Traditional Chinese medicine composition for adjuvant therapy of lung cancer

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for adjuvant therapy of lung cancer, which comprises the following components in parts by weight: 25-35 parts of rice worm, 5-15 parts of scorpion, 1-3 parts of centipede, 10-20 parts of American ginseng, 20-30 parts of oldenlandia diffusa, 8-18 parts of curcuma zedoary, 1-10 parts of liquorice and 1-10 parts of ginger. The traditional Chinese medicine composition can be used for alleviating the toxic and side effects of chemotherapy, enhancing the treatment effect and reducing the risk of relapse and metastasis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for adjuvant treatment of lung cancer. Background Technology

[0002] Lung cancer is one of the leading causes of death and morbidity among malignant tumors worldwide. While modern medicine's main treatments, such as chemotherapy, can directly kill tumor cells, they lack specific targeting capabilities. In attacking cancer cells, they severely damage normal tissues, particularly bone marrow hematopoietic cells, digestive tract mucosal cells, and cardiomyocytes, leading to significant toxic side effects such as bone marrow suppression, severe gastrointestinal reactions, hair loss, and cardiotoxicity. This causes many patients to discontinue treatment due to intolerance, severely impacting treatment effectiveness and quality of life.

[0003] From the perspective of Traditional Chinese Medicine (TCM) theory, chemotherapy drugs are considered to be "extremely cold and toxic." According to the core theory of "Yang transforms into Qi, Yin forms into shape" in the *Huangdi Neijing* (Yellow Emperor's Inner Classic), tumors, as tangible "Yin evils," arise and develop fundamentally from insufficient Yang Qi in the body, leading to the accumulation of pathological products such as "cold, dampness, phlegm, and blood stasis," creating a cold and yin-like internal environment. While chemotherapy attacks the "formed" tumor, it severely depletes the body's Yang Qi (spleen Yang, kidney Yang, and heart Yang), essentially adding insult to injury. Although it may temporarily shrink the tumor, it exacerbates the internal cold and yin-like state, creating a hidden danger for tumor recurrence and metastasis.

[0004] The "Warburg Effect" in modern medicine reveals the biological characteristics of cancer cells, which are abnormally active in a hypoxic, acidic (high lactic acid) microenvironment. This microscopic discovery is highly consistent with the macroscopic pathogenesis understanding in Traditional Chinese Medicine (TCM) of "coldness leading to qi stagnation and blood stasis (hypoxia), and dampness and turbidity leading to acid toxicity (phlegm-dampness)." Both point to the fact that one of the fundamental strategies for cancer treatment should be to reverse the pathological internal environment suitable for cancer cell survival. However, the market currently lacks a TCM composition that systematically follows the principle of "strengthening the body's resistance and eliminating pathogenic factors," integrates the aforementioned consensus between TCM and Western medicine, and effectively alters the internal environment while reducing the toxic side effects of chemotherapy through precise formulation. Therefore, it is necessary to develop a TCM composition for the adjuvant treatment of lung cancer to address these issues. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for adjuvant treatment of lung cancer, which addresses the shortcomings of the existing technology. This traditional Chinese medicine composition is used to adjuvant treatment of lung cancer to reduce the toxic side effects of chemotherapy, enhance the therapeutic effect, and reduce the risk of recurrence and metastasis.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0007] A traditional Chinese medicine composition for adjuvant treatment of lung cancer comprises the following components by weight: 25-35 parts of *Polygonum multiflorum*, 5-15 parts of *Scorpion*, 1-3 parts of *Scolopendra subspinipes*, 10-20 parts of *American ginseng*, 20-30 parts of *Hedyotis diffusa*, 8-18 parts of *Curcuma zedoaria*, 1-10 parts of *Glycyrrhiza uralensis*, and 1-10 parts of ginger.

