A Chinese medicine composition, Chinese medicine preparation and preparation method and application thereof

By using a traditional Chinese medicine preparation made of a Chinese medicine composition composed of a variety of Chinese herbal medicines, the problems of insufficient gastrointestinal motility, excessive gastric acid secretion and gastric mucosa damage in patients with Helicobacter pylori positive gastritis after combined drug treatment were solved, and the effects of improving gastrointestinal motility, inhibiting Helicobacter pylori, protecting the gastric mucosa and inhibiting excessive gastric acid secretion were achieved, reducing the side effects of combined medication.

CN119454872BActive Publication Date: 2025-04-04北京市中医药研究所
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Patent Information

Application Number
CN202510052614.2
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-01-14
Publication Date
2025-04-04
Estimated Expiration
2045-01-14

AI Technical Summary

Technical Problem

Clinically, patients with Helicobacter pylori-positive gastritis often experience symptoms such as insufficient gastrointestinal motility, excessive gastric acid secretion and gastric mucosa damage after receiving combined medication, and the side effects brought by combination medication are obvious.

Method used

It is provided with a traditional Chinese medicine composition composed of Chinese herbal medicines such as raw astragalus, white cherry, dandelion, perilla, fritillaria, sauerkalis, raw Atractylodes, fried chicken gizzard, charred malt, Yuanhu, Citrus aurantium, Magnolia officinalis and Buddha's hand. It is prepared into a traditional Chinese medicine preparation through decoction, which is used to improve gastrointestinal motility, inhibit Helicobacter pylori, protect the gastric mucosa and inhibit excessive secretion of gastric acid.

Benefits of technology

The Chinese medicine composition and preparation can effectively improve gastrointestinal motility, inhibit Helicobacter pylori, protect the gastric mucosa, inhibit excessive gastric acid secretion, thereby reducing adverse reactions caused by combined medication, and have good clinical application value.

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Abstract

The present invention relates to the technical field of traditional Chinese medicine, and in particular, to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, and a preparation method and application thereof. The traditional Chinese medicine composition is composed of the following raw materials by weight: 5-25 parts of raw astragalus, 3-20 parts of white ginseng, 20-40 parts of dandelion, 10-30 parts of perilla, 5-25 parts of thunbergii, 10-30 parts of cuttlebone, 10-30 parts of raw atractylodes, 5-25 parts of stir-fried chicken gizzard, 20-40 parts of scorched malt, 3-20 parts of corydalis, 3-20 parts of immature bitter orange, 3-20 parts of magnolia bark and 5-25 parts of bergamot. The traditional Chinese medicine composition provided by the present invention can not only improve gastrointestinal motility, but also inhibit Helicobacter pylori, and also has the effect of protecting gastric mucosa and inhibiting excessive gastric acid secretion, and can reduce adverse reactions caused by combined medication.
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Description

Technical Field

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

[0002] Clinically, patients with Helicobacter pylori-positive gastritis often have symptoms of insufficient gastrointestinal motility, excessive gastric acid secretion, or gastric mucosal damage, such as abdominal distension, abdominal pain, loss of appetite, heartburn, acid reflux, belching, nausea, vomiting, etc. For such patients, combined drug treatment is often used clinically, such as amoxicillin + clarithromycin + omeprazole + colloidal pectin bismuth, etc.

[0003] However, after combined use of the drugs, the side effects of the drugs in patients also increased significantly.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] The first purpose of the present invention is to provide a Chinese medicine composition, which can not only improve gastrointestinal motility, but also inhibit Helicobacter pylori, and also has the function of protecting gastric mucosa and inhibiting excessive gastric acid secretion, and can reduce the adverse reactions caused by combined medication.

[0006] The second purpose of the present invention is to provide a Chinese medicine preparation, which can significantly improve gastrointestinal motility and inhibit Helicobacter pylori, and also has the effect of protecting gastric mucosa and inhibiting excessive gastric acid secretion. The use of this Chinese medicine preparation can reduce the side effects of combined medication.

[0007] The third object of the present invention is to provide a method for preparing a Chinese medicine preparation, which has simple operation, short process and low cost.

[0008] The fourth object of the present invention is to provide a use of a Chinese medicine composition or a Chinese medicine preparation in the preparation of a gastrointestinal medicine.

[0009] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

[0010] The invention first provides a traditional Chinese medicine composition, which is composed of the following raw materials in parts by mass: 5-25 parts of raw astragalus, 3-20 parts of bletilla striata, 20-40 parts of dandelion, 10-30 parts of perilla frutescens, 5-25 parts of thunbergia thunbergii, 10-30 parts of cuttlebone, 10-30 parts of raw atractylodes macrocephala, 5-25 parts of stir-fried chicken gizzard lining, 20-40 parts of roasted malt, 3-20 parts of corydalis, 3-20 parts of immature bitter orange, 3-20 parts of magnolia bark and 5-25 parts of citron.

[0011] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by mass: 10-20 parts of raw astragalus, 5-15 parts of bletilla striata, 25-35 parts of dandelion, 15-25 parts of perilla frutescens, 10-20 parts of thunbergia thunbergii, 15-25 parts of cuttlebone, 15-25 parts of raw atractylodes, 10-20 parts of stir-fried chicken gizzard lining, 25-30 parts of roasted malt, 5-15 parts of corydalis, 5-15 parts of immature bitter orange, 5-15 parts of magnolia bark and 10-20 parts of citron.

[0012] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by mass: 13-17 parts of raw astragalus, 8-12 parts of bletilla striata, 27-33 parts of dandelion, 18-22 parts of perilla frutescens, 13-17 parts of thunbergia thunbergii, 18-22 parts of cuttlebone, 18-22 parts of raw atractylodes, 13-17 parts of stir-fried chicken gizzard lining, 27-33 parts of roasted malt, 8-12 parts of corydalis, 8-12 parts of immature bitter orange, 8-12 parts of magnolia bark and 13-17 parts of citron.

[0013] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by mass: 15 parts of raw astragalus, 10 parts of white twig, 30 parts of dandelion, 20 parts of perilla, 15 parts of thunbergia thunbergii, 20 parts of cuttlebone, 20 parts of raw atractylodes, 15 parts of stir-fried chicken gizzard lining, 30 parts of roasted malt, 10 parts of corydalis, 10 parts of immature bitter orange, 10 parts of magnolia bark and 15 parts of citron.

[0014] The present invention further provides a traditional Chinese medicine preparation, which is mainly prepared from the traditional Chinese medicine composition.

