Traditional Chinese medicine composition for treating epigastric pain and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating epigastric pain and a preparation method thereof, and belongs to the technical field of medicines. According to the technical scheme, the traditional Chinese medicine composition for treating epigastric pain consists of the following medicines in parts by weight: 3-10 parts of coptis chinensis, 15-60 parts of oldenlandia diffusa, 3-10 parts of amomum cardamomum, 2-6 parts of fructus amomi, 3-12 parts of mangnolia officinalis, 3-12 parts of fructus aurantii, 6-20 parts of corydalis tuber, 10-20 parts of cuttle bone, 10-20 parts of concha arcae and 2-6 parts of liquorice. The specific preparation method comprises the following steps: step 1, adding 8-10 times of water into the cuttle bone and the concha arcae in parts by weight, decocting and extracting for 1-2 hours, then adding the other medicines, continuously decocting for 1-3 times (1-2 hours each time), simultaneously collecting volatile oil, filtering medicine residues, and reserving filtrate for later use; and 2, concentrating the filtrate under reduced pressure to obtain clear paste with the relative density of 1.0-1.5 at 40-65 DEG C, and drying to prepare dry paste powder. And 3, taking the dry paste powder, adding a proper amount of auxiliary materials, spraying volatile oil, and preparing an oral solid preparation by using a conventional process.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and particularly relates to a traditional Chinese medicine composition for treating epigastric pain and a preparation method thereof. Background Art

[0002] Epigastric pain is a disease characterized by pain in the epigastric area near the heart, often accompanied by upper gastrointestinal symptoms such as noisy stomach, acid reflux, poor appetite, belching, nausea and vomiting.

[0003] The earliest known understanding of epigastric pain in Traditional Chinese Medicine can be found in the Neijing (Inner Canon of Medicine). For example, the Lingshu chapter on the manifestations of evil qi and internal organs states: "Patients with stomach problems experience abdominal distension and pain in the epigastrium." Traditional Chinese medicine believes that epigastric pain is primarily caused by external pathogenic factors, dietary irregularities, emotional imbalance, and spleen and stomach deficiency. External pathogens such as cold, heat, and dampness invade the stomach, causing stagnation of epigastric qi and pain. Improper diet, or overeating or starving, damages the spleen and stomach, leading to stagnant stomach qi and a loss of harmony and descending function, which in turn causes pain. An unregulated diet, including a predilection for spicy, rich, and fatty foods, can accumulate dampness and generate heat, harming the spleen and stomach, causing qi stagnation and epigastric pain. For example, the chapter on epigastric pain in the Zhengzhuan (Medical Theory): "The cause of the disease is often a preference for spicy and sour foods, drinking hot wine, and then eating cold, raw, and raw foods. This damage accumulates over time, leading to worsening epigastric pain." The liver is associated with anger, while the spleen is associated with thought. Worry, worry, and anger damage the liver and spleen, causing liver dysfunction and spleen dysfunction. This leads to stagnation of stomach qi, which in turn causes stomach pain. A weak spleen and stomach, impaired transport and transformation, poor qi flow, or insufficient middle yang, leading to coldness in the middle jiao and loss of warming nourishment, can cause epigastric pain.

[0004] The stomach is Yang Earth, preferring moisture and abhorring dryness. Its function is to promote circulation and descend, and it dislikes stagnation. The main pathological factors of epigastric pain include Qi stagnation, cold stagnation, heat stagnation, dampness obstruction, and blood stasis. The fundamental pathogenesis is stagnant stomach Qi, failure to harmonize and descend, and the resulting pain. Epigastric pain is located in the stomach and is closely related to the liver and spleen. Initial onset is often caused by external pathogens, diet, or emotional damage, often presenting as a syndrome of excess. Later stages often reflect spleen and stomach weakness, often a mixture of deficiency and excess.

[0005] In modern medicine, epigastric pain is a common symptom in a variety of digestive tract diseases, including acute and chronic gastritis, peptic ulcers, gastroesophageal reflux disease, and functional dyspepsia. With the rapid development of society, people's lifestyles and dietary habits have undergone significant changes compared to the past, leading to a yearly increase in the incidence of epigastric pain. Some patients even experience anxiety and depression due to the torment of epigastric pain, which seriously affects their quality of life and imposes a significant economic burden on society. Currently, modern medical treatments for epigastric pain primarily focus on acid suppression, antacids, and H. pylori eradication. The main treatments include drugs that inhibit gastric acid secretion (proton pump inhibitors and H2 receptor antagonists, such as omeprazole and famotidine), gastric mucosal protectants (aluminum carbonate preparations, montmorillonite powder, etc.), gastrointestinal prokinetics (sapride, metoclopramide, domperidone, etc.), and methods to eradicate Helicobacter pylori (Hp) (triple or quadruple therapy). These drugs have the advantages of accurate targeting, rapid action, convenient medication, and quick effect. However, long-term use can lead to drug dependence and rebound reactions upon withdrawal. Clinically, some patients also experience various adverse reactions such as decreased white blood cell count and mental abnormalities. In addition, there are problems such as high recurrence rate and long course of disease, and the long-term efficacy is poor.