[0008] As an improved technical solution, the traditional Chinese medicine composition comprises the following components by weight: 28-32 parts of *Polygonum multiflorum*, 8-12 parts of *Scorpion*, 1.5-2.5 parts of *Scolopendra subspinipes*, 12-18 parts of *Panax quinquefolius*, 22-28 parts of *Hedyotis diffusa*, 10-15 parts of *Curcuma zedoaria*, 2-8 parts of *Glycyrrhiza uralensis*, and 2-8 parts of ginger.

[0009] As a preferred technical solution, the traditional Chinese medicine composition comprises the following components by weight: 30 parts of rice weevil, 10 parts of scorpion, 2 parts of centipede, 15 parts of American ginseng, 25 parts of oldenlandia diffusa, 12 parts of turmeric, 6 parts of licorice and 5 parts of ginger.

[0010] The traditional Chinese medicine composition of the present invention can be formulated into preparations suitable for oral administration, specifically including: powders, granules, capsules, tablets or oral liquids and other dosage forms.

[0011] The pharmacological properties and efficacy of each herb in the above-described herbal composition are as follows:

[0012] Rice weevil: It is warm in nature and sweet in taste; it enters the spleen, stomach, and liver meridians. It has the effects of invigorating qi and nourishing deficiency, detoxifying and reducing swelling, and strengthening the spleen and eliminating food stagnation; its source: it is the larvae of longhorn beetles that parasitize the trunk of Caesalpinia decapetala (Roth) Alston, which are captured, washed, and dried at low temperature.

[0013] Scorpion: It is neutral in nature, pungent in taste, and poisonous. It enters the liver meridian. It has the effects of calming wind and relieving spasms, attacking toxins and dispersing nodules, and unblocking meridians and relieving pain.

[0014] Centipede: It is warm in nature, pungent in taste, and poisonous, and enters the liver meridian. It has the effects of calming wind and relieving spasms, clearing the meridians and relieving pain, and attacking toxins and dispersing nodules.

[0015] American ginseng: sweet, slightly bitter, and cool in nature; it enters the heart, lung, and kidney meridians; it has the effects of replenishing qi and nourishing yin, clearing heat and promoting body fluid production.

[0016] Hedyotis diffusa: slightly bitter and sweet in taste, cold in nature; enters the stomach, large intestine, and small intestine meridians; has the effects of clearing heat and detoxifying, promoting diuresis and relieving strangury, and cooling blood and detoxifying;

[0017] Curcuma zedoaria: It is warm in nature, pungent and bitter in taste, and enters the liver and spleen meridians; it has the effects of breaking up blood stasis, promoting qi circulation, eliminating stagnation and relieving pain.

[0018] Licorice: neutral in nature and sweet in taste; it enters the heart, lung, spleen, and stomach meridians. It has the effects of invigorating qi and strengthening the middle jiao, clearing heat and detoxifying, harmonizing various medicines, relieving spasms and pain, and moistening the lungs and relieving cough.

[0019] Ginger: warm in nature, pungent in taste; attributive to the lung, spleen and stomach meridians; pungent in taste and warm in nature. It has the effects of inducing sweating to dispel cold, warming the middle-jiao to arrest vomiting, resolving phlegm and relieving cough, and detoxifying and flavoring;

[0020] The relationship of monarch, minister, assistant and guide of the raw materials in this invention:

[0021] Doumi worm is the monarch drug, with a powerful force of "detoxifying and dissipating masses", directly hitting the core pathogenesis of "cancer toxin accumulation" in lung cancer; Scorpion and Centipede are the minister drugs, forming a "trio" with the monarch drug Doumi worm, and their synergistic effect greatly enhances the effect of breaking cancer toxin and dissipating masses; among them, scorpion is good at dredging collaterals to relieve pain and can relieve the chest and hypochondrium pain that may be caused by lung cancer; centipede is good at attacking toxin and dissipating masses, and the two are used in combination, with doubled effect. American ginseng and Oldenlandia diffusa are the assistant drugs. American ginseng can assist healthy qi and prevent the main attacking drugs from excessively consuming the patient's vital qi, providing a material basis for "eliminating pathogenic factors". Oldenlandia diffusa assists the monarch drug and the minister drugs to clear cancer toxin from the perspective of "clearing heat and detoxifying", and can counteract the inflammation that may be caused by tumors. Rhizoma zedoariae is a powerful drug for promoting blood circulation and removing blood stasis, which can help dissipate tumors and relieve pain caused by blood stasis and qi stagnation. Licorice and ginger are the guide drugs. Licorice harmonizes various drugs, relieves spasm and pain, and alleviates symptoms; moreover, its sweet and slow nature can relieve the drastic nature and toxicity of the monarch drug and the minister drugs, and protect the spleen and stomach; ginger harmonizes the stomach and reduces adverse qi, and protects the spleen and stomach.

