Nine-ingredient bacon source formula for treating chronic atrophic gastritis as well as preparation method and application of nine-ingredient bacon source formula

Abstract

The invention specifically discloses a nine-ingredient bacon formula for treating chronic atrophic gastritis as well as a preparation method and application thereof, and relates to the technical field of biological medicines. The nine-ingredient Bayuan prescription provided by the invention is designed for the core pathogenesis of spleen and stomach weakness and qi and blood disharmony of CAG, and has the effects of strengthening the spleen and stomach, consolidating the root and Bayuan, and regulating qi to alleviate pain.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a nine-ingredient formula for treating chronic atrophic gastritis, its preparation method, and its application. Background Technology

[0002] Gastric cancer was the fifth most common malignant tumor worldwide in 2020, with 1.089 million new cases annually. my country accounted for 43.9% of all new gastric cancer cases globally. How to prevent and intervene early in the occurrence and development of malignant tumors is a major population health issue that urgently needs to be addressed in my country. The development of gastric cancer is a gradual process, known as the cascade of gastric cancer development (normal gastric mucosa → non-atrophic gastritis → atrophic gastritis → intestinal metaplasia → dysplasia → gastric cancer). Moving the intervention "gate" earlier in gastric cancer development can effectively reduce its incidence and mortality.

[0003] Chronic atrophic gastritis (CAG) is considered the first step in a multi-step precancerous cascade and represents a crucial window for precancerous intervention. A nationwide survey showed that endoscopic diagnosis of atrophic gastritis accounted for 17.7%, pathological diagnosis of atrophy for 25.8%, intestinal metaplasia for 23.6%, and dysplasia for 7.3%. The annual incidence of gastric cancer with atrophic gastritis ranges from 0.1% to 0.25%, with a higher risk of gastric cancer due to greater degree and extent of atrophy; total gastric atrophy increases the risk of gastric cancer by 4.5 times. Early detection and treatment of CAG are crucial measures for current gastric cancer prevention and control.

[0004] Traditional Chinese medicine (TCM) and Western medicine differ in their approaches to diagnosing and treating precancerous lesions of atrophic gastritis (AG). Modern medicine emphasizes endoscopic screening and treatment of dysplasia and early-stage cancer. In treating AG, endoscopic follow-up is the primary method, with endoscopic surgical resection as needed. However, there are few effective drugs to reverse gastric mucosal atrophy and intestinal metaplasia; the main strategies are eradication of Helicobacter pylori and vitamin supplementation. Intervention methods for existing atrophic lesions are limited, and the overall symptoms of the patient cannot be improved, making it difficult to reverse the progression of precancerous lesions. TCM, on the other hand, focuses on clinical intervention, leveraging its advantages in holistic regulation and syndrome differentiation. Clinical practice has shown that TCM can effectively improve clinical symptoms and prevent the transformation of precancerous lesions into cancerous tissue. However, existing patents and literature reports on prescriptions mostly focus on single treatment methods such as "clearing heat and removing dampness", "activating blood and removing blood stasis" and "soothing the liver and regulating qi", failing to fully grasp the core pathogenesis of CAG as "deficiency of the root (weakness of the spleen and stomach) and excess of the branch (qi stagnation and blood stasis)". In terms of "strengthening the root and nourishing the source, and regulating qi and blood" to fundamentally block the process of precancerous lesions, there is a lack of precise prescriptions and significant efficacy verification. Summary of the Invention

[0005] (a) Technical problems to be solved Therefore, one of the main objectives of this invention is to provide a nine-ingredient formula for treating chronic atrophic gastritis (CAG), its preparation method, and its application. The nine-ingredient formula provided by this invention addresses the core pathogenesis of CAG, "spleen and stomach weakness, and disharmony of qi and blood," and has the functions of "strengthening the spleen and stomach, consolidating the foundation and nourishing the source, regulating qi and relieving pain." It is used to treat symptoms such as spleen and stomach deficiency and weakness in chronic atrophic gastritis. It can significantly improve symptoms of spleen and stomach deficiency and cold, such as stomach pain, bloating, loss of appetite, and loose stools. Through its effects of "strengthening the spleen and stomach and regulating qi and blood," it promotes gastric mucosal repair and may reverse atrophy and even precancerous lesions such as intestinal metaplasia. The entire formula is composed of commonly used Chinese medicinal herbs, has few side effects, and is suitable for long-term conditioning. Furthermore, the precise proportions, preparation method, and clear indications of this formula are provided, facilitating industrialization and quality control.