[0006] Traditional Chinese Medicine (TCM) offers unique advantages in treating this condition, with minimal adverse reactions, low recurrence rates, and proven long-term efficacy, gradually gaining acceptance among patients. In recent years, numerous physicians and scholars have developed a variety of Chinese patent medicines based on the etiology and pathogenesis of epigastric pain, which are widely used in clinical practice. Their proven efficacy, ease of administration, and portability have significantly increased patient compliance. Qizhi Weitong Granules are used to treat liver depression and qi stagnation, chest distension, and epigastric pain. Piling Weitong Granules are used to treat epigastric distension and stabbing pain caused by qi stagnation and blood stasis, promoting qi and blood circulation, and soothing the stomach and alleviating pain. Weisu Granules soothe the liver and regulate qi, soothe the stomach, promote downward movement, and relieve distension and pain. They also exert a bidirectional regulatory effect on gastrointestinal motility, increasing gastric juice secretion, promoting digestion, and enhancing appetite. Morodan has the benefits of soothing the stomach and relieving adverse reactions, strengthening the spleen and alleviating distension, and promoting blood circulation and pain relief. It also provides analgesic, anti-inflammatory, and hemostatic properties, and effectively protects the gastric mucosa.

[0007] The invention aims to give full play to the dialectical treatment of traditional Chinese medicine and rationally combine the drugs. The invention is composed of eleven ingredients, namely, coptis root, oldenlandia diffusa, white cardamom, amomum villosum, fritillaria, magnolia bark, fructus aurantii, yanhusuo (Rhizoma Corydalis), cuttlefish bone, citronella fruit and liquorice. The ingredients of the whole prescription are properly matched to play the role of clearing away heat and dampness, regulating qi and harmonizing the stomach, and reducing acid and relieving pain. The prescription is used for epigastric pain caused by damp-heat obstruction and spleen and stomach qi stagnation. Clinical trials have confirmed that the invention has a definite therapeutic effect in treating epigastric pain. Summary of the Invention

[0008] The invention provides a traditional Chinese medicine composition for treating epigastric pain.

[0009] Another object of the present invention is to provide a method for preparing the Chinese medicine composition.

[0010] The technical solution adopted by the present invention is a traditional Chinese medicine composition for treating epigastric pain, which is composed of the following medicinal ingredients in parts by weight:

[0011] 3-10 parts of Coptis chinensis, 15-60 parts of Hedyotis diffusa, 3-10 parts of white cardamom, 2-6 parts of Amomum villosum, 3-12 parts of Magnolia officinalis, 3-12 parts of Citrus aurantium, 6-20 parts of Corydalis yanhusuo, 10-20 parts of cuttlefish bone, 10-20 parts of Corrugated cardamom, and 2-6 parts of liquorice.

[0012] The specific preparation method of the traditional Chinese medicine composition for treating epigastric pain comprises the following steps:

[0013] The first step is to add 8-10 times the amount of water to the above-mentioned cuttlefish bones and corrugated paper and boil them for 1-2 hours, then add the remaining medicinal ingredients and continue boiling for 1-3 times, each time for 1-2 hours, while collecting volatile oil, filtering the residue, and using the filtrate for later use;

[0014] The second step is to reduce the pressure and concentrate the filtrate to a clear paste with a relative density of 1.0 to 1.5 at 40°C to 65°C, and then dry it to make a dry paste powder.

[0015] The third step is to take the dry paste powder, add appropriate amount of auxiliary materials, spray in volatile oil, and use conventional technology to make an oral solid preparation.

[0016] In a further preferred embodiment, the excipient is one or a mixture of any of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micropowdered silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.

[0017] The pharmacological effects of the components of the present invention and their combination are analyzed as follows:

[0018] The present invention aims to utilize Chinese medicine compatibility. Coptis chinensis is bitter and cold in nature. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It has the effects of clearing heat and dampness, purging fire and detoxifying. Hedyotis diffusa is cold in nature, bitter and slightly sweet in taste. It enters the stomach, large intestine, and small intestine meridians. The whole plant has the effects of clearing heat, detoxifying, reducing swelling, and relieving pain. Cardamomum villosum is pungent and warm in nature. It enters the lung, spleen, and stomach meridians. It has the effects of removing dampness and promoting qi, warming the middle and stopping vomiting, and stimulating the appetite and promoting digestion. Amomum villosum is pungent and warm in nature. It enters the spleen, stomach, and kidney meridians. It removes dampness and stimulates the appetite, warms the spleen and stops diarrhea, and regulates qi and stabilizes pregnancy. Fritillaria thunbergii is pungent in taste and neutral in nature. It has the effects of clearing heat and moistening the lungs, resolving phlegm and relieving cough. Magnolia officinalis is bitter, pungent, and warm in nature. It enters the spleen, stomach, lung, and large intestine meridians. It dries dampness and eliminates phlegm, and relieves qi and distension. Citrus aurantium is bitter, pungent, sour, and slightly cold. It enters the spleen and stomach meridians. Regulates Qi, relieves fullness, relieves stagnation, and relieves bloating. Corydalis yanhusuo (Yuanhusuo): Pungent, bitter, and warm. Enters the Liver and Spleen Meridians. Promotes blood circulation, promotes Qi, and relieves pain. Cuttlefish bone: Salty, astringent, and warm. Enters the Spleen and Kidney Meridians. Astringes and stops bleeding, astringes semen, stops leucorrhea, reduces acidity and relieves pain, and absorbs dampness and heals sores. Corrugated seeds: Salty and neutral. Enters the Lung, Stomach, and Liver Meridians. Eliminates phlegm and resolves blood stasis, softens and disperses nodules, reduces acidity and relieves pain. Licorice: Sweet and neutral. Enters the Heart, Lung, Spleen, and Stomach Meridians. Invigorates the Spleen and replenishes Qi, clears heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes the various herbs. The combined effects of the formula clear heat and dampness, regulate Qi and harmonize the stomach, reduce acidity and relieve pain. It is used for epigastric pain caused by damp-heat in the middle and stagnation of spleen and stomach Qi. Symptoms include epigastric distension and pain that extends to the flanks, fullness and acid regurgitation, nausea and vomiting, heaviness and fatigue, and short, yellow urine. Red tongue, yellow and greasy coating, slippery or rapid pulse. Chronic gastritis and peptic ulcer with the above symptoms.