[0022] After adopting the above technical solution, the beneficial effects of this invention are:

[0023] The monarch drug (Doumi worm) in this invention aims to strongly strengthen the congenital foundation and rekindle the fire of the gate of life, providing the most fundamental "energy source" for reversing the environment, rather than directly attacking cancer. The minister drugs (scorpion and centipede) are powerful and effective, directly attacking the yin pathogen of "forming shape"; among the assistant drugs, rhizoma zedoariae promotes blood circulation and activates qi, specifically solving the problem of hypoxia (qi stagnation and blood stasis) in the "Warburg environment"; Oldenlandia diffusa clears heat and detoxifies, resolving acid toxin (dampness, turbidity and heat toxin); American ginseng benefits qi and nourishes yin, protecting qi and yin during the attack, and ensuring the smooth process of environmental reversal. The guide drug (ginger) can quickly resolve cold-dampness from the root and provide continuous basic power for the entire "environmental reversal" project. The traditional Chinese medicine composition of this invention constructs a multi-target and synergistic "environmental reversal" system.

[0024] The traditional Chinese medicine composition of this invention can effectively prevent and alleviate chemotherapy-induced bone marrow suppression (such as decreased white blood cell and platelet counts), severe gastrointestinal reactions (nausea, vomiting, loss of appetite), and symptoms of Yang deficiency and cold intolerance, ensuring the smooth progress of chemotherapy. Furthermore, by improving the blood oxygen supply and acid-base balance of the tumor microenvironment, it may enhance the sensitivity to chemotherapy drugs; simultaneously, the supported vital energy (immunity) can actively and synergistically eliminate residual cancer cells, thereby improving the tumor remission rate. By altering the cold, damp, and stagnant environment within the body, it fundamentally weakens the survival basis of cancer cells, which has long-term strategic significance for controlling disease progression and preventing tumor recurrence and metastasis. It can significantly improve patients' mental state, physical strength, appetite, and sleep, alleviate cancer pain and malignant effusion, and achieve high-quality survival with the tumor or recovery. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0026] Example 1

[0027] A traditional Chinese medicine composition for adjuvant treatment of lung cancer comprises the following components by weight: 25 parts of rice weevil, 5 parts of scorpion, 1 part of centipede, 10 parts of American ginseng, 20 parts of oldenlandia diffusa, 8 parts of turmeric, 1 part of licorice, and 1 part of ginger.

[0028] After the above raw materials are crushed and sieved, a pharmaceutically acceptable carrier or diluent (such as filler, binder, disintegrant, lubricant, surfactant or flavoring agent) is added to the collected fine powder of Chinese medicine, and then packaged to obtain Chinese medicine powder.

[0029] Pharmaceutically acceptable carriers or diluents refer to conventional drug carriers in the pharmaceutical field, selected from one or more of fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents. Fillers are selected from one or more of starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose, or glucose. Binders are selected from one or more of cellulose derivatives, alginate, gelatin, or polyvinylpyrrolidone.

[0030] Example 2

[0031] A traditional Chinese medicine composition for adjuvant treatment of lung cancer comprises the following components by weight: 28 parts of rice weevil, 8 parts of scorpion, 1.5 parts of centipede, 12 parts of American ginseng, 22 parts of oldenlandia diffusa, 10 parts of turmeric, 2 parts of licorice, and 2 parts of ginger.

