A traditional Chinese medicine composition for treating primary liver cancer and application thereof

Abstract

This invention relates to a traditional Chinese medicine composition for treating primary liver cancer. The composition is made from the following raw materials in parts by weight: 25-30 parts of *Codonopsis pilosula*, 10-15 parts of *Cremastra appendiculata*, 15-20 parts of *Scutellaria barbata*, 20-25 parts of *Curcuma zedoaria*, 10-15 parts of *Polygonum cuspidatum*, and 5-10 parts of *Citrus reticulata*. This invention also provides applications of the traditional Chinese medicine composition. The "Liver-Clearing Formula" of this invention uses a combination of various traditional Chinese herbs, focusing on "damp-heat, phlegm, qi stagnation, and blood stasis." The six herbs are combined to both attack and tonify, supporting the body's resistance and eliminating pathogenic factors, aiming to achieve the goal of strengthening the body's resistance and reducing pathogenic factors, thus achieving the effects of clearing heat and dampness, promoting qi circulation, resolving phlegm, and breaking up blood stasis. This helps improve the patient's quality of life and prognosis. At the same time, the use of this traditional Chinese medicine is expected to reduce the toxicity and enhance the efficacy of Western medicine, reducing adverse reactions and achieving the best therapeutic effect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating primary liver cancer and its application. Background Technology

[0002] Primary liver cancer is one of the most common malignant tumors in clinical practice. It is prone to recurrence and metastasis. In the early stages, it is often asymptomatic or has atypical symptoms. By the time clinical symptoms become significant, the disease has usually progressed to the middle or late stages. Typical manifestations include pain in the liver area, gastrointestinal symptoms, fever, and ascites. 70-80% of liver cancer patients have already experienced tumor metastasis at the time of diagnosis, which is considered middle or late-stage liver cancer, making surgery an option. Among patients who undergo surgery, the 5-year recurrence rate is as high as 60-70%, affecting long-term survival and becoming a bottleneck for further improving the overall efficacy of liver cancer treatment. Therefore, expanding the treatment methods for liver cancer is of great clinical significance. The main methods of Western medicine treatment for liver cancer include surgical treatment, interventional vascular therapy, radiotherapy, local ablation therapy, chemotherapy, and molecular targeted therapy. Among these, surgical treatment is considered a positive and effective treatment option. However, surgical resection does not necessarily improve the overall survival rate, has a high complication rate, and carries significant surgical risks. Interventional vascular therapy has limited efficacy; local ablation therapy and radiotherapy have poor prognoses and are prone to recurrence; chemotherapy is still not ideal in improving the overall survival rate; and many new molecular targeted drugs are still in the experimental stage. Traditional Chinese medicine (TCM) treatment adopts a clinical diagnosis and treatment model that combines disease and syndrome differentiation. Focusing on the core pathogenesis of "the waxing and waning of cancer toxins," it categorizes liver cancer into three stages: early-stage (damaged vital energy, lingering cancer toxins), where treatment emphasizes prevention of postoperative recurrence and metastasis; mid-to-late-stage (internal accumulation of cancer toxins, lingering vital energy), where treatment focuses on reducing or alleviating complications and improving efficacy and quality of life; and end-stage (intense cancer toxins, deficient vital energy), where treatment emphasizes strengthening the body's resistance, leveraging its overall regulatory advantages to alleviate symptoms, improve quality of life, and appropriately prolong survival. Extensive clinical practice has demonstrated that TCM can effectively reduce the recurrence and metastasis rates of liver cancer, prolong patient survival, and improve their quality of life.

[0003] Currently, modern medicine offers a variety of treatments for liver cancer, including hepatectomy, liver transplantation, ablation therapy, endovascular interventional therapy, radiotherapy, and systemic anti-tumor therapy. Hepatectomy involves removing a localized lesion from the liver while preserving sufficient healthy liver tissue. Liver transplantation involves implanting a healthy liver into the patient. Liver cancer ablation therapy uses physical or chemical methods to target and kill tumor tissue directly. Transarterial chemoembolization (TACE) primarily inhibits tumor growth and induces tumor cell necrosis and apoptosis by embolizing the blood supply arteries to the tumor. Radiotherapy uses radiation to destroy the DNA of tumor cells, leading to cell death. Systemic therapy (systemic treatment) mainly refers to anti-tumor therapy, including targeted drug therapy, immunosuppressant therapy, chemotherapy, and traditional Chinese medicine. It also includes treatment for underlying liver cancer diseases, such as antiviral therapy, hepatoprotective and choleretic therapy, and supportive symptomatic treatment.

