Traditional Chinese medicine composition for treating sour regurgitation and / or heartburn

Abstract

The invention provides a traditional Chinese medicine composition which is prepared from bulk drugs or extracts thereof, and the bulk drugs comprise the following components in parts by weight: 200-600 parts of rhizoma bletillae, 25-75 parts of clove, 100-300 parts of cuttlebone, 25-75 parts of raw rhubarb and 25-75 parts of red halloysite. The components in the traditional Chinese medicine composition are scientifically proportioned, the synergistic effect of the medicinal materials is achieved, the symptoms of sour regurgitation and heartburn can be rapidly relieved, meanwhile, the spleen and the stomach are harmonized, and the normal function of the gastrointestinal tract is recovered. The traditional Chinese medicine composition is safe, effective and small in side effect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating acid reflux and / or heartburn. Background Art

[0002] Acid reflux and heartburn are common symptoms in the digestive system. Acid reflux refers to the feeling that the gastric contents (including food, gastric acid, bile, etc.) rush into the pharynx or oral cavity without nausea and without exertion. This feeling is usually accompanied by a sour or burning sensation and is a common symptom in the digestive system. Heartburn usually presents as a burning sensation in the stomach or behind the sternum, and this feeling may be caused by excessive gastric acid irritating the gastric mucosa. Acid reflux and heartburn may be caused by various reasons, such as gastroesophageal reflux disease (GERD), gastritis, peptic ulcer (PUD), etc., and may also be related to non-pathological factors such as improper diet and drug stimulation. As a common and characteristic manifestation of digestive tract diseases, heartburn and acid reflux significantly reduce the quality of life of patients. According to the literature, the incidence of acid reflux in patients with GERD is as high as 96%, and the heartburn symptom has a specificity of 89%. This data highlights the high incidence of acid reflux and heartburn symptoms and their importance in clinical practice. The chronic inflammatory state of the stomach and esophagus caused by acid reflux and heartburn has been proven to be the most important risk factor for esophageal adenocarcinoma and gastric cancer.

[0003] Acid reflux and heartburn are indeed recorded in traditional Chinese medicine classics, such as "vomiting acid", "swallowing acid", "pharyngeal acid", "vinegar heart", "heat in the epigastrium", "heart heat like fire", "stomach like being burned", "stomach like having fire", "epigastric pain and fever", "heat in the chest", "body heat like fire", etc. From the perspective of traditional Chinese medicine theory, the symptoms of acid reflux and heartburn mostly originate from inducements such as exogenous six pathogenic factors, excessive diet, and emotional disorders. Specifically, liver qi stagnation, spleen transportation disorder, and the obstruction of the descending function of the stomach lead to the failure of the clear yang to rise and the turbid yin to descend, and finally the stomach qi reverses upward, thus triggering the above-mentioned symptoms.

[0004] At present, the main treatment methods for acid reflux and heartburn are mainly drug treatments, including acid suppressants, mucosal protectants, and gastrointestinal motility agents. Currently, acid suppressant drugs, especially proton pump inhibitors (PPIs), are used as the first-line treatment plan. Acid suppressant drugs mainly include PPIs, H2 receptor antagonists (H2RAs), and potassium ion-competitive acid blockers (P-CABs). However, due to factors such as poor patient compliance, non-acid reflux, and esophageal hypersensitivity, about 30% of patients have poor symptom control after standardized PPI treatment, resulting in more stubborn and difficult-to-treat symptoms. In addition, long-term use of PPI treatment may increase the risk of infection, fractures, tumors, organ damage, and cognitive dysfunction. Therefore, the development of new drugs is imminent. Although there are many studies on related drugs, as of now, there are still no FDA-approved effective drugs in clinical treatment. Commonly used Western medicines have limitations such as a single action target, being unsuitable for long-term medication, and low safety. Traditional Chinese medicine treatment has obvious effects, few adverse reactions, and multiple action targets, and has gradually become a popular field in the research of new drugs for treating acid reflux and heartburn symptoms. Summary of the Invention

[0005] To solve the above problems existing in the prior art in this field, the inventor of the present invention originated from traditional Chinese medicine theory, summarized the experiences of multiple parties, and made the present invention.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition, which is made from raw medicinal materials or their extracts. By weight, the raw medicinal materials include 200-600 parts of Bletilla striata, 25-75 parts of Eugenia caryophyllata, 100-300 parts of Sepia seu cuttlebone, 25-75 parts of Rheum palmatum, and 25-75 parts of Halloysitum rubrum.

