Traditional Chinese medicine for treating lung cancer as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines and particularly relates to a traditional Chinese medicine for treating lung cancer and a preparation method and application thereof. The traditional Chinese medicine is prepared from the following raw materials in parts by weight through water extraction or decoction: 3-4 parts of wild buckwheat rhizome, 2-3 parts of sculellaria barbata, 2-3 parts of oldenlandia diffusa and 0.5-2 parts of pericarpium citri reticulatae. According to the traditional Chinese medicine formula, through the synergistic effect of compatibility of the raw materials, the treatment effect of the traditional Chinese medicine can be brought into play, after water extraction or decoction, the traditional Chinese medicine has the remarkable inhibition effect on lung cancer cells or lung cancer no matter at the cellular level or in the animal body, and the traditional Chinese medicine is simple in compatibility and low in cost, has the advantage of treating both symptoms and root causes of the lung cancer and has a wide application prospect. Good clinical values are realized.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine. More specifically, it relates to a traditional Chinese medicine for treating lung cancer, its preparation method and uses. Background Art

[0002] Currently, surgical operation combined with radiotherapy and chemotherapy is mostly used to treat lung cancer. Although the surgical operation can remove the primary lesion, when lung cancer cells have spread beyond the primary site in the advanced stage of lung cancer, treatment cannot rely solely on resection to achieve the purpose. Although radiotherapy and chemotherapy can kill cancer cells, during the treatment, normal tissue cells are also damaged, inducing gastrointestinal reactions, bone marrow suppression, and damage to the liver, kidney, and heart functions, making the patient's body weaker and more difficult to further treat. Therefore, finding a drug that can effectively kill cancer cells with less toxic and side effects is the goal pursued in the current treatment of advanced lung cancer.

[0003] There is no exact disease name for lung cancer in traditional Chinese medicine, but the treatment of lung cancer by traditional Chinese medicine has a long history and can be classified into the categories of "lung disease" and "breath-related disease". It is recorded in "Plain Questions: On Strange Diseases": "The disease is fullness under the hypochondrium with qi ascending in reverse, and the disease name is breath-related disease." "Classic of Difficult Issues" also states: "The accumulation of the lung is called breath-related disease, located under the right hypochondrium, as large as a cup." Physicians of past dynasties believed that lung cancer is mostly a mixture of deficiency and excess, often with deficiency of healthy qi as the root and the combination of phlegm stasis and heat toxin as the branch. During treatment, syndrome differentiation and treatment should be carried out, with different emphases on strengthening healthy qi and dispelling pathogens at different stages.

[0004] The treatment of lung cancer by traditional Chinese medicine has been widely recognized. It can not only reduce adverse reactions, increase the passing rate of chemotherapy, improve clinical symptoms, and enhance the quality of life, but also regulate the body's immune function, induce apoptosis of tumor cells, and to a certain extent reduce the risk of recurrence and metastasis and prolong the survival period. Oral traditional Chinese patent medicine is often used in combination with chemotherapy during the adjuvant treatment period of lung cancer due to its accessibility, safety, and effectiveness, and certain clinical curative effects are obtained through the therapeutic methods of replenishing qi and nourishing yin, clearing heat and detoxifying, promoting qi circulation and removing stasis, and dissipating phlegm and resolving masses. The etiology theory of traditional Chinese medicine is an important part of the basic theory of traditional Chinese medicine. It reveals the nature and pathogenic characteristics of different types of etiologies and is the future of clinical practice.

