Traditional Chinese medicine formula for adjuvant therapy of esophagus cancer and radiation esophagitis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine formula for adjuvant therapy of esophageal cancer and radiation esophagitis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine formula comprises the following raw materials: sculellaria barbata, hedyotis diffusa, nightshade, reed root, salvia chinensis, concha arcae, radix glehniae, radix actinidiae chinensis, cynanchum paniculatum, lotus leaf, blackberry lily, subprostrate sophora, rabdosia rubescens, scaphium scaphigerum, amomum cardamomum, fructus forsythiae, selfheal and garden balsam. , radix clematidis, radix scrophulariae, salvia miltiorrhiza and oyster. The formula has the effects of clearing away heat and toxic materials, diminishing swelling and removing stasis, nourishing yin and moistening dryness, and activating meridians to stop pain, can effectively relieve choking of esophageal cancer patients and red, swollen and painful throat of radiation esophagitis patients in the radiotherapy period, and improves the life quality and treatment effect of the patients.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine formula for auxiliary treatment of esophageal cancer and radiation esophagitis and a preparation method thereof. Background Art

[0002] Esophageal cancer is a common digestive tract malignancy with high morbidity and mortality rates worldwide. Radiation esophagitis is a common complication of radiotherapy for esophageal cancer patients, primarily manifesting as sore throat, redness, swelling, and difficulty swallowing. This condition severely impacts patients' quality of life and treatment compliance, ultimately affecting the effectiveness of esophageal cancer treatment.

[0003] Currently, treatments for esophageal cancer primarily include surgery, radiotherapy, chemotherapy, and combined therapies. For radiation-induced esophagitis, symptomatic treatments such as anti-inflammatory, analgesic, and nutritional support are often used, but these approaches often suffer from limited efficacy and significant side effects. Traditional Chinese medicine (TCM) offers unique advantages in treating tumors and related complications. Its multi-target, multi-pathway mechanism of action can effectively alleviate symptoms and improve quality of life, with relatively minimal side effects.

[0004] However, existing traditional Chinese medicine formulas for the adjuvant treatment of esophageal cancer and radiation esophagitis mostly focus on a single effect (such as only clearing away heat and detoxifying or promoting blood circulation and removing blood stasis), and still have certain deficiencies in efficacy and targeting, and cannot meet clinical needs. Therefore, there is an urgent need to develop a more effective traditional Chinese medicine formula for the adjuvant treatment of esophageal cancer and radiation esophagitis. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine formula for the auxiliary treatment of esophageal cancer and radiation esophagitis and a preparation method thereof. The formula has the effects of clearing away heat and detoxifying, reducing swelling and dispersing nodules, nourishing yin and moistening dryness, and unblocking meridians and relieving pain. It can effectively relieve the symptoms of choking when eating in patients with esophageal cancer and redness, swelling and pain in the throat during radiotherapy in patients with radiation esophagitis, thereby improving the quality of life of patients and the treatment effect.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A traditional Chinese medicine formula for auxiliary treatment of esophageal cancer and radiation esophagitis, comprising the following raw materials:

[0008] Scutellaria barbata, white snake grass, Solanum nigrum, reed root, stonewort, corrugated fruit, northern adenophora, vine pear root, Cynanchum indica, lotus leaf, Belamcanda chinensis, Sophora flavescens, Rubescens rubescens, Sterculia lychnophora, white cardamom, forsythia, selfheal, Aconitum carmichaelii, Clematis chinensis, Scrophularia ningpoensis, Salvia miltiorrhiza and oyster.