[0019] Modern pharmacological research has confirmed that:

[0020] Coptis chinensis (Coptis chinensis) has a bitter and cold taste. It enters the heart, spleen, stomach, liver, gallbladder, and large intestine meridians. It has the effects of clearing heat and dampness, purging fire and detoxifying. Modern pharmacological research shows that Coptis chinensis plays an important role in antipyretic, analgesic, and the treatment of gastrointestinal diseases. Hashemzaei et al. found that berberine in Coptis chinensis can effectively relieve pain caused by sciatica, diabetes, and chemotherapy by reducing cell membrane potential activity and inhibiting the NF-κB pathway. Mao Yanfei et al. found that cold compresses of a compound Coptis chinensis solution can effectively relieve pain and swelling in patients with limb fractures, alleviating suffering. Coptis chinensis, a commonly used drug in the clinical treatment of gastrointestinal diseases, has also made some progress in experimental research. Yang Honglian et al. found that Coptis chinensis has a significant effect on mice with spleen and stomach deficiency, and the effect is closely related to the dose of Coptis chinensis. High doses of Coptis chinensis have a "stomach-damaging" effect, while low doses have a "stomach-tonifying" effect. This dose-response mechanism may be related to direct regulation of gastrointestinal motility or indirect regulation of gastrointestinal hormone secretion. Yang et al. summarized recent literature and concluded that the mechanism of action of Coptis chinensis in treating gastrointestinal diseases is to inhibit oxidative stress, protect the intestinal mucosal epithelial barrier, regulate helper T cells and have antibacterial activity.

[0021] Hedyotis diffusa is cold in nature, bitter in taste, slightly sweet, and enters the stomach, large intestine, and small intestine meridians. The whole plant has pharmacological effects such as clearing heat and detoxifying, reducing swelling and relieving pain, anti-tumor, anti-inflammatory, antioxidant activity, and immunomodulatory effects. Clinically, it is widely used in inflammatory diseases such as gastritis, enteritis, appendicitis, tonsillitis, pharyngitis, and pelvic inflammatory disease, and is a good medicine for clearing heat and detoxifying. Lu Canhui et al. found that Hedyotis diffusa has a good therapeutic effect on inflammatory diseases of the digestive tract and urinary systems. Its single-ingredient decoction is also effective for esophagitis, gastritis, enteritis, acute appendicitis, etc. Clinically, fresh Hedyotis diffusa is also directly used as a single-ingredient decoction to treat conjunctivitis, esophagitis, gastritis, enteritis, acute appendicitis, etc.

[0022] White cardamom is pungent and warm. It enters the lung, spleen and stomach meridians. It has the effects of removing dampness and promoting qi, warming the middle and stopping vomiting, and stimulating appetite and digestion. It is used for dampness and turbidity blocking the middle, loss of appetite, the initial onset of damp-heat, chest tightness without hunger, vomiting due to cold and dampness, chest and abdominal distension and pain, and indigestion. Modern pharmacological studies have shown that it has pharmacological activities such as kidney protection, liver protection, anti-cancer, anti-inflammatory, and gastroprotective. Clinical trials have shown that white cardamom can promote gastrointestinal recovery after abdominal surgery, reduce gastrointestinal gas, and reduce related complications such as intestinal adhesions. Wei Zhongmin advocates the use of the "regulating the liver and unblocking the spleen" method to treat chronic gastritis with dampness and heat syndrome. White cardamom is combined with Magnolia officinalis, Talcum, and Piper melongena to soothe the liver and invigorate the spleen, promote qi and eliminate dampness without damaging yin. Among them, white cardamom can move the spleen and eliminate dampness, and restore the central jiao. For the sweating syndrome caused by heart and kidney deficiency and spleen and stomach disharmony, Diao Benshu prescribed Huanglian Ejiao Decoction with modifications, combining white cardamom with coptis chinensis, donkey-hide gelatin, hawthorn, etc., to connect the heart and kidney, harmonize the Ying and Wei, and to restrain the Yin fluid. Among them, white cardamom strengthens the spleen and stomach, helps the communication between the heart and kidney, and promotes the internalization of the Yin fluid.

