Traditional Chinese medicine preparation for damp-heat accumulation type WD children's lipid metabolism disorder and preparation method of traditional Chinese medicine preparation

Abstract

The invention discloses a traditional Chinese medicine preparation for damp-heat accumulation type WD children lipid metabolism disorder and a preparation method thereof, and relates to the field of traditional Chinese medicine preparations. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 500 to 1000 parts of herba hedyotidis diffusae, 300 to 600 parts of herba artemisiae scopariae, 300 to 600 parts of lotus leaves, 200 to 400 parts of rhizoma imperatae, 200 to 400 parts of herba taraxaci, 200 to 400 parts of poria cocos and 150 to 350 parts of rhizoma atractylodis macrocephalae. The invention aims to evaluate the influence of the traditional Chinese medicine preparation on related indexes of serum lipid metabolism and liver fatty degeneration of damp-heat type WD children, and provides a clinical basis for early standardized treatment of the disease. The traditional Chinese medicine preparation improves the life quality of WD child patients by adjusting lipid metabolism and the in-vivo damp-heat state, effectively delays disease progression and has important clinical application value. According to the invention, a new thought and method are expected to be provided for comprehensive treatment of damp-heat accumulation type WD children patients.

Description

Technical Field

[0001] The present invention relates to the field of Chinese medicine preparations, and in particular to a Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type and a preparation method thereof. Background Art

[0002] Wilson disease (WD) is a hereditary copper metabolism disorder caused by ATP7B gene mutation. Clinical manifestations include decreased synthesis of serum ceruloplasmin (CP) and impaired biliary copper excretion, which leads to the deposition of copper ions in the liver, brain, kidneys, cornea, and other parts. Abnormal lipid metabolism is one of the common clinical symptoms of WD. Excessive copper deposition in the liver leads to disordered regulation of the lipid metabolism network, accumulation of free fatty acids, free cholesterol, and other substances in the liver, and induces fatty degeneration of the liver under multiple pathways such as oxidative stress and lipid peroxidation, causing organelle dysfunction and even cell death. Long-term repair processes can lead to diffuse proliferation of liver fibrosis, which in turn causes liver inflammation, necrosis, fibrosis, and even cirrhosis. In traditional Chinese medicine theory, "damp-heat accumulation" refers to excessive damp-heat evil in the body, which leads to liver and spleen dysfunction and hinders normal physiological functions. Common symptoms of this state include indigestion and fat absorption disorders, which are closely related to abnormal lipid metabolism. In patients with damp-heat accumulation type WD, the occurrence of abnormal lipid metabolism increases the risk of liver fibrosis.

[0003] At present, heavy metal chelators (such as penicillamine, trientine and sodium dithiocarbamide sulfonate) are commonly used clinical drugs for WD patients. However, as the duration of medication increases, these copper-removing drugs may cause a variety of adverse reactions, such as loss of appetite, nausea, vomiting and other gastrointestinal reactions, allergic reactions, dizziness, headache, palpitations, leukopenia or thrombocytopenia, and aplastic anemia; some patients may also develop immune diseases such as systemic lupus erythematosus, myasthenia gravis and nephritis-pulmonary hemorrhage syndrome. These side effects make it difficult for most patients to undergo long-term maintenance treatment, thus affecting the quality of life and survival of WD patients.

[0004] Children and adolescents are the main groups of patients with WD caused by internal damp-heat syndrome. As the physiological structure and immune function of individuals in this age group are still in the development stage, long-term medication may cause significant side effects. Therefore, the development of a traditional Chinese medicine preparation that can effectively treat lipid metabolism abnormalities caused by internal damp-heat syndrome and take into account the safety of children has become an urgent problem to be solved in this field. Summary of the invention

