A traditional Chinese medicine compound preparation for treating colorectal cancer and a preparation method and application method thereof

Abstract

The present application relates to a kind of compound traditional Chinese medicine preparation for treating colorectal cancer, it is made by Devil's needle grass, chicken eye grass, Prunus, Terminalia according to certain weight distribution ratio, its preparation method is that the above raw material is added 60% ethanol 10 times, heated reflux extraction 3 times, every 2 hours, extract is combined, recovers ethanol, concentrates and evaporates dry, vacuum drying, different dosage forms corresponding appropriate amount of auxiliary materials are added, and conventional preparation method is used to be made into tablet, capsule, granule, pill and the like.The traditional Chinese medicine compound preparation described in the present application shows that the antitumor effect experiment result has the effect of inhibiting colorectal cancer tumor cell growth.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine compound preparation for treating colorectal cancer, its preparation method and application, belonging to the field of traditional Chinese medicine pharmaceutical manufacturing. Background Technology

[0002] Colorectal cancer (CRC) is a common and prevalent malignant tumor of the digestive system worldwide, characterized by high incidence and mortality. Despite continuous improvements in techniques such as surgery, chemotherapy, radiotherapy, and immunotherapy, many patients still face challenging problems such as poor prognosis, high postoperative recurrence rates, and low five-year survival rates. Traditional Chinese medicine (TCM) theory proposes that the pathogenesis of CRC involves the accumulation of dampness, heat, blood stasis, and toxins, leading to dysfunction of the internal organs. Over time, this results in the accumulation of damp-heat, coupled with insufficient vital energy to resist pathogenic factors. Over time, these pathogenic factors overflow, accumulate, and infiltrate the intestines, eventually leading to CRC. In-depth research into the potential pathological mechanisms and intervention targets of CRC, and the development of safe and effective preventive and therapeutic drugs based on this research, is of paramount clinical significance. TCM theory considers the pathogenesis of CRC to be nothing more than "blood stasis obstruction," "internal accumulation of blood stasis and toxins," and "damp-heat toxins." Therefore, the basic principle of treatment should be "activating blood circulation, removing blood stasis, clearing heat, and detoxifying." Traditional Chinese medicine prescriptions are closely integrated with clinical symptoms, which can give full play to the comprehensive advantages of "multi-component", "multi-pathway" and "multi-target" effects.

[0003] To address the aforementioned problems, this invention aims to provide a traditional Chinese medicine compound for treating colorectal cancer and its preparation method. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine compound preparation for treating colorectal cancer, which has the effect of improving the pathological changes of colorectal cancer. Another purpose of this invention is to provide a method for preparing this traditional Chinese medicine compound preparation.

[0005] A traditional Chinese medicine compound preparation for treating colorectal cancer is made from the following raw materials in the indicated weight ratios: Bidens pilosa 20-40 parts, Cornus officinalis 10-30 parts, Prunus japonica 5-15 parts, Terminalia chebula 3-8 parts.

[0006] The traditional Chinese medicine compound preparation for treating colorectal cancer is made from the following raw materials in the indicated weight ratios: 20 parts Bidens pilosa, 30 parts Cornus officinalis, 5 parts Prunus japonica seed, and 8 parts Terminalia chebula.

[0007] The traditional Chinese medicine compound preparation for treating colorectal cancer is made from the following raw materials in the indicated weight ratios: 40 parts Bidens pilosa, 10 parts Cornus officinalis, 15 parts Prunus japonica seed, and 3 parts Terminalia chebula.

[0008] The traditional Chinese medicine compound preparation for treating colorectal cancer is made from the following raw materials in the indicated weight ratios: 30 parts Bidens pilosa, 20 parts Cornus officinalis, 10 parts Prunus japonica seed, and 5 parts Terminalia chebula.

[0009] The traditional Chinese medicine compound preparation for treating colorectal cancer, after adding appropriate excipients, is prepared into oral liquid, granules, tablets, capsules or micro-pills using conventional preparation methods.

[0010] The traditional Chinese medicine compound preparation for treating colorectal cancer is prepared as follows: Bidens pilosa, Cornus officinalis, Prunus japonica seed, and Terminalia chebula are taken, and 10 times the amount of 60% ethanol is added. The mixture is heated and refluxed three times, each time for 2 hours. The extracts are combined, the ethanol is recovered, the mixture is concentrated and evaporated to dryness, dried under reduced pressure, pulverized into fine powder, and after adding appropriate excipients, the preparation is made using conventional methods.