[0005] Fagopyrum dibotrys herb is a commonly used medicinal material and a national endangered plant. The utilization and development of its green ecological resources are of great significance for protecting the endangered Fagopyrum dibotrys plant. Fagopyrum dibotrys has the effects of clearing heat and detoxifying, expelling pus and removing stasis, etc. Some studies have shown that certain components in Fagopyrum dibotrys may have a certain inhibitory effect on tumor cells and may play a certain adjuvant effect in the treatment of lung cancer. For example, it can help relieve some symptoms of lung cancer patients and reduce inflammatory reactions. For example, Chinese Patent CN104352797A discloses a traditional Chinese medicine for treating advanced lung cancer. The traditional Chinese medicine composition includes: 10 - 30 parts of Oldenlandia diffusa, 3 - 8 parts of Euphorbia helioscopia, 10 - 30 parts of Rhodiola rosea, 10 - 30 parts of wild chrysanthemum, 10 - 30 parts of Fagopyrum dibotrys, 8 - 15 parts of Scutellaria barbata, 20 - 30 parts of Chinese date, 20 - 30 parts of almond, 20 - 30 parts of lotus seed core, 3 - 8 parts of toad skin, 10 - 20 parts of smoked plum, 8 - 15 parts of white peony root, 8 - 15 parts of Prunella vulgaris, 8 - 15 parts of Cremastra appendiculata, 8 - 15 parts of Poria cocos, 10 - 20 parts of Chinese yam, 3 - 8 parts of Alisma orientale. In this formula, Oldenlandia diffusa, Euphorbia helioscopia, Rhodiola rosea, wild chrysanthemum, Fagopyrum dibotrys, Scutellaria barbata, and toad skin are the monarch drugs, which clear heat and detoxify, resolve phlegm and relieve cough, promote diuresis and reduce swelling; white peony root, Prunella vulgaris, and Cremastra appendiculata are the minister drugs, which resolve phlegm, clear away liver fire, and disperse swelling and dissipate nodules; Alisma orientale, Chinese yam, and Poria cocos are the assistant drugs, which strengthen the spleen, tonify the lung, promote diuresis, clear away heat, benefit the spleen and stomach; Chinese date, almond, lotus seed core, and smoked plum are the envoy drugs, which replenish qi and benefit the middle, nourish blood and soothe the nerves, activate blood circulation and promote fluid production; all the herbs assist each other and act synergistically to achieve the comprehensive therapeutic effect of tonifying qi and clearing the lung, improving intelligence and nourishing the heart, astringing and stopping bleeding, and dispersing stasis and reducing swelling, and have a significant curative effect on advanced lung cancer. However, this formula is too complex. On the one hand, it is difficult to control the drug efficacy and uniformity. On the other hand, it will also increase the medication cost of patients, which is not conducive to clinical promotion and application. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to overcome the problems of the existing traditional Chinese medicine formula for treating lung cancer being too complex and having a high cost. Combining with the modern theory of the development of traditional Chinese medicine, comprehensively exploring from aspects such as improving drug efficacy and reducing costs, through screening, extraction, and / or compatibility of traditional Chinese medicine components, a traditional Chinese medicine for treating lung cancer with significant efficacy, simple compatibility, and low cost is refined, which has the advantage of treating both the symptoms and root causes of lung cancer.

[0007] The purpose of the present invention is to provide a traditional Chinese medicine for treating lung cancer and its preparation method.

[0008] The above object of the present invention is achieved by the following technical solutions:

[0009] The present invention provides a traditional Chinese medicine for treating lung cancer, which is prepared by water extraction or decoction from the following raw materials in parts by weight: 3 - 4 parts of Fagopyrum dibotrys, 2 - 3 parts of Scutellaria barbata, 2 - 3 parts of Oldenlandia diffusa, and 0.5 - 2 parts of dried tangerine peel.

[0010] Preferably, the traditional Chinese medicine for treating lung cancer is prepared by water extraction or decoction from the following raw materials in parts by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Scutellaria barbata, 2.5 parts of Hedyotis diffusa, and 1 part of Tangerine Peel.

[0011] As a preferred embodiment, the preparation method of the traditional Chinese medicine for treating lung cancer is as follows: Weigh the prescribed amounts of Fagopyrum dibotrys, Scutellaria barbata, Hedyotis diffusa, and Tangerine Peel as raw materials, add water for decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract.

[0012] Among them, preferably, the filtrate is concentrated under reduced pressure to a relative density of 1.10 - 1.30 (60 °C).

[0013] That is, the relative density of the obtained extract at 60 °C is 1.10 - 1.30.

[0014] Preferably, the amount of water added for decoction is 6 - 10 times the total weight of the raw materials.

[0015] Preferably, the decoction is carried out 1 - 4 times, and each decoction lasts for 1 - 4 hours.