[0005] In order to solve the problems of the prior art, the present invention provides a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type and a preparation method thereof. The present invention uses Hedyotis diffusa and Artemisia capillaris as the main medicines, which have the effects of clearing heat and dampness, expelling copper and detoxifying; lotus leaf, Imperata root and dandelion are the assistant medicines, which play the role of clearing turbidity and reducing lipids and clearing heat and promoting diuresis; Atractylodes macrocephala and Poria cocos are the adjuvants, which aim to harmonize the spleen and stomach and coordinate the efficacy of the medicines; the synergistic effect of multiple traditional Chinese medicines jointly realizes the functions of clearing heat and dampness, expelling copper and detoxifying, and clearing turbidity and reducing lipids. Specifically, the technical scheme of the present invention includes the following contents:

[0006] One of the purposes of the present invention is to provide a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat type WD, the traditional Chinese medicine preparation comprising the following traditional Chinese medicine raw materials in parts by weight: 500-1000 parts of Hedyotis diffusa, 300-600 parts of Artemisia capillaris, 300-600 parts of lotus leaves, 200-400 parts of Imperata root, 200-400 parts of Taraxacum, 200-400 parts of Poria and 150-350 parts of Atractylodes macrocephala.

[0007] Preferably, the Chinese medicine preparation comprises the following Chinese medicine raw materials in parts by weight: 500 parts of Hedyotis diffusa, 330 parts of Artemisia capillaris, 330 parts of lotus leaves, 266 parts of Imperata rhizome, 266 parts of Taraxacum officinale, 266 parts of Poria cocos and 200 parts of Atractylodes macrocephala.

[0008] The second object of the present invention is to provide a method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type. The preparation method comprises the following steps: according to the formula, 500-1000 parts by weight of Hedyotis diffusa, 300-600 parts by weight of Artemisia capillaris, 300-600 parts by weight of lotus leaf, 200-400 parts by weight of Imperata cylindrica, 200-400 parts by weight of Taraxacum officinale, 200-400 parts by weight of Poria cocos and 150-350 parts by weight of Atractylodes macrocephala are weighed and mixed to obtain a traditional Chinese medicine raw material, water is added for the first decoction, and a first medicinal liquid and a first medicinal residue are obtained after filtering; water is added to the first medicinal residue for the second decoction, and a second medicinal liquid is obtained after filtering; the first medicinal liquid and the second medicinal liquid are combined, and then concentrated to prepare a fluid extract, and a pharmaceutically acceptable excipient is added to the fluid extract to prepare a corresponding dosage form, so as to obtain the traditional Chinese medicine preparation.

[0009] Furthermore, the amount of water used in the first decoction is 12 times the total weight of the Chinese medicinal raw materials.

[0010] Furthermore, the amount of water used in the second decoction is 8 times the total weight of the Chinese medicinal raw materials.

[0011] Furthermore, the temperature of the first decoction is 95-100°C, and the decoction time is 30-60 minutes.

[0012] Preferably, the temperature of the first decoction is 100° C. and the decoction time is 40 minutes.

[0013] Furthermore, the temperature of the second decoction is 95-100°C, and the decoction time is 30-60 minutes.

[0014] Preferably, the temperature of the second decoction is 100° C. and the decoction time is 40 minutes.

[0015] Furthermore, the density of the fluid extract is 1.15-1.25 g / mL.

[0016] Furthermore, the auxiliary material is dextrin.

[0017] Furthermore, the dosage form is a granular preparation.

[0018] The third purpose of the present invention is to provide a Chinese medicine preparation for treating abnormal lipid metabolism in children with WD of internal damp-heat type, and to use the preparation in the preparation of a drug for treating abnormal lipid metabolism in children with WD of internal damp-heat type.

[0019] Furthermore, the dosage of the traditional Chinese medicine preparation is 65g per package.

[0020] Furthermore, the Chinese medicine preparation is taken in the form of one packet each morning and evening, and each packet is taken after being brewed with 250 mL of water.

