Traditional Chinese medicine preparation for treating chronic esophagitis and esophageal precancerous lesions and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine preparation for treating chronic esophagitis and esophageal precancerous lesions and a preparation method thereof. The traditional Chinese medicine preparation is prepared from nux vomica, sal ammoniac, sculellaria barbata, Chinese lobelia, duchesnea indica, marsdenia tenacissima, solanum septemlobum bunge, selfheal, processed pinellia ternate, ginger, coptis chinensis, sticktight, airpotato yam, radix clematidis, borax, platycodon grandiflorum, hawthorn, kelp, seaweed, edible tulip and venenum bufonis. The preparation method comprises the following steps: processing or performing raw treatment on the materials, grinding into fine powder by using a grinder, finely screening by using a sieve, removing coarse stems, and mixing in parts by weight to obtain a finished product of the preparation. The traditional Chinese medicine is simple in preparation method and low in cost, can dissipate blood stasis, regulate liver and stomach and nourish stomach yin, and can effectively treat chronic esophagitis and esophageal precancerous lesions.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer, and its preparation method. Background Technology

[0002] Esophageal cancer, as an acute or chronic goiter, has an extremely high incidence and mortality rate worldwide. Finding effective prevention and treatment strategies for esophageal cancer has become a crucial and urgent issue. The development of esophageal cancer involves a progression from chronic esophagitis to precancerous lesions, which, over time, are sometimes treated as gastritis. Precancerous lesions include inflammation and dysplasia of the upper esophagus, where dysplasia, also known as intestinal inflammation, transforms into small goiter masses, eventually leading to esophageal cancer. Finding effective ways to slow, block, or reverse this pathological process has become a key focus of current medical research. Modern clinical medicine, facing this pathological process, lacks drugs that can block or reverse it, and often treats symptoms symptomatically. For example, for esophageal pain, vomiting, and difficulty drinking, esophageal pain and vomiting-preserving agents are administered quickly and effectively. This particular drug is a powder, and after administration, pain and vomiting subside for up to 1-3 hours. In addition to treating the disease, patients are advised to eat more rice porridge and strictly avoid chili peppers, mushrooms, rice wine, beef, rooster, and fish. Regular check-ups at the hospital are also recommended. Traditional Chinese medicine (TCM), as my country's traditional medicine, possesses unique experience and techniques in clinical treatment. Many studies have shown that TCM preparations have a delaying, blocking, and reversing effect on the pathological process of esophageal cancer, especially in the early stages of the disease. Compared with modern medical treatments for cancer, it has significant advantages. TCM preparations for treating the pathological process of esophageal cancer have a huge market prospect. TCM theory believes that external pathogens or internal emotional damage, improper diet, and other factors lead to stagnation of Qi and obstruction of meridians. These factors affect the normal physiological function of the esophagus, disrupt its stable internal environment, and cause pathological products such as phlegm, fire, and toxins to be produced in the esophagus. Over time, this can lead to yin deficiency and blood stasis in the esophagus, or even a deficiency of both yin and yang in the esophagus. Summary of the Invention

[0003] The purpose of this invention is to overcome the defects and shortcomings of the prior art and provide a traditional Chinese medicine preparation and its preparation method that is simple to manufacture, low in cost, and can effectively treat chronic esophagitis and precancerous lesions of esophageal cancer by dispersing blood stasis, regulating the liver and stomach, and nourishing stomach yin.

[0004] To achieve the above objectives, the technical solution of the present invention is: a traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus, characterized in that it is made from the following raw materials in parts by weight: Strychnos nux-vomica 0.3–6 parts, sal ammoniac 0.3–1 part, Scutellaria barbata 15–30 parts, Lobelia chinensis 15–30 parts, Duchesnea indica 10–30 parts, Tongguangsan 30–60 parts, Sophora flavescens 15–30 parts, Prunella vulgaris 10–15 parts, processed Pinellia ternata 3–10 parts, fresh ginger 3–10 parts, Coptis chinensis 1.5–3 parts, Bidens pilosa 15–30 parts, Dioscorea bulbifera 3–15 parts, Clematis chinensis 3–10 parts, Borax 1.5–3 parts, Platycodon grandiflorus 5–10 parts, Crataegus pinnatifida 10–15 parts, Laminaria japonica 15–30 parts, Sargassum fusiforme 15–30 parts, Cremastra appendiculata 0.6–0.9 parts, Toad venom 0.01–0.02 parts.

[0005] The dosage form of the medicine is a decoction or powder.