[0006] (II) Technical Solution To achieve the above objectives, the present invention provides a nine-ingredient formula for treating chronic atrophic gastritis, which is made from the following raw materials in parts by weight: 8-12 parts of roasted Astragalus membranaceus, 8-12 parts of stir-fried Atractylodes macrocephala, 8-12 parts of Dendrobium nobile, 6-8 parts of Cyperus rotundus, 3-5 parts of Cinnamomum cassia, 8-12 parts of stir-fried Coix lacryma-jobi, 8-12 parts of stir-fried Paeonia lactiflora, 3-5 parts of Artemisia capillaris, and 3-5 parts of roasted Glycyrrhiza uralensis.

[0007] In one embodiment, it is made from the following raw materials in parts by weight: 10 parts of roasted Astragalus membranaceus, 10 parts of stir-fried Atractylodes macrocephala, 10 parts of Dendrobium nobile, 7 parts of Cyperus rotundus, 4 parts of Cinnamomum cassia, 10 parts of stir-fried Coix lacryma-jobi, 10 parts of stir-fried Paeonia lactiflora, 4 parts of Artemisia capillaris, and 4 parts of roasted Glycyrrhiza uralensis.

[0008] In another aspect, the present invention provides a pharmaceutical composition comprising: (1) The above-mentioned nine-ingredient formula for nourishing the source is used in an effective therapeutic dose; (2) Pharmaceutically or immunologically acceptable carriers or excipients.

[0009] In another aspect, the present invention provides a pharmaceutical preparation comprising the above-described pharmaceutical composition.

[0010] In one embodiment, the dosage form of the pharmaceutical preparation includes decoction, pill, tablet, capsule and / or granule.

[0011] In one embodiment, the dosage form of the pharmaceutical preparation is a decoction, pills, and / or granules.

[0012] In another aspect, the present invention also provides a method for preparing the above-mentioned pharmaceutical preparation, comprising: According to the weight ratio of the above-mentioned nine-ingredient formula for nourishing the source, take roasted astragalus, stir-fried atractylodes macrocephala, dendrobium, cyperus rotundus, cinnamon twig, stir-fried coix seed, stir-fried white peony root, artemisia capillaris, and roasted licorice root, mix them together, add water, soak thoroughly, and decoct into a soup.

[0013] In one embodiment, it specifically includes: According to the weight ratio of the above nine-ingredient formula for nourishing the source, take 10g of roasted astragalus, 10g of stir-fried atractylodes macrocephala, 10g of dendrobium, 7g of cyperus rotundus, 4g of cinnamon twig, 10g of stir-fried coix seed, 10g of stir-fried white peony root, 4g of artemisia capillaris, and 4g of roasted licorice root. Mix them together, add water, soak thoroughly, and decoct into a soup.

[0014] In one embodiment, it also includes: According to the weight ratio of the above-mentioned nine-ingredient formula for nourishing the source, take 10g of roasted astragalus, 10g of stir-fried atractylodes macrocephala, 10g of dendrobium, 7g of cyperus rotundus, 4g of cinnamon twig, 10g of stir-fried coix seed, 10g of stir-fried white peony root, 4g of artemisia capillaris, and 4g of roasted licorice root. These ingredients are then pulverized, ground, and sieved in the preparation room to make a powder.

[0015] In one embodiment, the method further includes: adjusting the powder into pills with a honey-based mixture.

[0016] In another aspect, the present invention also provides a pharmaceutical preparation obtained by the above-described preparation method.

[0017] In one embodiment, the pharmaceutical preparation is administered twice daily, one dose each time.

[0018] In one embodiment, the pharmaceutical preparation is administered before, during, or after a meal.

[0019] In one embodiment, the pharmaceutical preparation is administered after a meal.

[0020] In one embodiment, the subject to whom the pharmaceutical preparation is administered is healthy.

[0021] In one embodiment, the subject to whom the drug formulation is administered is unhealthy.

