A traditional Chinese medicine composition for treating thromboangiitis obliterans

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating thrombotic arteriopathy. The traditional Chinese medicine composition contains radix rehmanniae 20-40 parts, red peony root 10-20 parts, radix paeoniae 10-20 parts, radix lithospermi 10-20 parts, water buffalo horn 10-20 parts, forsythia 20-40 parts, radix codonopsis 20-40 parts, white atractylodes 10-20 parts, poria 20-40 parts, sedum 20-40 parts, ladybell 20-40 parts, sophora 10-20 parts, caper 10-20 parts, radix clematidis 10-20 parts, big belly skin 20-40 parts, and licorice 5-14 parts. The traditional Chinese medicine composition has a good therapeutic effect on thrombotic arteriopathy, has a high clinical treatment efficiency, can obviously improve the clinical symptoms of patients, reduce the pain of patients, and pharmacological experiments show that the traditional Chinese medicine composition can significantly reduce the inflammatory symptoms of rats.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology and relates to a traditional Chinese medicine composition for treating thromboangiitis obliterans. Background Technology

[0002] Traditional Chinese medicine (TCM) considers thromboangiitis obliterans (TAO) to be a limb arterial embolic disease caused by non-invasive vascular complications. The onset is characterized by periodic attacks followed by periods of remission. Clinically, the dynamic changes of the disease are very obvious, generally manifesting as acute activity and remission / improvement. In treatment, staged diagnosis is extremely important. During the acute active phase, vascular complications are active, the vascular intima is damaged, blood viscosity increases, and straight thrombi continuously form. Its pathological characteristics can be summarized as "inflammation leading to thrombosis." TCM diagnosis is "due to pathogenic factors causing obstruction," which can be caused by external pathogens such as heat and dampness invading the collaterals, leading to stagnation of qi and blood, obstruction, and various "stasis" symptoms. In this stage, "pathogenic factors" dominate, and treatment must focus on "eliminating pathogenic factors," either by clearing heat and cooling blood, or resolving dampness and detoxifying. Once the pathogenic factors are eliminated, new ones will not form, and the disease will be difficult to control. This is because "stasis" is a pathological product of pathogenic damage to the collaterals; if the pathogenic factors are not eliminated, new ones will continuously form, making the condition difficult to control. The pathological mechanism of this disease is mainly the stagnation of qi and blood, and obstruction of blood vessels. Among the pathogenic factors of thromboangiitis obliterans, external factors include exposure to cold and dampness, improper diet, trauma, and poisoning. Internal factors include congenital deficiency, spleen and kidney yang deficiency, liver and kidney deficiency, and emotional distress, all of which lead to obstruction of the meridians. Cold causes contraction; when the meridians are exposed to cold, they spasm and contract, and blood congeals. After exposure to cold, yang qi cannot reach the limbs, resulting in poor blood circulation and stagnation. Obstruction causes pain, and with prolonged illness, both qi and blood become deficient, leading to malnourishment of the limbs.

[0003] The *Ling Shu* (Spiritual Pivot), in its chapter on carbuncles and boils, states: "When the *ying* and *wei* (nutritive and defensive qi) stagnate in the meridians, the blood becomes stagnant and cannot flow. When it cannot flow, the *wei* qi also becomes obstructed and cannot circulate." Liu Huijie believes that blood stasis plays a dominant role in the pathogenesis of this disease. In summary, its pathological mechanism can be mainly summarized as: cold-dampness obstructing the meridians, blood stasis, damp-heat descending, intense heat toxin, and deficiency of both qi and blood. The *Su Wen* (Plain Questions) chapter on Bi syndrome points out that "pain is caused by excessive cold qi; pain arises from cold." The *Su Wen* chapter on pain states: "Cold qi enters the meridians and stagnates, becoming stagnant and unable to flow. If it lodges outside the vessels, blood is scarce; if it lodges inside the vessels, qi is obstructed, hence the sudden pain." In its later stages, this disease is characterized by damage to tendons and bones, and deficiency of both qi and blood. The lesions mainly occur in the blood vessels and are more common in young and middle-aged male patients. Summary of the Invention

[0004] The main objective of this invention is to provide a new traditional Chinese medicine composition that has a good therapeutic effect on thromboangiitis obliterans, with a high clinical efficacy rate, reduces patient pain, is convenient to take, and increases patient compliance.