[0006] A method for preparing a traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus, characterized by comprising the following steps: S1. Strychnos nux-vomica, sal ammoniac, pinellia, coptis, hawthorn, and toad venom are processed separately to obtain semi-finished products, which are then classified and stored for later use. S2 Wash and dry the following herbs: Scutellaria barbata, Lobelia chinensis, Duchesnea indica, Tongguangsan, Shuyangquan, Prunella vulgaris, fresh ginger, Bidens pilosa, Dioscorea bulbifera, Clematis chinensis, borax, Platycodon grandiflorus, hawthorn, kelp, seaweed, and Cremastra appendiculata. Slice, cut into sections, or use raw according to their different properties. S3 The materials obtained from S1 and S2 are ground into fine powder using a pulverizer, and then sieved through a 70-90 mesh sieve to remove coarse stems. The mixture is then mixed according to the weight ratio to obtain the finished formulation.

[0007] The method for processing nux vomica in step S1 is as follows: mix nux vomica and fine yellow sand in a weight ratio of 1:3. First, put the sand into a pot and stir-fry until it turns reddish-brown. Then, put the nux vomica in and stir-fry it together with the sand until the surface hairs of the nux vomica turn from pale white to brownish-brown, the skin of the nux vomica swells up, and the inside of the nux vomica is yellow when cut open. Then, pour the mixture into a sieve to remove the sand, grind it into powder while it is still hot, and sift it with a sieve for later use.

[0008] The preparation method of ammoniac in step S1 is as follows: put ammoniac into a porcelain container and grind it into fine powder, then add vinegar of the same weight as ammoniac, first heat with high heat, then heat with low heat, until it is dried to obtain a grayish-yellow crystalline powder, and then sieve it into fine powder through an 80-mesh sieve.

[0009] The method for processing Pinellia ternata in step S1 is as follows: Take clean raw Pinellia ternata, soak it frequently in cold water until there is no numbing or spicy taste, dry it in the sun, add alum and boil it thoroughly, dry it in the sun and slice or crush it for use.

[0010] The preparation method of Coptis chinensis in step S1 is as follows: soak Coptis chinensis in rice wine for two hours, take it out, dry it in the sun, and stir-fry it in an iron pot for 30 minutes.

[0011] The method for processing hawthorn in step S1 is as follows: slice the whole hawthorn, dry it in the sun, and then stir-fry it until it is charred or carbonized.

[0012] In step S2, the following herbs are used raw: Scutellaria barbata, Lobelia chinensis, Tungseng powder, and Dioscorea bulbifera slices; Duchesnea indica, Gynostemma pentaphyllum, Bidens pilosa, Clematis chinensis, Laminaria japonica, and Sargassum fusiforme are used raw; Prunella vulgaris, ginger, borax, and Platycodon grandiflorus are used raw after sun-drying.

[0013] Strychnos nux-vomica is bitter, cold, and highly toxic. It is used to clear the meridians and relieve pain. It is the seed of the arborescent tree *Strychnos nux-vomica*, which is now found in Yunnan, my country. This seed can be used as a substitute for strychnos nux-vomica and has the characteristics of quickly and effectively clearing the meridians and relieving pain. It promotes blood circulation, removes blood stasis, clears heat and toxins, and is specifically used to treat goiter, lumps, and is a highly effective medicine for esophageal cancer.

[0014] Realgar: Salty, bitter, pungent, warm, and toxic; it quickly and effectively relieves heat toxicity, softens hard masses, dissipates nodules, and reduces swelling. It is a crystal of the halide mineral realgar. There are two types: one is cinnabar-colored, called bright red realgar, which is hard and does not dissolve when exposed to moisture, and is of superior quality; the other is bluish-white, resembling a salt block, called salt realgar, which dissolves in water when exposed to moisture and is of lower quality. Both bright red and bright red realgar clear heat toxicity, soften hard masses, dissipate nodules, and reduce carbuncles; they are also highly effective in treating esophageal cancer.

[0015] Scutellaria barbata: Bitter and cool, clears heat and detoxifies: used to treat cancer. It is the whole plant of Scutellaria barbata, a perennial herb of the Lamiaceae family, with the roots removed. It clears heat and detoxifies, treats jaundice, softens and disperses nodules, and is a good medicine for treating tumors and cancer.

