Traditional Chinese medicine composition as well as preparation method and application thereof in prevention and treatment of hyperuricemia

Abstract

The invention discloses a traditional Chinese medicine composition, a preparation method of the traditional Chinese medicine composition and application of the traditional Chinese medicine composition in prevention and / or treatment of hyperuricemia. The traditional Chinese medicine composition is mainly prepared from 5-25 parts of rhizoma pinellinae praeparata, 15-70 parts of malt, 5-25 parts of rhizoma dioscoreae hypoglaucae, 5-25 parts of pericarpium citri reticulatae, 7.5-35 parts of poria cocos, 5-25 parts of caulis bambusae in taeniam, 5-25 parts of rhizoma alismatis, 5-25 parts of fructus aurantii immaturus, 7.5-35 parts of lily, 5-25 parts of cortex phellodendri and 2.5-10 parts of honey-fried licorice root. The traditional Chinese medicine composition is applied to preparation of a medicine for preventing and / or treating hyperuricemia, in particular to prevention and treatment of hyperuricemia caused by antipsychotic drugs. The composition provided by the invention fully embodies the idea of'preventive treatment of diseases' in traditional Chinese medicine, can reduce the worry of patients with mental diseases in the aspect of resisting side effects of psychiatric medicines, and has practicability and important clinical significance.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition, a preparation method thereof, and an application in the prevention and / or treatment of hyperuricemia. Background Art

[0002] Hyperuricemia (HUA) is a metabolic disease characterized by abnormal elevation of blood uric acid level caused by purine metabolism disorder, which can be divided into primary and secondary types. Primary hyperuricemia is mainly caused by reduced uric acid excretion or increased production, while secondary hyperuricemia is caused by certain systemic diseases or taking certain drugs that inhibit uric acid excretion. In addition, eating too much high-purine food may also induce the onset of hyperuricemia.

[0003] Taking antipsychotic drugs (such as olanzapine) will cause metabolic adverse reactions and produce secondary hyperuricemia, which may lead to gout and heart and kidney damage if it persists for a long time. Modern medicine mostly uses uric acid-lowering drugs such as benzbromarone, allopurinol, febuxostat, etc. for treatment, but it may cause allergic reactions such as liver and kidney function damage, diarrhea, headache, nausea or vomiting.

[0004] According to traditional Chinese medicine theory, hyperuricemia belongs to the categories of "phlegm-dampness" and "turbid stasis", and the pathogenesis involves the liver failing to disperse and dredge, the spleen failing to transport and transform, and the kidney qi failing to transform properly, resulting in the accumulation of phlegm-dampness and turbid pathogenic factors. Existing traditional Chinese medicine treatments for hyperuricemia mostly start from regulating the three viscera of the liver, spleen, and kidney, but there are few special prescriptions for hyperuricemia caused by taking antipsychotic drugs. Summary of the Invention

[0005] Based on this, the purpose of the present invention is to provide a traditional Chinese medicine composition, a preparation method thereof, and an application with small side effects that can effectively prevent and / or treat hyperuricemia, especially hyperuricemia caused by taking antipsychotic drugs, and solve the problems of large side effects of existing chemical drugs and insufficient pertinence of traditional Chinese medicine.

[0006] The technical solutions to achieve the above purpose are as follows.

[0007] In the first aspect of the present invention, a traditional Chinese medicine composition is provided. Calculated by weight, the active ingredients of the traditional Chinese medicine composition are prepared from 5-25 parts of Pinelliae Rhizoma Praeparatum, 15-70 parts of Hordei Fructus Germinatus, 5-25 parts of Dioscoreae Hypoglaucae Rhizoma, 5-25 parts of Citri Reticulatae Pericarpium, 7.5-35 parts of Poria, 5-25 parts of Bambusae Caulis in Taeniam, 5-25 parts of Alismatis Rhizoma, 5-25 parts of Aurantii Fructus Immaturus, 7.5-35 parts of Bulbus Lilii, 5-25 parts of Phellodendri Chinensis Cortex, and 2.5-10 parts of Glycyrrhizae Radix Praeparata Cum Melle.

[0008] In some of these embodiments, calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 5 - 20 parts of Pinelliae Rhizoma Praeparatum, 15 - 60 parts of Fructus Hordei Germinatus, 5 - 20 parts of Dioscoreae Hypoglaucae Rhizoma, 5 - 20 parts of Citri Reticulatae Pericarpium, 7.5 - 30 parts of Poria, 5 - 20 parts of Caulis Bambusae in Taeniam, 5 - 20 parts of Alismatis Rhizoma, 5 - 20 parts of Aurantii Fructus Immaturus, 7.5 - 25 parts of Bulbus Lilii, 5 - 20 parts of Phellodendri Chinensis Cortex, and 2.5 - 10 parts of Glycyrrhizae Radix Praeparata Cum Melle.

