Traditional Chinese medicine composition for improving gastrointestinal motility disorder and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for improving gastrointestinal motility disorder and a preparation method thereof, and the traditional Chinese medicine composition is prepared from the following raw materials: fried malt, fried rice sprout, poria cocos, fructus amomi and liquorice. The traditional Chinese medicine composition disclosed by the invention can improve clinical symptoms such as postprandial fullness, early satiety, epigastric pain and epigastric discomfort caused by gastrointestinal motility disorder, epigastric burning feeling and epigastric spasmodic pain; insufficient gastric motility caused by gastrointestinal motility disorder is relieved, and nausea, vomiting, ozostomia, sour regurgitation or bitter regurgitation in the mouth are improved; the traditional Chinese medicine is used for treating weakness of spleen and stomach, and improving the symptoms of poor appetite, anorexia, fatigue, intolerance of cold, cold limbs and sweet excrement caused by stomach cold dull pain, stomach cold distention and fullness, warm and press liking.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for improving gastrointestinal motility disorders and its preparation method. Background Technology

[0002] Gastrointestinal motility disorders refer to decreased gastric and intestinal motility, dysfunction of gastrointestinal smooth muscle, and loss of normal rhythmic movement, leading to reduced digestive capacity, gastrointestinal dysfunction, and the inability of food and bile to smoothly enter the ileum, instead flowing upwards into the stomach, resulting in a series of symptoms. Clinical manifestations include esophageal burning, epigastric burning, abdominal distension or pain, especially after meals, persistent bad breath, poor appetite, chest and epigastric fullness, frequent belching, lower abdominal distension, fatigue, sallow complexion, facial edema, limb swelling, vomiting of bitter and sour substances, difficult and infrequent bowel movements, frequent urination at night, weight loss, aversion to cold and cold limbs, a pale and swollen tongue with a thin white coating and teeth marks on the edges, and a slow or deep and thready pulse. Severe cases can lead to anemia, gastritis, esophagitis, indigestion, bad breath, constipation, recurrent oral ulcers, duodenal reflux, pyloric relaxation, and cardiac sphincter relaxation. Color Doppler ultrasound, gastroscopy, and barium swallow can confirm the diagnosis.

[0003] Modern medicine treats this condition with prokinetic drugs such as domperidone and cisapride, which have achieved some efficacy, but relapse is common after discontinuation, and adverse reactions such as borborygmus, abdominal pain, diarrhea, and arrhythmia are frequent. Long-term use of Western medicine has significant side effects on the human body. Summary of the Invention

[0004] Traditional Chinese medicine does not have the concept of "gastrointestinal motility," but the digestive functions of the spleen and stomach are quite similar, so this is often the starting point in TCM treatment. According to the consensus of TCM experts on functional dyspepsia in 2017, functional dyspepsia is classified in TCM as "stomach pain" and "gastric fullness," which are closely related to the spleen and stomach. It is mainly divided into five categories: spleen deficiency and qi stagnation syndrome, liver and stomach disharmony syndrome, spleen and stomach damp-heat syndrome, spleen and stomach weakness (cold) syndrome, and mixed cold and heat syndrome.

[0005] In recent years, guided by the holistic view and syndrome differentiation and treatment principles of Traditional Chinese Medicine (TCM), TCM has explored the etiology and pathogenesis of gastric fullness from multiple perspectives. It is believed that this disease is mostly caused by exposure to external pathogens, improper diet, emotional distress, overwork, and congenital deficiency. Consuming cold and raw foods, leading to spleen yang deficiency and impaired spleen and stomach function (spleen and stomach deficiency-cold syndrome), is one of the common clinical patterns of insufficient gastrointestinal motility. Zhang Jingyue, in his *Jingyue Quanshu* (Complete Works of Jingyue), states that "spleen deficiency and impaired function lead to fullness and obstruction," indicating that spleen and stomach weakness and insufficient digestion are important pathogenic mechanisms of fullness and discomfort in the middle jiao (middle burner). Furthermore, the dysfunction of spleen and stomach function, coupled with the internal generation of phlegm and dampness, further impairs the spleen, which is the key pathogenic mechanism for the continued progression of the disease. TCM has shown unique advantages in improving clinical symptoms, reducing recurrence, improving quality of life, and regulating the balance of body and mind. The treatment method of Chinese herbal decoctions, with its convenient administration, has been widely promoted and applied in clinical practice.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for improving gastrointestinal motility disorders, the raw materials of which include: roasted malt, roasted germinated rice, Poria cocos, Amomum villosum, and licorice.

[0007] As a preferred embodiment, the raw materials prepared by weight include: 3-30 parts roasted malt, 3-30 parts roasted germinated rice, 3-15 parts Poria cocos, 1.5-15 parts Amomum villosum, and 3-15 parts licorice.