[0007] In some embodiments, the raw medicinal materials include 300-500 parts of Bletilla striata, 40-60 parts of Eugenia caryophyllata, 150-250 parts of Sepia seu cuttlebone, 40-60 parts of Rheum palmatum, and 40-60 parts of Halloysitum rubrum.

[0008] In some embodiments, the raw medicinal materials include 350-450 parts of Bletilla striata, 45-55 parts of Eugenia caryophyllata, 175-225 parts of Sepia seu cuttlebone, 45-55 parts of Rheum palmatum, and 45-55 parts of Halloysitum rubrum.

[0009] In some embodiments, the raw medicinal materials include any one form of dry medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, and processed medicinal materials.

[0010] In some embodiments, the raw medicinal materials include any one of natural medicinal materials and natural medicinal material equivalent substitutes.

[0011] In some embodiments, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0012] In some embodiments, the pharmaceutically acceptable excipients include at least one of a filler, a disintegrant, a diluent, a lubricant, a binder, a wetting agent, a flavoring agent, a suspending agent, a solvent, a sustained release agent, an emulsifier, a vegetable oil, an absorption enhancer, a surfactant or a preservative.

[0013] In some embodiments, the dosage form of the traditional Chinese medicine composition includes any one of a decoction, tablets, capsules, granules, pills, oral liquids, powders or ointments.

[0014] In some embodiments, the extract includes an extract obtained by extracting the raw medicinal materials after mixing, and / or an extract obtained by separately extracting the raw medicinal materials and then mixing.

[0015] The second aspect of the present invention provides the use of the traditional Chinese medicine composition of the first aspect in the preparation of a medicament for treating acid reflux and / or heartburn.

[0016] The beneficial effects of the present invention are as follows:

[0017] In the traditional Chinese medicine composition of the present invention, the components are scientifically proportioned to exert the synergistic effect of each medicinal material, and can quickly relieve the symptoms of acid reflux and heartburn, while regulating the spleen and stomach and restoring the normal function of the gastrointestinal tract. The traditional Chinese medicine composition of the present invention is safe, effective and has few side effects: the traditional Chinese medicine composition of the present invention uses natural medicinal materials without chemical additives and has high safety; at the same time, the synergistic effect between the medicinal materials makes the curative effect of the preparation more definite and the side effects are small. Description of the Drawings

[0018] Figure 1 Shows the pathological morphological changes of the gastric tissues of rats in each group (HE staining, 100×), where A, B, C, D, E, and F are the sham operation group, the model group, the acid suppression formula group, the Zhuchen acid suppression formula group, the Poria acid suppression formula group, and the positive drug group, respectively.

[0019] Figure 2 Shows the comparison of the serum IL-1β, TNF-α and IL-6 levels of rats in each group. Among them, compared with the sham operation group, #p < 0.0001; compared with the model group, ****P < 0.0001. Detailed Embodiments

[0020] The content of the present invention will be further described in detail through specific examples below. Unless otherwise specified, the raw materials, reagents or devices used in the examples can be obtained from conventional commercial channels or can be obtained by existing technical methods. Unless otherwise specified, the test or measurement methods are all conventional methods in the art.

[0021] In the first aspect of the present invention, a traditional Chinese medicine composition is provided. The traditional Chinese medicine composition is made from raw medicinal materials or their extracts. By weight, the raw medicinal materials include 200 - 600 parts of Bletilla striata, 25 - 75 parts of Eugenia caryophyllata, 100 - 300 parts of Sepia seu Sepiellae, 25 - 75 parts of Rheum palmatum, and 25 - 75 parts of Halloysitum rubrum.