[0011] The traditional Chinese medicine compound preparation for treating colorectal cancer is prepared under the following conditions: a temperature of 60-70℃ and a pressure of 0.08 MPa.

[0012] The application of the traditional Chinese medicine compound preparation for treating colorectal cancer in the preparation of drugs for treating colorectal cancer.

[0013] The traditional Chinese medicine compound preparation described in this invention originates from a research formula of Nanjing University of Traditional Chinese Medicine. It is selected from four traditional Chinese herbs—Bidens pilosa, Cornus officinalis, Prunus japonica seed, and Terminalia chebula—through rigorous screening. It features combined medicinal use, holistic treatment, and addressing both the root cause and symptoms, demonstrating significant efficacy against colorectal cancer. The pathogenesis of colorectal cancer in Traditional Chinese Medicine is primarily based on "blood stasis," "internal accumulation of toxins," and "damp-heat toxins." Qi stagnation leads to poor blood flow, and internal blood stasis results in abdominal masses. Accumulation of toxins in the internal organs, coupled with spleen and stomach weakness, ultimately leads to colorectal cancer. Based on these characteristics, this invention utilizes clinical methods of promoting blood circulation, removing blood stasis, eliminating carbuncles and detoxifying, and clearing heat and dissipating masses to create a traditional Chinese medicine compound preparation for treating colorectal cancer. This invention, in addition to using herbs that promote blood circulation, remove blood stasis, eliminate carbuncles and detoxify, also incorporates herbs that clear heat and dissipate masses, strengthen the spleen and eliminate dampness, and warm the stomach and intestines. While emphasizing strengthening the body's resistance and dispelling wind, it also focuses on preventing disease and regulating the internal organs.

[0014] The principal herb is Bidens bipinnata L., a plant in the Asteraceae family. It is bitter, slightly cold in nature, and non-toxic. It enters the liver, lung, and large intestine meridians. The *Fujian Folk Herbal Medicine* records that it "disperses blood stasis, invigorates blood circulation, eliminates carbuncles, and detoxifies." The *Illustrated Handbook of Chinese Medicinal Plants* records that "when decocted, it treats dysentery, sore throat, esophageal obstruction and vomiting, pyloric spasm, and esophageal dilatation. It has detoxifying, antidiarrheal, and antipyretic effects. Recently, it has been used to treat appendicitis." The *Quanzhou Materia Medica* records that it "disperses blood stasis, relieves pain, and heals wounds. It treats abdominal pain, postpartum blood stasis, amenorrhea, bleeding from wounds, intestinal bleeding, hemorrhagic diarrhea, and hematuria." The *Eastern Fujian Materia Medica* records that it "treats intestinal abscesses, gonorrhea, malaria, jaundice, dysuria, and traumatic injuries." Meanwhile, modern research shows that the whole Bidens pilosa plant contains alkaloids, tannins, saponins, flavonoids, and other components, and its extracts have anti-inflammatory, analgesic, and antitumor pharmacological effects. In addition, the main effects of Bidens pilosa are "clearing heat and detoxifying, promoting blood circulation and dispelling wind". It is effective for the pathogenesis of colorectal cancer, which is "blood stasis and damp-heat evil toxin". Therefore, Bidens pilosa is used as the chief herb and plays a major role in the treatment of colorectal cancer.

[0015] The herb used is *Kummerowia striata* (Thunb.) Schindl., a plant in the Fabaceae family. It is cool in nature and bitter in taste. It enters the Stomach and Large Intestine meridians. It has the effects of "clearing heat and detoxifying, strengthening the spleen and promoting diuresis." *Ben Cao Qiu Yuan* records that it "treats bruises and swelling, and detoxifies." *Zhi Wu Ming Shi Tu Kao* records that it "removes fire toxins. For heatstroke, pound it to extract the juice, mix it with cool water, and drink it." *Zhong Yao Yi Shi Yan Jiu* records that it "treats leukorrhea in women, damp-heat jaundice, summer diarrhea, intestinal bleeding, and dysentery." *Sichuan Zhong Yao Zhi* records that it "clears heat and disperses heat. Treats lower back pain, diarrhea, heatstroke, and white dysentery." *Shaanxi Zhong Cao Yao* records that it "astringes and consolidates. Treats uterine prolapse and rectal prolapse." Modern research shows that *Kummerowia striata* mainly contains apigenin, quercetin, and various glycosides. In addition, the book "Commonly Used Folk Herbs of Zhejiang" mentions that the main effects of *Gnaphalium affine* are "to promote diuresis and strengthen the spleen, relieve fever and stop dysentery". For the pathogenesis of colorectal cancer with "spleen deficiency and damp-heat evil toxin", it can be combined with the principal herb *Bidens pilosa* to play a better role in treating colorectal cancer. In addition, its spleen-strengthening effect can soothe the abdominal organs, so it is used as an assistant herb.

