Traditional Chinese medicine composition with pulmonary nodule treatment effect and preparation method

Abstract

The invention discloses a traditional Chinese medicine composition with a pulmonary nodule treatment effect and a preparation method, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines: fried scutellaria baicalensis, astragalus membranaceus, pericarpium citri reticulatae and semen coicis, and is matched with heat-clearing and detoxifying traditional Chinese medicines including dandelion, selfheal, thunberg fritillary bulb and radix ranunculi ternati; according to the traditional Chinese medicine composition, the traditional Chinese medicinal materials are optimized to tonify the stomach, the effect of improving middle-jiao qi and blood biochemical treatment is achieved, the medicine effect is reflected to the lung, and the treatment effect is improved; after compatibility, the treatment effect on pulmonary nodules is remarkably improved; the traditional Chinese medicine composition is combined with medicines for clearing away heat and toxic materials, so that the inhibition level on pulmonary nodules is further improved, treatment is performed according to syndrome differentiation, early treatment is performed according to the pulmonary sarcoidosis and syndrome development rule, the development to cancerization degree is avoided, and the application prospect is great.

Description

Technical Field

[0001] The present invention relates to a Chinese medicinal composition having a pulmonary nodule therapeutic effect, and also relates to a preparation method of the Chinese medicinal composition. Background Art

[0002] Lung nodules refer to circular shadows with a diameter of less than 3 cm on imaging, accounting for about 30% of the population undergoing chest CT examinations. In the early observation stage of lung nodules, there is a lack of truly effective drug treatments for lung nodules in the clinic. In addition, because of the potential malignancy in the development of the disease, the prevention and treatment of the development of lung nodules has become a major problem.

[0003] Pulmonary nodules belong to the category of accumulation in traditional Chinese medicine. Traditional Chinese medicine believes that nodules are mainly caused by qi stagnation turning into fire, lung heat and qi stagnation, and poor blood circulation; fire invades the lungs, promoting the occurrence of pulmonary nodules; and qi stagnation prevents the circulation of qi and blood, causing blood stasis to form local masses, which eventually leads to dysfunction of internal organs. The symptomatic treatment of traditional Chinese medicine can temporarily get rid of the difficulties of prevention and treatment in the observation stage of modern evidence-based medicine. The research on the treatment of pulmonary nodules using traditional Chinese medicine is guided by the combination of disease and syndrome, and the principle of strengthening the body and eliminating evil is used in treatment. The treatment is based on syndrome differentiation, and early treatment is carried out in accordance with the law of the development of pulmonary nodules and syndromes to avoid the development to the level of cancer.

[0004] At present, traditional Chinese medicine treatment of pulmonary nodules is mostly through the common "soothing the liver and regulating qi, resolving phlegm and eliminating phlegm, softening and dispersing nodules, promoting blood circulation and removing blood stasis, strengthening the spleen and eliminating dampness, clearing away heat and detoxifying, relieving pain and dispersing nodules". Therefore, cold Chinese medicine with the function of clearing heat and detoxifying is often used for treatment. In particular, cold Chinese medicines such as Prunella vulgaris, dandelion, and Fritillaria thunbergii are often used to "purge fire", and are supplemented with Chinese medicinal materials such as cat's claw grass, which has the function of "detoxifying and dispersing nodules" and is commonly used in the treatment of pulmonary nodules. However, although this method can achieve the effect of inhibiting pulmonary nodules, it ignores the side effects of long-term use of cold Chinese medicines on the gastrointestinal tract. These drugs are not only prone to cause gastrointestinal deficiency and coldness, accompanied by side effects such as abdominal pain and diarrhea, but also ignore the importance of the stomach in the human body's middle jiao system, and the role of the stomach organ in generating qi and blood. In traditional Chinese medicine theory, the stomach and spleen belong to the relationship of yin and yang, and the stomach and liver jointly regulate the human body's qi. Therefore, although the current Chinese medicine treatment methods are effective for a while, due to the neglect of gastrointestinal function, it will be unfavorable for the long-term treatment of pulmonary nodules.