[0004] Although there is no explicit name for liver cancer in ancient Chinese medical texts, there are numerous diseases with similar clinical symptoms, such as "abdominal distension," "jaundice," "accumulation," and "mass." Professor Wang believes that the main cause of liver cancer is the obstruction of damp heat, which leads to the obstruction of the flow of water, fire, and qi, gradually resulting in the accumulation of pathological products. Qi, phlegm, and blood stasis intertwine in the liver's blood vessels, gradually forming masses, accumulations, and mass.

[0005] Currently, the main treatments for primary liver cancer include hepatectomy, liver transplantation, ablation therapy, endovascular interventional therapy, and radiotherapy. However, the choice of treatment is limited depending on the patient's condition, and these treatments are often accompanied by unpleasant clinical symptoms and complications. Long-term use may lead to the following shortcomings: 1. Postoperative complications (including liver dysfunction, intra-abdominal hemorrhage, intra-abdominal infection, ascites, bile leakage, venous thrombosis, liver failure, etc.); 2. Tumor recurrence and metastasis; drug rash, hand-foot-mouth disease, gastrointestinal abnormalities, etc.; 3. Reduced response rate to repeat treatment: TACE treatment may result in a reduced response rate to repeat treatment.

[0006] Chinese patent document CN104857151A discloses a traditional Chinese medicine for treating primary liver cancer, composed of the following raw materials in the indicated weight ratios: 10-20 parts of *Polygonum multiflorum*, 5-15 parts of *Rhizoma Scutellariae*, 10-20 parts of *Alum*, 10-20 parts of *Astragalus membranaceus*, 10-20 parts of *Rhodiola rosea*, 5-10 parts of ginseng, 5-10 parts of *Ganoderma lucidum*, 5-15 parts of *Fructus Gardeniae*, 5-10 parts of *Herba Andrographis paniculata*, 25-40 parts of *Polygonum cuspidatum*, 15-25 parts of *Smilax china*, 5-10 parts of *Tripterygium wilfordii*, 5-15 parts of *Scutellaria barbata*, 5-10 parts of *Hedyotis diffusa*, 10-20 parts of *Radix Bupleuri*, 10-15 parts of *Cortex Rhizoma*, 10-20 parts of *Radix Panax notoginseng*, and 10-15 parts of *Solanum lyratum*. The traditional Chinese medicine for treating primary liver cancer of this invention is derived from years of clinical trials. It mainly uses Polygonum cuspidatum, Rabdosia rubescens, Solanum lyratum, and alum to inhibit the growth of cancer cells and eliminate the causes of liver cancer. It is supplemented with Ganoderma lucidum, ginseng, licorice, and Astragalus membranaceus to strengthen the body and nourish the vital energy. Combined with other drugs to clear heat and detoxify, it can effectively relieve and cure the symptoms of liver cancer tumors.

[0007] There are many traditional Chinese medicine (TCM) compositions for treating primary liver cancer, but they all have drawbacks to varying degrees. For example, they contain too many ingredients, are difficult to source, and are expensive; their efficacy is not obvious, and their treatment effect is poor. Therefore, there is an urgent need for TCM compositions that are effective in treating primary liver cancer, contain fewer ingredients, are practical to use, have high compliance, and are safe and effective. Summary of the Invention

[0008] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating primary liver cancer and its application.

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating primary liver cancer, the traditional Chinese medicine composition being made from the following raw materials in parts by weight: 25-30 parts of Codonopsis pilosula, 10-15 parts of Cremastra appendiculata, 15-20 parts of Scutellaria barbata, 20-25 parts of Curcuma zedoaria, 10-15 parts of Polygonum cuspidatum, and 5-10 parts of Citrus reticulata peel.

[0010] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 26-29 parts of Codonopsis pilosula, 11-14 parts of Cremastra appendiculata, 16-19 parts of Scutellaria barbata, 21-24 parts of Curcuma zedoaria, 11-14 parts of Polygonum cuspidatum, and 6-9 parts of Citrus reticulata peel.

[0011] As another preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 28 parts of Codonopsis pilosula, 12 parts of Cremastra appendiculata, 18 parts of Scutellaria barbata, 22 parts of Curcuma zedoaria, 13 parts of Polygonum cuspidatum, and 8 parts of Citrus reticulata peel.