[0016] In addition, the traditional Chinese medicine may further contain one or more pharmaceutically acceptable excipients and / or adjuvants, and is thus made into dosage forms such as decoctions, granules, capsules, dripping pills, pills, powders, ointments, or suspensions.

[0017] The pharmaceutically acceptable excipients and / or adjuvants may be at least one of sustained-release agents, diluents, lubricants, emulsifiers, plasticizers, glidants, adjuvants, fillers, binders, wetting agents, disintegrants, absorption promoters, and surfactants.

[0018] The traditional Chinese medicine composition of the present invention helps to exert the therapeutic effect of traditional Chinese medicine through the synergistic effect of the compatibility of raw materials. After water extraction or decoction, it has a significant inhibitory effect on lung cancer cells or lung cancer both at the cellular level and in animals, and the compatibility is simple, having the advantage of treating both the symptoms and the root cause of lung cancer. Therefore, the present invention also claims the application of the traditional Chinese medicine in the preparation of drugs for treating lung cancer.

[0019] The following component raw materials are used in the traditional Chinese medicine composition of the present invention:

[0020] Fagopyrum dibotrys, cool in nature, slightly pungent and astringent in taste. Meridian tropism: It pertains to the lung meridian. Functions and indications: Clearing heat and detoxifying, expelling pus and removing stasis, clearing the lung and resolving phlegm. It is used for lung abscess, measles pneumonia, and peritonsillar abscess.

[0021] Scutellaria barbata, pungent, bitter, and cold in nature, meridian tropism: lung, liver, and kidney meridians, having the effects of clearing heat and detoxifying, promoting blood circulation to remove stasis, and inducing diuresis.

[0022] Oldenlandia diffusa, nature and flavor: bitter, sweet, cold. Meridian tropism: it belongs to the stomach, large intestine, and small intestine meridians. It has the effects of clearing heat and detoxifying, dissipating carbuncles and nodules, and promoting diuresis and relieving stranguria. It is commonly used for carbuncles and sores, sore throat, snake bites, acute strangury with pain, edema, dysentery, enteritis, damp-heat jaundice and other diseases, and is also commonly used in modern clinical practice to treat various cancers.

[0023] Tangerine peel, nature and flavor: bitter, pungent, warm. Meridian tropism: it belongs to the spleen and lung meridians. It has the functions of promoting defecation and reducing adverse qi, and also has the effect of drying dampness. It disperses the qi of the lung to relieve cough and asthma, promotes the qi of the spleen and stomach to strengthen the spleen and harmonize the stomach, regulate qi and relieve pain, and can also promote the circulation of qi and blood, alleviating various discomforts caused by qi stagnation.

[0024] The present invention combines the ancestral experience prescription drugs with the modern pharmacological principles of lung cancer, and formulates according to the principle of monarch, minister, assistant, and courier in traditional Chinese medicine prescription, providing a traditional Chinese medicine composition for treating lung cancer. The monarch drug ingredient is Fagopyrum dibotrys, the minister drug ingredient is Scutellaria barbata, the assistant drug ingredient is Oldenlandia diffusa, and the courier drug ingredient is tangerine peel. In the prescription of the composition, Fagopyrum dibotrys exerts the effects of clearing heat and detoxifying, expelling pus and removing stasis, clearing the lung and resolving phlegm, and is the monarch drug; Scutellaria barbata exerts the effects of dispersing the lung and dissipating nodules, detoxifying and dissipating carbuncles, and is the minister drug; Oldenlandia diffusa exerts the effects of dissipating carbuncles and nodules, promoting diuresis and relieving stranguria, and is the assistant drug; tangerine peel exerts the effect of drying dampness and resolving phlegm, and is the courier drug. Lung cancer is caused by deficiency of healthy qi, invasion of various pathogens, resulting in stagnation of lung qi, failure of body fluids to be distributed, accumulation of body fluids into phlegm, coagulation of phlegm and qi stagnation, stasis blocking the collaterals, resulting in the combination of phlegm, stasis, and toxin into a mass. "Phlegm, toxin, stasis, and deficiency" are the key to the traditional Chinese medicine etiology and pathogenesis of lung cancer. The prescription of the composition of the present invention exerts the effects of dispersing the lung and resolving phlegm, detoxifying and dissipating carbuncles, relieving cough and asthma, and is used to treat lung cancer and pulmonary metastatic cancer, with symptoms such as coughing with profuse sputum, chest pain, fatigue, dry mouth, and poor appetite.