[0005] At present, when Chinese herbal medicine prescriptions for the treatment of lung nodules produce gastrointestinal adverse reactions, the adverse reactions caused by cold Chinese medicines are often dealt with by stopping the medication or reducing the dosage. Even if other drug means are used to treat gastrointestinal adverse reactions, such prescriptions have not considered the mechanism of action of Chinese medicine in the treatment of lung nodules from the perspective of the effect of the stomach on lung nodules, and have not studied the significant synergistic effects of specific Chinese herbal medicine combinations on lung nodules. Summary of the invention

[0006] Purpose of the invention: The purpose of the present invention is to prove its necessity in treating lung nodules from the perspective of tonifying the stomach, and to provide a Chinese medicine composition with the therapeutic effect of treating both the symptoms and the root causes of lung nodules. The Chinese medicine composition tonifies the stomach through the use of selected Chinese medicinal materials, thereby achieving the effect of enhancing the biochemical properties of qi and blood in the middle jiao, and attributes the medicinal effect to the lungs, thereby improving the therapeutic effect. A preparation method of the above-mentioned Chinese medicine composition is also provided.

[0007] Technical solution: The present invention discloses a Chinese medicine composition with the effect of treating lung nodules, which is composed of the following Chinese medicines: stir-fried scutellaria baicalensis, astragalus, tangerine peel, coix seed, and Chinese medicines for clearing away heat and detoxification, including dandelion, selfheal, thunbergia thunbergii, and cat's claw.

[0008] The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-20 parts of stir-fried scutellaria baicalensis, 7.5-30 parts of coix seeds, 5-20 parts of astragalus, 5-20 parts of tangerine peel, 7.5-30 parts of dandelion, 5-20 parts of selfheal, 5-20 parts of thunbergia thunbergii, and 7.5-30 parts of cat's claw.

[0009] The Chinese medicine composition preferably comprises: 10 parts of stir-fried scutellaria, 15 parts of coix seeds, 10 parts of astragalus, 10 parts of dried orange peel, 15 parts of dandelion, 10 parts of selfheal, 10 parts of thunbergia thunbergii, and 15 parts of cat's claw;

[0010] Wherein, in the traditional Chinese medicine composition, astragalus and tangerine peel are replaced by ganoderma lucidum and / or trillium.

[0011] The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-20 parts of stir-fried scutellaria baicalensis, 7.5-30 parts of coix seeds, 5-20 parts of ganoderma lucidum, 0-40 parts of trillium, 7.5-30 parts of dandelion, 5-20 parts of selfheal, 5-20 parts of thunbergia thunbergii, and 7.5-30 parts of cat's claw.

[0012] Or 15 parts of dandelion, 10 parts of stir-fried scutellaria, 10 parts of selfheal, 10 parts of thunbergia thunbergii, 15 parts of cat's claw, 10 parts of ganoderma lucidum, 15 parts of coix seed, 20 parts of trifoliate bulbs;

[0013] Or 15 parts of dandelions, 10 parts of stir-fried scutellaria, 10 parts of selfheal, 10 parts of thunbergia bulbs, 15 parts of cat's claw, 10 parts of ganoderma lucidum, and 15 parts of coix seeds.

[0014] Wherein, the stir-fried scutellaria baicalensis must be obtained from the processing of the traditional Chinese medicine scutellaria baicalensis.

[0015] The Chinese medicine composition can be combined with a pharmaceutically acceptable carrier to form various dosage forms.

[0016] Wherein, the dosage form is decoction, granules, powder, capsule, tablet, mixture or oral liquid.

[0017] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps:

[0018] (1) Mix the required medicinal materials with water, decoct over low heat, and filter to obtain a filtrate and a filter residue;

[0019] (2) mixing the filter residue with water again, repeating the decoction process in step (1) 2 to 3 times and filtering;

[0020] (3) All the filtrates are combined and concentrated to obtain the product.

[0021] Wherein, in step (1), the temperature of the slow fire is 80-90° C., and the decocting time is 1-4 h.

[0022] Wherein, in step (3), the concentration is carried out by using one of normal pressure concentration, reduced pressure concentration or thin film concentration to concentrate to 1 / 5 to 1 / 2 of the original volume.