[0021] Furthermore, the treatment cycle of the Chinese medicine preparation is 8 days per course, with a total of 6 courses.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] (1) The present invention provides a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type, which uses Hedyotis diffusa, Artemisia scutellaria, lotus leaf, Imperata root, dandelion, Poria cocos and Atractylodes macrocephala as raw materials, and follows the principle of "monarch, minister, assistant and envoy" in traditional Chinese medicine. In the prescription, Hedyotis diffusa and Artemisia scutellaria are monarch drugs, which have the effects of clearing heat and dampness, expelling copper and detoxifying; lotus leaf, Imperata root and dandelion are assistant drugs, which play the role of clearing turbidity and reducing lipids and clearing heat and promoting diuresis; Atractylodes macrocephala and Poria cocos are assistant drugs, which are intended to harmonize the spleen and stomach and coordinate the efficacy of the drugs; the traditional Chinese medicine preparation of the present invention is scientifically compatible, and the combination of various drugs can jointly achieve the functions of clearing heat and dampness, expelling copper and detoxifying, and clearing turbidity and reducing lipids.

[0024] (2) The double water extraction process can effectively retain the active ingredients in the medicinal materials, thereby improving the extraction efficiency.

[0025] (3) The Chinese medicine preparation prepared by the present invention not only has a high concentration, which is convenient for dosage control and absorption, but also has good concentration, which further improves the effectiveness of use.

[0026] (4) The Chinese medicine preparation prepared by the present invention is easy to carry and take due to its convenience, convenient to use, and suitable for different groups of people.

[0027] (5) The density of the Chinese medicine preparation prepared by the present invention is controlled between 1.15-1.25 g / mL, which helps to improve the stability of the product and extend the shelf life. DETAILED DESCRIPTION

[0028] The technical solution of the present invention will be clearly and completely described below through the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0029] Unless otherwise specified, the raw materials and reagents used in the present invention are commercially available or can be prepared by known methods.

[0030] Embodiment 1:

[0031] A method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type, comprising the following steps:

[0032] Weigh 500g of Hedyotis diffusa, 330g of Artemisia capillaris, 330g of lotus leaf, 260g of Imperata root, 266g of Taraxacum officinale, 266g of Poria cocos and 200g of Atractylodes macrocephala to obtain a Chinese medicine raw material, add water, the amount of water is 12 times the total weight of the Chinese medicine raw material, decoct for 40min in an environment of 100°C, and obtain a first medicinal liquid and a first medicinal residue after filtering; add water to the first medicinal residue, the amount of water is 8 times the total weight of the Chinese medicine raw material, decoct for 40min in an environment of 100°C, and obtain a second medicinal liquid after filtering; combine the first medicinal liquid and the second medicinal liquid, and then concentrate to prepare a fluid extract with a density of 1.20g / mL, add dextrin to the fluid extract, make granules, and obtain a Chinese medicine preparation.

[0033] Embodiment 2:

[0034] A method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type, comprising the following steps:

[0035] Weigh 800g of Hedyotis diffusa, 300g of Artemisia capillaris, 300g of lotus leaf, 200g of Imperata root, 200g of Taraxacum officinale, 200g of Poria cocos and 150g of Atractylodes macrocephala to obtain a Chinese medicine raw material, add water, the amount of water is 12 times the total weight of the Chinese medicine raw material, decoct for 60min in a 95°C environment, and obtain a first medicinal liquid and a first medicinal residue after filtering; add water to the first medicinal residue, the amount of water is 8 times the total weight of the Chinese medicine raw material, decoct for 60min in a 95°C environment, and obtain a second medicinal liquid after filtering; combine the first medicinal liquid and the second medicinal liquid, and then concentrate to prepare a fluid extract with a density of 1.15g / mL, add dextrin to the fluid extract, make granules, and obtain a Chinese medicine preparation.

[0036] Embodiment 3:

[0037] A method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type, comprising the following steps:

[0038] Weigh 1000g of Hedyotis diffusa, 600g of Artemisia capillaris, 600g of lotus leaf, 400g of Imperata root, 400g of Taraxacum officinale, 400g of Poria cocos and 350g of Atractylodes macrocephala to obtain a Chinese medicine raw material, add water, the amount of water is 12 times the total weight of the Chinese medicine raw material, decoct for 30 minutes at 97°C, and obtain a first medicinal liquid and a first medicinal residue after filtering; add water to the first medicinal residue, the amount of water is 8 times the total weight of the Chinese medicine raw material, decoct for 30 minutes at 97°C, and obtain a second medicinal liquid after filtering; combine the first medicinal liquid and the second medicinal liquid, and then concentrate to prepare a fluid extract with a density of 1.25g / mL, add dextrin to the fluid extract, prepare granules, and obtain a Chinese medicine preparation.