[0025] The present invention has the following beneficial effects:

[0026] The traditional Chinese medicine prescription for treating lung cancer of the present invention is simple, consisting of only 4 ingredients, including 3 - 4 parts of Fagopyrum dibotrys, 2 - 3 parts of Scutellaria barbata, 2 - 3 parts of Oldenlandia diffusa, and 0.5 - 2 parts of tangerine peel. And the preparation process is simple, only boiling water can be used to extract the active ingredients, without the cumbersome operations such as soaking and extracting with organic solvents, avoiding the use of toxic reagents, facilitating the control of process quality, and being beneficial to ensuring the stability and consistency of the drug.

[0027] This traditional Chinese medicine has a significant inhibitory effect on lung cancer cells or lung cancer, has the advantage of treating both the symptoms and root causes of lung cancer, and has great clinical value. Detailed implementation mode

[0028] The following specific examples are used to further illustrate the present invention, but the examples do not limit the present invention in any form.

[0029] Unless otherwise specified, the reagents, methods, and equipment used in the present invention are conventional reagents, methods, and equipment in the technical field.

[0030] Unless otherwise specified, the reagents and materials used in the following examples are all commercially available.

[0031] The following herbs are also used in the following experiments:

[0032] Patrinia scabiosaefolia, nature and flavor: pungent, bitter, slightly cold. Meridian tropism: stomach, large intestine, liver meridians. It has the effects of clearing heat and detoxifying, eliminating carbuncles and discharging pus, removing stasis and relieving pain. It is mainly used to treat intestinal abscess, lung abscess, carbuncle and sore toxin, postpartum stasis and abdominal pain, traumatic injury and other diseases.

[0033] Dandelion, nature and flavor: bitter, sweet, cold. Meridian tropism: liver, stomach meridians. It has the effects of clearing heat and detoxifying, dissipating swelling and nodules, promoting diuresis and relieving stranguria. It can be used for furuncle and sore toxin, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, stranguria with pain.

[0034] Rhodiola rosea: cold in nature, sweet and astringent in taste. It belongs to the lung meridian. It also belongs to the lung and heart meridians. It has the effects of tonifying qi and activating blood circulation, dredging meridians and relieving asthma, clearing the lung and relieving cough. It can be used to treat hemoptysis, hematemesis, pneumonia cough, qi deficiency and blood stasis, chest impediment pain, stroke hemiplegia, fatigue and asthma. Research shows that Rhodiola rosea has anti-cancer effects and can significantly inhibit and directly kill liver cancer, laryngeal cancer, gastric cancer, lung cancer cells, and is a good helper in resisting cancer.

[0035] Wild chrysanthemum: slightly cold in nature, bitter and pungent in taste. Meridian tropism: lung, liver meridians. It has the effect of clearing heat and detoxifying. It can be used for cold, tracheitis, hepatitis, hypertension, dysentery, carbuncle, furuncle, red and swollen eyes, scrofula, eczema.

[0036] Euphorbia helioscopia: slightly cold in nature, pungent and bitter in taste. Meridian tropism: lung, intestine meridians. It has the effects of promoting diuresis and reducing swelling, resolving phlegm and relieving cough, detoxifying and killing insects. It can be used for edema due to fluid-retention, phlegm retention and asthma, malaria, bacillary dysentery, scrofula, tuberculous fistula, osteomyelitis. In the field of anti-cancer, Euphorbia helioscopia also shows its unique advantages.

[0037] Pinellia ternata: warm in nature, pungent in taste. Meridian tropism: lung, spleen, stomach meridians. It has the effects of drying dampness and resolving phlegm, lowering adverse qi and stopping vomiting, dissipating binds and nodules. It can be used for damp phlegm and cold phlegm, cough with profuse phlegm, phlegm retention and dizziness, wind phlegm dizziness, phlegm syncope headache, vomiting and nausea, chest and epigastric stuffiness, plum-pit qi; externally treating carbuncle and phlegm nodes. Clinically, Pinellia ternata is commonly used to treat various cancers such as esophageal cancer, gastric cancer, tongue cancer, skin cancer and malignant lymphoma.