[0023] Principle of the invention: The medicinal composition of this Chinese medicine composition is based on stir-fried Scutellaria baicalensis as the main ingredient, and uses its effects of "clearing heat and purging fire, cooling blood and stopping bleeding, and replenishing qi and calming the mind" to target the pathogenesis of "lung heat and qi stagnation, poor qi and blood flow" of pulmonary nodules, while achieving the purpose of treatment and reducing the cold and stomach-damaging characteristics of Scutellaria baicalensis. Experiments have shown that the compatibility of stir-fried Scutellaria baicalensis with "stomach-tonifying Chinese medicine" and Coix seeds is significantly better than that of Scutellaria baicalensis. Combined with modern pharmacological research, Scutellaria baicalensis contains baicalein, which has antibacterial, anti-inflammatory and anti-allergic effects, and can also enhance immunity, but has no obvious effect on the formation of antibody-secreting cells. In addition, Scutellaria baicalensis has a certain anti-tumor effect. The medicinal composition of this Chinese medicine composition is based on the stomach-tonifying Chinese medicine "Astragalus, Tangerine Peel" or "Ganoderma Lucidum" or / and "Mountain Trillium" as adjuvants, replenishing the middle and replenishing qi, and enhancing the function of the middle jiao system to generate qi and blood, thereby achieving the effect of promoting the treatment of pulmonary nodules. And "Coix seed" is used as the messenger to achieve the purpose of the effect of entering the lung. The combination of the above three types of drugs can achieve an unexpected combined therapeutic effect in the inhibition of lung nodules. The above drug prescriptions are explained as follows: Stir-fried Scutellaria baicalensis clears heat and dampness, purges fire and detoxifies; Astragalus membranaceus replenishes vital energy and strengthens the spleen and stomach; Tangerine peel removes cold evil in the chest, breaks stagnant qi, and benefits the spleen and stomach; Ganoderma lucidum nourishes the lungs and stomach, activates blood circulation and moisturizes dryness; Trillium gracile clears heat and detoxifies, eliminates carbuncle and disperses knots, and treats nausea, vomiting, abdominal pain, and diarrhea; Coix seed enters the lung meridian, replenishes the lungs, and clears heat.

[0024] The Chinese medicine composition is composed of dandelion, selfheal, Fritillaria thunbergii, and cat's claw grass as ministers to assist the main medicine to improve the efficacy. "Ben Cao Zheng Yi" describes: "Dandelion, its nature is cool, treats all sores, carbuncles, redness, swelling, heat and toxicity, redness, swelling and hard masses, especially quick effect." Selfheal can clear away heat and dissipate stagnation, "Shennong Ben Cao Jing" calls it: "mainly cold and hot scrofula, rat fistula head sores, break up the tumor and disperse the gall gas." "Shen Nong Ben Cao Jing" calls Fritillaria thunbergii: "spicy and flat, hernia, throat paralysis, breast pain, gold wound." "Ben Cao Zheng Yi" describes: "the best phlegm and qi, good at relieving depression, treating throat paralysis, scrofula, breast abscess, back, all carbuncles, swelling and poison, damp-heat malignant sores, hemorrhoids, bleeding from gold wounds, and pain from fire sores." Cat's claw grass is an important medicine for detoxification, phlegm and dissipation. In vitro studies have found that the combination of the above drugs can synergistically enhance the overall efficacy of lung nodule treatment.

[0025] Beneficial effects: Compared with the prior art, the present invention has the following significant advantages: the Chinese medicine composition of the present invention nourishes the stomach by selecting Chinese medicinal materials to achieve the effect of improving the biochemical transformation of qi and blood in the middle jiao, and directs the drug effect to the lungs, thereby improving the therapeutic effect; among them, astragalus, tangerine peel, ganoderma lucidum, and trillium can nourish the middle jiao and replenish qi, and enhance the function of the middle jiao system to generate qi and blood, and "coix seed" is used as a messenger to achieve the purpose of directing the effect to the lungs. Experiments have shown that stir-fried scutellaria baicalensis is combined with Chinese medicine for nourishing the middle jiao and replenishing qi and supplemented with coix seed. The above three types of Chinese medicine significantly improve the therapeutic effect of lung nodules; at the same time, it is matched with dandelion, selfheal, Fritillaria thunbergii, and cat's claw to clear away heat and detoxify drugs, which further improves the inhibition level of lung nodules. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 The effect of the Chinese medicine composition of the present invention on the body weight of mice;

[0027] Figure 2 The effect of the Chinese medicine composition of the present invention on pulmonary nodules in mice;

[0028] Figure 3 To change the effect of the combination of active ingredients of a Chinese medicine composition on cell proliferation in vitro;

[0029] Figure 4 To change the effect of the combination of active ingredients in a traditional Chinese medicine composition on LPS-induced inflammation. DETAILED DESCRIPTION

[0030] The technical scheme of the present invention is further described below in conjunction with the examples. The test materials used in the examples can all be purchased through conventional channels.

[0031] Scutellaria baicalensis is the root of Scutellaria baicalensis Georgi, a plant of the Lamiaceae family.

[0032] Job's tears are the dried mature kernels of the Poaceae plant Coixlacryma-jobi L.var.ma-yuen (Roman.) Stapf.

