Gastritis traditional Chinese medicine composition for internal medicine of traditional Chinese medicine and preparation method thereof

Abstract

The invention provides a gastritis traditional Chinese medicine composition for internal medicine of traditional Chinese medicine and a preparation method of the gastritis traditional Chinese medicine composition, and belongs to the technical field of traditional Chinese medicine. Comprising the following raw material components: 48-52 parts of a mangnolia officinalis-scutellaria baicalensis extract, 12-16 parts of citron, 3-7 parts of immature bitter orange, 8-12 parts of alpinia katsumadai, 6-10 parts of galangal, 4-8 parts of lindera aggregata, 6-8 parts of elecampane and 3-5 parts of rhizoma bletillae. The traditional Chinese medicine composition adopts pure traditional Chinese medicine components, has no obvious side effect and has a remarkable curative effect on chronic gastritis.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for gastritis used in traditional Chinese medicine internal medicine and a preparation method thereof. Background Art

[0002] Chronic gastritis refers to a chronic inflammatory disease of the gastric mucosa caused by a variety of causes. The clinical manifestations are mainly upper abdominal pain, fullness and discomfort in the epigastric region, often accompanied by decreased appetite, acid reflux, heartburn, etc. Pathologically, lymphocyte infiltration is the main feature. Some patients may experience atrophy and metaplasia of the glands in the gastric mucosal lamina propria in the later stage, followed by intraepithelial neoplasia, which is closely related to the occurrence of gastric cancer. Nowadays, the prevalence of chronic gastritis is gradually increasing. The prevalence of chronic gastritis based on endoscopic diagnosis in my country is close to 90%. There are many factors that induce chronic gastritis, and Helicobacter pylori (HP) infection, autoimmunity, duodenal-gastric reflux and other factors can all lead to chronic gastritis. Among them, HP infection is the most common cause, which can cause chronic inflammatory damage to the gastric mucosa, and more than 50% of chronic gastritis patients are accompanied by HP infection.

[0003] The classification of chronic gastritis has not yet been unified. The International Classification of Diseases emphasizes the etiology of gastritis. However, since the main potential risk of chronic gastritis is canceration, and the risk of gastric cancer varies with the extent and severity of gastric mucosal atrophy, histological and endoscopic classifications of gastritis are still necessary. In actual clinical practice, there are many ways to classify chronic gastritis. Based on endoscopic and pathological diagnosis, chronic gastritis is divided into two categories: atrophic and non-atrophic.

[0004] Modern medicine mainly treats chronic non-atrophic gastritis with drugs that promote gastric motility, digestive enzyme preparations, gastric mucosal protective agents, HP eradication and acid-suppressing drugs. Chronic gastritis patients with obvious psychological factors can be treated with antidepressants or anti-anxiety drugs. In recent years, Western medicine has achieved certain clinical results in the treatment of this disease, but patients are prone to relapse, causing serious psychological disorders, which is not conducive to improving the quality of life of patients. In addition, due to the presence of certain drug resistance in bacteria, the expected therapeutic effect cannot be achieved. Therefore, the application of traditional Chinese medicine concepts and methods in the treatment of chronic gastritis is imminent, and the development of corresponding Chinese patent medicines is also imminent. Traditional Chinese medicine treatment has obvious advantages in alleviating the side effects and treatment methods of commonly used Western medicine treatments. It has become a hot research area in recent years and deserves further in-depth research and exploration. Summary of the invention

[0005] In order to solve the problems existing in the background technology, the present invention provides a Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine and a preparation method thereof, which adopts pure Chinese medicine ingredients, has no obvious side effects, and has a significant effect in treating chronic gastritis.

[0006] In order to achieve the above-mentioned purpose, in a first aspect, the present invention provides a Chinese medicine composition for gastritis for internal medicine of traditional Chinese medicine, which comprises the following raw material components by weight: 48-52 parts of Magnolia bark-Scutellaria baicalensis extract, 12-16 parts of Citron, 3-7 parts of Citrus aurantium, 8-12 parts of Amomum villosum, 6-10 parts of Alpinia officinarum, 4-8 parts of Linderae serrata, 6-8 parts of Costusroot rhizome and 3-5 parts of Bletilla striata.