[0008] The formulation principle of this traditional Chinese medicine composition is based on the theory of traditional Chinese medicine, targeting the pathogenesis of gastrointestinal motility disorders. It uses the basic principles of strengthening the spleen, harmonizing the stomach, and reducing turbidity to formulate a prescription based on syndrome differentiation, so as to achieve the goal of treating both the symptoms and the root cause.

[0009] Malt: Sweet, neutral. It enters the spleen and stomach meridians. It promotes qi circulation, aids digestion, strengthens the spleen, and stimulates appetite.

[0010] Wheat sprouts can promote digestion and relieve bloating. Roasted wheat sprouts, in particular, promote digestion and relieve bloating, and are used for indigestion. Wheat sprouts contain amylase, which can break down starch into maltose, facilitating absorption by the body. According to medical records, pancreatic amylase activator can be extracted from the decoction of roasted wheat sprouts. Identification and verification have shown that the extract contains no other components, only a mixture of a large amount of calcium nitrate and a small amount of sodium chloride, which has a significant activating effect on pancreatic amylase.

[0011] Chemical composition: Malt contains various enzymes such as amylase, invertase, esterase, oxidase, catalytic enzyme, cellobiase, gentiobiase, licheniformase, amygdalinase, and peroxidase. It also contains maltine, maltguanidine A and B, glucosides, and gramine. Furthermore, it contains adenine, choline, betaine, lecithin, amino acids, vitamins B, D, and E, and sucrose. Additionally, it contains Q-tocopherol, α-tocopherol, chloroquinone, and trichosanthes. Malt has digestive properties and appears to have a mild promoting effect on the secretion of gastric acid and pepsin.

[0012] Regarding the effects of malt, the *Treatise on the Nature of Medicinal Herbs* records that it digests undigested food, dispels cold qi, and relieves abdominal distension. The *Daily Materia Medica* records that it warms the middle jiao, lowers qi, improves appetite, stops cholera, relieves irritability, eliminates phlegm, breaks up masses, and can induce labor and miscarriage. The *Origins of Medicine* records that it tonifies the spleen and stomach, widens the intestines and stomach; it is finely ground, stir-fried until yellow, and used as a flour.

[0013] Germinated rice: Sweet, neutral. Enters the spleen and stomach meridians. Strengthens the spleen and improves appetite. Used for food stagnation; abdominal distension and diarrhea; poor appetite due to spleen deficiency. Chemical composition: Mainly contains yeast, amylase, vitamins, starch, maltose, choline, and various amino acids.

[0014] Poria cocos: Also known as Yunling, Bai Fuling, and Chi Fuling. Properties: Sweet, bland, neutral. Meridians: Heart, Spleen, and Stomach. Functions: Promotes diuresis and eliminates dampness, strengthens the spleen and stomach. Chemical composition: Contains polysaccharides, primarily pachymansi. Also contains diterpenoids, sterols, and other components.

[0015] Amomum villosum has a pungent and warm nature, and enters the spleen, stomach, and kidney meridians. It has the effects of resolving dampness and stimulating appetite, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. It is mainly used for symptoms such as dampness obstructing the middle jiao, epigastric fullness and lack of appetite, spleen and stomach deficiency and cold, vomiting and diarrhea, morning sickness, and threatened abortion.

[0016] The traditional Chinese medicine composition used in this invention is a modified version of Xiangsha Liujunzi Decoction based on modern clinical experience. It has excellent effects in strengthening the spleen and promoting digestion, and invigorating qi and harmonizing the stomach. In this formula, roasted barley and malt are the principal herbs, which can simultaneously strengthen the spleen and harmonize the middle jiao, promote qi circulation and aid digestion. Poria is the assistant herb, which drains dampness and promotes urination, strengthens the spleen and harmonizes the stomach, calms the mind and soothes the nerves; when combined with the principal herbs, it enhances the function of strengthening digestion. A small amount of Amomum villosum is used as an adjuvant herb, which warms the middle jiao and harmonizes qi. The *Compendium of Materia Medica* states, "If the qi of the upper jiao is obstructed and does not descend, the qi of the lower jiao is suppressed and does not ascend, and the qi of the middle jiao is condensed and not smooth, using Amomum villosum to treat this condition is the most effective and quickest." The combined use of these herbs achieves the functions of strengthening, promoting digestion, transforming qi, and tonifying. Although the number of herbs is small, the medicinal effect is not diminished; although the dosage is reduced, the medicinal power is refined.

[0017] As a preferred embodiment, the method for preparing roasted malt includes: preheating an iron wok, adding dried malt and ginger juice, and continuously stir-frying.

[0018] In a preferred embodiment, the ratio of the dried malt to ginger juice is 100g:(10-20)mL.

