Pharmaceutical composition for preventing and / or treating lung cancer as well as preparation method and application thereof

Abstract

The invention provides a pharmaceutical composition for preventing and / or treating lung cancer. The pharmaceutical composition is prepared from the following raw material medicines in parts by weight: 1-2 parts of astragaloside, 1-2 parts of codonopsis pilosula polysaccharide and 0.5-1 part of pericarpium citri reticulatae flavone. The invention also provides a preparation method and application of the pharmaceutical composition. High-purity effective parts such as astragaloside, codonopsis pilosula polysaccharide and pericarpium citri reticulatae flavone are prepared, the specific compatibility proportion of the astragaloside, the codonopsis pilosula polysaccharide and the pericarpium citri reticulatae flavone is optimized, and it is found through in-vivo and in-vitro activity research that after compatibility of the astragaloside, the codonopsis pilosula polysaccharide and the pericarpium citri reticulatae flavone, the obvious lung cancer inhibiting effect is achieved, and after compatibility, the obvious synergistic interaction effect can be achieved.

Description

Technical Field

[0001] This invention relates to a pharmaceutical composition for the prevention and / or treatment of lung cancer. Background Technology

[0002] According to data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 2.2 million new cases of lung cancer and 710,000 deaths worldwide in 2020. A large proportion of NSCLC patients are diagnosed at an advanced stage or with metastasis, missing the optimal window for surgical resection. Currently, the main treatments for advanced lung cancer are chemotherapy and targeted therapy. Gefitinib, erlotinib, and icotinib are first-line molecularly targeted drugs for treating lung cancer, offering advantages such as good tumor control and fewer side effects. However, many patients develop drug resistance 6-10 months after starting treatment, affecting the overall treatment outcome.

[0003] In recent years, traditional Chinese medicine (TCM) has made significant progress in clinical practice, drug development, and standardized research in cancer treatment through the holistic approach of syndrome differentiation and strengthening the body's resistance to pathogens. It has demonstrated unique advantages and potential, and can be combined with Western medicine to play a synergistic role, bringing richer and more humane treatment options to cancer patients. Its distinctive advantages mainly include: (1) "Prevention of disease" and holistic regulation: TCM has advantages in preventing and treating precancerous lesions by adjusting the balance of Yin and Yang and the body's immune system, improving the internal environment of the body, and blocking the path of tumor metastasis. (2) Reduced toxicity and enhanced efficacy: TCM treatment is given at the same time as tumor surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy to reduce toxicity and enhance efficacy, thereby improving the effectiveness of tumor treatment. The combination of Chinese medicine or the combined use of Chinese and Western medicine also shows a synergistic enhancement of anti-tumor effects and helps to reduce the toxic side effects of pure Western medicine. (3) Rehabilitation and quality of life: In the process of cancer rehabilitation, TCM improves physical condition by adjusting the balance of Yin and Yang and the body's immune system, helping patients achieve long-term survival with tumors and improving their quality of life.

[0004] Astragalus membranaceus (Huangqi) is used to treat lung cancer with the main syndrome pattern of "qi deficiency and stagnation of pathogenic factors" and "strengthening the body's resistance and eliminating pathogenic factors" as its basic treatment principle. The mechanism of action of Astragalus membranaceus in treating lung cancer includes inhibiting tumor cell proliferation and promoting apoptosis, inhibiting tumor invasion and migration, regulating the tumor microenvironment, inhibiting tumor angiogenesis, regulating autophagy, inducing macrophage polarization, enhancing the body's immunity and inhibiting immune escape, and reversing cisplatin resistance. The active components of Astragalus membranaceus in treating lung cancer include polysaccharides, saponins, and flavonoids (Ma Dingcai, et al., Research progress on Astragalus membranaceus and its active components in the treatment of lung cancer, Chinese Journal of Traditional Chinese Medicine, 2024, 49(2)). Codonopsis pilosula polysaccharide is one of the most important active parts of Codonopsis pilosula. Modern research shows that it has a variety of biological activities such as anti-tumor, immune enhancement, anti-inflammatory, antioxidant, neuroprotective, hepatoprotective, anti-osteoporosis, anti-obesity, wound healing promotion, lung protection, anti-aging, and others (Zhang Jing. Research progress on the isolation, extraction and bioactivity of Codonopsis pilosula polysaccharide, Shanghai Journal of Agricultural Sciences, 2025, 41(4): 190-194). Flavonoids in tangerine peel are one of the most important effective components of tangerine peel, mainly including hesperidin, hesperidin, and nosperidin. Modern research shows that they have physiological effects such as anti-oxidation, anti-tumor, anti-inflammation, and neuroprotection (Li Keke et al., Research progress on flavonoids in tangerine peel, Food Research and Development, 2017, 38(17): 221-224).