[0016] Adjuvant herb: Prunus japonica seed, the kernel of plants such as Prunus japonica, Prunus armeniaca, Prunus triloba, and Prunus persica in the Rosaceae family. It is neutral in nature and has a pungent, bitter, and sweet taste. It enters the spleen, large intestine, and small intestine meridians. It has the effects of moistening dryness and lubricating the intestines, lowering qi and promoting urination, treating large intestine qi stagnation, dryness and constipation, difficulty urinating, ascites, edema of the limbs, and beriberi. The *Zhenzhu Nang* records that it "breaks blood stasis and moistens dryness." The *Ben Cao Qiu Zhen* also states that "its taste is pungent, sweet, and bitter, and it can enter the spleen to lower qi, promote urination, and break blood stasis." Furthermore, the *Ri Hua Zi Ben Cao* records that it "eliminates undigested food and lowers qi." The *Ben Cao Zai Xin* records that Prunus japonica seed can "promote urination and lower qi, break blood stasis and reduce swelling, open joints, and treat pterygium." Li Gao, the elder of Dongyuan, also said that it "specifically treats large intestine qi stagnation, dryness, and constipation." Modern research shows that Prunus japonica seed has pharmacological effects such as purgation, anti-inflammatory analgesia, antitussive, and antiasthmatic effects. In summary, the main function of Prunus japonica seed in "moistening dryness and breaking up blood stasis" can work synergistically with Bidens pilosa, the principal herb in treating colorectal cancer, to address the main pathogenesis of "internal blood stasis". At the same time, Prunus japonica seed enters the spleen and small intestine meridians, "can enter the spleen and lower qi", protecting the abdominal organs, and thus serves as an adjuvant for the concurrent symptom of "spleen deficiency" in colorectal cancer.

[0017] The herb used is Terminalia chebula, the mature fruit of the plant Terminalia chebula Retz., belonging to the Combretaceae family. The *Tang Materia Medica* states that it is "bitter, warm, and non-toxic." The *Lei Gong's Treatise on the Processing and Properties of Medicinal Herbs* records that it "enters the lung, liver, spleen, kidney, and large intestine meridians." The main functions of Terminalia chebula are astringent intestinal and lung function, reducing water retention and soothing the throat; it belongs to the astringent category of lung-astringent and intestinal-astringent herbs. The ancient text *Rihuazi Materia Medica* records that it "eliminates phlegm, lowers qi, relieves irritability, treats edema, regulates the middle jiao, stops diarrhea and dysentery, treats cholera, treats kidney qi stagnation, treats shortness of breath, promotes digestion, treats intestinal bleeding, metrorrhagia and leukorrhea, treats five types of diaphragmatic qi, treats premature pregnancy, threatened abortion, and fetal movement, bloating and shortness of breath." Modern research shows that Terminalia chebula mainly contains tannins, chebulic acid, protochebulic acid, gallic acid, and tannin extract, possessing astringent, antidiarrheal, antibacterial, antitumor, and antispasmodic pharmacological effects. Using Terminalia chebula as the guiding herb can harmonize the effects of other herbs, enabling them to work together to expel pathogens. The other herbs mainly function to invigorate blood circulation, remove blood stasis, dispel dampness, strengthen the spleen, and break up stagnation and nodules. As a herb that astringes the lungs and intestines, Terminalia chebula can guide the other herbs directly to the site of the lesion. Its mild medicinal properties can also harmonize the cold and cooling properties of the principal and assistant herbs, thus making it the guiding herb.