[0016] Lobelia chinensis: Sweet, bland, slightly cold; clears heat and toxins, softens hard masses, dissipates nodules, and relieves pain and swelling. It is the whole herb of Lobelia chinensis, a perennial, low-growing herbaceous plant of the Campanulaceae family. It clears heat and detoxifies, and when properly combined with other herbs, it is an effective medicine for treating cancer, primarily for pain and esophageal cancer.

[0017] Snake venom: sweet, bitter, and cold in nature; clears heat and toxins, relieves pain, disperses blood stasis, and reduces swelling and pain. It is the whole herb of *Duchesnea indica*, a perennial herbaceous plant of the Rosaceae family. It clears heat, relieves blood stasis and pain, and treats various cancers; it is used raw after being dried.

[0018] Tongguang Powder: Bitter, slightly cold, clears heat and toxins, fights cancer and dissipates nodules; a good medicine for esophageal cancer. It is derived from the deciduous vine *Lysimachia christinae*. The stems of the vine are dried and used raw.

[0019] Shu Ban Quan: Slightly bitter and cold in nature, it has the effects of clearing heat and detoxifying, cooling blood and softening hard masses, and dispersing nodules. It is used for carbuncles and cancers, and also has the effects of promoting diuresis and relieving jaundice. It is the whole herb of the perennial climbing herbaceous plant Solanum lyratum, dried and used. Modern pharmacological studies have found that this product can enhance anti-toxic ability and is suitable for the treatment of esophageal cancer.

[0020] Prunella vulgaris: bitter, pungent, and cold in nature, it clears heat and disperses nodules. When decocted into a paste, it is often taken to have a strong dispersing effect on various types of chronic lymphadenitis. It is the flower spike of Prunella vulgaris, a perennial herb of the Lamiaceae family, and is used raw after being dried.

[0021] Prepared Pinellia: It is pungent, cold and toxic. It dries dampness and eliminates phlegm, relieves nausea and vomiting. It is a commonly used medicine for phlegm-heat chest tightness and vomiting. It is the underground spherical tuber of Pinellia, a perennial herb of the Araceae family. It is dug up, dried and prepared for use. Current clinical research shows that it is a major medicine for indigestion.

[0022] Ginger: pungent, slightly warm, strengthens the spleen and stomach and stops vomiting. It is the fresh rhizome of ginger, a perennial herbaceous plant, and is the main medicine for stopping vomiting.

[0023] Coptis chinensis: Bitter, cold. A unique medicine for strengthening the spleen and stomach and stopping vomiting. It is the rhizome of Coptis chinensis triangularis, a perennial herb of the Ranunculaceae family. Current clinical pharmacological studies have demonstrated that it is a highly effective medicine for promoting digestion, relieving stomach bloating, and treating vomiting. It is dried before use.

[0024] Bidens pilosa: Bitter, slightly cold in nature, clears heat and detoxifies, cools the blood and reduces swelling; treats boils, carbuncles, and esophageal cancer. It is the whole herb of Bidens pilosa, a perennial herbaceous plant of the Asteraceae family, and is an excellent medicine for promoting blood circulation and removing blood stasis.

[0025] Dioscorea bulbifera: bitter, neutral, detoxifying and softening hard masses; used for esophageal cancer; can be used alone or ground into powder for long-term use with remarkable effects. It is the underground tuber, sliced, and dried of Dioscorea bulbifera, a perennial herbaceous twining vine of the Dioscoreaceae family, used raw.

[0026] Clematis chinensis: pungent, salty, and warm in nature; it unblocks the meridians and relieves pain, and can open all twelve meridians; it has a strong penetrating effect. It is the root of Clematis chinensis, a multi-climbing vine belonging to the Ranunculaceae family, and is an excellent medicine for treating swellings and goiters.

[0027] Borax: sweet, salty, and cool. It reduces swelling and detoxifies. Borax is sweet and cool, clears heat, softens hard masses, and breaks up nodules.

[0028] Platycodon grandiflorus: bitter, pungent, and neutral in nature; clears heat and toxins, removes blood stasis, and relieves pain and swelling. It can be used regardless of whether the condition is caused by cold or heat. It is a perennial herb of the Campanulaceae family. It is an excellent medicine for draining pus and reducing swelling, regardless of whether the condition is caused by cold or heat. The outer skin should be scraped off, and the herbs dried before use.

[0029] Hawthorn: Sour, sweet, and slightly warm. It strengthens the stomach, aids digestion, relieves bloating, and eliminates food stagnation. It is the mature fruit of the hawthorn shrub, a deciduous shrub belonging to the Rosaceae family. It is effective in relieving indigestion and food stagnation, and can be used to treat abdominal distension and fullness. When combined with other herbs, it is highly effective.

