Traditional Chinese medicine composition for dissolving nodules and tumors, its preparation method and application

Abstract

This invention discloses a traditional Chinese medicine composition for dissolving nodules and tumors, its preparation method, and its application. The composition comprises the following components in parts by weight: 4-8g of *Taxus wallichiana*, 20-40g of *Actinidia chinensis* root, 5-25g of *Lobelia chinensis*, 20-40g of *Scutellaria barbata*, 20-40g of *Hedyotis diffusa*, 1-5g of *Scolopendra subspinipes*, 5-15g of *Curcuma zedoaria* (processed with vinegar), 5-25g of *Solanum lyratum*, 20-40g of *Astragalus membranaceus*, 5-15g of *Angelica sinensis*, 5-25g of *Pseudostellaria heterophylla*, 5-25g of *Poria cocos*, 5-25g of *Atractylodes macrocephala* (stir-fried with wheat bran), 20-40g of *Coix lacryma-jobi*, 5-15g of *Pinellia ternata* (processed with ginger), 5-15g of *Citrus reticulata* peel, and 5-15g of *Glycyrrhiza uralensis*. This formula combines tonification and purgation, nourishing qi and blood, regulating the spleen and stomach, and dissolving nodules and tumors. This invention, through the addition and subtraction of prescription drugs, can dissolve nodules and eliminate tumors in the early stage of gastric and intestinal tumor treatment, while protecting the spleen and stomach's qi and blood; in the middle stage of gastric and intestinal tumor treatment, it can strengthen the spleen, resolve dampness, detoxify and disperse nodules, combining attack and tonification; in the terminal stage of gastric and intestinal tumor treatment, it can invigorate qi and support the body's resistance, while also having anti-cancer effects.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine preparation for tumor treatment, in particular to the technical field of Huajie Xiaoliang traditional Chinese medicine composition, its preparation method and application. BACKGROUND

[0002] Tumor includes benign tumor and malignant tumor, while cancer refers to malignant tumor. At present, the main treatment methods of cancer include internal medicine treatment, surgical treatment and radiotherapy. The treatment characteristics of modern medicine are to pay attention to local control of tumor and to have strong killing power on tumor cells of cancer, which can better control local tumor, but often neglects the adjustment of whole body function, which easily leads to excessive treatment of cancer, and the result is often that the physical function of patients is damaged and the quality of life is reduced. In addition, patients with advanced cancer lack surgical indications, and radiotherapy, chemotherapy and targeted therapy usually cause great harm to the physical condition of patients.

[0003] At present, some industry insiders have prepared drugs for treating tumors according to traditional Chinese medicine, such as the cancer relieving and pain relieving ointment disclosed in the invention patent with the announcement number CN1052648C, the Huajie Xiaoliang ointment disclosed in the invention patent with the announcement number CN1111041C and the anti-leukemia traditional Chinese medicine preparation compound Huangdai tablet and its preparation method disclosed in the invention patent with the announcement number CN100393329C. However, the first two kinds of formulae both contain realgar, and the carrier in the ointment is not safe enough, and the compound Huangdai tablet involved in the third patent literature will cause the increase of ALT at large and medium doses, indicating that it has certain hepatotoxicity, and it is only applied to the treatment of hematological diseases, and is difficult to be applied to the treatment of digestive tract tumors. In addition, the invention patent with the announcement number CN102861193B also discloses a traditional Chinese medicine composition for treating gastric cancer. However, it is only effective for in vitro tumor experiments and mouse experiments, and the treatment effect on actual patients is questionable, the treatment cycle is not explained, and the actual promotion has certain limitations. SUMMARY

[0004] The purpose of the present application is to solve the problems in the prior art, and to propose a Huajie Xiaoliang traditional Chinese medicine composition, its preparation method and application. The pathogenesis of tumor cannot be separated from five factors of deficiency, dampness, heat, toxin and blood stasis. It is deficiency of vital qi, disorder of spleen and stomach transportation, dysfunction of viscera, leading to qi stagnation, dampness accumulation, heat and toxin, and accumulation for a long time. Therefore, the treatment principles are to invigorate the spleen, eliminate dampness, tonify qi and nourish blood, clear heat and resolve toxin, promote blood circulation to remove blood stasis, soften and resolve masses and support healthy qi and eliminate pathogenic factors. The present application uses strict drugs and strict compatibility, and has significant clinical effect, which is very suitable for the treatment of digestive tract cancer such as colorectal cancer and gastric cancer.