[0038] Example 1

[0039] A traditional Chinese medicine for treating lung cancer is made from the following raw materials in parts by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Scutellaria barbata, 2.5 parts of Hedyotis diffusa, 1 part of Tangerine Peel.

[0040] The preparation method includes the following steps: Weigh each component raw material, mix the component raw materials, add water with a volume 8 times that of the raw materials, decoct twice, each time for 2 hours, filter after cooling, and concentrate the filtrate to a relative density of 1.20 (60 °C).

[0041] Example 2

[0042] A traditional Chinese medicine for treating lung cancer is made from the following raw materials in parts by weight: 3 parts of Fagopyrum dibotrys, 2 parts of Scutellaria barbata, 2 parts of Hedyotis diffusa, and 0.5 part of dried tangerine peel.

[0043] The preparation method includes the following steps: Weigh each component raw material, mix the component raw materials, add water with a volume 10 times that of the raw materials, decoct 4 times, each time for 1 hour, filter after cooling, and concentrate the filtrate to a relative density of 1.30 (60 °C).

[0044] Example 3

[0045] A traditional Chinese medicine for treating lung cancer is made from the following raw materials in parts by weight: 4 parts of Fagopyrum dibotrys, 3 parts of Scutellaria barbata, 3 parts of Hedyotis diffusa, and 2 parts of dried tangerine peel.

[0046] The preparation method includes the following steps: Weigh each component raw material, mix the component raw materials, add water with a volume 6 times that of the raw materials, decoct once for 4 hours, filter after cooling, and concentrate the filtrate to a relative density of 1.10 (60 °C).

[0047] Comparative Example 1

[0048] A traditional Chinese medicine is made from the following raw materials in parts by weight: 9.5 parts of Fagopyrum dibotrys.

[0049] That is, the prescription only contains the monarch drug Fagopyrum dibotrys, and the preparation method is the same as that of Example 1.

[0050] Comparative Example 2

[0051] A traditional Chinese medicine is made from the following raw materials in parts by weight: 3 parts of Scutellaria barbata, 3 parts of Hedyotis diffusa, and 3.5 parts of dried tangerine peel.

[0052] That is, the prescription only contains the ministerial, adjuvant, and guiding drugs, and does not contain the monarch drug Fagopyrum dibotrys, and the preparation method is the same as that of Example 1.

[0053] Comparative Example 3

[0054] A traditional Chinese medicine is made from the following raw materials in parts by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Patrinia scabiosaefolia, 2.5 parts of Hedyotis diffusa, and 1 part of dried tangerine peel.

[0055] That is, the ministerial drug Scutellaria barbata is replaced with an equal amount of Patrinia scabiosaefolia with similar efficacy, and the others are the same as Example 1.

[0056] Comparative Example 4

[0057] A traditional Chinese medicine is made from the following raw materials by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Scutellaria barbata, 2.5 parts of Taraxacum mongolicum, and 1 part of dried tangerine peel.

[0058] That is, an equal amount of Taraxacum mongolicum with similar efficacy is used to replace the adjuvant herb Hedyotis diffusa, and the others are the same as in Example 1.

[0059] Comparative Example 5

[0060] A traditional Chinese medicine is made from the following raw materials by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Patrinia scabiosaefolia, 2.5 parts of Taraxacum mongolicum, and 1 part of dried tangerine peel.

[0061] That is, an equal amount of Patrinia scabiosaefolia with similar efficacy is used to replace Scutellaria barbata, and an equal amount of Taraxacum mongolicum with similar efficacy is used to replace Hedyotis diffusa, and the others are the same as in Example 1.

[0062] Comparative Example 6

[0063] A traditional Chinese medicine is made from the following raw materials by weight: 1 part of Fagopyrum dibotrys, 4 parts of Scutellaria barbata, 2 parts of Hedyotis diffusa, and 2.5 parts of dried tangerine peel.

[0064] The preparation method is the same as that in Example 1.

