A Chinese medicine composition for treating hyperuricemia with hyperlipidemia, medicine, preparation method and application thereof

Abstract

The present invention relates to the field of Chinese medicinal materials, and in particular to a Chinese medicine composition, a medicine, and a preparation method and application thereof for treating hyperuricemia with hyperlipidemia. The Chinese medicine composition and medicine provided by the present invention can intervene in the treatment of asymptomatic hyperuricemia combined with hyperlipidemia, and compared with traditional uric acid-lowering drugs (febuxostat), serum uric acid can be quickly reduced, and the uric acid level can be basically controlled within a normal range. No gout symptoms are found in patients within 6 months of treatment, and complications such as hypertension, hyperglycemia, and cardiovascular and cerebrovascular diseases can be significantly reduced, and the quality of life of patients can be improved; it can also overcome the technical deficiencies of uric acid-lowering drugs, such as many adverse reactions, difficult to sustain therapeutic effects, and limited applicable populations, and has the advantages of small side effects, long-lasting efficacy, and multiple drug targets.

Description

Technical Field

[0001] The present invention relates to the field of Chinese medicinal materials, and in particular to a Chinese medicinal composition for treating hyperuricemia associated with hyperlipidemia, a medicine, and a preparation method and application thereof. Background Art

[0002] Hyperuricemia (HUA) refers to a chronic metabolic disease characterized by abnormally elevated uric acid levels in the blood under normal dietary conditions. The main mechanisms leading to elevated uric acid levels involve two aspects: one is the disorder of purine metabolism leading to increased production of its terminal metabolite uric acid; the other is the reduced metabolism of uric acid excretion disorders. As an independent pathogenic factor, HUA has many effects on the human body. The most direct and common harm is gout. The serum uric acid level is positively correlated with the probability of gout. When the serum uric acid level is at a high level or in an acidic environment, the serum uric acid that is not excreted from the body is deposited in the cartilage, joints, skin and internal organs with the blood circulation. Uric acid precipitates urate crystals, inducing inflammation, joint deformity, severe pain and uric acid stones, forming gouty arthritis, gouty nephropathy and tophi. Modern research shows that uric acid and blood lipids are obviously related through multiple metabolic channels. Elevated uric acid can lead to abnormal blood lipid levels, and blood lipid metabolism disorders can also cause abnormal uric acid levels. HUA is a triggering factor for hyperlipidemia, diabetes, insulin resistance, and cardiovascular and cerebrovascular diseases. Although serum uric acid in early HUA is higher than normal, there are no obvious clinical symptoms. Patients cannot detect it in time or are unwilling to intervene. The disease progresses to gout or cardiovascular disease, which seriously affects the patient's quality of life and survival. It can be seen that HUA is a huge hidden danger that endangers the health of the body. Therefore, HUA should be intervened in the early stage to reduce the risk of gout in patients and delay the progression of complications.

[0003] According to the severity of the patient's hyperuricemia and whether there are complications, the main treatment measures for HUA in modern medicine are:

[0004] 1 General treatment:

[0005] That is, non-drug treatment, which is basic but more critical, mainly includes diet therapy and maintaining a healthy lifestyle. Patients should reduce smoking and drinking or quit drinking and smoking, change the high-purine and high-sugar diet structure, eat more green vegetables, eggs and milk, and drink water in moderation; in addition, they should also maintain good living habits, such as weight loss, exercise, and normal work and rest.

[0006] 2. Drug treatment:

[0007] 2.1 Uric acid-lowering drugs: Allopurinol, febuxostat or benzbromarone are the first choice for patients with gout to lower uric acid; allopurinol or benzbromarone are the first choice for asymptomatic HUA. Allopurinol is low-priced and highly effective, but it is prone to hypersensitivity reactions and death. Domestic patients need to undergo relevant genetic testing before using it to prevent allergies; febuxostat is highly safe and can be used in patients with renal insufficiency. It is the first-line drug for the treatment of gout in China; benzbromarone is suitable for patients with renal excretion disorders. It is easy to cause urate crystal deposition and stone formation, so it is contraindicated for patients with kidney stones or moderate to severe renal insufficiency. In terms of lipid-lowering, febuxostat is significantly better than allopurinol and benzbromarone in regulating TG and HDI-C.