[0005] To achieve the above purpose, the present application realizes the following technical scheme:

[0006] The herbal composition for dissolving nodules and eliminating tumors consists of the following components in parts by weight:

[0007] Southern yew 4-8g, Actinidia chinensis root 20-40g, Lobelia chinensis 5-25g, Scutellaria barbata 20-40g, Hedyotis diffusa 20-40g, Scolopendra subspinipes 1-5g, Curcuma zedoaria (processed with vinegar) 5-15g, Solanum lyratum 5-25g, Astragalus membranaceus 20-40g, Angelica sinensis 5-15g, Pseudostellaria heterophylla 5-25g, Poria cocos 5-25g, Atractylodes macrocephala (stir-fried with wheat bran) 5-25g, Coix lacryma-jobi 20-40g, Pinellia ternata (processed with ginger) 5-15g, Citrus reticulata peel 5-15g, and Glycyrrhiza uralensis 5-15g.

[0008] Preferably, the raw material consists of the following components in parts by weight:

[0009] 4g of Taxus wallichiana, 20g of Actinidia chinensis root, 5g of Lobelia chinensis, 20g of Scutellaria barbata, 20g of Hedyotis diffusa, 1g of Scolopendra subspinipes, 5g of Curcuma zedoaria (processed with vinegar), 5g of Solanum lyratum, 20g of Astragalus membranaceus, 5g of Angelica sinensis, 5g of Pseudostellaria heterophylla, 5g of Poria cocos, 5g of Atractylodes macrocephala (stir-fried with wheat bran), 20g of Coix lacryma-jobi, 5g of Pinellia ternata (processed with ginger), 5g of Citrus reticulata peel, and 5g of Glycyrrhiza uralensis.

[0010] Preferably, the raw material consists of the following components in parts by weight:

[0011] 6g of Taxus wallichiana, 30g of Actinidia chinensis root, 15g of Lobelia chinensis, 30g of Scutellaria barbata, 30g of Hedyotis diffusa, 3g of Scolopendra subspinipes, 10g of Curcuma zedoaria (processed with vinegar), 15g of Solanum lyratum, 30g of Astragalus membranaceus, 10g of Angelica sinensis, 15g of Pseudostellaria heterophylla, 15g of Poria cocos, 15g of Atractylodes macrocephala (stir-fried with wheat bran), 30g of Coix lacryma-jobi, 10g of Pinellia ternata (processed with ginger), 10g of Citrus reticulata peel, and 10g of Glycyrrhiza uralensis.

[0012] Preferably, the raw material consists of the following components in parts by weight:

[0013] 8g of Taxus wallichiana, 40g of Actinidia chinensis root, 25g of Lobelia chinensis, 40g of Scutellaria barbata, 40g of Hedyotis diffusa, 5g of Scolopendra subspinipes, 15g of Curcuma zedoaria (processed with vinegar), 25g of Solanum lyratum, 40g of Astragalus membranaceus, 15g of Angelica sinensis, 25g of Pseudostellaria heterophylla, 25g of Poria cocos, 25g of Atractylodes macrocephala (stir-fried with wheat bran), 40g of Coix lacryma-jobi, 15g of Pinellia ternata (processed with ginger), 15g of Citrus reticulata peel, and 15g of Glycyrrhiza uralensis.

[0014] The application of traditional Chinese medicine compositions for dissolving nodules and eliminating tumors is used in the preparation of drugs for the treatment of digestive tract tumors.