[0022] In one embodiment, the subject to whom the pharmaceutical preparation was administered suffered from chronic atrophic gastritis.

[0023] In one embodiment, the subject to whom the pharmaceutical preparation was administered did not suffer from chronic atrophic gastritis.

[0024] In one embodiment, the subjects include both mammals and non-mammals.

[0025] Examples of mammals include, but are not limited to, any member of the class Mammalia: humans, non-human primates such as chimpanzees and other apes and monkeys; farm animals such as cattle, horses, sheep, goats, and pigs; domesticated animals such as rabbits, dogs, and cats; and laboratory animals, including rodents such as rats, mice, and guinea pigs. Examples of non-mammals include, but are not limited to, birds, fish, or other non-mammals.

[0026] In one embodiment, the subject is a human being.

[0027] In another aspect, the present invention also provides a pharmaceutical product comprising the above-mentioned Nine-Ingredient Nourishing Formula, pharmaceutical composition and / or pharmaceutical preparation.

[0028] In one embodiment, the pharmaceutical product is a vial or box.

[0029] In another aspect, the present invention also provides the use of the above-mentioned nine-ingredient formula for nourishing the source, pharmaceutical composition, pharmaceutical preparation and / or product in the preparation of a drug for treating chronic atrophic gastritis.

[0030] (III) Beneficial Effects This invention provides a nine-ingredient formula for treating chronic atrophic gastritis, its preparation method, and its application. Compared with existing technologies, it has the following beneficial effects: 1. It can significantly improve symptoms of spleen and stomach deficiency and cold, such as stomach pain, bloating, loss of appetite, and loose stools. Through its effects of "strengthening the spleen and stomach and regulating qi and blood," it promotes the repair of the gastric mucosa and may reverse precancerous lesions such as atrophy and even intestinal metaplasia.

[0031] 2. The entire formula is composed of commonly used Chinese medicinal herbs, with few side effects, making it suitable for long-term conditioning. Furthermore, it provides the precise proportions, preparation method, and clear indications for the formula, facilitating industrialization and quality control. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a gastroscopy image of Subject 1 before treatment; Figure 2 This is a diagram of the mucosal biopsy results of Subject 1 before treatment; Figure 3 This is a gastroscopy image of Subject 1 after treatment; Figure 4 This is a diagram of the mucosal biopsy results of Subject 1 after treatment; Figure 5 This is a gastroscopy image of Subject 2 before treatment; Figure 6 This is a diagram of the mucosal biopsy results of subject 2 before treatment; Figure 7 This is a gastroscopy image of subject 2 after treatment; Figure 8 This is a diagram of the mucosal biopsy results of subject 2 after treatment. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] Terms and Definitions As used in this article, the term "processed Astragalus membranaceus" refers to the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., belonging to the Fabaceae family.

[0036] As used in this article, the term "fried Atractylodes macrocephala" refers to the processed product of the dried rhizome of Atractylodes macrocephala Koidz., a plant in the Asteraceae family.

[0037] As used in this article, the term "Dendrobium nobile Lindl" is also known as Xianhulanyun, Immortal Grass, Resurrection Grass, Purple Fairy Plant, Hanging Orchid, Forest Orchid, Forbidden Life, Golden Hairpin Flower, etc. The stem is erect, fleshy and thick, slightly flattened cylindrical, 10-60 cm long and up to 1.3 cm thick.

[0038] As used in this article, the term "Cyperus rotundus" refers to the dried rhizome of Cyperus rotundus L., a perennial herbaceous plant of the Cyperaceae family.

[0039] As used in this article, the term "cinnamon twig" refers to the dried young twig of Cinnamomum cassia Presl, a plant in the Lauraceae family.

[0040] As used in this article, the term "fried coix seed" refers to the dried, mature kernel of the grass Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf.

[0041] As used in this article, the term "fried white peony" refers to the processed product of the dried root of Paeonia lactiflora Pall., a plant in the Ranunculaceae family.

[0042] As used in this article, the term "Liu Ji Nu" refers to the dried whole herb of Artemisia anomala S. Moore, a plant in the Asteraceae family.

[0043] As used herein, the term "roasted licorice" refers to the dried, processed root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all belonging to the legume family.

