A traditional Chinese medicine composition with anti-hepatoma recurrence and metastasis effect and a preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine technology, specifically disclosing a traditional Chinese medicine composition with anti-recurrence and metastasis effects on liver cancer and its preparation method, made from the following raw materials: Codonopsis pilosula 20-40 parts, Astragalus membranaceus 20-40 parts, Atractylodes macrocephala 10-20 parts, Angelica sinensis 5-15 parts, Curcuma zedoaria 5-15 parts, Sparganium stoloniferum 5-15 parts, Gynostemma pentaphyllum 2-6 pieces, Turtle shell (processed with vinegar) 5-15 parts, Bupleurum chinense 5-15 parts, Curcuma longa 5-15 parts, Paeonia lactiflora 5-15 parts, Hedyotis diffusa 5-15 parts, and Prunella vulgaris. The traditional Chinese medicine composition provided by this invention uses Codonopsis pilosula, Astragalus membranaceus, and Atractylodes macrocephala to invigorate qi and strengthen the spleen, thereby enhancing the body's immune function. It is combined with Curcuma zedoaria, Sparganium stoloniferum, Gynostemma pentaphyllum, and Turtle shell (processed with vinegar) to break up blood stasis, soften hard masses, and dissipate nodules, directly acting on the pathogenic factors. It is further supplemented with Bupleurum chinense, Curcuma longa, and Paeonia lactiflora to soothe the liver, regulate qi, and promote blood circulation. It also includes Hedyotis diffusa, Prunella vulgaris, Fritillaria thunbergii, and Pinellia ternata to clear heat, detoxify, resolve phlegm, and dissipate nodules. The combined effects of all the herbs in the formula, employing both tonifying and purging methods, effectively inhibit the growth, proliferation, and invasion of liver cancer cells.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition with anti-recurrence and metastasis effects on liver cancer and its preparation method. Background Technology

[0002] Currently, clinical treatments for liver cancer mainly include surgical resection, hepatic artery interventional chemoembolization, radiofrequency ablation, molecular targeted therapy, and immune checkpoint inhibitor therapy. Surgical resection is only suitable for early-stage liver cancer patients; most patients with mid-to-late-stage liver cancer have already lost the opportunity for surgery at the time of diagnosis. Interventional therapy and radiofrequency ablation have good local control effects on large, solitary lesions. While targeted therapy and immunotherapy bring survival benefits to some patients, their efficacy is highly dependent on the expression of specific biomarkers, and only a small percentage of matched patients achieve significant therapeutic effects.

[0003] However, the aforementioned existing treatment techniques are all ineffective in preventing recurrence and distant metastasis after liver cancer surgery. Whether it's surgery, local ablation, or interventional therapy, they primarily target existing visible lesions, lacking the ability to clear tiny cancer cells in the circulatory system or micrometastases already present in the liver but undetectable by imaging. While targeted and immunotherapies can be administered systemically, they suffer from strong drug resistance and limited beneficiaries, failing to fundamentally address the high recurrence and metastasis rates. Clinical data shows that the 5-year recurrence rate after liver cancer surgery is as high as 60%-80%, and recurrence and metastasis have become a major cause of treatment failure and death for patients. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition with anti-recurrence and metastasis effects on liver cancer and its preparation method, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects on liver cancer, comprising:

[0007] It is made from the following raw materials: Codonopsis pilosula 20-40 parts, Astragalus membranaceus 20-40 parts, Atractylodes macrocephala 10-20 parts, Angelica sinensis 5-15 parts, Curcuma zedoaria 5-15 parts, Sparganium stoloniferum 5-15 parts, Vinegar-processed turtle shell 5-15 parts, Bupleurum chinense 5-15 parts, 2-6 pieces of Gynostemma pentaphyllum (approximately 1-2g each), Curcuma longa 5-15 parts, Paeonia lactiflora 5-15 parts, Hedyotis diffusa 5-15 parts, Prunella vulgaris 5-15 parts, Fritillaria thunbergii 5-15 parts, Pinellia ternata 5-15 parts, and Gallus gallus domesticus gizzard lining 5-15 parts.