[0009] In some of these preferred embodiments, calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 10 - 20 parts of Pinelliae Rhizoma Praeparatum, 30 - 50 parts of Fructus Hordei Germinatus, 10 - 20 parts of Dioscoreae Hypoglaucae Rhizoma, 8 - 15 parts of Citri Reticulatae Pericarpium, 10 - 20 parts of Poria, 8 - 15 parts of Caulis Bambusae in Taeniam, 8 - 15 parts of Alismatis Rhizoma, 8 - 15 parts of Aurantii Fructus Immaturus, 10 - 20 parts of Bulbus Lilii, 8 - 15 parts of Phellodendri Chinensis Cortex, and 3 - 8 parts of Glycyrrhizae Radix Praeparata Cum Melle.

[0010] In some of these preferred embodiments, calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 10 - 15 parts of Pinelliae Rhizoma Praeparatum, 30 - 40 parts of Fructus Hordei Germinatus, 10 - 15 parts of Dioscoreae Hypoglaucae Rhizoma, 8 - 15 parts of Citri Reticulatae Pericarpium, 10 - 20 parts of Poria, 8 - 15 parts of Caulis Bambusae in Taeniam, 8 - 15 parts of Alismatis Rhizoma, 8 - 15 parts of Aurantii Fructus Immaturus, 10 - 20 parts of Bulbus Lilii, 8 - 15 parts of Phellodendri Chinensis Cortex, and 3 - 8 parts of Glycyrrhizae Radix Praeparata Cum Melle.

[0011] In some of these more preferred embodiments, calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 10 parts of Pinelliae Rhizoma Praeparatum, 30 parts of Fructus Hordei Germinatus, 10 parts of Dioscoreae Hypoglaucae Rhizoma, 10 parts of Citri Reticulatae Pericarpium, 15 parts of Poria, 10 parts of Caulis Bambusae in Taeniam, 10 parts of Alismatis Rhizoma, 10 parts of Aurantii Fructus Immaturus, 15 parts of Bulbus Lilii, 10 parts of Phellodendri Chinensis Cortex, and 5 parts of Glycyrrhizae Radix Praeparata Cum Melle.

[0012] In some of these more preferred embodiments, calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 20 parts of Pinelliae Rhizoma Praeparatum, 50 parts of Fructus Hordei Germinatus, 20 parts of Dioscoreae Hypoglaucae Rhizoma, 10 parts of Citri Reticulatae Pericarpium, 15 parts of Poria, 10 parts of Caulis Bambusae in Taeniam, 10 parts of Alismatis Rhizoma, 10 parts of Aurantii Fructus Immaturus, 15 parts of Bulbus Lilii, 10 parts of Phellodendri Chinensis Cortex, and 5 parts of Glycyrrhizae Radix Praeparata Cum Melle.

[0013] The second aspect of the present invention is to provide a preparation method of the aforementioned traditional Chinese medicine composition: Weigh Pinelliae Rhizoma Praeparatum, Fructus Hordei Germinatus, Dioscoreae Hypoglaucae Rhizoma, Citri Reticulatae Pericarpium, Poria, Caulis Bambusae in Taeniam, Alismatis Rhizoma, Aurantii Fructus Immaturus, Bulbus Lilii, Phellodendri Chinensis Cortex, and Glycyrrhizae Radix Praeparata Cum Melle according to the proportion, extract with a solvent to obtain an extract, and make a traditional Chinese medicine composition.

[0014] In some of these embodiments, the extract is obtained by decocting with water, extracting 1 - 3 times, 0.5 - 3 hours each time, and combining the extracts.

[0015] In some of these embodiments, the extract is concentrated to a relative density of 1.10 - 1.20 at 60 °C.

[0016] In some embodiments, the Chinese medicine composition is an oral liquid, granules, powder, capsule or tablet.

[0017] The third aspect of the present invention is to provide the use of the aforementioned Chinese medicine composition in the preparation of a medicament for preventing and / or treating hyperuricemia.

[0018] The fourth aspect of the present invention is to provide the use of the aforementioned Chinese medicine composition in the preparation of a drug for preventing and / or treating hyperuricemia caused by antipsychotic drugs.