[0015] Preferably, the dosage form of the gastrointestinal tumor treatment drug is a decoction, pill, capsule, tablet or granule.

[0016] The preparation method of the traditional Chinese medicine composition for dissolving nodules and eliminating tumors includes the following steps:

[0017] a) Weigh out the following ingredients according to their respective weight proportions: 4-8g of Taxus wallichiana, 20-40g of Actinidia chinensis root, 5-25g of Lobelia chinensis, 20-40g of Scutellaria barbata, 20-40g of Hedyotis diffusa, 1-5g of Scolopendra subspinipes, 5-15g of Curcuma zedoaria (processed with vinegar), 5-25g of Solanum lyratum, 20-40g of Astragalus membranaceus, 5-15g of Angelica sinensis, 5-25g of Pseudostellaria heterophylla, 5-25g of Poria cocos, 5-25g of Atractylodes macrocephala (stir-fried with wheat bran), 20-40g of Coix lacryma-jobi, 5-15g of Pinellia ternata (processed with ginger), 5-15g of Citrus reticulata peel, and 5-15g of Glycyrrhiza uralensis.

[0018] b) Grind the centipede into a fine powder and set aside;

[0019] c) Soak the remaining sixteen herbs (excluding centipede) in water, then boil them several times. Combine the decoctions obtained from each boiling and filter them. Then concentrate the filtrate into an extract.

[0020] d) Mix the crushed centipede evenly into the extract.

[0021] Preferably, in step c), the soaking time is 20 to 40 minutes, and 10 to 14 times the amount of water is added during decoction, with a decoction time of 1 to 2 hours.

[0022] The pathogenesis of digestive tract tumors: The pathogenesis of gastric and colorectal cancer is due to a deficiency of the body's vital energy (Qi), which makes it unable to resist external pathogens, leading to the accumulation of pathogens in the stomach and intestines, resulting in disease. Therefore, "strengthening the body's vital energy" plays a crucial role in the entire treatment of gastric and colorectal cancer. Jin-Yuan dynasty physicians Zhang Yuansu and Li Dongyuan believed that a deficiency of the body's vital energy was a significant cause of accumulation, proposing the concept of "nourishing the body's vital energy to eliminate accumulation," which is the prototype of the later "strengthening the body's vital energy and nourishing the foundation" method. Ming dynasty physician Li Zhongzi proposed an aggressive treatment approach, which, while addressing the "accumulation," should adjust the proportion of medications according to the stage of the disease: in the early stage, the focus is on attacking the pathogens; in the middle stage, it is on strengthening the body's vital energy and attacking the pathogens; and in the late stage, it is on strengthening the body's vital energy. Furthermore, it is important to avoid being impatient in attacking the pathogens, so as not to damage the body's vital energy. The pathogenesis involves five factors: deficiency, dampness, heat, toxicity, and blood stasis. It stems from internal deficiency of vital energy, dysfunction of the spleen and stomach, and disharmony of the internal organs, leading to qi stagnation, dampness accumulation, and heat toxicity. Over time, these accumulate. Therefore, this formula strengthens the spleen, resolves dampness, detoxifies, and disperses nodules, exerting a combined effect of supporting the body's resistance to pathogens and tonifying while attacking to combat tumors. This invention fully embodies the scientific principle of medication that exerts anti-cancer therapeutic effects by regulating the balance of the body's overall physiological functions.

[0023] The treatment principle and method of this formula are: to strengthen the spleen, resolve dampness, detoxify, and dissipate nodules.