[0008] 2.2 Urine alkalinizing drugs: Regular oral administration of alkaline drugs such as sodium bicarbonate and citric acid preparations can increase uric acid excretion so that the pH value of morning urine should be controlled in the ideal range: 6.2-6.9.

[0009] 3Surgical intervention: For local infection, urinary tract obstruction or other serious problems caused by uric acid stones that affect the quality of life, surgical treatment can be chosen.

[0010] Although Western medicine has made great progress in the treatment of hyperuricemia, it has not yet achieved satisfactory results for some asymptomatic HUA patients, and there are still many aspects that need to be improved. For example, Febuxostat, the most widely used first-line drug in China, has a high safety factor, fast uric acid reduction, and good blood lipid control effect. It can be used for patients with HUA and hyperlipidemia, but it may cause side effects such as liver damage, gastrointestinal reactions, rashes, blurred vision, and edema during use, and it is contraindicated for pregnant women and children. Moreover, long-term medication compliance is poor, and discontinuation of medication is prone to relapse. How to avoid adverse reactions as much as possible, reduce the recurrence rate, and expand the applicable population while reducing lipids and acid is still a problem that technicians in this field need to solve urgently. Summary of the invention

[0011] The purpose of the present invention is to provide a Chinese medicine composition, medicine and preparation method and application thereof for treating hyperuricemia with hyperlipidemia, so as to solve the problems existing in the above-mentioned prior art. The present invention has developed a Chinese medicine composition that can intervene and treat asymptomatic HUA combined with hyperlipidemia, which can stimulate multi-target effects, improve the side effects of Western medicine treatment, improve the therapeutic effect on hyperuricemia, prevent disease progression, and reduce the recurrence rate of drug discontinuation.

[0012] There is no "hyperuricemia" in traditional Chinese medicine. From the main clinical manifestations and disease outcomes of patients in the later stage, asymptomatic HUA can be classified as the early stage of diseases such as "gout", "arthritis", "rheumatism", and "knee eye wind" in traditional Chinese medicine. Modern doctors believe that the essence of uric acid is similar to blood lipids, and both can be summarized as "blood turbidity" and "damp turbidity". The turbidity in the blood blocks the meridians and flows into the joints, causing joint swelling, deformation and pain. In the early stage of the disease, it is mostly due to the invasion of evil qi, which stagnates in the meridians, resulting in abnormal circulation of qi and blood, and abnormal distribution of body fluids; over time, it damages the internal organs, mostly involving spleen and kidney dysfunction, or due to improper diet, which hurts the spleen and stomach, abnormal transportation and transformation, and endogenous dampness; or due to congenital deficiency, the kidney is weak and the qi transformation function is weak, the body fluid distribution and excretion are abnormal, and the water and dampness cannot be removed and stay in the joints. As the disease progresses, water and dampness stagnate for a long time, become depressed and turn into heat, and dampness, heat, phlegm and blood stasis are generated endogenously and intertwined, causing a mixture of deficiency and excess, which aggravates the disease and causes it to become prolonged and recurrent.

[0013] The present invention is based on the diagnostic principle of traditional Chinese medicine, and based on the theory of qi, blood, body fluids and viscera, and has developed a Chinese medicine composition that can intervene and treat asymptomatic HUA combined with hyperlipidemia. The theory, method, prescription and medicine of the present invention are complete, and the clinical efficacy is definite. The pathogenesis of hyperuricemia is characterized by more excess in the early stage and mixed deficiency and excess in the later stage. The composition of the present invention treats hyperuricemia in the early stage, and mostly adopts the method of promoting blood circulation and removing blood stasis, strengthening the spleen and removing dampness, so as to remove turbidity and reduce fat, and open up joints; reduce uric acid and blood lipid levels, maintain stable indicators, delay disease progression, prevent disease recurrence, and improve quality of life.