[0019] Traditional Chinese medicine emphasizes the role of the liver, spleen and kidney in the pathogenesis of hyperuricemia. Hyperuricemia is closely related to diet and constitution. Eating too much rich food or drinking too much alcohol can cause the spleen to lose its function, help dampness and produce phlegm, and phlegm and dampness flow into the body, forming high uric acid. Tang Rongchuan pointed out in "Blood Symptoms and Zangfu Pathogenesis" that "food qi enters the stomach, and it depends entirely on the liver wood qi to dredge it, and then the water and food are transformed." The liver promotes the production and excretion of bile to maintain the normal rise and fall of the spleen and stomach qi to help digestion. If the emotions are not smooth, anger and depression hurt the liver, the liver qi invades the spleen, the spleen loses its function, and phlegm and dampness gather inside, causing hyperuricemia. In addition, the distribution of water in the body depends on the descending of the lungs, the transportation and transformation of the spleen, the qi transformation of the kidneys, and the patency of the triple energizer. The liver is responsible for dredging and regulating the triple energizer qi, so that the triple energizer water channels are smooth and water is easy to flow; in addition, the liver is responsible for dredging and dispersing, and when qi flows, water flows, and when qi flows, blood flows. When the Qi and blood flow smoothly and the meridians are unobstructed, the water flow is also normal, without the risk of stagnation. If the liver fails to release Qi, the Qi will not flow smoothly, the Qi transformation function of the triple burner will be disordered, and the water metabolism will be disordered, phlegm and dampness will accumulate, forming the evil of phlegm and dampness, which will cause hyperuricemia.

[0020] Antipsychotic drugs, especially the new generation of psychiatric drugs, are more likely to have side effects such as metabolic dysfunction and excessive weight gain. Patients taking the drugs often show symptoms or signs such as emotional discomfort, increased appetite, weight gain, tooth marks on the edges of the tongue, and thick and greasy white tongue coating. The key point of diagnosis is always the internal obstruction of phlegm and turbidity, which is basically consistent with the TCM pathogenesis of hyperuricemia.

[0021] Explanation of the formula: The formula of the present invention (hereinafter referred to as Wendan Jiangzhuo Decoction) includes Pinellia ternata (processed), malt, Dioscorea hypoglauca, tangerine peel, Poria cocos, bamboo shavings, Alisma orientale, Fructus Aurantii Immaturus, Lilium brownii, Phellodendron amurense, and roasted licorice root. In the formula, Pinellia ternata (processed) is good at drying dampness and resolving phlegm, and harmonizing the stomach and descending adverse qi; malt promotes qi flow to aid digestion and strengthens the spleen and stimulates the appetite; Dioscorea hypoglauca promotes diuresis and removes dampness, and separates the clear from the turbid, specifically treating the stagnation of damp turbidity. When dampness is removed, phlegm, stasis, etc. are not easily coagulated, and heat is not easily generated and attached to dampness. It is the monarch drug. Bamboo shavings clears heat and resolves phlegm, and tangerine peel regulates qi and promotes qi movement to resolve phlegm; Poria cocos and Alisma orientale mainly promote diuresis and remove dampness, with the intention of promoting uric acid excretion, and both are ministerial drugs. Fructus Aurantii Immaturus is used as an assistant to regulate qi and relieve depression, clear heat and break stagnation, strengthening the effect of promoting qi flow; Lilium brownii is used as an assistant to clear the heart and soothe the mind, relieving the feeling of discomfort due to emotional disharmony; Phellodendron amurense is used as an assistant to dry dampness with bitterness, and is good at removing damp-heat in the lower energizer; roasted licorice root is used as the envoy drug to harmonize various drugs and benefit the spleen and harmonize the middle. This formula together exerts the effects of clearing heat and resolving phlegm, promoting diuresis and reducing turbidity, and is beneficial for preventing and treating hyperuricemia caused by antipsychotic drugs.

[0022] Based on years of clinical experience and in combination with the principle of "resolving phlegm, promoting diuresis and reducing turbidity" in traditional Chinese medicine, the inventor innovatively proposed "Wendan Jiangzhuo Decoction". By regulating the functions of the liver, spleen and kidneys, it together exerts the effects of clearing heat and resolving phlegm, promoting diuresis and reducing turbidity, promoting uric acid excretion, and is used for preventing and / or treating hyperuricemia, especially the adverse reactions such as hyperuricemia caused by taking antipsychotic drugs. It has achieved definite curative effects clinically, with high safety and no significant toxic and side effects. This technology fully embodies the concept of "preventive treatment of disease" in traditional Chinese medicine, can reduce the concerns of psychiatric patients about the side effects of antipsychotic drugs, and has practicality and important clinical significance. Detailed implementation manners

[0023] To facilitate the understanding of the present invention, the present invention will be described more comprehensively below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, these embodiments are provided to make the understanding of the disclosed content of the present invention more thorough and comprehensive.

[0024] The experimental methods without specific conditions indicated in the following embodiments are usually carried out according to conventional conditions or according to the conditions recommended by the manufacturers. All kinds of commonly used chemical reagents used in the embodiments are commercially available products.

[0025] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the description of the present invention are only for the purpose of describing specific embodiments and are not used to limit the present invention. The term "and / or" used in the present invention includes any and all combinations of one or more of the related listed items.