[0024] The ingredients in this formula are derived from three classic formulas: Gui Bu Xue Tang, Liu Jun Zi Tang, and Xiao Liu Tang, with modifications. The chief herbs are Taxus chinensis and Actinidia chinensis root; the assistant herbs are Lobelia chinensis, Scutellaria barbata, Hedyotis diffusa, Scolopendra subspinipes, Curcuma zedoaria (processed with vinegar), and Solanum lyratum; the adjuvant herbs are Astragalus membranaceus, Angelica sinensis, Codonopsis pilosula, Citrus reticulata peel, Pinellia ternata (processed with ginger), and Coix lacryma-jobi; and the guiding herb is Glycyrrhiza uralensis. Among them, the principal herbs, Taxus chinensis and Actinidia chinensis root, have the effects of clearing heat and detoxifying, reducing swelling and stopping bleeding; the auxiliary herbs, Lobelia chinensis, Scutellaria barbata, Hedyotis diffusa, and Actinidia chinensis root, are used to clear heat and detoxify, reduce swelling and dissipate nodules. Centipede, Curcuma zedoaria (processed with vinegar), and Solanum lyratum are added to soften hardness and dissipate nodules, resolve blood stasis and relieve pain, and together they are the assistant herbs; the adjuvant herbs are Astragalus membranaceus, Angelica sinensis, and Codonopsis pilosula to replenish qi and nourish blood, and are combined with the Six Gentlemen Decoction plus Coix lacryma-jobi to dry dampness and resolve phlegm, regulate qi and harmonize the middle jiao, and invigorate qi and strengthen the spleen; Glycyrrhiza uralensis harmonizes all the herbs and is the guiding herb.

[0025] The beneficial effects of this invention are:

[0026] This formula employs a comprehensive approach, combining both tonifying and purging methods. It nourishes qi and blood, regulates the spleen and stomach, and also dissolves nodules and tumors. Through adjustments to the formula, this invention can dissolve nodules and tumors while protecting the spleen and stomach's qi and blood in the early stages of gastrointestinal tumor treatment; in the middle stages, it can strengthen the spleen, resolve dampness, detoxify, and disperse nodules, combining tonifying and purging methods; and in the final stages, it can tonify qi and strengthen the body's resistance, while also possessing anti-cancer effects. Therefore, this formula can exert good efficacy throughout the entire course of gastrointestinal tumor treatment.

Detailed Implementation Methods

[0027] Example 1:

[0028] Weigh out the following ingredients according to their respective weight proportions: 4g of Taxus wallichiana, 20g of Actinidia chinensis root, 5g of Lobelia chinensis, 20g of Scutellaria barbata, 20g of Hedyotis diffusa, 1g of Scolopendra subspinipes, 5g of Curcuma zedoaria (processed with vinegar), 5g of Solanum lyratum, 20g of Astragalus membranaceus, 5g of Angelica sinensis, 5g of Pseudostellaria heterophylla, 5g of Poria cocos, 5g of Atractylodes macrocephala (stir-fried with wheat bran), 20g of Coix lacryma-jobi, 5g of Pinellia ternata (processed with ginger), 5g of Citrus reticulata peel, and 5g of Glycyrrhiza uralensis. Grind the Scolopendra subspinipes into a fine powder and set aside. Soak the remaining sixteen herbs (excluding the Scolopendra subspinipes) in water for 0.5 hours to replenish the water absorption, then add 12 times the amount of water and decoct three times (1.5 hours each time). Combine the decoctions and let them settle overnight. Concentrate the filtrate under reduced pressure (concentration vacuum degree: -0.05 MPa, concentration temperature: 80℃) to a relative density of 1.30–1.40 (60℃), and set aside the extract. Add dextrin and crushed centipede to the extract and mix thoroughly. Then spray with 70% ethanol to granulate, dry at 70℃, and granulate to make 1000g of granules.

[0029] Example 2:

[0030] Weigh out the following ingredients according to their respective weight proportions: 6g of Taxus wallichiana, 30g of Actinidia chinensis root, 15g of Lobelia chinensis, 30g of Scutellaria barbata, 30g of Hedyotis diffusa, 3g of Scolopendra subspinipes, 10g of Curcuma zedoaria (processed with vinegar), 15g of Solanum lyratum, 30g of Astragalus membranaceus, 10g of Angelica sinensis, 15g of Pseudostellaria heterophylla, 15g of Poria cocos, 15g of Atractylodes macrocephala (stir-fried with wheat bran), 30g of Coix lacryma-jobi, 10g of Pinellia ternata (processed with ginger), 10g of Citrus reticulata peel, and 10g of Glycyrrhiza uralensis.