[0022] In traditional Chinese medicine theory, the symptoms of acid reflux and heartburn are often regarded as caused by disharmony of the spleen and stomach functions and disharmony of stomach qi. Although there is no direct disease name for acid reflux and heartburn in ancient Chinese medical classics, according to their symptom manifestations, they can be classified into the categories of "acid regurgitation", "noisy sensation" and so on. "Plain Questions - Treatise on the Most Important Principles in Treating Diseases" states: "All vomiting of acid, sudden diarrhea with a bearing-down sensation are due to heat." It points out that the symptom of acid reflux is mostly related to stomach heat. And "Miraculous Pivot - Channels" also mentions: "The Spleen Meridian of Foot - Taiyin... when it is abnormal, it will cause diseases... vomiting when eating." It implies that abnormal spleen and stomach functions can cause symptoms such as vomiting, including acid reflux. When the spleen fails to ascend the clear qi, the stomach fails to descend the turbid qi, and the clear and turbid qi are in disorder, and the pivotal mechanism of the middle - jiao cannot function properly, thus symptoms such as heartburn, vomiting acid water and salivation will occur. In the treatment of acid reflux and heartburn, traditional Chinese medicine emphasizes syndrome differentiation and treatment, with the key points being to regulate the spleen and stomach, clear heat and lower adverse qi, and astringe and control acid. The formula of the present invention selects five medicinal materials, namely Bletilla striata, Eugenia caryophyllata, Sepia seu Sepiellae, Rheum palmatum, and Halloysitum rubrum, aiming to achieve the above - mentioned treatment principles for the pathogenesis of acid reflux and heartburn.

[0023] Bletilla striata: Bitter, sweet, astringent, slightly cold. It belongs to the lung, liver and stomach meridians. It has the functions of arresting bleeding with astringents, detumescence and promoting granulation. It is used for hemoptysis, hematemesis, traumatic bleeding, sores and ulcers, and skin chaps. It is the dried tuber of the orchid plant Bletilla striata (Thunb.) Reichb.f.

[0024] Eugenia caryophyllata: Pungent, warm. It belongs to the spleen, stomach, lung and kidney meridians. It has the functions of warming the middle - jiao to arrest vomiting, tonifying the kidney and assisting yang. It is used for deficiency - cold of the spleen and stomach, hiccups and vomiting, anorexia and diarrhea, cold pain in the epigastrium and abdomen, and impotence due to kidney deficiency. It is the dried flower bud of the myrtle plant Eugenia caryophyllata Thunb.

[0025] Sepia seu Sepiellae: Salty, astringent, warm. It belongs to the spleen and kidney meridians. It has the functions of arresting bleeding with astringents, astringing essence and arresting leucorrhea, controlling acid and relieving pain, and astringing dampness and promoting granulation. It is used for hematemesis and epistaxis, metrorrhagia and metrostaxis, hematochezia, spermatorrhea and emission, leukorrhea with red and white discharge, stomachache with acid regurgitation; externally for traumatic bleeding, eczema and moist sores, and non - healing ulcers. It is the dried inner shell of the cuttlefish Sepiella maindroni de Rochebrune or Sepia esculenta Hoyle of the cuttlefish family.

[0026] Raw rhubarb: bitter, cold. It enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has the function of purging and attacking stagnation, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and removing dampness and jaundice. It is used for constipation due to excess heat accumulation, vomiting and bleeding due to blood heat, red eyes and swollen throat, carbuncle and furuncle, abdominal pain due to intestinal carbuncle, amenorrhea due to blood stasis, postpartum stasis, traumatic injury, damp-heat dysentery, jaundice and red urine, stranguria, edema; external treatment for burns and scalds. It is the dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim.ex Balf., or Rheumofficinale Baill., plants of the Polygonaceae family.

[0027] Red ochre: sweet, sour, astringent, warm. Enters the large intestine and stomach meridians. Astringes the intestines, stops bleeding, promotes tissue regeneration and heals sores. Used for chronic diarrhea, dysentery, hemorrhage, metrorrhagia and leukorrhea; external treatment of long-term ulcers that do not heal, wet sores with pus. It is a silicate mineral of the kaolinite family, mainly containing tetrahydrate aluminum silicate [Al4(Si4O 10 )(OH)8·4H2O〕.