[0005] The pharmacological activities of astragaloside, tangerine peel flavonoids, and codonopsis polysaccharides have been reported, but each has certain limitations in application: astragaloside and codonopsis polysaccharides are better at immunomodulation, but their direct inhibitory effect on tumor cells is relatively weak; although tangerine peel flavonoids can inhibit cancer cell proliferation, their target sites are relatively limited, and they may irritate the gastrointestinal tract. Furthermore, tumor development involves multiple signaling pathways and biological processes, making comprehensive intervention difficult with a single component. Currently, there are no reports in the literature on the combined use of these three effective components. Summary of the Invention

[0006] This invention provides a pharmaceutical composition for the prevention and / or treatment of lung cancer.

[0007] This invention provides a pharmaceutical composition for the prevention and / or treatment of lung cancer, which is prepared from the following active pharmaceutical ingredients in the indicated weight ratios: Astragalus saponins 1-2 parts, Codonopsis polysaccharides 1-2 parts, Citrus tangerine peel flavonoids 0.5-1 part.

[0008] Preferably, it is prepared from the following raw materials in the indicated weight ratios: One part of astragalus saponins, two parts of codonopsis polysaccharides, and 0.5 parts of tangerine peel flavonoids.

[0009] Among them, the total saponin content in Astragalus saponins shall not be less than 70.0% w / w, the total polysaccharide content in Codonopsis polysaccharides shall not be less than 80.0% w / w, and the total flavonoid content in Citrus reticulata flavonoids shall not be less than 70.0% w / w.

[0010] The pharmaceutical composition of the present invention is prepared into a commonly used pharmaceutical formulation by adding pharmaceutically acceptable excipients or auxiliary ingredients to the active ingredient of the aforementioned active pharmaceutical ingredient.

[0011] The preparation mentioned herein is an oral preparation or an injectable preparation.

[0012] This invention provides a method for preparing the pharmaceutical composition for the prevention and / or treatment of lung cancer, comprising the following steps: a. Weigh the raw materials according to the specified weight ratio; b. After mixing, add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a pharmaceutically commonly used formulation.

[0013] This invention provides the use of the pharmaceutical composition described herein in the preparation of medicaments for the prevention and / or treatment of lung cancer.

[0014] The lung cancer mentioned is non-small cell lung cancer.

[0015] This invention combines these three ingredients, not simply by adding them together, but by drawing on the traditional Chinese medicine concept of "principal, assistant, adjuvant, and guide" in drug formulation, and combining it with the modern pharmacological strategy of "multi-target synergy." The aim is to simultaneously exert multiple effects, including directly inhibiting tumor cells, regulating the tumor immune microenvironment, and enhancing the body's own anti-tumor capabilities. Through this formulation, it is hoped that while improving anti-tumor efficacy, potential side effects will be reduced, providing a more holistic and stable compound formula of effective components from traditional Chinese medicine for lung cancer treatment.