[0039] Application examples:

[0040] A method for using a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type, specifically comprising the following steps:

[0041] The Chinese medicine preparation prepared in Example 1 was packaged into 65g packages, and the patient took one package each morning and evening, and each package was added with 250mL of water for brewing before taking. The treatment cycle was 8 days for one course of treatment, and a total of 6 courses of treatment were given.

[0042] Clinical trials:

[0043] A total of 120 children who were admitted to the Brain Disease Center of the First Affiliated Hospital of Anhui University of Chinese Medicine and diagnosed with "abnormal WD lipid metabolism" and "endogenous damp-heat syndrome" (diagnostic criteria) were selected as the research subjects. To ensure the randomness and reliability of the study, 120 numbers were randomly generated using SPSS23.0 software, and random number cards were filled in and sealed in opaque envelopes. According to the children's visit time, they were included in the observation group and the control group in turn, with 60 cases in each group; to ensure the objectivity and scientificity of the study, the treatment operators and children were not blinded, and the indicator evaluators and data statistical analysts were blinded until the data statistical analysis was completed and the quality control personnel broke the blind.

[0044] 1. Western medicine diagnostic criteria:

[0045] (1) The Western medicine diagnostic criteria for WD are formulated in accordance with the Guidelines for the Diagnosis and Treatment of Hepatolenticular Degeneration with Integrated Traditional Chinese and Western Medicine (2023 Edition): ① Family history; ② History of liver disease or liver disease signs / extrapyramidal symptoms and signs; ③ KF rings confirmed by naked eye or slit lamp; ④ Serum ceruloplasmin or copper oxidase activity levels are significantly reduced and / or liver copper is increased; ⑤ Urine copper>100μg / 24h (>1.6μmol / 24h); ⑥ Liver copper>250μg / g (dry weight). Those who meet the above ①-③ or ①-④ items can be diagnosed with WD.

[0046] (2) The Western medicine diagnostic criteria for dyslipidemia in children were formulated in accordance with the Expert Consensus on the Prevention and Treatment of Dyslipidemia in Children and Adolescents: ①TG ≥ 1.70 mmol·L -1 ;②TC≥5.18mmol·L -1 ; ③LDL-C ≥ 3.37mmol·L -1 ④HDL-C≤1.04mmol·L -1 Children aged 2 years and above only need to meet any of the above requirements.

[0047] 2. TCM syndrome diagnostic criteria:

[0048] Syndrome of internal accumulation of damp-heat: Main symptoms: slurred speech, trembling limbs, abdominal distension and fullness, poor appetite; Secondary symptoms: heaviness in the head and body, dull complexion, dry mouth, yellow body and eyes, short and dark urine, dry and hard stools; Tongue and pulse: red tongue or red, yellow and greasy tongue coating, slippery and rapid pulse.

[0049] 3. Inclusion criteria:

[0050] (1) Meet the diagnostic criteria for WD and dyslipidemia in children and be aged 5 ≤ ≤ 12 years;

[0051] (2) No formal copper removal treatment was received in the 2 weeks before the visit, and no lipid-lowering or lipid metabolism-affecting drugs were used;

[0052] (3) The child and his / her guardian agree to participate voluntarily and the guardian signs the informed consent form on the child's behalf.

[0053] 4. Exclusion criteria:

[0054] (1) Patients with abnormal liver function caused by diseases such as autoimmune hepatitis and viral hepatitis;

[0055] (2) Patients with other metabolic diseases;

[0056] (3) Those who are allergic to the study drugs.

[0057] 5. Elimination criteria:

[0058] (1) Poor compliance;

[0059] (2) Failure to take medication as prescribed or changing treatment regimen during the trial;

[0060] (3) Failure to conduct a timely follow-up examination at the end of the treatment, resulting in incomplete relevant data and making it impossible to judge the efficacy and safety.