[0065] Comparative Example 7

[0066] A traditional Chinese medicine is made from the following raw materials by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Scutellaria barbata, 2.5 parts of Hedyotis diffusa, and 1 part of Pinellia ternata.

[0067] That is, an equal amount of Pinellia ternata with similar efficacy is used to replace dried tangerine peel, and the others are the same as in Example 1.

[0068] Comparative Example 8

[0069] A traditional Chinese medicine is made from the following raw materials by weight: 3.5 parts of Rhodiola rosea, 2.5 parts of Scutellaria barbata, 2.5 parts of Hedyotis diffusa, and 1 part of dried tangerine peel.

[0070] That is, an equal amount of Rhodiola rosea with similar efficacy is used to replace Fagopyrum dibotrys, and the others are the same as in Example 1.

[0071] Comparative Example 9

[0072] A traditional Chinese medicine is made from the following raw materials by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Chrysanthemum indicum, 2.5 parts of Euphorbia helioscopia, and 1 part of dried tangerine peel.

[0073] That is, an equal amount of Chrysanthemum indicum with similar efficacy is used to replace Scutellaria barbata, and an equal amount of Euphorbia helioscopia with similar efficacy is used to replace Hedyotis diffusa, and the others are the same as in Example 1.

[0074] Comparative Example 10

[0075] A traditional Chinese medicine is made from the following raw materials by weight: 3.5 parts of Rhodiola rosea, 2.5 parts of Chrysanthemum indicum, 2.5 parts of Euphorbia helioscopia, and 1 part of dried tangerine peel.

[0076] Replace Fagopyrum dibotrys with Rhodiola rosea with similar efficacy in equal amounts, Scutellaria barbata with Chrysanthemi indicum, and Hedyotis diffusa with Euphorbia helioscopia, and the rest is the same as in Example 1.

[0077] Comparative Example 11

[0078] A traditional Chinese medicine for treating lung cancer is prepared from the following raw materials in parts by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Scutellaria barbata, 2.5 parts of Hedyotis diffusa, and 1 part of dried tangerine peel.

[0079] The preparation method includes the following preparation steps:

[0080] (1) Decoct the dried tangerine peel with 8 times the volume of water for 2 times, each time for 2 hours. After cooling, filter to obtain a filtrate.

[0081] (2) Mix Hedyotis diffusa, Fagopyrum dibotrys, and Scutellaria barbata together, add 8 times the volume of 70% ethanol, reflux and extract for 3 times, each time for 2 hours. Combine the ethanol extracts, and remove ethanol by reduced pressure distillation to obtain an ethanol extract concentrate.

[0082] Combine the filtrate obtained in (1) and the ethanol extract concentrate obtained in (2), and concentrate to a relative density of 1.20 (60 °C). Experimental Example 1 Inhibitory effect of traditional Chinese medicine on the proliferation of mouse lung cancer cells

[0083] 1. Cell source:

[0084] Mouse lung cancer cell line M109, purchased from Shanghai Jinyuan Biotechnology Co., Ltd., was activated and cultured according to the conditions in the instruction manual for standby.

[0085] 2. Test drug solutions:

[0086] Respectively add the traditional Chinese medicines prepared in Examples 1 - 3 and Comparative Examples 1 - 6 to sterile water to prepare drug solutions with a concentration of 100 mg / L for standby;

[0087] Positive control group: Doxorubicin hydrochloride (DOX) with a concentration of 5 mg / L.

[0088] 3. Test method

[0089] Dilute the mouse lung cancer cell line M109 in the logarithmic growth phase to 1×10 5 cells / mL and inoculate into a 96-well cell culture plate, 200 μL per well. After culturing with DMEM complete medium for 24 hours until a monolayer is formed, aspirate the culture medium, and then divide it into a drug treatment group and a normal control group.

[0090] Among them, only DMEM complete medium was added to the normal control group, and the test article solutions of each group were added to the dosing groups. There were 3 replicates in each group. They were cultured in an incubator, and the morphological changes of the cells were observed daily. After 72 h, 20 μL of MTT was added to each well under light-proof conditions and incubated at 37 °C for 4 h. The supernatant was aspirated, and 150 μL of dimethyl sulfoxide was added to each well. It was shaken well, and the absorbance value (OD value) at 490 nm was measured.

