Traditional Chinese medicine composition, compound prescription and preparation method and application thereof for treating reflux gastritis

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition, compound, preparation method and application thereof for treating reflux gastritis. The traditional Chinese medicine composition is composed of Patchouli, Aucklandia, Aquilaria, Clove, Cyperus, Curcuma and Radix Codonopsis. The traditional Chinese medicine compound comprises the traditional Chinese medicine composition and at least one of Pinellia, Scutellaria, Dry Ginger, Ginseng, Licorice, Coptis, Jujube, Evodia, Panax Notoginseng and Radix Astragali. The present invention shows remarkable technical effects through scientific compatibility of traditional Chinese medicine and multi-faceted pharmacological effects. The various components play a comprehensive therapeutic role through multiple ways such as promoting qi and relieving pain, relieving depression and eliminating accumulation, overall conditioning, anti-inflammatory and protecting gastric mucosa, improving gastrointestinal function, etc., which can not only relieve symptoms in a short period of time, but also achieve fundamental treatment and prevention of reflux gastritis through long-term conditioning.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating reflux gastritis, a compound prescription, and a preparation method and application thereof. Background Art

[0002] Reflux gastritis is a common gastric disease, and its incidence has been on the rise in recent years. This disease is usually related to factors such as bad habits, exposure to external evil, stress, environmental pollution, irregular diet, mental stress, and changes in dietary structure. In some areas, the incidence of reflux gastritis has increased year by year. Reflux gastritis brings great pain to patients, mainly manifested in symptoms such as stomach discomfort, heartburn, acid reflux, and abdominal distension. Traditional Western medicine treatments mainly include antacids and gastric mucosal protectants, but these drugs can often only temporarily relieve symptoms, cannot fundamentally cure the disease, and long-term use will produce side effects. Summary of the invention

[0003] In view of the above technical problems, the present invention provides a Chinese medicine composition, compound prescription and preparation method and application thereof for treating reflux gastritis.

[0004] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition consisting of Patchouli, Costusroot, Aquilaria, Clove, Cyperus rotundus, Curcuma aromatica and Sweet Potato.

[0006] In the present invention, Patchouli, Aucklandia, Aquilaria, Cloves, and Cyperus are the main drugs, which are mainly used for promoting qi and relieving pain, and regulating gastrointestinal function; Curcuma Radix and Radix Polygoni Multiflori are the assistant drugs, which assist the main drugs, strengthen promoting qi and relieving depression, and have the effects of eliminating accumulation and relieving pain. The present invention can better eliminate the main symptoms of reflux gastritis through the compounding of the above-mentioned medicinal flavors, and shows significant therapeutic effects in treating sudden abdominal pain and bloating.

[0007] [Pharmacological action]

[0008] 1. Patchouli

[0009] Patchouli can aromatically eliminate dampness, stop vomiting, and relieve heat and relieve symptoms. After oral administration, it is mainly metabolized in the liver and excreted through bile and urine. Pharmacokinetic studies have found that Patchouli contains volatile oils such as methyl eugenol and geranone, as well as polysaccharide active ingredients, which have antibacterial, antiviral, and anti-inflammatory effects, can enhance immune function, and improve gastrointestinal absorption function.

[0010] 2. Aucklandia

[0011] Costus root can relieve pain, regulate the stomach, and is absorbed orally, enters the blood circulation through the gastrointestinal tract, and is mainly metabolized in the liver. Pharmacokinetic studies have shown that costus root contains volatile oils such as costus lactone and dehydrocostus lactone, as well as flavonoid compounds, which have analgesic, anti-inflammatory, anti-ulcer effects, regulate gastrointestinal motility, and promote gastric juice secretion.

[0012] 3. Agarwood

[0013] Agarwood can relieve pain, warm the middle and stop vomiting, and relieve asthma. It is absorbed orally, enters the blood circulation through the gastrointestinal tract, and is mainly metabolized in the liver. Pharmacokinetic studies have shown that agarwood contains volatile oils such as linalool and linalool terpenes, as well as flavonoid active ingredients, which have antibacterial, anti-inflammatory, analgesic, anti-gastric ulcer effects, and improve the symptoms of qi stagnation and blood stasis.

[0014] 4. Clove

[0015] Cloves can warm the middle and lower adverse reactions, warm the kidneys and boost yang. After oral absorption, they are widely distributed throughout the body and are mainly metabolized in the liver. Pharmacokinetic studies have shown that cloves contain volatile oils such as eugenol and eugenol acetate, as well as tannins, which have antibacterial, antiviral, antioxidant effects, promote gastric juice secretion, and improve digestion ability.

