Traditional Chinese medicine composition for treating functional dyspepsia and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating functional dyspepsia, relates to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating functional dyspepsia and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 60-72 parts of radix bupleuri, 60-72 parts of radix scutellariae, 60-72 parts of fructus aurantii, 60-72 parts of cortex magnoliae officinalis, 60-72 parts of rhizoma atractylodis, 60-72 parts of pericarpium citri reticulatae, 50-60 parts of rhizoma pinelliae, 50-60 parts of rhizoma atractylodis macrocephalae, 50-60 parts of radix curcumae, 50-60 parts of semen raphani, 50-60 parts of cortex albiziae, 50-60 parts of polygala tenuifolia and 45-55 parts of liquorice. The traditional Chinese medicine composition is mainly used for soothing liver and regulating qi, strengthening spleen and stomach and calming heart and tranquilizing mind, and has a bidirectional regulation effect on disordered gastrointestinal functions, so that dyspepsia symptoms such as epigastric distension, pain, nausea and anorexia are relieved or eliminated.

Description

Technical Field

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

[0002] Functional dyspepsia (FD) refers to functional lesions of the upper gastrointestinal tract with symptoms of dyspepsia that cannot be explained by organic lesions or biochemical abnormalities. Clinical manifestations include epigastric pain, bloating, belching, heartburn, nausea and vomiting, and other upper abdominal symptoms, which belong to the categories of "epigastric pain", "stomach distension", and "noisy" in traditional Chinese medicine. Traditional Chinese medicine believes that the key to the onset of the disease is the disorder of the ascending and descending of qi. Although the disease is in the stomach, it is closely related to the liver and spleen. The basic pathogenesis is weakness in the middle jiao, stagnation of qi, dysfunction of the ascending and descending of the spleen and stomach, and lack of nourishment of the clear orifices. The main treatments are to strengthen the spleen and stomach, soothe the liver and regulate qi, and calm the mind. The incidence rate is high, with a prevalence of 20% in the population, about 20-40% in general outpatient clinics, and about 60-70% in gastroenterology transfers, which seriously affects the quality of life of patients. At present, the search for effective drugs with overall two-way regulation and promotion of coordinated movement in the field of traditional Chinese medicine has been considered the best strategy for the treatment of FD.

[0003] The commonly used drugs for functional dyspepsia include gastrointestinal motility drugs, antispasmodics, probiotic preparations and gastric acid inhibitors, etc., which, combined with diet conditioning and lifestyle adjustments, can achieve good results in more than 80% of patients. For refractory patients who are ineffective with conventional treatment, antidepressants and psychotherapy have achieved good results, but there are also many side effects. Summary of the invention

[0004] In view of the above-mentioned problems, the present invention aims to provide a Chinese medicine composition for treating functional dyspepsia and a preparation method thereof, which can have a bidirectional regulation effect on the treatment of functional dyspepsia, is an effective drug for promoting coordinated movement, and has no obvious side effects.

[0005] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0006] A traditional Chinese medicine composition for treating functional dyspepsia, characterized in that the traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 60-72 parts of bupleurum, 60-72 parts of scutellaria, 60-72 parts of fructus aurantii, 60-72 parts of magnolia bark, 60-72 parts of atractylodes, 60-72 parts of tangerine peel, 50-60 parts of pinellia, 50-60 parts of atractylodes, 50-60 parts of curcuma, 50-60 parts of radish seeds, 50-60 parts of julibrissin bark, 50-60 parts of polygala, and 45-55 parts of liquorice.

[0007] Further, 66 parts of bupleurum, 66 parts of scutellaria, 66 parts of fructus aurantii, 66 parts of magnolia bark, 66 parts of atractylodes, 66 parts of dried tangerine peel, 55 parts of pinellia, 55 parts of atractylodes, 55 parts of curcuma, 55 parts of radish seeds, 55 parts of julibrissin, 55 parts of polygala, and 50 parts of liquorice.