[0091] The formula for calculating the inhibition rate of lung cancer cell proliferation is as follows:

[0092]

[0093] The results were analyzed using SPSS 27.0 statistical software, and the measurement data were expressed as mean ± standard deviation (mean ± SD). One-way ANOVA was used for comparison among multiple groups, and the t-test was used for comparison between two groups. p < 0.05 indicated that the difference was statistically significant.

[0094] 4. Test results

[0095] The results are shown in Table 1. The DOX in the traditional Chinese medicine groups of Examples 1-3 of the present invention and the positive control group all had a significant (p < 0.01) inhibitory effect on the proliferation of mouse lung cancer cells. In contrast, the inhibitory effect of the traditional Chinese medicine groups of Examples 1-3 of the present invention was slightly weaker than that of the positive control, but the difference was not significant.

[0096] In addition, Comparative Examples 3, 4 and Comparative Examples 6-9 also had a certain inhibitory effect on lung cancer cells (p < 0.05), but the inhibitory effect was significantly lower than that of the traditional Chinese medicine groups of Examples 1-3 of the present invention, indicating that the formula and dosage of the traditional Chinese medicine of the present invention had a great influence on the inhibitory effect. It shows that the traditional Chinese medicine of the present invention has a synergistic effect in raw material compatibility and content composition, and its compounding has a significant impact on the drug effect. According to the results of Comparative Example 11, the traditional Chinese medicine prescription for treating lung cancer of the present invention is not suitable for alcohol extraction.

[0097] Table 1 Inhibitory results of the traditional Chinese medicine of the present invention on the proliferation of mouse lung cancer cells

[0098]

[0099] Note: vs normal control group, * P < 0.05, ** P < 0.01; vs Example 1 group, among each dosing group & P < 0.05, && P < 0.01.

[0100] Test Example 2 Effect of traditional Chinese medicine on mouse transplanted tumor model

[0101] 1. Test animals:

[0102] SPF-grade 10-week-old male C57BL / 6 mice, weighing 20-25 g, with good fur luster, no hair loss, no trauma or disability, normal limb movement, and good spirit (purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., production license number: SCXK(Beijing)2016-0006, quality certificate number: NO.1100111911051800.) were adaptively fed with mouse maintenance feed that meets national standards for one week. Animal feeding conditions: 12-hour lighting, 12-hour darkness, raised in a SPF barrier environment, temperature maintained at 21-24 °C, humidity 40-60%, the breeding environment was kept quiet to prevent noise, and animals were allowed to eat and drink freely.

[0103] 2. Test materials:

[0104] The human small cell lung cancer cell line SHP-77 was purchased from the Cell Bank of the Chinese Academy of Sciences Committee for Type Culture Collection; Etoposide Injection (20 mg / mL) was purchased from Qilu Pharmaceutical (Hainan) Co., Ltd. (national drug approval number: H20143143).

[0105] 3. Test methods

[0106] (1) Establishment of the transplanted tumor model:

[0107] The C57BL / 6 mice were raised at room temperature. After they adapted to the environment, SHP-77 cells were inoculated into them, and each mouse was injected with 7×10 7 cells. One week after inoculation, the left axillary subcutaneous area of the mice was observed, and nodules the size of rice grains were found at the inoculation site of the mice. After continued breeding, when the tumor diameter was about 5 mm, mice with large differences in tumor size and body weight were excluded, and the remaining mice were randomly grouped.

[0108] (2) This test was divided into the following groups, with 5 tumor-bearing mice in each group:

[0109] Model control group: gavaged with an equal volume of normal saline once a day;

[0110] Positive control group: Etoposide, intraperitoneally injected with an equal volume at 2 mg / kg / day once a day;

[0111] Drug administration group: The traditional Chinese medicines in Example 1-3 groups and Comparative Example 1-5 groups were respectively gavaged with an equal volume at 30 mg / kg / day once a day.

