Traditional Chinese medicine composition for treating adolescent hyperuricemia

Abstract

The invention discloses a traditional Chinese medicine composition for treating adolescent hyperuricemia. The traditional Chinese medicine composition comprises the following components in parts by weight: 1-1.5 parts of astragalus membranaceus, 1-3 parts of Chinese yam, 0.5-1 part of golden cypress, 1 part of rhizoma atractylodis, 0-1 part of bighead atractylodes rhizome, 1 part of radix rehmanniae, 2-3 parts of rhizoma smilacis glabrae, 0-1 part of radix saposhnikoviae, 1-2 parts of rhizoma alismatis, 0-3 parts of coix seeds, 1 part of hawthorn, 0-1.5 parts of lotus leaves, 1-3 parts of corn stigma, 0-1 part of chrysanthemum and 0.5-1 part of liquorice. According to the main treatment principles of tonifying qi, strengthening spleen, resolving dampness and removing turbidity, various medicinal and edible traditional Chinese medicinal materials are adopted, through clinical verification and animal experiments, the curative effect is definite, the treatment effect is good, the safety is high, and a scientific basis is provided for exploring a new strategy for treating teenager hyperuricemia through combination of traditional Chinese medicine and western medicine.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition for treating hyperuricemia in adolescents. Background Technology

[0002] Hyperuricemia (HUA) is a metabolic pathological condition characterized by elevated uric acid levels in the body due to purine metabolism disorders and / or impaired uric acid excretion. Epidemiological survey data indicate that the overall prevalence of HUA in China is as high as 13.3%, with a total of approximately 177 million affected individuals, and the disease is showing a significant upward trend and affecting younger people. Clinical studies have shown that compared to adults, adolescents with hyperuricemia are more prone to complications such as renal insufficiency, hyperlipidemia, and arteriosclerosis, resulting in a poorer prognosis.

[0003] The causes and mechanisms of hyperuricemia (HUA) in adolescents mainly involve metabolic abnormalities, genetic factors, lifestyle habits, and secondary factors. Treatment principles include lifestyle improvement, control of serum uric acid levels, monitoring of target organ damage, and management of complications. Currently, clinically used uric acid-lowering drugs mainly include drugs that control uric acid production, such as allopurinol and febuxostat, and drugs that promote uric acid excretion, such as benzbromarone. However, none of these drugs are indicated for use in adolescents under the age of 18, and they have various adverse reactions. For example, allopurinol can cause gastrointestinal symptoms, rash, liver damage, bone marrow suppression, and occasionally serious "allopurinol hypersensitivity syndrome" such as exfoliative dermatitis; febuxostat can cause liver damage, jaundice, allergic reactions, rhabdomyolysis, mental disorders, tubulointerstitial nephritis, and increased risk of cardiovascular disease; benzbromarone and probenecid may cause gastrointestinal discomfort, diarrhea, rash, and liver damage, and are contraindicated in patients with decreased renal function and kidney stones.

[0004] Therefore, how to safely and effectively control the progression of adolescent hypersensitivity to inflammatory bowel disease (HUA) has become an important public health issue that urgently needs to be addressed. Traditional Chinese medicine, which treats both the symptoms and the root cause, has unique advantages in the treatment of adolescent HUA. Summary of the Invention

[0005] This invention addresses the problems existing in the prior art by providing a traditional Chinese medicine composition for treating hyperuricemia (HUA) in adolescents. Based on the physical characteristics and growth and development of adolescents, this invention primarily employs the principles of tonifying qi and strengthening the spleen, resolving dampness and eliminating turbidity. It utilizes a variety of medicinal and edible herbs, and clinical observations and animal experiments have verified its efficacy, good therapeutic effect, and high safety, providing a scientific basis for exploring new strategies for treating adolescent hyperuricemia using integrated traditional Chinese and Western medicine.