[0008] The present application also discloses a method for preparing a Chinese medicine composition for treating functional dyspepsia, which is characterized by comprising the following steps:

[0009] Step 1: Take 60-72 parts of Bupleurum, 60-72 parts of Scutellaria, 60-72 parts of Citrus aurantium, 60-72 parts of Magnolia officinalis, 60-72 parts of Atractylodes, 60-72 parts of Tangerine peel, 50-60 parts of Pinellia, 50-60 parts of Atractylodes, 50-60 parts of Curcuma, 50-60 parts of Radish Seed, 50-60 parts of Albizzia julibrissin, 50-60 parts of Polygala, and 45-55 parts of Licorice in parts by weight, wash and set aside;

[0010] Step 2: Mix the Bupleurum, Tangerine Peel, Magnolia Officinalis, Atractylodes, Pinellia, and Atractylodes Macrocephala weighed in step 1, add water to cover the medicine by 3-5 cm, soak for 50-90 minutes, heat for 10-15 minutes, decoct and extract volatile oil, and obtain drug residues and volatile oil;

[0011] Step 3: Mix the turmeric, radish seeds, julibrissin bark, polygala tenuifolia, and liquorice obtained in step 1 with the residue obtained in step 2 to obtain a mixed medicinal material, add water and boil for 120 minutes, and separate to obtain a filter residue 1 and a filtrate 1;

[0012] Step 4, boiling the filter residue 1 obtained in step 3 with water for 90 minutes, and separating to obtain filter residue 2 and filtrate 2;

[0013] Step 5, combining filtrate 1 and filtrate 2 to obtain a filtrate, and combining the filtrate with the volatile oil obtained in step 2 to obtain a Chinese medicine composition.

[0014] Furthermore, in step 3, the amount of water added is 8-10 times the weight of the mixed medicinal materials.

[0015] Furthermore, in step 4, the amount of water added is 6-8 times the weight of the filter residue 1.

[0016] The present application also discloses a capsule for treating functional dyspepsia, characterized in that it comprises the Chinese medicine composition as claimed in claim 1, wherein the Chinese medicine composition comprises a filtrate and volatile oil.

[0017] A method for preparing a capsule for treating functional dyspepsia, characterized in that it comprises the following steps:

[0018] Step 1: Concentrating the Chinese medicine composition according to claim 1 into a thick extract with a relative density of 1.4;

[0019] Step 2: Add auxiliary materials and extract to mix thoroughly to form a soft material, granulate and dry to obtain granules;

[0020] Step 3: Spray the volatile oil prepared in claim 3 evenly onto the granules obtained in step 2, mix them thoroughly, and pack them to prepare capsules.

[0021] The beneficial effects of the present invention are as follows: compared with the prior art, the present invention has the following improvements:

[0022] Spleen deficiency and liver depression are the basic pathology of FD patients, and liver qi invading the stomach is the pathological basis of FD. In the early stage of the disease, liver depression and qi stagnation are the main symptoms, followed by liver depression and stomach heat or liver depression and dampness obstruction, all of which are positive symptoms. Long-term illness consumes qi and yin, and liver depression and spleen deficiency, liver depression and yin deficiency, etc. appear, which are mixed symptoms of deficiency and excess, cold and heat. From the perspective of the entire disease process, liver depression and qi stagnation run through the entire disease process, and the pathological mechanism of liver depression and spleen deficiency can explain 50%-60% of the clinical symptoms. Through the substantial research on liver depression and qi stagnation, it is found that its pathological basis is first of all the functional disorder of the excitation and inhibition process of the cerebral cortex, which can affect abnormal changes in people's emotions, and then affect digestion, endocrine, metabolism and other functions. Clinically, most FD patients are more neurotic, anxious and depressed than healthy people, which are symptoms of liver depression and qi stagnation or liver qi reversal in traditional Chinese medicine. Therefore, the key to the treatment of FD is to maintain the ascending and descending functions of the spleen and stomach; soothing the liver and strengthening the spleen, and regulating the qi are the basic methods of treatment; the Chinese medicine composition for the treatment of functional dyspepsia is a formula for the treatment of FD that has been continuously improved and summarized through repeated clinical research. The prescription is composed of bupleurum, citrus aurantium, Magnolia officinalis, Cangbaizhu, dried orange peel, Curcuma, Pinellia, Scutellaria, Ligusticum chuanxiong, etc. In the prescription, bupleurum, citrus aurantium, Magnolia officinalis, dried orange peel, and Curcuma can soothe the liver and regulate qi, strengthen the spleen and dampness, and eliminate fullness; Pinellia and Ligusticum chuanxiong can soothe the stomach and reduce adverse reactions, stop vomiting, eliminate fullness and resolve knots; Ligusticum chuanxiong can soothe the liver and regulate qi, calm the mind and soothe the nerves, and relieve depression and restlessness; the combination of these medicines can strengthen the spleen and stomach, regulate the qi, eliminate fullness, and calm the mind, and can also promote gastrointestinal motility and strengthen digestion and absorption, thereby improving symptoms such as upper abdominal distension, pain, nausea and anorexia.