[0016] 5. Cyperus rotundus

[0017] Cyperus rotundus can soothe the liver and regulate qi, regulate menstruation and relieve pain. After oral absorption, it is mainly metabolized in the liver and kidneys. Pharmacokinetic studies have shown that Cyperus rotundus contains volatile oils such as cyperene and cyperone, as well as flavonoid compounds, which have analgesic, anti-inflammatory, anti-depressant and endocrine regulating effects.

[0018] 6. Curcuma acuminata

[0019] Curcuma longa can promote qi and relieve depression, promote blood circulation and relieve pain. After being absorbed by the gastrointestinal tract, it is mainly metabolized in the liver and excreted through bile and urine. Pharmacokinetic studies have shown that Curcuma longa contains active ingredients such as turmeric ketone, curcumin and volatile oil, which have anti-depressant, anti-inflammatory, analgesic, antioxidant and blood circulation promoting effects.

[0020] 7. Gold is incomparable

[0021] Golden Buds are used to promote qi circulation, eliminate stagnation, detoxify and relieve pain. After oral absorption, they are widely distributed throughout the body and are mainly metabolized in the liver. Pharmacokinetic studies have shown that Golden Buds contain a variety of active ingredients such as volatile oils, flavonoids and polysaccharides, which have anti-inflammatory, antibacterial, analgesic and digestive juice secretion promoting effects.

[0022] [Efficacy Analysis]

[0023] The Chinese medicine composition of the present invention exhibits significant technical effects through scientific Chinese medicine compatibility and multi-faceted pharmacological effects, as follows:

[0024] 1. Promote Qi flow and relieve pain

[0025] Patchouli, costusroot, agarwood, cloves, and cyperus rotundus - the five main herbs work together to promote qi and relieve pain. Patchouli, costusroot, and agarwood mainly regulate qi through aromatic dehumidification, reduce abdominal pain and flatulence caused by qi stagnation; cloves and cyperus rotundus further relieve pain by warming the middle and dispelling cold, soothing the liver and regulating qi.

[0026] Curcuma Radix and Radix Glechomae Radix - as adjuvant drugs, they strengthen the effect of promoting qi and relieving pain. Curcuma Radix can relieve pain caused by qi stagnation and blood stasis by promoting qi and relieving depression, promoting blood circulation and relieving pain; Radix Glechomae Radix can further reduce pain and flatulence caused by food accumulation by eliminating accumulation and fullness.

[0027] The various medicinal flavors in the present invention promote gastrointestinal motility and improve qi through different pharmacological action pathways, and play a synergistic role in rapidly relieving pain and flatulence in the stomach and abdomen. At the same time, the present invention has good safety, not only relieving pain in the short term, but also improving gastrointestinal function and preventing recurrence of pain through long-term conditioning.

[0028] 2. Relieve depression and eliminate stagnation

[0029] Curcuma australis and Radix Glehniae are the main drugs for relieving depression and eliminating accumulation. Curcuma australis contains turmeric ketone and curcumin, which have significant antidepressant, anti-inflammatory and analgesic effects, and can effectively relieve depression, promote blood circulation and relieve pain. Radix Glehniae is rich in volatile oils and flavonoids, which can eliminate abdominal distension and discomfort by promoting qi and eliminating accumulation.

[0030] Patchouli, costusroot, agarwood, cloves, and cyperus rotundus - together as the main medicine, they assist the effects of Curcuma aromatica and Sweet Potatoes by regulating Qi and improving digestive function.

[0031] On the one hand, the present invention regulates the liver and stomach qi, relieves abdominal distension, fullness and pain caused by qi stagnation, restores the normal function of the gastrointestinal tract and achieves qi regulation; on the other hand, it improves digestive function, promotes the secretion of gastric juice and digestive enzymes, accelerates the digestion and absorption of food, reduces the occurrence of food accumulation, achieves the elimination of accumulation and stagnation, fundamentally improves the pathological state of the gastrointestinal tract, improves the self-regulation ability of the digestive system, and reduces the occurrence of indigestion and food accumulation.

[0032] 3. Anti-inflammatory and protection of gastric mucosa

[0033] Patchouli, costusroot, agarwood, cloves, and cyperus rotundus - exert anti-inflammatory effects through different pathways, reduce the inflammatory response of the gastric mucosa, and protect the gastric mucosa.