[0030] Kelp: Salty and cold in nature, it resolves phlegm and dissipates nodules, showing significant efficacy in treating goiter and scrofula. It is a marine algae plant belonging to the Laminariaceae family, specifically the thallus of *Lactarius delavayi* (also known as wakame or kelp). According to medical, pharmacological, and clinical research, it has unique effects in treating various goiters, lumps, cancers, and esophageal cancers.

[0031] Seaweed: Clears heat and toxins, disperses carbuncles and swellings. It is the whole herb of Sargassum fusiforme, a perennial marine plant belonging to the Sargassum family. Seaweed is bitter and can purge lumps, salty and can soften hard masses, and cold and can clear heat. Therefore, it has the effects of softening hard masses and dispersing lumps, and is a highly effective medicine for treating esophageal cancer.

[0032] Mountain wormwood (Cremastra appendiculata) is sweet, slightly pungent, cold in nature, and slightly toxic. Current clinical pharmacological studies indicate its anti-tumor and anti-goiter properties. It is the underground bulb of the perennial herbaceous plant *Cremastra appendiculata* (Liliaceae family). It is a preferred medicine for clearing heat and detoxifying, reducing swelling and dissipating nodules, and treating esophageal cancer.

[0033] Toad venom: sweet, pungent, warm, and toxic; it draws out toxins and reduces swelling, used to treat various carbuncles, boils, goiters, and pain. It is the whole body of the Chinese giant toad or the black-rimmed toad (Bufo gargarizans). Current clinical pharmacological studies show that it is particularly effective in treating various tumors, goiters, and cancers, such as esophageal cancer, when properly combined with other herbs. Numerous clinical pharmacological studies demonstrate the effectiveness of traditional Chinese medicine in treating various tumors and cancers.

[0034] This invention creatively combines the properties of strychnos nux-vomica, sal ammoniac, scutellaria barbata, lobelia chinensis, dulcis, tongguangsan, and prunella vulgaris, which have the effects of resolving blood stasis and dispersing nodules, to quickly treat esophageal pain and regulate the liver, spleen, and stomach, achieving a high-end therapeutic effect. Furthermore, it adds processed pinellia, ginger, and coptis to enhance the protection of the stomach, liver, and spleen. The three ingredients together nourish stomach yin and eliminate the heat and toxins in the esophagus, allowing patients to take the medicine with water. This not only enhances the patient's resistance to disease but also demonstrates remarkable clinical efficacy. Detailed Implementation

[0035] Example 1 A traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus comprises the following ingredients by weight: 0.3g of Strychnos nux-vomica, 0.3g of Realgar, 15g of Scutellaria barbata, 15g of Lobelia chinensis, 8g of Duchesnea indica, 25g of Tongguang San, 12g of Shuyangquan, 8g of Prunella vulgaris, 3g of processed Pinellia ternata, 3g of fresh ginger, 1.5g of Coptis chinensis, 15g of Bidens pilosa, 3g of Dioscorea bulbifera, 3g of Clematis chinensis, 1.5g of Borax, 5g of Platycodon grandiflorus, 10g of Crataegus pinnatifida, 15g of Laminaria japonica, 15g of Sargassum fusiforme, 0.6g of Cremastra appendiculata, and 0.01g of Toad venom.

[0036] Example 2 A traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus comprises the following ingredients by weight: 0.6g of Strychnos nux-vomica, 3g of ammoniac, 30g of Scutellaria barbata, 30g of Lobelia chinensis, 30g of Duchesnea indica, 30g of Tongguang San, 30g of Shuyangquan, 15g of Prunella vulgaris, 10g of processed Pinellia ternata, 10g of fresh ginger, 3g of Coptis chinensis, 30g of Bidens pilosa, 15g of Dioscorea bulbifera, 10g of Clematis chinensis, 3g of borax, 10g of Platycodon grandiflorus, 15g of Crataegus pinnatifida, 30g of Laminaria japonica, 30g of Sargassum fusiforme, 9g of Cremastra appendiculata, and 0.02g of toad venom.

[0037] Example 3 A traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus comprises the following ingredients by weight: 0.8g of Strychnos nux-vomica, 5g of ammoniac, 32g of Scutellaria barbata, 28g of Lobelia chinensis, 28g of Duchesnea indica, 30g of Tongguang San, 25g of Shuyangquan, 20g of Prunella vulgaris, 12g of processed Pinellia ternata, 12g of fresh ginger, 5g of Coptis chinensis, 28g of Bidens pilosa, 15g of Dioscorea bulbifera, 12g of Clematis chinensis, 3g of borax, 15g of Platycodon grandiflorus, 18g of Crataegus pinnatifida, 32g of Laminaria japonica, 32g of Sargassum fusiforme, 10g of Cremastra appendiculata, and 0.02g of toad venom.