[0023] The Chinese medicine composition of the present application is a prescription for treating FD under the guidance of the idea of ​​combining the macroscopic syndrome differentiation of traditional Chinese medicine with the microscopic syndrome differentiation of modern medicine, and is based on the establishment of a prescription-disease relative research model. The prescription is mainly for soothing the liver and regulating qi, strengthening the spleen and stomach, and calming the mind. It has a bidirectional regulatory effect on disordered gastrointestinal function, thereby alleviating or eliminating indigestion symptoms such as upper abdominal distension, pain, nausea and anorexia.

[0024] Traditional Chinese medicine has obvious advantages in treating functional dyspepsia. Pharmacodynamics proves that the capsules made of the traditional Chinese medicine composition of this application can significantly improve the gastric emptying function, intestinal propulsion process, electrogastrogram, and gastrointestinal hormone abnormalities of rats with functional dyspepsia. Clinical and toxicological tests have proved that the drug is safe and non-toxic. The research of this project further reveals that traditional Chinese medicine has significant efficacy in treating functional dyspepsia, and has broad prospects, which deserves further in-depth research and promotion. DETAILED DESCRIPTION

[0025] In order to enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention is further described below in conjunction with embodiments.

[0026] Example 1

[0027] The following raw materials were weighed in parts by weight respectively: 66 parts of bupleurum, 66 parts of scutellaria, 66 parts of fructus aurantii, 66 parts of magnolia bark, 66 parts of atractylodes, 66 parts of tangerine peel, 55 parts of pinellia, 55 parts of atractylodes, 55 parts of curcuma, 55 parts of radish seeds, 55 parts of julibrissin, 55 parts of polygala, and 50 parts of liquorice.

[0028] Example 2

[0029] Weigh the following raw materials in parts by weight respectively: 60 parts of bupleurum, 60 parts of scutellaria, 60 parts of fructus aurantii, 60 parts of magnolia bark, 60 parts of atractylodes, 60 parts of tangerine peel, 50 parts of pinellia, 50 parts of atractylodes, 50 parts of curcuma, 50 parts of radish seeds, 50 parts of julibrissin bark, 50 parts of polygala, and 45 parts of liquorice.

[0030] Example 3

[0031] The following raw materials were weighed in parts by weight: 72 parts of Bupleurum, 72 parts of Scutellaria, 72 parts of Citrus aurantium, 72 parts of Magnolia officinalis, 72 parts of Atractylodes, 72 parts of Tangerine peel, 60 parts of Pinellia, 60 parts of Atractylodes, 60 parts of Curcuma, 60 parts of Radish Seed, 60 parts of Albizzia julibrissin, 60 parts of Polygala, and 55 parts of Licorice.

[0032] The preparation methods of Examples 1-3 are the same, and the preparation method in Example 1 is used as an example for description:

[0033] Step 1: Take the bupleurum, scutellaria, fructus aurantii, magnolia bark, atractylodes, tangerine peel, pinellia, atractylodes, curcuma, radish seeds, julibrissin bark, polygala, and liquorice in parts by weight in sequence in Example 1, and wash them;

[0034] Step 2: add water to cover the six Chinese medicinal herbs of Bupleurum, Tangerine Peel, Magnolia Officinalis, Atractylodes, Pinellia, and Atractylodes Macrocephala, soak for 60 minutes, heat and boil to extract volatile oil, and obtain the dregs and volatile oil for later use;

[0035] Step 3: Combine the residues in step 2 with the remaining medicine that was not soaked in step 2, and extract twice by decoction method. For the first extraction, add 8-10 times the amount of water, decoct for 120 minutes to obtain filtrate 1. For the second extraction, add 6-8 times the amount of water, decoct for 90 minutes to obtain filtrate 2. Combine filtrate 1 and filtrate 2 into filtrate.

[0036] The Chinese medicine composition is concentrated into a thick extract with a relative density of 1.4; an appropriate amount of auxiliary materials is added to the extract and fully mixed to form a soft material, which is granulated and dried to obtain granules; the volatile oil is evenly sprayed on the granules obtained in step 2 and fully mixed, and then filled into capsules at a rate of 0.5 g / granule to prepare 1000 granules.

[0037] It should be noted that there is no fixed ratio between the auxiliary materials and the extract in the present application, and the auxiliary materials are only used to adjust the materials during the granulation process; the auxiliary materials can be starch or dextrin.