[0034] Curcuma aromatica and Curcuma odoratum - rich in volatile oils and flavonoids, which have anti-inflammatory, antioxidant and tissue repair effects.

[0035] The present invention can reduce the inflammatory reaction of gastric mucosa, relieve the pain and discomfort caused by inflammation, promote the repair and regeneration of gastric mucosa, enhance the barrier function of gastric mucosa, reduce the damage of gastric acid and other harmful substances to gastric mucosa, and utilize the mutual cooperation between various medicinal flavors to produce a synergistic effect in anti-inflammatory and gastric mucosa protection. At the same time, the present invention not only relieves inflammation in the short term, but also can enhance the self-repair ability of gastric mucosa through long-term conditioning, and prevent the recurrence of gastric mucosal damage.

[0036] 4. Improve gastrointestinal function

[0037] Patchouli, costusroot, agarwood, cloves, and cyperus rotundus - regulate qi, promote gastrointestinal motility, and improve digestive function.

[0038] Curcuma aromatica and Radix Polygoni Multiflori - Promote the secretion of gastric juice and digestive enzymes and enhance the function of the digestive system by promoting the flow of qi and relieving depression.

[0039] On the one hand, the present invention promotes digestion, improves the digestion and absorption capacity of the gastrointestinal tract, and reduces abdominal distension and discomfort caused by indigestion. On the other hand, it can promote gastrointestinal motility, reduce the stagnation time of gastric contents, prevent food from being retained and fermented in the gastrointestinal tract, regulate gastrointestinal function, improve the overall health of the gastrointestinal tract, and enhance the body's resistance to external stimuli.

[0040] 5. Overall conditioning

[0041] The combined effects of the monarch and ministerial drugs of the present invention not only relieve symptoms in a short period of time, but also enhance the body's immunity and self-repair ability by regulating gastrointestinal function. The aroma of Patchouli can remove dampness, the regulating stomach and stomach of Aucklandia lappa and Aquilaria sinensis can regulate the middle and lower the adverse effect of Cloves, the soothing of the liver and regulating Qi of Cyperus rotundus, the promoting of Qi and relieving depression of Curcuma aromatica, and the elimination of accumulation and fullness of Rhizoma Polygoni Multiflori can act together on various aspects of the gastrointestinal system to form a complete conditioning system.

[0042] Each medicinal ingredient can bidirectionally regulate gastrointestinal function through different pharmacological action pathways, which can not only promote gastrointestinal motility and gastric juice secretion, but also reduce gastric mucosal damage caused by excessive gastric acid secretion. At the same time, it targets the various causes of reflux gastritis and plays a comprehensive therapeutic role through multiple pathways such as reducing inflammation, promoting ulcer healing, regulating gastrointestinal motility, improving digestive function and enhancing the body's immunity. Through continuous conditioning, it can improve spleen and stomach function, enhance the self-regulation and repair ability of the digestive system, and fundamentally prevent the recurrence of reflux gastritis.

[0043] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of Patchouli, 5-15 parts of Costusroot, 5-15 parts of Aquilaria, 5-15 parts of Cloves, 5-15 parts of Cyperus rotundus, 1-10 parts of Curcuma aromatica and 1-10 parts of Sweet Potato.

[0044] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 7-13 parts of Patchouli, 7-13 parts of Costusroot, 7-13 parts of Aquilaria, 7-13 parts of Cloves, 7-13 parts of Cyperus rotundus, 2-8 parts of Curcuma aromatica and 2-8 parts of Sweet Potato.

[0045] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9-11 parts of Patchouli, 9-11 parts of Costusroot, 9-11 parts of Aquilaria, 9-11 parts of Cloves, 9-11 parts of Cyperus rotundus, 4-6 parts of Curcuma aromatica and 4-6 parts of Sweet Potato.

[0046] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10-11 parts of Patchouli cloves, 10-11 parts of costusroot, 10-11 parts of agarwood, 10-11 parts of cloves, 10-11 parts of Cyperus rotundus, 5-6 parts of Curcuma aromatica and 5-6 parts of Sweet Potato.

[0047] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 9-10 parts of Patchouli, 9-10 parts of Costusroot, 9-10 parts of Aquilaria, 9-10 parts of Cloves, 9-10 parts of Cyperus rotundus, 4-5 parts of Curcuma aromatica and 4-5 parts of Sweet Potato.