[0008] Preferably, it is made from the following raw materials in parts by weight: Codonopsis pilosula 30 parts, Astragalus membranaceus 30 parts, Atractylodes macrocephala 15 parts, Angelica sinensis 10 parts, Gynostemma pentaphyllum 4 pieces, Curcuma zedoaria 10 parts, Sparganium stoloniferum 10 parts, Vinegar-processed turtle shell 10 parts, Bupleurum chinense 10 parts, Curcuma longa 10 parts, Paeonia lactiflora 10 parts, Hedyotis diffusa 10 parts, Prunella vulgaris 10 parts, Fritillaria thunbergii 10 parts, Pinellia ternata 10 parts, and Gallus gallus domesticus gizzard lining 10 parts.

[0009] A method for preparing a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects on liver cancer includes the following steps:

[0010] (a) Soak the stated weight parts of the raw material in water;

[0011] (b) The soaked raw materials are decocted for the first time, and the solid and liquid are separated to obtain the first decoction and the residue;

[0012] (c) Add water to the dregs obtained in step (b) and decoct for a second time, then separate the solid and liquid to obtain the second decoction;

[0013] (d) Combine the first decoction and the second decoction, mix well, and the product is obtained.

[0014] Preferably, in step (a), the soaking time is 20-40 minutes.

[0015] Preferably, in step (b), the amount of water added is 1.5-2.5 liters; the conditions for the first decoction are: bring to a boil over high heat, then simmer over low heat for 20-40 minutes.

[0016] Preferably, in step (c), the amount of water added is 1-2 liters, more preferably 1.5 liters; the conditions for the second decoction are: bring to a boil over high heat, then simmer over low heat for 20-40 minutes.

[0017] Application of traditional Chinese medicine compositions in the preparation of drugs for treating liver cancer.

[0018] The medication is used to relieve fatigue and / or poor appetite caused by liver cancer.

[0019] Application of traditional Chinese medicine compositions in the preparation of drugs for preventing recurrence and / or metastasis of liver cancer.

[0020] Preferably, the dosage form of the drug is a decoction, granules, capsules, or tablets.

[0021] Compared with the prior art, the beneficial effects of the present invention are:

[0022] (1) The traditional Chinese medicine composition provided by this invention uses Codonopsis pilosula, Astragalus membranaceus, Atractylodes macrocephala, and other qi-tonifying and spleen-strengthening herbs to support the body's vital energy and enhance its immune function. At the same time, it is combined with Curcuma zedoaria, Sparganium stoloniferum, Gynostemma pentaphyllum, and vinegar-processed turtle shell, which directly act on pathogenic factors to break up blood stasis, soften hardness, and dissipate nodules. It is further supplemented with Bupleurum chinense, Curcuma longa, and Paeonia lactiflora to soothe the liver, regulate qi, and promote blood circulation and remove blood stasis. Hedyotis diffusa, Prunella vulgaris, Fritillaria thunbergii, and Pinellia ternata are used to clear heat, detoxify, resolve phlegm, and dissipate nodules. The combined use of all the herbs in the formula combines attack and tonification, which can effectively inhibit the growth, proliferation, and invasion of liver cancer cells, and can also regulate the patient's internal environment as a whole and improve immune surveillance function.

[0023] (2) The composition can effectively relieve common cancer-related symptoms such as fatigue and poor appetite in liver cancer patients, improve their quality of life and nutritional status, and provide a good physical foundation for subsequent long-term treatment. Its preparation method is simple and the process conditions are mild. It adopts the traditional water decoction process, which is easy to promote and apply in clinical practice and at home, and patients have high compliance. Attached Figure Description

[0024] Figure 1 This is a process flow diagram of the present invention. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] Example 1:

[0027] Please see Figure 1 As shown, a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects in liver cancer is made from the following raw materials:

[0028] Codonopsis pilosula 30g, Astragalus membranaceus 30g, Atractylodes macrocephala 15g, Angelica sinensis 10g, Curcuma zedoaria 10g, Sparganium stoloniferum 10g, Vinegar-processed turtle shell 10g, Bupleurum chinense 10g, Curcuma longa 10g, 4 pieces of Tianlong (a type of medicinal herb), Paeonia lactiflora 10g, Hedyotis diffusa 10g, Prunella vulgaris 10g, Fritillaria thunbergii 10g, Pinellia ternata 10g, Chicken gizzard lining 10g.