[0014] To achieve the above object, the present invention provides the following solutions:

[0015] The invention provides a traditional Chinese medicine composition for treating hyperuricemia with hyperlipidemia. The traditional Chinese medicine composition comprises the following components in parts by weight: 25-35 parts of siegesbeckia herb, 12-18 parts of gynostemma pentaphyllum, 25-35 parts of raw coix seeds, 9-15 parts of tangerine peel, 9-15 parts of atractylodes, 12-18 parts of atractylodes, 25-35 parts of salvia miltiorrhiza, 12-18 parts of tuckahoe, 12-18 parts of leonurus japonicus, 6-10 parts of pinellia ternata and 4-8 parts of raw liquorice.

[0016] The present invention provides the use of the above-mentioned traditional Chinese medicine composition in preparing a medicine for treating hyperuricemia with hyperlipidemia.

[0017] The present invention provides a medicine for treating hyperuricemia associated with hyperlipidemia, and the medicine comprises the above-mentioned traditional Chinese medicine composition.

[0018] Preferably, the drug is a liquid preparation.

[0019] Preferably, the drug further comprises a pharmaceutically acceptable excipient.

[0020] The present invention provides a method for preparing the above-mentioned medicine, comprising the following steps:

[0021] Mixing Siegesbeckiae, Gynostemma pentaphyllum, raw coix seed, dried orange peel, Atractylodes lancea, Atractylodes macrocephala, Salvia miltiorrhiza, Poria, Leonurus japonicus, Pinellia ternata and raw liquorice, and performing a first water extraction to obtain a first filter residue and a first filtrate; performing a second water extraction on the first filter residue to obtain a second filter residue and a second filtrate; combining the first filtrate and the second filtrate to obtain a water extract;

[0022] fermenting the second filter residue to obtain a fermentation liquid;

[0023] The water extract and the fermentation liquid are mixed evenly to obtain the medicine.

[0024] Preferably, during the first water extraction, the mass ratio of the total mass of the herb Siegesbeckia, the Gynostemma pentaphyllum, the raw coix seed, the dried tangerine peel, the atractylodes, the atractylodes, the salvia miltiorrhiza, the Poria, the motherwort, the pinellia ternata and the raw liquorice to water is 1:3, and the time is 1 hour.

[0025] Preferably, during the second water extraction, the mass ratio of the first filter residue to water is 1:1.5, and the time is 0.5 h.

[0026] Preferably, during the fermentation, the fermentation bacteria used include Bacillus licheniformis and Lactococcus lactis;

[0027] The dosage of the fermentation bacteria agent is 3% of the mass of the second filter residue.

[0028] Preferably, the fermentation time is 18 hours and the temperature is 40°C.

[0029] The formulation principles of the Chinese medicine composition provided by the present invention are as follows:

[0030] Siegesbeckia: Spicy in taste, bitter and cold in nature, it enters the liver and kidney meridians, dispels rheumatism, benefits joints, and has the function of detoxification. It is an important medicine for dispelling wind, dampness and promoting blood circulation. Modern research shows that the main active ingredients in Siegesbeckia can reduce synovial inflammation, control uric acid formation, and inhibit the expression of inflammatory factors. It is often used to treat arthritis diseases.

[0031] Gynostemma pentaphyllum: sweet, bitter and cold in nature, it belongs to the lung and spleen meridians, and has the functions of invigorating qi and strengthening the spleen, clearing away heat and removing phlegm, nourishing the heart and calming the mind. Known as the "ginseng of the south", it can effectively prevent lipid substances from adhering to the blood vessel wall, improve plasma lipid coagulation, regulate blood circulation, and increase the body's immunity. It is often used in clinical treatments such as lowering blood pressure, lowering blood lipids, and protecting the liver;

[0032] Danshen: bitter, slightly warm, enters the heart and liver meridians, effects: promoting blood circulation, removing blood stasis, draining pus and relieving pain. Danshen alcohol extract promotes uric acid excretion to reduce serum uric acid;

[0033] Motherwort: Pungent, slightly bitter and cold, it can eliminate water and promote blood circulation, activate blood circulation, remove blood stasis and promote new blood circulation, and has the function of detoxification. This medicine can promote blood circulation without damaging new blood, nourish blood without stagnating blood; it has anti-inflammatory and analgesic effects;