[0026] The present invention will be further described in detail below in combination with specific embodiments.

[0027] Comparative Example 1

[0028] Weigh 10 parts of dried tangerine peel, 15 parts of poria, 10 parts of bamboo shavings, 10 parts of immature bitter orange, 10 parts of phellodendron bark, 10 parts of alisma, 15 parts of lily bulb, and 5 parts of honey-fried licorice root by weight, and prepare the granule by the method of Example 1 below.

[0029] Comparative Example 2

[0030] Weigh 10 parts of pinellia ternata, 10 parts of immature bitter orange, 10 parts of dioscorea hypoglauca, 10 parts of phellodendron bark, 15 parts of lily bulb, 30 parts of germinated barley, and 5 parts of honey-fried licorice root by weight, and prepare the granule by the method of Example 1 below.

[0031] Comparative Example 3

[0032] Weigh 10 parts of pinellia ternata, 10 parts of dried tangerine peel, 15 parts of poria, 10 parts of bamboo shavings, 10 parts of immature bitter orange, 10 parts of dioscorea hypoglauca, 10 parts of phellodendron bark, 10 parts of alisma, 15 parts of lily bulb, and 5 parts of honey-fried licorice root by weight, and prepare the granule by the method of Example 1 below.

[0033] Example 1

[0034] Formulation: Calculated by weight, 10 parts of pinellia ternata, 30 parts of germinated barley, 10 parts of dioscorea hypoglauca, 10 parts of dried tangerine peel, 15 parts of poria, 10 parts of bamboo shavings, 10 parts of alisma, 10 parts of immature bitter orange, 15 parts of lily bulb, 10 parts of phellodendron bark, and 5 parts of honey-fried licorice root.

[0035] Preparation method of Wendan Jiangzhuo Granules:

[0036] (1) Extraction and vacuum concentration: Weigh the drugs according to the ratio, put them into the decocting pot, add water to cover the medicinal materials, soak for 30 min and then decoct for 1 h, collect the medicinal liquid, decoct the medicinal residues twice in the same way, combine the medicinal liquids, and vacuum concentrate to a relative density of 1.10 at 60 °C.

[0037] (2) Spray drying: Centrifugally atomize the concentrated medicinal liquid at high speed, with a drying time of 5 seconds, and the moisture evaporates instantly in the drying tower to obtain the traditional Chinese medicine extract powder.

[0038] (3) Dry pressing and granulation: Utilize the inherent viscosity of the traditional Chinese medicine extract powder, and prepare the granule through the processes of tabletting, cutting, and sizing. Press directly into granules without adding excipients, and the granules are uniform and have the same color.

[0039] (4) Packaging: Pack the granules prepared above into packaging bags to obtain Wendan Jiangzhuo Granules, 30 g per bag.

[0040] Example 2

[0041] Formulation: Calculated by weight, 20 parts of pinellia ternata, 50 parts of germinated barley, 20 parts of dioscorea hypoglauca, 10 parts of dried tangerine peel, 15 parts of poria, 10 parts of bamboo shavings, 10 parts of alisma, 10 parts of immature bitter orange, 15 parts of lily bulb, 10 parts of phellodendron bark, and 5 parts of honey-fried licorice root.

[0042] Preparation method of Wendan Jiangzhuo Granules:

[0043] (1) Extraction and vacuum concentration: Weigh the medicines according to the proportion, put them into a decocting pot, add water to cover the medicinal materials, soak for 1 h and then decoct for 3 h, collect the medicinal liquid, decoct the medicinal residues once again in the same way, combine the medicinal liquids, and vacuum concentrate to a relative density of 1.20 at 60 °C.

[0044] (2) Spray drying: Centrifugally atomize the concentrated medicinal liquid at high speed, with a drying time of 6 s, and the moisture evaporates instantaneously in the drying tower to obtain the Chinese medicine extract powder.

[0045] (3) Dry granulation: Utilize the inherent viscosity of the Chinese medicine extract powder, and prepare into granules through the processes of tabletting, cutting, and sizing. Directly press into granules without adding excipients, and the granules are uniform and have the same color.

[0046] (4) Packaging: Put the granules obtained above into packaging bags to obtain Wendan Jiangzhuo Granules, 30 g per bag.

[0047] Example 3

[0048] Formulation: Calculated by weight parts, Pinelliae Rhizoma Praeparatum 10 parts, Hordei Fructus Germinatus 30 parts, Dioscoreae Hypoglaucae Rhizoma 10 parts, Citri Reticulatae Pericarpium 20 parts, Poria 30 parts, Bambusae Caulis in Taeniam 20 parts, Alismatis Rhizoma 20 parts, Aurantii Fructus Immaturus 10 parts, Lilii Bulbus 15 parts, Phellodendri Chinensis Cortex 10 parts, Glycyrrhizae Radix Praeparata 5 parts.