[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: A traditional Chinese medicine composition for treating adolescent hyperplasia (HUA) comprises the following components in parts by weight: Astragalus membranaceus 1-1.5 parts, Dioscorea opposita 1-3 parts, Atractylodes lancea 1 part, Phellodendron chinense 0.5-1 part, Atractylodes macrocephala 1 part, Rehmannia glutinosa 1 part, Smilax glabra 2-3 parts, Saposhnikovia divaricata 0.5-1 part, Alisma plantago-aquatica 1-2 parts, Coix lacryma-jobi 1-3 parts, Crataegus pinnatifida 1 part, Nelumbo nucifera leaf 1-1.5 parts, Zea mays 1-3 parts, Chrysanthemum morifolium 0.5-1 part, and Glycyrrhiza uralensis 0.5-1 part.

[0007] Preferably, the formula comprises the following components in parts by weight: 1-1.5 parts Astragalus membranaceus, 1-3 parts Dioscorea opposita, 1 part Atractylodes lancea, 0.5-1 part Phellodendron chinense, 1 part Atractylodes macrocephala, 1 part Rehmannia glutinosa, 2-3 parts Smilax glabra, 1-2 parts Alisma plantago-aquatica, 1-3 parts Coix lacryma-jobi, 1 part Crataegus pinnatifida, 1-1.5 parts Nelumbo nucifera, 1-3 parts Zea mays, and 0.5-1 part Glycyrrhiza uralensis.

[0008] Preferably, the formula comprises the following components by weight: Astragalus membranaceus 1-1.5 parts, Dioscorea opposita 1-3 parts, Atractylodes lancea 1 part, Phellodendron chinense 1 part, Atractylodes macrocephala 0-1 part, Rehmannia glutinosa 1 part, Smilax glabra 2-3 parts, Alisma plantago-aquatica 1-2 parts, Crataegus pinnatifida 1 part, Zea mays 1-3 parts, and Glycyrrhiza uralensis 0.5-1 part. This invention, considering the physical characteristics and disease features of adolescents, and taking into account the safety of clinical application and patient compliance, uses a formula of traditional Chinese medicine for strengthening the spleen and resolving dampness, while also nourishing yin and clearing heat, combining tonification and purgation to achieve the goal of invigorating qi without excessive yang and eliminating dampness without damaging yin.

[0009] The properties and effects of each component are as follows: Astragalus is sweet and slightly warm. It tonifies qi and raises yang, strengthens the exterior and stops sweating, promotes diuresis and reduces swelling, generates fluids and nourishes blood, promotes circulation and relieves pain, promotes the elimination of toxins and pus, and astringes sores and promotes tissue regeneration. When it enters the spleen meridian, it is especially good at tonifying spleen qi and raising the middle yang.

[0010] Yam is sweet and neutral in nature, and it nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, and tonifies the kidneys and astringes essence. It can replenish the qi of the spleen, lungs and kidneys, and also nourish the yin of the spleen, lungs and kidneys. It can be used regardless of whether the spleen qi is weak, the spleen and stomach yin is insufficient, the lung yin is deficient, or the kidneys are weak and unstable.

[0011] Phellodendron bark is bitter and cold, clearing heat and drying dampness, purging fire and eliminating steaming.

[0012] Atractylodes lancea is pungent, bitter, and warm in nature. It dries dampness, strengthens the spleen, dispels wind and cold, and improves eyesight.

[0013] Atractylodes macrocephala is sweet and warm in nature, and it invigorates the spleen and replenishes qi, dries dampness and promotes diuresis, and stops sweating.

[0014] Rehmannia root is sweet and cold in nature, clearing heat and cooling the blood, nourishing yin and promoting the production of body fluids.

[0015] Smilax glabra is sweet, bland, and neutral in nature. It detoxifies, removes dampness, and promotes joint mobility.

[0016] Fangfeng is pungent, sweet, and slightly warm. It disperses wind, releases the exterior, eliminates dampness, and relieves pain.

[0017] Alisma plantago-aquatica is sweet, bland, and cold in nature. It promotes diuresis and eliminates dampness, clears heat, resolves turbidity, and lowers lipids.

[0018] Job's tears are sweet, bland, and cool in nature. They promote diuresis, eliminate dampness, strengthen the spleen, and stop diarrhea.

[0019] Hawthorn has a sour and sweet taste, is slightly warm, and can aid digestion, strengthen the stomach, promote qi circulation, remove blood stasis, and reduce lipids.

