A traditional Chinese medicine composition for treating stomach diseases of liver qi invading stomach type

Abstract

The present application provides a kind of traditional Chinese medicine composition for treating liver qi invading stomach type stomach disease, the traditional Chinese medicine composition described in the present application is made of chicken gall, coptis, chuanbei, eaglewood, sanchi, sand ginger, pearl, dandelion, radish, sea scallop.The traditional Chinese medicine composition of the present application can increase the amount of free mucus, increase the content of PGE2, increase the SOD activity of gastric mucosa homogenate, reduce the content of MDA, and has a significant protective effect on liver qi invading stomach type gastric mucosa injury.Through clinical case analysis, the patients cured and markedly effective by the traditional Chinese medicine composition of the present application are significantly higher than the control group.The traditional Chinese medicine composition of the present application has good effect on treating liver qi invading stomach type bile reflux gastritis.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a traditional Chinese medicine composition for treating gastric diseases caused by liver qi invading the stomach. Background Technology

[0002] Stomach ailments are a general term for stomach-related diseases, including gastric tumors, gastroesophageal reflux, functional dyspepsia, gastritis, gastric ulcers, and gastric polyps. These are often caused by stress-related injuries, drug and alcohol irritation, Helicobacter pylori infection, and other factors that damage the gastric mucosa. Traditional Chinese medicine (TCM) stomach ailments mainly include symptoms such as stomach pain, epigastric fullness, vomiting, heartburn, and acid reflux, which correspond to common Western medical conditions such as acute and chronic gastritis, gastric and duodenal ulcers, and gastric cancer.

[0003] Traditional Chinese medicine categorizes stomach pain into "stomach pain, heart and stomach pain, and heart and abdomen pain," with pain in the epigastric region as the primary symptom. It is often caused by liver qi stagnation due to worry, anger, or overeating, or by damage to the spleen and stomach qi. The liver has the function of regulating and smoothing the flow of qi. Liver qi is a normal function of the liver in promoting the upward movement and regulating the flow of qi. When the liver is stagnant, one consequence is insufficient liver qi, resulting in a stagnation of liver qi due to its weak function of regulating and dispersing. Stagnation means impaired function of regulating and dispersing, leading to impaired spleen and stomach function and resulting in epigastric distension and pain. Another consequence is excessive liver qi, as the saying goes, "excessive qi is harmful," leading to disharmony of qi, impaired upward and downward movement, and liver qi stagnation invading the stomach (spleen), disrupting its harmony and causing liver qi to invade the stomach. The liver belongs to the wood element in the Five Elements theory. It is a strong organ that prefers free flow and dislikes stagnation. The stomach belongs to the earth element in the Five Elements theory. It is a "great" granary, an organ rich in qi and blood. It prefers moisture and is responsible for receiving and digesting. Between the liver and stomach, wood and earth interact, so when liver qi is stagnant, it first invades the stomach, leading to liver stagnation and obstruction, and causing liver and stomach qi pain.

[0004] Although stomach pain is located in the stomach, it is closely related to the liver and spleen. The stomach and spleen are connected by a membrane. The stomach is responsible for receiving and digesting food and water, and its function is to descend smoothly. The spleen is responsible for transportation and transformation, and its function is to ascend. Both are the foundation of postnatal health and the organs responsible for storage. Physiologically, they cooperate with each other. When the wood element is strong and overpowers the earth element (which controls earth), the earth element in the middle is congested, and the wood element is stagnant and cannot flow smoothly. Alternatively, there may be excessive liver fire that burns the stomach yin, or there may be liver blood stasis, which deprives the stomach of nourishment. Therefore, stomach diseases are often related to the liver.

[0005] Stomach pain due to liver qi invading the stomach is a common syndrome differentiation in traditional Chinese medicine. Symptoms include distending pain (dullness) in the stomach, stabbing pain, pain radiating to the ribs, frequent belching, constipation, stomach pain often aggravated by emotional changes such as worry and anger, sometimes with acute pain, irritability, heartburn, acid reflux, dry mouth and tongue coating, red tongue with yellow coating, and wiry and rapid or wiry and deep pulse.

[0006] Chinese patent CN102366525A discloses a method for preparing traditional Chinese medicine to treat gastritis of the liver-qi invading the stomach type. The selected raw materials and their weight components are as follows: Trichosanthes kirilowii 6g, Allium macrostemon 9g, Citrus reticulata seed 3g, Citrus reticulata peel 9g, Citrus aurantium 6g, Salvia miltiorrhiza seed 3g, Tobacco 6g, Citronella chinensis 9g, Cyperus rotundus 9g, Magnolia officinalis 6g, Litchi chinensis seed 9g, Litchi chinensis 9g, Raphanus sativus seed 12g, Carica papaya 3g, Iris tectorum 9g, Carrot 12g, Buckwheat 12g, Medicated leaven 9g, Quince 12g, Aucklandia lappa 6g, and Glycyrrhiza uralensis 9g. This formula consists of 21 Chinese herbs, has a short course of treatment and a high cure rate, but due to the large number of herbs and complex components, the cost is relatively high.