[0015] Furthermore, the traditional Chinese medicine preparation is made from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0016] Furthermore, the dosage form of the Chinese medicine preparation is decoction, pill, lozenge, tablet, granule, powder, paste or capsule.

[0017] Furthermore, the dosage form of the Chinese medicine preparation is a decoction.

[0018] The invention further provides a method for preparing the Chinese medicine preparation, comprising the following steps: mixing various raw materials with water and then decocting to obtain a water decoction.

[0019] The present invention also provides the use of the Chinese medicine composition or the Chinese medicine preparation in the preparation of gastrointestinal medicines; wherein the gastrointestinal medicines include: medicines for relieving, assisting in the treatment of or treating chronic superficial gastritis; medicines for relieving, assisting in the treatment of or treating functional dyspepsia; medicines for promoting gastrointestinal motility; medicines for inhibiting Helicobacter pylori; medicines for protecting gastric mucosa; medicines for inhibiting excessive gastric acid secretion; medicines for promoting gastrointestinal motility and inhibiting Helicobacter pylori; medicines for protecting gastric mucosa and inhibiting excessive gastric acid secretion; medicines for promoting gastrointestinal motility and protecting gastric mucosa; medicines for inhibiting Helicobacter pylori and protecting gastric mucosa; medicines for promoting gastrointestinal motility and inhibiting excessive gastric acid secretion; or, medicines for promoting gastrointestinal motility, inhibiting excessive gastric acid secretion and protecting gastric mucosa.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The Chinese medicine composition provided by the present invention has a synergistic effect among various raw materials, which can not only improve gastrointestinal motility, but also inhibit Helicobacter pylori, and also has the effects of protecting gastric mucosa and inhibiting excessive gastric acid secretion, which can reduce the occurrence of adverse reactions caused by combined medication and alleviate the economic burden of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0023] Figure 1 A typical graph of the fluorescence intensity of zebrafish intestine after the sample is treated with the decoction water solution of Example 1 provided by the present invention;

[0024] Figure 2 A comparison of fluorescence intensity of zebrafish intestine after sample treatment with the decoction water solution of Example 1 provided by the present invention;

[0025] Figure 3 A typical graph of the fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish after the sample was treated with the decoction water solution of Example 1 provided by the present invention;

[0026] Figure 4 This is a comparison chart of the fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish after the sample was treated with the water-soluble decoction of Example 1 provided by the present invention. DETAILED DESCRIPTION

[0027] The technical scheme of the present invention will be clearly and completely described below in conjunction with the accompanying drawings and specific embodiments, but it will be understood by those skilled in the art that the following described embodiments are part of embodiments of the present invention, rather than all embodiments, and are only used to illustrate the present invention, and should not be considered as limiting the scope of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative work are within the scope of protection of the present invention. If specific conditions are not specified in the embodiments, they are carried out according to normal conditions or conditions recommended by the manufacturer. If the manufacturer is not specified in the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0028] If there is no special explanation, in the present invention, "the first aspect", "the second aspect", "the third aspect", "the fourth aspect", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or quantity, nor can they be understood as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "the first", "the second", "the third", "the fourth", etc. only serve the purpose of non-exhaustive enumeration and description, and it should be understood that they do not constitute a closed limitation on quantity.

[0029] If there is no special explanation, the "include" and "comprising" mentioned in the present invention represent open-ended or closed-ended expressions. For example, the "include" and "comprising" may represent that other components not listed may also be included or only the listed components may be included or only the listed components may be included.

[0030] If there is no special explanation, in the present invention, "one or more" or "at least one" refers to any one, any two or more of the listed items. Among them, "several" refers to any two or more of the listed items.

[0031] In a first aspect, the present invention provides a traditional Chinese medicine composition which can simultaneously promote gastrointestinal motility and inhibit Helicobacter pylori, and also has the effects of protecting gastric mucosa and inhibiting excessive gastric acid secretion. The traditional Chinese medicine composition is composed of the following raw materials in parts by mass: 5-25 parts of raw astragalus, 3-20 parts of bletilla striata, 20-40 parts of dandelion, 10-30 parts of perilla frutescens, 5-25 parts of thunbergia thunbergii, 10-30 parts of cuttlebone, 10-30 parts of raw atractylodes, 5-25 parts of stir-fried chicken gizzard lining, 20-40 parts of roasted malt, 3-20 parts of corydalis, 3-20 parts of immature bitter orange, 3-20 parts of magnolia bark and 5-25 parts of citron.

[0032] Among them, raw astragalus includes but is not limited to 5 parts, 6 parts, 8 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 22 parts, 23 parts, 25 parts of any one of the point value or any range value between two parts by mass. Bletilla striata includes but is not limited to 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 18 parts, 20 parts of any one of the point value or any range value between two parts by mass. The mass percentage of dandelion includes but is not limited to any one of 20, 22, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 38, 40 parts or any range between them. The mass percentage of perilla includes but is not limited to any one of 10, 12, 13, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 28, 30 parts or any range between them. The mass percentage of Fritillaria thunbergii includes, but is not limited to, any one of 5, 6, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, and 25 parts, or any range between them. The mass percentage of Cuttlebone includes, but is not limited to, any one of 10, 12, 13, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 28, and 30 parts, or any range between them. Raw Atractylodes macrocephala includes, but is not limited to, 10, 12, 13, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 28, 30 parts by weight or any range between them. Stir-fried chicken gizzard lining includes, but is not limited to, 5, 6, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 23, 25 parts by weight or any range between them. The roasted malt includes, but is not limited to, 20, 22, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 38, 40 parts by mass or any range between them. The coriander includes, but is not limited to, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20 parts by mass or any range between them.Fructus Aurantii Immaturus includes but is not limited to 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 18 parts, 20 parts of any one of the point value or any two range values. Cortex Magnoliae includes but is not limited to 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 18 parts, 20 parts of any one of the point value or any two range values. Citron includes but is not limited to 5 parts, 6 parts, 8 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts, 22 parts, 23 parts, 25 parts of any one of the point value or any two range values.

[0033] The Chinese medicine composition provided by the present invention has a synergistic effect among various raw materials, which can not only improve gastrointestinal motility, but also inhibit Helicobacter pylori, and also has the effects of protecting gastric mucosa and inhibiting excessive gastric acid secretion.

[0034] The present invention is based on clinical experience of traditional Chinese medicine and utilizes the advantages of multi-target intervention and holistic treatment of traditional Chinese medicine. The traditional Chinese medicine composition has been successfully verified by animal experiments, has definite efficacy, and has great application prospects.