[0029] A method for preparing a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects on liver cancer includes the following steps:

[0030] Place the Chinese medicinal herbs in the above formula in a decoction pot, add drinking water to soak for 30 minutes, the water level should be 3cm above the herbs (about 1.5L). After soaking, add drinking water to a final volume of 2L, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter through an 80-mesh sieve to obtain the first decoction. Add 1.5L of purified water to the dregs, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter again to obtain the second decoction. Combine the two decoctions, concentrate to about 400mL, stir until completely dissolved, and divide into two 200mL packets.

[0031] Example 2:

[0032] Please see Figure 1 As shown, a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects in liver cancer is made from the following raw materials:

[0033] Codonopsis pilosula 30g, Astragalus membranaceus 30g, Atractylodes macrocephala 15g, Angelica sinensis 10g, Curcuma zedoaria 10g, Sparganium stoloniferum 10g, Vinegar-processed turtle shell 10g, Bupleurum chinense 10g, Curcuma longa 10g, 4 pieces of Tianlong (a type of medicinal herb), Paeonia lactiflora 10g, Hedyotis diffusa 10g, Prunella vulgaris 10g, Fritillaria thunbergii 10g, Pinellia ternata 10g, Chicken gizzard lining 10g.

[0034] A method for preparing a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects on liver cancer includes the following steps:

[0035] Place the medicinal materials in the above formula in an extraction tank, add 10 times the amount (v / w) of drinking water, and soak for 20 minutes. Heat to boiling, maintain a gentle boil and simmer for 40 minutes. Pass through a 100-mesh sieve to obtain the first extract. Add 8 times the amount of drinking water to the residue, and simmer for another 40 minutes. Filter to obtain the second extract. Combine the two extracts and concentrate under reduced pressure (temperature 60℃, vacuum degree -0.08MPa) to obtain an extract with a relative density of 1.10-1.15 (measured at 60℃). Take the extract, add an appropriate amount of dextrin to a total volume of 100g, mix well, soften with 85% ethanol, granulate through a 14-mesh sieve, dry at 60℃, and granulate to obtain granules. Each dose of medicinal materials is made into approximately 20g of granules, divided into 2 bags, each bag containing 10g. Take one dose daily, divided into two doses, dissolved in warm water.

[0036] Example 3;

[0037] The traditional Chinese medicine composition described in Example 1 was used to treat postoperative recurrence in hepatocellular carcinoma patients who underwent R0 resection at a tertiary hospital between 2005 and 2025. Inclusion criteria included age 18-75 years, Child-Pugh AB, and postoperative pathological confirmation of microvascular invasion (MVI) grade 2. Patients in the exposure group began taking the composition within 90 days post-surgery and continued for at least 60 doses. The control group did not receive any anti-recurrence treatment during the same period.

[0038] Patients with pre-existing metastasis or portal vein tumor thrombosis, those who received TACE / targeted / immunotherapy within 2 years post-surgery, and those lost to follow-up were excluded. A total of 24 valid cases were included.

[0039] The primary endpoint was recurrence-free survival (RFS), and the secondary endpoint was the 2-year recurrence rate.