[0028] The Chinese medicine composition of the present invention draws on the clinical essence of Liu's Cold Damage School in Yanjing, and integrates modern medical concepts. It reuses Bletilla striata to protect the gastric mucosa and reduce gastric acid stimulation with its astringent and hemostatic, swelling-reducing and muscle-generating functions; it is supplemented with cloves, which harmonize the stomach qi, warm the middle and reduce adverse reactions; it uses sea cucumber to suppress acid and relieve pain, neutralize gastric acid, and reduce the stimulation of gastric acid on the gastric mucosa; it is supplemented with raw rhubarb to take its heat-clearing and fire-purging power; and it uses red ochre to astringe and consolidate, synergistically protect the gastric mucosa and accelerate its repair process. While targeting the root cause of excessive gastric acid, it also protects the symptoms of the gastric mucosa, achieves both symptomatic and root treatment, and achieves a comprehensive conditioning effect. The Chinese medicine composition was verified by the reflux esophageal rat model to significantly improve the pathological conditions of the esophagus in the model group rats and significantly reduce the levels of IL-1β, TNF-α and IL-6 in the rat serum. Clinically verified, this Chinese medicine composition can not only quickly relieve patients' acid reflux, heartburn and other symptoms, but also promote the repair and regeneration of gastric mucosa, thereby achieving both symptomatic and root cause treatment of related diseases, with a clinical efficacy of up to 95%.

[0029] In the present invention, weight parts can be any fixed weight expressed in milligrams, grams or kilograms (such as 1mg, 1g, 2g or 1kg, etc.). For example, a Chinese medicine composition consisting of 1 weight part of component a and 9 weight parts of component b can be a Chinese medicine composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the Chinese medicine composition, the percentage content of a component = (weight parts of the component / sum of weight parts of all components) × 100%, therefore, in the Chinese medicine composition consisting of 1 weight part of component a and 9 weight parts of component b, the content of component a is 10%, and the content of component b is 90%.

[0030] In some embodiments, the bulk drug ingredient comprises 300 - 500 parts of Bletilla striata, 40 - 60 parts of Flos Caryophylli, 150 - 250 parts of Endoconcha Sepiae, 40 - 60 parts of Rheum officinale, and 40 - 60 parts of Halloysitum Rubrum.

[0031] In some embodiments, the bulk drug ingredient comprises 350 - 450 parts of Bletilla striata, 45 - 55 parts of Flos Caryophylli, 175 - 225 parts of Endoconcha Sepiae, 45 - 55 parts of Rheum officinale, and 45 - 55 parts of Halloysitum Rubrum.

[0032] In some embodiments, the bulk drug ingredient consists of 200 - 600 parts of Bletilla striata, 25 - 75 parts of Flos Caryophylli, 100 - 300 parts of Endoconcha Sepiae, 25 - 75 parts of Rheum officinale, 25 - 75 parts of Halloysitum Rubrum, 100 - 300 parts of Atractylodes macrocephala, and 100 - 300 parts of Pericarpium Citri Reticulatae.

[0033] In some embodiments, the bulk drug ingredient consists of 300 - 500 parts of Bletilla striata, 40 - 60 parts of Flos Caryophylli, 150 - 250 parts of Endoconcha Sepiae, 40 - 60 parts of Rheum officinale, 40 - 60 parts of Halloysitum Rubrum, 150 - 250 parts of Atractylodes macrocephala, and 150 - 250 parts of Pericarpium Citri Reticulatae.

[0034] In some embodiments, the bulk drug ingredient consists of 350 - 450 parts of Bletilla striata, 45 - 55 parts of Flos Caryophylli, 175 - 225 parts of Endoconcha Sepiae, 45 - 55 parts of Rheum officinale, 45 - 55 parts of Halloysitum Rubrum, 175 - 225 parts of Atractylodes macrocephala, and 175 - 225 parts of Pericarpium Citri Reticulatae.

[0035] Atractylodes macrocephala: Warm in nature, sweet and bitter in taste. It acts on the spleen meridian and stomach meridian. It is the rhizome of the plant Atractylodes macrocephala Koidz. of the Compositae family.

[0036] Pericarpium Citri Reticulatae: Bitter, pungent, warm. It acts on the lung and spleen meridians. It is the dried ripe pericarp of the plant Citrus reticulata Blanco of the Rutaceae family and its cultivated varieties.

[0037] In some embodiments, the bulk drug ingredient consists of 200 - 600 parts of Bletilla striata, 25 - 75 parts of Flos Caryophylli, 100 - 300 parts of Endoconcha Sepiae, 25 - 75 parts of Rheum officinale, 25 - 75 parts of Halloysitum Rubrum, and 200 - 600 parts of Poria cocos.

