A traditional Chinese medicine composition for treating ovarian cancer, its preparation method and uses

The prepared traditional Chinese medicine composition promotes blood circulation, removes blood stasis, and regulates tumor immune checkpoint proteins, thus solving the problems of chemotherapy resistance and immune escape in ovarian cancer, achieving effective treatment of ovarian cancer and improving quality of life.

CN118252883BActive Publication Date: 2026-01-06HEILONGJIANG UNIV OF CHINESE MEDICINE
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Patent Information

Application Number
CN202410368786.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-03-28
Publication Date
2026-01-06
Estimated Expiration
2044-03-28

AI Technical Summary

Technical Problem

Existing treatments for ovarian cancer suffer from problems such as strong chemotherapy resistance, weak patient constitution, significant side effects of Western medicine treatments, and ineffective utilization of tumor immune escape mechanisms. The application of traditional Chinese medicine combinations in the treatment of ovarian cancer is also insufficient.

Method used

A traditional Chinese medicine composition was developed, consisting of Astragalus membranaceus, Cinnamomum cassia, Poria cocos, Prunus persica, Gynostemma pentaphyllum, Paeonia suffruticosa, Magnolia officinalis, and Hirudo medicinalis. The composition was prepared into granules through ultra-micro pulverization and dynamic decoction processes. Combined with the effects of promoting blood circulation, removing blood stasis, and regulating tumor immune checkpoint proteins, the composition enhances the patient's immunity.

Benefits of technology

It significantly inhibits the proliferation of ovarian cancer cells, regulates tumor immunity, reduces the side effects of chemotherapy, prolongs patient survival, improves quality of life, and enhances immune function.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating ovarian cancer, a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw medicinal materials: Astragalus membranaceus (Fisch.) Bunge, Ramulus Cinnamomi, Poria cocos (Schw.) Wolf, Semen Persicae, Gynostemma pentaphyllum (Thunb.) Makino, Radix Moutan, Magnolia officinalis Rehd. et Wils., and Hirudo nipponia Whitfield. The traditional Chinese medicine composition has the effects of benefiting qi and activating blood, removing blood stasis and dredging collaterals. Therefore, the traditional Chinese medicine composition is suitable for patients after surgery or radiotherapy and chemotherapy for ovarian cancer, and is also suitable for patients who cannot tolerate surgery or radiotherapy due to poor physical condition. The traditional Chinese medicine composition has the effects of reducing tumor cell proliferation, regulating tumor immunity, reducing toxicity and increasing efficacy. In the maintenance treatment stage, the traditional Chinese medicine composition can enhance the immunity of patients, prolong the survival period of patients, and improve the life quality of patients.
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Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating ovarian cancer, its preparation method, and its uses. Background Technology

[0002] Ovarian cancer is the leading cause of death among gynecological malignancies and the fifth leading cause of cancer death in women. It accounts for 4.4% of cancer-related deaths globally, with approximately 240,000 new cases diagnosed annually worldwide. The 5-year overall survival rate for ovarian cancer is 45%, but only 25% for patients with advanced-stage disease. This is primarily due to the lack of obvious symptoms and effective screening in the early stages of ovarian cancer, leading to most patients (approximately 75%) being diagnosed at an advanced stage with metastasis to the peritoneum and distant sites. Standard treatment for advanced ovarian cancer includes cytoreductive surgery and standard chemotherapy. However, most patients relapse within 2-3 years after first-line chemotherapy and die from chemotherapy resistance. Therefore, the overall treatment outcome for ovarian cancer is not ideal, and the overall survival rate has only slightly improved over the past few decades. Finding new treatment strategies to improve the prognosis of ovarian cancer remains a crucial research topic. Currently, how to more rationally and effectively integrate existing treatment methods to improve efficacy and how to better balance treatment effectiveness and patient quality of life have become current research hotspots.