[0005] Specifically, the present invention employs the following technical solutions to achieve the above objectives:

[0006] A traditional Chinese medicine composition for treating thromboangiitis obliterans, comprising the following components by weight: 20-40 parts Rehmannia glutinosa, 10-20 parts Paeonia lactiflora, 10-20 parts Paeonia suffruticosa, 10-20 parts Lithospermum erythrorhizon, 10-20 parts Buffalo horn, 20-40 parts Forsythia suspensa, 20-40 parts Codonopsis pilosula, 10-20 parts Atractylodes macrocephala, 20-40 parts Poria cocos, 20-40 parts Sedum sarmentosum, 20-40 parts Agrimonia pilosa, 10-20 parts Sophora flavescens, 10-20 parts Artemisia capillaris, 10-20 parts Clematis chinensis, 20-40 parts Areca catechu, and 5-14 parts Glycyrrhiza uralensis.

[0007] Furthermore, the traditional Chinese medicine composition contains the following components in parts by weight:

[0008] 30 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora, 15 parts Paeonia suffruticosa, 15 parts Lithospermum erythrorhizon, 15 parts Buffalo horn, 30 parts Forsythia suspensa, 30 parts Codonopsis pilosula, 15 parts Atractylodes macrocephala, 30 parts Poria cocos, 30 parts Sedum sarmentosum, 30 parts Agrimonia pilosa, 15 parts Sophora flavescens, 15 parts Artemisia capillaris, 15 parts Clematis chinensis, 30 parts Areca catechu, and 9 parts Glycyrrhiza uralensis.

[0009] Furthermore, the traditional Chinese medicine composition contains the following components in parts by weight:

[0010] 20 parts Rehmannia glutinosa, 10 parts Paeonia lactiflora, 10 parts Paeonia suffruticosa, 10 parts Lithospermum erythrorhizon, 10 parts Buffalo horn, 20 parts Forsythia suspensa, 20 parts Codonopsis pilosula, 10 parts Atractylodes macrocephala, 20 parts Poria cocos, 20 parts Sedum sarmentosum, 20 parts Agrimonia pilosa, 10 parts Sophora flavescens, 10 parts Artemisia capillaris, 10 parts Clematis chinensis, 20 parts Areca catechu, and 5 parts Glycyrrhiza uralensis.

[0011] Furthermore, the traditional Chinese medicine composition contains the following components in parts by weight:

[0012] 40 parts Rehmannia glutinosa, 20 parts Paeonia lactiflora, 20 parts Paeonia suffruticosa, 20 parts Lithospermum erythrorhizon, 20 parts Buffalo horn, 40 parts Forsythia suspensa, 40 parts Codonopsis pilosula, 20 parts Atractylodes macrocephala, 40 parts Poria cocos, 40 parts Sedum sarmentosum, 40 parts Agrimonia pilosa, 20 parts Sophora flavescens, 20 parts Artemisia capillaris, 20 parts Clematis chinensis, 40 parts Areca catechu, and 14 parts Glycyrrhiza uralensis.

[0013] This invention provides specific uses of the above-mentioned traditional Chinese medicine composition, namely, its use in the preparation of drugs for treating thromboangiitis obliterans.

[0014] This invention provides a traditional Chinese medicine preparation made from the above-mentioned traditional Chinese medicine composition, wherein the traditional Chinese medicine preparation is prepared directly from the above-mentioned traditional Chinese medicine composition or with the addition of excipients.

[0015] Furthermore, the aforementioned traditional Chinese medicine preparations can be oral solid dosage forms and / or oral liquid dosage forms.