[0044] As used herein, the term "pharmaceutical composition" refers to a composition comprising Astragalus membranaceus (processed with honey), Atractylodes macrocephala (processed with honey), Dendrobium nobile, Cyperus rotundus, Cinnamomum cassia, Coix lacryma-jobi (processed with honey), Paeonia lactiflora (processed with honey), Artemisia capillaris, and Glycyrrhiza uralensis (processed with honey), formulated with one or more pharmaceutically acceptable carriers.

[0045] The formulation of the pharmaceutical composition can be adjusted according to the application. In particular, the pharmaceutical composition can be formulated using methods known in the art to provide rapid, continuous, or delayed release of the active ingredient upon administration to mammals. For example, the formulation can be selected from any of the following: decoctions, pills, tablets, capsules, and / or granules.

[0046] As used herein, the term "pharmaceuticalally acceptable" refers to a substance that is suitable for use in humans and / or animals without excessive adverse effects (such as toxicity, irritation, and allergic reactions), i.e., a reasonable benefit / risk ratio.

[0047] As used herein, the term "pharmaceuticalally acceptable carrier" or "pharmaceuticalally acceptable excipient" refers to a carrier used for the administration of therapeutic agents, including various excipients and diluents. This term refers to pharmaceutical carriers that are not essential active ingredients themselves and do not exhibit excessive toxicity upon administration.

[0048] Pharmaceutically acceptable carriers in a composition include any and all solvents, dispersion media, preservatives, antioxidants, coatings, isotonic and absorption-delaying agents, surfactants, fillers, disintegrants, binders, diluents, lubricants, flow aids, pH adjusters, buffers, enhancers, humectants, solubilizers, surfactants, antioxidants, etc., compatible with drug administration. The use of such media and agents for pharmaceutically active substances is well known in the art. The composition may contain other active compounds that provide complementary, additional, or enhanced therapeutic functions. Solid carriers or excipients, such as lactose, starch, or talc, or liquid carriers, such as water, fatty oils, or liquid paraffin, are possible. Other examples of carriers include culture media, such as DMEM or RPMI; and cryogenic storage media containing components that scavenge free radicals, provide pH buffering, osmotic / osmotic support, energy substrates, and ion concentrations to balance intracellular states at low temperatures; and mixtures of organic solvents with water.

[0049] The pharmaceutical compositions of the present invention can be administered using any known method. One of a variety of methods known to those skilled in the art can be used to administer the substance, compound, or agent to a subject using the terms "give" or "apply".

[0050] For example, compounds or agents can be administered intranasally (e.g., by inhalation), intrathecally (into the spinal canal or subarachnoid space), intraarterially, intradermally, intramuscularly, intraperitoneally, intravenously, subcutaneously, ocularly, sublingually, orally (by ingestion), intracerebrally, and transdermally (by absorption, e.g., through a skin catheter). Compounds or agents can also be suitably introduced via rechargeable or biodegradable polymeric devices or other devices (e.g., patches and pumps or formulations) that provide prolonged, slowed, or controlled release of the compound or agent. Administration can also be performed, for example, once, multiple times, and / or over one or more prolonged periods.

[0051] As used herein, the term “therapeutic effective dose” refers to a dose sufficient to treat a disease with a reasonable benefit / risk ratio suitable for medical treatment, and the effective dose level includes subject type and severity, age, sex, drug activity, drug sensitivity, time of administration, route of administration and excretion rate, duration of treatment, factors including concomitant drugs, and other factors known in the medical field.

[0052] As used herein, the term “treatment” for a symptom or patient refers to steps taken to achieve a beneficial or desired outcome, including clinical outcomes. Beneficial or desired clinical outcomes include, but are not limited to, eliminating, substantially inhibiting, slowing, or reversing the progression of a disease, symptom, or condition; substantially improving or alleviating the clinical or aesthetic symptoms of a symptom; substantially preventing the clinical or aesthetic symptoms of a disease, symptom, or condition; and avoiding harmful or unpleasant symptoms. Treatment also refers to achieving one or more of the following: (a) reducing the severity of the symptom; (b) limiting the development of characteristic symptoms of the symptom being treated; (c) limiting the exacerbation of characteristic symptoms of the symptom being treated; (d) limiting the recurrence of the symptom in patients who previously had the symptom; and / or (e) limiting the recurrence of symptoms in patients who previously did not have symptoms of the symptom.