[0048] In some embodiments, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Patchouli cloves, 10 parts of costusroot, 10 parts of agarwood, 10 parts of cloves, 10 parts of Cyperus rotundus, 5 parts of Curcuma aromatica and 5 parts of Sweet Potato.

[0049] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: soaking a formula amount of Patchouli, Costusroot, Aquilaria, Clove, Cyperus, Curcuma and Rhizoma Curcumae and Radix Codonopsis in water, decocting, filtering, and obtaining a filtrate, which is the traditional Chinese medicine composition.

[0050] In some embodiments, the ratio of the total mass of water to Patchouli, Costusroot, Aquilaria, Cloves, Cyperus rotundus, Curcuma aromatica and Sweet Potato is 1:5-15.

[0051] In some embodiments, the soaking conditions are: soaking temperature not exceeding 30°C, soaking time 20-40 min, preferably soaking temperature 15-30°C, soaking time 30 min.

[0052] In some embodiments, the decoction is performed at least once, preferably 1-5 times, more preferably 2-4 times; more preferably 2-3 times; and the decoction time for each time is at least 10 minutes, preferably 10-20 minutes, more preferably 15-20 minutes.

[0053] In some embodiments, the filtrate is concentrated, and the concentration is vacuum concentration and / or low-temperature concentration. The low temperature is a temperature not exceeding 70°C, preferably 40-60°C.

[0054] In some embodiments, the filtrate is concentrated at 40-60° C. to prepare a thick paste having a relative density of 1.10-1.12.

[0055] The Chinese medicine composition of the present invention can be used alone to treat reflux gastritis, and can also be used in combination with other components to exert the efficacy of treating reflux gastritis.

[0056] In a third aspect, the present invention provides a Chinese medicine compound, comprising the above-mentioned Chinese medicine composition.

[0057] In some embodiments, the Chinese medicine compound further comprises at least one of pinellia tuber, scutellaria baicalensis, dried ginger, ginseng, liquorice, coptis root, jujube, evodia rutaecarpa, notoginseng and astragalus.

[0058] Pinellia and dried ginger: warm the middle and dispel cold, regulate stomach qi, promote gastrointestinal motility, eliminate bloating and reduce counterflow.

[0059] Scutellaria baicalensis and Coptis chinensis: clear away heat and dampness, and relieve stomach discomfort.

[0060] Ginseng, licorice, and jujube: replenish qi and nourish the stomach, protect the gastric mucosa, and enhance gastrointestinal function.

[0061] Coptis chinensis and Evodia rutaecarpa: inhibit gastric acid secretion and reduce gastric mucosal inflammation.

[0062] Panax notoginseng and Astragalus: replenish Qi and generate blood, remove blood stasis and generate new blood, and promote ulcer healing.

[0063] In some embodiments, the Chinese medicine compound further includes at least one of the following raw materials in parts by weight: 5-10 parts of Pinellia, 15-20 parts of Scutellaria, 10-20 parts of Dried Ginger, 3-6 parts of Ginseng, 5-15 parts of Licorice, 5-15 parts of Coptis, 10-20 parts of Jujube, 5-10 parts of Evodia, 1-3 parts of Panax Notoginseng and 10-20 parts of Astragalus.

[0064] In some embodiments, the Chinese medicine compound, by weight, further includes the following raw materials: 5-10 parts of Pinellia, 15-20 parts of Scutellaria, 10-20 parts of Dried Ginger, 3-6 parts of Ginseng, 5-15 parts of Licorice, 5-15 parts of Coptis, 10-20 parts of Jujube, 5-10 parts of Evodia, 1-3 parts of Panax Notoginseng and 10-20 parts of Astragalus.