[0035] The Chinese medicine intervention method in this application can replace the combined medication regimen of patients with Western medicine, reduce the occurrence of adverse reactions caused by combined medication, and reduce the economic burden on patients. It has very good clinical application value and can generate very good economic value and social benefits.

[0036] The Chinese medicine composition provided by the present invention is mainly for patients with clinical spleen deficiency and qi stagnation, phlegm-dampness obstruction type stomach pain (chronic superficial gastritis), clinical symptoms include: bloating, stomach pain, hiccups, belching, heartburn, poor appetite, fatigue and irregular bowel movements, etc. Western medicine mainly treats patients with insufficient gastrointestinal motility, Helicobacter pylori positivity, gastric mucosal damage and excessive gastric acid secretion.

[0037] The Chinese medicine composition provided by the present invention has raw astragalus, raw atractylodes, immature bitter orange, and magnolia bark as main drugs, perilla, fritillaria thunbergii, cuttlebone, dandelion, bletilla striata, and corydalis as assistant drugs, and stir-fried chicken gizzard lining, scorched malt, and citron as adjuvant drugs. The specifics are as follows:

[0038] Raw Astragalus is sweet and slightly warm in nature. It enters the spleen and lung meridians, strengthens the body and consolidates the exterior, tonifies Qi and strengthens the spleen; raw Atractylodes is warm in nature, bitter and sweet in taste, enters the spleen and stomach meridians, strengthens the spleen, replenishes Qi and dries dampness; Citrus aurantium is bitter in taste and slightly cold in nature. It enters the spleen and stomach meridians, breaks up Qi and eliminates accumulation; Magnolia officinalis is bitter in taste, pungent and warm in nature. It enters the spleen, stomach, lung and large intestine meridians, dries dampness and resolves phlegm, descends Qi and eliminates fullness, and they are all the monarch drugs in the prescription; the above four medicines are mostly warm in nature and enter the spleen and stomach meridians, and together they have the effects of tonifying Qi and strengthening the spleen, promoting Qi and drying dampness, descending Qi and eliminating fullness.

[0039] Dandelion tastes bitter and sweet, is cold in nature, and enters the liver and stomach meridians. It can clear away heat and detoxify, promote diuresis and purge fire, and strengthen the spleen and stomach. Since the patient has spleen deficiency and qi stagnation for a long time and generates heat, dandelion is selected to clear away heat and detoxify without hurting the spleen and stomach; Perilla frutescens tastes pungent, is neutral in nature, and enters the spleen, stomach, and lung meridians. It can aromatically eliminate dampness, wake up the spleen and stimulate the appetite, and strengthen the dampness-eliminating power of the main medicine; Fritillaria thunbergii tastes bitter, is cold in nature, and enters the lung and heart meridians. It can clear away heat and resolve phlegm, disperse nodules and eliminate carbuncles, and refractory acid. Cuttlebone is warm in nature, salty and astringent, and mainly enters the spleen and kidney meridians. It can refract acid and relieve pain, astringent and stop bleeding, resolve phlegm and soften hard masses. Since gastritis patients have spleen deficiency and qi stagnation for a long time, Symptoms of gastric qi reflux and acid reflux are often seen. Cuttlebone and Fritillaria thunbergii are intended to reduce acid and prevent excessive gastric acid secretion on the one hand, and to strengthen the effect of clearing phlegm and dampness on the other hand; Bletilla striata is slightly cold in nature, bitter, sweet and astringent in taste, and enters the lung meridian, liver meridian and stomach meridian, and has the effects of astringent, hemostasis, swelling and tissue regeneration. Since qi stagnation turns into heat over a long period of time, heat forces blood circulation and damages the stomach, so Bletilla striata is used to stop bleeding and tissue regeneration; Corydalis yanhusuo is pungent, bitter and warm, and enters the heart, liver and spleen meridians, aiming to strengthen the effect of promoting qi and relieving pain. The six medicines are the ministers in the prescription, and together they play the effects of clearing phlegm and dampness, reducing acid and relieving pain, and stopping bleeding and tissue regeneration.

[0040] Fried chicken gizzard lining tastes sweet and is neutral in nature. It enters the spleen, stomach, small intestine, and bladder meridians, and can invigorate the stomach and help digestion. Scorched malt tastes sweet and is neutral in nature. It enters the spleen, stomach, and liver meridians, and can regulate the spleen and stomach, stimulate the appetite, eliminate stagnation, and regulate qi and relieve depression. Buddha's hand tastes pungent and bitter, and is warm in nature. It enters the liver, spleen, stomach, and lung meridians, and can soothe the liver and regulate qi, and harmonize the stomach and relieve pain. Together, they are adjuvants in the prescription. The three drugs work together to assist the main drug in regulating qi and harmonizing the stomach.

[0041] The Western medicine pharmacological effects of each raw material in the Chinese medicine composition provided by the present invention are as follows:

[0042] Astragalus: It can strengthen the body's immunity and improve disease resistance to treat gastritis; it can remove toxins and promote tissue repair and healing, and has an auxiliary recovery effect on gastric mucosal damage; it can replenish qi, and it can improve symptoms such as loss of appetite and abdominal distension caused by spleen and stomach weakness. Astragalus contains astragalus polysaccharides, which can promote gastric mucosal repair and strengthen the gastric mucosal barrier.

[0043] Atractylodes macrocephala: Atractylodes macrocephala decoction can promote gastric emptying and small intestinal propulsion in mice, and can prevent and treat experimental gastric ulcers. Atractylodes macrocephala lactone I has the effects of enhancing salivary amylase activity, promoting nutrient absorption, and regulating gastrointestinal function. Atractylodes macrocephala has a significant inhibitory effect on gastric mucosal damage, reduces gastric acidity, and reduces the excretion of gastric acid and pepsin; it adjusts gastrointestinal function. When the stomach and intestines are in an excited state, Atractylodes macrocephala has a good inhibitory effect; and when the stomach and intestines are in an inhibited state, Atractylodes macrocephala can excite the stomach and intestines, thereby stimulating the normal activity of the stomach and intestines. The effect of Atractylodes macrocephala decoction on the activity of the isolated intestinal tract of rabbits is related to the functional state of the intestinal tract. The acetone extract of the anti-ulcer Atractylodes macrocephala was administered intragastrically, and it had a significant inhibitory effect on the gastric mucosal damage of rats caused by hydrochloric acid-ethanol.