[0016] This invention prepares high-purity effective components such as astragaloside, codonopsis polysaccharide, and tangerine peel flavonoids, and optimizes the specific compatibility ratio of the three. In vivo and in vitro activity studies have shown that the combination of astragaloside, codonopsis polysaccharide, and tangerine peel flavonoids has a significant inhibitory effect on lung cancer, and the combination can produce a significant synergistic effect. Attached Figure Description

[0017] Figure 1 Comparison of tumor area and fluorescence intensity among different groups; Figure 2 Fluorescence images of tumor proliferation in zebrafish from different experimental groups. Detailed Implementation

[0018] Example 1: Preparation of the pharmaceutical composition of the present invention 1. Preparation of each effective component 1.1 Preparation of Astragalus Saponins Astragalus membranaceus was pulverized and passed through a 40-mesh sieve. 70% ethanol was added at a material-to-liquid ratio of 1:8, and the mixture was refluxed twice for 1.5 hours each time. The extracts were filtered, combined, and the ethanol was recovered under reduced pressure. The concentrated extract was extracted three times with water-saturated n-butanol (1:1). The n-butanol extracts were combined and concentrated under reduced pressure to obtain a crude extract of total saponins. The crude extract was dissolved in an appropriate amount of distilled water to prepare a solution of 15–25 mg / mL. This solution was then loaded onto an AB-8 macroporous adsorption resin column (the ratio of crude Astragalus membranaceus extract to AB-8 resin was 1:15) at a flow rate of 1 BV / h for dynamic adsorption. First, 4–5 BV of distilled water was used to remove water-soluble impurities such as sugars. Then, 4–5 BV of 70% ethanol solution was used for elution. The ethanol eluent was collected, concentrated under reduced pressure, and then freeze-dried to obtain the total saponins of Astragalus membranaceus.

[0019] The total saponin content of the extract, calculated on a dried basis, shall not be less than 70.0% using the following method.

[0020] Preparation of the reference solution: Take an appropriate amount of astragaloside A reference standard, accurately weigh it, and add methanol to prepare a solution containing 0.1 mg per ml.

[0021] Preparation of the test solution: Take an appropriate amount of total saponin extract of Astragalus membranaceus, accurately weigh it, add methanol to prepare a solution containing 0.15 mg per ml, filter it, and take the filtrate to obtain the test solution.

[0022] To construct the standard curve, accurately measure 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, and 1.0 ml of the reference solution into stoppered test tubes, evaporate to dryness in a water bath, cool, and accurately add 0.4 ml of freshly prepared 5% vanillin-glacial acetic acid solution and 1.6 ml of perchloric acid. Shake well, let stand for 5 minutes, and then develop the color in a boiling water bath for 15 minutes. Remove and immediately cool to room temperature in an ice bath. Then accurately add 8 ml of glacial acetic acid and shake well. Using the corresponding reagent as a blank, measure the absorbance at a wavelength of 538 nm using ultraviolet-visible spectrophotometry (General Chapter 0401, Part IV, Chinese Pharmacopoeia 2025). Plot the standard curve.

[0023] For the assay, accurately measure 1 ml of each test solution and place it in a stoppered test tube. Evaporate to dryness in a water bath and cool. Starting from "adding 0.4 ml of freshly prepared 5% vanillin-glacial acetic acid solution", measure the absorbance according to the method. Read the amount of astragaloside A in the test solution from the standard curve and calculate to obtain the result.

[0024] 1.2 Preparation of Codonopsis pilosula polysaccharides Codonopsis pilosula was pulverized and passed through a 40-mesh sieve. After defatting by reflux with 10 times the volume of 85% ethanol, purified water was added at a solid-liquid ratio of 1:15 (g / mL). Extraction was performed twice at 90℃ for 1.5 hours each time. The extracts were filtered, and the filtrates were combined and concentrated under reduced pressure at 60℃ and -0.08 MPa to a density of 1.10 g / mL (equivalent to 1 gram of crude drug per milliliter). Anhydrous ethanol was slowly added under stirring until the alcohol content reached 80%. The mixture was allowed to stand at 4℃ for 24 hours. The precipitate was collected, washed three times with an appropriate amount of anhydrous ethanol, and dried. The precipitate was redissolved and treated three times with Sevage's reagent (chloroform:n-butanol = 4:1, v / v) at a volume ratio of 1:4 to remove protein. The solution was then placed in a dialysis bag with a molecular weight cutoff of 3.5 kDa and dialyzed with distilled water for 24 hours. Finally, the solution in the dialysis bag was concentrated and freeze-dried to obtain Codonopsis pilosula polysaccharide.

