Mass-eliminating composition for treating gastric precancerous lesions as well as preparation method and application of mass-eliminating composition

Abstract

The invention discloses a mass-eliminating composition for treating gastric precancerous lesions as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The composition for eliminating mass comprises astragalus membranaceus, dragon's blood, cassia twig, poria cocos, radix paeoniae alba, perilla stem, immature bitter orange, mangnolia officinalis, rhizoma nardostachyos, oldenlandia diffusa, cuttlebone, thunberg fritillary bulb, pseudo-ginseng, rheum officinale, dark plum and honey-fried licorice root. Through the steps of decocting twice, concentrating into thick paste and the like, the mass-eliminating composition disclosed by the invention is prepared into the medicine for treating precancerous lesions of gastric cancer. Clinical experiment results show that the medicine provided by the invention can effectively relieve symptoms such as gastral cavity pain, sour regurgitation and the like of patients with precancerous lesions of gastric cancer, can also remarkably improve the degree of gastric mucosa atrophy, intestinal metaplasia and atypical hyperplasia, is high in safety and low in toxic and side effects, and is comprehensively superior to traditional prescriptions. The invention provides a novel medicine composition for treating precancerous lesions of gastric cancer and preventing gastric cancer, and has outstanding clinical application value and wide application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a composition for treating gastric precancerous lesions, and a preparation method and application thereof. Background Art

[0002] According to the latest report from the International Organization for Research on Cancer, gastric cancer (GC) ranks fifth in the global incidence of malignant tumors. In 2022, there were 968,350 new cases (accounting for 4.9% of all cancer cases) and 659,853 deaths (accounting for 6.8% of all cancer-related deaths), posing a serious threat to global human health. Therefore, how to prevent and treat the progression of gastric cancer at an early stage is a key issue that needs to be addressed. Precancerous lesions of the stomach (PLGC) refer to a type of pathological histological changes in the gastric mucosa that are prone to cancer, namely, dysplasia and intestinal metaplasia of the gastric mucosa, which are mainly associated with chronic atrophic gastritis. It is a key pre-pathological stage for the progression to gastric cancer, and prevention and treatment at this stage are of great significance.

[0003] Currently, PLGC is typically treated with Western medication. While Western medications offer advantages such as rapid effectiveness, most only provide temporary relief and are unable to cure the disease, resulting in a high recurrence rate. Several Traditional Chinese Medicine (TCM) prescriptions have been reported for treating PLGC. However, these existing TCM prescriptions suffer from limited efficacy and persistent effects. Furthermore, some prescriptions contain excessive dosages of individual herbs, posing the risk of compromising the patient's normal physiological functions. Therefore, there is an urgent need for a safe and reliable TCM composition that is effective and effective in treating PLGC. Summary of the Invention

[0004] The purpose of the present invention is to provide a composition for treating gastric precancerous lesions, a preparation method and application thereof, in order to solve the problems existing in the above-mentioned prior art. The medicine prepared by the present invention significantly improves the therapeutic effect on PLGC by adjusting the compatibility ratio of core medicinal materials such as astragalus and dragon's blood; it is superior to traditional prescriptions in improving the pathological state of gastric mucosa and alleviating spleen deficiency symptoms, and is very safe and reliable, suitable for clinical promotion and application.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] The present invention provides a composition for treating gastric precancerous lesions, comprising the following components in parts by mass:

[0007] 25-40 parts of Astragalus, 12-18 parts of Dragon's Blood, 8-12 parts of Cinnamon Twig, 18-25 parts of Poria, 12-20 parts of White Peony, 10-15 parts of Perilla Stem, 8-12 parts of Citrus Aurantii, 8-12 parts of Magnolia Bark, 8-12 parts of Nardostachys odoratus, 15-25 parts of Hedyotis Diffusa, 12-18 parts of Cuttlebone, 10-15 parts of Fritillaria Thunbergii, 5-8 parts of Panax Notoginseng, 5-8 parts of Rhubarb, 8-12 parts of Prunus Mume, and 5-8 parts of Radix Glycyrrhizae Preparata.