[0112] (3) Evaluation indicators: Tumor weight and tumor inhibition rate

[0113] After continuous drug administration for 4 weeks, the mice were sacrificed. After the tumor masses were dissected, they were weighed. The tumor inhibition rate was calculated according to the following formula:

[0114]

[0115] (4) The results were analyzed using SPSS 27.0 statistical software. Measurement data were expressed as mean ± standard deviation (mean ± SD). One-way analysis of variance was used for comparison among multiple groups, and the t-test was used for comparison between two groups. A p < 0.05 indicated a statistically significant difference.

[0116] 4. Experimental results

[0117] The results are shown in Table 2. In the experiment, after inoculating SHP-77 cells into mice, after a 5-day latency period, the tumors grew rapidly, indicating successful model construction.

[0118] As shown in Table 2, the tumors of mice in the positive control group, Example 1 group, Example 2 group, and Example 3 group were all significantly inhibited (**p < 0.01). Among them, the effects of Example 1-3 groups were already close to that of the positive control drug etoposide.

[0119] From the results of Comparative Examples 3-5, 7-10 groups, it can also be seen that when the medicinal flavors in the traditional Chinese medicine formula of the present invention were replaced, the effect of inhibiting small cell lung cancer in mice was significantly weakened, indicating that the curative effect of the traditional Chinese medicine formula of the present invention is closely related to the types of each medicinal flavor in the prescription, and there is a significant synergistic tumor-inhibiting effect among the various prescriptions. In addition, from Comparative Examples 1, 2, and 6 groups, it can be seen that the absence or content of the traditional Chinese medicine prescription of the present invention has a significant impact on the drug effect. According to the results of Comparative Example 11, the traditional Chinese medicine prescription for treating lung cancer of the present invention is not suitable for ethanol extraction.

[0120] Table 2 Inhibitory effect of the traditional Chinese medicine of the present invention on tumors in tumor-bearing mice

[0121]

[0122]

[0123] Note: vs model control group, * P < 0.05, ** P < 0.01; vs Example 1 group, among each administration group & P < 0.05, && P < 0.01.

[0124] The above describes the basic principle, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification is only the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine for treating lung cancer, characterized in that, It is prepared by water extraction or decoction from the following raw materials in parts by weight: 3 - 4 parts of Fagopyrum dibotrys, 2 - 3 parts of Scutellaria barbata, 2 - 3 parts of Hedyotis diffusa, and 0.5 - 2 parts of Pericarpium Citri Reticulatae.

2. The traditional Chinese medicine according to claim 1, wherein It is prepared by water extraction or decoction from the following raw materials in parts by weight: 3.5 parts of Fagopyrum dibotrys, 2.5 parts of Scutellaria barbata, 2.5 parts of Hedyotis diffusa, and 1 part of Pericarpium Citri Reticulatae.

3. The traditional Chinese medicine according to claim 1 or 2, wherein The preparation method is as follows: Weigh the prescribed amounts of Fagopyrum dibotrys, Scutellaria barbata, Hedyotis diffusa, and Pericarpium Citri Reticulatae as raw materials, add water for decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract.

4. The traditional Chinese medicine according to claim 3, wherein, The relative density of the said extract at 60 °C is 1.10 - 1.

30.

5. The traditional Chinese medicine according to claim 3, wherein The water addition amount for the said decoction is 6 - 10 times the total weight of the raw materials.

6. The traditional Chinese medicine according to claim 3, wherein, The said decoction is carried out 1 - 4 times, and each decoction lasts for 1 - 4 h.

7. The traditional Chinese medicine according to any one of claims 1-5, characterized in that, It also contains one or more pharmaceutically acceptable excipients and / or vehicles.

8. The traditional Chinese medicine according to claim 7, wherein The said pharmaceutically acceptable excipients and / or vehicles are at least one of sustained-release agents, diluents, lubricants, emulsifiers, plasticizers, glidants, vehicles, fillers, binders, wetting agents, disintegrants, absorption promoters, and surfactants.

9. The traditional Chinese medicine according to claim 8, characterized in that, The dosage form is decoction, granule, capsule, dripping pill, pill, powder, paste, or suspension.

10. Use of the traditional Chinese medicine according to any one of claims 1 - 9 in the preparation of a drug for treating lung cancer.

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