[0038] Example 4 A traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus comprises the following ingredients by weight: 0.3g of Strychnos nux-vomica, 1.5g of ammoniac, 12g of Scutellaria barbata, 10g of Lobelia chinensis, 10g of snake venom, 15g of Tongguang San, 12g of Shuyangquan, 12g of Prunella vulgaris, 8g of processed Pinellia ternata, 8g of fresh ginger, 3g of Coptis chinensis, 13g of Bidens pilosa, 3g of Dioscorea bulbifera, 3g of Clematis chinensis, 1.5g of borax, 5g of Platycodon grandiflorus, 8g of Crataegus pinnatifida, 20g of Laminaria japonica, 20g of Sargassum fusiforme, 0.8g of Cremastra appendiculata, and 0.01g of toad venom.

[0039] A method for preparing a traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of the esophagus, characterized by comprising the following steps: S1 Mix nux vomica and fine yellow sand in a weight ratio of 1:3. First, put the sand into a pot and stir-fry until it turns reddish-brown. Then, add the nux vomica and stir-fry together with the sand until the surface hairs of the nux vomica turn from pale white to brownish-brown, the skin of the nux vomica swells up, and the inside of the nux vomica is yellow. Then, pour the mixture into a sieve to remove the sand, grind it into powder while it is still hot, and sift it with a sieve for later use. Grind the sal ammoniac into a fine powder in a porcelain container, then add an equal weight of vinegar. First, heat over high heat, then simmer over low heat until the powder is dry, resulting in a grayish-yellow crystalline powder. Sift the powder through an 80-mesh sieve for later use. Select clean raw Pinellia ternata, soak it frequently in cold water until it no longer tastes spicy or numbing, dry it in the sun, add alum and boil it thoroughly, then dry it in the sun again and slice or crush it for later use. Soak Coptis chinensis in rice wine for two hours, then remove it, dry it in the sun, stir-fry it in an iron pot for 30 minutes, and set it aside. Slice the hawthorn whole and dry it in the sun. Then stir-fry it until it is charred or roasted for later use.

[0040] S2. Use raw slices of Scutellaria barbata, Lobelia chinensis, Tungseng powder, and Dioscorea bulbifera; use raw slices of Duchesnea indica, Gynostemma pentaphyllum, Bidens pilosa, Clematis chinensis, Laminaria japonica, and Sargassum fusiforme; use raw slices of Prunella vulgaris, ginger, borax, and Platycodon grandiflorus.

[0041] S3 The materials obtained from S1 and S2 are ground into fine powder using a pulverizer, and then sieved through an 80-mesh sieve to remove coarse stems. The mixture is then mixed according to the weight ratio to obtain the finished formulation.

[0042] The finished preparation is for patients to take three times a day, one teaspoon each time, with warm water before meals.

[0043] Case selection (1) Diagnostic criteria, including gastroscopy, imaging examinations, and other auxiliary examinations (such as endoscopic ultrasound): The ability to directly observe esophageal mucosal lesions and obtain tissue for pathological examination is the gold standard for diagnosing esophageal cancer. In this case, the gastroscopy results showed a mass in the esophagus, growing in a cauliflower-like pattern, with an uneven surface, and easy bleeding upon touch, leading to esophageal stenosis. Preliminary diagnosis of esophageal cancer was made. The patient's gastroscopy showed morphological changes in the esophagus, and the pathological report indicated squamous intraepithelial neoplasia. However, the patient's symptoms were obvious, and CT scan showed esophageal cancer.

[0044] 1. The CT scan at the best hospital in Shanghai showed thickening of the esophageal wall. A color Doppler ultrasound examination revealed cervical esophageal cancer and squamous hyperplasia of the esophageal epithelium.

[0045] (2) Inclusion criteria 1. Meets CT diagnostic criteria, and the diagnostic report is detailed.

[0046] 2. Age between 30 and 80 years old 3. The patient voluntarily accepted the traditional Chinese medicine prescription treatment prescribed by Professor Huang Wenfa of Wuhan Cancer Hospital.

[0047] (3) Exclusion criteria 1. Severe dysplasia of the esophageal mucosa or suspected malignant transformation.