[0023] Amomum villosum is pungent and warming. It enters the spleen, stomach, and kidney meridians. It eliminates dampness and stimulates appetite, warms the spleen and stops diarrhea, and regulates qi and stabilizes pregnancy. It is used for dampness and turbidity in the middle of the body, abdominal distension without hunger, spleen and stomach deficiency and cold, vomiting and diarrhea, nausea and vomiting during pregnancy, and fetal movement disorder. Modern pharmacological research has shown that Amomum villosum contains active ingredients such as volatile oils, polyphenols, flavonoids, and terpenes, which have antibacterial, antioxidant, and antihypertensive effects. It is clinically used for gastrointestinal protection and the treatment of gastrointestinal diseases such as ulcerative colitis. Ding et al., studying the pharmacological activities of Amomum villosum and its volatile oil from Yunnan, found that 270 mg / kg of Amomum villosum volatile oil exhibited analgesic and antidiarrheal effects. Zhang et al. evaluated the effects of Amomum villosum volatile oil on 5-fluorouracil (5-FU)-induced intestinal mucosal inflammation in rats. The results showed that Amomum villosum volatile oil significantly increased body weight, alleviated diarrhea, and reversed intestinal histopathological changes and inflammatory responses. Zhang Fengyu further discovered that Amomum villosum can promote the secretion of substance P and motilin in the human body and improve gastrointestinal motility.

[0024] Fritillaria thunbergii, with its pungent flavor and neutral properties, has the effects of clearing heat and moistening the lungs, resolving phlegm and relieving cough. It is primarily used to treat symptoms such as fever due to typhoid fever, stranguria caused by pathogenic qi, cough due to deficiency and cold, hernia, and laryngeal congestion. Modern pharmacological research indicates that it is primarily used to relieve cough and asthma, eliminate phlegm, and has anti-inflammatory, anti-tumor, and analgesic properties. Xu Fangzhou et al. discovered that thunbergine B, a compound found in Fritillaria thunbergii, has excellent analgesic effects and is non-addictive. The authors also found that in a formalin-induced mouse inflammatory model, dehydrofritinine (fritinine B) had essentially the same analgesic effects as morphine in both the early and late stages of the experimental period, demonstrating that dehydrofritinine has a strong ameliorative effect on inflammatory pain.

[0025] Magnolia officinalis is bitter, pungent, and warm. It enters the spleen, stomach, lung, and large intestine meridians. It dries dampness and eliminates phlegm, and relieves qi and distension. It is used for dampness stagnation, abdominal distension and vomiting and diarrhea, food accumulation and qi stagnation, abdominal distension and constipation, and cough and wheezing caused by phlegm and fluid retention. Modern pharmacological studies have shown that it has anti-inflammatory, analgesic, and stomach-tonifying effects. Hot plate and acetic acid writhing tests have confirmed that Magnolia officinalis, combined with cardamom and liquorice, has a significant analgesic effect. Metabolomics technology has revealed that its analgesic mechanism is closely related to the metabolic pathways of alanine, aspartate, and glutamate. Clinical studies have confirmed that Pingwei Powder, which is a combination of Magnolia officinalis, Chinese angelica dahurica, dried tangerine peel and Atractylodes macrocephala, has a significant therapeutic effect on functional gastrointestinal diseases: Qian Fang et al. added Pingwei Powder to the control group drugs (domperidone tablets and omeprazole enteric-coated tablets) to treat functional dyspepsia. The results showed that the patients in the treatment group had better improvement in the quality of life (SF-36) scale scores and abdominal discomfort symptoms such as premature satiety, belching, abdominal distension, loss of appetite, nausea and vomiting than the control group, and the overall effective rate was higher (92.86% vs. 77.50%).

[0026] Citrus aurantium (Fructus Aurantii) is bitter, pungent, sour, and slightly cold. It enters the spleen and stomach meridians. It regulates qi, relieves fullness, relieves stagnation, and relieves bloating. It is used to treat chest and flank qi stagnation, distension and pain, indigestion, phlegm and fluid retention, and organ prolapse. Modern pharmacological research has shown that it has gastrointestinal regulating, antibacterial, lipid-lowering, anti-gasification, anti-tumor, and liver-protective effects. Zheng Ying et al. found that both volatile oil and limonene from Citrus aurantium have a significant effect on promoting gastrointestinal motility, and that limonene content is positively correlated with this effect. Zhu Jing et al. found that aqueous extracts of raw and processed Citrus aurantium effectively enhanced the therapeutic effect of a rat model of functional dyspepsia. The mechanism of action is related to upregulating gastrin (GAS) expression and downregulating somatostatin (SS) protein expression in the hypothalamus and antrum.