[0053] The term "prevention" refers to reducing the likelihood of the onset (or recurrence) of a disease, disorder, condition, or associated symptoms.

[0054] As used in this article, “containing,” “having,” or “including” includes “containing,” “mainly composed of,” “substantially composed of,” and “composed of”; “mainly composed of,” “substantially composed of,” and “composed of” are subordinate concepts of “containing,” “having,” or “including.”

[0055] Unless otherwise specified, the experimental methods used in the following examples are conventional methods, and the reagents, methods and equipment used are conventional reagents, methods and equipment in this technical field.

[0056] Example 1: Subject Screening We collected data from 45 inpatients and 45 outpatients in the Department of Spleen and Stomach at the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine who received Jiuwei Peiyuan Fang and Piwei Peiyuan Wan treatments between January 1, 2024 and December 31, 2024. There were no statistically significant differences between the two groups in terms of underlying diseases, age, and gender, and the efficacy results were comparable.

[0057] 1. Inclusion criteria: 1.1. Western Medicine Diagnostic Criteria: This was formulated in accordance with the "Consensus Opinion on Chronic Gastritis in China (2017, Shanghai)". Endoscopic manifestations of CAG mainly include a paler color of the gastric mucosa, with alternating red and white areas, predominantly grayish-white, flattened folds, exposed mucosal blood vessels, and granular or nodular features on the atrophic mucosa. Diagnosis should be based on pathological diagnosis.

[0058] 1.2. Traditional Chinese Medicine Diagnosis: Formulated in accordance with the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine (2017)" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs": 1.2.1. Spleen and Stomach Deficiency Syndrome Main symptoms: ① Abdominal distension or dull pain; ② Stomach relieved by pressure or warmth.

[0059] Secondary symptoms: ① poor appetite; ② loose stools; ③ fatigue and weakness; ④ shortness of breath and reluctance to speak; ⑤ abdominal distension after meals.

[0060] 1.2.2. Tongue and pulse: The tongue is pale and the pulse is thin and weak.

[0061] 1.2.3. Syndrome identification: The main symptom and tongue appearance are essential, plus two or more secondary symptoms, and pulse diagnosis should be taken into account.

[0062] Example 2: Preparation of pharmaceutical formulation: Nine-Ingredient Nourishing Formula: Prescription: "Prepared Astragalus membranaceus 10g, stir-fried Atractylodes macrocephala 10g, Dendrobium nobile 10g, Cyperus rotundus 7g, Cinnamomum cassia 4g, stir-fried Coix lacryma-jobi 10g, stir-fried Paeonia lactiflora 10g, Artemisia capillaris 4g, prepared Glycyrrhiza uralensis 4g." Preparation: Grind the above nine ingredients into a fine powder, sift, and mix well. Add 10-15g of refined honey and an appropriate amount of water to every 100g of powder to make water-honey pills. Coat with talcum powder, polish, and dry.

[0063] Spleen and Stomach Nourishing Pill: Prescription: "Prepared Astragalus membranaceus 10g, stir-fried Atractylodes macrocephala 10g, Codonopsis pilosula 12g, Citrus reticulata peel 7g, Dendrobium nobile 10g, Cyperus rotundus 7g, Cinnamomum cassia 4g, stir-fried Coix lacryma-jobi 10g, stir-fried Paeonia lactiflora 10g, Artemisia capillaris 4g, Dioscorea opposita 12g, Curcuma zedoaria 5g, prepared Glycyrrhiza uralensis 4g." Preparation: Grind the above thirteen ingredients into a fine powder, sift, and mix well. Add 10-15g of refined honey and an appropriate amount of water to every 100g of powder to make water-honey pills. Coat with talcum powder, polish, and dry.

[0064] Example 3: Application of the treatment plan: The subjects screened in Example 1 were divided into two groups of 45 each, and administered the drug formulation prepared in Example 2. The group settings were as follows: Treatment group: Nine-ingredient Peiyuan Formula, twice a day, one dose each time, taken warm after breakfast and dinner, for a course of 6 months; Control group: Spleen and Stomach Nourishing Pills, twice a day, one dose each time, taken warm after breakfast and dinner, for a course of 6 months.