[0048] 2. Individuals with serious circulatory, respiratory, hematological, or nervous system diseases. 3. The patient has a severe mental illness and is unable to cooperate with the researchers.

[0049] 4. Pregnant and lactating women.

[0050] 5. Individuals currently participating in other drug trials or receiving other related drug treatments.

[0051] (4) Elimination criteria 1. Loss to follow-up includes patients who voluntarily withdraw.

[0052] 2. Poor adherence, failure to take medication as prescribed, or failure to complete the full course of treatment for 4 weeks.

[0053] 3. Those who took other traditional Chinese medicines or proprietary Chinese medicines that might affect the efficacy of the treatment for chronic esophagitis during the study period.

[0054] 4. Patients whose treatment plan needs to be changed due to their condition.

[0055] General Information and Research Methods 1. Participated in the "Technical Guidelines for Clinical Efficacy Evaluation of New Traditional Chinese Medicine Drugs for Chronic Esophagitis" 2022 Hubei Cancer Hospital.

[0056] 2. A total of 38 patients who visited Professor Huang Wenfa's outpatient clinic at Wuhan Cancer Hospital of Traditional Chinese Medicine in Hubei Province from May 1, 2022 to May 1, 2023 were collected, including 20 males and 18 females.

[0057] 3. A single-center, retrospective study was conducted at Hubei Provincial Cancer Hospital.

[0058] 4. The patient received treatment with Professor Huang Wenfa's traditional Chinese medicine prescription. After TCM diagnosis, the patient was treated with the main prescription of Example 1, once in the morning, noon and evening, three times a day before meals. The therapeutic effect of the combination of Example 1-2 was comparable to that of Example 3-4.

[0059] Therapeutic effect evaluation and results (1) Evaluation of TCM symptoms and therapeutic effects 1. Before treatment, and at 3 weeks and 5 weeks of treatment, the TCM symptom scores were evaluated using the 2022 "Traditional Chinese Medicine Symptom Scoring Table for Esophageal Diseases". The main symptoms included esophagitis, pain, loss of appetite, heartburn, acid reflux, stomach pain when drinking water, vomiting, or hiccups, scored as 0.2 for none, 4.6 for mild, moderate, and severe. The main symptoms included chest and rib pain, poor appetite, pain when drinking water, vomiting, nausea, infrequent bowel movements, insomnia, excessive dreaming, and fatigue, scored as 0.1 for none, 2.3 for mild, moderate, and severe.

[0060] 2. Evaluate the efficacy of TCM in treating symptoms at 2 weeks and 4 weeks of treatment: ① Clinical cure: Main symptoms: The physical signs of the disease have basically disappeared, and the TCM symptom score has decreased by ≥95%; ②Significant effect: Major symptoms and signs show significant improvement, with 70% ≤ TCM symptom score reduction < 95% ③ Effective: Improvement of main symptoms and signs by 30% ≤ reduction in TCM symptom score < 70%; ④ Ineffective: The main symptoms and signs do not improve significantly or worsen, and the TCM symptom score decreases by <30%.

[0061] Overall effective rate (%) = (Number of clinically cured cases + Number of cases with significant effect + Number of effective cases) / Total number of cases x 100%.

[0062] (2) Treatment results: The total effective rates of TCM symptoms at 3 weeks and 5 weeks of treatment were 95.6% and 100%, respectively. The TCM symptom efficacy at 5 weeks of treatment was better than that at 3 weeks of treatment, and the difference was statistically significant (p<0.05). See Table 1.

[0063] Table 1 Typical Case 1 Zhang Fayou, male, 55 years old, first visited the hospital on January 10, 2023. The patient underwent gastroscopy and pathological examination on April 8, 2023, which showed changes of chronic esophagitis and mild hyperplasia in part of the esophagus. At the time of the initial visit, he complained of esophageal pain and loss of appetite. After TCM diagnosis, the first thing to do was to treat the pain, which is the duty of TCM. Strychnos nux-vomica: 0.6g, sal ammoniac: 3g, Scutellaria barbata: 20g, Lobelia chinensis: 25g, Duchesnea indica: 15g, Tongguang San: 25g, Shuyangquan: 30g, Xiajiecao: 15g, Prepared Pinellia ternata: 10g, Ginger: 8g, Coptis chinensis: 3g, Bidens pilosa: 25g, Dioscorea bulbifera: 25g, Malva nut: 10g, Borax: 5g, Platycodon grandiflorus: 10g, Crataegus pinnatifida: 12g, Laminaria japonica: 25g, Sargassum: 25g, Cremastra appendiculata: 0.9g, Toad venom: 0.02g. After treatment with modifications to the main prescription, there were no obvious esophageal symptoms, and the esophageal pain disappeared. Appetite increased. A follow-up gastroscopy and pathology on July 8, 2024, showed no dysplasia in the chronic esophagitis, achieving pathological reversal.