[0033] Astragalus is the dried root of Astragalus membranaceus (Fisch.) Bge.var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family.

[0034] Tangerine peel is the dried mature peel of the Rutaceae plant Citrus reticulata Blanco and its cultivated varieties.

[0035] Dandelion is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum sinicumKitag. or several plants of the same genus in the Asteraceae family.

[0036] Prunella vulgaris is the dried fruit spike of Prunella vulgaris L., a plant of the Lamiaceae family.

[0037] Fritillaria thunbergii is the dried bulb of Fritillaria thunbergii Miq., a plant of the Liliaceae family.

[0038] Cat's claw is the dried root of Ranunculus ternatus Thunb., a plant of the Ranunculaceae family.

[0039] Ganoderma lucidum is the dried fruiting body of the Polyporaceae fungus Ganoderma lucidum (Leyss. ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang.

[0040] Trillium is the dried pseudobulb of Cremastra appendiculata (D.Don) Makino, Pleione bulbocodioides (Franch.) Rolfe or Pleione yunnanensis Rolfe of the orchid family.

[0041] Example 1

[0042] The Chinese medicine composition for treating pulmonary nodules of the present invention:

[0043] a) 5 parts of stir-fried Scutellaria baicalensis, 7.5 parts of Coix seeds, 5 parts of Astragalus, 5 parts of dried orange peel, 7.5 parts of Taraxacum, 5 parts of Prunella Vulgaris, 5 parts of Fritillaria thunbergii, and 7.5 parts of Cat's Claw.

[0044] b) 10 parts of stir-fried Scutellaria baicalensis, 15 parts of Coix seeds, 10 parts of Astragalus, 10 parts of dried orange peel, 15 parts of Taraxacum, 10 parts of Prunella Vulgaris, 10 parts of Fritillaria thunbergii, and 15 parts of Ranunculaceae.

[0045] c) 20 parts of fried scutellaria, 30 parts of coix seeds, 20 parts of astragalus, 20 parts of dried orange peel, 30 parts of dandelion,

[0046] 20 parts of Spica Prunellae, 20 parts of Bulbus Fritillariae Thunbergii, 30 parts of Herba Cat's Claws.

[0047] The preparation method is:

[0048] (1) Mix the required medicinal materials with water, decoct over a slow fire, and filter to obtain a filtrate and a filter residue; the slow fire temperature is 85±5° C., and the decoction time is 3±1 h;

[0049] (2) mixing the filter residue with water again, repeating the decoction process in step (1) for three times and filtering;

[0050] (3) All filtrates are combined and concentrated to obtain the product.

[0051] Verification of the pulmonary nodule inhibition / improvement effect of the Chinese medicine composition prepared in Example 1 of the present invention:

[0052] Dosage for mice: The Chinese medicine stock solution was concentrated to 30 mL, and the dosing volume was 0.2 mL. Chinese medicine composition a) was set as a low dose; Chinese medicine composition b) was set as a medium dose; Chinese medicine composition c) was set as a high dose. According to the amount of crude drug, the low, medium and high doses of mice were 7, 14 and 28 mg / kg, respectively. Animals: C57BL / 6 mice, provided by Hangzhou Medical College (production) (Experimental Animal Production License: SCXK (Zhejiang) 2024-0002). Age: 35-40 days; Weight: 18-20 g; Gender: female.

[0053] Positive drug: Cisplatin Injection, purchased from Jiangsu Hausen Pharmaceutical Group Co., Ltd. The dosage was 4 mg / kg.

[0054] Construction of pulmonary nodule model: Lewis lung cancer cell lines of mice in logarithmic growth phase were prepared into 1×10 7 / ml cell suspension, 0.1mL was inoculated into the tail vein of mice. The drug was administered starting the next day after inoculation for a total of 21 days.

[0055] Observation indicators: After the experiment, the animals were killed, their lungs were removed, and the number of lung nodules was recorded.

[0056] Data statistics and analysis: All data are expressed as mean ± SD. The differences among the groups were analyzed using Prism 8.0. *P < 0.05 was considered statistically significant.

[0057] Results and conclusions: As shown in Tables 1 and 2, the Chinese medicine composition has a significant inhibitory / improving effect on mouse lung nodules in a dose-dependent manner; as shown in Table 2, compared with the positive drug, each dose group of the Chinese medicine composition has no significant inhibitory effect on mouse body weight. This indicates that the Chinese medicine composition has a good inhibitory effect on lung nodules and is safe.