[0020] Lotus leaves are bitter and neutral in nature. They clear away summer heat and dampness, promote the upward movement of clear yang, cool the blood and stop bleeding.

[0021] Corn silk is sweet and neutral in nature, and it promotes diuresis, eliminates dampness, and reduces swelling.

[0022] Chrysanthemum is sweet and bitter, slightly cold in nature, and can dispel wind and clear heat, calm the liver and improve eyesight, and clear heat and detoxify.

[0023] Licorice is sweet and neutral in nature. It tonifies the spleen and replenishes qi, clears heat and detoxifies, and harmonizes the effects of other herbs.

[0024] The theoretical basis of this invention, based on traditional Chinese medicine theory, is as follows: The formula provided by this invention is based on the classic ancient formulas "Fangji Huangqi Tang" and "Si Miao Wan," and is modified to address the characteristic of "spleen deficiency and dampness obstruction" in local adolescents with hyperuricemia, according to the treatment principle of "tonifying qi and strengthening the spleen, resolving dampness and eliminating turbidity." The original formula of "Fangji Huangqi Tang" in Zhang Zhongjing's *Jinkui Yaolue* (Essentials from the Golden Cabinet) of the Eastern Han Dynasty consists of "Astragalus membranaceus, Fangji (Stephania tetrandra), Atractylodes macrocephala, and Glycyrrhiza uralensis," which has the effects of tonifying qi and dispelling wind, strengthening the spleen and promoting diuresis. The original formula of "Si Miao Wan" in Zhang Bingcheng's *Chengfang Bian Du* (Essentials for Convenience) of the Qing Dynasty consists of "Phellodendron amurense, Atractylodes lancea, Coix lacryma-jobi, and Achyranthes bidentata," which has the effects of clearing heat and dampness, and promoting blood circulation and relieving pain. Modern research shows that the above two formulas can effectively reduce blood uric acid levels in gout patients, protect kidney function, and improve glucose and lipid metabolism. This invention removes the bitter and cold Fangji (Stephania tetrandra) which is harmful to the stomach and the bitter and purgative Niuxi (Achyranthes bidentata) from the original formula, replacing them with Fangfeng (Saposhnikovia divaricata), which is dispersing without causing dryness and dispelling wind and releasing the exterior. It adds Dioscorea opposita and Atractylodes macrocephala to invigorate qi, strengthen the spleen, and regulate the middle jiao; Rehmannia glutinosa to clear heat, nourish yin, and generate fluids; Smilax glabra, Alisma plantago-aquatica, Coix lacryma-jobi, and corn silk to invigorate the spleen, dry dampness, promote diuresis, and clear heat; Crataegus pinnatifida to harmonize the spleen and stomach; and Nelumbo nucifera and Chrysanthemum morifolium to clear heat, resolve dampness, and promote the rise of clear yang. Astragalus membranaceus and Dioscorea opposita are the chief herbs, which together invigorate qi, strengthen the spleen, and benefit the kidneys. Phellodendron amurense and Atractylodes lancea are the assistant herbs. Phellodendron amurense is bitter and cold, clearing heat and drying dampness, and is good at clearing damp-heat in the lower jiao; Atractylodes lancea is pungent and dispersing, bitter and warm, and dries dampness, entering the middle jiao (spleen and stomach) to dry dampness and turbidity to strengthen the spleen. The combination of these two herbs, one warm and one cold, counteracts and complements each other, clearing damp-heat in the middle and lower jiao to strengthen the spleen qi. Atractylodes macrocephala, Smilax glabra, Rehmannia glutinosa, Saposhnikovia divaricata, Alisma plantago-aquatica, Coix lacryma-jobi, Crataegus pinnatifida, Ne The ten auxiliary herbs enhance the effects of the principal and assistant herbs in clearing heat and removing dampness, resolving turbidity and promoting diuresis, while also nourishing yin and tonifying the kidneys, harmonizing the spleen and stomach, and promoting qi circulation and dispersing blood stasis. Licorice root serves as the guiding herb, tonifying the spleen and replenishing qi, clearing heat and detoxifying, and harmonizing the effects of the other herbs. Together, these herbs work synergistically to tonify qi and regulate the middle jiao, strengthen the spleen and kidneys, resolve dampness and turbidity, and nourish yin and clear heat.