[0040] Median relapse response (RFS) and survival were calculated using the Kaplan-Meier method and compared with a matched control group (historical data, n=30) who did not receive any anti-relapse therapy during the same period. Of the 24 patients, 21 were male (87.5%) and 3 were female (12.5%); age ranged from 37 to 70 years, with a median age of 58 years. TNM staging: T1a in 5 cases, T1b in 11 cases, T2a in 3 cases, and T3 in 5 cases; MVI positive (m1) in 4 cases (16.7%). Preoperative median AFP was 108.5 ng / ml (range 1.89-2958.94). All patients underwent R0 resection, and postoperative pathological margins were negative, as shown in the table below.

[0041] 1 23700 March relapse 2 105422 May relapse 3 127005 6 years and 9 months (81 months) No recurrence 4 28890 Relapsed on June 3, 2021 (approximately 97 months later). relapse 5 44178 No recurrence to date (>150 months) No recurrence 6 87960 Last CT scan on September 23, 2024, showed no recurrence (>152 months). No recurrence 7 185551 No recurrence for 14 years after surgery (>168 months) No recurrence 8 215456 Relapsed on August 3, 2021 (approximately 61 months later) relapse 9 245993 No recurrence as of July 18, 2025 (>124 months) No recurrence 10 393770 Relapsed on June 20, 2019 (approximately 36 months later) relapse 11 692027 No recurrence (>18 months) No recurrence 12 690081 Relapsed on March 14, 2022 (approximately 18 months later) relapse 13 704044 No recurrence (>58 months) No recurrence 14 700640 Relapsed on December 13, 2019 (approximately 19 months later) relapse 15 698528 No recurrence (>84 months) No recurrence 16 767872 Relapsed on August 3, 2023 (approximately 37 months later). relapse 17 801085 No recurrence (>40 months) No recurrence 18 1276552 No recurrence (>28 months) No recurrence 19 1276269 No recurrence (>54 months) No recurrence 20 1282147 Relapsed on July 15, 2019 (approximately 20 months later) relapse 21 597008 Relapsed on September 10, 2020 (approximately 36 months later) relapse 22 1070046 Relapsed on September 1, 2021 (approximately 89 months later) relapse 23 2137169 No recurrence (>156 months) No recurrence 24 3585241 Relapsed on October 25, 2024 (approximately 16 months later). relapse

[0042] As shown above, among the 24 patients, the median follow-up time was 72 months (range 18-168 months). Relapses were observed in 12 cases, with a relapse rate of 50.0%. Kaplan-Meier calculations:

[0043] 1-year relapse-free survival rate: 87.5% (21 / 24);

[0044] 2-year relapse-free survival rate: 70.8% (17 / 24);

[0045] 5-year relapse-free survival rate: 54.2% (13 / 24);

[0046] Median relapse-free survival: Not reached (more than 50% of patients remained relapse-free at the follow-up endpoint);

[0047] Thirty matched patients (no statistically significant differences in age, TNM stage, and MVI status compared to the exposed group) who received no traditional Chinese medicine or anti-relapse treatment (only routine follow-up) during the same period and at the same center were selected as controls. The median relapse-free survival in the control group was 18 months (95% CI: 12–24 months), and the 2-year relapse-free survival rate was 46.7% (14 / 30). Compared with the exposed group, the median RFS was significantly prolonged (Log-rank test, P=0.003), and the 2-year relapse-free survival rate was increased by 24.1 percentage points (70.8% vs 46.7%).

[0048] Typical Cases

[0049] Case 1 (Case No. 185551): Cheng Qingxi, male, 60 years old, underwent R0 resection for liver cancer in May 2012. Postoperative pathology showed T1bN0M0 and MVI negative. He started taking medication on June 20, 2012, and continued intermittently until July 25, 2023. At the last follow-up (March 2025), nearly 13 years after the surgery, no signs of recurrence were observed on imaging or AFP.

[0050] Case 2 (Case No. 44178): Huang Taoming, male, 54 years old, underwent liver cancer resection in October 2012. His preoperative AFP level was 448.6 ng / ml. He has been taking medication since the surgery (as of March 2025) and has not relapsed for more than 12 years. His quality of life is good.