[0032] After pulverizing the above raw materials, add one or more pharmaceutically acceptable carriers or diluents (such as fillers, binders, disintegrants, lubricants, surfactants or flavoring agents, as in Example 1), granulate and fill capsules according to conventional methods to obtain traditional Chinese medicine capsules.

[0033] Example 3

[0034] A traditional Chinese medicine composition for adjuvant treatment of lung cancer comprises the following components by weight: 30 parts of rice weevil, 10 parts of scorpion, 2 parts of centipede, 15 parts of American ginseng, 25 parts of oldenlandia diffusa, 12 parts of turmeric, 6 parts of licorice and 5 parts of ginger.

[0035] Extracts of whole scorpion, centipede, American ginseng, Hedyotis diffusa, Curcuma zedoaria, licorice, and ginger, after extraction, filtration, and concentration, are mixed with crushed rice weevils. Pharmaceutically acceptable carriers (such as fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents, as in Example 1) or diluents are added, and the mixture is granulated and dried according to conventional methods to obtain traditional Chinese medicine granules.

[0036] Example 4

[0037] A traditional Chinese medicine composition for adjuvant treatment of lung cancer comprises the following components by weight: 32 parts of rice weevil, 12 parts of scorpion, 2.5 parts of centipede, 18 parts of American ginseng, 28 parts of oldenlandia diffusa, 15 parts of turmeric, 8 parts of licorice, and 8 parts of ginger.

[0038] Extracts of whole scorpion, centipede, American ginseng, Hedyotis diffusa, Curcuma zedoaria, licorice, and ginger, after extraction, filtration, and concentration, are mixed with crushed rice weevils. Pharmaceutically acceptable carriers (such as fillers, binders, disintegrants, lubricants, surfactants, or flavoring agents, as in Example 1) or diluents are added, and the mixture is granulated and dried according to conventional methods to obtain traditional Chinese medicine granules.

[0039] Example 5

[0040] A traditional Chinese medicine composition for adjuvant treatment of lung cancer comprises the following components by weight: 35 parts of rice weevil, 15 parts of scorpion, 3 parts of centipede, 20 parts of American ginseng, 30 parts of oldenlandia diffusa, 18 parts of turmeric, 10 parts of licorice, and 10 parts of ginger.

[0041] After pulverizing the above raw materials, add one or more pharmaceutically acceptable carriers or diluents (such as fillers, binders, disintegrants, lubricants, surfactants or flavoring agents, as in Example 1), and compress them into tablets according to conventional methods, then coat them with a film to obtain traditional Chinese medicine tablets.

[0042] To better demonstrate the superior technical effects of the traditional Chinese medicine composition of this invention, experiments were conducted on lung cancer patients and animals, as detailed below.

[0043] (I) Lung Cancer Patient Experiment

[0044] 1. Experimental subjects

[0045] A total of 210 cases were hospitalized and diagnosed as non-small cell lung cancer by CT or bronchoscopy for localization and pathological or cytological examination. They were randomly divided into five experimental groups (Group 1, Group 2, Group 3, Group 4, and Group 5) and two control groups (Group 1 and Group 2), with 30 cases in each group.

[0046] Experimental group 1 consisted of 14 males and 16 females, aged 33 to 67 years, with a mean age of (47.8 ± 7.5) years.

[0047] Experimental group 2 consisted of 17 males and 13 females, aged 37 to 69 years, with a mean age of (49.6 ± 6.8) years.

[0048] Experimental group 3 consisted of 12 males and 18 females, aged 40 to 71 years, with a mean age of (52.1 ± 8.7) years.

[0049] Experimental group 4 consisted of 11 males and 19 females, aged 35 to 72 years, with a mean age of (48.5 ± 6.5) years.

[0050] The experimental group consisted of 15 males and 15 females, aged 42 to 74 years, with a mean age of (53.3 ± 6.8) years.