[0065] Example 4: Verification of treatment results: Therapeutic indicators: 1. Mucosal biopsy histological examination, formulated in accordance with the "Technical Guidelines for Clinical Efficacy Evaluation of New Traditional Chinese Medicine Drugs for Chronic Gastritis (Trial Implementation)," with specific methods as follows: The endoscopist makes a determination based on the endoscopic findings, takes samples from the lesions, and evaluates gastric mucosal dysplasia using a combination of regional (location) and severity assessment methods. Samples from each site are placed in separate specimen boxes and sent for independent testing. Regions (locations): ① Antrum (lesser curvature, greater curvature); ② Angle; ③ Lesser curvature of the body (upper, lower); ④ Pylorus; ⑤ Body (excluding the lesser curvature, upper, lower); ⑥ Fundus. The severity of the lesions is assessed according to the "Pathological Diagnostic Criteria for Chronic Gastritis," using a "visual simulation scoring method," categorized into four levels: none, mild, moderate, and severe (0, 1, 2, 3 points respectively).

[0066] A comprehensive evaluation was conducted on the gastric mucosal atrophy, intestinal metaplasia, and dysplasia (intraepithelial neoplasia) in each region (site). The score for each region was the sum of the severity of the sites included in that region. Changes in the scores of each lesion and the total score before and after medication were evaluated. Effective treatment was defined as a decrease in the score by >30% after treatment. The formula is as follows: Total integral = Sum of actual regional integrals / Theoretical score range of actual region 100.

[0067] 2. Evaluation of the efficacy of traditional Chinese medicine: Traditional Chinese Medicine Syndrome Scoring Based on the "Consensus Opinion on the Diagnosis and Treatment of Chronic Atrophic Gastritis with Integrated Traditional Chinese and Western Medicine (2017)," the following criteria were selected from the TCM syndrome of spleen and stomach deficiency: Primary symptom: abdominal distension or dull pain, preference for pressure or warmth in the stomach; Secondary symptom: poor appetite, loose stools, fatigue, shortness of breath, reluctance to speak, and postprandial abdominal distension. Symptoms were scored as follows: none, mild, moderate, and severe, with primary and secondary symptoms recorded as "0, 2, 4, 6 points" and "0, 1, 2, 3 points," respectively. Changes in symptom scores or total symptom scores before and after treatment were compared between the two groups. (Baseline, Visit 1, Visit 2, and Visit 3 records were completed separately.) Traditional Chinese Medicine Syndrome Therapy This diagnosis was formulated in accordance with the "Consensus Opinion on the Diagnosis and Treatment of Chronic Atrophic Gastritis with Integrated Traditional Chinese and Western Medicine (2017)". ① Clinically cured: Main symptoms and signs disappear or basically disappear, efficacy index ≥ 95%; ② Significantly effective: Main symptoms and signs significantly improve, 70% ≤ efficacy index < 95%; ③ Effective: Main symptoms and signs significantly improve, 30% ≤ efficacy index < 70%; ④ Ineffective: Main symptoms and signs show no significant improvement, or even worsen, efficacy index < 30%.

[0068] Note: Efficacy index = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%.

[0069] Efficacy analysis: Determination of non-inferiority value: Based on clinical judgment, the preset non-inferiority threshold (△) was -15%, that is, if the reduction in efficacy between the treatment group and the control group did not exceed 15%, then the Jiuwei Peiyuan Formula was considered to have clinical non-inferiority. The results are shown in Table 1.

[0070] Table 1 Evaluation of Clinical Cure Rate Table 1 shows that the clinical cure rates (pathological mucosal scores) in the treatment group and the control group were 68.9% (31 / 45) and 75.6% (34 / 45), respectively, with a difference of -6.7% between the groups. The lower limit of the 95% confidence interval (-14.7%) was greater than the pre-specified non-inferiority margin (-15%). Regarding the evaluation of TCM efficacy, the effective rates in the treatment group and the control group were 91.1% (41 / 45) and 95.6% (43 / 45), respectively, with a difference of -4.5% between the groups. The lower limit of the 95% confidence interval (-12.5%) was greater than the pre-specified non-inferiority margin (-15%). These results support the non-inferiority hypothesis, indicating that the therapeutic effect of Jiuwei Peiyuan Formula is not inferior to that of Piwei Peiyuan Pill.