[0007] Furthermore, the preparation method of the Magnolia Bark-Scutellaria Baicalensis Extract is as follows:

[0008] A1. Mix 1 part of Magnolia officinalis and 0.6-0.8 part of Scutellaria baicalensis by weight, dry to constant weight, grind, and pass through a 60-100 mesh sieve to obtain a mixed powder;

[0009] A2, add 10-20 parts of ethanol solution to the mixed powder obtained in A1, soak for 60-120 minutes, decoct for 1-1.5 hours, filter and obtain an extract;

[0010] A3. Cool the extract obtained in A2 to room temperature, add 0.8-1.2 parts of modified β-cyclodextrin, stir and mix, concentrate and dry to obtain Magnolia officinalis-Scutellaria baicalensis extract.

[0011] Furthermore, in A1, the drying temperature is 70-90°C.

[0012] Furthermore, in A2, the volume fraction of the ethanol solution is 50-70%.

[0013] Furthermore, in A3, the mixture is stirred at a stirring speed of 180-200 r / min for 2-2.5 h.

[0014] Further, in A3, the preparation method of the modified β-cyclodextrin is as follows:

[0015] B1. Add 5 parts of β-cyclodextrin to 80-120 parts of water by weight and stir evenly to obtain Liquid A;

[0016] B2, dissolving 1 part of polylactic acid-co-glycolic acid in 4-6 parts of dichloromethane, stirring evenly to obtain liquid B;

[0017] B3. Add the liquid B obtained in B2 to the liquid A obtained in B1, stirring while adding. After the addition is completed, continue stirring for 1-2 hours, then heat and evaporate to a paste. After cooling to room temperature, add 0.02-0.04 parts of sodium bicarbonate, stir for 20-40 minutes, then dry, crush, and pass through a 40-80 mesh sieve to obtain modified β-cyclodextrin.

[0018] Furthermore, the stirring speeds in B1, B2 and B3 are all 150-180 r / min.

[0019] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition for gastritis for internal medicine of traditional Chinese medicine, comprising the following steps: mixing Magnolia bark-Scutellaria baicalensis extract, Citron, Immature Citrus aurantium, Amomum villosum, Alpinia officinalis, Linderae strychnifolia, Costus root and Bletilla striata, putting into a vacuum oven, drying to constant weight, crushing and grinding, and passing through a 80-120 mesh sieve to obtain the Chinese medicine composition for gastritis for internal medicine of traditional Chinese medicine.

[0020] Furthermore, the temperature of the vacuum oven is controlled at 60-80°C.

[0021] Furthermore, the Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine is made into an oral preparation, which is any one of pills, powders, granules, capsules and tablets.

[0022] This application has the following beneficial effects:

[0023] 1. In the present invention, by extracting Magnolia officinalis and Scutellaria baicalensis separately, a higher content of effective ingredients such as alkaloids, flavonoids and saponin compounds is obtained, thereby increasing the overall effective ingredient content in the pharmaceutical composition. Alkaloids, flavonoids and saponin compounds have poor solubility, which affects the effective effect. In the present invention, modified β-cyclodextrin is added to encapsulate alkaloids, flavonoids and saponin compounds. β-cyclodextrin is a barrel-shaped cavity structure, the cavity ring is hydrophilic outside, the ring is hydrophobic inside, the hydrophilic group is exposed to the outside, and the alkaloids, flavonoids and saponin compounds are coated inside. The formation of this coating greatly increases the total amount of active substances dissolved in the pharmaceutical composition.

[0024] 2. In the preparation of modified β-cyclodextrin, polylactic acid-glycolic acid copolymer is a degradable polymer material with good biocompatibility and film-forming properties. By compounding polylactic acid-glycolic acid copolymer with β-cyclodextrin, the dissolution rate of the effective ingredients in the extract can be effectively slowed down, and the time of action of the active substances can be prolonged. By adding sodium bicarbonate, the drug can form a porous structure, and the uniform dissolution and release of the active substances in the modified β-cyclodextrin can be achieved, so that the active ingredients in the drug can play a more stable and uniform role, improve their effect, and ultimately increase the relative utilization of the dissolved active substances. In addition, the sodium carbonate produced after the decomposition of sodium bicarbonate has the effect of neutralizing gastric acid in the human body, which can reduce the irritation to the gastrointestinal tract and achieve the effect of protecting the gastric mucosa. When polylactic acid-glycolic acid copolymer is used together with sodium bicarbonate, the two can play a synergistic role and synergistically improve the effectiveness of treating chronic gastritis. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 , a comparative trend chart of the test data of the analgesic effect (characterized by the number of writhing times of mice) of the Chinese medicine compositions prepared in Examples 1-7 of the present invention and Comparative Examples 1-3;