[0025] The total polysaccharide content of the extract, calculated on a dried basis, shall not be less than 80.0% using the following method.

[0026] Preparation of the reference solution: Accurately weigh anhydrous glucose reference standard and add water to prepare a standard solution of 100 μg / mL.

[0027] Preparation of the test solution: Accurately weigh 10 mg of Codonopsis pilosula polysaccharide extract, place it in a beaker, add 50 ml of water, heat and stir to dissolve, cool to room temperature, make up to 100 ml, shake well, filter, and take the filtrate to obtain the test solution.

[0028] To prepare the standard curve, accurately measure 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, and 1.0 ml of the reference solution into stoppered test tubes, add water to each to bring the volume to 1.0 ml, accurately add 1 ml of 5% phenol solution (prepare immediately before use), shake well, then accurately add 5 ml of sulfuric acid, shake well, heat in a boiling water bath for 20 minutes, remove, cool in an ice bath for 5 minutes, and use the corresponding reagent as a blank. Measure the absorbance at a wavelength of 488 nm using ultraviolet-visible spectrophotometry (General Chapter 0401, Part IV, Chinese Pharmacopoeia 2025). Plot the standard curve.

[0029] The assay method involves accurately transferring 1.0 ml of the sample stock solution into a 10 ml stoppered test tube, and measuring the absorbance according to the procedure starting from "accurately adding 1 ml of 5% phenol solution". The amount of anhydrous glucose in the test solution is read from the standard curve, and the result is calculated.

[0030] 1.3 Preparation of flavonoids from tangerine peel Fresh tangerine peel was crushed and passed through a 40-mesh sieve. Petroleum ether was added at a solid-liquid ratio of 1:8, and the mixture was refluxed at 60°C for 2 hours to defatted. The solvent was evaporated from the filter residue. The defatted tangerine peel powder was then extracted three times with 80% ethanol at a solid-liquid ratio of 1:12, refluxed for 60 minutes each time, filtered, and the filtrates were combined. The extracts were concentrated under reduced pressure at 55°C and -0.085 MPa until no alcohol odor remained. The concentrate was extracted three times with an equal volume of ethyl acetate. The organic phases were combined and concentrated under reduced pressure to obtain a crude flavonoid extract. The crude extract was dissolved in an appropriate amount of hydrochloric acid solution at pH 4 and loaded onto a polyamide resin column (80-100 mesh) at a ratio of 1:15 (g crude extract: mL resin). The column was eluted first with 5 BV of distilled water, then with 3 BV of 30% ethanol, and finally with 4 BV of 70% ethanol for target elution. The 70% ethanol eluent was collected. After being concentrated under reduced pressure at 50℃ and -0.09 MPa, the total flavonoids of Xinhui tangerine peel were obtained by freeze drying.

[0031] The total flavonoid content of the extract, calculated on a dried basis, shall not be less than 70.0% using the following method.

[0032] Preparation of the reference solution: Accurately weigh the hesperidin reference standard and add methanol to prepare a 500 μg / mL standard solution.

[0033] Preparation of the test solution: Weigh approximately 50 mg of total flavonoid extract from Xinhui tangerine peel accurately, place it in a 100 ml volumetric flask, dissolve it in methanol and dilute to the mark, shake well, filter, and collect the filtrate to obtain the test solution.