[0003] In recent years, the efficacy of traditional Chinese medicine (TCM) in treating various benign and malignant tumors has been increasingly confirmed, and its role in the multidisciplinary comprehensive treatment model for malignant tumors has become increasingly important. Various studies on TCM treatment of malignant tumors are also being conducted extensively and in-depth, and the mechanisms by which TCM works are gradually being revealed. While TCM does not directly discuss ovarian cancer, based on its clinical manifestations, it corresponds to the TCM concepts of "zhengjia" or "jiju." The *Zhu Bing Yuan Hou Lun* (Treatise on the Causes and Symptoms of Various Diseases) states: "If the disease is immobile, it is simply called zheng. If the disease has masses that can be moved, it is called zhengjia." Regarding the pathogenesis of ovarian cancer, both ancient physicians and modern scholars generally agree that it is a syndrome characterized by deficiency of vital energy (Qi) combined with pathogenic factors, exhibiting both underlying deficiency and superficial excess. Ovarian cancer has a long course and complex pathogenesis. On the one hand, patients experience varying degrees of deficiency of vital energy, including Qi deficiency, blood deficiency, Yang deficiency, and Yin deficiency. On the other hand, factors such as blood stasis, phlegm-dampness, cold coagulation, and heat toxicity often intertwine and combine to cause the disease.

[0004] Currently, Western medicine primarily treats ovarian cancer with surgery, followed by chemotherapy, and a few patients undergo radiotherapy. In Western treatment, patients often experience post-operative weakness, poor appetite, and severe side effects from chemotherapy and radiotherapy, making the entire process quite painful and impacting the progress and effectiveness of treatment. Traditional Chinese medicine (TCM) treatment for ovarian cancer is generally less effective at directly killing cancer cells; its main focus is on regulating Yin-Yang balance, enhancing the body's immunity, and improving quality of life.

[0005] Furthermore, tumor immunotherapy is a cutting-edge cancer treatment method in recent years, which involves stimulating the body's own immune system to kill tumor cells. To evade the immune system, tumor cells utilize immune checkpoint proteins such as PD-L1 and CTLA-4 to shut down the defensive activity of immune T cells, thus allowing them to evade the immune system's attack. Tumor immunotherapy regulates immune checkpoint proteins, thereby stimulating and guiding the immune system to kill tumor cells. However, current research on whether traditional Chinese medicine compositions can regulate tumor immune checkpoint proteins and enhance tumor immunity is very limited.

[0006] In view of this, if a traditional Chinese medicine composition can be developed that combines directly killing cancer cells with effectively inhibiting tumor immune checkpoint targets and improving the patient's tumor immunity, and can also promote the patient's overall immune function and stimulate the immune system to kill tumor cells, it will have greater clinical significance for the treatment of ovarian cancer. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of the existing technology and provide a traditional Chinese medicine composition for treating ovarian cancer, its preparation method and uses.

[0008] Specifically, the present invention is achieved through the following technical solutions:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating ovarian cancer, the composition being made from the following raw materials in parts by weight: Astragalus membranaceus 5-30 parts, Cinnamomum cassia 5-30 parts, Poria cocos 5-20 parts, Prunus persica 5-20 parts, Gynostemma pentaphyllum 5-20 parts, Paeonia suffruticosa 1-15 parts, Magnolia officinalis 1-15 parts, and Hirudo medicinalis 1-10 parts.

[0010] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Astragalus membranaceus 10-30 parts, Cinnamomum cassia 10-30 parts, Poria cocos 10-20 parts, Prunus persica 10-20 parts, Gynostemma pentaphyllum 10-20 parts, Paeonia suffruticosa 1-10 parts, Magnolia officinalis 1-10 parts, and Hirudo medicinalis 3-5 parts.

[0011] As an optional method, in the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts of Astragalus membranaceus, 20 parts of Cinnamomum cassia, 15 parts of Poria cocos, 15 parts of Prunus persica, 15 parts of Gynostemma pentaphyllum, 10 parts of Paeonia suffruticosa, 5 parts of Magnolia officinalis, and 4 parts of Hirudo medicinalis.