[0009] In the traditional Chinese medicine formula of the present invention, Scutellaria barbata, Herba Lycopodii, Solanum nigrum, Herba Lycopodii, Rabdosiae rubescens, Fructus Forsythiae, and Herba Prunellae have the effects of clearing away heat and detoxifying, reducing swelling and dispersing nodules, can effectively inhibit the growth of tumor cells, and alleviate inflammatory reactions; Radix Rehmanniae, Radix Glehniae, and Radix Scrophulariae nourish yin and moisten dryness, can relieve symptoms such as dry mouth and lack of fluid, and improve the patient's yin deficiency state; Fructus Coriolus and Concha Ostreae soften and dissipate nodules, and help to dissipate tumor agglomerates; Radix Pyriferae, Radix Cynanchum, and Radix Clematis chinensis unblock meridians and relieve pain, and can alleviate the feeling of eating obstruction and throat pain and discomfort; Lotus leaf, Belamcanda chinensis, Radix Sophorae flavescentis, Radix Sterculiae lycopodii, and Radix Cardamomum villosum relieve throat swelling, promote qi and harmonize the stomach, and have a positive effect on relieving throat swelling and improving digestive function; Radix Aconitum carmichaelii breaks blood, softens hard masses, and eliminates accumulation, and Radix Salviae miltiorrhizae promotes blood circulation and removes blood stasis, and the combination of the two can promote local blood circulation and enhance the efficacy of the medicine. The combination of these medicines has the effects of clearing away heat and detoxifying, reducing swelling and dispersing nodules, nourishing yin and moistening dryness, and unblocking meridians and relieving pain. It is suitable for the auxiliary treatment of esophageal cancer and radiation esophagitis related symptoms.

[0010] In the formula of the present invention, Scutellaria barbata and Herba Ophiopogonis are the main ingredients. Scutellaria barbata has the effects of clearing heat and detoxifying, dispersing blood stasis and stopping bleeding, and promoting diuresis and reducing swelling. Modern research has shown that it has an inhibitory effect on various tumor cells. Herba Ophiopogonis is also good at clearing heat and detoxifying, eliminating carbuncles and dispersing nodules. The combination of the two can effectively target esophageal cancer tumor lesions, inhibit tumor cell growth, and alleviate the inflammatory response caused by radiation esophagitis, playing a key therapeutic role in the prescription.

[0011] Solanum nigrum, Lithospermum officinale, Rubescens herb, Forsythia suspensa, and Prunella vulgaris are the assistant herbs. Solanum nigrum clears heat and detoxifies, acts as a diuretic and reduces swelling, and can assist the main herbs in enhancing their anti-cancer efficacy. Lithospermum officinale promotes blood circulation and removes stasis, clears heat and detoxifies, and helps improve blood circulation at the tumor site and enhance drug penetration. Rubescens herb, Forsythia suspensa, and Prunella vulgaris all have the effects of clearing heat and detoxifying, reducing swelling and dispersing nodules, and can work with the main herbs to alleviate esophageal inflammation, relieve symptoms such as redness, swelling, and pain, and together assist the main herbs in achieving a more significant therapeutic effect.

[0012] Auxiliary drugs: reed root, northern adenophora, and scrophulariae nourish yin and moisten dryness, relieve symptoms of yin deficiency such as dry mouth and lack of fluid, and improve the patient's fluid damage caused by disease and radiotherapy; corrugated seeds and oyster soften and disperse lumps, and assist in dispersing tumor agglomerations; vine pear root, Cynanchum chinense, and clematis dredge meridians and relieve pain, and reduce the feeling of eating obstruction and throat pain; lotus leaf, beam dryness, Sophora flavescens, Sterculia lychnophora, and white cardamom relieve throat swelling, promote qi and soothe the stomach, relieve throat swelling and improve digestive function. These drugs assist the monarch and ministerial drugs in exerting their therapeutic effects; Auxiliary drugs: Many heat-clearing and detoxifying drugs in the prescription have cold properties, and white cardamom and other qi-promoting and stomach-soothing drugs can alleviate their damage to the spleen and stomach to a certain extent, playing an auxiliary role, and playing a role in restraining the harshness or toxicity of the monarch and ministerial drugs;

[0013] Enabling drugs have two functions. One is the guiding drug, that is, the drug that can guide the drugs in the prescription to the specific disease site; the other is the harmonizing drug, that is, the drug that can harmonize the effects of the drugs in the prescription. In the formula of the present invention, Salvia miltiorrhiza can invigorate blood circulation and nourish blood, play the role of harmonizing qi and blood, promoting drug absorption and circulation, and at the same time helping to improve local blood circulation in the esophagus, and can be regarded as a harmonizing drug; although the guiding drug is not clearly stated in the formula, from the perspective of the drug's meridians, some drugs belong to the lung, stomach, and esophagus meridians, which can make the drug power directly reach the disease site and work together to exert therapeutic effects.