[0034] To prepare the standard curve, accurately measure 0.2 ml, 0.4 ml, 0.6 ml, 0.8 ml, and 1.0 ml of the reference solution into stoppered test tubes. Add methanol to each tube to a final volume of 5.0 ml. Accurately add 0.3 mL of 5% NaNO₂ solution to each tube, shake well, and let stand for 6 minutes. Then accurately add 0.3 mL of 10% Al(NO₃)₃ solution, shake well, and let stand for 6 minutes. Add 4.0 mL of 4% NaOH solution, and add methanol to a final volume of 10 ml. Shake well. Using the corresponding reagents as blanks, measure the absorbance at 510 nm using UV-Vis spectrophotometry (Chinese Pharmacopoeia 2025, Part IV, General Chapter 0401) to plot the standard curve.

[0035] The assay method involves accurately transferring 1.0 ml of the sample stock solution into a 10 ml stoppered test tube, and measuring the absorbance according to the procedure starting from "accurately adding 0.3 ml of 5% NaNO2 solution". The amount of hesperidin in the test solution is read from the standard curve and calculated.

[0036] Astragalus saponins, Codonopsis polysaccharides and tangerine peel flavonoids were prepared according to the above method, and their contents were determined. The results are shown in Table 1.

[0037] Table 1. Determination of the content (%) of astragaloside, codonopsis polysaccharide and tangerine peel flavonoid extract batch Astragalus saponins Codonopsis polysaccharides Tangerine peel flavonoids 1 71.4 85.3 71.6 2 73.7 83.2 72.3 3 75.0 84.1 73.5 2. Preparation of the composition Extracts of astragalus saponins, codonopsis polysaccharides, and tangerine peel flavonoids are pulverized, passed through a 100-mesh sieve, and mixed in a weight ratio of 1:2:0.5 to obtain the composition of the present invention.

[0038] Example 2 Preparation of the pharmaceutical composition formulation of the present invention The compositions of the present invention can be used to prepare various dosage forms of pharmaceuticals, including but not limited to capsules, granules, tablets, oral liquids, etc.

[0039] 1. Capsules Take 35g of the composition of the present invention (containing 10g of astragaloside, 20g of codonopsis polysaccharide, and 5g of tangerine peel flavonoids), add 465g of microcrystalline cellulose, and mix in a V-type mixer for 20 minutes until uniform using the equal-increment method. Then add 5g of magnesium stearate and mix for 5 minutes. Fill the powder into No. 0 gelatin empty capsules with a filling amount of 500mg / capsule. After polishing and inspection, package the capsules with aluminum-plastic blister packs to obtain the final product.

[0040] 2. Granules Take 35g of the composition of the present invention (containing 10g of astragaloside, 20g of codonopsis polysaccharide, and 5g of tangerine peel flavonoids), 1500g of soluble dextrin, 450g of sucrose, and 5g of silicon dioxide, and mix them thoroughly using an equal-incrementing method; then add an appropriate amount of 5% HPMC solution as a binder, and granulate it into a soft mass using a high-speed shear granulator, dry it in a fluidized bed at 60-65°C for 30min, granulate it through a 16-mesh sieve, and use an automatic granulation packaging machine to package it into aluminum foil composite bags at 2g per bag to obtain the final product.

[0041] 3. Tablets Take 35g of the composition of the present invention (containing 10g of astragaloside, 20g of codonopsis polysaccharide, and 5g of tangerine peel flavonoids), 400g of lactose, and 50g of croscarmellose sodium. Mix them thoroughly, add an appropriate amount of 5% PVP K30 solution for wet granulation, dry the resulting wet granules in a fluidized bed at 60°C, granulate them, add 5g of magnesium stearate and mix evenly, compress them into tablets with a weight of 500mg / tablet using a rotary tablet press, coat them with a film, and finally package them in aluminum-plastic blister packs to obtain the final product.