[0051] Control group 1 consisted of 17 males and 13 females, aged 32 to 66 years, with a mean age of (51.9 ± 7.6) years.

[0052] Control group 2 consisted of 16 males and 14 females, aged 31 to 68 years, with a mean age of (50.7 ± 8.5) years.

[0053] There were no significant differences in gender, age, etc. between experimental groups 1-5 and control groups 1-2 (P>0.05), making them comparable.

[0054] Exclusion criteria: No clear tumor lesions, not meeting the inclusion criteria; pregnant or lactating women; those with serious cardiovascular or cerebrovascular diseases, mental disorders, etc.; poor compliance.

[0055] 2. Efficacy criteria

[0056] (1) Quality of life (K) was assessed using the Kamofsky score, with specific treatment outcomes categorized into three levels:

[0057] Significant improvement, with all symptoms relieved or disappearing, and a survival period of more than three and a half years.

[0058] It is effective, with partial symptom relief and a survival period of more than one and a half years.

[0059] Ineffective, symptoms showed no improvement, and death occurred within a short period.

[0060] (2) The efficacy evaluation criteria for changes in lesions are divided into 4 levels according to the different changes in the size of the tumor;

[0061] ① Complete remission: The tumor lesions completely disappear and remain so for at least 4 weeks;

[0062] ② Partial remission: The product of the maximum diameter and the maximum vertical diameter of the tumor lesion is reduced by ≥50% and maintained for more than 4 weeks, with no new lesions appearing;

[0063] ③ Stable: The product of the two diameters of the lesion decreases by <50% and increases by <25%, and remains stable for more than 4 weeks without the appearance of new lesions;

[0064] ④ Deterioration: The tumor increases in size by ≥25% or new lesions appear.

[0065] 3. Treatment methods

[0066] All cases in this group had not undergone surgery, chemotherapy, or radiotherapy. Experimental groups 1, 2, 3, 4, and 5 used the traditional Chinese medicine formulas described in Examples 1, 2, 3, 4, and 5, respectively. One dose was taken daily, decocted in water, for two consecutive months as one course of treatment. All patients included in this observation group completed more than one course of treatment and underwent regular follow-up chest X-rays or CT scans.

[0067] Control group 1 received combination chemotherapy, specifically the PC regimen (pemetrexed + cisplatin / carboplatin), depending on the specific circumstances. Specific dosage: Pemetrexed 500 mg / m². 2 Day 1, intravenous infusion; cisplatin 75 mg / m² 2 Alternatively, carboplatin with an AUC of 5-6 was administered via intravenous infusion on day 1. Each cycle lasted 3 weeks, and 2-3 cycles constituted one course of treatment. All patients included in this observation group completed at least one course of treatment and underwent regular follow-up chest X-rays or CT scans.

[0068] Control group 2 received combination chemotherapy, with the GP regimen (gemcitabine + cisplatin / carboplatin) selected based on specific circumstances. Specific dosage: gemcitabine 1000-1250 mg / m². 2 Intravenous infusion on days 1 and 8; cisplatin 75 mg / m² 2 Alternatively, carboplatin with an AUC of 5-6 was administered via intravenous infusion on day 1. Each cycle lasted 3 weeks, and 2-3 cycles constituted one course of treatment. All patients included in this observation group completed at least one course of treatment and underwent regular follow-up chest X-rays or CT scans.

[0069] 4. Results and Analysis

[0070] (1) Results and analysis of quality of life (K)

[0071]

[0072] As shown in Table 1, the overall effective rate of quality of life after treatment with the traditional Chinese medicine compositions of Examples 1-5 was significantly higher than that of the control group (P < 0.05), and no serious adverse events related to the test drug were observed during the treatment. Among them, the traditional Chinese medicine compositions of Examples 3, 4, and 5 showed the best therapeutic effects.

[0073] (2) Results and analysis of efficacy evaluation criteria for changes in lesions

[0074]

[0075] As shown in Table 2, in terms of tumor lesion control, the proportion of patients with stable conditions after treatment with the traditional Chinese medicine compositions of Examples 2-5 was higher than that of the control group, and the proportion of deterioration was lower; among them, the lesion control effect of the traditional Chinese medicine compositions of Examples 3-5 was the most outstanding.