[0049] Preparation method of Wendan Jiangzhuo Granules:

[0050] (1) Extraction and vacuum concentration: Weigh the medicines according to the proportion, put them into a decocting pot, add water to cover the medicinal materials, soak for 40 min and then decoct for 30 min, collect the medicinal liquid, and vacuum concentrate to a relative density of 1.20 at 60 °C.

[0051] (2) Spray drying: Centrifugally atomize the concentrated medicinal liquid at high speed, with a drying time of 2 s, and the moisture evaporates instantaneously in the drying tower to obtain the Chinese medicine extract powder.

[0052] (3) Dry granulation: Utilize the inherent viscosity of the Chinese medicine extract powder, and prepare into granules through the processes of tabletting, cutting, and sizing. Directly press into granules without adding excipients, and the granules are uniform and have the same color.

[0053] (4) Packaging: Put the granules obtained above into packaging bags to obtain Wendan Jiangzhuo Granules, 30 g per bag.

[0054] Example 4

[0055] Formulation: Calculated by weight parts, Pinelliae Rhizoma Praeparatum 10 parts, Hordei Fructus Germinatus 30 parts, Dioscoreae Hypoglaucae Rhizoma 10 parts, Citri Reticulatae Pericarpium 10 parts, Poria 15 parts, Bambusae Caulis in Taeniam 10 parts, Alismatis Rhizoma 10 parts, Aurantii Fructus Immaturus 20 parts, Lilii Bulbus 25 parts, Phellodendri Chinensis Cortex 20 parts, Glycyrrhizae Radix Praeparata 5 parts.

[0056] Preparation method of Wendan Jiangzhuo Granules:

[0057] (1) Extraction and vacuum concentration: Weigh the drugs according to the proportion, put them into a decocting pot, add water to cover the medicinal materials, soak for 30 min and then decoct for 2 h, collect the medicinal liquid, and vacuum concentrate it to a relative density of 1.20 at 60 °C.

[0058] (2) Spray drying: High-speed centrifugally atomize the concentrated medicinal liquid, with a drying time of 5 seconds, and the moisture evaporates instantaneously in the drying tower to obtain the traditional Chinese medicine extract powder.

[0059] (3) Dry pressing and granulation: Utilize the inherent viscosity of the traditional Chinese medicine extract powder, and through the processes of tabletting, cutting, and sizing, prepare it into granules. Directly press into granules without adding excipients, and the granules are uniform and have a consistent color.

[0060] (4) Packaging: Put the granules obtained above into packaging bags to obtain Wendan Jiangzhuo Granules, 30 g per bag.

[0061] Effect evaluation of Example 5 in preventing and treating hyperuricemia induced by antipsychotic drugs

[0062] 1. Experimental grouping and operation

[0063] Randomly divide 50 mice into 5 groups: blank group, model group, high-dose group, medium-dose group, and low-dose group, with 10 mice in each group.

[0064] Except for the blank group, the remaining groups are administered once a day for 14 consecutive days by intragastric gavage with olanzapine oral soluble film (Qilu Pharmaceutical Co., Ltd., specification 10 mg, national drug approval number H20210005) at a dose of 0.2 mg / kg in equal volume.

[0065] While intragastrically administering olanzapine oral soluble film, the high-dose group, medium-dose group, and low-dose group are given Wendan Jiangzhuo Granules of Example 1 for treatment, and are intragastrically administered Wendan Jiangzhuo Granules (prepared and produced by Guangdong Yifang Pharmaceutical Co., Ltd.) at doses of 0.5 g / kg (according to the experimental zoology dose conversion method, the dosage of this group is equivalent to that of treatment group 1 below), 0.33 g / kg, and 0.17 g / kg respectively, with a gavage volume of 10 mL / kg. The mice in the blank group and the model group are intragastrically administered normal saline in equal volume. Intragastrically administer continuously for 14 days, twice a day.

[0066] Fast the mice in each group for 12 h with free access to water before the first administration and after the last administration. Take blood from the eyes of the mice in each group, centrifuge at 3000 r / min at 4 °C for 20 min, and store at -80 °C for standby. Use an automatic biochemical analyzer to measure the uric acid content in the mouse serum.

[0067] 2. Experimental results

[0068] The serum uric acid levels of each group are shown in Table 1. There was no significant difference in the baseline serum uric acid levels among the groups. Compared with the blank group, the serum uric acid level in the model group of mice was significantly increased; compared with the model group of mice, the high-dose group could significantly reduce the hyperuricemia level caused by olanzapine orally disintegrating film. The medium-dose group and the low-dose group could reduce the hyperuricemia level caused by olanzapine orally disintegrating film, but the reduction amplitude was significantly lower than that of the high-dose group. The research results showed that the high-dose group was the group with the best effect.