[0042] 4. Oral liquid Take an appropriate amount of purified water, heat it to 50°C, and then add 35g of the composition of this invention (containing 10g of astragaloside, 20g of codonopsis polysaccharide, and 5g of tangerine peel flavonoids), 10g of sodium benzoate, 5g of stevia, and 1g of ascorbic acid in sequence. Stir until completely dissolved. Adjust the pH of the solution to 4.5-5.5 with citric acid, add purified water to a total volume of 10L, filter through a 0.45μm microporous membrane, fill into 10mL brown oral liquid bottles, screw on the caps and seal. Finally, sterilize by steaming at 100°C for 30 minutes to obtain the final product.

[0043] The following efficacy tests demonstrate the beneficial effects of this invention.

[0044] Test Example 1: In vitro antitumor activity test of the composition 1. Experimental materials Experimental cells: human lung adenocarcinoma cells A549, human breast cancer cells MCF-7, and human liver cancer cells HepG2.

[0045] Test samples: the following compositions of the present invention (Astragalus saponins: Codonopsis polysaccharides: Citrus flavonoids 1:2:0.5), Composition 2 (Astragalus saponins: Codonopsis polysaccharides: Citrus flavonoids 2:1:0.5), Composition 3 (Astragalus saponins: Codonopsis polysaccharides: Citrus flavonoids 1.5:1:1), Composition 4 (Astragalus saponins: Codonopsis polysaccharides 1:2.5), Composition 5 (Astragalus saponins: Citrus flavonoids 2:1.5), Composition 6 (Codonopsis polysaccharides: Citrus flavonoids 2:1.5), the Astragalus saponin group, the Codonopsis polysaccharide group, the Citrus flavonoid group, and the positive control drug cisplatin.

[0046] 2. Experimental Methods Cells in the logarithmic growth phase were used for experiments. After digestion into single-cell suspensions with trypsin, cell counting was performed, and 5000 cells per well were seeded into 96-well plates. The plates were then incubated at 37°C in a 5% CO2 incubator for 24 hours. Different concentrations (0, 1.5625, 3.125, 6.25, 12.5, 25, 50, and 100 μM) of the composition of this invention were added, with five replicates for each concentration. The plates were then incubated at 37°C in a 5% CO2 incubator for another 72 hours. Afterward, 20 μL of 5 mg / ml MTT was added to each well, and the plates were incubated for another 4 hours. After this time, the solution in each well was aspirated, and 150 μL of DMSO was added. The absorbance of each well was measured using a microplate reader at a wavelength of 490 nm, and the half-maximal inhibitory concentration (IC50) of the target composition of this invention against each cell line was calculated. The half-maximal inhibitory concentrations (IC50) of compositions 2, 3, 4, 5, and 6, astragaloside, codonopsis polysaccharide, tangerine peel flavonoids, and the positive control drug cisplatin against each cell line were determined using the same method. Experimental data are expressed as mean ± SEM, and statistical methods such as t-tests or one-way ANOVA were used for data analysis.

[0047] 3. Experimental Results The experimental results are shown in Table 2.

[0048] Table 2. Experimental results of the anti-tumor activity of the compositions of the present invention.

[0049]

[0050] Note: * Compared with composition 1, p<0.05; ** Compared with composition 1, p<0.001.

[0051] As shown in Table 1, Composition 1 effectively inhibits the growth of various tumor cells, including lung adenocarcinoma cells, breast cancer cells, and liver cancer cells. In particular, its IC50 value against lung adenocarcinoma cells A549 is as low as 10.62 ± 0.21 μM. The IC50 of Composition 1 against lung adenocarcinoma cells is significantly lower than that of single extracts such as astragaloside, codonopsis polysaccharide, and tangerine peel flavonoids, indicating the best inhibitory effect against lung adenocarcinoma cells. Composition 1 is the optimal formulation.

[0052] Experimental Example 2: In vivo anti-lung cancer activity test of the pharmaceutical composition of the present invention (zebrafish lung cancer model) (1) Experimental instruments and materials Fish used in the experiment: The zebrafish used in this test were wild-type AB strain zebrafish.