[0044] Citrus aurantium: It has the effects of stimulating gastrointestinal smooth muscle, anti-inflammatory, and enhancing immunity. (1) Promoting the secretion of digestive juice: Citrus aurantium contains volatile oils and flavonoids, which can stimulate the gastric mucosa, increase the secretion of gastric acid and digestive enzymes, improve the digestion and absorption of food by increasing the activity of digestive juice, and relieve the symptoms of stagnation. (2) Enhancing gastrointestinal motility: The organic acids in Citrus aurantium can directly act on smooth muscle and have the effect of relaxing smooth muscle; Citrus aurantium has a certain therapeutic effect on symptoms such as gastrointestinal dysfunction and loss of appetite. (3) Anti-ulcer formation: Some alkaloids and flavonoids in Citrus aurantium have antioxidant and anti-inflammatory effects, which can reduce damage to the gastric mucosa. Citrus aurantium has a preventive and therapeutic effect on gastric ulcers. (4) Analgesic and antispasmodic: Some components in Citrus aurantium have a certain central nervous system inhibitory effect, which can relieve pain and muscle spasms.

[0045] Magnolia officinalis: The volatile oil components in Magnolia officinalis have anti-inflammatory, antibacterial, and antiviral effects, and can effectively relieve the inflammatory response of the gastric mucosa. At the same time, Magnolia officinalis can also promote gastrointestinal motility and improve the digestive function of the gastrointestinal tract, thereby relieving stomach discomfort symptoms such as bloating, stomach pain, nausea, and vomiting. Low doses of Magnolia officinalis decoction have an excitatory effect on the intestine. Both raw Magnolia officinalis and ginger products have anti-gastric ulcer effects, especially the latter. The main ingredient, magnolol, can treat duodenal spasm, inhibit excessive gastric acid secretion, protect the gastric mucosa, and inhibit the occurrence of gastric ulcers.

[0046] Dandelion: Dandelion has a certain inhibitory and killing effect on Helicobacter pylori infection. Dandelion contains unique nutritional active ingredients such as alcohol, choline, glucose, vitamins, etc., and also has a certain protective effect on the gastric mucosa.

[0047] Perilla: Exciting effect on gastric smooth muscle: Modern pharmacological studies have shown that most aromatic dehumidifying Chinese medicines have an excitatory effect on gastric smooth muscle. Studies have shown that Perilla increases the tension of the gastric fundus and gastric body muscle strips, among which the effect of increasing the gastric fundus is blocked by atropine and hexamethonium, respectively, while the effect of increasing the tension of the gastric body muscle strips is only blocked by hexamethonium. Further studies have shown that Perilla's effect of enhancing gastric smooth muscle is manifested through specific receptors, among which the effect of enhancing the tension of the gastric fundus muscle strips is mediated by cholinergic M and N receptors, respectively, and the effect of increasing the tension of the gastric body muscle strips is mediated by cholinergic N receptors.

[0048] Fritillaria thunbergii: It has anti-inflammatory, antibacterial, and gastric mucosal protective effects, and can relieve symptoms such as stomach pain, excessive gastric acid, and indigestion. Anti-ulcer effect: Studies have shown that Fritillaria thunbergii has a significant therapeutic effect on animal models. Further studies have shown that the alcohol extract of Fritillaria thunbergii can effectively inhibit the formation of water-induced stress ulcers and hydrochloric acid ulcers in mice.

[0049] Cuttlebone: (1) Neutralize gastric acid: Cuttlebone mainly contains calcium carbonate, as well as shell keratin, mucus, calcium phosphate, etc. It is generally believed that the neutralization of hydrochloric acid by calcium carbonate is the mechanism of action for preventing excessive gastric acid. However, cuttlebone polysaccharides also have the effect of neutralizing gastric acid. (2) Protect mucous membrane and resist ulcers: Studies have shown that cuttlebone polysaccharide CPS-1 can significantly increase the levels of epidermal growth factor (EGF) and platelet-derived growth factor (PDGF) in the blood of UC mice, accelerate the healing of ulcer tissue, and reduce the expression of tumor necrosis factor (TNF), thereby alleviating inflammation.

[0050] Bletilla striata: Promotes the repair of gastrointestinal mucosa Bletilla striata can promote the repair and healing of gastrointestinal mucosa and digestive tract ulcers, and protect the function of gastric mucosa. Studies have shown that Bletilla striata polysaccharides can reduce inflammatory cell infiltration and repair intestinal mucosal damage. Studies have shown that Bletilla striata polysaccharides can reduce inflammation, protect gastric mucosa and repair its tissue. In addition, Bletilla striata extract can enhance the antioxidant capacity of gastric mucosa, accelerate the proliferation of epithelial cells and the formation of new capillaries in the tissue around the ulcer, promote metabolism and wound healing, inhibit the growth of Helicobacter pylori, and alleviate postoperative ulcers and digestive tract symptoms.

[0051] Yuanhusuo: Yanhusuo alkaloids have the effects of anti-ulcer and inhibiting gastric acid secretion. Yanhusuo powder, Yanhusuo alkaloids, Yanhusuo A, B and C all have analgesic effects.

[0052] Chicken gizzard lining: It has the function of digestive enzymes, can also promote the secretion of digestive juices and regulate gastrointestinal motility. Chicken gizzard lining can also reduce gastric acid secretion in the human body and improve the phenomenon of increased gastric acid secretion caused by gastritis. In addition, studies have shown that chicken gizzard lining contains gastrin, keratin, trace amounts of pepsin and other ingredients, which can regulate gastrointestinal function and improve gastric mucosal motility.

[0053] Burnt malt: Burnt malt can help strengthen the spleen and stomach function and promote appetite. Burnt malt is rich in enzyme substances, which can promote the digestion and absorption of food and relieve indigestion. It has a convergence effect and can effectively relieve diarrhea symptoms, especially for chronic diarrhea caused by weak spleen and stomach. It can regulate gastrointestinal peristalsis and improve gastrointestinal dysfunction; it has a certain analgesic effect and can relieve the pain caused by stomach discomfort.

[0054] Buddha's hand: The extract of Buddha's hand may have antioxidant, anti-inflammatory and gastric mucosal protective properties. Buddha's hand has anti-inflammatory and analgesic effects. It also has a certain effect on the gastrointestinal tract, can promote the secretion of digestive juices, relieve duodenal spasms, and help relieve stomach pain and stomach spasm symptoms.