[0065] In some embodiments, the Chinese medicine composition is more than 3% of the total weight of the Chinese medicine compound, preferably more than 5%, for example, 5-90%, 5-85%, 5-80%, 5-75%, 5-70%, 5-65%, 5-60%, 5-55%, 5-50%, 5-45%, 5-40%, 5-35%, 5-30%, 5-25%, 5-20%, 5-15%, 5-10%, 6-90%, 6-85%, 6-80%, 6-75%, 6-70%, 6-65%, 6-60%, 6-55%, 6-50%, 6-45%, 6-40%, 6-35%, 6-30%, 6- -25%, 6-20%, 6-15%, 6-10%, 7-90%, 7-85%, 7-80%, 7-75%, 7-70%, 7-65%, 7-60%, 7-55%, 7-50%, 7-45%, 7-40%, 7-35%, 7-30%, 7-25%, 7-20%, 7-15%, 7-10%, 8-90%, 8-85%, 8-80%, 8-75%, 8-70%, 8-65%, 8-60%, 8-55%, 8-50%, 8-45%, 8-40%, 8-35%, 8-30%, 8-25%, 8-20%, 8-15%, 8 -10%, 9-90%, 9-85%, 9-80%, 9-75%, 9-70%, 9-65%, 9-60%, 9-55%, 9-50%, 9-45%, 9-40%, 9-35%, 9-30%, 9-25%, 9-20%, 9-15%, 9-10%, 10-90%, 10-85%, 10-80%, 10-75%, 10-70%, 10-65%, 10-60%, 10-55%, 10-50%, 10-45%, 10-40%, 10-35%, 10-30%, 10-25%, 10-20%, 10-15%, 11 -90%, 11-85%, 11-80%, 11-75%, 11-70%, 11-65%, 11-60%, 11-55%, 11-50%, 11-45%, 11-40%, 11-35%, 11-30%, 11-25%, 11-20%, 11-15%, 12-90%, 12-85%, 12-80%, 12-75%, 12-70%, 12-65%, 12-60%, 12-55%, 12-50%, 12-45%, 12-40%, 12-35%, 12-30%, 12-25%, 12-20%, 12-15%.

[0066] In a fourth aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine compound, comprising the following steps: crushing, decocting, filtering, and concentrating the filtrate of all raw materials except the Chinese medicine composition to obtain an extract; mixing the extract with the Chinese medicine composition to obtain the Chinese medicine compound.

[0067] In some embodiments, the decoction is performed at least once, and each decoction time does not exceed 30 minutes; preferably, the decoction is performed 2-4 times, and each decoction time is 15-30 minutes; further preferably, the decoction is performed 2-3 times, and each decoction time is 20-30 minutes.

[0068] In a fifth aspect, the present invention provides use of the above-mentioned Chinese medicine composition or Chinese medicine compound in the preparation of a medicament for treating reflux gastritis.

[0069] In a sixth aspect, the present invention provides a pharmaceutical composition comprising the aforementioned Chinese medicine composition or Chinese medicine compound and pharmaceutically acceptable excipients.

[0070] In some embodiments, the pharmaceutical composition is in the form of tablets, pills, capsules, granules, powders, granules, pastes, solutions, or suspensions.

[0071] Compared with the prior art, the present invention has the following beneficial effects:

[0072] (1) The Chinese medicine composition of the present invention exhibits remarkable technical effects through scientific Chinese medicine compatibility and multi-faceted pharmacological effects. The various components work together to exert a comprehensive therapeutic effect through multiple pathways such as promoting qi and relieving pain, relieving depression and eliminating accumulation, overall conditioning, anti-inflammatory and protecting gastric mucosa, and improving gastrointestinal function. Its scientificity and effectiveness are not only reflected in short-term symptom relief, but also through long-term conditioning, it can achieve the fundamental treatment and prevention of reflux gastritis, providing patients with a safe and effective treatment plan.

[0073] (2) The pathogenesis of reflux gastritis is complex. It is not only due to abnormal function of the lower esophageal sphincter and esophageal motility, but also accompanied by gastric emptying and pyloric sphincter dysfunction, and is related to diet and emotions. Traditional Chinese medicine does not specifically discuss reflux gastritis, which generally falls into the category of abdominal distension, epigastric pain, acid reflux, and noisy stomach. Its pathogenesis is that the stomach fails to harmonize and descend, and the body fluids are stagnant with the ascending qi for a long time, and the dampness turns into heat. The dampness and heat are glued together to form a syndrome of mixed cold and heat, spleen deficiency and qi stagnation. The disease often recurs and has a long course. It is based on spleen and stomach deficiency and is closely related to the liver's drainage. In the formula, Pinellia and Dry Ginger are pungent in opening and dispersing stagnation and removing cold; Scutellaria and Coptis are bitter in descending and purging heat and removing abdominal distension; Ginseng, Licorice and Jujube are sweet and warm in nature and invigorate Qi and replenish deficiency; Panax notoginseng and Astragalus reduce swelling, promote tissue regeneration, astringe and stop bleeding; Evodia rutaecarpa inhibits the liver, harmonizes the stomach and reduces acid. Wuxiang Erjin Powder can treat all kinds of sudden abdominal pain, bloating, promote Qi circulation and relieve pain, eliminate abdominal distension and disperse accumulation. Overall, the whole formula uses both cold and warm effects, both tonifying and purging, pungent in opening and bitter in descending, and harmonizes Yin and Yang, thereby achieving the purpose of restoring the ascending and descending of the middle burner and harmonizing the liver and stomach. DETAILED DESCRIPTION

[0074] The present invention is described below through specific embodiments to make the technical solution of the present invention easier to understand and grasp, but the present invention is not limited thereto, and the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments.