[0069] Table 1

[0070]

[0071]

[0072] Note: The results of covariance analysis showed that: compared with the blank group: *P < 0.05; compared with the model group: #P < 0.05; compared with the high-dose group: ※P < 0.05.

[0073] Example 6 Evaluation of the Effect of Preventing and Treating Hyperuricemia Caused by Antipsychotic Drugs (Clinical Research)

[0074] 1. Experimental Purpose

[0075] To analyze the effect of Wendan Jiangzhuo Granules prepared from the formula of the present invention in preventing and treating hyperuricemia caused by antipsychotic drugs through comparison.

[0076] 2. Experimental Method

[0077] Clinical Research Data

[0078] 2.1. Source of cases: All cases were from inpatients in the Brain Hospital Affiliated to Guangzhou Medical University. Schizophrenia patients who met the inclusion criteria and were taking the antipsychotic drug olanzapine orally disintegrating film (Qilu Pharmaceutical Co., Ltd., specification 10 mg, national drug approval number H20210005) were included in this clinical observation. All of them voluntarily participated in this study and signed the informed consent form. There were 240 cases in total, which were randomly divided into a control group and a treatment group according to the order of admission.

[0079] 2.2. Diagnostic criteria: Meet the diagnostic criteria for schizophrenia (F20) in the "ICD-10 Classification of Mental and Behavioral Disorders" (ICD-10).

[0080] 2.3. Inclusion Criteria

[0081] (1) Aged 18 - 60 years old;

[0082] (2) Meet the above diagnostic criteria;

[0083] (3) The subjects or their guardians were informed and voluntarily signed the informed consent form.

[0084] 2.4 Exclusion criteria

[0085] (1) Organic or drug-induced mental disorders;

[0086] (2) substance dependence or abuse;

[0087] (3) People with mental retardation or intellectual disability;

[0088] (4) Those suffering from serious physical illness.

[0089] 2.5. Shedding Standard

[0090] (1) The subject's condition worsens and is not suitable for continued Chinese medicine treatment;

[0091] (2) those who dropped out during the observation period due to sudden discharge or non-compliance with the follow-up plan;

[0092] (3) The observation process had to be terminated due to unexpected adverse events or serious adverse reactions.

[0093] 2.6 Intervention measures

[0094] The cases that met the inclusion criteria were divided into treatment group 1 (Example 1), treatment group 2 (Example 2), treatment group 3 (Example 3), treatment group 4 (Example 4) and blank group, control group 1 (Comparative Example 1), control group 2 (Comparative Example 2), control group 3 (Comparative Example 3) according to the principle of randomization and control, with 30 cases in each group, for a total of 240 cases. The data of each group were statistically processed in terms of age, gender, BMI, and course of disease (x 2 There was no significant difference between the samples, and the samples were comparable.

[0095] The subjects in treatment groups 1-4 were given Wendanjiangzhuo granules prepared according to the formulation of Example 1-4 (manufactured and produced by Guangdong Yifang Pharmaceutical Co., Ltd.) while starting the olanzapine oral film treatment. The blank group was not given any other treatment in addition to the olanzapine oral film treatment. The control group 1-3 was given granules prepared according to the formulation of Comparative Example 1-3 while starting the olanzapine oral film treatment. The granules were taken with boiled water (about 100 ml), once in the morning and evening, 1 bag each time.

[0096] 2.7 Observation Indicators

[0097] (1) Serum uric acid level: The index detection work was completed by professionals from the Laboratory Department of the Affiliated Brain Hospital of Guangzhou Medical University.

[0098] (2) Safety evaluation

[0099] The adverse reactions were evaluated using the Treatment Effectiveness Scale (TESS).

[0100] Observation time points: Evaluate once at the start of treatment and once at 4 weeks of treatment.

[0101] 3. Experimental results

[0102] 3.1 Efficacy evaluation

[0103] After a course of treatment, the serum uric acid levels of the eight groups of subjects all changed to varying degrees. The analysis results of the changes in the serum uric acid levels of each group are shown in Table 2. It can be seen from Table 2 that there was a significant difference between Treatment Group 1 (Example 1) and the blank group (P = 0.009), indicating that Treatment Group 1 could significantly reduce the high uric acid level caused by olanzapine orally disintegrating films. Treatment Groups 2 - 4 could all reduce the high uric acid level caused by olanzapine orally disintegrating films compared with the blank group, but the reduction amplitude was lower than that of Treatment Group 1.

[0104] Table 2

[0105]

[0106] Note: The results of covariance analysis suggest that: compared with the blank group: *P < 0.05; compared with Treatment Group 1: #P < 0.05.