[0016] Furthermore, the aforementioned oral solid dosage forms are pills, granules, etc.; more preferably, the oral liquid dosage forms are granules.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] In this invention's herbal composition, Rehmannia glutinosa is the principal ingredient, cooling the blood and removing blood stasis; Paeonia lactiflora, Paeonia suffruticosa, and Lithospermum erythrorhizon are the assistant ingredients, clearing heat and cooling the blood; Codonopsis pilosula, Atractylodes macrocephala, and Poria cocos strengthen the spleen, protect the liver, and act as assistant ingredients; Sophora flavescens, Sedum sarmentosum, Artemisia capillaris, and Clematis chinensis benefit the liver meridian by clearing damp-heat; Areca catechu and Agrimonia pilosa are the adjuvant ingredients, benefiting the liver meridian by clearing damp-heat and expelling pathogenic factors from the liver meridian; and Glycyrrhiza uralensis harmonizes the effects of all the ingredients. This herbal composition can improve blood circulation and microcirculation, increase blood flow to the limbs, improve local tissue nutrition, dilate peripheral blood vessels, and relieve vasospasm. Attached Figure Description

[0019] Figure 1 The grading of treatment results in each embodiment.

[0020] Figure 2 The INF-γ content in the plasma of rats in each group during the efficacy test after treatment in each embodiment.

[0021] Figure 3 The TNF-α content in the plasma of rats in each group during the efficacy test of each embodiment.

[0022] Figure 4 The IL-4 content in the plasma of rats in each group during the efficacy test of each embodiment.

[0023] Figure 5 The efficacy tests of each group of rats in each embodiment included thrombin time (TT), prothrombin time (PT), and activated partial thromboplastin time (APTT).

[0024] Figure 6 The fibrinogen (FIB) content levels in each group of rats during the efficacy tests of each embodiment. Detailed Implementation

[0025] Example 1: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation are as follows:

[0026] Rehmannia glutinosa 30g, Paeonia lactiflora 15g, Paeonia suffruticosa 15g, Lithospermum erythrorhizon 15g, Buffalo horn 15g, Forsythia suspensa 30g, Codonopsis pilosula 30g, Atractylodes macrocephala 15g, Poria cocos 30g, Sedum sarmentosum 30g, Agrimonia pilosa 30g, Sophora flavescens 15g, Artemisia capillaris 15g, Clematis chinensis 15g, Areca catechu 30g, Glycyrrhiza uralensis 9g.

[0027] The above 16 ingredients are decocted twice with water, the first time for 1.5 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.11 to 1.33 (70-75℃). Dextrin, pregelatinized starch, and aspartame are added, and the mixture is granulated in a fluidized bed and dried to obtain granules.

[0028] Example 2: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation are as follows:

[0029] 20g Rehmannia glutinosa, 10g Paeonia lactiflora, 10g Paeonia suffruticosa, 10g Lithospermum erythrorhizon, 10g Buffalo horn, 20g Forsythia suspensa, 20g Codonopsis pilosula, 10g Atractylodes macrocephala, 20g Poria cocos, 20g Sedum sarmentosum, 20g Agrimonia pilosa, 10g Sophora flavescens, 10g Artemisia capillaris, 10g Clematis chinensis, 20g Areca catechu, 5g Glycyrrhiza uralensis.

[0030] The preparation process is the same as in Example 1.

[0031] Example 3: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0032] 40g Rehmannia glutinosa, 20g Paeonia lactiflora, 20g Paeonia suffruticosa, 20g Lithospermum erythrorhizon, 20g Buffalo horn, 40g Forsythia suspensa, 40g Codonopsis pilosula, 20g Atractylodes macrocephala, 40g Poria cocos, 40g Sedum sarmentosum, 40g Agrimonia pilosa, 20g Sophora flavescens, 20g Artemisia capillaris, 20g Clematis chinensis, 40g Areca catechu, 14g Glycyrrhiza uralensis.

[0033] The preparation process is the same as in Example 1.