[0061] 6. Treatment methods:

[0062] Children in the control group received dithiopropane sulfonate sodium [DMPS, Shanghai Hefeng Pharmaceutical Co., Ltd., national medicine standard H31021514, 0.125 mg (2 mL) -1 ] Treatment, the specific treatment plan is to dissolve DMPS at a dose of 20 mg / kg in 250 mL or 500 mL of 5% glucose injection, once a day, by slow intravenous drip, after 6 consecutive days of treatment, enter a 2-day interval, during the interval, give 10% calcium gluconate injection (Sichuan Meida Kanghuakang Pharmaceutical, National Medicine Standard No. H51023153, 10 mL·g -1 )20mL, the treatment cycle is 8 days per course, and a total of 6 courses of treatment. In addition, throughout the treatment process, patients need to follow the low-copper and high-protein diet guidance.

[0063] On the basis of the treatment plan for the children in the control group, the patients in the observation group additionally took the Chinese medicine preparation prepared in Example 1 of the present invention for treatment. Each package of the Chinese medicine preparation was 65 g, and the children took one package each morning and evening. Each package was added with 250 mL of water for brewing and then taken. The treatment cycle was 8 days for one course of treatment, and a total of 6 courses of treatment were given.

[0064] 7. Observation indicators:

[0065] (1) TCM syndrome scoring: referring to the TCM syndrome scoring method in the Guiding Principles for Clinical Research of New Chinese Medicines, symptoms are divided into four levels: none, mild, moderate, and severe. The main symptoms are scored as 0, 2, 4, and 6 points respectively, and the secondary symptoms are scored as 0, 1, 2, and 3 points respectively. The full score is 42 points.

[0066] (2) Clinical efficacy: Referring to the efficacy judgment criteria in the Guiding Principles for Clinical Research of New Chinese Medicines, a reduction of ≥70% in the TCM syndrome score was considered significant efficacy; a reduction of ≥30% was considered effective; and a reduction of <30% was considered ineffective. The total effective rate of this study = (number of significant efficacy cases + number of effective cases) / total number of cases × 100%.

[0067] (3) Serum lipid metabolism indicators: triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and free fatty acids (FFA). These indicators were detected using Hitachi 7600-120 / ISE fully automatic biochemical analyzer.

[0068] (4) Hepatic fatty degeneration index: ① HSI: The calculation formula is HSI = 8 × ALT (U·L -1 ) / AST(U·L -1 )+BMI (kg·m -2 )(+2, if female; +2, if diabetic); ②UDFF: Siemens Acuson Sequoia ultrasound diagnostic instrument was used, with a probe frequency of 1.0MHz to 5.7MHz; during the examination, the patient was in a supine position with the right arm raised to fully expose the examination area; first, a B-mode image of the liver was acquired, and the patient was asked to breathe calmly, then hold his breath for 3s to 5s, and the UDFF mode was started for measurement; during the process, large blood vessels or focal lesions in the liver should be avoided, and a region of interest (ROI) was vertically drawn 1 to 2cm away from the liver capsule. Click "Update" to obtain the UDFF value. Each patient underwent 5 UDFF measurements, and the average value was expressed.

[0069] Experimental Example 1: Comparison of TCM Syndrome Scores

[0070] Table 1. Comparison of TCM syndrome scores between the two groups before and after treatment

[0071]

[0072] Note: Compared with the same group before treatment, * P<0.05; compared with the control group, # P<0.05.

[0073] As shown in Table 1, there was no significant difference in the TCM syndrome scores between the two groups before treatment (P>0.05); compared with before treatment, the TCM syndrome scores of the two groups of children decreased significantly after treatment (P<0.05); compared between the two groups after treatment, the decrease in the observation group was more significant than that in the control group (P<0.05), which indicates that in the treatment of TCM syndrome scores of WD children with endogenous damp-heat type lipid metabolism abnormalities, the therapeutic effect of the Chinese medicine preparation prepared by the present invention is better than that of conventional copper removal treatment.