[0026] Figure 2, a comparative trend chart of the experimental data of the efficacy (effectiveness) of the Chinese medicine composition prepared in Example 1 of the present invention and Comparative Examples 1-3 in treating chronic gastritis. DETAILED DESCRIPTION

[0027] The present application is further described in detail below with reference to the embodiments.

[0028] Unless otherwise specified, the raw materials used in the examples and comparative examples of the present application are all commercially available.

[0029] Example 1: (1) Preparation of modified β-cyclodextrin, the preparation method thereof is as follows:

[0030] B1. Add 5 parts of β-cyclodextrin to 100 parts of water by weight and stir at 160 r / min for 20 min to obtain Liquid A.

[0031] B2. According to the same standard weight percentage, dissolve 1 part of polylactic acid-glycolic acid copolymer in 5 parts of dichloromethane, stir at 180r / min for 30min, and obtain liquid B.

[0032] B3. Add the liquid B obtained in B2 to the liquid A obtained in B1, stirring while adding at a speed of 180 r / min. After the addition is completed, continue stirring for 1.5 hours, then heat and evaporate to a paste. After cooling to room temperature, add 0.03 parts of sodium bicarbonate, and stir at a constant speed of 180 r / min for 30 minutes. Then evaporate to dryness, crush, and pass through a 60-mesh sieve to obtain modified β-cyclodextrin.

[0033] Among them, β-cyclodextrin (food grade, content 99%) was purchased from Ningbo Jingshun Biotechnology Co., Ltd. Polylactic acid-glycolic acid copolymer (LA / GA=75 / 25) was purchased from Jinan Daigang Bioengineering Co., Ltd. Dichloromethane (pharmaceutical grade, relative density 1.3266, viscosity 0.43mPa·s) was purchased from Hubei Xinrunde Chemical Co., Ltd. Sodium bicarbonate (food grade, content 99%) was purchased from Henan Fengwei Biotechnology Co., Ltd.

[0034] (2) preparing a Magnolia officinalis-Scutellaria baicalensis extract, the preparation method thereof is as follows:

[0035] A1. Mix 1 part of Magnolia officinalis and 0.7 part of Scutellaria baicalensis by weight, dry in a vacuum oven at 80°C to constant weight, grind, and pass through an 80-mesh sieve to obtain a mixed powder.

[0036] A2. Add 15 parts of 60% ethanol solution by volume to the mixed powder obtained in A1, soak for 100 minutes, boil for 1.2 hours, filter and obtain an extract.

[0037] A3. The extract obtained in A2 is cooled to room temperature, 1 part of modified β-cyclodextrin is added, and the mixture is stirred at a stirring speed of 180 r / min for 2 hours. After stirring and mixing, the mixture is concentrated and dried. Specifically, the extract is first concentrated at a low temperature (about 45° C.) using a vacuum concentrator to remove most of the solvent, which can effectively reduce the effect of heating on the active ingredients of the extract. The concentrated extract is then spray-dried using a spray dryer. The spray drying is carried out at a high temperature (about 180° C.) and a fast spray rate, which can evaporate the water in the droplets more efficiently and quickly, thereby avoiding destruction of the active ingredients in the extract. After concentration and drying, the Magnolia officinalis-Scutellaria baicalensis extract is obtained.

[0038] (3) A Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine is prepared, wherein the preparation method is as follows: 50 parts of Magnolia officinalis-Scutellaria baicalensis extract, 13 parts of Citron, 5 parts of Citrus aurantium, 10 parts of Amomum villosum, 7 parts of Alpinia officinalis, 5 parts of Linderae strychnifolia, 7 parts of Aucklandia lappa and 4 parts of Bletilla striata are mixed by weight, placed in a vacuum oven, the temperature is controlled at 70°C, dried to constant weight, crushed and ground, and passed through a 100-mesh sieve to obtain a Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine.