[0008] Furthermore, the following components are included in parts by mass:

[0009] 30 parts of Astragalus, 15 parts of Dragon's Blood, 10 parts of Cinnamon Twig, 20 parts of Poria, 15 parts of White Peony Root, 12 parts of Perilla Stem, 10 parts of Citrus Aurantii, 10 parts of Magnolia Bark, 10 parts of Nardostachys Root, 20 parts of Hedyotis Diffusa, 15 parts of Cuttlebone, 12 parts of Fritillaria Thunbergii, 6 parts of Panax Notoginseng, 6 parts of Rhubarb, 10 parts of Prunus Mume, and 6 parts of Preparing Licorice Root.

[0010] The Xiaopi combination is centered around "tonifying Qi and activating blood circulation, promoting Qi and eliminating abdominal distension, resolving phlegm and dispersing stagnation, and clearing away heat and detoxifying." It targets the pathogenesis of PLGC, characterized by "spleen deficiency with blood stasis and toxins blocking the collaterals," and achieves treatment through the following synergistic effects:

[0011] Strengthening the Spleen and Replenishing Qi: Astragalus is the main herb, significantly tonifying the spleen and enhancing the spleen and stomach's transport and transformation functions, improving symptoms of Qi deficiency such as fatigue and poor appetite. Removing Blood Stasis and Unblocking the Meridians: Blood-activating herbs like Dragon's Blood Jelly and Panax Notoginseng dissolve blood stasis, unblocking blocked stomach meridians and relieving symptoms of blood stasis such as stabbing and fixed epigastric pain. Clearing Heat and Drying Dampness: Herbs like Hedyotis Dichroa, Nardostachys grandiflora, and Fritillaria thunbergii clear heat and resolve phlegm, clearing away damp-heat and toxic pathogens from the stomach, alleviating symptoms like acid reflux and a bitter taste in the mouth. Harmonizing Herbs: Cinnamon Twig warms Yang and transforms Qi, preventing stomach damage from cold and cooling herbs; White Peony Root and Black Plum nourish Yin and moisten dryness, addressing Yin fluid deficiency; Cuttlebone antacids and analgesics directly relieve epigastric pain.

[0012] The present invention also provides a use of the above-mentioned anti-pi composition in preparing a medicine for treating gastric precancerous lesions.

[0013] The present invention also provides a medicine for treating gastric precancerous lesions, which uses the above-mentioned anti-pi composition as a main active ingredient.

[0014] Furthermore, pharmaceutically acceptable excipients are also included.

[0015] Furthermore, the dosage form of the drug is decoction, pills, tablets, granules or concentrated liquid preparation.

[0016] The present invention also provides a method for preparing the above-mentioned medicine, comprising the following steps:

[0017] Weigh the above-mentioned abdominal distension-relieving composition and wash it;

[0018] Grind dragon's blood, Panax notoginseng and rhubarb into fine powder to make fine powder medicinal materials;

[0019] Cutting astragalus root, cinnamon twig, poria, white peony root, perilla stem, immature bitter orange, magnolia bark, spikenard, oldenlandia diffusa, cuttlebone, fritillaria thunbergii, black plum and roasted liquorice into pieces as medicinal materials for the pieces;

[0020] Mix the medicinal materials with clean water, soak, boil, adjust to a slight boil, perform a first decoction, and filter to collect the first filtrate and filter residue;

[0021] Add 8 times the weight of water to the filter residue, boil, adjust to a slight boil, perform a second decoction, filter and collect the second filtrate, combine it with the first filtrate, and concentrate under reduced pressure to obtain a clear paste;

[0022] The clear paste is mixed with the fine powdered medicinal materials, stirred evenly, and continued to concentrate to a thick paste.

[0023] Furthermore, the mass volume ratio of the medicinal materials to the clean water is 1g:10mL.

[0024] Furthermore, the soaking time is 40 minutes.

[0025] Furthermore, the first decoction time is 30 minutes; the second decoction time is 20 minutes.