[0027] Corydalis yanhusuo (Yuhusuo) is pungent, bitter, and warm. It enters the liver and spleen meridians. It promotes blood circulation, promotes qi, and relieves pain. It is used to treat chest, flank, and abdominal pain, chest pain, heart pain, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain from falls. Modern pharmacological research shows that Corydalis yanhusuo has anti-inflammatory, analgesic, sedative, hypnotic, and antiarrhythmic effects. Corydalis yanhusuo total alkaloids can increase the pain threshold of mice induced by a hot plate, and their analgesic effect is superior to that of tetrahydropalmatine. The analgesic mechanism of Corydalis yanhusuo involves multiple aspects, including anti-inflammation, effects on calcium ion channels, and effects on neurotransmitters. These effects work together to exert an analgesic effect, making Corydalis yanhusuo a broad-spectrum, highly effective analgesic in Traditional Chinese Medicine.

[0028] Cuttlebone (Cuttlebone) is salty, astringent, and warming. It enters the spleen and kidney meridians. It astringes and stops bleeding, stops leukorrhea, reduces acidity and relieves pain, and absorbs dampness and heals ulcers. It is used for hematemesis, epistaxis, metrorrhagia, hematochezia, spermatorrhea, leucorrhea, stomach pain, and acid reflux. It is also used externally to treat bleeding injuries, eczema, eczema, and persistent ulcers. Modern pharmacological research shows that it has gastric acid neutralizing, mucosal protection, anti-ulcer, hemostatic, and analgesic effects. Cuttlebone can be combined with qi-regulating herbs such as Corydalis yanhusuo, Cyperus rotundus, costus root, Amomum villosum, and Curcuma aromatica to enhance its analgesic effects. It is used to treat epigastric distension and pain caused by stomach qi disharmony, reflux esophagitis, and gastric ulcers. Cuttlebone mainly contains calcium carbonate, as well as shell keratin, mucus, and calcium phosphate. Cuttlebone polysaccharides also have the effect of neutralizing gastric acid. Guo Yifeng et al. pretreated mice with the salt-washed component of polysaccharide extracted from cuttlebone (CBP-s) and then gavaged them with anhydrous ethanol. The results showed that after 3 and 5 days of CBP-s pretreatment, the pH of each group was significantly increased, and was basically close to that of the normal group, suggesting that cuttlebone polysaccharides have the effect of increasing gastric acid pH.

[0029] Corrugated seeds are salty and neutral. They enter the lung, stomach, and liver meridians. They eliminate phlegm and resolve blood stasis, soften and disperse hard masses, and relieve acid and pain. They are used to treat stubborn and sticky phlegm that is difficult to cough up, goiters, scrofula, lumps in the abdomen, and stomachache and acid reflux. The Shandong Handbook of Chinese Herbal Medicine states that they "relieve acid and relieve pain, and treat ulcers." Therefore, calcined Corrugated seeds are a special antacid. Modern pharmacological studies have shown that Corrugated seeds are mainly composed of calcium carbonate and contain a variety of inorganic elements and organic substances. After calcination, they can significantly increase the elements beneficial to the human body and greatly reduce the elements harmful to the human body. In addition, Corrugated seeds and their different processed products can significantly reduce the gastric mucosal ulcer index and gastric juice pH value, significantly increase the levels of superoxide dismutase and vascular endothelial growth factor in rat serum, and reduce the level of propylene glycol in rat serum. Their acid and pain relief effects are closely related to their trace elements.

[0030] Licorice is sweet and neutral. It enters the Heart, Lung, Spleen, and Stomach meridians. It tonifies the spleen and replenishes Qi, clears heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal herbs. It is used to treat spleen and stomach deficiency, fatigue, palpitations and shortness of breath, cough with sputum, acute pain in the abdomen and limbs, carbuncles and sores, and to alleviate drug toxicity and potency. Modern pharmacological research has shown that licorice has anti-inflammatory, anti-tumor, antibacterial, antiviral, antioxidant, and immunomodulatory effects, and has excellent therapeutic effects on cardiovascular and cerebrovascular diseases, diabetes, and liver disease. Yan et al. found that licorice chalcone A can reduce the expression of inflammasomes, IL-1β, and IL-18, thereby alleviating LPS-induced chondrocyte necrosis. Shaoyaogancao Decoction, a combination of licorice and peony, is commonly used in modern clinical practice to treat various pain conditions, including low back and leg pain, gastric pain, sciatica associated with lumbar spine disease, hemifacial spasm, and trigeminal neuralgia. Jin Quan et al. observed the analgesic effect of Licorice and Aconite Decoction on the cold-dampness syndrome pain model in mice and found that the analgesic effect of Licorice and Aconite Decoction on the cold-dampness syndrome pain model in mice was more significant than that on the simple mouse pain model, indicating that its therapeutic effect is closely related to the syndrome type and has a good analgesic effect.

[0031] It regulates Qi and harmonizes the stomach, reduces acidity and relieves pain. It is used for epigastric pain caused by damp-heat in the middle and stagnation of Qi in the spleen and stomach. Symptoms include epigastric distension and pain that extends to the flanks, fullness and acid reflux, nausea and vomiting, heaviness and fatigue, and short, yellow urine. The tongue is red with a greasy, yellow coating, and a slippery or rapid pulse. It is used for chronic gastritis and peptic ulcers with the above symptoms. DETAILED DESCRIPTION

[0032] Example 1:

[0033] A traditional Chinese medicine composition for treating epigastric pain is composed of the following medicinal ingredients in parts by weight: 6 parts of coptis root, 30 parts of oldenlandia diffusa, 6 parts of white cardamom, 3 parts of amomum villosum, 6 parts of magnolia bark, 6 parts of fructus aurantii, 10 parts of corydalis yanhusuo, 12 parts of cuttlefish bone, 12 parts of citrus aurantium, and 3 parts of liquorice.