[0034] Poria: sweet, light, neutral, enters the heart, spleen, and kidney meridians; promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind; large doses can completely expel dampness deposited in the joints;

[0035] Raw coix seed: sweet and mild, cool, enters the spleen, stomach and lung meridians; has the effects of diuresis, infiltration of dampness, strengthening the spleen, pus discharge, detoxification and stagnation; many of its ingredients can lower cholesterol levels, protect cardiovascular system and enhance the body's immunity;

[0036] Tangerine peel: bitter, pungent and warm. It regulates qi, regulates the middle, dries dampness and resolves phlegm; it can prevent the generation of phlegm and further spread; modern pharmacological research shows that tangerine peel extract has anti-inflammatory effects; regulates microcirculation; improves liver structure; protects bones; regulates genes related to fat production, etc.

[0037] Atractylodes: pungent and warm, bitter. Enters the spleen, stomach, and liver meridians. Efficacy: drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight; Atractylodes can reduce the activity of xanthine oxidase, inhibit the release of inflammatory factors, and reduce uric acid. It is a targeted drug for the treatment of HUA;

[0038] Atractylodes macrocephala: bitter and sweet in nature, warm in nature, enters the spleen and stomach meridians, functions and indications: tonifies the spleen, benefits the stomach, dries dampness, and harmonizes the middle; the lactone components in Atractylodes macrocephala have anti-inflammatory, anti-tumor, and hypoglycemic effects;

[0039] Pinellia tuber: pungent and warm, enters the spleen, stomach and lung meridians; dries dampness, resolves phlegm, disperses nodules, reduces swelling and relieves pain; its volatile oil components can resist inflammation and bacteria, lower blood pressure and reduce fat;

[0040] Raw licorice: neutral in nature, sweet in taste; enters the heart, lung, spleen and stomach meridians. It nourishes the spleen and replenishes qi, relieves pain, and harmonizes various medicines; it is good at relieving cramps and relieving pain. Studies have found that licorice glycosides can improve mental state and relieve anxiety.

[0041] In the composition, Herba Siegesbeckiae and Herba Gynostemma are both the main drugs; Herba Siegesbeckiae is pungent to dissipate wind and dredge collaterals, bitter to clear heat and dissipate dampness, and improves joint inflammation through multiple channels; Herba Gynostemma can invigorate qi, invigorate the spleen and dissipate dampness, and can also clear heat and reduce fat. The two drugs are bitter and cold in nature and can be used in combination to dissipate the "turbidity" of joints and clear the "turbidity" of meridians. Salvia miltiorrhizae and Herba Leonuri can promote blood circulation, dissipate blood stasis and relieve pain, and prevent uric acid from depositing and precipitating uric acid crystals; Poria cocos and raw Coix seeds can invigorate the spleen and dissipate dampness, and benefit the tendons and collaterals, and dredge the joints; the above four drugs (Salvia miltiorrhizae, Herba Leonuri, Poria cocos and raw Coix seeds) can promote qi and blood circulation, dissipate blood stasis and relieve pain, and make the joints and meridians smooth in qi and blood, move freely, and prevent deformation, and are all the minister drugs. Tangerine peel, Pinellia tuber, Atractylodes lancea and Atractylodes macrocephala can invigorate the spleen, dry dampness and resolve phlegm, and the four drugs can help the monarch and ministers to remove turbidity and restore the body fluid metabolism to normal, and are all the adjuvant drugs. Raw licorice is sweet and mild in nature, which can alleviate the bitter and cold nature and can harmonize various medicines, and is a guiding medicine. The combination of various medicines can play the effects of promoting blood circulation, removing turbidity, and strengthening the spleen.

[0042] The present invention discloses the following technical effects:

[0043] The present invention provides a Chinese medicine composition and medicine that can intervene and treat asymptomatic HUA combined with hyperlipidemia. Compared with traditional uric acid-lowering drugs (febuxostat), serum uric acid can be quickly reduced, and the uric acid level can be basically controlled within a normal range. No gout symptoms were found in patients within 6 months of treatment, and complications such as hypertension, hyperglycemia, cardiovascular and cerebrovascular diseases can be significantly reduced, and the quality of life of patients can be improved. The present invention can also overcome the technical deficiencies of acid-lowering drugs such as many adverse reactions, difficult to sustain therapeutic effects, and limited applicable populations. At the same time, it has the advantages of small side effects, long-lasting efficacy, and multiple drug targets.