[0026] The present invention discloses the following technical effects:

[0027] The anti-pi composition provided by the present invention comprises: astragalus root, dragon's blood, cinnamon twig, poria, white peony root, perilla stem, immature bitter orange, magnolia bark, nardus root, white flower oldenlandia diffusa, cuttlebone, thunbergia thunbergii, panax notoginseng, rhubarb, black plum and roasted liquorice. Through the steps of double decoction and concentration into a thick paste, the anti-pi composition is made into a medicine for treating gastric precancerous lesions. Clinical experimental results show that the medicine provided by the present invention can effectively relieve symptoms such as epigastric pain and acid reflux in patients with gastric precancerous lesions, and can also significantly improve the degree of gastric mucosal atrophy, intestinal metaplasia and dysplasia, and has high safety, low toxicity and side effects, and is comprehensively superior to traditional prescriptions. The present invention provides a new drug formulation for the treatment of gastric precancerous lesions and the prevention of gastric cancer, with outstanding clinical application value and broad application prospects.

[0028] From a Traditional Chinese Medicine (TCM) perspective: The present invention's relieving-pi composition, formulated according to TCM theory, treats PLGC, a condition characterized by spleen deficiency and stasis and toxins, by tonifying Qi and activating blood circulation, promoting Qi circulation and eliminating lumps, resolving phlegm and dispersing nodules, and clearing away heat and detoxifying. Astragalus invigorates the spleen and replenishes Qi, enhancing the spleen and stomach's transport and transformation functions and improving the body's resistance; blood-activating herbs like Dragon's Blood Jelly and Panax Notoginseng improve blood stasis in the stomach collaterals; heat-clearing and dampness-drying herbs like Hedyotis Diffusa eliminate heat and toxins; cinnamon twig harmonizes the medicinal properties, white peony root and black plum nourish yin and moisten dryness, and cuttlebone reduces acidity and relieves pain. The entire formula works synergistically to regulate the body's yin and yang balance and restore normal spleen and stomach function.

[0029] From a modern medical perspective: Modern medical research suggests that the anti-pi composition and drug of the present invention may have multiple pharmacological mechanisms. They may modulate the body's immune function, enhancing the body's immune surveillance and clearance of tumor cells; inhibit tumor cell growth and proliferation, and induce tumor cell apoptosis; improve gastric mucosal microcirculation, increase gastric mucosal blood supply, and promote gastric mucosal repair and regeneration; and may also regulate gastric acid secretion, reducing gastric acid irritation on the gastric mucosa and alleviating symptoms such as epigastric pain and acid reflux. DETAILED DESCRIPTION

[0030] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0031] It should be understood that the terms described herein are intended only to describe particular embodiments and are not intended to limit the present invention. In addition, for numerical ranges herein, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. The intermediate value within any stated value or stated range, and each smaller range between any other stated value or intermediate value within the stated range, is also encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded within the scope.

[0032] Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein may also be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of any conflict with any incorporated document, the contents of this specification shall prevail.

[0033] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from the description of the invention. The description and examples are intended to be exemplary only.

[0034] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0035] Formula Principle: This formula is modified and adapted from the classic Zhishi Xiaopi Decoction, a traditional Chinese medicine formula for dispersing qi, eliminating stagnation, and resolving phlegm to dispel abdominal distension. The formula focuses on tonifying qi and activating blood circulation, while also promoting qi circulation, dissolving phlegm and dispersing stagnation, and clearing heat and detoxifying, effectively dispelling abdominal distension. Astragalus membranaceus is heavily used as the main herb, aiming to strengthen the spleen and replenish qi, thereby protecting the spleen from pathogenic factors. Based on the theory that "chronic illness leads to stasis" and "long-term disease enters the meridians," dragon's blood jelly is added as the main herb, supplemented by Panax notoginseng to promote blood circulation and unblock the meridians. Hedyotis diffusa, rhubarb, fritillaria thunbergii, and poria are added to clear heat and dampness. Cinnamon twig is added to prevent the medicine from being too cold. White peony root and black plum are added to nourish yin and moisten dryness, promoting the production of body fluids and supporting spleen and stomach health. Finally, cuttlebone is added to reduce acidity and relieve pain.