[0038] In some embodiments, the bulk drug ingredient consists of 300 - 500 parts of Bletilla striata, 40 - 60 parts of Flos Caryophylli, 150 - 250 parts of Endoconcha Sepiae, 40 - 60 parts of Rheum officinale, 40 - 60 parts of Halloysitum Rubrum, and 300 - 500 parts of Poria cocos.

[0039] In some embodiments, the active pharmaceutical ingredient is composed of 350 - 450 parts of Bletilla striata, 45 - 55 parts of Eugenia caryophyllata, 175 - 225 parts of Endoconcha Sepiae, 45 - 55 parts of Rheum officinale, 45 - 55 parts of Halloysitum rubrum, and 350 - 450 parts of Poria cocos.

[0040] Poria cocos: sweet, light, neutral. It acts on the heart, lung, spleen, and kidney meridians. It is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf of the family Polyporaceae.

[0041] In some embodiments, the active pharmaceutical ingredient is composed of Bletilla striata, Eugenia caryophyllata, Endoconcha Sepiae, Rheum officinale, and Halloysitum rubrum.

[0042] In some embodiments, the active pharmaceutical ingredient is composed of 200 - 600 parts of Bletilla striata, 25 - 75 parts of Eugenia caryophyllata, 100 - 300 parts of Endoconcha Sepiae, 25 - 75 parts of Rheum officinale, and 25 - 75 parts of Halloysitum rubrum.

[0043] In some embodiments, the active pharmaceutical ingredient is composed of 300 - 500 parts of Bletilla striata, 40 - 60 parts of Eugenia caryophyllata, 150 - 250 parts of Endoconcha Sepiae, 40 - 60 parts of Rheum officinale, and 40 - 60 parts of Halloysitum rubrum.

[0044] In some embodiments, the active pharmaceutical ingredient is composed of 350 - 450 parts of Bletilla striata, 45 - 55 parts of Eugenia caryophyllata, 175 - 225 parts of Endoconcha Sepiae, 45 - 55 parts of Rheum officinale, and 45 - 55 parts of Halloysitum rubrum.

[0045] In the present invention, the active pharmaceutical ingredient refers to the Chinese medicinal materials used as the active ingredients in the traditional Chinese medicine composition of the present invention. The Chinese medicinal materials may include various forms. For example, the Chinese medicinal materials include (but are not limited to) dried medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, processed medicinal materials, or combinations thereof.

[0046] The active pharmaceutical ingredient in the present invention can be natural - sourced Chinese medicinal materials or equivalent substitutes for natural - sourced Chinese medicinal materials. In some embodiments, the traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

[0047] In some embodiments, the pharmaceutically acceptable excipients include at least one of fillers, disintegrants, diluents, lubricants, binders, wetting agents, flavoring agents, suspending agents, solvents, sustained - release agents, emulsifiers, vegetable oils, absorption promoters, surfactants, or preservatives.