[0031] Everything else is the same as in Example 1.

[0032] Example 3:

[0033] Weigh out the following ingredients according to their respective weight proportions: 8g of Taxus wallichiana, 40g of Actinidia chinensis root, 25g of Lobelia chinensis, 40g of Scutellaria barbata, 40g of Hedyotis diffusa, 5g of Scolopendra subspinipes, 15g of Curcuma zedoaria (processed with vinegar), 25g of Solanum lyratum, 40g of Astragalus membranaceus, 15g of Angelica sinensis, 25g of Pseudostellaria heterophylla, 25g of Poria cocos, 25g of Atractylodes macrocephala (stir-fried with wheat bran), 40g of Coix lacryma-jobi, 15g of Pinellia ternata (processed with ginger), 15g of Citrus reticulata peel, and 15g of Glycy

[0034] Everything else is the same as in Example 1.

[0035] Example 4:

[0036] A mouse subcutaneous xenograft model of colon cancer was established to verify the intervention effect of Huajie Digestive Tumor Granules (the granules prepared in Example 2) on colon cancer (CC) and its regulation of related proteins.

[0037] A mouse subcutaneous xenograft model of colon cancer was established using the CT 26.WT colon cancer cell line as cuttings. Tumor-bearing mice were randomly divided into a model group, a positive control group (Tegafur, Gimeracil and Oteracil Potassium Capsules, S-1), a low-dose Huajiexiaoliu Granules group (36.92 g / kg, HJFL), a high-dose Huajiexiaoliu Granules group (73.84 g / kg, HJFH), and low / high dose Huajiexiaoliu Granules combined with Tegafur Capsules groups (HJFL+S-1, HJFH+S-1). The effects of these treatments on growth status, tumor growth, and body weight changes were observed in each group. Simultaneously, hematoxylin-eosin (HE) staining was used to examine changes in tumor tissues of mice in each group. Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) in mouse serum. Immunohistochemistry (IHC) was used to investigate the regulatory effect of Huajie Xiaoliu Granules on apoptosis-related proteins in mice. Western blotting (WB) was used to investigate the regulatory effect of Huajie Xiaoliu Granules on the expression of related proteins and key target proteins in tumor tissues, further elucidating the in vivo anti-CC mechanism of Huajie Xiaoliu Granules.

[0038] In tumor-bearing mouse experiments, compared with the model group, mice in the tegafur capsule group, the high- and low-dose Huajiexiaoliu granule groups, and the combined tegafur capsule group showed better survival. Among them, the two groups using Huajiexiaoliu granule combined with tegafur capsules showed the best survival. In the comparison model group, all groups of mice showed significant inhibitory effects on tumor growth, significantly reducing the tumor volume growth trend and tumor weight (P<0.01). The inhibition rate, from highest to lowest, was: high-dose Huajiexiaoliu granule + tegafur capsule group > low-dose Huajiexiaoliu granule + tegafur capsule group > tegafur capsule group > high-dose Huajiexiaoliu granule group > low-dose Huajiexiaoliu granule group. In addition, HE staining results showed that the cells in the tumor tissue of the model group mice were tightly packed and the overall growth was good. In the tumor tissues of the other groups of mice, the tumor cell nuclear structure showed varying degrees of necrosis and rupture, and the remaining intact cells were loosely packed and swollen. Among them, the combination of Huajiexiaoliu granule and tegafur capsules showed the most significant inhibitory effect on tumor tissue. ELISA results showed that the serum levels of IL-1β, IL-6, and TNF-α in the model control group were significantly higher than those in the blank control group (P < 0.01). The serum levels in all other groups of tumor-bearing mice were significantly lower than those in the model control group. In the preliminary study of the mechanism of action, immunohistochemical and Western blotting results indicated that the high- and low-dose groups of Huajie Xiaoliu granules, the tegafur capsule group, and the combined administration group all significantly regulated the expression of the PI3K / AKT signaling pathway and apoptosis-related proteins.