[0038] Properties: The contents of this capsule are brown granules with a slight fragrance and bitter taste.

[0039] Efficacy: Strengthens the spleen and stomach, soothes the liver and regulates qi, calms the mind and soothes the nerves.

[0040] Main indications: functional dyspepsia.

[0041] Usage: Oral, 4 capsules / time, 3 times / day.

[0042] Contraindications: Pregnant women should take with caution.

[0043] Specification: 0.5 g / pill.

[0044] The following is a typical case for Example 1

[0045] Name: Li Moumou, female, 36 years old, from Weiyang District, Xi'an, no history of herbal allergies. On February 20, 2023, she was treated in the outpatient clinic of Huang Yahui, director of the Department of Spleen and Stomach, Xi'an Traditional Chinese Medicine Hospital. Main complaint: bloating for 15 years. Current medical history: bloating occurred without obvious cause 15 years ago, and was treated in outpatient clinics in various places, but the symptoms did not significantly relieve. Now she is seeking further Chinese medicine treatment in our outpatient clinic. Current symptoms: bloating, obvious after anger, easy to sigh, frequent hiccups, usually irritable temperament, poor appetite, poor night rest, shallow sleep and easy to wake up, stool 1-2 days 1 line, dry quality. Past history: healthy, denial of diabetes, hypertension, coronary heart disease history. Allergy history: denied. Marital and childbearing history: married at the age of 25, pregnant with 1 child and 1 child, son is healthy. Menstrual history: last menstrual period: 2023.02.10, denied pregnancy. Physical examination: clear consciousness, good spirit, no obvious abnormality of skin and mucous membranes, superficial lymph nodes were not touched, no obvious abnormality was found in the head and neck, thorax, heart and lungs, and abdomen. Physiological reflexes existed, and pathological reflexes were not elicited. No obvious abnormality was found in the specialist physical examination. Tongue diagnosis: pale tongue, white fur. Pulse diagnosis: stringy. Diagnosis: functional dyspepsia (liver and stomach disharmony syndrome). Treatment method: mainly soothing the liver and regulating qi, strengthening the spleen and stomach, calming the mind and tranquilizing the nerves, and taking the drug of the present invention orally for 2 months. Reexamination after oral administration of the drug of the present invention. On April 20, 2023, the patient reported a telephone follow-up on taking the drug for 1 month. The bloating was obvious after being angry, easy to sigh, and the hiccups were significantly improved. After 2 months, the above symptoms basically disappeared. Diagnosis: functional dyspepsia (stomach distension and liver and stomach disharmony syndrome). Doctor's advice: prohibit drinking, raw and cold, spicy stimulation, mood swings, and follow-up for discomfort.

[0046] Name: Wang, male, 24 years old. Visited the doctor on March 15, 2024. The patient reported that he was under too much work pressure, and had epigastric distension and poor appetite in the past 7 months, accompanied by poor sleep at night, many dreams, irritability, and hair loss. The tongue was pale, the tongue coating was thick and white, and the pulse was stringy. No obvious abnormalities were found in the physical examination. No obvious abnormalities were found in the gastrointestinal endoscopy. Diagnosis: functional dyspepsia (stomach distension and liver-stomach disharmony syndrome). Treatment: Oral administration of capsules prepared from the Chinese medicine composition of this application (3 capsules / time 3 times / day) to soothe the liver and spleen, calm the mind and tranquilize the nerves. On April 1, 2024, the patient reported increased appetite, significant relief of epigastric distension, and improved sleep at night. After continuing to take the capsules prepared from the Chinese medicine composition of this application orally for 2 weeks as instructed, the symptoms disappeared.

[0047] Clinical Research:

[0048] 1. Controlled treatment experiment: In accordance with the "Guidelines for Clinical Research on New Traditional Chinese Medicines for the Treatment of Gastric Distension Syndrome" issued by the Ministry of Health, formulate diagnostic criteria, syndrome differentiation criteria, inclusion criteria, exclusion criteria, observation indicators and efficacy judgment criteria.

[0049] 2. Research method: The selected cases were randomly divided into a treatment group and a control group, with a total of 120 cases (90 in the treatment group and 30 in the control group).

[0050] 3. Medication method: The treatment group took capsules prepared from the Chinese medicine composition of the present application (hereinafter referred to as Weidongling Capsules), 4 capsules / time, 3 times / day. The control group took metoclopramide, 10 mg / time, 3 times / day. Both drugs are taken before meals, and one month is a course of treatment. Take one course of treatment. During the observation period and within one week before treatment, it is prohibited to use other gastrokinetic drugs and all drugs with antispasmodic, antiemetic, acid-suppressing, analgesic and other effects that affect this study.