[0074] Test Example 2: Comparison of clinical efficacy

[0075] Table 2. Comparison of clinical efficacy between the two groups of children (%)

[0076]

[0077] Note: Compared with the control group, # P<0.05.

[0078] As shown in Table 2, the total effective rate of the observation group was 91.7% (55 / 60), and the total effective rate of the control group was 76.6% (46 / 60). The total effective rate of the observation group was significantly higher than that of the control group (P<0.05), which shows that in the clinical efficacy of treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type, the therapeutic effect of the Chinese medicine preparation prepared by the present invention is better than that of conventional copper removal treatment.

[0079] Test Example 3: Comparison of lipid metabolism indicators

[0080] Table 3. Comparison of lipid metabolism indicators between normal children and WD children (mmol·L -1 )

[0081]

[0082] Note: Compared with the normal group, # P<0.05.

[0083] Table 4. Comparison of lipid metabolism indicators between the two groups before and after treatment (mmol·L -1 )

[0084]

[0085] Note: Compared with the same group before treatment, * P<0.05; compared with the control group, # P<0.05.

[0086] As shown in Table 3, compared with the normal group, the TG, TC, and LDL-C levels of children with WD were significantly increased, and the HDL-C level was significantly decreased, and the difference was statistically significant (P<0.05).

[0087] As shown in Table 4, there was no significant difference in lipid metabolism indicators between the two groups before treatment (P>0.05). Compared with those before treatment, the TG, TC and LDL-C levels of the two groups of children were significantly reduced, and the HDL-C level was significantly increased after treatment (P<0.05). Compared with those before treatment, the TG, TC and LDL-C levels of the observation group were more significantly reduced, and the HDL-C level was more significantly increased than those of the control group (P<0.05). This indicates that in terms of the lipid metabolism level of WD children, the therapeutic effect of the Chinese medicine preparation prepared by the present invention is better than that of conventional copper excretion treatment.

[0088] Test Example 4: Comparison of lipoprotein metabolism indicators

[0089] Table 5. Comparison of lipoprotein metabolism indicators between normal children and WD children (mmol·L -1 )

[0090]

[0091]

[0092] Note: Compared with the normal group, # P<0.05.

[0093] Table 6. Comparison of lipoprotein metabolism indicators between the two groups before and after treatment

[0094]

[0095] Note: Compared with the same group before treatment, * P<0.05; compared with the control group, # P<0.05.

[0096] As shown in Table 5 , compared with the normal group, the levels of ApoA1, ApoB, and FFA in children with WD were significantly increased, and the differences were statistically significant (P<0.05).

[0097] As shown in Table 6, there was no significant difference in lipoprotein metabolism indicators between the two groups before treatment (P>0.05); compared with those before treatment, the levels of ApoA1, ApoB and FFA in the two groups were significantly reduced after treatment (P<0.05); compared between the two groups after treatment, the levels of ApoA1, ApoB and FFA in the observation group were more significantly reduced than those in the control group (P<0.05), which indicates that in the treatment of lipoprotein metabolism in WD children, the therapeutic effect of the Chinese medicine preparation prepared by the present invention is better than that of conventional copper excretion treatment.

[0098] Test Example 5: Comparison of liver fatty degeneration index HSI

[0099] Table 7. Comparison of HSI between the two groups before and after treatment

[0100]

[0101]

[0102] Note: Compared with the same group before treatment, * P<0.05; compared with the control group, # P<0.05.

[0103] As shown in Table 7, there was no significant difference in HSI between the two groups before treatment (P>0.05); compared with before treatment, the HSI scores of the two groups decreased significantly after treatment (P<0.05); compared between the two groups after treatment, the HSI score of the observation group decreased more significantly than that of the control group (P<0.05). The decrease in HSI score proves that the Chinese medicine preparation prepared by the present invention can effectively reduce the degree of liver fatty degeneration in WD children, and the effect is better than conventional copper removal treatment.

[0104] Test Example 6: Comparison of liver fatty degeneration index UDFF

[0105] Table 8. Comparison of UDFF between the two groups before and after treatment

[0106]

[0107] Note: Compared with the same group before treatment, * P<0.05; compared with the control group, # P<0.05.