[0034] Example 4: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0035] Rehmannia glutinosa 30g, Paeonia lactiflora 15g, Paeonia suffruticosa 15g, Lithospermum erythrorhizon 15g, Buffalo horn 15g, Forsythia suspensa 30g, Codonopsis pilosula 30g, Atractylodes macrocephala 15g, Poria cocos 30g, Sedum sarmentosum 30g, Agrimonia pilosa 30g, Sophora flavescens 15g, Artemisia capillaris 15g, Clematis chinensis 15g, Areca catechu 30g, Glycyrrhiza uralensis 9g.

[0036] The above 16 ingredients are decocted twice with water, the first time for 1.5 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.11-1.33 (70-75℃). The extract is dried, pulverized, and an appropriate amount of starch is added. The extract is then made into a soft mass using povidone K30, formed into pills, and dried to obtain pills, each weighing approximately 1.5g.

[0037] Comparative Example 1: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0038] Chicken blood vine 30g, red peony root 15g, peony bark 15g, purple gromwell root 15g, buffalo horn 15g, forsythia fruit 30g, codonopsis root 30g, atractylodes rhizome 15g, poria cocos 30g, sedum sarmentosum 30g, agrimony 30g, sophora flavescens root 15g, artemisia capillaris 15g, clematis root 15g, areca peel 30g, licorice root 9g.

[0039] The preparation process is the same as in Example 1.

[0040] Comparative Example 2: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0041] 30g Rehmannia glutinosa, 15g Paeonia lactiflora, 15g Commiphora myrrha, 15g Zanthoxylum bungeanum, 15g Scolopendra subspinipes, 30g Forsythia suspensa, 30g Codonopsis pilosula, 15g Atractylodes macrocephala, 30g Poria cocos, 30g Sedum sarmentosum, 30g Agrimonia pilosa, 15g Sophora flavescens, 15g Artemisia capillaris, 15g Clematis chinensis, 30g Areca catechu, 9g Glycyrrhiza uralensis.

[0042] The preparation process is the same as in Example 1.

[0043] Comparative Example 3: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0044] 50g Rehmannia glutinosa, 5g Paeonia lactiflora, 5g Paeonia suffruticosa, 5g Lithospermum erythrorhizon, 5g Buffalo horn, 15g Forsythia suspensa, 40g Codonopsis pilosula, 25g Atractylodes macrocephala, 15g Poria cocos, 15g Sedum sarmentosum, 50g Agrimonia pilosa, 15g Sophora flavescens, 15g Artemisia capillaris, 15g Clematis chinensis, 44g Areca catechu, 20g Glycyrrhiza uralensis.

[0045] The preparation process is the same as in Example 1.

[0046] Comparative Example 4: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0047] 40g Rehmannia glutinosa, 15g Paeonia lactiflora, 15g Paeonia suffruticosa, 15g Lithospermum erythrorhizon, 15g Buffalo horn, 30g Codonopsis pilosula, 40g Poria cocos, 40g Sedum sarmentosum, 40g Agrimonia pilosa, 15g Sophora flavescens, 15g Artemisia capillaris, 15g Clematis chinensis, 30g Areca catechu, 9g Glycyrrhiza uralensis.

[0048] The preparation process is the same as in Example 1.

[0049] Comparative Example 5: A traditional Chinese medicine composition for treating thromboangiitis obliterans, the composition and preparation of which are as follows:

[0050] Honeysuckle 80g, Rehmannia glutinosa 50g, Rehmannia glutinosa 30g, Forsythia suspensa 40g, Scrophularia ningpoensis 40g, Coptis chinensis 29g, Lophatherum gracile 10g, Salvia miltiorrhiza 40g, Ophiopogon japonicus 20g.

[0051] The preparation process is the same as in Example 1.

[0052] Pharmacodynamic experiments

[0053] To further corroborate the efficacy of the traditional Chinese medicine composition of the present invention in treating peripheral vascular diseases, especially thromboangiitis obliterans, the inventor specifically commissioned a third-party testing institution with relevant qualifications to conduct relevant pharmacodynamic experimental studies based on clinical use. The animal models used in the following pharmacodynamic experiments were prepared based on reference to the existing literature technology.