[0044] The present invention also provides a method for preparing a drug for treating hyperuricemia with hyperlipidemia. The method comprises the steps of water extracting the raw material and then using Bacillus licheniformis and Lactococcus lactis to perform biological fermentation on the obtained filter residue. The Bacillus licheniformis and Lactococcus lactis used in the present invention contain rich enzyme systems. The combined action of these enzymes can destroy the tight structure of macromolecular substances in the raw material, so that the effective components can be better extracted, thereby significantly improving the efficacy of the drug. DETAILED DESCRIPTION

[0045] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0046] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0047] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0048] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0049] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0050] Unless otherwise specified, the raw materials and strains used in the examples are all purchased by those skilled in the art.

[0051] Example 1

[0052] A Chinese medicine composition for treating hyperuricemia with hyperlipidemia, the raw materials of which include the following components in parts by weight:

[0053] 35 parts of Siegesbeckiae, 18 parts of Gynostemma pentaphyllum, 25 parts of raw Coix seeds, 10 parts of dried orange peel, 12 parts of Atractylodes, 18 parts of Atractylodes macrocephala, 35 parts of Salvia miltiorrhiza, 12 parts of Poria, 15 parts of Leonurus japonicus, 10 parts of Pinellia ternata and 6 parts of raw Licorice.

[0054] Preparation method:

[0055] (1) After weighing the raw materials according to the raw material formula, rinse them with clean water once, filter out dust and impurities, and then extract them with water at a solid-liquid ratio of 1:3 (i.e., 1 kg:3 L) and 100° C. for 1 hour to obtain a first filtrate and a first filter residue; extract the first filter residue with water at a solid-liquid ratio of 1:1.5, a temperature of 100° C., and a time of 30 minutes to obtain a second filtrate and a second filter residue; combine the first filtrate and the second filtrate to obtain a water extract;

[0056] (2) The second filter residue was mixed with water in a mass ratio of 1:1, and then a fermentation agent was added, and fermented at 40° C. for 18 h to obtain a fermentation liquid, wherein the amount of the fermentation agent was 3% of the mass of the second filter residue, and the fermentation agent consisted of Bacillus licheniformis and Lactococcus lactis, and the number of viable bacteria of Bacillus licheniformis in the fermentation agent was 1×10 7 CFU / mL, the number of viable Lactococcus lactis is 1×10 7 CFU / mL;

[0057] (3) The water extract and the fermentation liquid are mixed evenly to obtain a drug for treating hyperuricemia with hyperlipidemia.

[0058] Example 2

[0059] A Chinese medicine composition for treating hyperuricemia with hyperlipidemia, the raw materials of which include the following components in parts by weight:

[0060] 30 parts of Siegesbeckiae, 12 parts of Gynostemma pentaphyllum, 35 parts of raw Coix seeds, 9 parts of dried orange peel, 15 parts of Atractylodes, 15 parts of Atractylodes macrocephala, 30 parts of Salvia miltiorrhiza, 15 parts of Poria, 18 parts of Leonurus japonicus, 6 parts of Pinellia ternata and 4 parts of raw Licorice.

[0061] The drug preparation method is the same as in Example 1.

[0062] Example 3

[0063] A Chinese medicine composition for treating hyperuricemia with hyperlipidemia, the raw materials of which include the following components in parts by weight:

[0064] 25 parts of Siegesbeckiae, 15 parts of Gynostemma pentaphyllum, 30 parts of raw Coix seeds, 15 parts of dried orange peel, 9 parts of Atractylodes, 12 parts of Atractylodes macrocephala, 25 parts of Salvia miltiorrhiza, 18 parts of Poria, 12 parts of Leonurus japonicus, 8 parts of Pinellia ternata and 8 parts of raw Licorice.