[0019] As a preferred embodiment, the continuous stir-frying conditions are: stir-frying at 120-150℃ for 15-20 times per minute for 8-10 minutes, until the surface is deep yellow, the cross-section is light yellow, and a rich wheat aroma is released. As another preferred embodiment, the preparation method of the stir-fried germinated barley includes: stir-frying over a low heat of 100-130℃ for 20-25 times per minute for 8-12 minutes, until the surface is light yellow, the cross-section is light yellow, it is easily crumbled by hand, and there is no dampness.

[0020] In summary, this invention focuses on the clinical efficacy of using "refined formulas" to treat gastrointestinal motility disorders caused by spleen and stomach deficiency by modifying classical formulas. By comparing the efficacy and safety of this formula with commonly used Western medicines, it aims to explore diversified treatment options for gastrointestinal motility disorders, ensure clinical efficacy, reduce toxic side effects, and inherit the classics of traditional Chinese medicine.

[0021] In a preferred embodiment, the Poria cocos, Amomum villosum, and Glycyrrhiza uralensis are prepared using a compound extraction process, specifically including the following steps:

[0022] S1. Mix Poria cocos, Amomum villosum, and Glycyrrhiza uralensis and pulverize them to a particle size of less than 100 mesh to obtain a dry mixed powder. Add water to mix, add cellulase and pectinase, and enzymatically hydrolyze for 2-3 hours. Then boil to inactivate the enzyme to obtain product 1.

[0023] S2. Extract product 1 in a microwave oven at 400-500W and 50-80℃ for 10-30 minutes. Concentrate and dry the extract to obtain mixed extract 1.

[0024] In a preferred embodiment, the amount of cellulase used is 10-15 U / g dry mixed powder; the amount of pectinase used is 8-10 U / g dry mixed powder.

[0025] In a preferred embodiment, the mass of the water is 8-10 times the mass of the mixed powder.

[0026] A second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for improving gastrointestinal motility disorders, comprising the following steps:

[0027] S1. Grind roasted malt and roasted germinated rice into powder, sift, and set aside the powder.

[0028] S2. Add the drug powder to ethanol, microwave for 2-5 times, 10-15 min each time, combine the extracts, concentrate under reduced pressure to extract, obtain a mixture, centrifuge, take the filtrate, and dry at 70-75℃ to obtain mixed extract 2.

[0029] S3. Combine mixed extract 1 and mixed extract 2 to obtain the traditional Chinese medicine composition.

[0030] A third aspect of the present invention provides a traditional Chinese medicine preparation comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0031] In one preferred embodiment, the traditional Chinese medicine preparation is one or more of granules, decoctions, powders, pills, and beverages.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] 1. The traditional Chinese medicine composition of the present invention can improve the clinical symptoms of postprandial fullness, early satiety, upper abdominal pain, and upper abdominal discomfort caused by gastrointestinal motility disorders, and significantly reduce or relieve upper abdominal burning sensation and upper abdominal spasmodic pain.

[0034] 2. The traditional Chinese medicine composition of the present invention can relieve gastric motility insufficiency caused by gastrointestinal motility disorders, improve postprandial fullness or slow digestion, and alleviate symptoms such as nausea, vomiting, halitosis, acid reflux or bitter taste in the mouth caused by gastric motility insufficiency.

[0035] 3. The traditional Chinese medicine composition of the present invention can treat spleen and stomach weakness, improve symptoms such as stomach cold and dull pain, stomach cold and fullness, poor appetite, fatigue, belching and hiccups caused by preference for warmth and pressure.

[0036] 4. The herbal composition of this invention can promote digestion and absorption, improve gastrointestinal motility, accelerate gastric emptying, and relieve food retention, thereby improving nutrient absorption efficiency. It is especially suitable for malnourished patients or patients recovering from surgery. By improving the gastrointestinal environment, it indirectly promotes the proliferation of probiotics (such as lactobacilli and bifidobacteria), inhibits harmful bacteria (such as Helicobacter pylori), and reduces intestinal fermentation and gas production. It provides a comprehensive conditioning solution for symptoms such as abdominal distension, belching, and reflux caused by non-organic lesions.

[0037] 5. The herbal composition of the present invention may have a certain auxiliary effect on obese or metabolic syndrome patients by accelerating metabolism and reducing food retention, relieving gastroparesis symptoms (such as intractable abdominal distension and constipation) in diabetic patients, and stabilizing postprandial blood glucose fluctuations.

[0038] 6. The herbal composition of the present invention can reduce the erosion of the mucosa by gastric acid or bile reflux, and assist in the treatment of chronic gastritis and gastric ulcer. Based on the traditional Chinese medicine theory that "the spleen and stomach are the foundation of acquired constitution", it can improve the physical weakness and susceptibility to repeated infections caused by spleen deficiency. Targeting the characteristic that "the spleen governs the muscles", it can reduce muscle weakness and lethargy caused by poor digestive function.