[0058] Table 1. Inhibitory effect of Example 1 on the number of lung nodules in mice (mean ± SD)

[0059] Group Number of lung nodules Inhibition rate (%) Blank control group 72.33±18.54 0 Cisplatin 22.83±8.21** 68.44 High dose group 23.33±9.39** 67.75 Medium dose group 28.83±10.29** 60.14 Low dose group 61.17±17.82 15.43

[0060] **P<0.01, compared with the blank control group

[0061] Table 2 Effects of Example 1 and positive drugs on mouse body weight (mean ± SD)

[0062] Group Starting weight (g) Final body weight (g) Blank control group 20.88±0.34 26.92±1.30 Cisplatin 20.50±0.38 18.47±0.94** High dose group 20.78±0.22 24.25±0.50 Medium dose group 20.87±0.31 24.67±1.09 Low dose group 20.680±0.28 26.70±0.87

[0063] **P<0.01, compared with the blank control group

[0064] As shown in Table 3, one abundant compound of various medicinal materials in the Chinese medicine composition of Example 1 of the present invention was taken to verify the effectiveness of the Chinese medicine composition of the present invention at the in vitro cell level:

[0065] Table 3. Information on Chinese medicinal materials and active ingredients

[0066]

[0067]

[0068] *The content is derived from the literature. The literature source can be found in [Qiao Ruirui, Liu Shuo, Bai Yaya, et al. Study on the changes in the main components and chromaticity values ​​of Scutellaria baicalensis during charcoaling and its hemostatic effect [J]. Chinese Herbal Medicine, 2024(15).][Zhao Huiru, Guo Ting. Simultaneous determination of quercetin and luteolin in dandelion by reversed-phase HPLC [J]. Chinese Pharmacist, 2014(7):3.][Yan Qingzi, Bai Yubing, Tang Jie, et al. Study on the determination method of oleanolic acid and ursolic acid in Prunella vulgaris [J]. Central South Pharmacy, 2017, 15(8):4.][Che Peng, Liu Jiushi, Qi Yaodong, et al. Simultaneous determination of the contents of 6 alkaloids in Fritillaria medicinal materials by UPLC-ELSD [J]. China Journal of Traditional Chinese Medicine, 2020, 45(6):6.]. [Qian Jiayan, Huang Zihui, Chen Ken, et al. Simultaneous determination of 7 components in compound Wufengcao liquid by UPLC-PDA[J]. Chinese Traditional Patent Medicine, 2020, 42(1):4.][Wang Yali, Tian Man, Li Jiang, et al. Simultaneous determination of the contents of 10 components in Astragalus by HPLC-DAD-ELSD[J]. Central South Pharmacy, 2018, 16(9):4.][Wang Yifei. HPLC determination of hesperidin in tangerine peel preparations[J]. Modern Diagnosis and Treatment, 2023, 34(14):2176-2179.].

[0069] **Action concentrations are rounded.

[0070] Cell type for in vitro cell level validation experiment: Mouse Lewis lung cancer cell line

[0071] Drugs and reagents: Drugs and product numbers are shown in Table 3; DMEM medium (GIBCO, Carlsbad, CA, USA), fetal bovine serum (GIBCO); MTT solution: Protect from light, 0.05g MTT (Yisheng Biotechnology, Shanghai, China) powder is dissolved in 10mL PBS buffer, ultrasonicated for 20min, and prepared into a concentration of 5mg / mL solution. Filter with a 0.22μm sterile filter, divide into aliquots, and store at -80℃. Dissolve at room temperature in advance before use. LPS:

[0072] Detection methods used:

[0073] Cell proliferation and viability detection: Operation process: Cells were cultured evenly in a 96-well plate, and drugs were prepared according to Table 3. Cells were cultured in a 37°C, 5% CO2 incubator; after the drug effect ended, 15 μL of MTT solution was added to each well. After incubation in the incubator for 3 hours, the OD value at 570 nM was measured using an enzyme marker. Inhibition rate % = (1-average absorbance value of cells in the drug group / average absorbance value of cells in the control group) × 100%; Graphpad Prism 8.0 software was used to calculate the half-maximal inhibitory concentration (50% inhibiting concentration, IC50 ).

[0074] After the cells were pretreated with LPS for 24 hours, the drugs were prepared according to Table 3 and the cells were treated. The expression of cellular inflammatory factors was detected by qRT-PCR.