[0065] The drug preparation method is the same as in Example 1.

[0066] Experimental Example 1 Effect Verification

[0067] 1. Materials and methods

[0068] 1.1 General Information

[0069] A total of 60 patients with asymptomatic hyperuricemia and hyperlipidemia were randomly divided into 4 groups, with 15 patients in each group.

[0070] 1.2 Diagnostic criteria

[0071] (1) Western medicine diagnostic criteria for hyperuricemia

[0072] Refer to the "Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout in China (2019 Edition)" and the "Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia-Related Diseases in China (2023 Edition)";

[0073] The diagnostic criteria for asymptomatic hyperuricemia are: no gout attack, fasting serum uric acid (SUA) concentration > 420 μmol / L on two different days. It is divided into two stages: hyperuricemia stage and monosodium salt crystal (MSU) deposition stage.

[0074] 1.3 Inclusion criteria

[0075] (1) The patient's SUA concentration was ≥480 μmol / L, meeting the Western medical diagnostic criteria for asymptomatic hyperuricemia and hyperlipidemia;

[0076] (2) Gender is not limited, age range is 15-70 years old;

[0077] (3) Not taking acid-lowering or lipid-lowering drugs within one month and not participating in other clinical observation trials.

[0078] 1.4 Exclusion criteria

[0079] (1) Hyperuricemia has progressed to the stage of gouty arthritis, tophi, and bone destruction;

[0080] (2) Patients with liver and kidney dysfunction; patients with other endocrine diseases, metabolic diseases, cardiovascular and cerebrovascular diseases, or mental disorders;

[0081] (3) Pregnant women or breastfeeding women.

[0082] 1.5 Treatment options

[0083] Control group: took Febuxostat (trade name: Febuxostat tablets, manufacturer: Jiangsu Wanbang Biochemical Pharmaceutical Co., Ltd., national medicine standard number: H20130058), once a day, 20 mg each time, before breakfast.

[0084] Experimental groups: took the medicines prepared in Examples 1-3 respectively; taken warm in the morning and evening, 200 mL each time, and were recorded as Experimental Group 1 to Experimental Group 7.

[0085] The above treatment plans are all for one month as a course of treatment, and the medication is discontinued after 3 courses of treatment. During this period, the changes in the patient's various indicators are recorded, and a review is conducted after 6 months.

[0086] In addition to the above-mentioned differences in medication, patients in the control group and experimental treatment group also followed the following treatment methods:

[0087] (1) Eat more green vegetables, eggs and milk, and eat less high-purine foods such as seafood and fish. Eat a low-sugar, low-salt, and low-fat diet; do not drink alcohol or drinks containing fructose;

[0088] (2) Maintain a good lifestyle, quit smoking during treatment, and avoid passive smoking;

[0089] (3) Increase water intake. Daily water intake should be ≥ 2000 ml to increase urine output.

[0090] (4) Maintain good living habits and do moderate exercise. It is recommended to do at least 2 hours of moderate-intensity aerobic exercise per week and drink water in time after exercise; obese patients can lose weight appropriately.

[0091] 1.6 Criteria for determining efficacy

[0092] 1.6.1 Items for observation of therapeutic efficacy:

[0093] (1) Laboratory indicators:

[0094] Serum uric acid (SUA) and urine acidity (pH).

[0095] (2) Safety indicators:

[0096] Liver and kidney functions were checked at the beginning of treatment and one month after treatment; complications after treatment and during follow-up were observed and recorded.

[0097] The above tests were performed once at the beginning of treatment, at the end of one course of treatment, and at the end of three courses of treatment. They were also performed again at the follow-up visit after 6 months.

[0098] 1.6.2 Efficacy evaluation criteria

[0099] The values ​​of the efficacy indicators of the two groups before and after treatment were recorded, and the efficacy was evaluated according to the "Clinical Disease Diagnosis Based on Cure and Improvement Criteria (2002 Edition)" and "Chinese Multidisciplinary Expert Consensus on Diagnosis and Treatment of Hyperuricemia-Related Diseases (2023 Edition)". Clinical cure is defined as: serum uric acid (SUA) <360μmol / L, cholesterol <5.2mmol / L, triglyceride <1.7mmol / L. All indicators are controlled within the normal range.