[0007] Conventional Western medicine treatment for stomach pain focuses on symptomatic relief and pain control. However, it cannot cure the disease, has a high recurrence rate, and long-term use can lead to drug tolerance, affecting the overall treatment effect. Traditional Chinese medicine believes that when liver qi is stagnant, the ascending and descending of qi is disordered, and the flow of qi is impaired, the spleen and stomach's digestive function is weakened, manifesting as symptoms such as distension and pain in the chest, hypochondrium, and stomach. Therefore, in clinical practice, the focus should be on soothing the liver and stomach, regulating qi, and relieving pain. Summary of the Invention

[0008] The purpose of this invention is to provide a traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type. The traditional Chinese medicine composition of this invention is made from chicken gizzard lining, Coptis chinensis, Fritillaria cirrhosa, Aquilaria sinensis, Panax notoginseng, Amomum villosum, pearl, Taraxacum mongolicum, Raphanus sativus seed, and Cuttlebone.

[0009] Specifically, the traditional Chinese medicine composition can be prepared from the following components:

[0010] Chicken gizzard lining 10-40 parts by weight; Coptis chinensis 2-20 parts by weight; Fritillaria cirrhosa 5-20 parts by weight; Agarwood 8-25 parts by weight

[0011] Panax notoginseng 18-25 parts by weight, Amomum villosum 5-25 parts by weight, Pearl powder 5-25 parts by weight, Dandelion 15-40 parts by weight

[0012] Radish seeds 20-50 parts by weight, cuttlebone 5-40 parts by weight.

[0013] In some embodiments, the traditional Chinese medicine composition may be prepared from the following components:

[0014] Chicken gizzard lining 20-30 parts by weight; Coptis chinensis 5-15 parts by weight; Fritillaria cirrhosa 8-15 parts by weight; Agarwood 12-20 parts by weight

[0015] Panax notoginseng 18-25 parts by weight, Amomum villosum 10-20 parts by weight, Pearl powder 10-20 parts by weight, Dandelion 20-30 parts by weight

[0016] Radish seeds 30-40 parts by weight, cuttlebone 10-30 parts by weight.

[0017] In some embodiments, the traditional Chinese medicine composition may be prepared from the following components:

[0018] Chicken gizzard lining 22-28 parts by weight; Coptis chinensis 8-13 parts by weight; Fritillaria cirrhosa 10-13 parts by weight; Agarwood 15-18 parts by weight

[0019] Panax notoginseng 20-23 parts by weight, Amomum villosum 12-18 parts by weight, Pearl powder 12-18 parts by weight, Dandelion 22-28 parts by weight

[0020] Radish seeds 33-37 parts by weight, cuttlebone 15-25 parts by weight.

[0021] In one embodiment, the traditional Chinese medicine composition may be prepared from the following components:

[0022] Chicken gizzard lining 25 parts by weight, Coptis chinensis 10 parts by weight, Fritillaria cirrhosa 12 parts by weight, Agarwood 16 parts by weight

[0023] 22 parts by weight of Panax notoginseng, 15 parts by weight of Amomum villosum, 15 parts by weight of pearl powder, and 25 parts by weight of dandelion.

[0024] Radish seeds 35 parts by weight, cuttlebone 20 parts by weight.

[0025] Agarwood is pungent, bitter, and slightly warm. It enters the spleen, stomach, and kidney meridians, promoting qi circulation and relieving pain, warming the middle jiao and stopping vomiting, and regulating qi and relieving asthma. It is used for chest and abdominal distension and pain, vomiting and hiccups due to stomach cold, and shortness of breath due to kidney deficiency.

[0026] Panax notoginseng has a slightly bitter taste and warm properties. It enters the liver and stomach meridians and has the effects of dispersing blood stasis, stopping bleeding, reducing swelling, and relieving pain. It is often used to treat epistaxis, hematemesis, hemoptysis, hematochezia, metrorrhagia, chest and abdominal pain, traumatic bleeding, and swelling and pain from falls and injuries. Clinically, it can now be used to treat upper gastrointestinal bleeding, hyphema, coronary heart disease, cerebrovascular disease, and postoperative intestinal adhesions.

[0027] Amomum villosum has a pungent and warm nature, and enters the spleen and stomach meridians. It has the effects of resolving dampness, stimulating appetite, regulating qi, and relieving chest congestion. It is mainly used to treat symptoms such as abdominal distension, vomiting, diarrhea, and borborygmus, and can therefore be used as an adjunct treatment for stomach ailments.