[0039] The Chinese medicine composition for treating gastritis in traditional Chinese medicine can be used as a powder, directly mixed with water to make a liquid medicine for oral administration, or can be made into other oral preparations, such as pills, granules, capsules or tablets. The preparation methods of pills, granules, capsules or tablets all have prior art, which will not be repeated here.

[0040] Example 2: The difference between this example and Example 1 is that: (1) modified β-cyclodextrin is prepared, and the preparation method thereof is as follows:

[0041] B1. Add 5 parts of β-cyclodextrin to 100 parts of water by weight and stir at 180 r / min for 20 min to obtain Liquid A.

[0042] B2. According to the same standard weight percentage, dissolve 1 part of polylactic acid-glycolic acid copolymer in 4 parts of dichloromethane, stir at 180r / min for 30min, and obtain liquid B.

[0043] B3. Add the liquid B obtained in B2 to the liquid A obtained in B1, stirring while adding at a speed of 180 r / min. After the addition is completed, continue stirring for 2 hours, then heat and evaporate to a paste. After cooling to room temperature, add 0.04 parts of sodium bicarbonate, and stir at a constant speed of 180 r / min for 30 minutes. Then evaporate to dryness, crush, and pass through a 80-mesh sieve to obtain modified β-cyclodextrin.

[0044] Example 3: The difference between this example and Example 1 is that modified β-cyclodextrin is prepared, and the preparation method thereof is as follows:

[0045] B1. Add 5 parts of β-cyclodextrin to 120 parts of water by weight and stir at 160 r / min for 20 min to obtain Liquid A.

[0046] B2. According to the same standard weight percentage, dissolve 1 part of polylactic acid-glycolic acid copolymer in 4 parts of dichloromethane, stir at 160r / min for 30min, and obtain liquid B.

[0047] B3. Add the liquid B obtained in B2 to the liquid A obtained in B1, stirring while adding at a speed of 160 r / min. After the addition is completed, continue stirring for 2 hours, then heat and evaporate to a paste. After cooling to room temperature, add 0.05 parts of sodium bicarbonate, and stir at a constant speed of 160 r / min for 30 minutes. Then evaporate to dryness, crush, and pass through a 60-mesh sieve to obtain modified β-cyclodextrin.

[0048] Example 4: The difference between this example and Example 1 is that: (2) Magnolia bark-Scutellaria baicalensis extract is prepared, and the preparation method thereof is as follows:

[0049] A1. Mix 1 part of Magnolia officinalis and 0.6 part of Scutellaria baicalensis by weight, dry in a vacuum oven at 70°C to constant weight, grind, and pass through a 60-mesh sieve to obtain a mixed powder.

[0050] A2. Add 10 parts of 50% ethanol solution by volume to the mixed powder obtained in A1, soak for 60 minutes, boil for 1 hour, filter and obtain an extract.

[0051] A3. Cool the extract obtained in A2 to room temperature, add 0.8 parts of modified β-cyclodextrin, stir at a stirring speed of 180 r / min for 2 hours, mix thoroughly, concentrate and dry to obtain the Magnolia officinalis-Scutellaria baicalensis extract.

[0052] Example 5: The difference between this example and Example 1 is that: (2) Magnolia bark-Scutellaria baicalensis extract is prepared, and the preparation method thereof is as follows:

[0053] A1. Mix 1 part of Magnolia officinalis and 0.8 part of Scutellaria baicalensis by weight, dry in a vacuum oven at 90°C to constant weight, grind, and pass through a 100-mesh sieve to obtain a mixed powder.

[0054] A2. Add 20 parts of 70% ethanol solution by volume to the mixed powder obtained in A1, soak for 120 minutes, boil for 1.5 hours, filter and obtain an extract.

[0055] A3. Cool the extract obtained in A2 to room temperature, add 1.2 parts of modified β-cyclodextrin, stir at a stirring speed of 200 r / min for 2.5 hours, mix thoroughly, concentrate and dry to obtain the Magnolia officinalis-Scutellaria baicalensis extract.