[0025] Another objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating adolescent hyperplasia (HUA).

[0026] Preferably, the drug further includes a drug-acceptable carrier and excipients.

[0027] Preferably, the dosage form of the drug includes decoction, granules, tablets, capsules, or oral liquid.

[0028] Another object of the present invention is to provide a pharmaceutical preparation for treating hyperuricemia in adolescents, wherein the pharmaceutical preparation uses the above-mentioned traditional Chinese medicine composition or an extract of the traditional Chinese medicine composition as the active ingredient.

[0029] Preferably, the pharmaceutical preparation further includes a pharmaceutically acceptable carrier and excipients.

[0030] Preferably, the dosage form of the pharmaceutical preparation includes decoction, granules, tablets, capsules, or oral liquid.

[0031] The beneficial effects of this invention are: 1. The formulation of the traditional Chinese medicine composition of this invention is rationally designed. Combined with a large number of clinical application studies and animal experimental studies, it has been confirmed that it has the effects of replenishing qi and regulating the middle jiao, strengthening the spleen and benefiting the kidneys, promoting diuresis and eliminating turbidity, nourishing yin and clearing heat, so as to achieve the purpose of safely and effectively lowering uric acid.

[0032] 2. Clinical efficacy studies on adolescent HUA patients before and after treatment with the herbal composition of this invention show that the herbal composition of this invention can safely reduce the blood uric acid level of patients, simultaneously improve the chronic inflammatory state of adolescents, and effectively alleviate clinical symptoms.

[0033] 3. Through the establishment of a juvenile-like HUA mouse model, concurrent animal experiments showed that the model mice exhibited metabolic dysfunction, kidney stones, kidney atrophy, and elevated levels of acute and chronic kidney damage. After intervention with the herbal composition of this invention via gavage, metabolic dysfunction and kidney damage could be improved.

[0034] 4. Compared with current clinical uric acid-lowering drugs, this application uses a variety of medicinal and edible materials, which are safer for adolescents. Furthermore, by preparing it into a modern Chinese medicine preparation, it is convenient to mix and take clinically, and the quality is controllable, making it suitable for large-scale industrial production. Attached Figure Description

[0035] Figure 1 This is a schematic diagram illustrating the changes in serum uric acid levels in mice during Experiment Example 1. Figure 2 This is a schematic diagram showing the changes in creatinine levels in mice in Experiment Example 1. Figure 3 This is a schematic diagram illustrating the changes in blood urea nitrogen levels in mice during Experiment Example 1. Figure 4 This is a schematic diagram illustrating the changes in TNF-α levels in mice during Experiment Example 1. Figure 5This is a schematic diagram illustrating the changes in IL-6 levels in mice during Experiment Example 1. Figure 6 This is a schematic diagram showing the changes in IL-1β levels in mice in Experiment Example 1; Figure 7 The results of HE and Masson staining of the kidneys of HUA mice in Experiment Example 1; Figure 8 The results of staining for kidney-related markers in HUA mice in Experiment Example 1; Detailed Implementation The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the 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.

[0036] Example 1 A traditional Chinese medicine composition for treating adolescent hyperplasia (HUA) comprises the following components in parts by weight: Astragalus membranaceus 1.5 parts, Dioscorea opposita 2 parts, Atractylodes lancea 1 part, Phellodendron chinense 1 part, Rehmannia glutinosa 1 part, Smilax glabra 2 parts, Alisma plantago-aquatica 2 parts, Crataegus pinnatifida 1 part, Zea mays 1 part, and Glycyrrhiza uralensis 0.5 parts. It is prepared using the following steps: weigh each raw material and soak the herbs in cold water for 30 minutes; bring to a boil over high heat, then simmer over low heat for 40 minutes, and filter the liquid; add water again for a second decoction, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter the liquid. Combine the two decoctions and concentrate to a specified volume; 1g of solution contains 2.5g of raw herbs.