[0075] The endpoints and any value of the scope disclosed in this article are not limited to the accurate scope or value, and these scopes or values ​​should be understood to include values ​​close to these scopes or values. For numerical ranges, between the endpoint values ​​of each scope, between the endpoint values ​​of each scope and a separate point value, and between separate point values, one or more new numerical ranges can be combined with each other, and these numerical ranges should be considered as specifically disclosed in this article. Unless the context clearly indicates otherwise, the singular form "one", "a kind of" and "described" as used herein include singular and plural indicators. The numerical range described by the endpoint is included in all numerical values ​​and fractions within the corresponding range, as well as the described endpoint.

[0076] In a specific embodiment, the Chinese medicine composition, Chinese medicine compound or pharmaceutical composition described in the present invention is provided in an effective amount in a drug (eg, a therapeutically effective amount).

[0077] The "pharmaceutically acceptable excipients" described in the present invention include inert diluents, dispersants and / or granulating agents, disintegrants, binders, preservatives, buffers. Excipients (such as cocoa butter), colorants, coating agents, sweeteners, flavoring agents and aromatics may also be present in the pharmaceutical composition.

[0078] The "drug" described in the present invention can be prepared by any method known in pharmacy. Generally speaking, these preparation methods include associating the aforementioned Chinese medicine composition (i.e., the first active ingredient) with a carrier or excipient and / or one or more other auxiliary ingredients, and then if necessary and / or desired, molding and / or packaging the product into a desired single dose or multiple dose unit.

[0079] The "drugs" of the present invention can be prepared according to known methods, such as the methods described in the general rules for preparation of the Chinese Pharmacopoeia (2020 edition), the Japanese Pharmacopoeia 16th edition, the United States Pharmacopoeia and the European Pharmacopoeia 9th edition. It depends on the dosage form.

[0080] The first active ingredient and pharmaceutically acceptable excipients in the "medicament" of the present invention will vary according to the attributes, body shape and / or condition of the subject to be treated and further according to the administration route of the composition. The medicament may contain between 0.1% and 100% (w / w) of the first active ingredient.

[0081] The Chinese medicine composition, Chinese medicine compound or pharmaceutical composition described in the present invention can also be used as one of the raw materials contained in medicines, functional foods or health products.

[0082] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention. The experimental methods described in the following embodiments are conventional methods unless otherwise specified; the reagents and materials described are commercially available unless otherwise specified.

[0083] Chinese medicine composition of Example 1-3 and Comparative Example 1-2 (Five-spiced and Two-gold Powder)

[0084] [Preparation method]

[0085] According to the formula of the Chinese medicine composition in Table 1, take Patchouli, Costusroot, Aquilaria, Clove, Cyperus, Curcuma, and Sweet Potato, mix them, add 10 times the amount of water, soak at 30°C for 30 min, decoct twice, each time for 20 min, remove the residue, combine the filtrate, and concentrate the filtrate at 50°C to a thick paste with a relative density of 1.12-1.12 (50°C).

[0086] Table 1 Formula of the Chinese medicine composition of the embodiment and comparative example (unit: g)

[0087]

[0088]

[0089] Example 4 Study on the effect of Chinese medicine composition on reflux gastritis

[0090] 1. Experimental Animals

[0091] Healthy SPF-grade SD rats (150 g-170 g), male, were purchased from Guangdong Medical Experimental Animal Center.