[0039] Example 5:

[0040] Using HCT 116 human colon cancer cells as subjects, the effects of serum containing Huajie Xiaoliu Granules (granules prepared in Example 2) on the proliferation, migration and apoptosis of HCT 116 human colon cancer cells were preliminarily investigated using the Cell Counting Kit-8 (CCK8) method, plate cloning, scratch test and Hoechst 33342 staining test.

[0041] The CCK8 assay results showed that the serum containing Huajiexiaoliu granules exhibited a significant dose- and time-dependent inhibitory effect on HCT116 cells in vitro. At the same concentration, the inhibitory rate on HCT116 cells gradually increased with prolonged treatment time; and within the same time frame, the inhibitory effect on cell proliferation gradually increased with increasing concentration from 5%, 10%, to 20%. Plate colony assay results showed that the serum containing Huajiexiaoliu granules reduced the number of HCT116 cell colonies in a dose-dependent manner. Hoechst 33342 staining results showed that the serum containing Huajiexiaoliu granules promoted HCT116 cell apoptosis in a dose-dependent manner. Scratch assay results showed that the serum containing Huajiexiaoliu granules inhibited HCT116 cell migration. These results preliminarily validate that the serum containing Huajiexiaoliu granules can inhibit the proliferation, migration, and apoptosis of HCT116 cells.

[0042] Example 6:

[0043] The granules prepared in Example 2 were used in a clinical study of gastric cancer treatment with the nodule-dissolving and tumor-reducing granules.

[0044] (I) Research Subjects:

[0045] This study recruited 186 patients with gastric cancer. The eight participating hospitals covered five major cities in Hubei Province, all of which were tertiary-level Class A hospitals. The lead institution, Union Hospital affiliated with Huazhong University of Science and Technology, is a national drug clinical trial institution.

[0046] (II) Research Methods:

[0047] This study was a randomized, double-blind, placebo-controlled, multicenter, superiority clinical trial. Patients were randomly assigned to two groups, receiving either Huajie Xiaoliu Granules (experimental group) or a Huajie Xiaoliu Granules mimic (control group) for 6 months. A competitive enrollment process was used among the research centers.

[0048] Dosage and administration: One sachet of Huajie Xiaoliu Granules per dose, dissolved in warm water, three times daily; one sachet of Huajie Xiaoliu Granules mimicry per dose, dissolved in warm water, three times daily. The primary efficacy endpoint is clinical efficacy = (CR + PR + SD) / total number of cases × 100%. Secondary efficacy endpoints include the patient's quality of life score (KPS score), patient safety indicators, and laboratory tests.

[0049] (III) Research Results:

[0050] 1. General Information:

[0051] There were no statistically significant differences in age and sex between the two groups of cases (P>0.05), indicating they were comparable. See

[0052] Tables 1 and 2:

[0053]

[0054] Table 1 Comparison of age distribution between the two groups

[0055] Statistical analysis showed no significant difference in gender distribution between the two groups (P>0.05).

[0056]

[0057] Table 2 Comparison of gender distribution between the two groups

[0058] Statistical analysis showed no significant difference in age distribution between the two groups (P>0.05).

[0059] 2. Comparison of therapeutic efficacy indicators:

[0060] 1) Comparison of the overall clinical effective rate between the two groups of patients:

[0061] After treatment, the total effective rate in the experimental group was 93.55%, which was significantly higher than that in the control group (79.57%) (P<0.05), as shown in Table 3.