[0037] Example 2 A traditional Chinese medicine composition for treating adolescent hyperplasia (HUA) comprises the following components in parts by weight: Astragalus membranaceus 1.5 parts, Dioscorea opposita 2 parts, Atractylodes lancea 1 part, Phellodendron chinense 1 part, Atractylodes macrocephala 1 part, Rehmannia glutinosa 1 part, Smilax glabra 2 parts, Saposhnikovia divaricata 1 part, Alisma plantago-aquatica 2 parts, Coix lacryma-jobi 2 parts, Crataegus pinnatifida 1 part, Nelumbo nucifera leaf 1 part, Zea mays silk 1 part, Chrysanthemum morifolium 1 part, and Glycyrrhiza uralensis 0.5 parts.

[0038] The preparation process involves the following steps: Weighing each raw material and soaking the herbs in cold water for 30 minutes, bringing to a boil over high heat, then simmering over low heat for 40 minutes, and filtering out the liquid; adding water again for a second decoction, bringing to a boil over high heat, then simmering over low heat for 30 minutes, and filtering out the liquid. Combining the two decoctions, the mixture is concentrated to the specified volume, with 1g of solution containing 2.5g of raw herbs.

[0039] Experimental Example 1 This experimental example uses a juvenile-like HUA mouse model to preliminarily explore the possible mechanism by which the composition of the present invention improves kidney injury caused by HUA in adolescents.

[0040] Forty 4-week-old clean-grade male ICR mice were randomly divided into four groups of 10 mice each: a control group, a HUA group, a Western medicine group (HUA modeling + febuxostat treatment group (20 mg / kg)), and a traditional Chinese medicine group (HUA modeling + treatment group of Example 1). After one week of acclimatization feeding, starting from week 5, the mice were administered the following medications by gavage at 8:00 AM daily to establish the HUA model (using 5% sterile sodium carboxymethyl cellulose solution to suspend potassium oxonate and ethambutol hydrochloride tablets; the control group received an equal volume of physiological saline by gavage). At 6:00 PM daily, the control group and the HUA model group were administered physiological saline by gavage, while the other groups received the corresponding medications by gavage for 21 consecutive days. The mice were kept on a fasting diet but allowed free access to water before, on day 10, and on day 21 of gavage. Two hours after administration, blood was collected from the subclavian vein, centrifuged at 4000 r / min at 4 ℃ for 10 min, and the supernatant was collected and stored at -80 ℃ for analysis. On day 21 after gavage, the total weight of the mice was measured. Blood was collected, and the mice were euthanized. Both kidneys were harvested and weighed to calculate the renal index [Organ Index = (Organ weight / Final body weight) × 100]. One kidney was demembranous, and the middle portion was fixed in 4% paraformaldehyde for histopathological observation. The other kidney was used to extract RNA and protein for subsequent experiments. All procedures were performed on ice. The gavage dose for each group was 0.2 mL / 20 g (body weight).

[0041] Animal experiments used the concentrated decoction prepared in Example 1, administered at a dosage per kilogram of body weight. The specific daily dosage per kilogram of body weight was as follows: Astragalus membranaceus 0.3g, Dioscorea opposita 0.4g, Atractylodes lancea 0.2g, Phellodendron chinense 0.2g, Rehmannia glutinosa 0.2g, Smilax glabra 0.4g, Alisma plantago-aquatica 0.4g, Crataegus pinnatifida 0.2g, Zea mays 0.2g, and Glycyrrhiza uralensis 0.1g. Cell experiments used a lyophilized powder of the traditional Chinese medicine composition dissolved in a culture medium. The compound containing the above ten herbs was soaked in cold water for 30 minutes, brought to a boil over high heat, then simmered over low heat for 40 minutes, and the liquid was filtered out. Water was added again for a second decoction, brought to a boil over high heat, then simmered over low heat for 30 minutes, and the liquid was filtered out again. The two decoctions were combined and concentrated to the specified volume; 1g of solution contained 2.5g of raw herbs.

[0042] The effects of the traditional Chinese medicine composition of the present invention on the body weight of mice are shown in Table 1. Starting from day 21, compared with the blank group, the body weight of HUA mice began to decrease significantly. Through treatment in Example 1 or treatment with Western medicine uric acid-lowering drugs, the body weight of HUA mice was significantly improved (p<0.001).