[0028] Pearl is sweet, salty, and cold in nature. It enters the heart and liver meridians, calms the mind and relieves fright, improves eyesight and removes corneal opacity, detoxifies and promotes tissue regeneration, moisturizes the skin and removes blemishes. It is used for palpitations and insomnia, infantile convulsions and epilepsy, red eyes with corneal opacity, non-healing sores, and skin blemishes.

[0029] Dandelion is cold in nature, bitter and sweet in taste, and enters the liver and stomach meridians. It has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules, and promoting diuresis and relieving strangury.

[0030] Radish seeds are pungent and sweet in taste, neutral in nature, and enter the spleen, stomach, lung, and large intestine meridians. They have the effect of relieving indigestion and bloating, and can be used to treat symptoms such as abdominal distension, belching, abdominal pain, and poor appetite caused by food stagnation and qi stagnation.

[0031] Cuttlebone is salty and astringent in taste, and slightly warm in nature. It enters the liver and kidney meridians and has the effects of astringing and stopping bleeding, astringing essence and stopping leukorrhea, neutralizing acid and relieving pain, and astringing and healing sores. It can be used to treat hematemesis, metrorrhagia, hematochezia, stomach pain, bleeding from ulcers and other diseases.

[0032] The present invention also aims to provide specific medicinal uses of the above-mentioned traditional Chinese medicine composition, namely, the use of the traditional Chinese medicine composition in the preparation of drugs for the prevention or treatment of stomach diseases caused by liver qi invading the stomach.

[0033] Specifically, the liver qi invading the stomach type of gastric disease includes liver qi invading the stomach type of gastric cancer, liver qi invading the stomach type of gastroesophageal reflux, liver qi invading the stomach type of functional dyspepsia, liver qi invading the stomach type of gastritis, or liver qi invading the stomach type of gastric ulcer.

[0034] Preferably, the liver qi invading the stomach type gastritis is liver qi invading the stomach type chronic superficial gastritis, liver qi invading the stomach type chronic non-atrophic gastritis, liver qi invading the stomach type chronic atrophic gastritis, or liver qi invading the stomach type bile reflux gastritis.

[0035] Based on the experience of clinicians, the *Guidelines for the Diagnosis and Treatment of Tumors with Traditional Chinese Medicine*, compiled by the China Association of Traditional Chinese Medicine in 2008, standardized the syndrome differentiation of gastric cancer, classifying it into six types: Liver Qi Invading the Stomach Syndrome, Stomach Heat Injuring Yin Syndrome, Qi Stagnation and Blood Stasis Syndrome, Phlegm-Dampness Congealing Syndrome, Spleen and Stomach Deficiency-Cold Syndrome, and Qi and Blood Deficiency Syndrome. Referring to the 2008 edition of the *Guidelines for the Diagnosis and Treatment of Tumors with Traditional Chinese Medicine*, the primary symptoms are: epigastric distension, intermittent dull pain radiating to the hypochondria, hiccups, belching, acid reflux, and heartburn; secondary symptoms include: nausea and vomiting, dry mouth and bitter taste, poor appetite, and poor sleep; tongue and pulse: pale red or dark red tongue, thin white or thin yellow coating, deep or wiry pulse. A diagnosis can be made based on the presence of two primary symptoms and one secondary symptom, or one primary symptom and two secondary symptoms, combined with tongue and pulse examination.

[0036] Gastroesophageal reflux disease (GERD) is a clinical syndrome characterized by the reflux of gastric and duodenal contents into the esophagus, causing a series of uncomfortable symptoms and complications in the esophagus and / or outside the esophagus. The diagnostic classification of GERD largely refers to the 2009 "Consensus Opinion on the Diagnosis and Treatment of Gastroesophageal Reflux Disease in Traditional Chinese Medicine" (divided into 5 types: liver-stomach stagnation with heat, gallbladder heat invading the stomach, deficiency of the middle jiao with qi reversal, qi stagnation with phlegm obstruction, and blood stasis) and the 2010 "Consensus Opinion on the Diagnosis and Treatment of Gastroesophageal Reflux Disease in Integrated Traditional Chinese and Western Medicine" (divided into 6 types: liver-stomach disharmony, liver-stomach stagnation with heat, deficiency of the middle jiao with qi reversal, phlegm-dampness obstruction, qi deficiency with blood stasis, and mixed cold and heat).

[0037] Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" formulated in 2002 and the diagnostic points of Liver Qi Invading the Stomach Syndrome in "Traditional Chinese Medicine Diagnostics", and integrating the "Consensus Opinions on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Gastroesophageal Reflux Disease" and the syndrome differentiation and treatment of stomach pain, acid reflux, heartburn, epigastric fullness, vomiting, and regurgitation in "Traditional Chinese Medicine Internal Medicine", the following TCM diagnostic criteria are proposed: Primary symptoms: ① Belching and acid reflux; ② Heartburn; ③ Chest tightness and pain (excluding true heart pain). Secondary symptoms: ① Abdominal distension; ② Poor appetite; ③ Dry mouth and bitter taste; ④ Nausea and vomiting; ⑤ Hypochondriac pain; ⑥ Irritability; ⑦ Constipation. Tongue and pulse: Pale red or red tongue, thin white or thick white / thick yellow coating, wiry or thready wiry pulse. A diagnosis of Liver Qi Invading the Stomach Syndrome can be made if two or more primary symptoms and two or more secondary symptoms are present, and the tongue coating and pulse are consistent.