[0107] Treatment Group 2 increased the compatibility doses of the three monarch drugs, Pinelliae Rhizoma Praeparatum, Dioscoreae Hypoglaucae Rhizoma, and Hordei Fructus Germinatus. It could reduce the serum uric acid levels before and after, but there was no statistical difference compared with the blank group. Treatment Group 3 increased the compatibility doses of the four ministerial drugs, Bambusae Caulis in Taeniam, Citri Reticulatae Pericarpium, Poria, and Alismatis Rhizoma. It could reduce the serum uric acid levels before and after, but its effects were worse than those of Treatment Group 1 and Treatment Group 2, and there was no statistical difference compared with the blank group. Treatment Group 4 increased the compatibility doses of the three adjuvant drugs, Aurantii Fructus Immaturus, Lilii Bulbus, and Phellodendri Chinensis Cortex. It could reduce the serum uric acid levels before and after, but its effects were worse than those of Treatment Groups 1 - 3, and there was no statistical difference compared with the blank group. The results showed that too high compatibility doses of monarch drugs, ministerial drugs, or adjuvant drugs would reduce the function of the whole composition in controlling serum uric acid, proving that Treatment Group 1 was the best compatibility.

[0108] Control Group 1 reduced the three monarch drugs, Pinelliae Rhizoma Praeparatum, Dioscoreae Hypoglaucae Rhizoma, and Hordei Fructus Germinatus, and its efficacy was significantly reduced. Emotional discomfort, anger damaging the liver, the liver qi invading the spleen, and the spleen losing its transportation and transformation function, then the water metabolism is disordered, and phlegm-dampness accumulates. The above three monarch drugs have the effects of promoting qi circulation, strengthening the spleen and stomach, and dredging and draining water-dampness phlegm-turbidity, indicating that the simultaneous regulation of the liver, spleen, and kidney plays an important role in the prevention and treatment of hyperuricemia caused by antipsychotic drugs in the prescription of the present invention.

[0109] In control group 2, four ministerial drugs, namely bamboo shavings, dried tangerine peel, poria, and alisma, were reduced, and its efficacy was also significantly decreased. Patients with mental disorders often have stagnation of liver qi, and the liver fails to dredge and discharge qi, resulting in disorders of the ascending function of the spleen and the descending function of the stomach. The spleen fails to transport and transform properly, generating dampness, and the endogenous dampness transforms into heat. These four ministerial drugs can assist the sovereign drug to enhance the efficacy of clearing heat and promoting diuresis, regulating qi and resolving phlegm, indicating that regulating qi, promoting diuresis, resolving phlegm, and clearing heat are important treatment principles of the prescription of the present invention in preventing and treating hyperuricemia caused by antipsychotic drugs.

[0110] In control group 3, one sovereign drug, malt, was reduced, and its efficacy was still significantly decreased. Modern research shows that malt has the function of regulating the endocrine system. Psychiatric drugs such as olanzapine orally disintegrating films often affect the endocrine and metabolic functions of the body, causing hyperprolactinemia, metabolic syndrome, and hyperuricemia, which are closely related to the liver, spleen, and kidney functions of the body. Malt enters the liver meridian, can soothe the liver and regulate qi, eliminate food stagnation and distension, improve the circulation of qi and blood, and effectively reduce hyperuricemia caused by antipsychotic drugs. Therefore, the compatibility of the monarch, minister, assistant, and envoy drugs in this composition is reasonable and indispensable.

[0111] 3.2. Safety evaluation

[0112] The results of the safety evaluation are shown in Table 3. During the clinical observation, the side effects in the blank group were mostly muscle tension, drowsiness, tremors, weight gain, etc. At the 4th week of treatment, the TESS scores of control groups 1-3 and treatment groups 1-4 were significantly lower than those of the blank group, and the decrease in treatment group 1 was the most obvious. Compared with treatment group 1, the TESS scores of each group were significantly higher than those of treatment group 1, indicating that the Wendan Jiangzhuo Granules of the present invention can improve the side effects caused by psychiatric drugs and have treatment safety.

[0113] Table 3

[0114] Group Number of cases After 4 weeks of treatment Blank group 30 10.2±1.4# Control group 1 30 7.2±1.8*# Control group 2 30 6.5±1.4*# Control group 3 30 6.7±1.7*# Treatment group 1 30 4.3±1.2* Treatment group 2 30 5.4±0.9*# Treatment group 3 30 5.8±1.7*# Treatment group 4 30 7.3±1.6*#

[0115] Note: The results of the independent samples t-test suggest that compared with the blank group: *P < 0.05; compared with treatment group 1: #P < 0.05

[0116] The above-described embodiments only represent several implementation manners of the present invention, and the description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the invention patent of the present invention shall be subject to the appended claims.