[0075] In vitro cell level validation experimental results and conclusions: Figure 3 As shown, the active ingredients (a+b+c+d) of the Chinese medicine composition can significantly inhibit the proliferation ability of Lewis cells. Figure 4 As shown, the active ingredients (a+b+c+d) of the Chinese medicine composition can significantly inhibit the expression level of inflammatory factors in Lewis cells. This result shows from in vitro experiments that the Chinese medicine composition has the effect of resisting pulmonary nodules.

[0076] Example 2

[0077] The medicinal ingredients of the Chinese medicine composition of Example 1 are adjusted, and the astragalus and tangerine peel are replaced with ganoderma. The Chinese medicine composition with the therapeutic effect of pulmonary nodules of the present invention:

[0078] a) 5 parts of stir-fried Scutellaria baicalensis, 7.5 parts of Coix seeds, 5 parts of Ganoderma lucidum, 7.5 parts of Taraxacum herb, 5 parts of Prunella vulgaris, 5 parts of Fritillaria thunbergii, and 7.5 parts of Cat's Claw;

[0079] b) 10 parts of stir-fried Scutellaria baicalensis, 15 parts of Coix seeds, 10 parts of Ganoderma lucidum, 15 parts of Taraxacum herb, 10 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, and 15 parts of Cat's Claw;

[0080] c) 20 parts of stir-fried Scutellaria baicalensis, 30 parts of Coix seeds, 20 parts of Ganoderma lucidum, 30 parts of Taraxacum officinale, 20 parts of Prunella vulgaris,

[0081] 20 parts of Fritillaria thunbergii, 30 parts of Radix Ranunculi.

[0082] The preparation method of the Chinese medicine composition, the lung nodule (mouse Lewis lung cancer transplant tumor) model, the positive drug, the experimental animal, and the experimental method are the same as those in Example 1. The dosage for mice: the Chinese medicine stock solution is prepared by concentrating to 30 mL, and the dosage volume is 0.2 mL. The Chinese medicine composition a) is set as a low dose; the Chinese medicine composition b) is set as a medium dose; and the Chinese medicine composition c) is set as a high dose. According to the amount of crude drug, the low, medium, and high doses of mice are 7, 14, and 28 mg / kg, respectively.

[0083] Experimental results: The prescription of Example 2 was administered orally by gavage at three different doses, once a day for 15 days. The high and medium dose groups had significant inhibitory effects on lung nodules. The prescription of Example 2 had no significant inhibitory effect on the weight of mice, while the cisplatin group had a significant inhibitory effect on the weight of mice.

[0084] Table 4. Effect of Example 2 on mouse body weight (X±SD)

[0085]

[0086] Compared with the blank control group, *P<0.05, **P<0.01

[0087] Table 5. Effect of Example 2 on mouse lung nodules (X±SD)

[0088]

[0089] Compared with the blank control group, *P<0.05, **P<0.01 Figure 1 and 2 As shown in Tables 4 and 5, the medium-dose group and high-dose group of Example 2 and the positive drug cisplatin have a significant inhibitory effect on the mouse lung nodule (Lewis lung cancer cell transplant tumor) model. The prescription of Example 2 has no significant effect on the body weight of the animals, but the cisplatin group has a significant inhibitory effect on the body weight of the mice.

[0090] Example 3

[0091] The medicinal ingredients of the Chinese medicine composition of Example 1 were adjusted, and the astragalus and tangerine peel were adjusted to ganoderma lucidum and trillium. The Chinese medicine composition with the therapeutic effect of pulmonary nodules of the present invention:

[0092] d) 5 parts of stir-fried Scutellaria baicalensis, 7.5 parts of Coix seeds, 5 parts of Ganoderma lucidum, 10 parts of Psoralea corylifolia, 7.5 parts of Taraxacum mongolicum, 5 parts of Prunella vulgaris, 5 parts of Fritillaria thunbergii, and 7.5 parts of Cat's Claw;

[0093] e) 10 parts of stir-fried Scutellaria baicalensis, 15 parts of Coix seeds, 10 parts of Ganoderma lucidum, 20 parts of Psoralea corylifolia, 15 parts of Taraxacum officinale, 10 parts of Prunella vulgaris, 10 parts of Fritillaria thunbergii, and 15 parts of Cat's Claw;

[0094] f) 20 parts of fried Scutellaria baicalensis, 30 parts of Coix seeds, 20 parts of Ganoderma lucidum, 40 parts of Trillium, 30 parts of Taraxacum,

[0095] 20 parts of Spica Prunellae, 20 parts of Bulbus Fritillariae Thunbergii, 30 parts of Herba Cat's Claws.