[0048] In some embodiments, the filler is selected from at least one of starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose or glucose; the disintegrant is selected from at least one of corn starch, potato starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, carboxymethyl cellulose, cross-linked sodium carboxymethyl cellulose, calcium carboxymethyl cellulose and alginic acid; the diluent is selected from at least one of lactose, sucrose, mannitol, corn starch, potato starch, calcium phosphate, calcium citrate and crystalline cellulose; the lubricant is selected from at least one of stearic acid, polyethylene glycol, calcium carbonate, sodium bicarbonate, colloidal silica, talc, anhydrous silica and magnesium stearate; the binder is selected from at least one of cellulose derivatives, alginates, starch, water, dextrin, gelatin, hydroxypropyl cellulose, methyl cellulose or polyvinylpyrrolidone; the wetting agent is selected from at least one of glycerol, Tween-80, oxyhydrogenated castor oil, sodium dodecyl sulfate and lecithin; the flavoring agent is selected from at least one of aspartame, sucralose, essence, steviol glycosides, acesulfame potassium, citric acid and sodium saccharin; the suspending agent is selected from at least one of colloidal silica, beeswax, cellulose, sodium carboxymethyl cellulose and solid polyethylene glycol; the solvent is selected from at least one of water, ethanol, liquid polyethylene glycol, isopropanol, Tween-80, glycerol, propylene glycol and vegetable oil, wherein the vegetable oil is selected from at least one of rapeseed oil, beeswax, soybean oil, castor oil, peanut oil and blended oil; the sustained-release agent is selected from at least one of ethyl cellulose, cellulose acetate, polyethylene, polypropylene, polylactic acid, polyglycolic acid, polylactic acid-polyglycolic acid copolymer, polyvinyl chloride, polycarbonate, epoxy resin, polyamide, acetal polymer, polyester, polyurethane, polyimide and polystyrene derivatives, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, gelatin, peach gum, polyvinylpyrrolidone; the emulsifier is selected from at least one of anionic surfactants (such as sodium stearate, potassium stearate, sodium oleate, potassium oleate, calcium stearate, sodium dodecyl sulfate, sulfated castor oil hexadecyl), zwitterionic surfactants (such as lecithin and soya lecithin), nonionic surfactants (such as polysorbates, sorbitan fatty acid esters, poloxamer, glycerol monostearate, glyceryl tristearate, sucrose stearate, polyoxyethylene fatty acid esters, polyoxyethylene fatty alcohol ethers), gum arabic, gelatin, tragacanth, oil-in-water (O / W) emulsifiers (such as magnesium hydroxide, aluminum hydroxide, silicon dioxide, bentonite), water-in-oil (W / O) emulsifiers (calcium hydroxide, zinc hydroxide, magnesium stearate); the absorption enhancer is selected from at least one of sodium caprylate and its derivatives, sodium caprate and its derivatives, alkyl glycosides, EDTA, chitosan and its derivatives, polyamidoamine dendrimers (PAMAM).The surfactant is selected from at least one of sodium dodecylbenzenesulfonate, stearic acid, polyoxyethylene-polyoxypropylene (PEO-PPO) block polyether, sorbitan fatty acid ester, and polysorbate; the preservative is selected from at least one of methyl paraben or propyl paraben.

[0049] In some embodiments, the dosage form of the traditional Chinese medicine composition includes any one of decoction, tablets, capsules, granules, pills, oral liquids, powders, or ointments.

[0050] In some embodiments, the dosage form of the traditional Chinese medicine composition is powder.

[0051] The powder preparation process of the present invention is simple, and quality control is easy to implement, which can ensure the uniformity and stability of each batch of products, thereby improving the medication compliance and treatment effect of patients.

[0052] In some embodiments, the dosage form of the traditional Chinese medicine composition is capsule, which is convenient for patients to swallow.

[0053] In some embodiments, the extract includes the extract obtained by extracting the mixed raw materials of each Chinese medicinal material, and / or the extract obtained by separately extracting each Chinese medicinal material and then mixing them. Optionally, the extract is further refined and purified. Among them, the extraction methods include decoction extraction, reflux extraction, maceration extraction, ultrasonic extraction, percolation extraction, microwave extraction, etc.: the refining and purification methods include water extraction and alcohol precipitation, alkali dissolution and acid precipitation, and / or various column chromatography purification methods, such as macroporous resin column, silica gel column, gel column, reverse phase column, etc.

[0054] The second aspect of the present invention provides the application of the traditional Chinese medicine composition of the first aspect in the preparation of a drug for treating acid reflux and / or heartburn.

[0055] The treatment in the present invention includes delaying and terminating the progression of the disease, or eliminating the disease, and does not require 100% inhibition, elimination, and reversal.

[0056] Example 1

[0057] The raw materials for preparing the traditional Chinese medicine composition are as follows: 4 g of Bletilla striata, 0.5 g of Eugenia caryophyllata, 2 g of Sepia seu Sepiellae, 0.5 g of Rheum palmatum, and 0.5 g of Halloysitum rubrum. The above medicinal materials are ground into powder and prepared into powder.

[0058] Example 2

[0059] The raw materials for preparing the traditional Chinese medicine composition are as follows: 3.8 g of Bletilla striata, 0.5 g of Eugenia caryophyllata, 2 g of Sepia seu Sepiellae, 0.5 g of Rheum palmatum, and 0.5 g of Halloysitum rubrum. The above medicinal materials are ground into powder and prepared into powder.

[0060] Example 3

[0061] The raw materials for preparing the traditional Chinese medicine composition are as follows: 4 g of Bletilla striata, 0.5 g of Eugenia caryophyllata, 2.2 g of Sepia seu Sepiella, 0.5 g of Rheum officinale, and 0.5 g of Halloysitum rubrum. The above medicinal materials are ground into powder and prepared into powder agent.