[0018] In summary, Bidens pilosa, as the principal herb, plays a key role in this compound preparation by dispersing blood stasis, promoting blood circulation, eliminating swelling, and detoxifying. It addresses the TCM pathogenesis of colorectal cancer, characterized by "internal blood stasis and damp-heat toxins," and thus plays a major role in its treatment. Simultaneously, it warms the stomach, stops diarrhea, relieves pain, and stops bleeding, thus also having a certain regulatory effect on other parts of the body. Therefore, it is considered the principal herb. Cornflower (Gnaphalium affine) clears heat and detoxifies, strengthens the spleen, and promotes diuresis. As a secondary herb, Cornflower assists the principal herb, Bidens pilosa, in treating the primary pathogenesis of colorectal cancer, namely "internal blood stasis," and also addresses the secondary symptoms of colorectal cancer, namely "spleen deficiency and weak stomach, damp-heat toxins," thus playing a certain role in the overall health of the patient. Therefore, it is considered the secondary herb. Prunus japonica seed, as an adjuvant herb, has the main effects of moistening dryness, lubricating the intestines, lowering qi, and promoting diuresis. It can assist the principal herb in treating the primary symptoms. At the same time, Prunus japonica seed enters the spleen and large and small intestine meridians, addressing the secondary symptom of "spleen deficiency." Furthermore, the kernel of Prunus japonica is neutral in nature and will not aggravate the cold nature of the principal and assistant herbs. As for Terminalia chebula, the *Haiyao Bencao* states that it is "sour and astringent in taste, warm, and non-toxic," and can harmonize the effects of other herbs. The *Bencao Tongxuan* records that "when used raw, it can clear heat and regulate qi; when simmered, it can warm the stomach and strengthen the intestines." Therefore, using Terminalia chebula as an assistant herb can enhance the therapeutic effect of the principal herb and also ensure a relatively mild therapeutic effect during treatment, preventing harm to the body.

[0019] In summary, this traditional Chinese medicine compound preparation is based on the concept of "human body as an organic whole," rationally applying theories such as "dialectical treatment" and "holistic view," and prepared according to the principle of "principal, assistant, adjuvant, and guide" drug combination. Its components are clearly defined, and its efficacy is well-known. This compound preparation is non-toxic and harmless to the human body, with mild medicinal properties, and has a significant therapeutic effect on colorectal cancer. It provides colorectal cancer patients with greater options for traditional Chinese medicine compound preparations, offering more treatment options. This can bring certain economic benefits to related enterprises and promote the rapid development of related pharmaceutical industries. At the same time, the development of this traditional Chinese medicine compound preparation also promotes our traditional Chinese medicine culture to a certain extent, allowing more people to recognize and use traditional Chinese medicine products. Attached Figure Description

[0020] Figures 1-4 This invention relates to the effect of a traditional Chinese medicine compound preparation on tumor growth in tumor-bearing mice, wherein... Figure 1 Photos of tumors in mice from each group. Figure 2 This is a statistical graph showing the tumor volume of mice in each group. Figure 3 A statistical chart showing the tumor quality of mice in each group. Figure 4 The graph shows the weight statistics of mice in each group.

[0021] Figures 5-8 This invention relates to the effects of a traditional Chinese medicine compound preparation on liver injury indicators in tumor-bearing mice. Figure 5 This relates to the effect of traditional Chinese medicine compound preparations on serum ALT. Figure 6 The effect of traditional Chinese medicine compound preparations on serum AST. Figure 7The effect of traditional Chinese medicine compound preparations on serum TBIL. Figure 8 This study investigated the effect of traditional Chinese medicine compound preparations on serum ALP levels.

[0022] Figures 9-10 This invention relates to the effects of a traditional Chinese medicine compound preparation on renal injury indicators in tumor-bearing mice, wherein... Figure 9 The effect of traditional Chinese medicine compound preparations on serum BUN. Figure 10 This relates to the effect of traditional Chinese medicine compound preparations on serum CREA.

[0023] Figure 11 This invention relates to the effects of a traditional Chinese medicine compound preparation on the tumor tissue structure of tumor-bearing mice. Detailed Implementation

[0024] The following examples further illustrate the preparation of the traditional Chinese medicine compound preparation of the present invention and its efficacy in treating colorectal cancer.

[0025] Example 1: Preparation of oral liquid

[0026] Take 30g of Bidens pilosa, 20g of Cornus officinalis, 10g of Prunus japonica seed, and 5g of Terminalia chebula. Add 10 times the amount of 60% ethanol and heat under reflux to extract three times, each time for 2 hours. Filter, combine the filtrates, and concentrate under reduced pressure (temperature 65℃, pressure 0.08Mpa) to a relative density of 1.08 (temperature 65℃). Add 1% aspartame and 2% citric acid, stir well, let stand for more than 12 hours, filter, dispense, and sterilize to obtain the final product.