[0036] Sole Herb Combination: The synergistic combination of Astragalus and Dragon's Blood Drainage breaks away from the traditional Zhishi Xiaopi Decoction's focus on Zhishi and Magnolia Bark to promote qi and resolve abdominal distension. Astragalus is prioritized as the sole herb, strengthening the spleen and replenishing qi, targeting the core pathogenesis of PLGC, characterized by spleen qi deficiency. Dragon's Blood Drainage, based on the theory that chronic illness often leads to stasis, is added alongside Astragalus as the sole herb, creating an innovative "Qi-tonifying and blood-activating" combination. This enhances the blood-stasis-removing and collateral-draining effects, improving gastric mucosal microcirculation.

[0037] Precise modification of auxiliary and guiding drugs: Panax notoginseng is added to cooperate with dragon blood stasis to promote blood circulation and unclog meridians, enhancing the anti-fibrosis effect; Houttuynia cordata and Nardostachys odoratus clear away heat, detoxify and dry dampness, targeting the pathological characteristics of PLGC "blood stasis and toxins blocking the meridians"; cinnamon twig, white peony root and black plum harmonize the medicinal properties, taking into account warming yang, nourishing yin and acid control, thereby improving the safety of medication.

[0038] Pathogenesis-oriented drug combinations:

[0039] Tonify Qi and activate blood circulation: Astragalus + Dragon's Blood Jie + Panax notoginseng, improve the state of Qi deficiency and blood stasis, and inhibit gastric mucosal atrophy and intestinal metaplasia.

[0040] Clearing away heat and dispersing stagnation: Houttuynia cordata + Fritillaria thunbergii + Rhubarb, clear away heat, toxins and blood stasis, and block the progression of precancerous lesions.

[0041] Acid-reducing film: Cuttlebone + Fritillaria thunbergii, directly relieve gastric acid irritation and promote gastric mucosal repair.

[0042] Combination of Traditional Chinese Medicine Theory and Modern Pharmacology:

[0043] For the first time, the "replenishing qi and activating blood circulation" theory was systematically applied to the treatment of PLGC, combined with modern research (such as astragalus polysaccharides regulating immunity and dragon's blood jelly inhibiting tumor cell proliferation), to form an innovative solution that combines traditional Chinese and Western medicine.

[0044] Identify new uses for PLGC:

[0045] For the first time, the traditional "Xiaopi" prescription was extended to the prevention and treatment of gastric precancerous lesions, and its reversal effect on gastric mucosal atrophy, intestinal metaplasia and dysplasia was verified by clinical data (such as the intestinal metaplasia reversal rate of 32% in Example 1).

[0046] Differentiated efficacy: Compared with traditional Zhishi Xiaopi Decoction (the intestinal metaplasia reversal rate of comparison example 1 is only 8%), Qijie Xiaopi Decoction has significant advantages in pathological improvement, forming a technical barrier.

[0047] Design of toxicity-reducing combinations: Avoid using toxic herbs such as raw Chuanwu and raw Caowu, and reduce the irritation of blood-activating drugs through combinations with astragalus and white peony to ensure long-term drug safety (no serious adverse reactions were observed in clinical trials).

[0048] Example 1 Basic formula and preparation method

[0049] 1. Drug formulation

[0050] Take 30g of Astragalus, 15g of Dragon's Blood, 10g of Cinnamon Twig, 20g of Poria, 15g of White Peony, 12g of Perilla Stem, 10g of Citrus Aurantii, 10g of Magnolia Bark, 10g of Nardostachys 10g, 20g of Hedyotis Diffusa, 15g of Cuttlebone, 12g of Fritillaria Thunbergii, 6g of Panax Notoginseng, 6g of Rhubarb, 10g of Prunus Mume, and 6g of Roasted Licorice Root, and set aside.

[0051] 2. Preparation Steps

[0052] 2.1 Pretreatment of medicinal materials

[0053] Wash the astragalus root, dragon's blood and other medicinal materials with clean water to remove mud and impurities; grind dragon's blood, Panax notoginseng and rhubarb into fine powder for later use; cut the remaining medicinal materials into slices.

[0054] 2.2 Decoction and extraction

[0055] First decoction: Put the medicinal materials (except fine powder) into the decoction pot, add 10 times the amount of clean water (about 1500mL), soak for 40 minutes, then boil over high heat, turn to low heat and simmer for 30 minutes, and filter the liquid.

[0056] Second decoction: Add 8 times the amount of water (about 1200 mL) to the medicinal residue, boil over high heat, then simmer over low heat for 20 minutes, and filter to obtain the medicinal liquid.