[0092] 2. Modeling and grouping

[0093] SD rats were randomly divided into a blank control group, a model group, a positive group, an embodiment 1 group, an embodiment 2 group, an embodiment 3 group, a comparative example 1 group and a comparative example 2 group according to body weight, with 10 rats in each group. Except for the blank control group, each group was gavaged with 15mL / kg of reflux fluid (containing 2.4wt% sodium taurocholate, 1.5wt% pancreatic enzyme, 0.2wt% lecithin and the remainder of normal saline), once a day, for 4 consecutive weeks, and the blank control group was gavaged with an equal volume of normal saline every day. After the modeling was completed, the drug administration group was gavaged with 4g crude drug / kg of the Chinese medicine composition of the corresponding embodiment and the comparative example every day, the positive group was gavaged with 2.78mg / kg of domperidone, and the blank control group and the model group were gavaged with an equal volume of normal saline for 2 consecutive weeks.

[0094] 3. Sample collection

[0095] The drugs were administered at a fixed time every day. Rats were fasted but not watered 1 day before the last administration. 2 hours after the last administration, SD rats were anesthetized with isoflurane, and whole blood was collected from the abdominal aorta. After standing at room temperature for 1 hour, the blood was centrifuged at 4°C and 3500r / min for 10 minutes, and the supernatant was taken and frozen at -20°C for later use. After the whole blood from the abdominal aorta was collected, the gastric tissue was collected, and the gastric mucosal tissue was collected after washing with physiological saline. 120 mg of the blood was pulped, centrifuged at 4°C and 3500r / min for 10 minutes, and the supernatant was taken and frozen at -20°C for later use.

[0096] 3. Biochemical index detection

[0097] The ELISA method was used to detect the levels of serum IL-6 and IL-8, and the ELISA method was used to detect the levels of PGE2 and IL-8 in gastric mucosal tissue. The detection method was carried out according to the instructions of the biochemical kit of Nanjing Jiancheng Biotechnology Co., Ltd.

[0098] 4. Test results

[0099] 4.1 Detection of serum inflammatory factors in rats in each group

[0100] The results showed that compared with the blank control group, the serum IL-6 and IL-8 levels of the rats in the model group increased significantly (P < 0.05). After drug treatment, compared with the model group, the serum IL-6 and IL-8 levels of the rats in the Example 1-3 group and the positive group decreased significantly (P < 0.05), indicating that the Chinese medicine composition provided by Example 1-3 and the positive medicine have anti-inflammatory effects. Compared with the model group, there was no significant change in the serum IL-6 and IL-8 levels of the rats in the Comparative Example 1-2 group (P > 0.05), indicating that the Chinese medicine composition provided by the Comparative Example 1-2 has no anti-inflammatory effect, as shown in Table 2.

[0101] Table 2 Detection results of serum inflammatory factors in rats in each group (unit ng / L, )

[0102]

[0103] Note: Different letters in the table indicate significant differences among the groups (P < 0.05).

[0104] 4.2 IL-8 and PGE in gastric mucosal tissue 2 content

[0105] The results showed that compared with the blank control group, the IL-8 content in the gastric mucosal tissue of the rats in the model group was significantly increased (P < 0.05), and the PGE 2After drug administration, compared with the model group, the IL-8 content in the gastric mucosal tissue of rats in Example 1-3 groups and the positive group was significantly reduced (P < 0.05), and PGE 2 The content of IL-8 and PGE in gastric mucosal tissue of rats in groups 1 to 3 was significantly increased (P < 0.05). 2 The contents of the two groups were significantly different (P < 0.05), indicating that the Chinese medicine composition provided in Examples 1-3 of the present invention can inhibit the level of inflammatory factors, reduce the inflammatory damage of reflux fluid to the gastric mucosa, and increase PGE 2 Compared with the model group, the IL-8 content and PGE 2 There was no significant change in the content (P>0.05), indicating that the Chinese medicine composition provided by Comparative Example 1-2 had no effect of inhibiting the level of inflammatory factors and protecting the gastric mucosa.

[0106] Table 3 IL-8 and PGE in gastric mucosal tissue of rats in each group 2 Content test results

[0107]

[0108] Note: Different letters in the table indicate significant differences among the groups (P < 0.05).

[0109] Example 5 Safety Evaluation

[0110] The Chinese medicine composition of the present invention is mainly metabolized by the liver and kidneys. In order to further verify the safety of the above-mentioned combination of five spices and two golds, the inventors also studied the effects of the Chinese medicine composition on the levels of ALT, AST and BUN in rat serum. It was found that compared with the blank control group, there were no statistically significant differences in the levels of ALT, AST and BUN in the serum of rats in the drug-treated group (P>0.05), indicating that the Chinese medicine composition of the present invention will not produce toxic side effects on the liver and kidneys and has good safety.