[0012] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect above, the method comprising the following steps:

[0013] (1) Mix cinnamon twigs, gynostemma pentaphyllum, magnolia bark and leeches and pulverize them into a mixed ultrafine powder;

[0014] (2) Add water to Astragalus membranaceus, Poria cocos, peach kernel and peony bark and decoct. After the first decoction is 1-3 hours, filter to obtain the first filtrate. Add water to the residue and decoct for another 1-3 hours. Filter to obtain the second filtrate. Combine the first filtrate and the second filtrate and concentrate to obtain the concentrated liquid.

[0015] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0016] Alternatively, in the above preparation method, in step (1), the fineness of the ultrafine powder is 100 mesh.

[0017] As an optional approach, in the above preparation method, in step (2), the time for the first and second decoctions is 1.5 hours.

[0018] In a third aspect, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect above, or the traditional Chinese medicine composition prepared by the preparation method described in the second aspect above, in the preparation of a medicament for treating ovarian cancer.

[0019] Alternatively, in the above-described uses, the ovarian cancer is qi stagnation and blood stasis type ovarian cancer.

[0020] Alternatively, in the above-described uses, the dosage form of the drug is granules, tablets, oral liquid, or capsules.

[0021] Alternatively, in the above-described uses, the dosage form of the drug is granules.

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

[0023] (1) The traditional Chinese medicine composition of the present invention is mainly for promoting blood circulation and removing blood stasis, and also has the effects of invigorating qi and promoting blood circulation, removing blood stasis and unblocking collaterals.

[0024] (2) The traditional Chinese medicine composition of the present invention is suitable for patients who have undergone ovarian cancer surgery or radiotherapy and chemotherapy, as well as patients who cannot tolerate surgery or radiotherapy and chemotherapy due to poor physical condition. The traditional Chinese medicine composition of the present invention has the effects of reducing tumor cell proliferation, regulating tumor immunity, reducing toxicity and increasing efficacy. During the maintenance treatment stage, it can enhance the patient's immunity, prolong the patient's survival time, and improve the patient's quality of life.

[0025] (3) Based on traditional medical prescriptions, this invention utilizes modern pharmaceutical processes and performs in-depth optimization, employing dynamic decoction process and one-step granulation technology. The preparation method described in this invention has the advantages of simple preparation process, high efficiency, energy saving, and minimal damage to effective components. Detailed Implementation

[0026] The present invention will be further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0027] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0028] Unless otherwise specified, the experimental methods used in the following embodiments are conventional methods. Unless otherwise specified, the experimental materials used in the following embodiments are commercially available products.

[0029] Preparation Example:

[0030] Example 1:

[0031] A traditional Chinese medicine composition for treating ovarian cancer, said composition being made from the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Cinnamomum cassia 20 parts, Poria cocos 15 parts, Prunus persica 15 parts, Gynostemma pentaphyllum 15 parts, Paeonia suffruticosa 10 parts, Magnolia officinalis 5 parts, and Hirudo medicinalis 4 parts.

[0032] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0033] (1) Mix cinnamon twig, gynostemma pentaphyllum, magnolia bark and leech and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh;

[0034] (2) Add water to Astragalus membranaceus, Poria cocos, peach kernel and peony bark and decoct. After the first decoction is 1.5 hours, filter to obtain the first filtrate. Add water to the residue and decoct for another 1.5 hours. Filter to obtain the second filtrate. Combine the first filtrate and the second filtrate and concentrate to obtain the concentrated liquid.

[0035] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0036] Example 2:

[0037] A traditional Chinese medicine composition for treating ovarian cancer, said composition being made from the following raw materials in parts by weight: Astragalus membranaceus 25 parts, Cinnamomum cassia 20 parts, Poria cocos 10 parts, Prunus persica 15 parts, Gynostemma pentaphyllum 20 parts, Paeonia suffruticosa 5 parts, Magnolia officinalis 5 parts, and Hirudo medicinalis 4 parts.

[0038] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0039] (1) Mix cinnamon twig, gynostemma pentaphyllum, magnolia bark and leech and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh;

[0040] (2) Add water to Astragalus membranaceus, Poria cocos, peach kernel and peony bark and decoct. After the first decoction is 1.5 hours, filter to obtain the first filtrate. Add water to the residue and decoct for another 1.5 hours. Filter to obtain the second filtrate. Combine the first filtrate and the second filtrate and concentrate to obtain the concentrated liquid.