[0053] Instruments and equipment: ZA-D5 five-layer single-row independent culture unit (Shanghai Haisheng Biological Experimental Equipment Co., Ltd.); SZ780 continuous zoom stereomicroscope (Chongqing Aote Optical Instrument Co., Ltd.); ZXSD-A1090 curve-controlled biochemical incubator (Shanghai Zhicheng Analytical Instrument Manufacturing Co., Ltd.); SQP 0.001g electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd.); PV820 microinjection (Pneumatic PicoPump); DMi8 fluorescence microscope (Leica, Germany).

[0054] Reagents and consumables: 24-well plates, tricaine (Tokyo Kasei Corporation).

[0055] (2) Experimental methods Experimental groups: divided into a model control group, a cisplatin control group, and the composition of the present invention (prepared in Example 1). The model control group used purified water; the composition of the present invention used purified water to prepare a 10 µg / ml solution; and the cisplatin control group used purified water to prepare a 5 µg / ml solution.

[0056] Establishment of a zebrafish lung cancer model: Wild-type AB strain zebrafish embryos at 48 hpf were selected and placed in 24-well plates, one embryo per well, with six embryos per group. A549 cells were stained with DiI fluorescent labeling and prepared for later use. 200–300 A549 cells were microinjected into the yolk sac of wild-type AB strain zebrafish embryos to establish a zebrafish lung cancer model at 48 hpf.

[0057] Experimental methods: Zebrafish with established lung cancer model (48h) were incubated in 24-well plates (1 fish per well, 6 fish per group). 1000 μL of each experimental group solution was added to each well. The tumors were photographed every 24 hours using a fluorescence microscope, and the observation and recording were performed for 3 days to observe the tumor proliferation in the zebrafish.

[0058] Experimental results: see Figures 1-2 .

[0059] The antitumor activity of a drug can be determined based on the tumor fluorescence intensity and area. Generally, the lower the fluorescence intensity and the smaller the fluorescence area, the stronger the antitumor activity of the drug. Results showed that after treatment with the drug and culturing for 72 hours, compared with the model control group, the tumor fluorescence area and intensity in the zebrafish of this invention were significantly reduced, indicating that the composition of this invention has significant anti-lung cancer activity.

Claims

1. A pharmaceutical composition for the prevention and / or treatment of lung cancer, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: Astragalus saponins 1-2 parts, Codonopsis polysaccharides 1-2 parts, Citrus tangerine peel flavonoids 0.5-1 part.

2. The pharmaceutical composition for the prevention and / or treatment of lung cancer according to claim 1, characterized in that: It is prepared from the following raw materials in the indicated weight ratios: One part of astragalus saponins, two parts of codonopsis polysaccharides, and 0.5 parts of tangerine peel flavonoids.

3. The pharmaceutical composition for the prevention and / or treatment of lung cancer according to claim 1 or 2, characterized in that: The total saponin content in Astragalus saponins shall not be less than 70.0% w / w, the total polysaccharide content in Codonopsis polysaccharides shall not be less than 80.0% w / w, and the total flavonoid content in Citrus reticulata flavonoids shall not be less than 70.0% w / w.

4. The pharmaceutical composition for the prevention and / or treatment of lung cancer according to claim 1 or 2, characterized in that: It is prepared into a commonly used pharmaceutical formulation by adding pharmaceutically acceptable excipients or auxiliary ingredients to the active ingredient, as described above.

5. The pharmaceutical composition for the prevention and / or treatment of lung cancer according to claim 4, characterized in that: The preparation is an oral or injectable preparation.

6. A method for preparing a pharmaceutical composition for the prevention and / or treatment of lung cancer according to any one of claims 1-5, characterized in that: It includes the following steps: a. Weigh the raw materials according to the specified weight ratio; b. After mixing, add pharmaceutically acceptable excipients or auxiliary ingredients to prepare a pharmaceutically commonly used formulation.

7. Use of the pharmaceutical composition according to any one of claims 1-5 in the preparation of a medicament for the prevention and / or treatment of lung cancer.

8. The use according to claim 7, characterized in that: The lung cancer mentioned is non-small cell lung cancer.

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