[0051] 4. Observation indicators;

[0052] ①Safety testing:

[0053] A. General physical examination.

[0054] B. Routine examination for blood, urine and stool.

[0055] C. Heart, liver and kidney function tests.

[0056] ②Efficacy observation:

[0057] A. Comparison of symptom scores before and after treatment.

[0058] B. Perform gastroscopy and B-ultrasound examination before treatment to rule out organic lesions.

[0059] C. Electrogastrogram and B-ultrasound examination were performed before and after treatment to observe gastric emptying function.

[0060] Experimental research:

[0061] 1. Main pharmacodynamic studies: Improvement of gastric emptying function, intestinal propulsion process, gastric electricity and gastrointestinal hormone abnormalities in functional dyspepsia.

[0062] ① Establishment of animal model: Guo Haijun's method was used to establish the functional dyspepsia animal model.

[0063] Tail clamping stimulation was used to induce rats to fight. Long sponge clamps were used to clamp the distal 1 / 3 of the rat's tail, but not to break it, so that it would be furious and fight with other rats to provoke all rats. Each stimulation lasted 30 minutes, and continuous stimulation within half an hour. As the fight intensified, the rats might be scratched. To avoid inflammation, 0.5% iodine could be repeatedly applied to the injured area to control infection. Stimulation was performed every 3 hours, 4 times a day, for 7 consecutive days.

[0064] ② Gastric emptying function measurement, intestinal propulsion process influence, electrogastrogram and gastrointestinal hormone examination before and after medication.

[0065] Experimental method data:

[0066] Clinical Data

[0067] All 145 patients were outpatients and inpatients of our hospital (Xi'an Traditional Chinese Medicine Hospital) from 2003 to 2006. Laboratory, B-ultrasound, X-ray and other examinations excluded organic lesions of liver, gallbladder and pancreas, and gastroscopy excluded organic lesions of erosion, ulcer and tumor. Among the 145 patients, 53 were males and 92 were females; their ages ranged from 19 to 65 years with an average of 39.6 years; their disease course ranged from 3 months to 5 years; according to TCM syndrome differentiation, there were 38 cases of liver-stomach disharmony type, 44 cases of spleen and stomach weakness type, 32 cases of spleen and stomach damp-heat type, and 31 cases of stomach yin deficiency type.

[0068] Western medicine diagnostic criteria

[0069] The internationally accepted diagnostic criteria for FD are as follows:

[0070] (1) Chronic upper abdominal pain, fullness, heartburn, acid reflux, belching, nausea or (and) vomiting and other symptoms that last for at least 4 weeks;

[0071] (2) Endoscopic examination was normal or ruled out organic lesions such as erosion, ulcer, and tumor;

[0072] (3) Laboratory, abdominal ultrasound and X-ray examinations exclude organic lesions of the liver, gallbladder, pancreas and other organs;

[0073] (4) No diabetes, connective tissue disease, or mental illness;

[0074] (5) No history of abdominal surgery.

[0075] TCM Syndrome Differentiation

[0076] Disharmony between the liver and stomach: abdominal distension, or wandering distension and pain, belching, sighing, induced by emotions; thin white tongue coating, wiry pulse.

[0077] Weak spleen and stomach: dull pain in the stomach, aggravated by hunger, poor appetite, tasteless mouth, loose stools, fatigue, limb weakness, sallow complexion; pale tongue with teeth marks on the edges, thin white or pale tongue coating, and thready and weak pulse.

[0078] Damp-heat in the spleen and stomach: burning pain in the stomach, sticky and bitter mouth, constipation, fatigue, acid reflux; red tongue, yellow or thin yellow tongue coating, and wiry or rapid pulse.

[0079] Deficiency of stomach yin: distension or dull pain in the stomach, poor appetite, dry mouth, fever in the five parts of the body, dry stool; red tongue with little or no coating, and thready pulse.

[0080] Treatment

[0081] All 145 patients were treated with Weidongling Capsules: 3 capsules / time, 3 times / day, 30 minutes before meals; 6 weeks of continuous medication as a course of treatment. Each patient underwent a gastroscopy, blood routine, renal function, liver function, electrocardiogram and other examinations before and after treatment, and 3 pieces of gastric antral mucosa were taken for pathological examination.