[0014] Preferably, the following raw materials are included in parts by weight:

[0015] 15-30 parts of Scutellaria barbata, 15-30 parts of Herba Epimedii, 6-9 parts of Solanum nigrum, 15-30 parts of Radix Rehmanniae, 6-15 parts of Radix Lithospermi, 30-60 parts of Fructus Corrugae, 9-12 parts of Radix Adenophorae, 9-30 parts of Radix Pyriferae, 6-12 parts of Radix Cynanchifoliae, 9-15 parts of Folium Nelumbo, 6-12 parts of Rhizoma Belamcandae, 6-9 parts of Radix Sophorae Tonkinensis, 6-15 parts of Rabdosia rubescens, 6-15 parts of Sterculia lycopersicum, 6-15 parts of Fructus Amomi, 9-15 parts of Fructus Forsythiae, 9-15 parts of Spica Prunellae, 6-9 parts of Fructus Aconitum, 6-9 parts of Radix Clematis, 9-15 parts of Radix Scrophulariae, 9-15 parts of Radix Salviae Miltiorrhizae and 30-60 parts of Concha Ostreae.

[0016] Preferably, the following raw materials are included in parts by weight:

[0017] 15 parts of Scutellaria barbata, 15 parts of Herba Epimedii Hanceii, 6 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Herba Lycopodii, 30 parts of Fructus Corrugae, 9 parts of Radix Adenophorae, 9 parts of Radix Pyriferae, 6 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 6 parts of Radix Sophorae Tonkinensis, 6 parts of Rabdosiae Rubescens, 6 parts of Sterculiae Dahuricae, 6 parts of Fructus Amomi, 9 parts of Fructus Forsythiae, 9 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematidis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae.

[0018] Preferably, the following raw materials are included in parts by weight:

[0019] 25 parts of Scutellaria barbata, 25 parts of Herba Epimedii Hanceii, 8 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Radix Lithospermi, 45 parts of Fructus Corrugae, 12 parts of Glehnia littoralis, 9 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 6 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosia rubescens, 6 parts of Sterculia lycopersicum, 6 parts of Fructus Amomi, 9 parts of Fructus Forsythiae, 9 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematidis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae.

[0020] Preferably, the following raw materials are included in parts by weight:

[0021] 25 parts of Scutellaria barbata, 25 parts of Herba Epimedii Hanceii, 8 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Radix Lithospermi, 45 parts of Fructus Corrugae, 12 parts of Glehnia littoralis, 9 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 6 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosia rubescens, 6 parts of Sterculia lycopersicum, 6 parts of Fructus Amomi, 9 parts of Fructus Forsythiae, 9 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematidis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae.

[0022] Preferably, the following raw materials are included in parts by weight:

[0023] 25 parts of Scutellaria barbata, 25 parts of Herba Epimedii Hanceii, 7 parts of Solanum nigrum, 25 parts of Radix Rehmanniae, 12 parts of Radix Lithospermi, 45 parts of Fructus Corrugae, 10 parts of Radix Adenophorae, 20 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 12 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 7 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosiae Rubescens, 10 parts of Sterculiae Dahuricae, 10 parts of Fructus Amomi, 12 parts of Fructus Forsythiae, 12 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 9 parts of Radix Clematidis, 12 parts of Scrophulariae, 12 parts of Radix Salviae Miltiorrhizae and 45 parts of Concha Ostreae.

[0024] Preferably, the following raw materials are included in parts by weight:

[0025] 20 parts of Scutellaria barbata, 20 parts of Herba Epimedii Hanceii, 7 parts of Solanum nigrum, 20 parts of Radix Rehmanniae, 10 parts of Radix Lithospermi, 40 parts of Fructus Corrugae, 10 parts of Radix Adenophorae, 15 parts of Radix Pyriferae, 8 parts of Radix Cynanchifoliae, 10 parts of Leaf of Lotus, 8 parts of Rhizoma Belamcandae, 7 parts of Radix Sophorae Tonkinensis, 10 parts of Rabdosiae Rubescens, 10 parts of Sterculiae Dahuricae, 10 parts of Fructus Amomi, 10 parts of Fructus Forsythiae, 10 parts of Spica Prunellae, 7 parts of Fructus Aconitum, 7 parts of Radix Clematidis, 10 parts of Scrophulariae, 10 parts of Salviae Miltiorrhizae and 40 parts of Concha Ostreae.