[0043] Table 1. Effects of Experiment 1 on mouse body weight

[0044] The effects of Experiment 1 on serum uric acid, creatinine, blood urea nitrogen, and inflammatory markers such as TNF-α, IL-6, and IL-1β in mice are shown in the figure. Figure 1-6As shown in the figure, serum uric acid, creatinine, blood urea nitrogen, and inflammatory factors IL-1β, TNF-α, and IL-6 were significantly elevated in HUA mice. These indicators were significantly improved after treatment with the drug of this invention.

[0045] Figure 7-8 This demonstrates the effects of drug treatment on the kidneys of mice. Figure 7 The images show HE and Masson staining results of kidney pathology in HUA mice. The figures show RTECs edema and renal tubular dilation, while Masson trichrome staining results show a significant increase in collagen fibers. Figure 8 IHC staining results showed significantly increased expression of acute kidney injury markers NGAL and immunoglobulin IgG, decreased expression of apoptosis proteins Caspase-3 and E-Cadherin, and significantly increased expression of α-SMA and the proliferation index Ki67. This indicates that the traditional Chinese medicine composition of the present invention has significant therapeutic effects.

[0046] Experimental Example 2 This study included adolescents with hyperuricemia who visited our hospital between December 2023 and April 2026. Patients were randomly assigned to either a treatment observation group or a control group (the control group received treatment with a traditional Chinese medicine combination, while the control group received lifestyle intervention therapy; one course of treatment lasted 14 days). Basic information and physical examination results were collected from both groups. Based on the WHO expert group report Adolescent Health Measurement (2022), adolescents were defined as aged 12-18 years, and both groups included males.

[0047] The clinical trial used the concentrated decoction prepared in Example 2, which was administered according to the proportion of body weight per kilogram. The specific daily dosage per kilogram of body weight was as follows: Astragalus membranaceus 0.3g, Dioscorea opposita 0.4g, Atractylodes lancea 0.2g, Phellodendron chinense 0.2g, Atractylodes macrocephala 0.2g, Rehmannia glutinosa 0.2g, Smilax glabra 0.4g, Saposhnikovia divaricata 0.2g, Alisma plantago-aquatica 0.4g, Coix lacryma-jobi 0.4g, Crataegus pinnatifida 0.2g, Nelumbo nucifera leaf 0.2g, Zea mays 0.2g, Chrysanthemum morifolium 0.2g, and Glycyrrhiza uralensis 0.1g.

[0048] The preparation method is as follows: Weigh all raw materials and soak the herbs in cold water for 30 minutes. Bring to a boil over high heat, then simmer over low heat for 40 minutes. Filter the liquid. Add water again and decoct a second time, bringing to a boil over high heat, then simmering over low heat for 30 minutes. Filter the liquid again. Combine the two decoctions and concentrate to the specified volume; 1g of solution contains 2.5g of raw herbs.

[0049] Analysis results indicate: 1. Efficacy evaluation: Markedly effective: Serum uric acid levels decreased by 25% or more compared to before treatment or approached normal levels; clinical symptoms were significantly relieved, such as a marked reduction in joint pain and swelling; and the frequency of gout attacks was significantly reduced or ceased. Effective: Serum uric acid levels decreased by 15% compared to before treatment; clinical symptoms were somewhat relieved; joint pain and swelling were somewhat reduced; and the frequency of gout attacks was somewhat reduced. Ineffective: Serum uric acid levels increased compared to before treatment; symptoms and signs showed no significant improvement, or even worsened compared to before.

[0050] The total effective rate of the Jianpi Jiangsuan Decoction group was 93.48%, while that of the lifestyle intervention group was 23.26%. Chi-square test showed a significant difference in the total effective rate between the Jianpi Jiangsuan Decoction group and the lifestyle intervention group (P<0.01). (See Table 2-6 for details).

[0051] Table 2. Baseline comparison of patients before treatment with Jianpi Jiangsuang (a traditional Chinese medicine formula) and before lifestyle intervention.