[0076] (3) Post-treatment survival

[0077]

[0078] Note: 0-6 months excludes 6 months, 6-12 months includes 6 months but excludes 12 months.

[0079] As shown in Table 3, the 2-year survival rate after treatment with the traditional Chinese medicine compositions of Examples 2-5 was significantly higher than that of the control group, and the difference was statistically significant (P < 0.05).

[0080] Typical Case

[0081] Case 1

[0082] Patient Zhang, male, 58 years old, with lung adenocarcinoma. After the first cycle of chemotherapy, his white blood cell count dropped to 2.1 × 10⁻⁶. 9 / L. During the second cycle, the drug of this invention was administered, and the lowest white blood cell count during the chemotherapy cycle was maintained at 3.5 × 10⁹ / L. 9 With a volume of over / L, chemotherapy was carried out on time.

[0083] Case 2

[0084] Patient Li, female, 62 years old, with squamous cell carcinoma of the lung. She experienced severe vomiting and loss of appetite after chemotherapy. After taking the drug of this invention for 3 days, her nausea significantly decreased, and her appetite basically returned to normal after a week, with her weight stabilizing.

[0085] Case 3

[0086] Patient Wang, male, 71 years old, had lung adenocarcinoma. Due to his advanced age and poor tolerance, after receiving reduced-dose chemotherapy and continuously taking the drug of this invention for 6 months, a follow-up CT scan showed that the tumor lesions were stable (SD), and his mental state and appetite were good.

[0087] Case 4

[0088] Patient Zhou, male, 70 years old, suffered from squamous cell carcinoma of the lung accompanied by chest pain. After taking the drug of this invention for 10 days, the pain was relieved, and the dosage of opioid analgesics was reduced by 1 / 3.

[0089] Case 5

[0090] Patient Wu, male, 60 years old, underwent surgery for lung adenocarcinoma. After completing adjuvant chemotherapy, he consistently took the composition of this invention for consolidation therapy for 2 years. Regular follow-up examinations 3 years post-surgery showed no recurrence or metastasis.

[0091] (ii) Animal experiments

[0092] 1. Laboratory animals and model construction

[0093] Experimental subjects: SPF-grade C57BL / 6 mice, male, 6-8 weeks old, weighing 18-22g, totaling 60 mice. All mice were housed under standard laboratory conditions (constant temperature and humidity, 12-hour light-dark cycle) with free access to food and water.

[0094] Tumor model: Lewis lung cancer cell line (LLC) was passaged intraperitoneally in mice. LLC cells in the logarithmic growth phase were harvested, and the cell concentration was adjusted to 1×10^7 cells / mL with physiological saline. 0.2 mL of cell suspension was then subcutaneously inoculated into the right anterior axilla of each mouse.

[0095] 2. Experimental grouping and drug administration

[0096] Twenty-four hours after inoculation, mice were randomly divided into six groups of ten mice each: Model control group: administered an equal volume of physiological saline by gavage once daily. Cisplatin positive control group: intraperitoneal injection of cisplatin (3 mg / kg) every three days for a total of three times. Low-dose group: administered 1.0 g / kg by gavage once daily. Medium-dose group: administered 2.0 g / kg by gavage once daily. High-dose group: administered 4.0 g / kg by gavage once daily. Blank control group: no model was established; administered an equal volume of physiological saline by gavage once daily. Treatment continued for 14 days.