[0038] The pathogenesis of functional dyspepsia due to liver qi invading the stomach is complex and not yet fully understood. Many modern medical researchers believe its onset is directly or indirectly related to lifestyle habits, psychological factors, mental factors, genetics, and stress. In traditional Chinese medicine, this disease is categorized under "stomach pain," "heartburn," "abdominal distension," and "vomiting," and its onset is related to emotional imbalance, external pathogenic factors, liver qi stagnation, and damage to the spleen and stomach due to improper diet and overwork. The liver governs the free flow of qi, the spleen governs digestion and absorption, and the stomach governs receiving and digesting; the daily activities of the spleen and stomach rely on the free flow of liver qi. If liver qi stagnates, it can invade the stomach, impairing the spleen and stomach's qi mechanism, leading to abnormal gastrointestinal motility and causing disease.

[0039] Liver Qi invading the stomach type of chronic superficial gastritis is a relatively common type of chronic superficial gastritis. Patients may experience various digestive symptoms such as nausea, vomiting, acid reflux, and belching after eating, which can affect their normal life.

[0040] The "Consensus Opinion on the Diagnosis and Treatment of Chronic Non-Atrophic Gastritis with Integrated Traditional Chinese and Western Medicine (2017)" outlines the following diagnostic criteria for chronic non-atrophic gastritis of the liver-qi invading the stomach type: 1) Distending pain in the epigastrium radiating to the hypochondrium, relieved by belching or flatulence; 2) Epigastric discomfort, exacerbated or recurring due to emotional distress; 3) Frequent belching; 4) Heartburn and acid reflux; 5) Frequent sighing. Tongue and pulse: Pale red tongue with a thin white coating; wiry pulse. The onset is often triggered or aggravated by emotional distress.

[0041] In clinical practice, chronic atrophic gastritis of the liver-qi invading the stomach type is common. Its main pathogenesis is worry and anger, which leads to liver dysfunction or excessive liver qi, resulting in liver qi invading the stomach and obstructing the flow of qi in the middle jiao, causing symptoms such as stomach pain, acid reflux, and belching. The treatment should focus on soothing the liver, regulating qi, clearing heat, and eliminating stagnation.

[0042] Bile reflux gastritis falls under the categories of "stomach pain," "heartburn," and "acid reflux," with the lesion located in the liver and gallbladder. The most common type is liver qi invading the stomach, and its pathogenesis is related to heat stagnation in the gallbladder and liver qi stagnation. The "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine (2017)" defines the liver qi invading the stomach type as follows: main symptoms include heartburn and acid reflux, stabbing pain, chest tightness and belching, abdominal distension, pale red tongue with a thick or thin greasy coating, and a wiry pulse.

[0043] Any of the above-mentioned traditional Chinese medicine compositions for treating gastric diseases of the liver-qi invading the stomach type according to the present invention further includes a pharmaceutically acceptable carrier and / or excipient.

[0044] Another object of the present invention is to provide a formulation comprising the above-mentioned traditional Chinese medicine composition for treating gastric diseases of the liver-qi invading the stomach type, including tablets, capsules, pills or granules.

[0045] The present invention has the following beneficial effects:

[0046] The herbal composition of this invention can increase the amount of free mucus, increase the content of PGE2, increase the SOD activity of gastric mucosal homogenate, and reduce the content of MDA, thus having a significant protective effect on gastric mucosal damage caused by liver qi invading the stomach.

[0047] Clinical case analysis showed that the proportion of patients cured and those with significant improvement by the herbal composition of this invention was significantly higher than that in the control group, indicating that the herbal composition of this invention has a good effect on treating bile reflux gastritis of the liver qi invading the stomach type.

[0048] The herbal composition of this invention, through scientific formulation, allows each herb to exert a synergistic effect, achieving a significant therapeutic effect on gastric diseases caused by liver qi invading the stomach. It has high clinical application value and broad application prospects. Specific Implementation

[0049] The following detailed description of specific embodiments further illustrates the content of the present invention, but it should not be construed as limiting the scope of the above-mentioned subject matter of the present invention to the following embodiments. The following embodiments are used to illustrate the technical solutions of the present invention and not to limit the scope of protection of the present invention. Modifications or equivalent substitutions made by those skilled in the art to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention shall still fall within the scope of protection of the present invention.

[0050] Example 1: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0051] Chicken gizzard lining 25g, Coptis chinensis 10g, Fritillaria cirrhosa 12g, Agarwood 16g

[0052] 22g Panax notoginseng, 15g Amomum villosum, 15g pearl powder, 25g dandelion

[0053] Radish seeds 35g, cuttlebone 20g.