[0039] 7. The traditional Chinese medicine composition of the present invention can alleviate the side effects of chemotherapy in cancer patients, such as nausea, vomiting, and loss of appetite, and improve constipation, poor appetite, and malnutrition in the elderly caused by decreased gastrointestinal motility. Detailed Implementation

[0040] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and 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.

[0041] Examples 1-8

[0042] Examples 1-8 provide a traditional Chinese medicine preparation for improving gastrointestinal motility disorders. The raw materials and their mass fractions are shown in Table 1.

[0043] Table 1

[0044] Example Fried rice sprouts Roasted malt Poria Amomum villosum licorice Example 1 6 6 3 3 3 Example 2 30 30 15 6 6 Example 3 15 15 9 3 3 Example 4 3 3 1 1.5 / Example 5 30 30 30 9 9 Example 6 25 25 10 10 / Example 7 10 10 5 5 / Example 8 15 15 9 9 /

[0045] The method for preparing roasted malt includes: at 130°C, adding dried malt and ginger juice (100g:15mL) to a pot, stirring 20 times per minute for 10 minutes, until the surface is dark yellow, the cross-section is light yellow, and a rich malt aroma is released, then the process is complete.

[0046] The method for preparing roasted germinated barley includes: simmering at 120℃ over low heat, stirring 25 times per minute for 12 minutes, until the surface is light yellow, the cross-section is light yellow, it is easily broken by hand, and it feels dry.

[0047] The Poria cocos, Amomum villosum, and Glycyrrhiza uralensis are prepared using a compound extraction process, which specifically includes the following steps:

[0048] S1. Mix Poria cocos, Amomum villosum, and Glycyrrhiza uralensis, then pulverize them to a particle size of less than 100 mesh to obtain a dry mixed powder. Add 10 times the weight of water and mix. Add cellulase and pectinase, and after enzymatic hydrolysis for 3 hours, boil to inactivate the enzyme to obtain product 1. The amount of cellulase used is 15 U / g dry mixed powder; the amount of pectinase used is 10 U / g dry mixed powder.

[0049] S2. Product 1 was extracted in a microwave oven at 500W and 80℃ for 20 minutes. The extract was then concentrated and dried to obtain mixed extract 1.

[0050] Preparation methods of traditional Chinese medicine preparations in Examples 1-8:

[0051] S1. Grind roasted malt and roasted germinated rice into powder, sift, and set aside the powder.

[0052] S2. Add the drug powder to ethanol, microwave it 4 times for 15 minutes each time, combine the extracts, concentrate it under reduced pressure to obtain an extract, centrifuge, take the filtrate, and dry it at 70°C to obtain mixed extract 2.

[0053] S3. Combine mixed extract 1 and mixed extract 2 to obtain a traditional Chinese medicine composition. Dissolve the traditional Chinese medicine composition in water to obtain a traditional Chinese medicine preparation.

[0054] Performance testing

[0055] To evaluate whether the efficacy of the Tiaoheng Gumai Decoction treatment group (hereinafter referred to as the traditional Chinese medicine group) was superior to that of the domperidone Western medicine control group (hereinafter referred to as the control group), a non-inferiority test was used to estimate the sample size. The significance level was set at α = 0.025 (one-sided), and the type II error β = 0.1 (i.e., 90% power). The primary efficacy indicator was the change in symptom scores. The treatment group and control group were designed in a 1:1 ratio, and the sample size was estimated based on a one-sided two-sample t-test. The results showed that the estimated total sample size was 48, with 24 cases in the treatment group and 24 cases in the control group. Considering a 20% loss to follow-up rate and pre-planned statistical analysis, this invention intends to include 30 cases in the treatment group and 30 cases in the control group, for a total of 60 cases.

[0056] Randomized grouping method

[0057] This invention is a randomized, controlled, parallel clinical trial, with the trial subjects coming from Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine.

[0058] Randomization: This trial employed a centrally stratified block randomization method. All patients meeting the inclusion criteria were randomly assigned to either the treatment or control group. A total of 60 subjects were enrolled, with 30 in the treatment group and 30 in the control group. Randomization codes were generated by statistical professionals using SAS 9.4 software on a computer. Randomization was conducted online; researchers applied for enrollment based on the order of subjects' medical visits, and the system automatically generated random numbers. Appropriate treatment was administered according to the group corresponding to the assigned number.

[0059] Selection of parallel group design and control

[0060] This trial uses a parallel group design, meaning that each subject is assigned to receive only one experimental treatment.

[0061] Control group: The differences in efficacy between the groups were compared using traditional Chinese medicine and Western medicine respectively.

[0062] Treatment group: Administered barley and wheat drink.

[0063] Control group: Received conventional FD therapy and domperidone tablets (Sichuan Weiao Pharmaceutical Co., Ltd., 10mg / tablet, National Drug Approval Number H20093491) twice daily, one tablet each time, taken 15-30 minutes before breakfast and dinner.