[0057] 2.3 Concentration and mixing

[0058] Combine the two filtrates and concentrate under reduced pressure to a relative density of 1.15-1.20 to obtain a clear paste. Add dragon's blood, Panax notoginseng, and rhubarb powder, stir evenly, and continue to concentrate until it becomes a thick paste.

[0059] 2.4 Formulation

[0060] The thick paste is dried and crushed, and granulated with an appropriate amount of starch, and pressed into tablets, each tablet being 5g (containing about 2.5g of crude drug).

[0061] 3. Clinical application:

[0062] Dosage and administration: 3 times a day, 4 tablets each time, 30 minutes after meals, for 3 months.

[0063] Effect: 50 patients with PLGC were treated, with an 88% rate of epigastric pain relief, an 82% rate of acid reflux improvement, and 64% of patients experiencing a reduction in gastric mucosal atrophy as shown by gastroscopy.

[0064] Example 2 Optimized formula (for patients with obvious spleen deficiency)

[0065] 1. Drug formulation

[0066] Astragalus 40g, Dragon's Blood Drainage 12g, Cinnamon Twig 8g, Poria 25g, White Peony 20g, Perilla Stem 10g, Citrus Aurantii 8g, Magnolia Bark 8g, Nardostachys 8g, Hedyotis Diffusa 15g, Cuttlebone 12g, Fritillaria Thunbergii 10g, Panax Notoginseng 5g, Rhubarb 5g, Prunus Mume 12g, and Roasted Licorice 8g.

[0067] 2. Preparation Method

[0068] Same as Example 1, the only difference is that the dosage of the medicinal materials is adjusted.

[0069] 3. Clinical Application

[0070] Dosage and administration: 3 times a day, 4 tablets each time, 30 minutes after meals, for 3 months.

[0071] Indications: PLGC patients with spleen deficiency symptoms such as fatigue, poor appetite, and loose stools.

[0072] Effect: After treating 30 patients, the improvement rate of spleen deficiency symptoms was 92%, and the pepsinogen level (reflecting gastric function) increased by 35%.

[0073] Example 3 Concentrated liquid preparation

[0074] 1. Drug formulation

[0075] Astragalus 25g, Dragon's Blood Drainage 18g, Cinnamon Twig 12g, Poria 18g, White Peony 12g, Perilla Stem 15g, Citrus Aurantii 12g, Magnolia Bark 12g, Nardostachys 12g, Hedyotis Diffusa 25g, Cuttlebone 18g, Fritillaria Thunbergii 15g, Panax Notoginseng 8g, Rhubarb 8g, Prunus Mume 8g, and Roasted Licorice 5g.

[0076] 2. Preparation Steps

[0077] 2.1 Pretreatment of medicinal materials

[0078] The same method as in Example 1 was used.

[0079] 2.2 Decoction and extraction

[0080] For the first decoction, add 12 times the amount of water, soak for 1 hour, boil over high heat, then simmer over low heat for 40 minutes. For the second decoction, add 10 times the amount of water and simmer for 30 minutes.

[0081] 2.3 Concentration

[0082] The filtrates were combined and concentrated to 1 g of crude drug per mL, and dispensed into 100 mL bottles.

[0083] 3. Clinical Application

[0084] Usage: Orally take 50 mL twice a day.

[0085] Effect: In 40 patients treated, the reversal rate of gastric mucosal intestinal metaplasia reached 45%, and the serum gastrin level (reflecting gastric mucosal atrophy) improved by 28%.

[0086] Comparative Example 1: Traditional Zhishi Xiaopi Decoction

[0087] 1. Drug formulation

[0088] Zhishi 15g, Magnolia officinalis 12g, Coptis chinensis 9g, Pinellia 9g, Dry ginger 3g, Malt koji 6g, Poria 6g, Ginseng 6g, Atractylodes macrocephala 6g, and Roasted Licorice 6g.

[0089] 2. Preparation Method

[0090] Prepare by conventional decoction method. Concentrate to 1g of crude drug per mL and dispense into 100mL bottles.

[0091] 3. Clinical Application

[0092] Usage: Orally take 50 mL twice a day.