[0062] Example 4

[0063] The raw materials for preparing the traditional Chinese medicine composition are as follows: 4.2 g of Bletilla striata, 0.5 g of Eugenia caryophyllata, 1.8 g of Sepia seu Sepiella, 0.5 g of Rheum officinale, and 0.5 g of Halloysitum rubrum. The above medicinal materials are ground into powder and prepared into powder agent.

[0064] Example 5

[0065] The raw materials for preparing the traditional Chinese medicine composition are as follows: 4 g of Bletilla striata, 0.6 g of Eugenia caryophyllata, 2 g of Sepia seu Sepiella, 0.5 g of Rheum officinale, and 0.5 g of Halloysitum rubrum. The above medicinal materials are ground into powder and prepared into powder agent.

[0066] Example 6 Shuchen Acid Suppression Formula

[0067] The raw materials for preparing the traditional Chinese medicine composition are as follows: 4 g of Bletilla striata, 0.5 g of Eugenia caryophyllata, 2 g of Sepia seu Sepiella, 0.5 g of Rheum officinale, 0.5 g of Halloysitum rubrum, 2 g of Atractylodes macrocephala, and 2 g of Citrus reticulata Blanco. The above medicinal materials are ground into powder and prepared into powder agent.

[0068] Example 7 Poria Acid Suppression Formula

[0069] The raw materials for preparing the traditional Chinese medicine composition are as follows: 4 g of Bletilla striata, 0.5 g of Eugenia caryophyllata, 2 g of Sepia seu Sepiella, 0.5 g of Rheum officinale, 0.5 g of Halloysitum rubrum, and 4 g of Poria cocos. The above medicinal materials are ground into powder and prepared into powder agent.

[0070] The therapeutic effect was verified by esophago-duodenal side-to-side anastomosis for the reflux esophagitis model

[0071] Forty 6- to 8-week-old male SD rats (200 ± 20 g) were adaptively fed for one week and then randomly divided into 6 groups: blank group, model group, acid suppression formula group (powder agent in Example 1), Shuchen acid suppression formula group (powder agent in Example 6), Poria acid suppression formula group (powder agent in Example 7), and positive drug group (Mosapride Citrate Dispersible Tablets).

[0072] The reflux esophagitis model was prepared by esophago-duodenal side-to-side anastomosis. The rats were fasted for 24 h before surgery without water restriction (fed with 5% glucose solution 1 day before surgery). After anesthesia with isoflurane, a midline incision was made at the xiphoid process in the upper abdomen to enter the abdominal cavity layer by layer. The stomach was lifted out with a probe to expose the stomach, the hepatogastric ligament was cut, and the esophagus was exposed. A 1.5-cm incision was made along the long axis at the esophagogastric junction and the free edge of the duodenum 1 cm from the pylorus, respectively. Then, the inner white mucosa of the esophagus was torn off, and the mucosal surfaces were opposed to perform side-to-side anastomosis. The entire stomach was retained, the duodenum was exposed, and the abdomen was closed. The rats woke up about 3 h later and could drink 5% glucose solution, and were fasted for 24 h. Regular diet was resumed 3 days later. The rats in the Yisuanfang group were treated with intragastric administration of 28.35 g / (kg·d) of traditional Chinese medicine powder, those in the Shuchen Yisuanfang group were treated with intragastric administration of 23.25 g / (kg·d) of traditional Chinese medicine powder, those in the Fuling Yisuanfang group were treated with intragastric administration of 28.75 g / (kg·d) of traditional Chinese medicine powder, the positive drug group was given a dosage of 3.125 mg / (kg·d), and the blank group and the model group were intragastrically administered with an equal volume of sterile normal saline daily. When administering the powder, it was diluted and dissolved with deionized water for easy swallowing. The body weight changes of the rats were recorded, and HE staining of esophageal tissues was used to evaluate the inflammatory infiltration, and the levels of serum IL-1β, TNF-α, and IL-6 were detected.

[0073] HE staining of rat esophageal tissues showed ( Figure 1 ), in the sham operation group, the esophageal mucosa was relatively smooth, the structure was clear and complete, the cells were arranged neatly, and no obvious inflammatory cell infiltration was seen. While in the model group, obvious mucosal thickening occurred, accompanied by keratinization thickening, and local mucosal papillary protrusions were present. The pathological changes in each treatment group were significantly improved compared with the model group; compared with the positive drug, the improvement of esophageal pathology in the Shuchen Yisuanfang group and the Fuling Yisuanfang group was not as significant as that in the Yisuanfang group, and the curative effect of the Yisuanfang group was similar to that of the positive drug group.