Claims

1. A traditional Chinese medicine composition, characterized in that: Calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 5-25 parts of Pinelliae Rhizoma Praeparatum, 15-70 parts of Fructus Hordei Germinatus, 5-25 parts of Dioscoreae Hypoglaucae Rhizoma, 5-25 parts of Pericarpium Citri Reticulatae, 7.5-35 parts of Poria, 5-25 parts of Caulis Bambusae in Taeniam, 5-25 parts of Alismatis Rhizoma, 5-25 parts of Fructus Aurantii Immaturus, 7.5-35 parts of Bulbus Lilii, 5-25 parts of Cortex Phellodendri Chinensis, and 2.5-10 parts of Glycyrrhizae Radix Preparata.

2. The traditional Chinese medicine composition according to claim 1, wherein: Calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 5-20 parts of Pinelliae Rhizoma Praeparatum, 15-60 parts of Fructus Hordei Germinatus, 5-20 parts of Dioscoreae Hypoglaucae Rhizoma, 5-20 parts of Pericarpium Citri Reticulatae, 7.5-30 parts of Poria, 5-20 parts of Caulis Bambusae in Taeniam, 5-20 parts of Alismatis Rhizoma, 5-20 parts of Fructus Aurantii Immaturus, 7.5-25 parts of Bulbus Lilii, 5-20 parts of Cortex Phellodendri Chinensis, and 2.5-10 parts of Glycyrrhizae Radix Preparata.

3. The traditional Chinese medicine composition according to claim 2, wherein: Calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 10-20 parts of Pinelliae Rhizoma Praeparatum, 30-50 parts of Fructus Hordei Germinatus, 10-20 parts of Dioscoreae Hypoglaucae Rhizoma, 8-15 parts of Pericarpium Citri Reticulatae, 10-20 parts of Poria, 8-15 parts of Caulis Bambusae in Taeniam, 8-15 parts of Alismatis Rhizoma, 8-15 parts of Fructus Aurantii Immaturus, 10-20 parts of Bulbus Lilii, 8-15 parts of Cortex Phellodendri Chinensis, and 3-8 parts of Glycyrrhizae Radix Preparata.

4. The Chinese medicinal composition according to claim 3, wherein: Calculated by weight parts, the active ingredients of the traditional Chinese medicine composition are prepared from 10 parts of Pinelliae Rhizoma Praeparatum, 30 parts of Fructus Hordei Germinatus, 10 parts of Dioscoreae Hypoglaucae Rhizoma, 10 parts of Pericarpium Citri Reticulatae, 15 parts of Poria, 10 parts of Caulis Bambusae in Taeniam, 10 parts of Alismatis Rhizoma, 10 parts of Fructus Aurantii Immaturus, 15 parts of Bulbus Lilii, 10 parts of Cortex Phellodendri Chinensis, and 5 parts of Glycyrrhizae Radix Preparata; or the active ingredients of the traditional Chinese medicine composition are prepared from 20 parts of Pinelliae Rhizoma Praeparatum, 50 parts of Fructus Hordei Germinatus, 20 parts of Dioscoreae Hypoglaucae Rhizoma, 10 parts of Pericarpium Citri Reticulatae, 15 parts of Poria, 10 parts of Caulis Bambusae in Taeniam, 10 parts of Alismatis Rhizoma, 10 parts of Fructus Aurantii Immaturus, 15 parts of Bulbus Lilii, 10 parts of Cortex Phellodendri Chinensis, and 5 parts of Glycyrrhizae Radix Preparata.

5. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that: Weigh Pinelliae Rhizoma Praeparatum, Fructus Hordei Germinatus, Dioscoreae Hypoglaucae Rhizoma, Pericarpium Citri Reticulatae, Poria, Caulis Bambusae in Taeniam, Alismatis Rhizoma, Fructus Aurantii Immaturus, Bulbus Lilii, Cortex Phellodendri Chinensis, and Glycyrrhizae Radix Preparata according to the proportion, extract with a solvent to obtain an extract, and prepare a traditional Chinese medicine composition.

6. The preparation method of the traditional Chinese medicine composition according to claim 5, characterized in that: The preparation method of the extract includes: decocting with water for extraction 1-3 times, each time for 0.5-3 hours, and combining the extracts.

7. The preparation method of the traditional Chinese medicine composition according to claim 6, characterized in that: Concentrate the extract to a relative density of 1.10-1.20 at 60 °C.

8. The preparation method of the traditional Chinese medicine composition according to claim 5, wherein: The traditional Chinese medicine composition is oral liquid, granule, powder, capsule or tablet.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for preventing and / or treating hyperuricemia.

10. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for preventing and / or treating hyperuricemia caused by antipsychotic drugs.

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