[0054] 1 Materials

[0055] 1.1 Animals:

[0056] Wistar rats, SPF grade, 180 - 220 g, experimental animal license number: SYXK(Shandong)20230031, Affiliated Hospital of Shandong University of Traditional Chinese Medicine. They were adaptively fed for one week before the experiment.

[0057] 1.2 Drugs, reagents

[0058] 1.2.1 Drugs

[0059] The granules obtained in Example 1, Example 2, Example 3 of the present invention and Comparative Examples 1 - 6.

[0060] 1.2.3 Dosage

[0061] Calculated according to the human dosage, assuming the human weight is 60 kg, the rat dosage is 6.3 times the human dosage, and the crude drug dosage for rats is 71.19 g / kg.

[0062] 2 Experimental procedure

[0063] Take 90 rats and randomly divide them into a model group, an Example 1 group, an Example 2 group, an Example 3 group, a Comparative Example 1 group, a Comparative Example 2 group, a Comparative Example 3 group, a Comparative Example 4 group, and a Comparative Example 5 group, with 10 rats in each group. After the rats were anesthetized, they were fixed in the supine position. The left lower groin was used as the surgical site, the hair was removed, and it was disinfected. A longitudinal incision was made at the midpoint of the groin to expose the femoral artery sheath, and the femoral artery at the upper end of the superficial epigastric artery was dissected. The proximal end of the femoral artery was blocked with an arterial clamp to stop blood flow. 0.1 mL of 7 g / L sodium silicate solution was injected distally 1 cm below the arterial clamp, and the puncture site was sealed with medical glue. After 1 minute, there was no bleeding in the femoral artery, and the skin was sutured. After the operation, it was disinfected to prevent infection. On the second day after modeling, except for the model group, the rats in the other groups were given the corresponding drugs by gavage, and the model group was given distilled water by gavage for 30 consecutive days.

[0064] Another 10 normal rats were taken, injected with normal saline into the femoral artery and given distilled water by gavage as the sham operation group.

[0065] 3 Detection indexes

[0066] 3.1 Lesion score of the affected limb of rats

[0067] After establishing the rat model, the changes in the left hind leg of the rats were observed daily. After the drug treatment ended, the overall score was calculated, and the criteria were as follows:

[0068] Level 0: No change in overall appearance;

[0069] Grade I: The lesion is limited to the toenail;

[0070] Grade II: The lesion is limited to the toes;

[0071] Grade III: Lesions are limited to the toes and claws;

[0072] Grade IV: Lesions extend beyond the ankle joint and below the knee joint;

[0073] Grade V: The lesion has progressed above the knee joint.

[0074] 3.2 Detection of biochemical indicators in rats

[0075] After the rats were treated with the drug, blood was collected from the abdominal aorta to measure the levels of tumor necrosis factor TNF-α, interferon-gamma (IFN-γ), and interleukin-4 (IL-4) in the plasma.

[0076] 3.3 Measurement of coagulation and fibrinolysis-related indicators using a fully automated coagulation analyzer

[0077] After centrifuging the blood from the sodium citrate anticoagulation blood collection tube, the supernatant plasma was collected, and the levels of thrombin time (TT), prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen (FIB) were measured using the magnetic bead coagulation method on an automated coagulation analyzer.

[0078] 4. Statistical Analysis

[0079] The obtained data were statistically analyzed using GraphPadPrism software. Quantitative data were analyzed using... The value is indicated by P < 0.05.

[0080] 5 Results Analysis

[0081] 5.1 Lesions in the affected limbs of rats

[0082] After drug administration, the lesions in the affected limbs of rats in the model group were most pronounced, with over 80% of rats exhibiting grade III or higher lesions, indicating successful model establishment and experimental feasibility. In both the examples and comparative examples, the severity of lesions in each drug administration group was significantly reduced compared to the model group. The mildest lesions were observed in groups 1-3 of the examples, particularly in example 1, where no rats exhibited grade V lesions. Compared to the control group, and especially compared to comparative examples 1-5, no rats showed grade I lesions. See details... Figure 1 As shown.