[0064] Subject selection and withdrawal

[0065] Inclusion criteria

[0066] Subjects must meet all of the following criteria to be enrolled:

[0067] Subjects who meet the diagnostic criteria of Western medicine and the TCM syndrome of spleen and stomach deficiency and cold;

[0068] Western medical diagnostic criteria (Rome IV diagnostic criteria)

[0069] 1. Includes one or more of the following:

[0070] a. Postprandial fullness and discomfort

[0071] b. Discomfort from early satiety

[0072] c. Upper mid-abdominal pain (referring to discomforting upper mid-abdominal pain)

[0073] d. Burning discomfort in the upper middle abdomen

[0074] 2. There is no evidence of structural disease (including gastroscopy) that could explain the above symptoms.

[0075] *Symptoms must have been present for at least 6 months prior to diagnosis, and the patient must have met the above diagnostic criteria for the past 3 months.

[0076] Traditional Chinese Medicine Diagnostic Criteria (based on the latest "Expert Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Traditional Chinese Medicine (2017)" published in 2017)

[0077] The diagnostic criteria related to this invention are as follows:

[0078] Spleen and stomach deficiency-cold syndrome

[0079] Main symptoms: ① Dull pain or fullness in the stomach; ② Preference for warmth and pressure.

[0080] Secondary symptoms: ① Frequent vomiting of clear water; ② Poor appetite or loss of appetite; ③ Fatigue; ④ Cold hands and feet;

[0081] ⑤ Loose stools.

[0082] Tongue and pulse: Pale tongue, white coating, and weak pulse.

[0083] Syndrome diagnosis: The main symptom is essential, plus two secondary symptoms, and with reference to the tongue and pulse, a diagnosis can be made.

[0084] Age between 18 and 65 years old;

[0085] The patient had not taken any gastrointestinal prokinetic drugs for at least 15 days prior to treatment and had not participated in any other clinical studies;

[0086] Participants must sign an informed consent form, informing the participants of the purpose, process, and duration of the clinical study, and clearly explaining the potential benefits and risks involved, before voluntarily participating in the study.

[0087] Exclusion criteria

[0088] Subjects who meet any of the following criteria cannot be enrolled:

[0089] It is complicated by gastroesophageal reflux disease (GERD), irritable bowel syndrome, functional diarrhea, abdominal pain, constipation, etc.

[0090] Patients with impaired consciousness or mental status who cannot accurately express their symptoms, or patients with a history of mental illness;

[0091] Patients with serious underlying cardiovascular and cerebrovascular diseases or other systemic diseases, or those with malignant tumors;

[0092] Pregnant or expectant women, breastfeeding women;

[0093] People with allergies or allergies to multiple medications.

[0094] Shedding and rejection criteria

[0095] Those with poor compliance who are unable to receive treatment according to the prescribed procedures or even stop treatment on their own;

[0096] Patients with liver or kidney dysfunction during the trial;

[0097] Those who voluntarily withdraw from the clinical trial for personal reasons, or who subjectively do not wish to continue participating in the trial;

[0098] Cases may be lost to follow-up or dropped out due to any force majeure event.

[0099] Criteria for Suspension and Exit

[0100] During the trial, the participant voluntarily withdrew from the trial.

[0101] During the course of the disease, the patient experienced severe or intolerable adverse reactions and complications;

[0102] The condition worsens during the course of the disease, requires surgical treatment, or there is a threat to life;

[0103] Unplanned pregnancy.

[0104] Study arrangements and follow-up

[0105] Subjects in the treatment group and the control group were treated with Gumai Yin (a traditional Chinese medicine drink) for 4 consecutive weeks, while the control group was treated with domperidone tablets. They were followed up for 4 weeks after treatment, and the total treatment course was 8 weeks.

[0106] Screening period (0 visits)

[0107] After confirming that the patient has signed informed consent and meets all inclusion and exclusion criteria, baseline examinations are performed on the patient.

[0108] Baseline (Visit 1)

[0109] Physical examination (including height, weight, blood pressure, and heart rate);

[0110] Review the inclusion and exclusion criteria for test subjects;

[0111] Symptom score: Refer to the grading standards and TCM syndrome score quantification table formulated by the Spleen and Stomach Diseases Professional Committee of the China Association of Traditional Chinese Medicine in the "Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Integrated Traditional Chinese and Western Medicine (2017)".

[0112] The Nepean Dyspepsia Index (NDI)

[0113] Complete blood count, liver and kidney function tests (week 0 ± 3 days, fasting blood tests)

[0114] Traditional Chinese Medicine Symptom Scale

[0115] Visit 2, Week 2

[0116] Symptom score: Refer to the grading standards and TCM syndrome score quantification table formulated by the Spleen and Stomach Diseases Professional Committee of the China Association of Traditional Chinese Medicine in the "Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Integrated Traditional Chinese and Western Medicine (2017)".