[0108] As shown in Table 8, there was no significant difference in UDFF between the two groups before treatment (P>0.05); compared with before treatment, the UDFF scores of the two groups decreased significantly after treatment (P<0.05); after treatment, the UDFF scores of the observation group decreased more significantly than those of the control group (P<0.05). The decrease in UDFF indicated by the results of ultrasound imaging can effectively reduce the degree of fatty degeneration of the liver in WD children, and the effect is better than conventional copper removal treatment.

[0109] In summary, the Chinese medicine preparation prepared by the present invention can be used to treat WD children with abnormal lipid metabolism and has a good therapeutic effect. At the same time, the present invention systematically evaluates serological indicators and ultrasound imaging on children with abnormal lipid metabolism of WD, and studies the therapeutic effect of the Chinese medicine preparation prepared by the present invention on them, thereby forming an objective evaluation of abnormal lipid metabolism in WD children, providing a basis for standardized clinical treatment, and having very important clinical significance for improving the prognosis of patients.

[0110] The above-described embodiments provide a detailed description of the technical solutions and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected.

Claims

1. A Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat WD, characterized in that: The traditional Chinese medicine preparation comprises the following traditional Chinese medicine raw materials in parts by weight: 500-1000 parts of oldenlandia diffusa, 300-600 parts of wormwood, 300-600 parts of lotus leaf, 200-400 parts of Imperata root, 200-400 parts of dandelion, 200-400 parts of Poria and 150-350 parts of Atractylodes macrocephala.

2. A Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat type WD according to claim 1, characterized in that: The traditional Chinese medicine preparation comprises the following traditional Chinese medicine raw materials in parts by weight: 500 parts of oldenlandia diffusa, 330 parts of wormwood, 330 parts of lotus leaf, 266 parts of Imperata rhizome, 266 parts of dandelion, 266 parts of Poria cocos and 200 parts of Atractylodes macrocephala.

3. A method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with WD of endogenous damp-heat type according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: according to a formula, 500-1000 parts by weight of Hedyotis diffusa, 300-600 parts by weight of Artemisia capillaris, 300-600 parts by weight of lotus leaf, 200-400 parts by weight of Imperata cylindrica, 200-400 parts by weight of Taraxacum officinale, 200-400 parts by weight of Poria cocos and 150-350 parts by weight of Atractylodes macrocephala are weighed and mixed to obtain Chinese medicine raw materials, water is added for the first decoction, and a first medicinal liquid and a first medicinal residue are obtained after filtering; water is added to the first medicinal residue for the second decoction, and a second medicinal liquid is obtained after filtering; the first medicinal liquid and the second medicinal liquid are combined, and then concentrated to prepare a fluid extract, and pharmaceutically acceptable excipients are added to the fluid extract to prepare a corresponding dosage form, so as to obtain the Chinese medicine preparation.

4. The method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat type WD according to claim 3, characterized in that: The amount of water used in the first decoction is 12 times the total weight of the Chinese medicinal raw materials, and the amount of water used in the second decoction is 8 times the total weight of the Chinese medicinal raw materials.

5. The method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat type WD according to claim 3, characterized in that: The first decoction takes 30-60 minutes and the decoction temperature is 95-100°C.

6. The method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat type WD according to claim 3, characterized in that: The second decoction time is 30-60 minutes, and the decoction temperature is 95-100°C.

7. The method for preparing a traditional Chinese medicine preparation for treating lipid metabolism abnormalities in children with endogenous damp-heat type WD according to claim 3, characterized in that: The dosage form is a granule preparation.

8. Use of a traditional Chinese medicine preparation for treating abnormal lipid metabolism in WD children with endogenous damp-heat type as claimed in claim 1 or 2, or a traditional Chinese medicine preparation prepared by the method for preparing a traditional Chinese medicine preparation for treating abnormal lipid metabolism in WD children with endogenous damp-heat type as claimed in any one of claims 3 to 7 in preparing a drug for treating abnormal lipid metabolism in WD children with endogenous damp-heat type.

Images