[0027] Example 2: Capsule Preparation

[0028] Take 20g of Bidens pilosa, 30g of Cornus officinalis, 5g of Prunus japonica seed, and 8g of Terminalia chebula. Add 10 times the amount of 60% ethanol and extract by reflux three times, 2 hours each time. Combine the extracts, recover the ethanol, concentrate and evaporate to dryness, dry under reduced pressure (temperature 60℃, pressure 0.08 MPa), pulverize into a fine powder, granulate with ethanol, dry, and encapsulate to obtain the final product.

[0029] Example 3: Granule Preparation

[0030] Take 40g of Bidens pilosa, 10g of Cornus officinalis, 15g of Prunus japonica seed, and 3g of Terminalia chebula. Add 10 times the amount of 60% ethanol and heat under reflux to extract three times, each time for 2 hours. Filter, combine the filtrates, and concentrate under reduced pressure (temperature 70℃, pressure 0.08Mpa) to a relative density of 1.05 (temperature 70℃). Add 2% aspartame, stir well, spray dry, dry granulate, and package in aluminum-plastic composite film to obtain the final product.

[0031] Example 4: Study on the therapeutic effect of the traditional Chinese medicine compound preparation of the present invention on colorectal cancer

[0032] Animal model preparation and drug administration: Six female Balb / c mice (weighing 18g-20g) were randomly divided into a tumor-bearing control group and a tumor-bearing treatment group, with three mice in each group. Mice were cultured in an animal experimental center, given free access to food and water. Mice diets conformed to Chinese standards (LAD1000), and drinking water met the requirements of "Experimental Animal Environment and Facilities" (GB14925-2010). A standard light cycle of 14 hours of light and 10 hours of darkness was maintained, room temperature was controlled between 18-26℃, relative humidity was maintained between 40-70%, noise levels were controlled below 85 decibels, ammonia concentration was maintained below 20 ppm, and ventilation was maintained at 8-12 times / hour. All mice underwent one week of acclimatization before subsequent experiments.

[0033] CT26 cells, a type of colon cancer cell, were cultured and expanded in mice. Two million tumor cells were subcutaneously inoculated into the right back of each mouse. The cells were cultured and expanded until the tumor reached 200 mm in size. 3 Treatment began at [time missing]. Tumor-bearing mice in the treatment group were administered the traditional Chinese medicine compound preparation prepared according to the method described in Example 1 of this invention via gavage at a dose of 300 mg / kg, once daily for 4 weeks. After all experiments were completed, blood was collected from the eyeballs of each mouse. The standard operating procedure (SOP) for euthanizing experimental animals (mice and rabbits) was strictly followed. Each mouse was weighed and the weight recorded. The tumors were dissected, and complete images of the tumors in each tumor-bearing mouse were captured using a camera. The weight of each tumor was measured and recorded using an analytical balance, and the length and width of each tumor were measured and recorded using calipers. After the collected blood samples were allowed to stand at room temperature for 2 hours, they were centrifuged at 3500 rpm for 15 minutes. The supernatant was collected and stored at -20°C for subsequent serological marker detection. A small portion of the tumor from each mouse was fixed in 4% paraformaldehyde for subsequent histopathological section HE staining. We found that the traditional Chinese medicine compound preparation described in this invention can significantly inhibit tumor growth without significant damage to the liver and kidneys. Detailed results are shown in the appendix. Figure 4 .

[0034] 4.1 Effects of traditional Chinese medicine compound preparations on tumor growth in tumor-bearing mice

[0035] We constructed a tumor-bearing mouse model using the CT26 cell line of colorectal cancer derived from mice to investigate the antitumor effect of the traditional Chinese medicine compound preparation described in this invention. The results showed that, compared with the tumor-bearing control group, the tumors in the tumor-bearing treatment group grew more slowly, were smaller in size, and had lower tumor mass. There was no difference in body weight between the two groups. (See details...) Figures 1-4 .