[0062]

[0063] Table 3 Comparison of overall clinical efficacy between the two groups

[0064] 2) Traditional Chinese Medicine Symptom Scoring:

[0065] Before treatment, there was no statistically significant difference in TCM symptom scores between the experimental group and the control group (P>0.005). After treatment, the TCM symptom scores of both groups decreased compared with those before treatment (P<0.05). Compared with the control group, the treatment group had lower TCM symptom scores and better treatment effects, with statistically significant differences (P<0.05), as shown in Table 4.

[0066]

[0067] Table 4. TCM symptom scores (χ±s) for the two groups

[0068] 3) Comparison of quality of life between the two groups of patients:

[0069] There was no statistically significant difference in KPS scores between the two groups before treatment (P>0.05); after treatment, the KPS scores of both groups increased compared with those before treatment, and the experimental group was higher than that of the control group (P<0.05), as shown in Table 5:

[0070]

[0071] Table 5 Comparison of the two groups of KPS scores

[0072] The results showed that the effective treatment rate was higher in the experimental group compared with the control group. Compared with before treatment, the TCM symptom scores of both groups decreased after treatment, with the experimental group showing a significantly lower TCM symptom score. Compared with before treatment, the quality of life scores of both groups improved after treatment, with the experimental group showing a significantly higher quality of life score. These findings suggest that the formula for dissolving nodules and eliminating tumors can effectively improve patients' clinical symptoms and enhance their quality of life.

[0073] 3. Safety indicators:

[0074] 1) General physical examination:

[0075] Among the 186 patients observed during the project, no abnormalities were found in respiration, blood pressure, pulse, body temperature, heart rate, and physical examinations of the heart, liver, spleen, lungs, and kidneys before and after treatment.

[0076] 2) Routine blood, urine, and stool tests:

[0077] In the 186 patients observed during the project, no abnormalities were found in routine blood, urine and stool tests before and after treatment.

[0078] 3) Kidney function (Scr, BUN), liver function (ALT, AST):

[0079] Among the 186 patients observed during the project, no abnormalities were found in indicators such as Scr, BUN, ALT, and AST before and after treatment, indicating that liver and kidney function remained relatively stable before and after treatment.

[0080] 4) Electrocardiogram (ECG):

[0081] Of the 186 patients observed during the project, none showed any abnormal signs on electrocardiograms.

[0082] 5) Adverse reactions:

[0083] No adverse reactions were found among the 186 patients observed during the project.

[0084] (IV) Conclusion:

[0085] Huajie Xiaoliu Granules can effectively improve the clinical treatment outcomes of gastric cancer patients, effectively alleviate clinical symptoms such as stomach pain, bloating, and loss of appetite, and improve patients' quality of life. Regarding safety indicators, including general physical examinations, routine blood, urine, and stool tests, renal function (Scr, BUN), liver function (ALT, AST), and electrocardiogram, no adverse reactions were observed, indicating that this formula has high safety. The results clearly demonstrate that Huajie Xiaoliu Granules are an effective formula for the clinical treatment of gastric cancer, providing a new and safe treatment method for gastric cancer and worthy of clinical promotion.