[0117] The Nepean Dyspepsia Index (NDI)

[0118] Record adverse events and concomitant medications

[0119] Visit 3, Week 4

[0120] Symptom score: Refer to the grading standards and TCM syndrome score quantification table formulated by the Spleen and Stomach Diseases Professional Committee of the China Association of Traditional Chinese Medicine in the "Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Integrated Traditional Chinese and Western Medicine (2017)".

[0121] The Nepean Dyspepsia Index (NDI)

[0122] Traditional Chinese Medicine Symptom Scale

[0123] Complete blood count, liver and kidney function tests (week 4 ± 3 days, fasting blood tests)

[0124] Therapeutic effect score

[0125] Record adverse events and concomitant medications, and conduct safety evaluations.

[0126] Visit 4, follow-up 4 weeks after treatment completion

[0127] Symptom score: Refer to the grading standards and TCM syndrome score quantification table formulated by the Spleen and Stomach Diseases Professional Committee of the China Association of Traditional Chinese Medicine in the "Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Integrated Traditional Chinese and Western Medicine (2017)".

[0128] The Nepean Dyspepsia Index (NDI)

[0129] Record adverse events and concomitant medications

[0130] Research Plan

[0131] This invention is planned to be completed from January 2023 to December 2024, a total of 24 months. Data statistical analysis and statistical reporting will each take approximately 2 months.

[0132] Test treatment

[0133] Treatment group: The group was given the barley drink from Example 1, 2 packets per dose, 1 dose per day, taken twice a day before meals.

[0134] Control group: Received conventional FD therapy, and was given domperidone tablets (Sichuan Weiao Pharmaceutical Co., Ltd., 10mg / tablet, National Drug Approval Number H20093491) twice daily, one tablet each time, taken 15-30 minutes before breakfast and dinner.

[0135] efficacy assessment

[0136] Main therapeutic indicators

[0137] Symptom score: Refer to the grading standards and TCM syndrome score quantification table formulated by the Spleen and Stomach Diseases Professional Committee of the China Association of Traditional Chinese Medicine in the "Consensus Opinion on the Diagnosis and Treatment of Functional Dyspepsia with Integrated Traditional Chinese and Western Medicine (2017)".

[0138] Secondary efficacy endpoints

[0139] The Nepean Dyspepsia Index (NDI)

[0140] Complete blood count, liver and kidney function tests

[0141] Traditional Chinese Medicine Symptom Scale

[0142] Security assessment

[0143] Adverse events are identified through patient interviews (avoiding leading questions), pre- and post-treatment physical examinations, and laboratory tests, and causal analysis is performed on these adverse events.

[0144] 5 Results

[0145] The male-to-female ratio of participants was 86%.

[0146] (1) Symptom score

[0147] Symptom scores in the treatment group

[0148] Symptom score (postprandial fullness, early satiety, upper abdominal pain / burning sensation in the upper abdomen) Before treatment Week 2 of treatment Week 4 of treatment Four weeks after completing treatment maximum 24 15 9 9 Minimum 12 6 3 3 average 15.9 10.2 5.1 6

[0149] Control group symptom scores

[0150] Symptom score (postprandial fullness, early satiety, upper abdominal pain / burning sensation in the upper abdomen) Before treatment Week 2 of treatment Week 4 of treatment Four weeks after completing treatment maximum 15 12 12 15 Minimum 15 12 9 12 average 15 12 10.5 13.5

[0151] (2) Nipin Indigestion Index (average)

[0152] Nipine dyspepsia index (mean) in the treatment group

[0153] Nipin Indigestion Index (Average) Before treatment Week 2 of treatment Week 4 of treatment Four weeks after completing treatment upper abdominal pain 2.7 1.6 0.6 0.5 upper abdominal discomfort 3.4 2.1 1.5 1.4 Burning sensation in the upper abdomen 1.9 1.1 0.6 0.7 Heartburn (burning sensation in the chest) 1.0 2.7 0.4 0.5 Spasmodic pain in the upper abdomen 1.4 0.8 0.1 0 - Chest pain 0.5 0.2 0 0 Unable to eat regularly 1.9 1.7 1.3 1.2 Acidity or bitterness in the mouth or throat 2.3 1.4 1.1 1.1 Postprandial fullness or slow digestion 3.2 2.2 1.7 1.6 upper abdominal pressure 1.5 1.3 0.8 0.5 upper abdominal bloating 2.6 2 1.5 1.4 -nausea 1.9 1.4 1.0 0.8 belching 2.8 2.0 1.4 1.4 Vomit 0.5 0.2 0 0 Bad breath 2.3 1.8 0.8 0.9 Average impact of stomach problems 3.9 3.1 1.9 2

[0154] The average nipine dyspepsia index in the control group.