[0012] As another preferred example, the medicine composition is in the form of tablets, capsules, granules, oral liquids, or syrups.

[0013] Secondly, this invention provides the application of traditional Chinese medicine compositions in the preparation of drugs for treating primary liver cancer.

[0014] The advantages of this invention are:

[0015] This invention relates to a traditional Chinese medicine composition (Qinggan Fang), consisting of Codonopsis pilosula, Citrus reticulata peel, Polygonum cuspidatum, Scutellaria barbata, Curcuma zedoaria, and Cremastra appendiculata. It is used for patients with primary liver cancer whose vital energy is not yet depleted, damp-heat is not yet eliminated, and phlegm and blood stasis are intertwined. Polygonum cuspidatum: The *Jinkui Yaolue* (Essential Prescriptions of the Golden Chamber) states, "All cases of jaundice originate from dampness." Professor Wang, through clinical observation, believes that the initial cause of liver cancer is inseparable from dampness, with damp-heat being the most common. Damp-heat accumulates and transforms into turbid pathogens, entering the blood, thus causing jaundice of the skin and sclera. This is confirmed in *Danxi Xinfa* (Danxi's Heart Method): "Jaundice need not be divided into five types; they are all due to damp-heat, similar to the jaundice in Anqu." In liver cancer patients, phlegm and blood stasis are entangled in the blood. Herbs like Artemisia capillaris and Lysimachia christinae, which clear damp-heat from the qi level, are insufficient to combat the disease's progression. Therefore, Polygonum cuspidatum, which clears damp-heat from the blood level and enters the liver and gallbladder meridians, is necessary. Polygonum cuspidatum is bitter and cold in nature; its bitterness can dry dampness, and its coldness can clear heat. The *Mingyi Bielu* records that it can "promote menstruation and break up blood stasis." Modern pharmacological studies have shown that Polygonum cuspidatum can inhibit the proliferation, migration, and invasion of liver cancer cells through multiple pathways: for example, polygalactosin upregulates miR-877-5p to inhibit Huh-7 liver cancer cells; it can also fight cancer by promoting apoptosis, such as upregulating the protein expression of Bax, Caspase-3, and Caspase-9 and downregulating the protein expression of Bcl-2 to induce apoptosis in liver cancer. As for dried tangerine peel (Chenpi): the *Suwen* states, "All dampness and swelling belong to the spleen." Although liver cancer originates in the liver, its source of damp-heat lies in the spleen. The *Bingji Shazhuan* states, "Dampness steams and heat accumulates, obstructing the flow of qi." Gastrointestinal symptoms in liver cancer patients, such as decreased appetite, abdominal distension, and a thick, greasy tongue coating, can all be attributed to dampness obstructing the flow of Qi, leading to dysfunction of Qi circulation and the accumulation of phlegm and dampness. The *Yimen Falu* states, "Mass, lumps, and lumps are the root of distension," while the *Shennong Bencao Jing* considers tangerine peel to "treat chest masses, heat, and rebellious Qi." Therefore, tangerine peel is used to regulate Qi and dry dampness. Regulating Qi makes it difficult for lumps to accumulate, and drying dampness reduces the further damage to the body caused by pathological products. Modern pharmacological studies show that the main active ingredient in tangerine peel, noriheptacortine, can induce cell cycle arrest and apoptosis by downregulating Bcl-2 and Cox-2 and upregulating the expression of Bax and Caspase-3 proteins, thus playing an anti-proliferation and anti-apoptotic role in liver cancer cells. Codonopsis pilosula: The *Synopsis of Prescriptions of the Golden Chamber* states, "When one sees a liver disease, knowing that the liver transmits to the spleen, one should first strengthen the spleen." *Collection of Treatises on Diagnosis and Treatment* says, "Distension and fullness are invariably caused by initial deficiency of the spleen and stomach, leading to