[0082] Efficacy criteria

[0083] All the selected FD patients were observed for clinical symptoms of gastric motility disorder before and after treatment, and the scores were calculated according to the symptom scoring criteria, and the clinical efficacy was determined according to the efficacy judgment criteria.

[0084] Symptom scoring criteria

[0085] The symptom scoring standard is 0, 1, 2, and 3 points for the five symptoms of early satiety, upper abdominal distension, nausea, loss of appetite, and gastric burning sensation, respectively, as none (no symptoms), mild (the patient can be aware of the symptoms after being reminded), moderate (the patient is aware of the symptoms but normal activities are not restricted), and severe (the patient has symptoms and normal activities are restricted).

[0086] Efficacy criteria

[0087] The efficacy index is calculated based on the main symptom scores before and after treatment: efficacy index = [(pre-treatment score - post-treatment score) ÷ pre-treatment score] × 100%. Clinical cure: the main symptoms basically disappear, the efficacy index ≥ 90%; marked effect: the main symptoms are significantly improved by 60% ≤ efficacy index < 90%; effective: the main symptoms are improved by 30% ≤ efficacy index < 60%; ineffective: the main symptoms are not significantly improved or even aggravated, the efficacy index < 30%.

[0088] Statistical methods

[0089] The χ2 test was used for statistical analysis.

[0090] Treatment Outcomes

[0091] The comparison of symptom scores before and after treatment is shown in Table 1-1; the comparison of therapeutic effects of different symptom types is shown in Table 1-2.

[0092] Table 1-1 Comparison of symptom scores before and after treatment

[0093]

[0094] Note: P<0.05. There is a significant difference between before and after treatment

[0095] Table 1-2 Comparison of therapeutic effects of different syndromes [n(%)]

[0096]

[0097] Experimental study on the treatment of functional dyspepsia with Weidongling capsule

[0098] Materials and Methods

[0099] 1. Test drugs and reagents

[0100] Motilin powder was provided by Xi'an Traditional Chinese Medicine Hospital (production batch number: 040604); cisapride was produced by Xi'an Janssen Pharmaceutical Co., Ltd. (batch number: 020527814); the motilin radioimmunoassay kit was provided by Beijing Furui Bioengineering Co., Ltd. (batch number: 20040723); and the gastrin radioimmunoassay kit was provided by Beijing Furui Bioengineering Co., Ltd. (batch number: 20040901).

[0101] 2. Animals and instruments

[0102] Animals: ICR mice, weighing 20-22 g, and SD rats, weighing 180-200 g, were provided by the Animal Center of Shaanxi Institute of Traditional Chinese Medicine;

[0103] Instruments: EGG1A electrogastrograph, AL104 1 / 10,000 electronic balance were produced by Mettler-Toledo Instrument (Shanghai Mettler-ToledoGrog) Co., Ltd., and FJ-2008Pγ radioimmunoassay counter was produced by the State-owned No. 262 Factory.

[0104] 3. Methods

[0105] 3.1 Effects on gastric emptying function in mice

[0106] 60 mice, half male and half female, were randomly divided into 5 groups according to sex and weight, with 12 mice in each group, namely the normal water control group, and the 3 dose groups of Weidongling Capsule (large, medium and small (6, 3, 1.5 g / kg).

[0107] Positive control group: Cisapride tablets 15 mg / kg. The mice were given the above-mentioned dose (15 mg / kg Cisapride tablets) once a day for 10 consecutive days. The mice were fasted but not allowed to drink water in the afternoon before the experiment. On the day of the experiment, the mice were given 1 hour after the administration. The mixture was ground and sieved into a 30% paste animal feed, and 0.8 mL / mouse was gavaged (ig) to the mice. After 20 minutes, the animals were killed by dislocation, the stomach was carefully removed and weighed, and then the stomach was cut open along the greater curvature of the stomach, the stomach contents were removed, the water in the stomach was absorbed with filter paper, and the weight was weighed. The difference between the two was the residual feed in the stomach.

[0108] 3.2 Effects on small intestinal propulsion in mice

[0109] Take 55 mice, 25 females and 30 males, and randomly divide them into 5 groups according to sex and weight, with 11 mice in each group, namely normal water control group, 3 dose groups of Weidongling capsule (large, medium and small (6, 3, 1.5g / kg), and positive control group: 15mg / kg of Cisapride tablets. Administer the above doses once a day for 10 consecutive days. Fasting but not water is allowed in the afternoon of the day before the experiment. 20min after administration on the day of the experiment, gavage 0.3mL / mouse of Indian ink, and kill the animals 20min later, cut open the abdomen, gently pull open the intestines, measure the length from the front end of the ink to the pylorus and the length from the pylorus to the ileocecal part, and the ratio of the two is the propulsion rate of the ink, which is used to judge the influence of the propulsion of the small intestine.