[0083] 5.2 Biochemical indicators of rats

[0084] Compared with the sham-operated group, the plasma levels of TNF-α, IFN-γ, and IL-4 in the model group rats were significantly increased (P<0.05 or P<0.01); compared with the model group, the plasma levels of TNF-α, IFN-γ, and IL-4 in each treatment group rats were decreased. For a detailed comparison between the examples and the comparative examples, please refer to [link to example]. Figure 2-4 .

[0085] 5.3 Comparison of coagulation and fibrinolysis-related indices among different groups of rats

[0086] Compared with the sham-operated group, the model group showed statistically significant differences in TT, PT, APTT, and FIB (P<0.05 or P<0.01). The model group rats exhibited significantly reduced TT, PT, and APTT times (P<0.05 or P<0.01), and significantly increased FIB levels (P<0.05 or P<0.01). For a detailed comparison between the examples and the comparative examples, please refer to [link to example]. Figure 5-6 .

Claims

1. A traditional Chinese medicine composition for treating thromboangiitis obliterans, characterized in that, It is made from the following components in parts by weight: 20-40 parts Rehmannia glutinosa, 10-20 parts Paeonia lactiflora, 10-20 parts Paeonia suffruticosa, 10-20 parts Lithospermum erythrorhizon, 10-20 parts Buffalo horn, 20-40 parts Forsythia suspensa, 20-40 parts Codonopsis pilosula, 10-20 parts Atractylodes macrocephala, 20-40 parts Poria cocos, 20-40 parts Sedum sarmentosum, 20-40 parts Agrimonia pilosa, 10-20 parts Sophora flavescens, 10-20 parts Artemisia capillaris, 10-20 parts Clematis chinensis, 20-40 parts Areca catechu, and 5-14 parts Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, It is made from the following components in parts by weight: 30 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora, 15 parts Paeonia suffruticosa, 15 parts Lithospermum erythrorhizon, 15 parts Buffalo horn, 30 parts Forsythia suspensa, 30 parts Codonopsis pilosula, 15 parts Atractylodes macrocephala, 30 parts Poria cocos, 30 parts Sedum sarmentosum, 30 parts Agrimonia pilosa, 15 parts Sophora flavescens, 15 parts Artemisia capillaris, 15 parts Clematis chinensis, 30 parts Areca catechu, and 9 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition as described in claim 1, characterized in that, It is made from the following components in parts by weight: 20 parts Rehmannia glutinosa, 10 parts Paeonia lactiflora, 10 parts Paeonia suffruticosa, 10 parts Lithospermum erythrorhizon, 10 parts Buffalo horn, 20 parts Forsythia suspensa, 20 parts Codonopsis pilosula, 10 parts Atractylodes macrocephala, 20 parts Poria cocos, 20 parts Sedum sarmentosum, 20 parts Agrimonia pilosa, 10 parts Sophora flavescens, 10 parts Artemisia capillaris, 10 parts Clematis chinensis, 20 parts Areca catechu, and 5 parts Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following components in parts by weight: 40 parts Rehmannia glutinosa, 20 parts Paeonia lactiflora, 20 parts Paeonia suffruticosa, 20 parts Lithospermum erythrorhizon, 20 parts Buffalo horn, 40 parts Forsythia suspensa, 40 parts Codonopsis pilosula, 20 parts Atractylodes macrocephala, 40 parts Poria cocos, 40 parts Sedum sarmentosum, 40 parts Agrimonia pilosa, 20 parts Sophora flavescens, 20 parts Artemisia capillaris, 20 parts Clematis chinensis, 40 parts Areca catechu, and 14 parts Glycyrrhiza uralensis.

5. Use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for treating thromboangiitis obliterans.

6. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition according to any one of claims 1-4.

7. The traditional Chinese medicine preparation as described in claim 6, characterized in that, The traditional Chinese medicine preparations mentioned are oral solid dosage forms and oral liquid dosage forms.

8. The traditional Chinese medicine preparation as described in claim 7, characterized in that, The oral solid dosage form is selected from pills and granules.

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