[0086] The above embodiments are illustrative of the present invention and are not intended to limit the present invention. Any simple modifications to the present invention are within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating digestive tract tumor, characterized in that: the raw materials are composed of the following components in weight ratio: Taxus chinensis var. mairei 4-8 g, Smilax riparia 20-40 g, Lobelia deflexa 5-25 g, Lobelia chinensis 20-40 g, Spermacoce latifolia 20-40 g, Solenopsis geminata 1-5 g, Curcuma zedoary 5-15 g, Solanum xanthocarpum 5-25 g, Astragalus membranaceus 20-40 g, Angelica sinensis 5-15 g, Pseudostellaria heterophylla 5-25 g, Poria cocos 5-25 g, Poria cocos 5-25 g, Poria cocos 5-25 g, Coix lachryma-jobi 20-40 g, Pinellia ternata 5-15 g, Citrus reticulata 5-15 g, and Glycyrrhiza 5-15 g; The preparation method comprises the following steps: a) respectively take Taxus chinensis var. mairei 4-8 g, Smilax riparia 20-40 g, Lobelia deflexa 5-25 g, Lobelia chinensis 20-40 g, Spermacoce latifolia 20-40 g, Solenopsis geminata 1-5 g, Curcuma zedoary 5-15 g, Solanum xanthocarpum 5-25 g, Astragalus membranaceus 20-40 g, Angelica sinensis 5-15 g, Pseudostellaria heterophylla 5-25 g, Poria cocos 5-25 g, Poria cocos 5-25 g, Poria cocos 5-25 g, Coix lachryma-jobi 20-40 g, Pinellia ternata 5-15 g, Citrus reticulata 5-15 g, and Glycyrrhiza 5-15 g in weight ratio; b) grind Solenopsis geminata into fine powder for standby; c) soak the remaining sixteen kinds of medicine except Solenopsis geminata in water, then boil in water for several times, combine and filter the decoction obtained in each time, and then concentrate the filtrate into extract; the soaking time is 20-40 min, 10-14 times of water is added during boiling, and the boiling time is 1-2 h; d) uniformly mix the ground Solenopsis geminata into the extract.

2. The Chinese medicine composition for treating digestive tract tumor according to claim 1, characterized in that: the raw materials are composed of the following components in weight ratio: Taxus chinensis var. mairei 4 g, Smilax riparia 20 g, Lobelia deflexa 5 g, Lobelia chinensis 20 g, Spermacoce latifolia 20 g, Solenopsis geminata 1 g, Curcuma zedoary 5 g, Solanum xanthocarpum 5 g, Astragalus membranaceus 20 g, Angelica sinensis 5 g, Pseudostellaria heterophylla 5 g, Poria cocos 5 g, Poria cocos 5 g, Poria cocos 5 g, Coix lachryma-jobi 20 g, Pinellia ternata 5 g, Citrus reticulata 5 g, and Glycyrrhiza 5 g.

3. The Chinese medicine composition for treating digestive tract tumor according to claim 1, characterized in that: the raw materials are composed of the following components in weight ratio: Taxus chinensis var. mairei 6 g, Smilax riparia 30 g, Lobelia deflexa 15 g, Lobelia chinensis 30 g, Spermacoce latifolia 30 g, Solenopsis geminata 3 g, Curcuma zedoary 10 g, Solanum xanthocarpum 15 g, Astragalus membranaceus 30 g, Angelica sinensis 10 g, Pseudostellaria heterophylla 15 g, Poria cocos 15 g, Poria cocos 15 g, Poria cocos 15 g, Coix lachryma-jobi 30 g, Pinellia ternata 10 g, Citrus reticulata 10 g, and Glycyrrhiza 10 g.

4. The Chinese medicine composition for treating digestive tract tumor according to claim 1, characterized in that: the raw materials are composed of the following components in weight ratio: Taxus chinensis var. mairei 8 g, Smilax riparia 40 g, Lobelia deflexa 25 g, Lobelia chinensis 40 g, Spermacoce latifolia 40 g, Solenopsis geminata 5 g, Curcuma zedoary 15 g, Solanum xanthocarpum 25 g, Astragalus membranaceus 40 g, Angelica sinensis 15 g, Pseudostellaria heterophylla 25 g, Poria cocos 25 g, Poria cocos 25 g, Poria cocos 25 g, Coix lachryma-jobi 40 g, Pinellia ternata 15 g, Citrus reticulata 15 g, and Glycyrrhiza 15 g. The digestive tract tumor treating medicine is prepared. The dosage form of the digestive tract tumor treating medicine is decoction, pill, capsule, tablet or granule. ​ ​ 5. The use of the Chinese medicine composition for treating tumors according to any one of claims 1 to 4, characterized in that: ​ 6. The use of the Chinese medicine composition according to claim 5, characterized in that: ​

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