[0054] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0055] Example 2: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0056] Chicken gizzard lining 22g, Coptis chinensis 8g, Fritillaria cirrhosa 13g, Agarwood 15g

[0057] 20g Panax notoginseng, 18g Amomum villosum, 12g pearl powder, 28g dandelion

[0058] Radish seeds 33g, cuttlebone 25g.

[0059] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0060] Example 3: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0061] Chicken gizzard lining 28g, Coptis chinensis 13g, Fritillaria cirrhosa 10g, Agarwood 18g

[0062] Panax notoginseng 23g, Amomum villosum 12g, Pearl 18g, Dandelion 22g

[0063] 37g of radish seeds and 15g of jellyfish.

[0064] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0065] Example 4: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0066]

[0067] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0068] Example 5: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0069]

[0070] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0071] Comparative Example 1: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0072] Chicken gizzard lining 5g, Coptis chinensis 25g, Fritillaria cirrhosa 12g, Agarwood 23g

[0073] 5g Panax notoginseng, 15g Amomum villosum, 15g pearl powder, 25g dandelion

[0074] Radish seeds 10g, cuttlebone 20g.

[0075] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0076] Comparative Example 2: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0077] Chicken gizzard lining 45g, Coptis chinensis 1g, Fritillaria cirrhosa 30g, Agarwood 5g

[0078] 15g Panax notoginseng, 30g Amomum villosum, 4g pearl powder, 45g dandelion

[0079] Radish seeds 55g, cuttlebone 4g.

[0080] Take the above-mentioned medicinal materials, add 10 times the amount of water and decoct twice, one hour each time. Combine the two decoctions and concentrate to about 500ml. Filter to obtain the medicinal liquid, which should be taken in 1-2 doses.

[0081] Comparative Example 3: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0082] This comparative example provides a composition that differs from Example 1 in that the composition does not contain cuttlebone. The reduced mass is made up by the remaining medicinal ingredients (chicken gizzard lining, Coptis chinensis, Fritillaria cirrhosa, Aquilaria sinensis, Panax notoginseng, Amomum villosum, pearl, dandelion, and radish seed). The mass ratio of the remaining medicinal ingredients remains unchanged, and the other parameters and steps are consistent with those of Example 1.

[0083] Comparative Example 4: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0084] This comparative example provides a composition that differs from Example 1 in that the composition does not contain radish seeds. The reduced mass is made up by the remaining medicinal ingredients (chicken gizzard lining, Coptis chinensis, Fritillaria cirrhosa, Aquilaria sinensis, Panax notoginseng, Amomum villosum, pearl, dandelion, and cuttlebone). The mass ratio of the remaining medicinal ingredients remains unchanged, and the remaining parameters and steps are consistent with those of Example 1.

[0085] Comparative Example 5: A traditional Chinese medicine composition that can be used to treat gastritis of the liver-qi invading the stomach type.

[0086] Chicken gizzard lining 25g, Coptis chinensis 10g, Fritillaria cirrhosa 12g, Agarwood 16g

[0087] 22g Panax notoginseng, 15g Amomum villosum, 15g pearl powder, 15g dandelion

[0088] 15g of radish seeds and 50g of jellyfish.

[0089] The preparation method is the same as in Example 1.

[0090] Comparative Example 6: A traditional Chinese medicine composition for treating stomach diseases of liver qi invading the stomach type

[0091] 25 g of chicken inner gold, 10 g of coptis, 12 g of fritillaria cirrhosa, 16 g of lignum aquilariae resina

[0092] 22 g of notoginseng, 15 g of amomum villosum, 15 g of pearls, 45 g of dandelion

[0093] 15 g of semen raphani, 20 g of cuttlefish bone.

[0094] The preparation method is the same as that of Example 1.

[0095] Pharmacodynamic experiment

[0096] The inventor carried out relevant pharmacodynamic experimental studies to prove the efficacy of the traditional Chinese medicine composition of the present invention in treating stomach diseases of liver qi invading the stomach type. It should be noted that the drugs selected in the following pharmacodynamic experiments are the drugs obtained from the representative formulations and dosage forms of the present invention.

[0097] 1 Materials

[0098] 1.1 Experimental drugs

[0099] The compositions of Examples 1-3 of the present invention; the compositions of Comparative Examples 1-6.

[0100] 1.2 Experimental animals

[0101] SPF-grade Wistar rats, half male and half female, 160-200 g, experimental animal license number: SYXK(Shandong)20180008, and adaptively fed under standard conditions for 1 week before the experiment.

