, Citrus reticulata peel 4-5 parts, Scutellaria baicalensis 2-4 parts, Nelumbo nucifera leaf 4-5 parts, Crataegus pinnatifida 4-5 parts, Anemarrhena asphodeloides 14-16 parts, Coptis chinensis 1-3 parts, Polygonatum sibiricum 4-5 parts, Pueraria lobata 28-32 parts, Schisandra chinensis 2-4 parts, Smilax glabra 28-32 parts, Cimicifuga foetida 2-4 parts, processed chicken gizzard lining 6-9 parts, Lycopus lucidus 4-5 parts, Atractylodes lancea 4-5 parts, Phellodendron chinense 4-5 parts, and Liquidambar formosana 4-5 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: Codonopsis pilosula 5 parts, Astragalus membranaceus 15 parts, Bupleurum chinense 3 parts, Citrus reticulata 3 parts, Citrus reticulata 5 parts, Scutellaria baicalensis 3 parts, Nelumbo nucifera leaf 5 parts, Crataegus pinnatifida 5 parts, Anemarrhena asphodeloides 15 parts, Coptis chinensis 1.5 parts, Polygonatum sibiricum 5 parts, Pueraria lobata 30 parts, Schisandra chinensis 3 parts, Smilax glabra 30 parts, Cimicifuga foetida 3 parts, processed chicken gizzard lining 7.5 parts, Lycopus lucidus 5 parts, Atractylodes lancea 5 parts, Phellodendron chinense 5 parts, and Liquidambar formosana 5 parts.

4. A method for preparing the traditional Chinese medicine composition for treating hyperuricemia complicated with metabolic syndrome according to any one of claims 1 to 3, characterized in that, The process includes the following steps: Take Codonopsis pilosula, Astragalus membranaceus, Bupleurum chinense, Citrus reticulata peel, Citrus reticulata peel, Scutellaria baicalensis, Nelumbo nucifera leaf, Crataegus pinnatifida, Anemarrhena asphodeloides, Coptis chinensis, Polygonatum sibiricum, Pueraria lobata, Schisandra chinensis, Smilax glabra, Cimicifuga foetida, processed chicken gizzard lining, Lycopus lucidus, Atractylodes lancea, Phellodendron chinense, and Liquidambar formosana according to the weight proportions, soak and decoct them in 3 to 5 times the amount of water, and combine the filtrates to obtain the final product.

5. The preparation method according to claim 4, characterized in that, The soaking time is 30-50 minutes; and / or the decocting is performed 2-3 times, each decocting including first boiling over high heat and then simmering over low heat for 30-50 minutes.

6. A pharmaceutical preparation, characterized in that, The traditional Chinese medicine composition comprising any one of claims 1-3.

7. A pharmaceutical preparation, characterized in that, An extract comprising the traditional Chinese medicine composition according to any one of claims 1-3.

8. The pharmaceutical preparation according to claim 7, characterized in that, The extract is a water extract.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3, the pharmaceutical preparation according to claim 6, or the pharmaceutical preparation according to claim 7 in the preparation of a drug for treating hyperuricemia complicated with metabolic syndrome.

10. The application according to claim 9, characterized in that, The aforementioned combination of traditional Chinese medicines treats hyperuricemia complicated with metabolic syndrome by lowering uric acid, blood sugar, blood lipid and blood pressure levels.

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