[0026] Preferably, the dosage form of the traditional Chinese medicine formula is a decoction.

[0027] The method for preparing the above-mentioned traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis comprises the following specific steps:

[0028] (1) Weigh the raw materials according to the mass parts, wash them, drain the water and set aside;

[0029] (2) crushing or slicing the drained raw materials and then mixing them evenly to obtain a mixed material;

[0030] (3) Add 8-10 times the total weight of the mixture in water, soak and boil, and then filter to obtain the medicinal solution.

[0031] Preferably, the soaking time in step (3) is 30-60 minutes, so that the medicinal materials can fully absorb water and soften, thereby promoting the dissolution of the active ingredients;

[0032] The decoction is to first boil the soaked medicinal materials over high heat, then immediately turn to low heat after boiling, and keep decocting at a slight boiling state for 30-40 minutes.

[0033] The Chinese medicine formula of the present invention is mainly used to treat: early stage of choking, when the vital energy is not deficient but the evil energy is strong; patients with esophageal cancer who are still able to eat, and acute throat swelling and pain during radiotherapy;

[0034] Indications: 1) Early-stage choking, with pathogenic factors obstructing the upper Jiao (Jiao Jiao), while the patient can still eat, with a noticeable sense of obstruction, or accompanied by pharyngeal pain and discomfort, dry mouth, normal or dry stools, short dark urine, red or light red tongue, thin yellow or greasy fur, and a thready, rapid, slippery, and strong pulse. 2) Patients with esophageal cancer whose target area is located in the upper and middle segments of the esophagus, experiencing acute or chronic pharyngeal pain and discomfort during radiotherapy, dry mouth, normal or dry stools, short dark urine, red or light red tongue, thin yellow or greasy fur, and a thready, rapid, slippery, and strong pulse.

[0035] Preferably, the method of taking the decoction is:

[0036] Take 1-20ml each time, take frequently with an interval of 20-30 minutes. The total daily dosage is 300-500ml.

[0037] It can be seen from the above technical solution that compared with the prior art, the beneficial effects of the present invention are as follows:

[0038] The entire formula of this invention is based on a core ingredient (main ingredient) that clears heat and detoxifies, reduces swelling and resolves stagnation, and is combined with ingredients (minister ingredient and adjuvant ingredient) that nourish yin and moisten dryness, soften and resolve stagnation, and dredge meridians and relieve pain. This formula addresses both systemic symptoms and localized pathological changes, harmonizing and guiding the other ingredients. The ingredients synergize with each other, acting through multiple targets and pathways on esophageal cancer and radiation-induced esophagitis. This not only suppresses tumor lesions but also effectively alleviates radiation-induced inflammation and related discomfort. It also prioritizes regulating the body's yin and yang balance and reducing drug side effects, thereby achieving the goal of adjuvant treatment. DETAILED DESCRIPTION

[0039] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0040] Example 1

[0041] The present invention provides a method for preparing a traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis, comprising the following specific steps:

[0042] (1) Weigh the following raw materials: 15 parts of Scutellaria barbata, 15 parts of Herba Lycopodii, 6 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Ipomoea batatas, 30 parts of Fructus Corrugae, 9 parts of Glehnia littoralis, 9 parts of Radix Pyriferae, 6 parts of Cynanchum indicum, 9 parts of Lotus leaf, 6 parts of Belamcanda chinensis, 6 parts of Radix Sophorae Tonkinensis, 6 parts of Rabdosia rubescens, 6 parts of Sterculia lycopersicum, 6 parts of White Cardamom, 9 parts of Fructus Forsythiae, 9 parts of Herba Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae, and 30 parts of Concha Ostreae. Wash and drain the water for later use.

[0043] (2) crushing or slicing the drained raw materials and then mixing them evenly to obtain a mixed material;

[0044] (3) Add 9 times the total weight of the mixture in water, soak for 30 minutes, and then boil the medicinal materials over high heat. Immediately after boiling, turn to low heat and keep it at a slight boil for 30 minutes, then filter to obtain the medicinal liquid.