[0102] 2. Methods

[0103] 2.1 Modeling method and grouping

[0104] Before modeling, the rats were randomly divided into 11 groups according to gender and body weight, with 10 rats in each group, half male and half female. They were respectively the blank group, the model group, the Example 1 group, the Example 2 group, the Example 3 group, the Comparative Example 1 group, the Comparative Example 2 group, the Comparative Example 3 group, the Comparative Example 4 group, the Comparative Example 5 group, and the Comparative Example 6 group.

[0105] Referring to the literature method, the binding method was used. The limbs of the modeled rats were bound with thin binding strips to a degree that they did not fall off (if they fell off, they should be re-bound in time) and caused the rats to have difficulty walking and limited activities, and then they were placed in a feeding cage. The diet was not restricted, and the binding was continued for 14 days.

[0106] 2.2 Administration

[0107] The blank group was conventionally raised without any stimulation, and intragastrically administered with 1 ml / 100 g of normal saline, 2 times a day for 14 consecutive days.

[0108] The model group had their limbs restrained and were given 1 ml / 100 g of physiological saline by gavage twice a day for 14 consecutive days.

[0109] In Example 1, the limbs were bound and the composition of Example 1 was administered by gavage at a rate of 1 ml / 100 g twice daily for 14 consecutive days.

[0110] Rats in Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and Comparative Example 5 were given the corresponding drug at 1 ml / 100 g twice daily for 14 consecutive days.

[0111] 3. Statistical processing

[0112] SPSS 22.0 software was used to perform statistical analysis on the obtained data. Quantitative data were represented using (…). The numbers indicate that comparisons among multiple groups were performed using one-way ANOVA, and comparisons between two groups were performed using independent samples t-tests. A p-value < 0.05 was considered statistically significant.

[0113] 4. Observation Indicators

[0114] 4.1 General Observation

[0115] Observe and compare the changes in general conditions such as coat color, diet, weight, and emotional behavior of rats in each group before and after model replication and drug administration.

[0116] 4.2 Determination of free mucus volume and PGE2 content in gastric juice

[0117] After fasting for 48 hours, rats in the control group, model group, Examples 1-3, and Comparative Examples 1-6 were anesthetized by intraperitoneal injection of 3% sodium pentobarbital (40 mg / kg). The abdominal cavity was opened, and the esophagus was ligated to prevent saliva from entering the stomach and to block the vagus nerve. 2 ml of 0.9% saline was injected into the stomach through the duodenum and pylorus, and the pylorus was quickly ligated. Four hours postoperatively, the rats were sacrificed, the stomach was removed, cut along the lesser curvature, and the gastric juice was collected, with the mucus thoroughly dispersed.

[0118] The amount of free mucus and the content of prostaglandin PGE2 were measured.

[0119] PGE2 (ug / ml) = E 278 *M / ε*Vt*D

[0120] (Vt: Volume of gastric fluid taken (ml); Molecular weight of PGE2: 352; ε: Molecular absorption coefficient of PGE2 at 278nm: 26.800; D: Dilution factor; M / ε = 13.13).

[0121] 4.3 Determination of SOD and MDA content in gastric mucosal homogenate

[0122] The cut-open rat stomach was quickly turned inside out to expose the gastric mucosa. It was rinsed with cold physiological saline to remove blood and residue, and then gently blotted dry with filter paper. The stomach was laid flat on an ice tray, and approximately 200 mg of gastric mucosal tissue was gently scraped off with a glass slide. After weighing, the tissue was homogenized in a glass homogenizer. A 10% tissue homogenate was prepared by adding 1 ml of physiological saline to 100 mg of gastric mucosal tissue and storing it in a low-temperature freezer. The specific operating procedures for the assay were performed according to the manufacturer's instructions.

[0123] 5. Analysis of Experimental Results

[0124] 5.1 Observation of the general condition of rats in each group

[0125] Before modeling, the animals in the control group and the other groups were in good spirits, moved nimbly, had whitish and glossy fur, rosy skin and mucous membranes, and consumed more food and water, resulting in weight gain. When provoked, they exhibited behaviors such as screaming and bristling hair.

[0126] After modeling, the rats showed significantly reduced activity, squeaking, huddling together, drooping whiskers, dark red face, dull fur, reduced food intake, and slower weight gain. They also exhibited avoidance responses to irritants.

[0127] In Examples 1-3, the animals were agile, with whitish and glossy fur. Compared with the control group, their food and water intake and weight gain showed no significant abnormalities. When provoked, the animals exhibited behaviors such as screaming, bristling fur, and standing on their hind legs.

[0128] Compared with the model group rats, the animals in the control groups 1-6 showed no significant increase in activity, made soft squeaking noises, had drooping whiskers, poor coat and facial color, poor food and water intake, slow weight gain, and poor overall condition.

[0129] 5.2 Gastric juice free mucus volume and PGE2 content

[0130] Compared with the control group, the amount of free mucus in the stomach of rats in the model group was significantly reduced (P<0.01); compared with the model group, the amount of free mucus in the stomach of rats in Example 1, Example 2 and Example 3 groups was significantly increased (P<0.01), as shown in Table 1. Compared with comparative examples 1-6, the amount of free mucus in the stomach of rats in Example 1 of this invention was significantly increased (P<0.05).