the inability to transform dampness, turbidity, and phlegm." Gao Shizong believed that abdominal distension was caused by "deficiency of the spleen and failure of the earth element, resulting in a lack of interaction between heaven and earth." Therefore, protecting the spleen is essential throughout the treatment of liver cancer. Codonopsis pilosula is mild in nature, tonifying qi and nourishing yin, strengthening the spleen, and inhibiting the source of phlegm production, without the dryness and stagnation associated with herbs like Astragalus membranaceus and Codonopsis pilosula. Curcuma zedoaria: Although phlegm and blood stasis are pathological products, they inevitably accumulate over time, harming the liver and spleen, making the disease stubborn and difficult to treat. *Danxi's Heart Method* states, "When clear and turbid substances mix, the channels are blocked, stagnation occurs, qi stagnates and blood stagnates..." In liver cancer patients, the initial damp-heat evil lingers, leading to stagnation of spleen and stomach qi, accumulation of fluids and phlegm, flowing into the liver vessels, obstructing blood flow, and forming blood stasis.This theory aligns with the academic thought in *Zheng Zhi Hui Bu* that "phlegm mixed with blood stasis congeals to form masses," and also conforms to Zhu Danxi's academic view that "qi itself forms masses, masses themselves form phlegm, and phlegm mixed with blood stasis forms masses." Therefore, in treatment, *Curcuma zedoaria* is chosen to break up blood stasis and qi stagnation, while *Cremastra appendiculata* is used to resolve phlegm and dissipate masses. Zhang Xichun believed that *Curcuma zedoaria* can both break up blood stasis and regulate qi. *Medical Records of Integrating Chinese and Western Medicine* states: "If we talk about dissipating qi and blood, *Cyperus rotundus* is even more effective than *Sparganium stoloniferum* and *Curcuma zedoaria*. If we talk about eliminating masses, even ten times the amount of *Cyperus rotundus* is not as good as *Sparganium stoloniferum* and *Curcuma zedoaria*." In addition, this formula contains *Codonopsis pilosula* and *Citrus reticulata* to protect the spleen and stomach's vital energy, and the blood-activating herbs can be chosen with confidence. Furthermore, modern research has found that *Curcuma zedoaria* can increase serum albumin levels in rats with liver fibrosis and improve the pathological changes in liver tissue of model rats. *Cremastra appendiculata*: As a common anti-tumor drug, it has the effects of resolving phlegm and dissipating nodules, and can exert cytotoxic effects. Its main component, total alkaloids of *Cremastra appendiculata*, can directly kill tumor cells; it can also inhibit cancer cell proliferation by increasing cAMP levels, changing the growth characteristics of cancer cell membranes, and inhibiting the cell cycle; it also induces tumor cell apoptosis by upregulating p53 and downregulating Bcl-2 expression. It also inhibits tumor angiogenesis: by inhibiting vascular endothelial cell proliferation and preventing cells from entering the cell cycle. It is a major force in traditional Chinese medicine's anti-tumor efforts. *Scutellaria barbata*: The *Synopsis of Prescriptions of the Golden Chamber* states, "When blood is not flowing smoothly, it becomes water." Traditional Chinese medicine believes that blood and water, as pathological products, are of the same origin and can transform into each other. Therefore, treatment should address both blood and water simultaneously, following the "removing stagnant matter" method in the *Inner Canon of Medicine*, promoting blood circulation to promote diuresis, and promoting diuresis to promote blood circulation. *Scutellaria barbata* is chosen to promote blood circulation and diuresis, transforming tangible accumulations into water, providing an outlet for pathogenic factors. Modern research has confirmed that the anti-cancer effect is exerted by arresting the cell cycle, inducing apoptosis and autophagy, and inhibiting tumor metastasis and tumor angiogenesis.