[0100] 1.7 Data Processing

[0101] Statistical methods: All data were analyzed using SPSS 23.0 statistical software. Measurement data were expressed as x ± s. Data with equal variance were tested using two independent sample t tests, and data with unequal variance were tested using approximate t tests. Count data were tested using χ 2 Test. Rank sum test was used for rank data. P < 0.05 indicated a significant difference, and P < 0.01 indicated a very significant difference.

[0102] 2. Results

[0103] 2.1 Analysis of general data before treatment

[0104] The basic information of the patients in the experimental group and the control group is shown in Table 1. There was no statistically significant (P>0.05) difference in gender and age distribution between the patients, and they were comparable.

[0105] Table 1 Basic information of patients in different groups (N=15)

[0106]

[0107] 2.2 Comparison of serum uric acid (SUA) and urine acidity (pH) between the experimental group and the control group The results are shown in Table 2.

[0108] Table 2 Survey results of serum uric acid and urine acid-alkalinity in patients in different groups (N=15)

[0109]

[0110] As shown in Table 2, the drugs prepared in Examples 1-3 of the present invention can effectively reduce the patient's blood uric acid and balance the uric acid alkalinity to keep it within a reasonable range of 6.2-6.9. It can be seen that the drugs provided by the present invention can effectively treat uricemia.

[0111] 2.3 Comparison of cholesterol and triglyceride between the experimental group and the control group The results are shown in Table 3.

[0112] Table 3 Survey results of cholesterol and triglyceride in patients in different groups (N=15)

[0113]

[0114]

[0115] As shown in Table 3, the drugs prepared in Examples 1-3 of the present invention can effectively reduce the blood lipids of patients, especially cholesterol and triglycerides. It can be seen that the drugs provided by the present invention can effectively treat patients with hyperuricemia and hyperlipidemia.

[0116] 2.4 Comparison of comprehensive treatment effects between the experimental group and the control group after 3 courses of treatment

[0117] The comprehensive therapeutic effects of the experimental group and the control group after 3 courses of treatment are shown in Table 4. The results show that the comprehensive therapeutic effects of the experimental groups 1-3 are better than those of the control group. According to the Pearson chi-square test, the experimental groups 1-3 were compared with the control group P < 0.05, and there was a statistical difference. It can be seen that the therapeutic effect of the drug prepared by Examples 1-3 of the present invention on patients with hyperuricemia is better than that of Febuxostat.

[0118] Table 4 Statistical table of comprehensive treatment effects of experimental group and control group

[0119] Group Total number of cases (n) Number of effective cases Invalid cases Total effective rate (%) Experimental Group 1 15 14 1 93.33 Experimental Group 2 15 13 2 86.67 Experimental Group 3 15 13 2 86.67 Control group 15 9 6 60.00

[0120] 2.5 Comparison of abnormal indicators in the experimental group and the control group in the 6-month follow-up after treatment

[0121] The statistical results of the number of abnormal indicators in the experimental group and the control group after 6 months of follow-up are shown in Table 5. The results show that the number of patients with complications in the experimental groups 1-3 after 6 months of follow-up was significantly lower than that in the control group; at the same time, no patients were found to have gout symptoms within 6 months of treatment.

[0122] Table 5 Statistical results of complications in the experimental group and the control group after 6 months of treatment (n = 15)

[0123] complication Experimental Group 1 Experimental Group 2 Experimental Group 3 Control group Serum uric acid 1 2 2 5 TG 1 1 2 2 Joint Ultrasound 1 2 1 1 Total (number of cases) 3 5 5 8

[0124] Note: Pearsonχ 2Test, P<0.05.

[0125] The above results show that the drugs prepared in Examples 1-3 are significantly effective in treating asymptomatic hyperuricemia compared with traditional uric acid-lowering drugs, can quickly reduce serum uric acid, and basically control uric acid levels within the normal range. Moreover, no gout symptoms were found in patients within 6 months of treatment, which can improve the quality of life of patients.