[0041] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0042] Comparative Example 1:

[0043] A traditional Chinese medicine composition, wherein the composition is made from the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Cinnamomum cassia 20 parts, Poria cocos 15 parts, Prunus persica 15 parts, Scutellaria barbata 15 parts, Paeonia suffruticosa 10 parts, Magnolia officinalis 5 parts, and Hirudo medicinalis 4 parts.

[0044] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0045] (1) Mix cinnamon twig, Scutellaria barbata, Magnolia officinalis and leech and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh.

[0046] (2) Add water to Astragalus membranaceus, Poria cocos, peach kernel and peony bark and decoct. After the first decoction is 1.5 hours, filter to obtain the first filtrate. Add water to the residue and decoct for another 1.5 hours. Filter to obtain the second filtrate. Combine the first filtrate and the second filtrate and concentrate to obtain the concentrated liquid.

[0047] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0048] Comparative Example 2:

[0049] A traditional Chinese medicine composition, wherein the composition is made from the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Cinnamomum cassia 20 parts, Poria cocos 15 parts, Prunus persica 15 parts, Gynostemma pentaphyllum 20 parts, Paeonia suffruticosa 10 parts, and Hirudo medicinalis 4 parts.

[0050] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0051] (1) Mix cinnamon twigs, gynostemma pentaphyllum and leeches and pulverize them into ultrafine powder to obtain mixed ultrafine powder with a fineness of 100 mesh;

[0052] (2) Add water to Astragalus membranaceus, Poria cocos, peach kernel and peony bark and decoct. After the first decoction is 1.5 hours, filter to obtain the first filtrate. Add water to the residue and decoct for another 1.5 hours. Filter to obtain the second filtrate. Combine the first filtrate and the second filtrate and concentrate to obtain the concentrated liquid.

[0053] (3) The mixed ultrafine powder obtained in step (1) is used as the base material and sprayed into the concentrated liquid obtained in step (2). After one-step granulation and mixing, the traditional Chinese medicine composition granules are obtained.

[0054] Comparative Example 3:

[0055] A traditional Chinese medicine composition, wherein the composition is made from the following raw materials in parts by weight: Astragalus membranaceus 20 parts, Cinnamomum cassia 20 parts, Poria cocos 15 parts, Prunus persica 15 parts, Gynostemma pentaphyllum 15 parts, Paeonia suffruticosa 10 parts, Magnolia officinalis 5 parts, and Hirudo medicinalis 4 parts.

[0056] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0057] (1) Add water to cinnamon twig, gynostemma pentaphyllum, magnolia bark, astragalus, poria cocos, peach kernel, peony bark, and leech and decoct. After the first decoction is 1.5 hours, filter to obtain the first filtrate. Add water to the residue and decoct for another 1.5 hours, then filter to obtain the second filtrate. Combine the first and second filtrates and concentrate to obtain the concentrated liquid.

[0058] (2) The concentrate obtained in step (1) is concentrated to obtain the extract of the traditional Chinese medicine composition. Example of effectiveness:

[0059] Example 1: Pharmacodynamic study of the traditional Chinese medicine composition of the present invention in the treatment of ovarian cancer

[0060] 1.1 Main experimental animals and materials

[0061] SPF-grade BALB / c female nude mice, 6-8 weeks old, weighing 20-22g, were purchased from the Experimental Animal Center of Heilongjiang University of Traditional Chinese Medicine.

[0062] Skov-3 human ovarian cancer cells were purchased from Shanghai Boson Biotechnology Co., Ltd.

[0063] 1.2 Experimental Methods

[0064] 1.2.1 Establishment of mouse xenografts

[0065] Skov-3 human ovarian cancer cells in the logarithmic growth phase were prepared into a concentration of 1.5 × 10⁻⁶. 7 A suspension of tumor cells per mL was implanted subcutaneously into the axillary region of BALB / c nude mice (approximately 0.20 mL per mouse). After inoculation, the mice's mental state, diet, and defecation were observed regularly.