[0155] Nipin Indigestion Index (Average) Before treatment Week 2 of treatment Week 4 of treatment Four weeks after completing treatment upper abdominal pain 1.5 1.5 1.5 2 upper abdominal discomfort 2.5 2 2.5 2.5 Burning sensation in the upper abdomen 2.0 1.5 1.0 1.0 Heartburn (burning sensation in the chest) 1.0 1.0 1.0 1.0 Spasmodic pain in the upper abdomen 1.0 0.50 0.5 0.5 - Chest pain 0.5 0.5 0.5 0.5 Unable to eat regularly 1.5 1.5 1.5 1.5 Acidity or bitterness in the mouth or throat 0.5 1.5 0.5 0.5 Postprandial fullness or slow digestion 2.5 2.0 2.0 2.0 upper abdominal pressure 2 1.5 1.5 1.5 upper abdominal bloating 2.5 1.5 1.5 2.0 -nausea 1.5 1.5 1.0 1.0 belching 1.5 1.5 2.0 2.0 Vomit 0.5 0 0 0 Bad breath 1.0 1.0 0.5 1.0 Average impact of stomach problems 4.0 3.0 2.5 2.5

[0156] (3) Traditional Chinese Medicine Syndrome Scoring

[0157] Traditional Chinese Medicine Syndrome Scores in Treatment Group

[0158] Traditional Chinese Medicine Syndrome Score (Average) Before treatment Week 2 of treatment Week 4 of treatment Four weeks after completing treatment Stomach cold and dull pain 3.2 2.2 1.6 1.6 Stomach cold and fullness 4.2 3.2 2.0 1.8 Xi Wen Xi An 4.0 2.0 1.8 1.6 belching and hiccups 2.5 1.7 1.0 0.8 Poor appetite 2.2 1.2 0.8 0.8 - Feeling tired and weak 2.4 1.6 1.1 0.9 - Feeling cold and having cold limbs 2.4 1.6 0.8 0.7 Loose stools 2.4 1.1 0.5 0.7

[0159] 5.3.2 Comparison with Traditional Chinese Medicine Syndrome Scores

[0160] Traditional Chinese Medicine Syndrome Score (Average) Before treatment Week 2 of treatment Week 4 of treatment Four weeks after completing treatment Stomach cold and dull pain 4.0 4.0 4.0 4.0 Stomach cold and fullness 4.0 4.0 3.0 3.0 Xi Wen Xi An 3.0 3.0 3.0 3.0 belching and hiccups 3.0 2.0 2.0 2.0 Poor appetite 2.0 2.0 2.0 1.5 - Feeling tired and weak 2.0 1.5 2.0 2.0 - Feeling cold and having cold limbs 2.0 1.5 1.5 1.5 Loose stools 1.5 1 0.5 1

[0161] Example 2

[0162] Treatment group: The group was treated with the barley and wheat drink of Example 2, 2 packets per dose, 1 dose per day, taken twice a day before meals.

[0163] Symptom scores in the treatment group

[0164] Symptom score (postprandial fullness, early satiety, upper abdominal pain / burning sensation in the upper abdomen) Before treatment Week 2 of treatment Week 4 of treatment Postprandial fullness syndrome score 6 3 3 Early satiety syndrome points 6 3 0 Upper abdominal pain / burning sensation syndrome score 3 3 3

[0165] Nipine dyspepsia index (mean) in the treatment group

[0166] Nipin Indigestion Index (Average) Before treatment Week 2 of treatment Week 4 of treatment upper abdominal pain 6 3 3 upper abdominal discomfort 11 6 3 Burning sensation in the upper abdomen 4 2 2 Heartburn (burning sensation in the chest) 0 0 0 Spasmodic pain in the upper abdomen 0 0 0 - Chest pain 0 0 0 Unable to eat regularly 7 5 4 Acidity or bitterness in the mouth or throat 8 4 4 Postprandial fullness or slow digestion 11 6 4 upper abdominal pressure 8 3 2 upper abdominal bloating 10 5 3 -nausea 8 4 3 belching 11 5 3 Vomit 0 0 0 Bad breath 6 5 3 Average impact of stomach problems 3.28 2 1.68

[0167] Traditional Chinese Medicine Syndrome Scores in Treatment Group

[0168] Traditional Chinese Medicine Syndrome Score (Average) Before treatment Week 2 of treatment Week 4 of treatment Stomach cold and dull pain 2 2 2 Stomach cold and fullness 4 2 2 Xi Wen Xi An 4 2 0 belching and hiccups 2 1 1 Poor appetite 2 1 0 - Feeling tired and weak 2 2 1 - Feeling cold and having cold limbs 1 1 1 Loose stools 1 1 1

[0169] Example 3

[0170] Treatment group: The group was treated with the barley and wheat drink of Example 3, 2 packets per dose, 1 dose per day, taken twice a day before meals.