[0064] Typical Case 2 Zhao Chunfa, male, 56 years old, first visited on May 8, 2023. The patient underwent gastroscopy and pathological examination on July 8, 2023, which indicated chronic esophagitis. On July 18, 2023, a color Doppler ultrasound examination revealed squamous hyperplasia of the cervical esophageal epithelium. Initially, he complained of pain and decreased appetite due to chronic esophagitis. Based on traditional Chinese medicine diagnosis, a prescription of 20 grams of *Strombus haematomyces* and *Strychnos nux-vomica* was given. 4g of sal ammoniac, 2g of scutellaria barbata, 15g of scutellaria barbata, 30g of Tongguang powder, 20g of lobelia chinensis, 25g of scutellaria barbata, 12g of citrus aurantium, 15g of prepared pinellia ternata, 12g of ginger, 5g of coptis chinensis, 12g of hawthorn, 15g of platycodon grandiflorus, 2g of borax, 8g of clematis chinensis, 12g of dioscorea bulbifera, 20g of beggar-ticks, 2g of toad venom, 12g of pseudobulb of cremastrae, 20g of seaweed, and 25g of kelp were used as the main prescription with modifications. After treatment, there was no pain and the appetite increased. On September 18, 2023, a color Doppler ultrasound examination of the esophagus pathology showed that the epithelialization of the esophageal intestinal segment was intact and there were no lesions, achieving pathological reversal.

[0065] Typical Case 3 Luo Guifang, female, 52 years old, first visited the hospital on June 7, 2023. On July 10, 2023, the patient underwent esophagogastric endoscopy and pathological examination revealed esophageal intestinal epithelial hyperplasia (1+). On July 25, 2023, a second esophagogastric endoscopy was performed. The pathology report indicated esophagitis (2+) and esophageal epithelial hyperplasia. At the initial consultation, the patient experienced heartburn, esophageal pain, and pain when drinking water. After TCM diagnosis, the patient was treated with a modified prescription, mainly consisting of: Strychnos nux-vomica 0.6g, ammoniac 3g, Prunella vulgaris 10g, Sophora flavescens 20g, Tongguang San 25g, snake venom 20g, Lobelia chinensis 18g, Scutellaria barbata 25g, processed Pinellia ternata 12g, fresh ginger 10g, Coptis chinensis 10g, Bidens pilosa 20g, Dioscorea bulbifera 12g, Clematis chinensis 8g, borax 2g, Platycodon grandiflorus 15g, hawthorn 20g, kelp 18g, Sargassum fusiforme 18g, Cremastra appendiculata 12g, and toad venom 2g. After the treatment, the pain was significantly reduced, the esophageal pain symptoms disappeared, and the appetite increased. On October 29, 2023, a follow-up gastroscopy and ultrasound examination and pathology results showed that the chronic esophagitis had completely disappeared, appetite had increased, and the pathology had been reversed.

[0066] Typical Case 4 Song Chunlan, female, 62 years old, first visited on August 5, 2023. The patient underwent gastroscopy and pathological examination on October 3, 2023, which showed that the esophagitis had spread and was accompanied by mild intestinal metaplasia. Moderate intestinal metaplasia was commonly seen in the esophagus. The esophagus was accompanied by moderate intestinal metaplasia. At the time of the initial visit, she complained of occasional chest pain in the esophagus and decreased appetite. After TCM diagnosis, the patient was treated with a formula consisting of: 30g of snakeberry, 25g of Tongguang powder, 20g of Shuyangquan (a type of herb), 15g of Prunella vulgaris, 2g of sal ammoniac, 6g of Strychnos nux-vomica, 20g of Lobelia chinensis, 30g of Scutellaria barbata, 15g of processed Pinellia ternata, 10g of fresh ginger, 3g of Coptis chinensis, 20g of Bidens pilosa, 15g of Dioscorea bulbifera, 3g of Clematis chinensis, 2g of borax, 15g of Platycodon grandiflorus, 20g of Crataegus pinnatifida, 25g of Laminaria japonica, 20g of Sargassum fusiforme, 2g of Pseudobulbus Cremastrae, and 0.2g of toad venom. After treatment with modifications, the patient experienced no significant discomfort, the pain subsided, and appetite increased. A follow-up gastroscopy and ultrasound on November 23, 2023, and the pathology report showed complete resolution of the esophagitis, achieving pathological reversal.