[0056] Example 6: The difference between this example and Example 1 is that: (3) A Chinese medicine composition for gastritis for use in internal medicine of traditional Chinese medicine is prepared, and its preparation method is as follows: by weight, 48 parts of Magnolia bark-Scutellaria baicalensis extract, 12 parts of Citron, 3 parts of Citrus aurantium, 8 parts of Amomum villosum, 6 parts of Alpinia officinalis, 4 parts of Linderae scutellariae, 6 parts of Costus root and 3 parts of Bletilla striata are mixed, put into a vacuum oven, control the temperature to 60°C, dry to constant weight, crush and grind, and pass through an 80-mesh sieve to obtain a Chinese medicine composition for gastritis for use in internal medicine of traditional Chinese medicine.

[0057] Example 7: The difference between this example and Example 1 is that: (3) A Chinese medicine composition for gastritis for use in internal medicine of traditional Chinese medicine is prepared, and its preparation method is as follows: by weight, 52 parts of Magnolia bark-Scutellaria baicalensis extract, 16 parts of Citron, 7 parts of Citrus aurantium, 12 parts of Amomum villosum, 10 parts of Alpinia officinalis, 8 parts of Linderae scutellariae, 8 parts of Costusroot lonicera and 5 parts of Bletilla striata are mixed, put into a vacuum oven, control the temperature to 80°C, dry to constant weight, crush and grind, and pass through a 120-mesh sieve to obtain a Chinese medicine composition for gastritis for use in internal medicine of traditional Chinese medicine.

[0058] Comparative Example 1: The difference between this comparative example and Example 1 is that in the preparation of the Magnolia Bark-Scutellaria Baicalensis Extract, the modified β-cyclodextrin is replaced by β-cyclodextrin.

[0059] Specifically, the Magnolia Bark-Scutellaria Baicalensis Extract is prepared, and the preparation method thereof is as follows:

[0060] A1. Mix 1 part of Magnolia officinalis and 0.7 part of Scutellaria baicalensis by weight, dry in a vacuum oven at 80°C to constant weight, grind, and pass through an 80-mesh sieve to obtain a mixed powder.

[0061] A2. Add 15 parts of 60% ethanol solution by volume to the mixed powder obtained in A1, soak for 100 minutes, boil for 1.2 hours, filter and obtain an extract.

[0062] A3. Cool the extract obtained in A2 to room temperature, add 1 part of β-cyclodextrin, stir at a stirring speed of 180 r / min for 2 hours, mix thoroughly, concentrate and dry to obtain the Magnolia officinalis-Scutellaria baicalensis extract.

[0063] Comparative Example 2: The difference between this comparative example and Example 1 is that in the preparation of the modified β-cyclodextrin, no polylactic acid-glycolic acid copolymer is added.

[0064] Specifically, the modified β-cyclodextrin is prepared, and the preparation method thereof is as follows:

[0065] B1. Add 5 parts of β-cyclodextrin to 100 parts of water by weight and stir at 160 r / min for 20 min to obtain Liquid A.

[0066] B2. Heat the liquid A obtained in B1 and evaporate it to a paste. After cooling to room temperature, add 0.03 parts of sodium bicarbonate and stir at a stirring speed of 180 r / min for 30 minutes. Then evaporate to dryness, grind and pass through a 60-mesh sieve to obtain modified β-cyclodextrin.

[0067] Comparative Example 3: The difference between this comparative example and Example 1 is that no sodium bicarbonate is added in the preparation of modified β-cyclodextrin.

[0068] Specifically, the modified β-cyclodextrin is prepared, and the preparation method thereof is as follows:

[0069] B1. Add 5 parts of β-cyclodextrin to 100 parts of water by weight and stir at 160 r / min for 20 min to obtain Liquid A.

[0070] B2. According to the same standard weight percentage, dissolve 1 part of polylactic acid-glycolic acid copolymer in 5 parts of dichloromethane, stir at 180r / min for 30min, and obtain liquid B.

[0071] B3. Add the liquid B obtained in B2 to the liquid A obtained in B1, stirring while adding, and the stirring speed is 180r / min. After the addition is completed, continue stirring for 1.5 hours, then heat and evaporate to a paste, continue evaporating and drying, crush, and pass through a 60-mesh sieve to obtain modified β-cyclodextrin.

[0072] Test Example 1: Test item: drug administration toxicity test.

[0073] Test subjects: Chinese medicine compositions were prepared according to Examples 1-7 and Comparative Examples 1-3.