[0016] This invention, the "Liver-Clearing Formula," employs a combination of various traditional Chinese herbs, focusing on "damp-heat, phlegm, qi stagnation, and blood stasis." The six herbs work together to both attack and tonify, supporting the body's resistance and eliminating pathogenic factors. The aim is to strengthen the body's vital energy and reduce pathogenic factors, achieving the effects of clearing heat and dampness, promoting qi circulation, resolving phlegm, and breaking up blood stasis. This helps improve patients' quality of life and prognosis. Furthermore, the use of traditional Chinese medicine is expected to reduce the toxicity and enhance the efficacy of Western medicine, minimizing adverse reactions and achieving optimal therapeutic results. It is hoped that the development of the "Liver-Clearing Formula" will provide new ideas and methods for the clinical treatment of primary liver cancer. Attached image description:

[0017] Figure 1 The inhibitory effect of Qingganfang on the growth of subcutaneous xenografts of liver cancer in mice: (A) Tumor growth curves of mice in each group; (B) Display of mice with subcutaneous xenografts of liver cancer in each group; (C) Final weight of mice with subcutaneous xenografts of liver cancer in each group.

[0018] Figure 2 HE staining of mouse sections with subcutaneous hepatocellular carcinoma xenografts

[0019] Note: L: Low-dose group of Qingganfang, M: Medium-dose group of Qingganfang, H: High-dose group of Qingganfang. Detailed Implementation

[0020] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0021] Example 1: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (Part 1)

[0022] 28 parts of Codonopsis pilosula, 12 parts of Cremastra appendiculata, 18 parts of Scutellaria barbata, 22 parts of Curcuma zedoaria, 13 parts of Polygonum cuspidatum, and 8 parts of Citrus reticulata peel.

[0023] Example 2: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (Part Two)

[0024] 28 parts of Codonopsis pilosula, 10 parts of Cremastra appendiculata, 20 parts of Scutellaria barbata, 22 parts of Curcuma zedoaria, 10 parts of Polygonum cuspidatum, and 6 parts of Citrus reticulata peel.

[0025] Example 3: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (Part Three)

[0026] 25 parts of Codonopsis pilosula, 15 parts of Cremastra appendiculata, 16 parts of Scutellaria barbata, 20 parts of Curcuma zedoaria, 15 parts of Polygonum cuspidatum, and 9 parts of Citrus reticulata peel.

[0027] Example 4: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (Part Four)

[0028] Codonopsis pilosula 30 parts, Cremastra appendiculata 11 parts, Scutellaria barbata 19 parts, Curcuma zedoaria 25 parts, Polygonum cuspidatum 11 parts, Citrus reticulata 8 parts.

[0029] Example 5: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (Part 5)

[0030] 26 parts of Codonopsis pilosula, 14 parts of Cremastra appendiculata, 18 parts of Scutellaria barbata, 21 parts of Curcuma zedoaria, 14 parts of Curcuma longa, and 5 parts of Citrus reticulata peel.

[0031] Example 6: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (VI)

[0032] 29 parts of Codonopsis pilosula, 12 parts of Cremastra appendiculata, 15 parts of Scutellaria barbata, 24 parts of Curcuma zedoaria, 13 parts of Polygonum cuspidatum, and 10 parts of Citrus reticulata peel.

[0033] Example 7: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (VII)

[0034] 28 parts of Codonopsis pilosula, 11 parts of Cremastra appendiculata, 19 parts of Scutellaria barbata, 25 parts of Curcuma zedoaria, 15 parts of Polygonum cuspidatum, and 9 parts of Citrus reticulata peel.

[0035] Example 8: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (Part 8)

[0036] 25 parts of Codonopsis pilosula, 14 parts of Cremastra appendiculata, 18 parts of Scutellaria barbata, 21 parts of Curcuma zedoaria, 11 parts of Polygonum cuspidatum, and 8 parts of Citrus reticulata peel.

[0037] Example 9: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (IX)

[0038] Codonopsis pilosula 30 parts, Cremastra appendiculata 12 parts, Scutellaria barbata 15 parts, Curcuma zedoaria 24 parts, Polygonum cuspidatum 14 parts, Citrus reticulata 5 parts.

[0039] Example 10: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (X)

[0040] 26 parts of Codonopsis pilosula, 10 parts of Cremastra appendiculata, 20 parts of Scutellaria barbata, 22 parts of Curcuma zedoaria, 13 parts of Polygonum cuspidatum, and 10 parts of Citrus reticulata peel.

[0041] Example 11: A Traditional Chinese Medicine Composition for Treating Primary Liver Cancer (XI)

[0042] 29 parts of Codonopsis pilosula, 15 parts of Cremastra appendiculata, 16 parts of Scutellaria barbata, 20 parts of Curcuma zedoaria, 10 parts of Polygonum cuspidatum, and 6 parts of Citrus reticulata peel.

[0043] Example 12: Preparation of a Traditional Chinese Medicine Composition for Treating Primary Liver Cancer

[0044] Weigh each component according to the Chinese medicine formula (take any of the drug compositions described in Examples 1-11), add water to cover the raw herbs, soak for 30-40 minutes, bring to a boil over high heat, then simmer over low heat for 20-30 minutes. Repeat the simmering process 2-3 times, and then combine the decoctions.