[0074] The levels of IL-1β, TNF-α, and IL-6 in the sera of rats in different groups ( n = 6) are shown in Table 1 and Figure 2 as follows. Compared with the model group, the levels of IL-1β, TNF-α, and IL-6 in the Yisuanfang group, the Shuchen Yisuanfang group, the Fuling Yisuanfang group, and the positive drug group all decreased significantly. The Yisuanfang group was closer to the effect of the positive drug group compared with the Shuchen Yisuanfang group and the Fuling Yisuanfang group. It was verified that the powders in Examples 2 - 5 had similar effects to the powder in Example 1.

[0075] Table 1 The levels of IL-1β, TNF-α, and IL-6 in the sera of rats in different groups ( n = 6)

[0076] Group IL-1β TNF-α IL-6 Sham operation group 71.57±6.10 110.5±7.65 38.49±2.52 Model group 148.10±14.05 167.9±9.11 56.96±4.16 Acid suppression formula group 86.81±5.46 131.8±6.90 42.86±2.14 Old Chen acid suppression formula group 93.12±3.29 141.8±7.72 47.41±2.29 Poria acid suppression formula group 105.00±4.17 141.4±5.71 47.87±2.93 Positive drug group 77.07±3.85 131.7±6.75 41.47±1.45

[0077] Clinical treatment effect

[0078] According to the treatment effects of nearly 200 patients with manifestations such as acid reflux and heartburn, the powder in Example 1 can not only rapidly relieve the symptoms of acid reflux and heartburn in patients, but also promote the repair and regeneration of gastric mucosa, thus achieving the simultaneous treatment of the symptoms and root causes of related diseases, with a clinical effective rate as high as 95%. After receiving treatment, many patients not only had their symptoms significantly controlled, but also had an increase in appetite, an improvement in digestive ability, and a significant improvement in their overall health status.

[0079] The above embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited by the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications made without departing from the spirit and principle of the present invention shall be equivalent replacement methods and are all included in the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, which is made from raw medicinal materials or their extracts. Calculated by weight parts, the raw medicinal materials include 200 - 600 parts of Bletilla striata, 25 - 75 parts of Eugenia caryophyllata, 100 - 300 parts of Sepia seu cuttlebone, 25 - 75 parts of Rheum palmatum, and 25 - 75 parts of Halloysitum rubrum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that The raw medicinal materials include 300 - 500 parts of Bletilla striata, 40 - 60 parts of Eugenia caryophyllata, 150 - 250 parts of Sepia seu cuttlebone, 40 - 60 parts of Rheum palmatum, and 40 - 60 parts of Halloysitum rubrum.

3. The traditional Chinese medicine composition according to claim 1, wherein The raw medicinal materials include 350 - 450 parts of Bletilla striata, 45 - 55 parts of Eugenia caryophyllata, 175 - 225 parts of Sepia seu cuttlebone, 45 - 55 parts of Rheum palmatum, and 45 - 55 parts of Halloysitum rubrum.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The raw medicinal materials consist of Bletilla striata, Eugenia caryophyllata, Sepia seu cuttlebone, Rheum palmatum, and Halloysitum rubrum.

5. The traditional Chinese medicine composition according to claim 1, wherein, The raw medicinal materials include any one form of dry medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, and processed medicinal materials.

6. The traditional Chinese medicine composition according to claim 1, wherein The raw medicinal materials include any one of natural medicinal materials and equivalent substitutes of natural medicinal materials.

7. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition further includes pharmaceutically acceptable excipients.

8. The traditional Chinese medicine composition according to claim 1, wherein The dosage form of the traditional Chinese medicine composition includes any one of decoction, tablets, capsules, granules, pills, oral liquids, powders, or ointments.

9. The traditional Chinese medicine composition according to claim 1, wherein The extracts include the extract obtained by extracting the mixed raw medicinal materials, and / or the extract obtained by separately extracting each raw medicinal material and then mixing them.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 - 9 in the preparation of a drug for treating acid reflux and / or heartburn.

Images