[0110] 3.3 Effects on electrogastrogram in rats with functional dyspepsia

[0111] Model preparation and animal grouping treatment: The functional dyspepsia animal model was prepared using Guo Haijun's method.

[0112] 60 SD rats were randomly divided into 6 groups according to sex and weight, with 10 rats in each group. That is, normal control group, model group, 3 dose groups of Weidongling capsule (4, 2, 1g / kg), positive control group: 10mg / kg of Cisapride tablets. Except for the normal control group, the other 5 groups were used to make a functional dyspepsia model of liver depression and spleen deficiency. The distal 1 / 3 of the tail of all rats was clamped with iron clamps to make them furious and fight with other rats to provoke all rats in the cage. Each stimulation lasted 30 minutes, and the stimulation was once every 3 hours, 4 times a day, for 8 consecutive days. At the same time, the above groups were gavaged or given water every day, once a day, for a total of 8 days. Fasting but not water in the afternoon of the day before the experiment. 30 minutes after the last administration on the day of the experiment, 10% urethane (0.5mL / 100g) was used to lightly anesthetize the animals, the hair on the abdomen was cut off, and the skin was routinely disinfected. Perform electrogastrogram on rats for 5 minutes and record the electrogastrogram paper speed, 1min / s, sensitivity 150V / 5min, and count the slow wave frequency and average amplitude within 3 minutes to determine whether the model is successful. This is to judge the effect of Weidongling on the gastric electrical activity of rats.

[0113] 3.4 Effects on motilin, gastrin and gastrointestinal propulsion in rats with functional dyspepsia

[0114] After the EGG of FD model rats was measured, each rat was gavaged with 3 mL of ink. Ten minutes after the drug administration, blood was collected from the common carotid artery, 2 mL of anticoagulated blood was centrifuged to obtain plasma, and 2 mL of non-anticoagulated blood was centrifuged to obtain serum. Plasma motilin and serum gastrin were measured by radioimmunoassay (the determination of motilin and gastrin were carried out according to the regulations of the radioimmunoassay kit). Fifteen minutes after the ink gavage, the rats were killed, the abdomen was opened, the intestines were gently pulled open, and the length from the front end of the ink to the pylorus and the length from the pylorus to the ileocecal part were measured. The ratio of the two was the propulsion rate of the ink, which was used to determine the effect on small intestinal propulsion.

[0115] Statistical processing methods

[0116] SPSS11.0 statistical software was used for analysis. The experimental data were expressed as mean ± SD. T-test was performed between groups to test the significance of the drugs.

[0117] result

[0118] The effects on gastric emptying function of mice are shown in Table 1;

[0119] The effects on intestinal propulsion in mice are shown in Table 2 ;

[0120] The effects of the capsule on the electrogastrogram of FD rats are shown in Table 3 ;

[0121] The effect of Weidongling Capsule on gastrointestinal propulsion function in functional dyspepsia is shown in Table 4;

[0122] The effects of Weidongling on plasma motilin and serum motilin in FD rats are shown in Table 5.

[0123] Table 1 Effect of Weidongling Capsule on Gastric Emptying

[0124]

[0125] Note: *P<0.05, **P<0.01 compared with the control group.

[0126] Table 2 Effect of Weidongling Capsule on gastrointestinal propulsion function

[0127]

[0128] Note: Compared with the control group, *P<0.05, **P<0.01.

[0129] Table 3 Effects of Weidongling on gastric electrical activity in rats with functional dyspepsia

[0130]

[0131] Note: Compared with the model group, *P<0.05, **P<0.01.

[0132] The experimental results in Tables 1 to 3 show that compared with the control group, the slow wave frequency and average amplitude of the electrogastrogram of the model group rats were significantly reduced (P < 0.01, P < 0.05), indicating that the rat model of functional dyspepsia is successful. Compared with the model group, the slow wave frequency and average amplitude of the electrogastrogram of the high-dose Weidongling capsule group and the positive drug cisapride group were significantly increased (P < 0.05).

[0133] Table 4 Effect of Weidongling Capsule on gastrointestinal propulsion function in rats with functional dyspepsia

[0134]

[0135] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001.