[0067] In summary, this invention found that patients' symptom scores improved to varying degrees after treatment. Furthermore, the improvement after 4 weeks of treatment was better than that after 2 weeks, indicating that the traditional Chinese medicine composition of this invention is significantly effective in improving clinical symptoms and can be used clinically based on syndrome differentiation.

Claims

1. A traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer, characterized in that, The following raw materials are combined by weight parts: Semen strychni 0.3-6 parts, borax 0.3-1 part, Herba barbatae 15-30 parts, Herba lobeliae 15-30 parts, Herba rubi 10-30 parts, Herba scutellariae 30-60 parts, Herba rhynchosiae 15-30 parts, Herba prunellae 10-15 parts, Rhizoma pinelliae 3-10 parts, Rhizoma zingiberis 3-10 parts, Rhizoma coptidis 1.5-3 parts, Herba bidens 15-30 parts, Radix aconiti 3-10 parts, borax 1.5-3 parts, Radix platycladi 5-10 parts, Fructus crataegi 10-15 parts, Laminaria japonica 15-30 parts, Sargassum 15-30 parts, Herba arundinaceae 0.6-09 parts, Venenum bufonis 0.01-0.02 parts.

2. The Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer according to claim 1, characterized in that: The dosage form of the medicament is decoction or powder.

3. The preparation method of the traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer according to claim 1 or 2, characterized in that, The method comprises the following steps: S1: Semen strychni, borax, Rhizoma pinelliae, Rhizoma coptidis, Fructus crataegi and Venenum bufonis are processed respectively to obtain semi-finished products which are classified and stored for later use; S2: Herba barbatae, Herba lobeliae, Herba rubi, Herba scutellariae, Herba rhynchosiae, Herba prunellae, fresh Rhizoma zingiberis, Herba bidens, Radix aconiti, borax, Radix platycladi, Laminaria japonica, Sargassum and Herba arundinaceae are washed, dried and then cut into slices, segments or used directly according to different materials; S3: The materials obtained in S1 and S2 are ground into fine powder by a grinder, sieved by a 70-90 mesh screen, and then mixed according to the weight parts to obtain the finished product.

4. The preparation method of the traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer according to claim 3, characterized in that, In the step S1, the processing method of Semen strychni is as follows: Semen strychni and borax are mixed according to a weight ratio of 1:3, the borax is first put into a pot and fried until the borax turns red, then Semen strychni is added and fried together, the surface of Semen strychni turns from pale to brown, the surface of Semen strychni swells, and the inside of Semen strychni turns yellow, then the mixture is poured into a sieve to remove the borax, and the mixture is ground into powder while hot, and then sieved by a screen.

5. The preparation method of the traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer according to claim 3, characterized in that, In the step S1, the processing method of borax is as follows: borax is ground into fine powder in a porcelain, and then the same weight of vinegar is added, the mixture is first heated by strong fire and then by weak fire until it is dried, and then a yellowish gray crystalline powder is obtained, which is sieved by a 80 mesh screen.

6. The preparation method of the traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer according to claim 3, characterized in that, In the step S1, the processing method of Rhizoma pinelliae is as follows: clean Rhizoma pinelliae is soaked in cold water until it tastes no spicy, then it is dried, and then it is boiled with alum until it is cooked through, and then it is dried, cut into slices or crushed.

7. The method of claim 3, wherein the preparation method of the Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer is characterized by, In the step S1, the processing method of Rhizoma coptidis is as follows: Rhizoma coptidis is soaked in yellow rice wine for two hours, then it is taken out and dried, and then it is fried in an iron pot for 30 minutes.

8. The method of claim 3, wherein the preparation method of the Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer is characterized by, In the step S1, the processing method of Fructus crataegi is as follows: Fructus crataegi is cut into slices and dried, and then it is fried until it is charred or carbonized.

9. The preparation method of the traditional Chinese medicine preparation for treating chronic esophagitis and precancerous lesions of esophageal cancer according to claim 3, characterized in that: In the step S2, Herba barbatae, Herba lobeliae, Herba scutellariae, Radix aconiti, Laminaria japonica, Sargassum, Rhizoma zingiberis, borax and Radix platycladi are used directly after being cut into slices or segments and dried.

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