[0045] Example 2

[0046] The present invention provides a method for preparing a traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis, comprising the following specific steps:

[0047] (1) Weigh the following raw materials: 25 parts of Scutellaria barbata, 25 parts of Herba Lycopodii, 8 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Ipomoea batatas, 45 parts of Fructus Corrugae, 12 parts of Glehnia littoralis, 9 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo Nuciferae, 6 parts of Belamcanda chinensis, 6 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosia rubescens, 6 parts of Sterculia lycopersicum, 6 parts of White Cardamom, 9 parts of Fructus Forsythiae, 9 parts of Herba Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae, wash and drain the water for later use;

[0048] (2) crushing or slicing the drained raw materials and then mixing them evenly to obtain a mixed material;

[0049] (3) Add 9 times the total weight of the mixture in water, soak for 30 minutes, and then boil the medicinal materials over high heat. Immediately after boiling, turn to low heat and keep it at a slight boil for 30 minutes, then filter to obtain the medicinal liquid.

[0050] Example 3

[0051] The present invention provides a method for preparing a traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis, comprising the following specific steps:

[0052] (1) Weigh the following raw materials: 20 parts of Scutellaria barbata, 20 parts of Herba Lycopithecis, 7 parts of Solanum nigrum, 20 parts of Radix Rehmanniae, 10 parts of Ipomoea batatas, 40 parts of Fructus Corrugae, 10 parts of Glehnia littoralis, 15 parts of Radix Pyriferae, 8 parts of Cynanchum chinense, 10 parts of Lotus leaf, 8 parts of Belamcanda chinensis, 7 parts of Radix Sophorae flavescentis, 10 parts of Rabdosia rubescens, 10 parts of Sterculia lycopersicum, 10 parts of White Cardamom, 10 parts of Fructus Forsythiae, 10 parts of Herba Prunellae, 7 parts of Fructus Aconitum, 7 parts of Radix Clematis, 10 parts of Scrophulariae ningpoensis, 10 parts of Salvia miltiorrhiza and 40 parts of Concha Ostreae, wash and drain the water for later use;

[0053] (2) crushing or slicing the drained raw materials and then mixing them evenly to obtain a mixed material;

[0054] (3) Add 8 times the total weight of the mixture in water, soak for 30 minutes, and then boil the medicinal materials over high heat. Immediately after boiling, turn to low heat and keep it at a slight boil for 30 minutes, then filter to obtain the medicinal liquid.

[0055] Example 4

[0056] The present invention provides a method for preparing a traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis, comprising the following specific steps:

[0057] (1) Weigh the following raw materials: 15 parts of Scutellaria barbata, 15 parts of Herba Lycopodii, 6 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Ichthyostegatae, 30 parts of Fructus Corrugae, 12 parts of Glehnia littoralis, 30 parts of Radix Pyriferae, 12 parts of Radix Cynanchifoliae, 15 parts of Folium Nelumbo, 12 parts of Radix Sophorae flavescentis, 15 parts of Rabdosiae Rubescens, 15 parts of Sterculia lycopersicum, 15 parts of Cardamom, 15 parts of Fructus Forsythiae, 15 parts of Herba Prunellae, 9 parts of Fructus Aconitum, 9 parts of Radix Clematis, 15 parts of Scrophulariae ningpoensis, 15 parts of Salvia miltiorrhizae and 60 parts of Concha Ostreae, wash and drain the water for later use;

[0058] (2) crushing or slicing the drained raw materials and then mixing them evenly to obtain a mixed material;

[0059] (3) Add 10 times the total weight of the mixture in water, soak for 60 minutes, and then boil the medicinal materials over high heat. Immediately after boiling, turn to low heat and keep it at a slight boil for 40 minutes, then filter to obtain the medicinal liquid.