[0055] In some specific embodiments, in order to further improve the effects of improving gastrointestinal motility (i.e. promoting intestinal peristalsis), inhibiting Helicobacter pylori, protecting gastric mucosa and inhibiting excessive gastric acid secretion, the Chinese medicine composition is composed of the following raw materials in parts by mass: 10-20 parts of raw astragalus, 5-15 parts of white schizonepeta, 25-35 parts of dandelion, 15-25 parts of perilla, 10-20 parts of thunbergii, 15-25 parts of cuttlebone, 15-25 parts of raw atractylodes, 10-20 parts of stir-fried chicken gizzard lining, 25-30 parts of roasted malt, 5-15 parts of Corydalis yanhusuo, 5-15 parts of immature bitter orange, 5-15 parts of Magnolia officinalis and 10-20 parts of citron.

[0056] In some specific embodiments, in order to further improve the effects of improving gastrointestinal motility, inhibiting Helicobacter pylori, protecting gastric mucosa and inhibiting excessive gastric acid secretion, the Chinese medicine composition is composed of the following raw materials in parts by mass: 13-17 parts of raw astragalus, 8-12 parts of white schizonepeta, 27-33 parts of dandelion, 18-22 parts of perilla, 13-17 parts of thunbergii, 18-22 parts of cuttlebone, 18-22 parts of raw atractylodes, 13-17 parts of stir-fried chicken gizzard lining, 27-33 parts of roasted malt, 8-12 parts of Corydalis, 8-12 parts of Citrus aurantium, 8-12 parts of Magnolia officinalis and 13-17 parts of citron.

[0057] In some specific embodiments, in order to further improve the effects of improving gastrointestinal motility, inhibiting Helicobacter pylori, protecting gastric mucosa and inhibiting excessive gastric acid secretion, the Chinese medicine composition is composed of the following raw materials in parts by mass: 15 parts of raw astragalus, 10 parts of white schizonepeta, 30 parts of dandelion, 20 parts of perilla, 15 parts of thunbergii, 20 parts of cuttlebone, 20 parts of raw atractylodes, 15 parts of stir-fried chicken gizzard lining, 30 parts of roasted malt, 10 parts of Corydalis, 10 parts of Citrus aurantium, 10 parts of Magnolia officinalis and 15 parts of citron.

[0058] In a second aspect, the present invention provides a traditional Chinese medicine preparation, which is mainly made of the above-mentioned traditional Chinese medicine composition.

[0059] The traditional Chinese medicine preparation can significantly improve gastrointestinal motility and inhibit Helicobacter pylori. The use of the traditional Chinese medicine preparation can reduce the side effects caused by combined medication.

[0060] At the same time, the Chinese medicine preparation also has the effect of protecting the gastric mucosa and inhibiting excessive gastric acid secretion.

[0061] In some specific embodiments, the traditional Chinese medicine preparation is made of the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0062] In some specific embodiments, the pharmaceutically acceptable excipients include one or more of fillers, binders, disintegrants, lubricants, surfactants or flavoring agents, but are not limited thereto.

[0063] In some specific embodiments, the dosage form of the Chinese medicine preparation is decoction, pill, lozenge, tablet, granule, powder, paste or capsule, but not limited thereto.

[0064] In some specific embodiments, the dosage form of the Chinese medicine preparation is a decoction.

[0065] In a third aspect, the present invention provides a method for preparing the Chinese medicine preparation, comprising the following steps: mixing the raw materials with water and then boiling them to obtain a water decoction, i.e., a decoction.

[0066] The preparation method has the advantages of simple operation, easy implementation, short process and low cost.

[0067] It is understandable that the parameters such as the boiling temperature and time and the amount of water added may adopt any parameters commonly used in the art, and the present invention is not limited thereto.

[0068] In some specific embodiments, the decoction may be substituted for decoction.

[0069] In a fourth aspect, the present invention provides use of the Chinese medicine composition or the Chinese medicine preparation in the preparation of gastrointestinal medicine.

[0070] Among them, the gastrointestinal drugs include: drugs for relieving, assisting in the treatment of or treating chronic superficial gastritis; drugs for relieving, assisting in the treatment of or treating functional dyspepsia; drugs for promoting gastrointestinal motility; drugs for inhibiting Helicobacter pylori; drugs for protecting gastric mucosa; drugs for inhibiting excessive gastric acid secretion; drugs for promoting gastrointestinal motility and inhibiting Helicobacter pylori; drugs for protecting gastric mucosa and inhibiting excessive gastric acid secretion; drugs for promoting gastrointestinal motility and protecting gastric mucosa; drugs for inhibiting Helicobacter pylori and protecting gastric mucosa; drugs for promoting gastrointestinal motility and inhibiting excessive gastric acid secretion; or, drugs for promoting gastrointestinal motility, inhibiting excessive gastric acid secretion and protecting gastric mucosa.

[0071] That is, the uses of the Chinese medicine composition or Chinese medicine preparation provided by the present invention include: use in the preparation of drugs for relieving, assisting in the treatment or treating chronic superficial gastritis; use in the preparation of drugs for relieving, assisting in the treatment or treating functional dyspepsia; use in the preparation of drugs for promoting gastrointestinal motility; use in the preparation of drugs for inhibiting Helicobacter pylori; use in the preparation of drugs for protecting gastric mucosa; use in the preparation of drugs for inhibiting excessive gastric acid secretion; use in the preparation of drugs for promoting gastrointestinal motility and inhibiting Helicobacter pylori; use in the preparation of drugs for protecting gastric mucosa and inhibiting excessive gastric acid secretion; use in the preparation of drugs for promoting gastrointestinal motility and protecting gastric mucosa; use in the preparation of drugs for inhibiting Helicobacter pylori and protecting gastric mucosa; use in the preparation of drugs for promoting gastrointestinal motility and inhibiting excessive gastric acid secretion; and use in the preparation of drugs for promoting gastrointestinal motility, inhibiting excessive gastric acid secretion and protecting gastric mucosa.

[0072] The Chinese medicine composition or Chinese medicine preparation provided by the present invention can simultaneously achieve the effects of promoting gastrointestinal motility and inhibiting Helicobacter pylori, and also has the effects of protecting gastric mucosa and inhibiting excessive gastric acid secretion. The use of the Chinese medicine composition or Chinese medicine preparation to replace the combined use of Western medicine can reduce the adverse reactions caused by the combined use of Western medicine.

[0073] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be considered as limiting the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be obtained commercially.