[0131] Table 1 Comparison of free mucus in the stomach of rats in each group ( n=10)

[0132]

[0133] Note: Compared with the blank group, ## p < 0.01; compared with the model group, *p < 0.05, **p < 0.01;

[0134] Compared with Comparative Example 1, @ p<0.05; compared with the control group 2, & p<0.05;

[0135] Compared with the three control groups, ￥ p<0.05; compared with the 4 comparative groups, ^p<0.05;

[0136] Compared with the 5 control groups, Θ p<0.05; compared with the 6 control groups, Z p<0.05.

[0137] Compared with the control group, the PGE2 content in the model group rats was significantly reduced (P<0.01); compared with the model group, the PGE2 content in the rats of Example 1, Example 2 and Example 3 groups was significantly increased (P<0.01), as shown in Table 2. Compared with comparative examples 1-6, the PGE2 content in the rats of Example 1 group of the present invention was significantly increased (P<0.05).

[0138] Table 2 Comparison of PGE2 content in rats of different groups ( n=10)

[0139]

[0140] Note: Same as Table 1.

[0141] 5.3 Comparison of SOD activity and MDA content in rat gastric mucosal homogenate

[0142] Compared with the control group, the SOD activity in the gastric mucosal homogenate of rats in the model group was significantly reduced (P<0.01); compared with the model group, the SOD activity in the gastric mucosal homogenate of rats in Example 1, Example 2 and Example 3 groups was significantly increased (P<0.01), as shown in Table 3. Compared with comparative examples 1-6, the SOD activity in the gastric mucosal homogenate of rats in Example 1 of this invention was significantly increased (P<0.05).

[0143] Table 3 Comparison of SOD activity and MDA content in gastric mucosal homogenates of rats in different groups n=10)

[0144]

[0145]

[0146] Note: Same as Table 1.

[0147] Compared with the control group, the MDA content in the gastric mucosal homogenate of rats in the model group was significantly increased (P<0.01); compared with the model group, the MDA content in the gastric mucosal homogenate of rats in Example 1, Example 2 and Example 3 groups was significantly decreased (P<0.01), as shown in Table 3. Compared with comparative examples 1-6, the MDA content in the gastric mucosal homogenate of rats in Example 1 of this invention was significantly decreased (P<0.05).

[0148] The herbal composition of this invention can increase the amount of free mucus, increase the content of PGE2, increase the SOD activity of gastric mucosal homogenate, and reduce the content of MDA, thus having a significant protective effect on gastric mucosal damage caused by liver qi invading the stomach.

[0149] Clinical Case Analysis

[0150] 1. Materials and Methods

[0151] 1.1 General Information

[0152] Eighty-two patients with superficial gastritis of the liver-qi invading the stomach type admitted to our hospital were selected as the research subjects.

[0153] Inclusion criteria:

[0154] 1) Meets the diagnostic criteria of the 2017 edition of the "Expert Consensus Opinion on the Diagnosis and Treatment of Chronic Gastritis with Traditional Chinese Medicine".

[0155] 2) The diagnosis of reflux gastritis was confirmed by gastroscopy.

[0156] 3) The syndrome was determined to be liver qi invading the stomach according to traditional Chinese medicine diagnosis.

[0157] 4) Age between 23 and 65 years old.

[0158] 5) No gastric mucosal protectants, acid suppressants, or prokinetic drugs have been taken recently.

[0159] Exclusion criteria:

[0160] 1) Suffering from a serious disease of the digestive system or other serious illnesses.

[0161] 2) History of abdominal organ surgery.

[0162] 3) During pregnancy or lactation.

[0163] 4) History of allergies to related drugs.

[0164] 5) For patients who are intolerant to any of the medications used.

[0165] 6) Patients who did not complete the entire study process for any reason.

[0166] 7) Patients who have been using proton pump inhibitors or H2 receptor blockers for a long time.

[0167] 8) Patients who use prokinetic drugs for a long time.

[0168] Patients were randomly divided into two groups using a random number table: the treatment group consisted of 19 males and 22 females, with a mean age of (50.24±11.75) years; the control group consisted of 17 males and 24 females, with a mean age of (55.35±12.03) years. There were no statistically significant differences in general characteristics between the two groups during the study (P>0.05).

[0169] 1.2 Treatment methods

[0170] The control group received 1g of aluminum magnesium carbonate three times a day, 30 minutes after meals; 10mg of domperidone three times a day, 30 minutes before meals; and pantoprazole 40mg was added for patients with severe symptoms, 30 minutes before breakfast.