[0093] Effect: 30 patients with PLGC were treated, with a 70% relief rate for epigastric distension, but no significant improvement was found for gastric mucosal atrophy and intestinal metaplasia.

[0094] Qijie Xiaopi Decoction significantly improves the therapeutic effect of PLGC by adjusting the compatibility ratio of core medicinal materials such as astragalus and dragon's blood jelly and combining it with modern preparation technology. It is especially superior to traditional prescriptions in improving the pathological state of gastric mucosa and alleviating spleen deficiency symptoms.

[0095] Experimental Example 1

[0096] This experimental example conducts an in-depth clinical application study on the drug prepared in Example 1.

[0097] 1. Sample selection criteria

[0098] 1.1 Inclusion criteria

[0099] Patients aged 18-75 years were diagnosed with PLGC (gastric mucosal atrophy with or without intestinal metaplasia and dysplasia) by gastroscopy and pathological examination; met the diagnostic criteria of "spleen deficiency and blood stasis syndrome" in traditional Chinese medicine (main symptoms: epigastric pain, fatigue, poor appetite; secondary symptoms: acid reflux and belching); signed the informed consent form and voluntarily participated in the study.

[0100] 1.2 Exclusion criteria

[0101] Patients with severe heart, liver, and kidney dysfunction (ALT / AST>3 times the upper limit of normal, Cr>1.5mg / dL); pregnant or lactating women; those who have recently (within 3 months) received other drug treatments for PLGC; those who are allergic to any ingredient in the formula.

[0102] 2. Treatment options

[0103] Dosage and administration: 4 tablets each time (each tablet contains 2.5g of crude drug), 3 times a day, orally taken 30 minutes after meals, for continuous treatment for 3 months.

[0104] 3. Efficacy testing methods

[0105] 3.1 Symptom score

[0106] Epigastric pain: Visual analogue scale (VAS, 0-10 points); Acid reflux and belching frequency: Record the number of episodes per day.

[0107] 3.2 Gastroscopy and pathological evaluation

[0108] Gastroscopy was performed before and after treatment, and biopsies of the gastric antrum and gastric body mucosa were taken. Pathological evaluation was performed independently by two pathologists using a double-blind method, and scores were given according to the OLGA staging (degree of atrophy) and the Sydney system (grade of intestinal metaplasia and dysplasia).

[0109] 3.3 Biochemical index detection

[0110] Serum pepsinogen I / II ratio (PGI / PGII): ELISA kit; Gastrin-17 (G-17): chemiluminescence detection.

[0111] 3.4 Safety Assessment

[0112] Monitor liver and kidney function (ALT, AST, Cr) and blood routine; record adverse reactions (such as diarrhea, rash, etc.).

[0113] 4. Data Statistics

[0114] SPSS 26.0 software was used for statistical analysis. The measurement data were expressed as mean ± standard deviation, and the t test was used for comparison between groups. The enumeration data were expressed as rate (%) and the chi-square test was used.

[0115] 5. Results

[0116] A total of 60 patients were treated, and 50 completed treatment. Symptoms improved in all those who fully completed treatment, including 32 who experienced improvement in gastric mucosal atrophy, 24 who experienced a reduction in the extent of intestinal metaplasia, and 6 who experienced reversal of dysplasia. This suggests that the drug has significant clinical efficacy.

[0117] 5.1 Symptom relief

[0118] The VAS score of epigastric pain in the treated patients decreased from 7.2±1.5 before treatment to 1.8±0.9 (P<0.01); the frequency of acid reflux decreased from 5.3±2.1 times per week to 1.2±0.7 times (P<0.01).

[0119] 5.2 Pathological improvement

[0120] The improvement rate of OLGA stage of gastric mucosal atrophy in treated patients was 64% (32 / 50); the reduction of intestinal metaplasia by ≥50% was 48% (24 / 50); and the reversal rate of dysplasia was 12% (6 / 50).

[0121] 5.3 Biochemical indicators

[0122] The PGI / PGII ratio of treated patients increased from 3.2±0.8 to 4.5±1.1 (P<0.05); the G-17 level decreased from 25.6±6.4 pmol / L to 18.3±5.2 pmol / L (P<0.05).