[0074] Example 1

[0075] The Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 15 parts of raw astragalus, 10 parts of white ginseng, 30 parts of dandelion, 20 parts of perilla, 15 parts of thunbergia thunbergii, 20 parts of cuttlebone, 20 parts of raw atractylodes, 15 parts of stir-fried chicken gizzard lining, 30 parts of roasted malt, 10 parts of corydalis, 10 parts of immature bitter orange, 10 parts of Magnolia officinalis and 15 parts of citron.

[0076] Example 2

[0077] The Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 17 parts of raw astragalus, 12 parts of white ginseng, 33 parts of dandelion, 22 parts of perilla, 17 parts of thunbergia thunbergii, 22 parts of cuttlebone, 22 parts of raw atractylodes, 17 parts of stir-fried chicken gizzard lining, 33 parts of roasted malt, 12 parts of corydalis, 12 parts of immature bitter orange, 12 parts of Magnolia officinalis and 17 parts of citron.

[0078] Example 3

[0079] The Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 13 parts of raw astragalus, 8 parts of white schizonepeta, 27 parts of dandelion, 18 parts of perilla, 13 parts of thunbergia thunbergii, 18 parts of cuttlebone, 18 parts of raw atractylodes, 13 parts of stir-fried chicken gizzard lining, 27 parts of roasted malt, 8 parts of corydalis, 8 parts of immature bitter orange, 8 parts of Magnolia officinalis and 13 parts of citron.

[0080] Example 4

[0081] The Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 20 parts of raw astragalus, 5 parts of white ginseng, 25 parts of dandelion, 15 parts of perilla, 10 parts of thunbergia thunbergii, 15 parts of cuttlebone, 25 parts of raw atractylodes, 10 parts of stir-fried chicken gizzard lining, 25 parts of roasted malt, 5 parts of corydalis, 15 parts of immature bitter orange, 15 parts of Magnolia officinalis and 10 parts of citron.

[0082] Example 5

[0083] The Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 10 parts of raw astragalus, 15 parts of white schizonepeta, 35 parts of dandelion, 25 parts of perilla, 20 parts of thunbergia thunbergii, 25 parts of cuttlebone, 15 parts of raw atractylodes, 20 parts of stir-fried chicken gizzard lining, 30 parts of roasted malt, 15 parts of corydalis, 5 parts of immature bitter orange, 5 parts of Magnolia officinalis and 20 parts of citron.

[0084] Example 6

[0085] The Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 23 parts of raw astragalus, 20 parts of white ginseng, 20 parts of dandelion, 27 parts of perilla, 22 parts of thunbergia thunbergii, 27 parts of cuttlebone, 28 parts of raw atractylodes, 25 parts of stir-fried chicken gizzard lining, 20 parts of roasted malt, 20 parts of Corydalis, 17 parts of Citrus aurantium, 16 parts of Magnolia officinalis and 5-25 parts of citron.

[0086] Comparative Example 1

[0087] The composition of the Chinese medicine composition provided in this comparative example is basically the same as that of Example 1, except that raw astragalus is not added, and the mass fraction of raw atractylodes is replaced by 35 parts; at the same time, Corydalis yanhusuo is not added, and the mass fraction of Bletilla striata is replaced by 20 parts.

[0088] Comparative Example 2

[0089] The composition of the Chinese medicine composition provided in this comparative example is basically the same as that in Example 1, except that Magnolia officinalis is not added, and the mass portion of Citrus aurantium is replaced by 20 parts; at the same time, Fritillaria thunbergii is not added, and the mass portion of Cyperus rotundus is replaced by 35 parts.

[0090] Comparative Example 3

[0091] The composition of the Chinese medicine composition provided in this comparative example is basically the same as that of Example 1, except that no Citrus aurantium is added, and the mass portion of Magnolia officinalis is replaced by 20 parts; at the same time, no roasted malt is added, and the mass portion of stir-fried chicken gizzard lining is replaced by 45 parts.

[0092] Comparative Example 4

[0093] The Chinese medicine composition provided in this comparative example is composed of the following raw materials in parts by mass: 4 parts of raw astragalus, 25 parts of white ginseng, 10 parts of dandelion, 8 parts of perilla, 30 parts of thunbergia thunbergii, 7 parts of cuttlebone, 5 parts of raw atractylodes, 35 parts of stir-fried chicken gizzard lining, 10 parts of roasted malt, 2 parts of Corydalis, 25 parts of Citrus aurantium, 30 parts of Magnolia officinalis and 35 parts of citron.

[0094] Experimental Example 1: Effect of Promoting Intestinal Peristalsis

[0095] 1. Test materials

[0096] 1.1. Sample preparation information

[0097] The Chinese medicine compositions of the embodiments and comparative examples are respectively used to decoct decoctions, and the original liquid is sucked out and used directly when used.

[0098] Positive control: Metoclopramide® Domperidone Tablets, white tablets, batch number NBJ6613, Xi'an Janssen Pharmaceutical Co., Ltd., solvent is DMSO.

[0099] 1.2. Experimental animals

[0100] Zebrafish were kept in aquaculture water at 28°C (water quality: 200 mg instant sea salt was added to 1 L of reverse osmosis water, conductivity was 450-550 μS / cm; pH was 6.5-8.5; hardness was 50-100 mg / L CaCO 3 ), bred and provided by a fish farming center, the experimental animal use license number is: SYXK (Zhejiang) 2022-0004, the breeding and management complies with the requirements of the international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2024-9952-01.

[0101] 1.3. Instruments, consumables and reagents

[0102] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Bellambo Biotechnology Co., Ltd., China); electric focus continuous zoom fluorescence microscope (AZ100, Nikon, Japan); 150mm×25mm culture dish (OrangeScientific, Belgium); fully automatic sample rapid grinding machine (JXFSTPRP-24L, Shanghai Jingxin Experimental Equipment Technology Department, China).

[0103] Dimethyl sulfoxide (DMSO, batch number I2229063, Shanghai Aladdin Biochemical Technology Co., Ltd., China); Nile red (batch number SLBP9326V, Sigma, India); methylcellulose (batch number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China).

[0104] 2. Detection Method

[0105] Maximum detectable concentration (MTC) determination

[0106] Wild-type AB strain zebrafish 5 days post-fertilization (5 dpf) were randomly selected and Nile red was administered in water as a fluorescent indicator of intestinal contents. Nile red was eluted after feeding for 16 hours, and zebrafish were randomly assigned to 6-well plates, with 30 zebrafish treated in each well (experimental group). The decoction of Example 1 was administered in water to the samples (concentrations shown in Table 1), and a normal control group was set up at the same time, with a capacity of 3 mL per well. After treatment at 28°C for 1 day, the MTC of the samples on normal zebrafish was measured.