[0126] Experimental Example 2

[0127] Liu, male, 52 years old, was diagnosed with hyperuricemia and hyperlipidemia. The patient's blood uric acid was 674 μmol / L, serum total cholesterol was 9.62 mmol / L, and triglycerides were 7.65 mmol / L. Take the medicine prepared in Example 1, warm and take it in the morning and evening, 200 mL each time. After a follow-up visit one month later, blood uric acid, serum total cholesterol, and triglycerides dropped to 455 μmol / L, 5.76 mmol / L, and 3.74 mmol / L, respectively. After a follow-up visit three months later, blood uric acid, serum total cholesterol, and triglycerides dropped to 372 μmol / L, 4.32 mmol / L, and 1.96 mmol / L, respectively.

[0128] Experimental Example 3

[0129] Yang Moumou, male, 57 years old, came to the hospital for hyperuricemia with hyperlipidemia. Laboratory tests showed that the patient's blood uric acid was 804μmol / L, serum total cholesterol was 11.61mmol / L, and triglycerides were 9.43mmol / L. Afterwards, take the medicine prepared in Example 1, warm in the morning and evening, 200mL each time. After a follow-up visit one month later, blood uric acid, serum total cholesterol, and triglycerides dropped to 500μmol / L, 5.93mmol / L, and 3.82mmol / L, respectively. After a follow-up visit three months later, blood uric acid, serum total cholesterol, and triglycerides dropped to 403μmol / L, 4.44mmol / L, and 1.74mmol / L, respectively.

[0130] The embodiments described above are only descriptions of the preferred modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating hyperuricemia with hyperlipidemia, characterized in that: The traditional Chinese medicine composition consists of the following components in parts by mass: 25-35 parts of Siegesbeckiae, 12-18 parts of Gynostemma pentaphyllum, 25-35 parts of raw coix seeds, 9-15 parts of dried tangerine peel, 9-15 parts of Atractylodes macrocephala, 12-18 parts of Atractylodes macrocephala, 25-35 parts of Salvia miltiorrhiza, 12-18 parts of Poria, 12-18 parts of Leonurus japonicus, 6-10 parts of Pinellia ternata and 4-8 parts of raw licorice.

2. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for treating hyperuricemia with hyperlipidemia.

3. A drug for treating hyperuricemia with hyperlipidemia, characterized in that: The medicine comprises the Chinese medicine composition according to claim 1.

4. The drug according to claim 3, characterized in that The medicine is a liquid preparation.

5. The drug according to claim 3, characterized in that The drug also includes pharmaceutically acceptable excipients.

6. The method for preparing the drug according to any one of claims 3 to 5, characterized in that: The following steps are involved: Mixing Siegesbeckiae, Gynostemma pentaphyllum, raw coix seed, dried orange peel, Atractylodes lancea, Atractylodes macrocephala, Salvia miltiorrhiza, Poria, Leonurus japonicus, Pinellia ternata and raw liquorice, and performing a first water extraction to obtain a first filter residue and a first filtrate; performing a second water extraction on the first filter residue to obtain a second filter residue and a second filtrate; combining the first filtrate and the second filtrate to obtain a water extract; fermenting the second filter residue to obtain a fermentation liquid; The water extract and the fermentation liquid are mixed evenly to obtain the medicine.

7. The preparation method according to claim 6, characterized in that: During the first water extraction, the total mass ratio of the herb Siegesbeckiae, the Gynostemma pentaphyllum, the raw coix seeds, the dried tangerine peel, the atractylodes, the atractylodes, the salvia miltiorrhiza, the Poria, the motherwort, the pinellia ternata and the raw liquorice to water is 1:3, and the extraction time is 1 hour.

8. The preparation method according to claim 6, characterized in that: During the second water extraction, the mass ratio of the first filter residue to water is 1:1.5, and the time is 0.5 h.

9. The preparation method according to claim 6, characterized in that: During the fermentation, the fermentation bacteria used include Bacillus licheniformis and Lactococcus lactis; The dosage of the fermentation bacteria agent is 3% of the mass of the second filter residue.

10. The preparation method according to claim 6, characterized in that: The fermentation time is 18 hours and the temperature is 40°C.

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