[0052] Table 3. Comparison of serum uric acid, liver function, kidney function, and blood lipid levels in patients before and after treatment with Jianpi Jiangsuang (a traditional Chinese medicine formula).

[0053] Table 4. Comparison of serum uric acid, liver function, kidney function, and blood lipid levels before and after lifestyle intervention.

[0054] Table 5. Comparison of serum uric acid, liver function, kidney function, and blood lipid levels between patients treated with Jianpi Jiangsuang and those treated with lifestyle intervention.

[0055] Table 6 Comparison of overall treatment efficacy among patients

[0056] Note: Based on the chi-square test, compared with the lifestyle intervention group, * P=0.003<0.05 At a significance level of α=0.05, there was a statistically significant difference in the total effective rate between the Jianpi Jiangsuan group and the lifestyle intervention group.

[0057] 2. Adverse reactions and safety analysis: No obvious side effects or adverse reactions were observed in patients treated with Jianpi Jiangsuan Decoction.

[0058] In summary, the above embodiments are merely illustrative examples of preferred embodiments of the present invention and do not encompass all aspects of the invention. Those skilled in the art can make various modifications and refinements without departing from the spirit and scope of the present invention; therefore, the scope of protection of the present invention is defined by the claims.

Claims

1. A traditional Chinese medicine composition for treating hyperuricemia in adolescents, characterized in that, It includes the following components by weight: Astragalus membranaceus 1-1.5 parts, Dioscorea opposita 1-3 parts, Phellodendron chinense 0.5-1 part, Atractylodes lancea 1 part, Atractylodes macrocephala 0-1 part, Rehmannia glutinosa 1 part, Smilax glabra 2-3 parts, Saposhnikovia divaricata 0.5-1 part, Alisma plantago-aquatica 1-2 parts, Coix lacryma-jobi 1-3 parts, Crataegus pinnatifida 1 part, Nelumbo nucifera leaf 1-1.5 parts, Zea mays 1-3 parts, Chrysanthemum morifolium 0.5-1 part, and Glycyrrhiza uralensis 0.5-1 part.

2. The traditional Chinese medicine composition for treating hyperuricemia in adolescents according to claim 1, characterized in that, It includes the following components by weight: Astragalus membranaceus 1-1.5 parts, Dioscorea opposita 1-3 parts, Phellodendron chinense 0.5-1 part, Atractylodes lancea 1 part, Atractylodes macrocephala 1 part, Rehmannia glutinosa 1 part, Smilax glabra 2-3 parts, Alisma plantago-aquatica 1-2 parts, Coix lacryma-jobi 1-3 parts, Crataegus pinnatifida 1 part, Nelumbo nucifera leaf 1-1.5 parts, Zea mays 1-3 parts, and Glycyrrhiza uralensis 0.5-1 part.

3. The traditional Chinese medicine composition for treating hyperuricemia in adolescents according to claim 1, characterized in that, It includes the following components by weight: Astragalus membranaceus 1-1.5 parts, Dioscorea opposita 1-3 parts, Phellodendron chinense 0.5-1 part, Atractylodes lancea 1 part, Atractylodes macrocephala 0-1 part, Rehmannia glutinosa 1 part, Smilax glabra 2-3 parts, Alisma plantago-aquatica 1-2 parts, Crataegus pinnatifida 1 part, Zea mays 1-3 parts, and Glycyrrhiza uralensis 0.5-1 part.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating hyperuricemia in adolescents.

5. The application according to claim 4, characterized in that, The drug also includes drug-acceptable carriers and excipients.

6. The application according to claim 4, characterized in that, The dosage forms of the drug include decoctions, granules, tablets, capsules, or oral liquids.

7. A pharmaceutical preparation for treating hyperuricemia in adolescents, characterized in that, The pharmaceutical preparation uses the above-mentioned traditional Chinese medicine composition or extract of the traditional Chinese medicine composition as its active ingredient.

8. The pharmaceutical preparation according to claim 7, characterized in that, The pharmaceutical preparation also includes pharmaceutically acceptable carriers and excipients.

9. The pharmaceutical preparation according to claim 7, characterized in that, The dosage forms of the pharmaceutical preparations include decoctions, granules, tablets, capsules, or oral liquids.

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