[0107] 2.2. Evaluation of intestinal motility efficacy

[0108] 5 dpf wild-type AB strain zebrafish were randomly selected and administered with water-soluble Nile red as a fluorescent indicator of intestinal contents. Nile red was eluted after 16 h of feeding, and the zebrafish were randomly distributed into 6-well plates, with 30 zebrafish treated in each well (experimental group). The decoctions of each embodiment and each comparative example were dissolved in water and administered to the samples (concentrations are shown in Table 2), with a positive control concentration of domperidone of 87.5 µg / mL. A normal control group was also set up with a capacity of 3 mL per well. After treatment at 28°C for 1 day, 10 zebrafish were randomly selected from each group and photographed under a fluorescence microscope and the images were saved. The images were analyzed and collected using NIS-Elements D 3.20 advanced image processing software, and the fluorescence intensity of the zebrafish intestine was analyzed. The statistical analysis results of this indicator were used to evaluate the intestinal motility efficacy of the samples. The statistical processing results are expressed as mean±SE. SPSS 26.0 software was used for statistical analysis. P <0.05 indicated that the difference was statistically significant.

[0109] 3. Test results

[0110] 3.1. MTC

[0111] Under the experimental conditions, the maximum detection concentration (MTC) of the decoction of the Chinese medicine composition in Example 1 for promoting intestinal peristalsis is 62.5 μL / mL. See Table 1 for details.

[0112] Table 1. Results of the concentration exploration experiment on the intestinal motility effect of samples (n=30)

[0113]

[0114] 3.2. Evaluation of intestinal motility efficacy

[0115] Under the experimental conditions, the decoctions of the Chinese medicine compositions in each example all have the effect of promoting intestinal peristalsis, as shown in Table 2 for details.

[0116] Table 2 Results of the intestinal motility evaluation test of samples (n=10)

[0117]

[0118] Compared with the normal control group,* P <0.01,*** P <0.001.

[0119] Compared with the positive control group, P <0.01,### P <0.001.

[0120] Compared with the 62.5 μg / mL group in Example 1, P <0.001.

[0121] As shown in Table 2, after being treated with the decoctions of the embodiments, the fluorescence intensity of the zebrafish intestine decreased significantly compared with the normal control group, indicating that the Chinese medicine composition provided by the present invention can promote intestinal peristalsis.

[0122] At the same time, the intestinal fluorescence intensity of zebrafish treated with samples with a concentration of 62.5 μg / mL after the decoctions of each embodiment were dissolved in water was significantly lower than that of zebrafish treated with the positive drug domperidone, indicating that the effect of the Chinese medicine composition provided by the present invention in promoting intestinal peristalsis is significantly stronger than that of 87.5 μg / mL domperidone.

[0123] In addition, the fluorescence intensity of the zebrafish intestine treated with samples having a concentration of 62.5 μg / mL after the decoction of Example 1 was dissolved in water was significantly lower than the fluorescence intensity of the zebrafish intestine treated with samples having a concentration of 62.5 μg / mL after the decoction of Comparative Example 1 was dissolved in water, indicating that the raw materials in the traditional Chinese medicine composition provided by the present invention have a synergistic effect, and controlling the ratio of the raw materials is beneficial to further promote intestinal peristalsis.

[0124] Among them, the typical graph of zebrafish intestinal fluorescence intensity after the decoction water solution in Example 1 was administered to the sample for treatment is shown in Figure 1 As shown, Figure 1 The yellow dotted line area in the middle is the zebrafish intestinal analysis area. Figure 2 shown.

[0125] Experimental Example II Anti-Helicobacter pylori Efficacy

[0126] 1. Test materials

[0127] 1.1. Sample preparation information

[0128] The Chinese medicine compositions of the embodiments and comparative examples are respectively used to decoct decoctions, and the original liquid is sucked out and used directly when used.

[0129] Positive control: clarithromycin, white powder, batch number E1529013, Shanghai Aladdin Biochemical Technology Co., Ltd. The solvent is DMSO.

[0130] 1.2. Experimental animals and bacteria

[0131] Zebrafish were kept in aquaculture water at 28°C (water quality: 200 mg instant sea salt was added to 1 L of reverse osmosis water, conductivity was 450-550 μS / cm; pH was 6.5-8.5; hardness was 50-100 mg / L CaCO 3 ), bred and provided by a fish farming center, the experimental animal use license number is: SYXK (Zhejiang) 2022-0004, the breeding and management complies with the requirements of the international AAALAC certification (certification number: 001458), IACUC ethics review number: IACUC-2024-9952-01.

[0132] Helicobacter pylori, Helicobacter pylori medium (7 mL of sterile defibrinated sheep blood and 1 tube of Helicobacter pylori supplement per 100 mL), microaerophilic, 37°C, 150 rpm shaking culture.

[0133] 1.3. Instruments, consumables and reagents

[0134] Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); precision electronic balance (CP214, OHAUS, USA); 6-well plate (Zhejiang Bellanbo Biotechnology Co., Ltd., China); electric focus continuous zoom fluorescence microscope (AZ100, Nikon, Japan); constant temperature oscillator (HZ-9211K, Taicang Hualida Experimental Equipment Co., Ltd., China); vertical laminar flow clean bench (CA-1390-1, Shanghai Shangjing Purification Equipment Co., Ltd., China); desktop large-capacity low-speed centrifuge (TD5A, Changsha Yingtai Instrument Co., Ltd., China).

[0135] Methylcellulose (Batch No. C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); dimethyl sulfoxide (DMSO, Batch No. BCCD8942, Sigma, Switzerland); Helicobacter pylori culture medium (liquid) (Batch No. 20230823, Qingdao High-tech Industrial Park Haibo Biotechnology Co., Ltd., China); defibrinated sheep blood (Batch No. 20240813, Haibo Biotechnology Co., Ltd., China); Helicobacter pylori additive (Batch No. 20240617, Haibo Biotechnology Co., Ltd., China); CM-DiI (Batch No. 2335589, Thermo Fisher Scientific (China) Co., Ltd., China).