[0097] 3. Observation indicators and detection methods

[0098] (1) Examination of tumor inhibition rate

[0099] Four weeks after drug administration or at the humane endpoint, mice were euthanized, and the lung tumors were dissected and weighed to calculate the tumor inhibition rate. Tumor volume and tumor inhibition rate: The long axis (a) and short axis (b) of the tumor were measured with calipers every 3 days, and the tumor volume was calculated using the formula V=ab² / 2. Twenty-four hours after the last administration, all mice were sacrificed, the tumor tissue was completely dissected, weighed, and the tumor inhibition rate was calculated. Tumor inhibition rate (%) = (average tumor weight of the model control group - average tumor weight of the drug-treated group) / average tumor weight of the model control group × 100%;

[0100]

[0101] Table 4 shows that, compared with the model control group, *P<0.05, **P<0.01. The traditional Chinese medicine composition of this invention significantly inhibited tumor growth in low, medium, and high dosage forms, exhibiting a dose-dependent effect.

[0102] (2) Examination of immune organ index

[0103] The spleen and thymus of mice were harvested, weighed, and the organ index (mg / g) was calculated as: organ weight (mg) / body weight (g). Detailed experimental results are shown in Table 5.

[0104]

[0105] Table 5 shows that, compared with the blank control group (##P<0.01), the thymus and spleen indices of the model control group were significantly decreased, demonstrating that successful tumor growth led to immunosuppression in the mice. Compared with the model control group (*P<0.05, **P<0.01);

[0106] The traditional Chinese medicine composition of the present invention can effectively antagonize the immunosuppressive state caused by Lewis lung cancer in a dose-dependent manner, and has a protective effect on the immune system while inhibiting the tumor. This is quite different from the immunotoxicity characteristics of the conventional chemotherapy drug cisplatin.

[0107] (3) Immunohistochemical detection of related protein expression: The protein expression levels of Ki-67 (proliferation marker) and Caspase-3 (apoptosis marker) in tumor tissue were detected. See Tables 3 and 4 for details.

[0108]

[0109] Table 6 shows that the Ki-67 positivity rate was highest in the model control group, indicating active tumor cell proliferation. Compared with the model control group, the Ki-67 positivity rates in the low, medium, and high dose groups were significantly lower (*P<0.05, **P<0.01), showing a dose-dependent effect; that is, the higher the dose, the stronger the inhibitory effect on proliferation. The traditional Chinese medicine composition of this invention can significantly inhibit the proliferative activity of Lewis lung cancer cells.

[0110]

[0111] Table 7 shows that the Caspase-3 positivity rate in the model control group was very low, indicating that there were very few tumor cells undergoing spontaneous apoptosis. Compared with the model control group, the Caspase-3 positivity rates in the low, medium, and high dose groups were significantly increased (*P<0.05, **P<0.01), showing a dose-dependent effect. The traditional Chinese medicine composition of this invention can effectively activate Caspase-3, thereby inducing apoptosis in Lewis lung cancer cells.

[0112] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for adjuvant treatment of lung cancer, characterized in that, The ingredients, by weight, include the following components: 25-35 parts of rice weevil, 5-15 parts of scorpion, 1-3 parts of centipede, 10-20 parts of American ginseng, 20-30 parts of oldenlandia diffusa, 8-18 parts of turmeric, 1-10 parts of licorice, and 1-10 parts of ginger.

2. The traditional Chinese medicine composition for adjuvant treatment of lung cancer according to claim 1, characterized in that, The ingredients, by weight, are as follows: 28-32 parts of rice weevil, 8-12 parts of scorpion, 1.5-2.5 parts of centipede, 12-18 parts of American ginseng, 22-28 parts of oldenlandia diffusa, 10-15 parts of turmeric, 2-8 parts of licorice, and 2-8 parts of ginger.

3. A traditional Chinese medicine composition for adjuvant treatment of lung cancer according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition comprises the following components by weight: 30 parts of rice weevil, 10 parts of scorpion, 2 parts of centipede, 15 parts of American ginseng, 25 parts of oldenlandia diffusa, 12 parts of turmeric, 6 parts of licorice and 5 parts of ginger.

4. A traditional Chinese medicine preparation for adjuvant treatment of lung cancer, characterized in that, The traditional Chinese medicine preparation is made from the traditional Chinese medicine composition of claim 1 and a pharmaceutically acceptable carrier.

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