[0136] Table 5 Effect of Weidongling FD on plasma motilin and serum gastrin in rats

[0137]

[0138] Note: Compared with the model group, *P<0.05.

[0139] Tables 4 and 5 show that Weidongling Capsule can accelerate gastric emptying and promote gastrointestinal propulsion function in normal mice; it can significantly increase the slow wave frequency and average amplitude of electrogastrogram in FD model rats, and has a significant effect of promoting gastrointestinal propulsion function; it can significantly increase the plasma motilin content and gastrin content in FD model rats. It suggests that Weidongling Capsule is an ideal drug for the treatment of FD and is worthy of clinical promotion and application.

[0140] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A Chinese medicine composition for treating functional dyspepsia, characterized in that: The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 60-72 parts of bupleurum, 60-72 parts of scutellaria, 60-72 parts of fructus aurantii, 60-72 parts of magnolia bark, 60-72 parts of atractylodes, 60-72 parts of tangerine peel, 50-60 parts of pinellia, 50-60 parts of atractylodes, 50-60 parts of curcuma, 50-60 parts of radish seeds, 50-60 parts of julibrissin bark, 50-60 parts of polygala, and 45-55 parts of liquorice.

2. A Chinese medicine composition for treating functional dyspepsia according to claim 1, characterized in that: 66 parts of Bupleurum, 66 parts of Scutellaria, 66 parts of Fructus Aurantii Immaturus, 66 parts of Magnolia officinalis, 66 parts of Atractylodes, 66 parts of Citrus Reticulatae, 55 parts of Pinellia, 55 parts of Atractylodes, 55 parts of Curcuma, 55 parts of Radish Seeds, 55 parts of Albizzia Julibrissin, 55 parts of Polygala, and 50 parts of Liquorice.

3. The method for preparing a Chinese medicine composition for treating functional dyspepsia according to claim 1, characterized in that: The following steps are involved: Step 1: Take 60-72 parts of Bupleurum, 60-72 parts of Scutellaria, 60-72 parts of Citrus aurantium, 60-72 parts of Magnolia officinalis, 60-72 parts of Atractylodes, 60-72 parts of Tangerine peel, 50-60 parts of Pinellia, 50-60 parts of Atractylodes, 50-60 parts of Curcuma, 50-60 parts of Radish Seed, 50-60 parts of Albizzia julibrissin, 50-60 parts of Polygala, and 45-55 parts of Licorice in parts by weight, wash and set aside; Step 2: Mix the Bupleurum, Tangerine Peel, Magnolia Officinalis, Atractylodes, Pinellia, and Atractylodes Macrocephala weighed in step 1, add water to cover the medicine by 3-5 cm, soak for 50-90 minutes, heat for 10-15 minutes, decoct and extract volatile oil, and obtain drug residues and volatile oil; Step 3: Mix the turmeric, radish seeds, julibrissin bark, polygala tenuifolia, and liquorice obtained in step 1 with the residue obtained in step 2 to obtain a mixed medicinal material, add water and boil for 120 minutes, and separate to obtain a filter residue 1 and a filtrate 1; Step 4, boiling the filter residue 1 obtained in step 3 with water for 90 minutes, and separating to obtain filter residue 2 and filtrate 2; Step 5, combining filtrate 1 and filtrate 2 to obtain a filtrate, and combining the filtrate with the volatile oil obtained in step 2 to obtain a Chinese medicine composition.

4. The method for preparing a Chinese medicine composition for treating functional dyspepsia according to claim 3, characterized in that: In step 3, the amount of water added is 8-10 times the weight of the mixed medicinal materials.

5. The method for preparing a Chinese medicine composition for treating functional dyspepsia according to claim 3, characterized in that: In step 4, the amount of water added is 6-8 times the weight of the filter residue 1.

6. A capsule for treating functional dyspepsia, characterized in that: The invention comprises the traditional Chinese medicine composition as claimed in claim 1, wherein the traditional Chinese medicine composition comprises a filtrate and volatile oil.

7. A method for preparing a capsule for treating functional dyspepsia, characterized in that: The following steps are involved: Step 1: Concentrating the Chinese medicine composition according to claim 1 into a thick extract with a relative density of 1.4; Step 2: Add auxiliary materials and extract to mix thoroughly to form a soft material, granulate and dry to obtain granules; Step 3: spray the volatile oil prepared in claim 3 evenly onto the granules obtained in step 2, mix them thoroughly, and pack them to prepare capsules.

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