[0136] 2. Detection Methods

[0137] 3 dpf wild-type AB strain zebrafish were randomly selected in a 6-well plate, and 30 zebrafish were treated in each well. The decoctions of each embodiment and each comparative example were dissolved in water and administered to the samples (concentrations are shown in Table 3), the positive control group had a clarithromycin concentration of 125 μg / mL, and a model control group was set up at the same time, with a volume of 3 mL per well. After treatment at 28°C for 48 hours, all groups were added with 5×10 7 CFU / mL Helicobacter pylori was used to establish a zebrafish Helicobacter pylori infection model. After 24 hours of treatment at 28°C, 10 zebrafish were randomly selected from each group and photographed under a fluorescence microscope and the images were saved. NIS-Elements D 3.20 advanced image processing software was used to collect data and analyze the fluorescence intensity of Helicobacter pylori in the zebrafish gastrointestinal tract. The statistical results of this indicator were used to evaluate the anti-Helicobacter pylori efficacy of the sample. The statistical processing results were expressed as mean±SE. SPSS 26.0 software was used for statistical analysis. P <0.05 indicated that the difference was statistically significant.

[0138] 3. Test results

[0139] Under the experimental conditions, the decoctions of the Chinese medicine compositions in each example all have anti-Helicobacter pylori efficacy, as shown in Table 3 for details.

[0140] Table 3. Results of the sample anti-Helicobacter pylori efficacy evaluation experiment (n=10)

[0141]

[0142] Compared with the model control group,*** P <0.001.

[0143] Compared with the positive control clarithromycin group, ### P <0.001.

[0144] Compared with the 62.5 μg / mL group in Example 1, P <0.001. As shown in Table 3, after being treated with the decoctions of the examples, the fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish decreased significantly compared with the model control group, indicating that the Chinese medicine composition provided by the present invention can promote intestinal peristalsis.

[0145] At the same time, the fluorescence intensity of the zebrafish intestine treated with samples with a concentration of 62.5 μg / mL after the decoctions of each embodiment were dissolved in water was significantly lower than the fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish treated with clarithromycin, indicating that the effect of the Chinese medicine composition provided by the present invention in promoting intestinal peristalsis is significantly stronger than that of 125 μg / mL clarithromycin.

[0146] In addition, the fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish treated with samples having a concentration of 62.5 μg / mL after the decoction of Example 1 was dissolved in water, which was significantly lower than the fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish treated with samples having a concentration of 62.5 μg / mL after the decoction of Comparative Example 1 was dissolved in water, indicating that the raw materials in the traditional Chinese medicine composition provided by the present invention have a synergistic effect, and controlling the ratio of the raw materials is beneficial to inhibiting Helicobacter pylori.

[0147] The typical fluorescence intensity of Helicobacter pylori in the gastrointestinal tract of zebrafish after the decoction water solution of Example 1 was administered to the sample for treatment is shown in FIG. Figure 3 As shown, Figure 3 The yellow dotted line area in the middle is the zebrafish gastrointestinal tract analysis area. Example 1 Decoction water solution after zebrafish gastrointestinal Helicobacter pylori fluorescence intensity comparison diagram see Figure 4 shown.

[0148] In summary, the Chinese medicine composition provided by the present invention has the effects of promoting intestinal peristalsis (i.e. promoting gastrointestinal motility) and inhibiting Helicobacter pylori, and also has the effects of protecting gastric mucosa and inhibiting excessive gastric acid secretion.

[0149] Although the present invention has been illustrated and described with specific embodiments, it should be appreciated that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Those skilled in the art should understand that the technical solutions described in the above embodiments may be modified, or some or all of the technical features thereof may be replaced by equivalents without departing from the spirit and scope of the present invention. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. Therefore, this means that all such replacements and modifications within the scope of the present invention are included in the appended claims.

Claims

1. A Chinese medicine composition, characterized in that: The invention is prepared from the following raw materials by weight: 5-25 parts of raw astragalus, 3-20 parts of bletilla, 20-40 parts of dandelion, 10-30 parts of perilla, 5-25 parts of thunbergia, 10-30 parts of cuttlebone, 10-30 parts of raw atractylodes, 5-25 parts of stir-fried chicken gizzard lining, 20-40 parts of roasted malt, 3-20 parts of corydalis, 3-20 parts of immature bitter orange, 3-20 parts of magnolia bark and 5-25 parts of citron; The traditional Chinese medicine composition is used for promoting gastrointestinal motility, inhibiting Helicobacter pylori, protecting gastric mucosa and inhibiting excessive gastric acid secretion.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by mass: 10-20 parts of raw astragalus, 5-15 parts of bletilla striata, 25-35 parts of dandelion, 15-25 parts of perilla frutescens, 10-20 parts of thunbergia thunbergii, 15-25 parts of cuttlebone, 15-25 parts of raw atractylodes macrocephala, 10-20 parts of stir-fried chicken gizzard lining, 25-30 parts of roasted malt, 5-15 parts of corydalis, 5-15 parts of immature bitter orange, 5-15 parts of magnolia bark and 10-20 parts of citron.

3. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by mass: 13-17 parts of raw astragalus, 8-12 parts of bletilla striata, 27-33 parts of dandelion, 18-22 parts of perilla frutescens, 13-17 parts of thunbergia thunbergii, 18-22 parts of cuttlebone, 18-22 parts of raw atractylodes macrocephala, 13-17 parts of stir-fried chicken gizzard lining, 27-33 parts of roasted malt, 8-12 parts of corydalis, 8-12 parts of immature bitter orange, 8-12 parts of magnolia bark and 13-17 parts of citron.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by mass: 15 parts of raw astragalus, 10 parts of white twig, 30 parts of dandelion, 20 parts of perilla, 15 parts of thunbergia thunbergii, 20 parts of cuttlebone, 20 parts of raw atractylodes, 15 parts of stir-fried chicken gizzard lining, 30 parts of roasted malt, 10 parts of corydalis, 10 parts of immature bitter orange, 10 parts of magnolia bark and 15 parts of citron.

5. A Chinese medicine preparation, characterized in that: The method is mainly prepared from the Chinese medicine composition as described in any one of claims 1 to 4.

6. The Chinese medicine preparation according to claim 5, characterized in that: The traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

7. The Chinese medicine preparation according to claim 5, characterized in that: The dosage form of the Chinese medicine preparation is decoction, pill, lozenge, tablet, granule, powder, paste or capsule.

8. The Chinese medicine preparation according to claim 5, characterized in that: The dosage form of the Chinese medicine preparation is decoction.

9. The method for preparing the Chinese medicine preparation according to claim 5, characterized in that: The following steps are involved: The raw materials are mixed with water and boiled to obtain a decoction.

10. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine preparation according to any one of claims 5 to 8 in the preparation of drugs for promoting gastrointestinal motility, inhibiting Helicobacter pylori, protecting gastric mucosa and inhibiting excessive gastric acid secretion.

Citation Information

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