[0051] Case 3 (Case No. 127005): Li Yongguang, male, 64 years old, underwent surgery in November 2014, took medication for about 1 year after surgery, and achieved a relapse-free survival of 6 years and 9 months (81 months), which far exceeded the average relapse time of similar patients (about 12-24 months).

[0052] As shown above, the aforementioned traditional Chinese medicine formula, when used for patients after R0 resection of liver cancer, can significantly prolong recurrence-free survival (median RFS not reached vs. 18 months in the control group), with a 2-year recurrence-free survival rate of 70.8%, and some patients achieving more than 10 years of recurrence-free survival. This supports the clinical value of traditional Chinese medicine compositions based on the principles of invigorating qi, promoting blood circulation, removing blood stasis, and eliminating masses in the prevention of liver cancer recurrence and metastasis.

[0053] 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 composition with anti-recurrence and anti-metastasis effects on liver cancer, characterized in that, It is made from the following raw materials: Codonopsis pilosula 20-40 parts, Astragalus membranaceus 20-40 parts, Atractylodes macrocephala 10-20 parts, Gynostemma pentaphyllum 2-6 pieces, Angelica sinensis 5-15 parts, Curcuma zedoaria 5-15 parts, Sparganium stoloniferum 5-15 parts, Vinegar-processed turtle shell 5-15 parts, Bupleurum chinense 5-15 parts, Curcuma longa 5-15 parts, Paeonia lactiflora 5-15 parts, Hedyotis diffusa 5-15 parts, Prunella vulgaris 5-15 parts, Fritillaria thunbergii 5-15 parts, Pinellia ternata 5-15 parts, and Gallus gallus domesticus gizzard lining 5-15 parts.

2. The traditional Chinese medicine composition with anti-recurrence and anti-metastasis effect for liver cancer according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Codonopsis pilosula 30 parts, Astragalus membranaceus 30 parts, Atractylodes macrocephala 15 parts, Gynostemma pentaphyllum 4 pieces, Angelica sinensis 10 parts, Curcuma zedoaria 10 parts, Sparganium stoloniferum 10 parts, Vinegar-processed turtle shell 10 parts, Bupleurum chinense 10 parts, Curcuma longa 10 parts, Paeonia lactiflora 10 parts, Hedyotis diffusa 10 parts, Prunella vulgaris 10 parts, Fritillaria thunbergii 10 parts, Pinellia ternata 10 parts, and Gallus gallus domesticus gizzard lining 10 parts.

3. A method for preparing a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects on liver cancer, characterized in that, Includes the following steps: (a) Soak the stated weight parts of the raw material in water; (b) The soaked raw materials are decocted for the first time, and the solid and liquid are separated to obtain the first decoction and the residue; (c) Add water to the dregs obtained in step (b) and decoct for a second time, then separate the solid and liquid to obtain the second decoction; (d) Combine the first decoction and the second decoction, mix well, and the product is obtained.

4. The method for preparing a traditional Chinese medicine composition with anti-recurrence and anti-metastasis effects for liver cancer according to claim 3, characterized in that: In step (a), the soaking time is 20-40 minutes.

5. The method for preparing a traditional Chinese medicine composition with anti-recurrence and metastasis effect of liver cancer according to claim 3, wherein in step (b), the amount of water added is 1.5-2.5 liters; and the conditions for the first decoction are: bring to a boil over high heat and then simmer over low heat for 20-40 minutes.

6. The method for preparing a traditional Chinese medicine composition with anti-recurrence and metastasis effect of liver cancer according to claim 3, wherein in step (c), the amount of water added is 1-2 liters, preferably 1.5 liters; and the conditions for the second decoction are: bring to a boil over high heat and then simmer over low heat for 20-40 minutes.

7. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating liver cancer.

8. The application according to claim 7, characterized in that, The drug is used to relieve fatigue and / or poor appetite caused by liver cancer.

9. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for preventing recurrence and / or metastasis of liver cancer.

10. The application according to any one of claims 7-9, characterized in that, The dosage form of the drug is decoction, granules, capsules or tablets.

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