[0123] 5.4 Security

[0124] Three patients experienced mild diarrhea, which was relieved after dose adjustment; no abnormal liver or kidney function or allergic reactions were found.

[0125] In summary, the medicine prepared by the present invention significantly improves the therapeutic effect on PLGC by adjusting the compatibility ratio of core medicinal materials such as astragalus and dragon's blood, combined with modern preparation technology; effectively relieves symptoms such as stomach pain and acid reflux in patients with PLGC with spleen deficiency and blood stasis syndrome, and significantly improves the digestive tract pathological conditions and biochemical indicators; especially in improving the pathological state of gastric mucosa and alleviating spleen deficiency symptoms, it is superior to traditional prescriptions, and is very safe and reliable, suitable for clinical promotion and application.

[0126] The embodiments described above are merely descriptions of preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Without departing from the spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by persons skilled in the art should fall within the scope of protection defined by the claims of the present invention.

Claims

1. A composition for treating gastric precancerous lesions, characterized in that: Calculated by mass, it includes the following components: 25-40 parts of Astragalus, 12-18 parts of Dragon's Blood, 8-12 parts of Cinnamon Twig, 18-25 parts of Poria, 12-20 parts of White Peony, 10-15 parts of Perilla Stem, 8-12 parts of Citrus Aurantii, 8-12 parts of Magnolia Bark, 8-12 parts of Nardostachys odoratus, 15-25 parts of Hedyotis Diffusa, 12-18 parts of Cuttlebone, 10-15 parts of Fritillaria Thunbergii, 5-8 parts of Panax Notoginseng, 5-8 parts of Rhubarb, 8-12 parts of Prunus Mume, and 5-8 parts of Radix Glycyrrhizae Preparata.

2. The anti-abdominal composition according to claim 1, wherein Calculated by mass, it includes the following components: 30 parts of Astragalus, 15 parts of Dragon's Blood, 10 parts of Cinnamon Twig, 20 parts of Poria, 15 parts of White Peony Root, 12 parts of Perilla Stem, 10 parts of Citrus Aurantii, 10 parts of Magnolia Bark, 10 parts of Nardostachys Root, 20 parts of Hedyotis Diffusa, 15 parts of Cuttlebone, 12 parts of Fritillaria Thunbergii, 6 parts of Panax Notoginseng, 6 parts of Rhubarb, 10 parts of Prunus Mume, and 6 parts of Preparing Licorice Root.

3. Use of the anti-pi composition according to claim 1 or 2 in the preparation of a medicament for treating gastric precancerous lesions.

4. A drug for treating gastric precancerous lesions, characterized in that: The anti-pissing composition according to claim 1 or 2 is used as the main active ingredient.

5. The drug according to claim 4, wherein Pharmaceutically acceptable excipients are also included.

6. The drug according to claim 4, wherein The dosage form of the medicine is decoction, pill, tablet, granule or concentrated liquid preparation.

7. A method for preparing the drug according to claim 4, characterized in that: The following steps are involved: Weigh the anti-piss composition according to claim 1 or 2 and wash it; Grind dragon's blood, Panax notoginseng and rhubarb into fine powder to make fine powder medicinal materials; Cutting astragalus root, cinnamon twig, poria, white peony root, perilla stem, immature bitter orange, magnolia bark, spikenard, oldenlandia diffusa, cuttlebone, fritillaria thunbergii, black plum and roasted liquorice into pieces as medicinal materials for the pieces; Mix the medicinal materials with clean water, soak, boil, adjust to a slight boil, perform a first decoction, and filter to collect the first filtrate and filter residue; Add 8 times the weight of water to the filter residue, boil, adjust to a slight boil, perform a second decoction, filter and collect the second filtrate, combine it with the first filtrate, and concentrate under reduced pressure to obtain a clear paste; The clear paste is mixed with the fine powdered medicinal materials, stirred evenly, and continued to concentrate to a thick paste.

8. The method according to claim 7, wherein The mass volume ratio of the medicinal material to the clean water is 1g:10mL.

9. The method according to claim 7, wherein The soaking time is 40 minutes.

10. The method according to claim 7, wherein: The first decoction time is 30 minutes; the second decoction time is 20 minutes.