[0111] Example 6

[0112] In order to verify the efficacy of the present invention, a clinical experiment on 82 patients with reflux gastritis was conducted, as follows:

[0113] (1) Clinical data

[0114] 82 outpatients who met the diagnostic criteria were randomly divided into a treatment group and a control group. There were 41 cases in the treatment group, including 20 males and 21 females; the age ranged from 112 to 73 years, with an average age of 45 years; the course of disease ranged from 15 days to 2 years. There were 41 cases in the control group, including 20 males and 21 females; the age ranged from 112 to 75 years, with an average age of 47 years; the course of disease ranged from 13 days to 2 years. The TCM syndrome differentiation was consistent with mixed cold and heat, spleen deficiency and qi stagnation. There was no significant difference in gender, age, course of disease and TCM syndrome differentiation between the two groups after statistical processing, and they were comparable.

[0115] Diagnostic criteria

[0116] Basis of TCM diagnosis: Routine Diagnosis and Treatment of Common Diseases in TCM and relevant standards of TCM Internal Medicine, with symptoms of stomachache, fullness, heartburn, heat, noisy or vomiting, yellowish or greasy tongue coating, and syndrome differentiation conforms to mixed cold and heat, spleen deficiency and qi stagnation type.

[0117] Western medicine diagnostic criteria: refer to the diagnostic criteria of reflux gastritis in the Western medicine "Internal Medicine", with typical heartburn, heartburn, pain behind the sternum, dysphagia and pain after swallowing, and foreign body sensation as the main clinical manifestations. Meet the endoscopic diagnostic criteria, or perform 24-hour esophageal pH monitoring.

[0118] (2) Treatment methods

[0119] Treatment group: took the Wuxiang Erjin powder provided in Example 1, twice a day, 4 g each time, for 6 consecutive weeks, 1 course of treatment.

[0120] Control group: 10 mg of domperidone, 3 times a day, 0.5 hours before meals; 150 mg of ranitidine, 2 times a day, 0.5 hours before meals; 4 tablets of Gaiweiping, 3 times a day, chewed during meals. Combined administration, 0.5 hours interval between each dose, 6 weeks of continuous administration as one course of treatment.

[0121] During the treatment period, both groups were prohibited from smoking and drinking, eating spicy and greasy food, chocolate, coffee, etc., eating a light diet, avoiding excessive fatigue and mental stress. When sleeping, the head of the bed was raised 20 cm, tight clothes were not worn, frequent bending over and exerting force were avoided, and drugs that reduce the pressure of the lower esophageal sphincter were avoided.

[0122] (3) Treatment outcomes

[0123] The efficacy evaluation criteria are as follows:

[0124] Markedly effective: The symptoms of reflux gastritis disappeared completely, and the signs of esophagitis found in endoscopic examination basically disappeared.

[0125] Effective: The symptoms of reflux gastritis were significantly alleviated, and the esophagitis grade showed a slight change in endoscopic examination.

[0126] Ineffective: There was no significant change in the symptoms of reflux gastritis and the esophagitis grade in endoscopic examination before and after treatment.

[0127] The comparison of the therapeutic effects between the two groups is shown in Table 4.

[0128] Table 4

[0129] Group Significant effect efficient invalid Total effective rate (%) Treatment Group 34 2 5 87.8 Control group 10 8 23 43.9

[0130] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating reflux gastritis, characterized in that: The invention is prepared from the following raw materials in parts by weight: 9-11 parts of Patchouli, 9-11 parts of Costusroot, 9-11 parts of Aquilaria, 9-11 parts of Cloves, 9-11 parts of Cyperus, 4-6 parts of Curcuma Aromatica and 4-6 parts of Sweet Potato.

2. The method for preparing the Chinese medicine composition for treating reflux gastritis according to claim 1, characterized in that: The method comprises the following steps: soaking a formula amount of Patchouli, Costusroot, Aquilaria, Clove, Cyperus, Curcuma and Radix Codonopsis in water, decocting, filtering and obtaining a filtrate.

3. Use of the Chinese medicine composition for treating reflux gastritis according to claim 1 in the preparation of a medicament for treating reflux gastritis.

4. A pharmaceutical composition for treating reflux gastritis, characterized in that: The composition is made from the Chinese medicine composition according to claim 1 and pharmaceutically acceptable excipients.

5. The pharmaceutical composition according to claim 4, characterized in that The dosage form of the pharmaceutical composition is tablet, pill, capsule, granule, powder, paste, solution or suspension.

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