[0060] Effect verification

[0061] In vitro cell experiments

[0062] Experimental Materials: Human esophageal cancer Eca-109 cell line (Shanghai Jingfeng Biotechnology Co., Ltd.), human normal esophageal epithelial Het-1A cell line (Shanghai Xinyu Biotechnology Co., Ltd.); a traditional Chinese medicine decoction of the present invention (the product of Example 1, sterilized with a 0.22 μm filter and concentrated to a crude drug concentration of 1 g / mL); RPMI 1640 medium, Dulbecco's Methionin (DMEM) medium; fetal bovine serum (FBS); MTT reagent; DMSO;

[0063] Experimental methods

[0064] Cell culture: Eca-109 cells were cultured in RPMI 1640 medium supplemented with 10% FBS, and Het-1A cells were cultured in DMEM medium supplemented with 10% FBS in a 37°C, 5% CO2 incubator. Subsequent experiments were performed when the cells reached the logarithmic growth phase.

[0065] MTT assay to detect cell proliferation inhibition rate: Eca-109 cells and Het-1A cells in the logarithmic growth phase were taken and 5×10 3 Cells were seeded in 96-well plates with a volume of 100 μL per well. After 24 h of culture, the original culture medium was discarded, and different concentrations (0.01, 0.1, 1, and 10 mg / mL) of a traditional Chinese medicine decoction were added to the experimental group, with five replicate wells for each concentration. An equal volume of culture medium was added to the control group, and culture was continued for 24 h, 48 h, and 72 h. Then, 20 μL of MTT solution (5 mg / mL) was added to each well and incubated at 37°C for 4 h. The supernatant was discarded, and 150 μL of DMSO was added to each well. The plates were shaken for 10 min to fully dissolve the crystals. The absorbance (OD value) was measured at a wavelength of 570 nm using a microplate reader, and the cell proliferation inhibition rate was calculated according to the formula: Cell proliferation inhibition rate (%) = (1 - OD value of experimental group / OD value of control group) × 100%.

[0066] Experimental Conclusion

[0067] Effects on Eca-109 cells: With the increase of the concentration of the Chinese medicine decoction and the extension of the action time, the inhibition rate of Eca-109 cell proliferation gradually increased. After 24 hours of action, the cell proliferation inhibition rates of the 0.01, 0.1, 1, and 10 mg / mL concentration groups were (12.3±1.5)%, (25.6±2.2)%, (48.7±3.1)%, and (72.4±4.0)%, respectively; after 48 hours of action, the cell proliferation inhibition rates were (20.5±1.8)%, (38.9±2.5)%, (65.2±3.6)%, and (85.3±4.5)%, respectively; after 72 hours of action, the cell proliferation inhibition rates were (28.7±2.1)%, (52.1±3.0)%, (78.9±4.2)%, and (92.6±5.0)%, respectively.

[0068] Effect on Het-1A cells: The water decoction of the Chinese medicine formula had no obvious effect on the proliferation of Het-1A cells at low concentrations (0.01, 0.1 mg / mL). After 24h, 48h, and 72h of action, the cell proliferation inhibition rate was less than 5%; when the concentration reached 1 mg / mL, the cell proliferation inhibition rate was (8.2±1.2)% after 72h of action; the cell proliferation inhibition rate of the 10 mg / mL concentration group was (15.6±1.8)% after 72h of action, indicating that the formula has low toxicity to normal esophageal epithelial cells.

[0069] Clinical application experiments

[0070] Experimental subjects: 125 patients with esophageal cancer were selected, including 45 patients with early-stage esophageal cancer and 80 patients with radiation esophagitis during esophageal cancer radiotherapy. The patients were aged between 30 and 75 years old, with an average age of 48 years old. All patients met the indications described in this invention.

[0071] The water decoction prepared by the Chinese medicine formula of Example 1 of the present invention was taken for treatment. The specific preparation method was as follows: according to the formula of 15g of Scutellaria barbata, 15g of Herba Epimedii, 6g of Solanum nigrum, 15g of Radix Rehmanniae, 6g of Lithospermum officinale, 30g of Fructus Adenophorae, 9g of Radix Glehniae, 9g of Radix Pyriferae, 6g of Cynanchum indicum, 9g of Lotus leaf, 6g of Belamcanda 6g, 6g of Radix Sophorae Tonkinensis, 6g of Rabdosia rubescens, 6g of Sterculia lycopersicum, 6g of White Cardamom, 9g of Forsythia suspensa, 9g of Herba Prunellae, 6g of Fructus Aconitum, 6g of Radix Clematis, 9g of Scrophulariae, 9g of Salvia miltiorrhiza and 30g of Concha Ostreae, Chinese medicinal raw materials were weighed, 9 times the weight of the raw materials were added to drinking water, soaked for 30min, boiled over high heat, decocted over low heat for 30min, filtered to obtain juice, and concentrated to 500ml. The usage was as follows: 20ml each time, taken multiple times frequently, with an interval of 25 minutes, a total daily dose of 500ml, 30 consecutive days as a course of treatment, and 4 courses of treatment were taken;