[0066] 1.2.2 Experimental grouping and drug administration

[0067] The major diameter (a) and minor diameter (b) of the tumor nodule were measured using vernier calipers, and the result was calculated using the formula V = a × b. 2 The tumor volume is calculated by multiplying by 0.52 when the subcutaneous xenograft grows to 10 mm. 3Then, nude mice with tumors of uniform size were randomly divided into 7 groups of 8 mice each, as follows:

[0068] Model group: Administered an equal volume of physiological saline via gavage once daily.

[0069] Positive control group: 5-fluorouracil (5-Fu), 2 mg / kg / day, administered by gavage in equal volume once daily.

[0070] Examples 1-2 and Comparative Examples 1-3: were administered by gavage at a volume of 30 mg / kg / day once daily.

[0071] After 21 consecutive days of administration, the tumor was removed and its weight was measured 24 hours after the last administration.

[0072] 1.2.3 Experimental Data Processing

[0073] Statistical analysis was performed using GraphPad Prism 8.0, and the experimental results are presented in the following figures. The mean was expressed as p < 0.05. One-way ANOVA analysis was used to compare means among multiple groups, and p < 0.05 was considered statistically significant.

[0074] 1.3 Experimental Results

[0075] The experimental results are shown in Table 1 below.

[0076] Table 1: Effects of the traditional Chinese medicine composition of the present invention on Skov-3 mouse xenografts

[0077] Group Tumor weight (g) Model 2.05±0.78 Positive control 0.53±0.61** Example 1 <![CDATA[0.55±0.59 ** ]]> Example 2 <![CDATA[0.58±0.64 ** ]]> Comparative Example 1 1.57±0.85 Comparative Example 2 1.76±0.83 Comparative Example 3 <![CDATA[0.87±0.72 * ]]>

[0078] Note: Compared with the model group, *p<0.05, **p<0.01.

[0079] As can be seen from the experimental results in Table 1, the effects of the traditional Chinese medicine composition of the present invention (Example 1 and Example 2) on inhibiting ovarian xenograft tumors in mice are comparable to those of the positive control drug 5-Fu, and their effects are significantly different from those of the model group (**p<0.01).

[0080] The results from Comparative Examples 1-3 also show that when the medicinal ingredients in the herbal composition of the present invention are replaced or removed, the effect of the herbal composition on inhibiting ovarian tumors in mice is significantly weakened, indicating that the efficacy of the herbal composition of the present invention is closely related to the types of medicinal ingredients in the prescription. Furthermore, the preparation method of the herbal composition of the present invention also has a significant impact on its effect on inhibiting ovarian tumors in mice; when the preparation method is modified to a direct extract, the efficacy of the herbal composition of the present invention is significantly reduced.

[0081] Example 2: Effect of the herbal composition of the present invention on the interaction of tumor immune checkpoint proteins PD-L1 / PD-1

[0082] The inhibitory activity of the traditional Chinese medicine composition of the present invention on the interaction of tumor immune checkpoint proteins PD-L1 / PD-1 was detected using a kit, thereby detecting the regulatory effect of the traditional Chinese medicine composition of the present invention on tumor immunity.

[0083] Tumor immune escape is a fundamental characteristic of malignant tumors. Tumor cells highly express immune checkpoint proteins such as PD-L1 on their surface. When these proteins bind to PD-1 and other proteins on the surface of cytotoxic T lymphocytes, the T lymphocytes are released from immune surveillance and immune-mediated killing of tumor cells; this is the immune escape mechanism. A PD-L1 kit (Cisbio PD-1 / PD-L1 binding assay kit) containing anti-tag1-Eu, anti-tag2-XL665, and detection buffer, and the positive control drug BMS-1018 was purchased. The various traditional Chinese medicine compositions prepared in the above preparation examples were dissolved in DMSO to prepare buffer solutions with specific concentration gradients. After thorough mixing, 2 mL of the solutions were added to 96-well white ELISA plates. After diluting PD-L1 and PD-1 proteins with buffer, 4 mL was added to each well of a 96-well white microplate. After incubation for 15 minutes, anti-tag1-Eu, anti-tag2-XL665, and detection buffer were added. After incubation at room temperature for 2 hours, fluorescence signals at 665 nm and 620 nm were detected using a Tecan Infinite F200 microplate reader. The inhibition rate of PD-L1 / PD-1 binding was calculated based on the fluorescence ratio, and the IC50 was calculated. 50 The value and evaluation of the regulatory effect of the traditional Chinese medicine composition of the present invention on tumor immunity were also conducted.