[0045] Example 13

[0046] Effects of Qinggan Formula on Growth Inhibition and Pathological Morphology of Mouse Model of Subcutaneous Hepatocellular Carcinoma Xenograft

[0047] 1.1 Experimental Materials

[0048] 1.1.1 Laboratory Animals

[0049] Twenty-five SPF-grade male C57BL / 6 mice, 6 weeks old and weighing 18.5±0.9g, were purchased from Shanghai Slack Laboratory Animal Co., Ltd. The animals were housed in the animal laboratory of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, under a temperature maintained at 22±2℃ and a relative humidity maintained at 45%-55%, in a 12h light / dark cycle environment.

[0050] 1.1.2 Experimental Cells

[0051] The murine hepatocellular carcinoma cell line Hepa1-6 was purchased from the Cell Bank of the Chinese Academy of Sciences and is stored at the Shared Experimental Platform Institute of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine.

[0052] 1.1.3 Experimental Drugs

[0053] The liver-clearing granules were provided by Sichuan New Green Pharmaceutical Technology Development Co., Ltd., and purchased from the outpatient pharmacy of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated to Shanghai University of Traditional Chinese Medicine.

[0054] 1.2 Experimental Methods

[0055] 1.2.1 Animal experimental protocol:

[0056] Inject 0.2 mL per mouse at a density of 5*10 6 A mouse model of subcutaneous hepatocellular carcinoma xenograft was constructed using Hepa1-6 cell suspension at a concentration of [number] cells / mL. The mice were randomly divided into five groups of five mice each, based on body weight: model group, low-dose Qingganfang (Example 1) group, medium-dose Qingganfang (Example 1) group, high-dose Qingganfang (Example 1) group, and sorafenib group. The model was established on day seven post-injection, and drug administration began. Administered via gavage continuously. The low-dose Qingganfang group received 0.195 g / kg / day, the medium-dose Qingganfang group received 0.39 g / kg / day, and the high-dose Qingganfang group received 0.78 g / kg / day. The model group received saline via gavage. The sorafenib group received 30 mg / kg / day. Blood samples were collected after 21 days of administration and stored at -80°C for later use.

[0057] 1.2.2 HE staining of tumor tissue

[0058] The extracted subcutaneous tumor tissue was fixed and dehydrated by immersion in 4% paraformaldehyde, followed by serial sectioning and drying. The sections were dewaxed, washed, and stained, then immersed in anhydrous ethanol and xylene, and finally mounted with neutral resin. After completing these steps, the mouse subcutaneous xenograft sections were scanned and photographed using a panoramic tissue cell quantitative analysis system.

[0059] 1.3 Experimental Results

[0060] The experimental results showed that, compared with the model group, both the medium-dose group (P<0.05) and the high-dose group (P<0.01) of Qingganfang could inhibit the growth of tumors in mice. The high-dose group of Qingganfang had a stronger inhibitory effect than the medium-dose group and was close to that of the sorafenib group (P<0.01). Although the statistical difference in the low-dose group of Qingganfang was not significant, it still suggests that different doses of Qingganfang inhibited the growth of subcutaneous xenografts modeled with Hepa1-6 cells, and the inhibitory effect was stronger with the increase of the concentration of Qingganfang.

[0061] ( Figure 1 )

[0062] After drug administration, the morphological changes of subcutaneous xenografts in mice of each group were observed by HE staining. Figure 2The liver cancer cells in the model group and the low-dose Qingganfang treatment group showed larger nuclei, deeper staining, and more compact cell arrangement. Compared with the model group, the liver cancer cells in the medium- and high-dose Qingganfang treatment groups showed larger intercellular spaces, looser cell arrangement, ruptured and shrunken nuclei, and lighter overall staining.

[0063] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating primary liver cancer, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 25-30 parts of Codonopsis pilosula, 10-15 parts of Cremastra appendiculata, 15-20 parts of Scutellaria barbata, 20-25 parts of Curcuma zedoaria, 10-15 parts of Polygonum cuspidatum, and 5-10 parts of Citrus reticulata peel.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 26-29 parts of Codonopsis pilosula, 11-14 parts of Cremastra appendiculata, 16-19 parts of Scutellaria barbata, 21-24 parts of Curcuma zedoaria, 11-14 parts of Polygonum cuspidatum, and 6-9 parts of Citrus reticulata peel.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 28 parts of Codonopsis pilosula, 12 parts of Cremastra appendiculata, 18 parts of Scutellaria barbata, 22 parts of Curcuma zedoaria, 13 parts of Polygonum cuspidatum, and 8 parts of Citrus reticulata peel.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is in the form of tablets, capsules, granules, oral liquids, or syrups.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for treating primary liver cancer.

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