[0072] Observation indicators: Observe the improvement of the patient's clinical symptoms (eating obstruction, pharyngeal pain and discomfort, dry mouth, etc.) before and after treatment, and record the occurrence of adverse reactions;

[0073] Criteria for determining efficacy

[0074] Markedly effective: Clinical symptoms basically disappear, patients can eat normally, and their quality of life is significantly improved;

[0075] Effective: Clinical symptoms were significantly alleviated, obstruction and pharyngeal pain were relieved, and semi-liquid food could be taken;

[0076] Ineffective: Clinical symptoms have no significant improvement or may even worsen.

[0077] Total effective rate = (number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0078] The relevant conclusions are shown in Tables 1-3;

[0079] Table 1 Clinical efficacy data

[0080]

[0081]

[0082] As can be seen from the above, the Chinese medicine formula of the present invention has significant therapeutic effects in the auxiliary treatment of esophageal cancer and radiation esophagitis, and can effectively relieve symptoms such as throat pain and dysphagia, with an effective rate of over 96%.

[0083] Table 2 Symptom improvement time data

[0084] index Patients with early-stage esophageal cancer Patients with radiation esophagitis Time to relief of eating obstruction (days) 7.2±1.5 6.6±1.5 Throat pain relief time (days) 6.8±1.2 6.8±1.5 Time for dry mouth and lack of saliva to be relieved (days) 5.1±1.1 5.9±1.6

[0085] It can be seen from the above that the Chinese medicine formula of the present invention can effectively relieve symptoms such as sore throat and dysphagia, and the effect is fast.

[0086] The incidence of adverse reactions in patients treated with the Chinese medicine formula of the present invention was 4% (2 patients with early esophageal cancer and 3 patients with radiation esophagitis), mainly manifested as mild diarrhea, indicating that the Chinese medicine formula of the present invention is applicable to a wide range of people and is safe and effective.

[0087] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis, characterized in that: Including the following raw materials: Scutellaria barbata, white snake grass, Solanum nigrum, reed root, stonewort, corrugated fruit, northern adenophora, vine pear root, Cynanchum indica, lotus leaf, Belamcanda chinensis, Sophora flavescens, Rubescens rubescens, Sterculia lychnophora, white cardamom, forsythia, selfheal, Aconitum carmichaelii, Clematis chinensis, Scrophularia ningpoensis, Salvia miltiorrhiza and oyster.

2. A Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: Including the following raw materials by weight: 15-30 parts of Scutellaria barbata, 15-30 parts of Herba Epimedii, 6-9 parts of Solanum nigrum, 15-30 parts of Radix Rehmanniae, 6-15 parts of Radix Lithospermi, 30-60 parts of Fructus Corrugae, 9-12 parts of Radix Adenophorae, 9-30 parts of Radix Pyriferae, 6-12 parts of Radix Cynanchifoliae, 9-15 parts of Folium Nelumbo, 6-12 parts of Rhizoma Belamcandae, 6-9 parts of Radix Sophorae Tonkinensis, 6-15 parts of Rabdosia rubescens, 6-15 parts of Sterculia lycopersicum, 6-15 parts of Fructus Amomi, 9-15 parts of Fructus Forsythiae, 9-15 parts of Spica Prunellae, 6-9 parts of Fructus Aconitum, 6-9 parts of Radix Clematis, 9-15 parts of Radix Scrophulariae, 9-15 parts of Radix Salviae Miltiorrhizae and 30-60 parts of Concha Ostreae.

3. A Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: Including the following raw materials by weight: 15 parts of Scutellaria barbata, 15 parts of Herba Epimedii Hanceii, 6 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Herba Lycopodii, 30 parts of Fructus Corrugae, 9 parts of Radix Adenophorae, 9 parts of Radix Pyriferae, 6 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 6 parts of Radix Sophorae Tonkinensis, 6 parts of Rabdosiae Rubescens, 6 parts of Sterculiae Dahuricae, 6 parts of Fructus Amomi, 9 parts of Fructus Forsythiae, 9 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematidis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae.