[0084] The experimental results are shown in Table 2.

[0085] Table 2: Regulatory effects of the traditional Chinese medicine composition of the present invention on tumor immunity

[0086]

[0087]

[0088] As can be seen from the experimental results in Table 2, the regulatory effect of the traditional Chinese medicine composition of the present invention (Example 1 and Example 2) on tumor immunity is comparable to that of the positive control drug.

[0089] The results from Comparative Examples 1-3 also show that when the medicinal ingredients in the herbal composition of this invention are replaced or removed, the regulatory effect of the herbal composition on tumor immunity is significantly weakened, indicating that the efficacy of the herbal composition of this invention is closely related to the types of medicinal ingredients in the prescription. Furthermore, the preparation method of the herbal composition of this invention also has a significant impact on its tumor immune-regulating effect; when the preparation method is modified to a direct extract, the efficacy of the herbal composition of this invention is significantly reduced.

[0090] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating ovarian cancer, characterized in that: The traditional Chinese medicine composition is made of raw medicinal materials in the following weight proportions: 20 parts of Huangqi, 20 parts of Guizhi, 15 parts of Fuling, 15 parts of Taoren, 15 parts of Jiaogulian, 10 parts of Danpi, 5 parts of Houpu, and 4 parts of Shuijia, ​ The preparation method of the traditional Chinese medicine composition comprises the following steps: (1) mixing Guizhi, Jiaogulian, Houpu, and Shuijia to perform ultrafine grinding, to obtain mixed ultrafine powder, wherein the fineness of the ultrafine powder is 100 mesh; (2) decocting Huangqi, Fuling, Taoren, and Danpi with water, filtering the first decoction liquid after 1.5 hours of first decoction, adding water to the filter residue to perform second decoction for 1.5 hours, filtering the second decoction liquid, combining the first decoction liquid and the second decoction liquid, and preparing a concentrated liquid through concentration; (3) spraying the mixed ultrafine powder prepared in step (1) into the concentrated liquid prepared in step (2) as a base material, performing one-step granulation, mixing uniformly, and preparing the traditional Chinese medicine composition granules, The traditional Chinese medicine composition has the effects of reducing tumor cell proliferation, regulating tumor immunity, and reducing toxicity and increasing efficacy.

2. The preparation method of the traditional Chinese medicine composition according to claim 1, characterized in that: The preparation method comprises the following steps: (1) mixing Guizhi, Jiaogulian, Houpu, and Shuijia to perform ultrafine grinding, to obtain mixed ultrafine powder, wherein the fineness of the ultrafine powder is 100 mesh; (2) decocting Huangqi, Fuling, Taoren, and Danpi with water, filtering the first decoction liquid after 1.5 hours of first decoction, adding water to the filter residue to perform second decoction for 1.5 hours, filtering the second decoction liquid, combining the first decoction liquid and the second decoction liquid, and preparing a concentrated liquid through concentration; (3) spraying the mixed ultrafine powder prepared in step (1) into the concentrated liquid prepared in step (2) as a base material, performing one-step granulation, mixing uniformly, and preparing the traditional Chinese medicine composition granules.

3. Use of the traditional Chinese medicine composition of claim 1 or the traditional Chinese medicine composition prepared by the preparation method of claim 2 in the preparation of a medicine for treating ovarian cancer.

4. Use according to claim 3, characterized in that: The ovarian cancer is ovarian cancer of the type of qi stagnation and blood stasis.

5. Use according to claim 3 or claim 4, characterized in that: The dosage form of the medicine is granules, tablets, oral liquid, or capsules.

6. Use according to claim 5, characterized in that: The dosage form of the medicine is granules.