[0071] Example 5 Typical therapeutic effect in subjects #1: Symptoms upon admission: upper abdominal distension and discomfort, aggravated by cold or eating, belching, regurgitation of clear fluid, fatigue and poor appetite, weakness in the limbs, cold hands and feet, loose stools, pale tongue with white coating, and weak pulse.

[0072] Traditional Chinese Medicine Diagnosis: Stomach fullness (Spleen and Stomach Deficiency Syndrome) Western medicine diagnosis: Chronic atrophic gastritis Treatment plan: The main principle of traditional Chinese medicine is to "strengthen the spleen and replenish qi, harmonize the stomach and eliminate stagnation". The "Nine-Ingredient Peiyuan Pill" formula is used for treatment. The formula is as follows: Astragalus membranaceus 10g, Atractylodes macrocephala 10g, Dendrobium nobile 10g, Cyperus rotundus 7g, Cinnamomum cassia 4g, Coix lacryma-jobi 10g, Paeonia lactiflora 10g, Artemisia capillaris 4g, Glycyrrhiza uralensis 4g.

[0073] Usage: One dose per day, taken with warm water.

[0074] Post-treatment symptoms: The patient's abdomen was not distended, his spirits were fair, he had no fatigue, and his bowel movements were normal.

[0075] Pre-treatment gastroscopy: Chronic atrophic gastritis. Pathology showed: most of the submitted mucosal glands were atrophied, with significantly reduced layers; connective tissue hyperplasia in the interstitium, with abundant plasma cells and lymphocytes infiltrating, significant lymphoid tissue hyperplasia, and lymphoid follicle formation. (Greater curvature of the gastric body) Chronic atrophic inflammation of the mucosa, mild inflammation, mild activity, severe atrophy, and lymphoid follicle formation; (Lesser curvature of the gastric antrum) Chronic atrophic inflammation of the mucosa, mild inflammation, mild activity, severe atrophy, and lymphoid follicle formation; (Angiform angle of the gastric body) Chronic atrophic inflammation of the mucosa, mild inflammation, mild activity, severe atrophy, and mild intestinal metaplasia. (e.g.) Figures 1-2 (As shown).

[0076] A follow-up gastroscopy six months after treatment showed chronic atrophic gastritis. Pathology revealed a small amount of chronic inflammatory cell infiltration in the interstitium of the submitted mucosal tissue, predominantly lymphocytes and plasma cells. (Greater curvature of the gastric body) Mild chronic inflammation of the mucosa; (lesser curvature of the gastric antrum) Mild chronic atrophic inflammation of the mucosa with mild intestinal metaplasia; (gastric angle) Mild chronic atrophic inflammation of the mucosa with mild intestinal metaplasia. Figures 3-4 (As shown).

[0077] Example 6 Typical therapeutic effect in subjects #1: Admission symptoms: dull pain and discomfort in the upper abdomen, the pain is persistent and relieved by warmth and pressure, poor appetite and fatigue, cold hands and feet, loose stools, pale tongue with white coating, and weak pulse.

[0078] Traditional Chinese Medicine Diagnosis: Stomach pain (Spleen and Stomach Deficiency Syndrome) Western medicine diagnosis: Chronic atrophic gastritis Treatment plan: The main principle of traditional Chinese medicine is to "strengthen the spleen and replenish qi, harmonize the stomach and eliminate stagnation". The "Nine-Ingredient Peiyuan Pill" formula is used for treatment. The formula is as follows: Astragalus membranaceus 10g, Atractylodes macrocephala 10g, Dendrobium nobile 10g, Cyperus rotundus 7g, Cinnamomum cassia 4g, Coix lacryma-jobi 10g, Paeonia lactiflora 10g, Artemisia capillaris 4g, Glycyrrhiza uralensis 4g.

[0079] Usage: One dose per day, taken with warm water.