[0171] Symptom scores in the treatment group

[0172] Symptom score (postprandial fullness, early satiety, upper abdominal pain / burning sensation in the upper abdomen) Before treatment Week 2 of treatment Week 4 of treatment Postprandial fullness syndrome score 6 3 3 Early satiety syndrome points 3 3 0 Upper abdominal pain / burning sensation syndrome score 6 3 3

[0173] Nipine dyspepsia index (mean) in the treatment group

[0174] Nipin Indigestion Index (Average) Before treatment Week 2 of treatment Week 4 of treatment upper abdominal pain 7 5 3 upper abdominal discomfort 10 7 5 Burning sensation in the upper abdomen 7 4 2 Heartburn (burning sensation in the chest) 4 2 2 Spasmodic pain in the upper abdomen 0 0 0 - Chest pain 0 0 0 Unable to eat regularly 7 4 4 Acidity or bitterness in the mouth or throat 9 6 6 Postprandial fullness or slow digestion 9 6 6 upper abdominal pressure 5 3 3 upper abdominal bloating 7 7 7 -nausea 3 3 3 belching 8 5 5 Vomit 0 0 0 Bad breath 5 3 3 Average impact of stomach problems 2.64 2.24 1.68

[0175] Traditional Chinese Medicine Syndrome Scores in Treatment Group

[0176] Traditional Chinese Medicine Syndrome Score (Average) Before treatment Week 2 of treatment Week 4 of treatment Stomach cold and dull pain 2 2 2 Stomach cold and fullness 4 2 2 Xi Wen Xi An 2 2 2 belching and hiccups 2 2 1 Poor appetite 1 1 0 - Feeling tired and weak 2 1 1 - Feeling cold and having cold limbs 1 1 1 Loose stools 1 1 0

[0177] The above clinical trials show that the traditional Chinese medicine composition of the present invention can improve the clinical symptoms of postprandial fullness, early satiety, upper abdominal pain, and upper abdominal discomfort caused by gastrointestinal motility disorders. It can also treat spleen and stomach weakness, improve symptoms of cold stomach pain, cold stomach fullness, poor appetite, fatigue, cold limbs, and loose stools caused by preference for warmth and pressure.

[0178] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for improving gastrointestinal motility disorders, characterized in that, The raw materials for preparation include: roasted malt, roasted germinated rice, Poria cocos, Amomum villosum, and licorice.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials for preparation, by weight, include: 3-30 parts roasted malt, 3-30 parts roasted germinated rice, 3-15 parts Poria cocos, 1.5-15 parts Amomum villosum, and 3-15 parts licorice.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The method for preparing roasted malt includes: at 120-150℃, adding dried malt and ginger juice to a pot and continuously stir-frying until the surface is dark yellow, the cross-section is light yellow, and a rich malt aroma is released, then the process is complete.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The preparation method of the stir-fried germinated barley includes: stir-frying over a low heat of 100-130℃, stirring 20-25 times per minute for 8-12 minutes until the surface is light yellow, the cross-section is light yellow, it is easily broken by hand, and there is no dampness.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The Poria cocos, Amomum villosum, and Glycyrrhiza uralensis are prepared using a compound extraction process, which specifically includes the following steps: S1. Mix Poria cocos, Amomum villosum, and Glycyrrhiza uralensis and pulverize them to a particle size of less than 100 mesh to obtain a dry mixed powder. Add water to mix, add cellulase and pectinase, and enzymatically hydrolyze for 2-3 hours. Then boil to inactivate the enzyme to obtain product 1. S2. Extract product 1 in a microwave oven at 400-500W and 50-80℃ for 10-30 minutes. Concentrate and dry the extract to obtain mixed extract 1.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, The amount of cellulase used is 10-15 U / g dry mixed powder; the amount of pectinase used is 8-10 U / g dry mixed powder.

7. The traditional Chinese medicine composition according to claim 5, characterized in that, The mass of the water is 8-10 times the mass of the dry mixed powder.

8. A method for preparing a traditional Chinese medicine composition for improving gastrointestinal motility disorders according to claim 7, characterized in that, Includes the following steps: S1. Grind roasted malt and roasted germinated rice into powder, sift, and set aside the powder. S2. Add the drug powder to ethanol, microwave for 2-5 times, 10-15 min each time, combine the extracts, concentrate under reduced pressure to extract, obtain a mixture, centrifuge, take the filtrate, and dry at 70-75℃ to obtain mixed extract 2. S3. Combine mixed extract 1 and mixed extract 2 to obtain the traditional Chinese medicine composition.

9. A traditional Chinese medicine preparation, characterized in that, The composition comprises any one of the traditional Chinese medicine compositions according to claims 1-7 and pharmaceutically acceptable excipients.

10. A traditional Chinese medicine preparation according to claim 9, characterized in that, The traditional Chinese medicine preparations mentioned are one or more of the following: granules, decoctions, powders, pills, and beverages.