[0034] The specific preparation method includes the following steps: calculating according to weight parts.

[0035] The first step is to add 8-10 times the amount of water to the above-mentioned cuttlefish bones and corrugated paper and boil them for 1-2 hours, then add the remaining amount of the above-mentioned medicinal ingredients and continue boiling for 1-3 times, each time for 1-2 hours, while collecting the volatile oil, filtering the residue, and setting aside the filtrate;

[0036] The second step is to reduce the pressure and concentrate the filtrate to a clear paste with a relative density of 1.0 to 1.5 at 40°C to 65°C, and then dry it to make a dry paste powder;

[0037] The third step is to take the dry paste powder, add appropriate amount of auxiliary materials, spray in volatile oil, and use conventional technology to make an oral solid preparation.

[0038] The auxiliary materials are: one or a mixture of any of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micropowder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.

[0039] Example 2:

[0040] A traditional Chinese medicine composition for treating epigastric pain is composed of the following medicinal ingredients in parts by weight: 3 parts of coptis root, 15 parts of oldenlandia diffusa herb, 3 parts of white cardamom, 2 parts of amomum villosum, 3 parts of magnolia bark, 3 parts of fructus aurantii, 6 parts of yanhusuo (corydalis yanhusuo), 10 parts of cuttlefish bone, 10 parts of citronella, and 2 parts of liquorice.

[0041] The specific preparation method includes the following steps: calculating according to weight parts.

[0042] The first step is to add 8-10 times the amount of water to the above-mentioned cuttlefish bones and corrugated paper and boil them for 1-2 hours, then add the remaining amount of the above-mentioned medicinal ingredients and continue boiling for 1-3 times, each time for 1-2 hours, while collecting the volatile oil, filtering the residue, and setting aside the filtrate;

[0043] The second step is to reduce the pressure and concentrate the filtrate to a clear paste with a relative density of 1.0 to 1.5 at 40°C to 65°C, and then dry it to make a dry paste powder;

[0044] The third step is to take the dry paste powder, add appropriate amount of auxiliary materials, spray in volatile oil, and use conventional technology to make an oral solid preparation.

[0045] The auxiliary materials are: one or a mixture of any of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micropowder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.

[0046] Example 3:

[0047] A traditional Chinese medicine composition for treating epigastric pain is composed of the following medicinal ingredients in parts by weight: 10 parts of coptis root, 60 parts of oldenlandia diffusa, 10 parts of white cardamom, 6 parts of amomum villosum, 12 parts of magnolia bark, 12 parts of fructus aurantii, 20 parts of yanhusuo (corydalis yanhusuo), 20 parts of cuttlefish bone, 20 parts of citronella, and 6 parts of liquorice.

[0048] The specific preparation method includes the following steps: calculating according to weight parts.

[0049] The first step is to add 8-10 times the amount of water to the above-mentioned cuttlefish bones and corrugated paper and boil them for 1-2 hours, then add the remaining amount of the above-mentioned medicinal ingredients and continue boiling for 1-3 times, each time for 1-2 hours, while collecting the volatile oil, filtering the residue, and setting aside the filtrate;

[0050] The second step is to reduce the pressure and concentrate the filtrate to a clear paste with a relative density of 1.0 to 1.5 at 40°C to 65°C, and then dry it to make a dry paste powder;

[0051] The third step is to take the dry paste powder, add appropriate amount of auxiliary materials, spray in volatile oil, and use conventional technology to make an oral solid preparation.

[0052] The auxiliary materials are: one or a mixture of any of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micropowder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.

[0053] The above-mentioned drugs can be made into any other oral preparations in pharmacy, such as tablets, granules, capsules, powders, pills, oral liquids, etc.

[0054] To demonstrate the efficacy of the present invention in treating epigastric pain, a clinical trial report of the present invention is provided below:

[0055] Clinical research data

[0056] 1. General Data: 122 patients were randomly divided into two groups. The treatment group consisted of 80 patients (42 males and 38 females, aged 28-68 years, average age 43.6 years). The control group consisted of 42 patients (22 males and 20 females, aged 27-65 years, average age 42.8 years). There was no statistically significant difference in the general data between the two groups, indicating that the two groups were comparable.

[0057] 1.1 Traditional Chinese Medicine Diagnostic Criteria:

[0058] Refer to the Traditional Chinese Medicine diagnosis and treatment plan for epigastric pain issued by the State Administration of Traditional Chinese Medicine in 2017 and "Traditional Chinese Medicine Internal Medicine" (edited by Zhang Boli, published by People's Medical Publishing House in 2012).

[0059] Main symptoms: epigastric pain of varying degrees and nature.

[0060] Secondary symptoms: epigastric fullness, stuffiness, belching, acid reflux, poor appetite, flank distension, abdominal distension, etc.

[0061] This disease can occur in any age group, but is more common in middle-aged and elderly people. It often recurs and is difficult to cure.