[0171] The treatment group used the following raw materials to prepare a traditional Chinese medicine composition as one dose: 25g chicken gizzard lining, 10g Coptis chinensis, 12g Fritillaria cirrhosa, 16g agarwood, 22g Panax notoginseng, 15g Amomum villosum, 15g pearl, 25g dandelion, 35g radish seed, and 20g cuttlebone (Example).

[0172] 1) Take 2 doses daily, once in the morning and once in the evening, for a treatment period of 4 weeks.

[0173] 1.3 Observation Indicators

[0174] Clinical efficacy assessment: The comprehensive evaluation was conducted in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and the results of gastroscopy examinations before and after treatment.

[0175] Cure: All clinical symptoms and signs of the patients who participated in the treatment completely disappeared, and the mucosa was found to have returned to normal on gastroscopy, with no bile reflux.

[0176] Significant effect: The patient's symptoms improved significantly (symptoms were significantly reduced or the frequency of attacks was significantly decreased), physical signs were significantly reduced, and gastroscopy showed that the mucosa had basically returned to normal and bile reflux had basically disappeared.

[0177] Effective: Patient's symptoms improve (symptoms are milder or the frequency of attacks decreases), physical signs are reduced, gastroscopy shows improvement in gastric mucosa, and bile reflux is reduced.

[0178] Invalid: The above standards were not met.

[0179] Overall effectiveness rate: The percentage of cases that are cured, show significant improvement, and are effective out of the total number of cases.

[0180] 1.4 Statistical Methods

[0181] SPSS 22.0 software was used to perform statistical analysis on the obtained data. Quantitative data were analyzed using... This indicates that one-way ANOVA was used for comparisons among multiple groups, and independent samples t-tests were used for comparisons between two groups. A p-value < 0.05 was considered statistically significant.

[0182] 2 Results

[0183] 2.1 Comparison of clinical efficacy and microscopic findings between the two groups after treatment

[0184] The overall effective rates were 92.7% in the treatment group and 75.6% in the control group, with the treatment group showing a significantly higher rate than the control group (P<0.05). A follow-up study was conducted on all patients six months after the end of treatment. The recurrence rates in the treatment group and the control group were 9.76% and 29.3%, respectively, with a statistically significant difference (P<0.05). This indicates that the long-term efficacy of the treatment group was superior to that of the control group. See Tables 4 and 5.

[0185] Table 4 Comparison of clinical efficacy between the two groups

[0186]

[0187] Note: Compared with the control group, # p<0.05.

[0188] Table 5 Comparison of recurrence rates between the two groups

[0189]

[0190] Note: Compared with the control group, # p<0.05.

[0191] The proportion of patients cured and those showing significant improvement with the herbal composition of this invention was significantly higher than that in the control group. The herbal composition of this invention has a good therapeutic effect on bile reflux gastritis of the liver qi invading the stomach type.

[0192] The above embodiments are not intended to limit the present invention in any way. For those skilled in the art, any modifications or substitutions made within the scope of the present invention based on its technical essence shall still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition with protective effect against gastric mucosal damage caused by liver qi invading the stomach, characterized in that, The traditional Chinese medicine composition is made from the following components: 20-30 parts by weight of chicken gizzard lining, 5-15 parts by weight of Coptis chinensis, 8-15 parts by weight of Fritillaria cirrhosa, 12-20 parts by weight of Aquilaria sinensis, 18-25 parts by weight of Panax notoginseng, 10-20 parts by weight of Amomum villosum, 10-20 parts by weight of pearl, and 20-30 parts by weight of Taraxacum mongolicum. Radish seeds 30-40 parts by weight, cuttlebone 10-30 parts by weight.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following components: Chicken gizzard lining 22-28 parts by weight; Coptis chinensis 8-13 parts by weight; Fritillaria cirrhosa 10-13 parts by weight; Agarwood 15-18 parts by weight Panax notoginseng 20-23 parts by weight, Amomum villosum 12-18 parts by weight, Pearl powder 12-18 parts by weight, Dandelion 22-28 parts by weight Radish seeds 33-37 parts by weight, cuttlebone 15-25 parts by weight.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following components: Chicken gizzard lining 25 parts by weight, Coptis chinensis 10 parts by weight, Fritillaria cirrhosa 12 parts by weight, Agarwood 16 parts by weight 22 parts by weight of Panax notoginseng, 15 parts by weight of Amomum villosum, 15 parts by weight of pearl powder, and 25 parts by weight of dandelion. Radish seeds 35 parts by weight, cuttlebone 20 parts by weight.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament that has a protective effect against gastric mucosal damage caused by liver qi invading the stomach.

5. A preparation that has a protective effect against gastric mucosal damage caused by liver qi invading the stomach, prepared from the traditional Chinese medicine composition according to any one of claims 1-3.

6. The formulation according to claim 5, characterized in that, The traditional Chinese medicine composition is prepared into a pharmaceutically acceptable dosage form.

7. The formulation according to claim 6, characterized in that, The dosage form is one of tablets, capsules, pellets, or granules.

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