4. A Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: Including the following raw materials by weight: 25 parts of Scutellaria barbata, 25 parts of Herba Epimedii Hanceii, 8 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Radix Lithospermi, 45 parts of Fructus Corrugae, 12 parts of Glehnia littoralis, 9 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 6 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosia rubescens, 6 parts of Sterculia lycopersicum, 6 parts of Fructus Amomi, 9 parts of Fructus Forsythiae, 9 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematidis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae.

5. The Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: Including the following raw materials by weight: 25 parts of Scutellaria barbata, 25 parts of Herba Epimedii Hanceii, 8 parts of Solanum nigrum, 15 parts of Radix Rehmanniae, 6 parts of Radix Lithospermi, 45 parts of Fructus Corrugae, 12 parts of Glehnia littoralis, 9 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 9 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 6 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosia rubescens, 6 parts of Sterculia lycopersicum, 6 parts of Fructus Amomi, 9 parts of Fructus Forsythiae, 9 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 6 parts of Radix Clematidis, 9 parts of Radix Scrophulariae, 9 parts of Radix Salviae Miltiorrhizae and 30 parts of Concha Ostreae.

6. A traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: Including the following raw materials by weight: 25 parts of Scutellaria barbata, 25 parts of Herba Epimedii Hanceii, 7 parts of Solanum nigrum, 25 parts of Radix Rehmanniae, 12 parts of Radix Lithospermi, 45 parts of Fructus Corrugae, 10 parts of Radix Adenophorae, 20 parts of Radix Pyriferae, 9 parts of Radix Cynanchifoliae, 12 parts of Folium Nelumbo, 6 parts of Rhizoma Belamcandae, 7 parts of Radix Sophorae Tonkinensis, 12 parts of Rabdosiae Rubescens, 10 parts of Sterculiae Dahuricae, 10 parts of Fructus Amomi, 12 parts of Fructus Forsythiae, 12 parts of Spica Prunellae, 6 parts of Fructus Aconitum, 9 parts of Radix Clematidis, 12 parts of Scrophulariae, 12 parts of Radix Salviae Miltiorrhizae and 45 parts of Concha Ostreae.

7. The Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: Including the following raw materials by weight: 20 parts of Scutellaria barbata, 20 parts of Herba Epimedii Hanceii, 7 parts of Solanum nigrum, 20 parts of Radix Rehmanniae, 10 parts of Radix Lithospermi, 40 parts of Fructus Corrugae, 10 parts of Radix Adenophorae, 15 parts of Radix Pyriferae, 8 parts of Radix Cynanchifoliae, 10 parts of Leaf of Lotus, 8 parts of Rhizoma Belamcandae, 7 parts of Radix Sophorae Tonkinensis, 10 parts of Rabdosiae Rubescens, 10 parts of Sterculiae Dahuricae, 10 parts of Fructus Amomi, 10 parts of Fructus Forsythiae, 10 parts of Spica Prunellae, 7 parts of Fructus Aconitum, 7 parts of Radix Clematidis, 10 parts of Scrophulariae, 10 parts of Salviae Miltiorrhizae and 40 parts of Concha Ostreae.

8. The Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 1, characterized in that: The dosage form of the traditional Chinese medicine formula is a water decoction.

9. A method for preparing a traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to any one of claims 1 to 8, characterized in that: The specific steps include: (1) Weigh the raw materials according to the mass parts, wash them, drain the water and set aside; (2) crushing or slicing the drained raw materials and then mixing them evenly to obtain a mixed material; (3) Add 8-10 times the total weight of the mixture in water, soak and boil, and then filter to obtain the medicinal solution.

10. The method for preparing a traditional Chinese medicine formula for adjuvant treatment of esophageal cancer and radiation esophagitis according to claim 9, characterized in that: The soaking time in step (3) is 30-60 min; The decoction is to first boil the soaked medicinal materials over high heat, then immediately turn to low heat after boiling, and keep decocting at a slight boiling state for 30-40 minutes.

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