[0096] The preparation method of the Chinese medicine composition is the same as that in Example 1.

[0097] Comparative Example 1

[0098] Take 10 parts of stir-fried Scutellaria baicalensis, 15 parts of Coix seeds, 10 parts of Astragalus, and 10 parts of dried orange peel, and prepare the Chinese medicinal materials according to the prescriptions in Table 6.

[0099] Table 6, Comparative Example 1 Prescription Settings

[0100] prescription Chinese Herbal Medicine Prescription No. 1 Stir-fried Scutellaria baicalensis + dried tangerine peel, Astragalus Prescription No. 2 Stir-fried Scutellaria baicalensis + Coix seeds Prescription No. 3 Stir-fried Scutellaria baicalensis + dried orange peel, Astragalus membranaceus + Coix seed Prescription No. 4 Scutellaria baicalensis + dried orange peel, Astragalus membranaceus + Coix seed

[0101] The dosage and concentration of the prescription preparation method are consistent with those in Example 1. The dosage for mice is the same as that of the high-dose group in Example 1. Animals, positive drugs, lung nodule model construction, observation indicators, data statistics and analysis are the same as those in Example 1.

[0102] Results and conclusions:

[0103] Table 7. Effects of Prescriptions No. 1, 2, and 3 in Comparative Example 1 on Pulmonary Nodules in Mice (mean ± SD)

[0104] Group Number of lung nodules Inhibition rate (%) Blank control group 131.50±33.57 0 Prescription No. 1 95.00±25.78** 27.76 Prescription No. 2 98.50±28.20** 25.10 Prescription No. 3 47.25±13.16 64.07

[0105] **P<0.01, compared with prescription No. 3

[0106] As shown in Table 7, the inhibitory effects of Prescription 1 and Prescription 2 on lung nodules were significantly lower than that of Prescription 3, indicating that the simultaneous action of stir-fried Scutellaria baicalensis, dried tangerine peel, Astragalus membranaceus and Coix seed can produce a significant combined synergistic effect in inhibiting the growth of lung nodules.

[0107] Comparative Example 2

[0108] As shown in Table 8, when the stir-fried Scutellaria baicalensis was replaced by Scutellaria baicalensis, the inhibitory effect of Prescription 4 on lung nodules was significantly lower than that of Prescription 3, indicating that the role of stir-fried Scutellaria baicalensis in the traditional Chinese medicine composition is irreplaceable by Scutellaria baicalensis.

[0109] Table 8 Effects of Prescriptions No. 3 and No. 4 in Comparative Example 2 on Pulmonary Nodules in Mice (mean ± SD)

[0110] Group Number of lung nodules Inhibition rate (%) Blank control group 152.67±40.62 0 Prescription No. 3 62.50±24.21 59.06 Prescription No. 4 98.67±21.72** 35.54

[0111] **P<0.01, compared with prescription No. 3, comparative example 3

[0112] The synergistic effect of the main active ingredients in the decoction of "stir-fried Scutellaria baicalensis (A) + Astragalus membranaceus, dried orange peel (B) + Coix seeds (C)" - baicalein (a), astragaloside IV (b1), hesperidin (b2), and vitamin D (c) - was verified in vitro. Figure 3 As shown, the main active ingredient is baicalin, but baicalin can achieve significant synergistic effects with astragaloside IV, hesperidin, and vitamin D in inhibiting cell proliferation. Furthermore, the main active ingredients of the adjuvants are added to a+b+c, and the four adjuvants (d1 / 2 / 3 / 4) are added separately to the combination of a+b+c, but none of them achieves a significant improvement in inhibiting cell proliferation; the four adjuvants are added simultaneously (d) to significantly enhance the inhibitory level on Lewis cells. This shows that the combination of the four Chinese medicines of fried scutellaria, astragalus, tangerine peel, and coix seed can significantly enhance the inhibitory effect on the proliferation of lung nodules, and the four Chinese medicines can achieve significant synergistic effects when used together. The addition of the four adjuvants alone cannot significantly improve the efficacy, and only when they are added simultaneously can the efficacy of the whole Chinese medicine combination be improved.