[0062] Syndrome diagnosis: Damp-heat obstructing the middle part of the body, stagnation of spleen and stomach qi. Clinical manifestations include: urgent epigastric pain, accompanied by a feeling of fullness, burning sensation, belching, noisy, acid reflux, poor appetite, nausea, dry and bitter mouth, heaviness and drowsiness, and short, yellow urine. A red tongue with a yellow or greasy coating and a slippery or rapid pulse are present.

[0063] 1.2 Western medicine diagnostic criteria

[0064] Refer to the "Chinese Consensus on Chronic Gastritis (2012, Shanghai)" and the "Kyoto Global Consensus on Helicobacter pylori Gastritis (2014, Kyoto)" issued by the Gastroenterology Branch of the Chinese Medical Association in 2012.

[0065] Chronic gastritis often presents with upper abdominal pain, early satiety, decreased appetite, reduced food intake, or heartburn and acid reflux. Symptoms are nonspecific, and diagnosis relies on gastroscopy, pathology, and Helicobacter pylori testing.

[0066] (1) Endoscopic diagnosis

[0067] Non-atrophic gastritis: Endoscopic findings include erythema (dots, strips, flakes), rough mucosa, bleeding spots or patches, and mucosal edema or exudation.

[0068] Atrophic gastritis: Endoscopically, the mucosa may be red and white, with white being the main color. Mucosal folds may become flat or even disappear. Mucosal blood vessels may be exposed, and the mucosa may be granular or nodular.

[0069] If accompanied by bile reflux, erosion, intramucosal bleeding, etc., it is described as atrophic gastritis or non-atrophic gastritis with bile reflux, erosion, intramucosal bleeding, etc.

[0070] (2) Pathological diagnosis

[0071] Two to five biopsies may be obtained as needed. The endoscopist should provide the pathology department with the sample site, endoscopic findings, and a brief medical history. The pathologist should report the histological changes in each biopsy specimen and grade H. pylori, chronic inflammation, active inflammation, atrophy, intestinal metaplasia, and dysplasia.

[0072] If a biopsy of chronic gastritis shows atrophy of the intrinsic glands, it can be diagnosed as atrophic gastritis. It is not necessary to consider the number and degree of atrophy in the biopsy specimen. Clinicians can make a judgment on the scope and degree of the lesion based on the pathological results and endoscopic findings.

[0073] 1.3 Inclusion criteria

[0074] Meet the diagnostic criteria of chronic gastritis in Western medicine;

[0075] Meet the TCM syndrome differentiation criteria of damp-heat obstruction and spleen and stomach qi stagnation;

[0076] Aged 18-70 years old, willing to participate in this study;

[0077] 1.4 Exclusion criteria

[0078] Those who do not meet the Chinese medicine dialectical standards and Western medicine diagnosis;

[0079] Those aged under 18 or over 70;

[0080] Patients with serious diseases of the heart, liver, kidney, hematopoietic system, mental and nervous system, or tumors;

[0081] Patients with duodenal ulcer and esophageal cancer;

[0082] Patients with bacillary dysentery, intestinal tuberculosis, and inflammatory bowel disease;

[0083] Those with critical conditions and unstable vital signs;

[0084] Pregnant or breastfeeding women;

[0085] Unwilling to cooperate with clinical observers;

[0086] 2. Treatment Methods

[0087] 2.1 Treatment group: This product decoction (1 bag per time, twice daily) combined with omeprazole enteric-coated tablets (20 mg / dose, once daily on an empty stomach in the morning) for 2 weeks. Other Chinese patent medicines with similar efficacy were prohibited during the observation period.

[0088] 2.2 The control group received omeprazole enteric-coated tablets (20 mg / dose) orally once daily in the morning on an empty stomach for 2 weeks. The use of other Chinese patent medicines with similar efficacy was prohibited during the observation period.

[0089] 3. Observation indicators

[0090] 3.1 Safety indicators

[0091] General physical examination items, blood routine, urine routine, stool routine, electrocardiogram, liver function (ALT, AST, GGT, ALP, TBIL), renal function (BUN, Cr) and observation of adverse events.

[0092] 3.2 Efficacy indicators: main symptoms, TCM syndromes, gastroscopy,

[0093] 3.2.1. Evaluation criteria for efficacy of main symptoms

[0094] The main symptoms of epigastric pain, fullness, and acid reflux were recorded and evaluated. Percentage of symptom improvement = (total score before treatment - total score after treatment) / total score before treatment × 100%.

[0095] (1) Recovery: symptoms disappear;

[0096] (2) Significantly effective: symptom improvement rate ≥80%;

[0097] (3) Effective: 50% ≤ symptom improvement percentage < 80%;

[0098] (4) Ineffective: symptom improvement percentage <50%;

[0099] 3.2.2. Evaluation criteria for syndrome efficacy

[0100] The efficacy index was calculated using the nimodipine method: (score before treatment - score after treatment) / score before treatment × 100%.