[0036] 4.2 Effects of Traditional Chinese Medicine Compound Preparations on Liver Function Indicators in Tumor-Bearing Mice

[0037] We used a biochemical analyzer to detect serum liver function indicators in tumor-bearing mice. The results showed that the serum ALT level in the normal mouse control group was 20.21±1.74 U / L, AST level was 156.75±10.04 U / L, TBIL level was 16.10±1.02 μmol / L, and ALP level was 79.03±7.32 U / L. In contrast, the serum ALT level in the tumor-bearing mouse control group was 22.52±1.81 U / L, AST level was 226.13±8.24 U / L, TBIL level was 17.88±1.62 μmol / L, and ALP level was 133.20±6.38 U / L. In the tumor-bearing mouse treatment group, serum ALT levels were 23.11±2.32 U / L, AST levels were 189.15±7.91 U / L, TBIL levels were 17.05±1.47 μmol / L, and ALP levels were 89.37±5.41 U / L. While there were no significant differences in ALT and TBIL levels, significant differences were observed in AST and ALP levels, suggesting that the traditional Chinese medicine compound preparation can effectively improve liver function. (See details...) Figures 5-8 .

[0038] Table 1: Serum liver function indicators ALT, AST, TBIL, and ALP in mice of each group (x±S)

[0039]

[0040] (Compared with the normal control group, ***P<0.001, **P<0.05)

[0041] 4.3 Effects of Traditional Chinese Medicine Compound Preparations on Renal Injury Indicators in Tumor-Bearing Mice

[0042] We used a biochemical analyzer to detect serum renal injury markers in tumor-bearing mice. The results showed that the serum BUN level in the normal mouse control group was 5.62±0.69 mg / dL, and the CREA level was 32.07±3.35 μmol / L. In the tumor-bearing mouse control group, the serum BUN level was 6.47±0.88 mg / dL, and the CREA level was 33.22±2.47 μmol / L. In the tumor-bearing mouse treatment group, the serum BUN level was 4.65±0.87 mg / dL, and the CREA level was 37.44±4.35 μmol / L. These results suggest that the traditional Chinese medicine compound preparation can effectively improve renal function. (See details...) Figures 9-10 .

[0043] Table 2: Results of serum renal function indicators BUN and CREA in mice of each group (x±S)

[0044]

[0045] 4.4 Effects of Traditional Chinese Medicine Compound Preparations on Tumor Tissue Structure in Tumor-Bearing Mice

[0046] We performed histopathological examination of tumors in each group of mice using HE staining. The results showed that tumor cells in the control group of tumor-bearing mice exhibited vigorous growth, while the treatment group showed increased tumor cell necrosis and inflammatory cell infiltration, with significant differences (see details below). Figure 11 This indicates that the traditional Chinese medicine compound preparation of the present invention has a certain therapeutic effect on colorectal cancer and also has an effect on improving liver and kidney function.

[0047] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine compound preparation for treating colorectal cancer, characterized in that... It is made from the following raw materials in the indicated weight ratios: 20-40 parts Bidens pilosa, 10-30 parts Cornus officinalis, 5-15 parts Prunus japonica, and 3-8 parts Terminalia chebula.

2. The traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 1, characterized in that, It is made from the following raw materials in the following weight ratio: 20 parts Bidens pilosa, 30 parts Cornus officinalis, 5 parts Prunus japonica seed, and 8 parts Terminalia chebula.

3. The traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 1, characterized in that, It is made from the following raw materials in the indicated weight ratios: 40 parts Bidens pilosa, 10 parts Cornus officinalis, 15 parts Prunus japonica seed, and 3 parts Terminalia chebula.

4. The traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 1, characterized in that, It is made from the following raw materials in the indicated weight ratios: 30 parts Bidens pilosa, 20 parts Cornus officinalis, 10 parts Prunus japonica seed, and 5 parts Terminalia chebula.

5. The traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 1, characterized in that, The preparation method is as follows: Take Bidens pilosa, Cornus officinalis, Prunus japonica seed, and Terminalia chebula, add 10 times the amount of 60% ethanol, heat and reflux to extract 3 times, 2 hours each time, combine the extracts, recover the ethanol, concentrate and evaporate to dryness, dry under reduced pressure, pulverize into fine powder, add appropriate excipients, and prepare the preparation into a formulation using conventional preparation methods.

6. The traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 5, characterized in that, The dosage form of the preparation is one of the following: oral liquid, granules, tablets, capsules, or micro-pellets.

7. The traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 5, characterized in that, The vacuum drying conditions in the preparation method are a temperature of 60-70℃ and a pressure of 0.08 MPa.

8. The application of the traditional Chinese medicine compound preparation for treating colorectal cancer as described in claim 1 in the preparation of drugs for treating colorectal cancer.

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