[0113] Comparative Example 4

[0114] Inflammation is the main physiological change accompanying the development of lung nodules. The experiment used LPS as an inducer to act on Lewis cells to promote inflammation. The main active ingredients in the decoction of "stir-fried scutellaria baicalensis (A) + astragalus, tangerine peel (B) + coix seed (C)" - baicalein (a), astragaloside Ⅳ (b1), hesperidin (b2), and vitamin D (c) - were verified in vitro to have a synergistic effect on the inhibition of inflammation. Figure 4 As shown in the figure, after 24 hours of action, the main active ingredient is baicalin, but baicalin can achieve a significant synergistic effect with astragaloside IV, hesperidin, and vitamin D in inhibiting inflammation. Further, the main active ingredients of the ministerial drugs are added to a+b+c, and the four ministerial drugs (d1 / 2 / 3 / 4) are added separately to the combination of a+b+c, but none of them achieves a significant improvement in inhibiting inflammation; the four ministerial drugs are added simultaneously (d) to significantly enhance the inhibitory level of LPS-induced Lewis cell inflammation. This shows that the combination of the four Chinese medicines of fried scutellaria, astragalus, tangerine peel and coix seed can significantly enhance the inhibitory effect on pulmonary nodules, and the four Chinese medicines can achieve a significant synergistic effect when used together. The four ministerial drugs cannot significantly improve the efficacy when added alone, and the efficacy of the whole Chinese medicine combination can be improved when added simultaneously.

[0115] Therefore, the Chinese medicine composition of the present invention nourishes the stomach by selecting the best Chinese medicinal materials, so as to achieve the effect of improving the biochemical transformation of qi and blood in the middle jiao, and transfers the medicinal effect to the lungs, thereby improving the therapeutic effect; after being combined, the therapeutic effect of lung nodules is significantly improved; and it is combined with heat-clearing and detoxifying drugs to further improve the inhibition level of lung nodules, and treat the disease according to syndrome differentiation, and carry out early treatment in accordance with the development law of lung nodules to avoid development to the level of cancer, which has great application prospects.

Claims

1. A Chinese medicine composition having a therapeutic effect on pulmonary nodules, characterized in that: The Chinese medicine composition is composed of the following Chinese medicines: stir-fried scutellaria baicalensis, astragalus, tangerine peel, coix seed, and Chinese medicines for clearing away heat and detoxifying, including dandelion, selfheal, fritillaria thunbergii, and cat's claw.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-20 parts of stir-fried scutellaria baicalensis, 7.5-30 parts of coix seeds, 5-20 parts of astragalus, 5-20 parts of tangerine peel, 7.5-30 parts of dandelion, 5-20 parts of selfheal, 5-20 parts of thunbergia thunbergii, and 7.5-30 parts of cat's claw.

3. The Chinese medicine composition according to claim 1, characterized in that In the traditional Chinese medicine composition, astragalus and tangerine peel are replaced by ganoderma lucidum and / or trillium.

4. The Chinese medicine composition according to claim 3, characterized in that: The Chinese medicine composition is composed of the following medicinal materials in parts by weight: 5-20 parts of stir-fried scutellaria baicalensis, 7.5-30 parts of coix seeds, 5-20 parts of ganoderma lucidum, 0-40 parts of trillium, 7.5-30 parts of dandelion, 5-20 parts of selfheal, 5-20 parts of thunbergia thunbergii, and 7.5-30 parts of cat's claw.

5. The Chinese medicine composition according to claim 1, characterized in that: The stir-fried scutellaria baicalensis must be obtained from the processing of the traditional Chinese medicine scutellaria baicalensis.

6. The Chinese medicine composition according to claim 1, wherein the preparation method comprises the following steps: (1) Mix the required medicinal materials with water, decoct over low heat, and filter to obtain a filtrate and a filter residue; (2) mixing the filter residue with water again, repeating the decoction process in step (1) 2 to 3 times and filtering; (3) All the filtrates are combined and concentrated to obtain a concentrate.

7. The Chinese medicine composition according to claim 6, characterized in that: The concentrated solution obtained after the preparation of the traditional Chinese medicine composition is combined with a pharmaceutically acceptable carrier to prepare various dosage forms.

8. The Chinese medicine composition according to claim 6, characterized in that: The concentrated solution obtained after the preparation of the Chinese medicine composition is added with a flavor corrector to obtain a decoction, a mixture or an oral solution.

9. The Chinese medicine composition according to claim 6, characterized in that: The concentrated solution obtained after the preparation of the traditional Chinese medicine composition is added with auxiliary materials to be prepared into granules, capsules, tablets or powders.

10. The preparation method according to claim 6, characterized in that: In step (1), the temperature of the slow fire is 80-90° C., and the boiling time is 1-4 hours. In step (3), the concentration is carried out by one of normal pressure concentration, reduced pressure concentration or thin film concentration.

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