[0101] (1) Clinical recovery: symptoms and signs disappear or almost disappear, efficacy index ≥ 95%;

[0102] (2) Markedly effective: symptoms and signs are significantly improved, with an efficacy index of 70% ≤ < 95%;

[0103] (3) Effective: symptoms and signs improved significantly, 30% ≤ efficacy index < 70%;

[0104] (4) Ineffective: Symptoms and signs have no significant improvement or even worsen, and the efficacy index is <30%.

[0105] 3.2.3. Endoscopic evaluation criteria for gastric mucosal efficacy

[0106] The endoscopic erythema, erosion, bleeding, pallor, exposed blood vessels, and mucosal nodules were counted separately, and the improvement grade of each individual endoscopic manifestation and the degree of improvement of the total score were calculated.

[0107] (1) Recovery: gastric mucosa returns to normal;

[0108] (2) Significant effect: gastric mucosal lesion score decreased by more than 2 grades;

[0109] (3) Effective: gastric mucosal lesion score decreased by 1 grade;

[0110] (4) Ineffective: Gastric mucosal lesions remain unchanged or worsen.

[0111] 4. Treatment outcomes

[0112] 4.1 Efficacy on Main Symptoms

[0113] Table 1 Efficacy of main symptoms

[0114] Group N Cured Significantly effective Effective Ineffective Total effective rate (%) Treatment group 80 12 (15.00) 35 (43.75) 29 (36.25) 4 (5.00) 95.00 Control group 42 2 (4.76) 15 (35.71) 12 (28.57) 13 (30.95) 69.05

[0115] After 2 weeks of medication, 47 patients in the treatment group showed significant improvement, 29 patients were effective, and 4 patients were ineffective, with a total effective rate of 95.00%. In the control group, 17 patients showed significant improvement, 12 patients were effective, and 13 patients were ineffective, with a total effective rate of 69.05%.

[0116] Compared with the control group, p<0.05.

[0117] 4.2 Efficacy of TCM Syndrome

[0118] Table 2 Therapeutic effect of TCM syndromes

[0119] Group N Cured Significantly effective Effective Ineffective Total effective rate (%) Treatment group 80 12 (15.00) 32 (40.00) 30 (37.50) 6 (7.50) 92.50 Control group 42 2 (4.76) 13 (30.95) 12 (28.57) 15 (35.71) 64.28

[0120] After 2 weeks of medication, 44 patients in the treatment group showed significant improvement, 30 patients were effective, and 6 patients were ineffective, with a total effective rate of 92.50%. In the control group, 15 patients showed significant improvement, 12 patients were effective, and 15 patients were ineffective, with a total effective rate of 64.28%.

[0121] Compared with the control group, p<0.05.

[0122] 4.3 Efficacy of gastroscopy

[0123] Table 3 Efficacy of gastroscopy

[0124] Group N Cured Significantly effective Effective Ineffective Total effective rate (%) Treatment group 80 17 (21.25) 30 (37.50) 27 (33.75) 6 (7.50) 92.50 Control group 42 4 (9.52) 13 (30.95) 10 (23.81) 15 (35.71) 64.28

[0125] After 2 weeks of medication, 47 patients in the treatment group showed significant improvement, 27 patients were effective, and 6 patients were ineffective, with a total effective rate of 92.50%. In the control group, 17 patients showed significant improvement, 10 patients were effective, and 15 patients were ineffective, with a total effective rate of 64.28%.

[0126] No adverse events occurred during the medication period, and no abnormalities were found in routine blood tests, routine urine tests, routine stool tests, electrocardiograms, liver function tests (ALT, AST, GGT, ALP, TBIL), and renal function tests (BUN, Cr) before and after treatment.

Claims

1. A Chinese medicine composition for treating epigastric pain, characterized in that: It is composed of the following medicinal ingredients in parts by weight: 3-10 parts of Coptis chinensis, 15-60 parts of Hedyotis diffusa, 3-10 parts of white cardamom, 2-6 parts of Amomum villosum, 3-12 parts of Magnolia officinalis, 3-12 parts of Citrus aurantium, 6-20 parts of Corydalis yanhusuo, 10-20 parts of cuttlefish bone, 10-20 parts of Corrugated cardamom, and 2-6 parts of liquorice.

2. A method for preparing a Chinese medicine composition for treating epigastric pain, characterized in that: The following steps are involved: The first step is to add 8-10 times the amount of water to the above-mentioned cuttlefish bones and corrugated paper and boil them for 1-2 hours, then add the remaining medicinal ingredients and continue boiling for 1-3 times, each time for 1-2 hours, while collecting volatile oil, filtering the residue, and using the filtrate for later use; The second step is to reduce the pressure and concentrate the filtrate to a clear paste with a relative density of 1.0 to 1.5 at 40°C to 65°C, and then dry it to make a dry paste powder; The third step is to take the dry paste powder, add appropriate amount of auxiliary materials, spray in volatile oil, and use conventional technology to make an oral solid preparation.

3. The method for preparing the Chinese medicine composition for treating epigastric pain according to claim 2, wherein: The auxiliary materials are: one or a mixture of any of microcrystalline cellulose, starch, sucrose, lactose, dextrin, calcium carbonate, magnesium stearate, gelatin, hydroxymethyl cellulose, micropowder silica gel, xylitol, silicon dioxide, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose or sodium carboxymethyl starch.