[0080] Post-treatment symptoms: The patient's abdomen was not distended, his spirits were fair, he had no fatigue, and his bowel movements were normal.

[0081] Pre-treatment gastroscopy: Most of the submitted mucosal glands were atrophied, with significantly reduced layers; connective tissue hyperplasia was observed in the interstitium, with abundant plasma cells and lymphocytes infiltrating, significant lymphoid tissue hyperplasia, and lymphoid follicle formation. (Lesser curvature of the antrum) Chronic inflammation of the mucosa, mild inflammation, with intestinal metaplasia in some glands; (Greater curvature of the antrum) Chronic atrophic inflammation of the mucosa, mild inflammation, severe atrophy, and mild intestinal metaplasia; (Angle of the stomach) Chronic atrophic inflammation of the mucosa, mild inflammation, severe atrophy, and mild intestinal metaplasia. (e.g.) Figures 5-6 (As shown).

[0082] A follow-up gastroscopy six months after treatment showed: The submitted mucosal tissue contained a small amount of chronic inflammatory cell infiltration in the interstitium, predominantly lymphocytes and plasma cells. Mild chronic inflammation of the lesser curvature of the antrum mucosa with focal glandular intestinal metaplasia; mild chronic inflammation of the greater curvature of the antrum mucosa; mild chronic inflammation of the gastric angle mucosa. Figures 7-8 (As shown).

[0083] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0084] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A nine-ingredient formula for treating chronic atrophic gastritis, characterized in that, It is made from the following raw materials in parts by weight: 8-12 parts of roasted Astragalus membranaceus, 8-12 parts of stir-fried Atractylodes macrocephala, 8-12 parts of Dendrobium nobile, 6-8 parts of Cyperus rotundus, 3-5 parts of Cinnamomum cassia, 8-12 parts of stir-fried Coix lacryma-jobi, 8-12 parts of stir-fried Paeonia lactiflora, 3-5 parts of Artemisia capillaris, and 3-5 parts of roasted Glycyrrhiza uralensis.

2. The nine-ingredient formula for nourishing the source according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 10 parts roasted Astragalus membranaceus, 10 parts stir-fried Atractylodes macrocephala, 10 parts Dendrobium nobile, 7 parts Cyperus rotundus, 4 parts Cinnamomum cassia, 10 parts stir-fried Coix lacryma-jobi, 10 parts stir-fried Paeonia lactiflora, 4 parts Artemisia capillaris, and 4 parts roasted Glycyrrhiza uralensis.

3. A pharmaceutical composition, characterized in that, include: (1) The therapeutically effective amount of the Nine-Ingredient Nourishing Formula as described in claim 1 or 2; (2) Pharmaceutically or immunologically acceptable carriers or excipients.

4. A pharmaceutical preparation, characterized in that, Includes the pharmaceutical composition according to claim 3.

5. The pharmaceutical preparation according to claim 4, characterized in that, The dosage forms of the pharmaceutical preparations include decoctions, pills, tablets, capsules, and / or granules.

6. The pharmaceutical preparation according to claim 5, characterized in that, The dosage form of the pharmaceutical preparation is decoction, pill, and / or granule.

7. The method for preparing the pharmaceutical formulation according to any one of claims 4-6, characterized in that, include: According to the weight ratio of the nine-ingredient formula for nourishing the source as described in claim 1 or 2, take roasted astragalus, stir-fried atractylodes macrocephala, dendrobium, cyperus rotundus, cinnamon twig, stir-fried coix seed, stir-fried white peony root, artemisia annua, and roasted licorice root, mix them, add water, soak thoroughly, and decoct into a soup.

8. A pharmaceutical preparation, characterized in that, It is obtained by the preparation method described in claim 7.

9. A pharmaceutical product, characterized in that, Includes the Nine-Ingredient Nourishing Formula as described in claim 1 or 2, the pharmaceutical composition as described in claim 3, and / or the pharmaceutical preparation as described in any one of claims 4-6 or 8.

10. The use of the Nine-Ingredient Nourishing Formula of claim 1 or 2, the pharmaceutical composition of claim 3, the pharmaceutical preparation of any one of claims 4-6 or 8, and / or the product of claim 9 in the preparation of a drug for treating chronic atrophic gastritis.

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