[0074] Test method and results: 50 ICR mice were selected, half male and half female, weighing 18.0-22.0g, and randomly divided into 10 groups according to sex and weight, with 5 mice in each group. Before administration, fasting but not water confinement was performed for about 13 hours, and then the Chinese medicine composition liquid prepared by Example 1-7 and Comparative Example 1-3 was administered by oral gavage at 40mL / kg (0.4g Chinese medicine composition / mL liquid), and the drug was administered twice on the day of administration (with an interval of 6h between administrations, fasting but not water confinement between administrations), and the cumulative dose on the day was 32g Chinese medicine composition / kg. No abnormality was observed in the mice after administration, and no obvious abnormality was observed in the weight and autonomous activity of the mice during the 14-day observation period after administration. After the end of the observation period, all mice were anesthetized and euthanized, and no obvious abnormality was observed in each organ after gross dissection and naked eye observation. It shows that the Chinese medicine compositions prepared by Example 1-7 and Comparative Example 1-3 are non-toxic.

[0075] Under the conditions of this experiment, the dosage of mice was approximately equivalent to 107-320 times the clinical dosage for adults (calculated by kilogram body weight). No toxic reactions or deaths were observed in all mice, indicating that its MTD>32.0g Chinese medicine composition / kg.

[0076] Test example 2: Test item: analgesic effect of drug administration.

[0077] Test subjects: Chinese medicine compositions were prepared according to Examples 1-7 and Comparative Examples 1-3.

[0078] Test content: This test evaluates the peripheral analgesic effect of the corresponding Chinese medicine composition by the experiment of acetic acid-induced writhing reaction in mice: 60 ICR mice qualified for quarantine were selected, half male and half female, weighing 18.5-23.7g, and randomly divided into a model control group, a Weikangling capsule group, an embodiment 1-7 group and a comparative example 1-3 group according to gender and weight, with 5 mice in each group. Each group of mice (except the model control group) was given the corresponding drug solution (0.4g drug / mL drug solution) by oral gavage at 30mL / kg, and the model control group was given an equal amount of 0.5% CMC-Na by gavage, once a day, for 7 consecutive days. 30min after the last administration, each group of mice was intraperitoneally injected with 0.6% acetic acid solution 0.2mL / mouse, and observed continuously for 15min. Observe and record the number of writhing reactions (abdomen concave, stretching hind limbs, buttocks raised) of each mouse, and calculate the average value. The smaller the number of writhing times, the better the analgesic effect of the corresponding drug, which can better relieve visceral pain.

[0079] Test results: See Table 1.

[0080] Table 1. Statistical data of Experiment 2

[0081] Grouping / Group Number of twists (average) / times Model comparison 20.7 Weikangling Capsules 9.1 Example 1 7.2 Example 2 6.8 Example 3 6.8 Example 4 7.5 Example 5 6.9 Example 6 7.1 Example 7 7.7 Comparative Example 1 11.9 Comparative Example 2 10.1 Comparative Example 3 10.5

[0082] Result analysis: Analyze the model control group, Weikangling capsule group and Examples 1-7 and combine the data in Table 1 and Figure 1 It can be seen that the Chinese medicine composition prepared by the present invention has good analgesic effect, and is superior to the analgesic effect of Weikangling Capsules.

[0083] Analyze Example 1 and Comparative Examples 1-3 and combine the data in Table 1 and Figure 1 It can be seen that in the preparation of modified β-cyclodextrin, the addition of polylactic acid-glycolic acid copolymer can improve the analgesic effect of the final Chinese medicine composition; the addition of sodium bicarbonate can also improve the analgesic effect of the final Chinese medicine composition; and there is a synergistic effect between the two. The two are added together to prepare modified β-cyclodextrin, and the modified β-cyclodextrin is used to prepare Magnolia bark-Scutellaria baicalensis extract, and the Magnolia bark-Scutellaria baicalensis extract is used to prepare the Chinese medicine composition, which can work synergistically and synergistically improve the analgesic effect of the prepared Chinese medicine composition.

[0084] Test example 3: Test project: Clinical treatment trial of chronic gastritis.

[0085] Test subjects: Chinese medicine compositions were prepared according to Example 1 and Comparative Examples 1-3.

[0086] Experimental method: 1. Grouping: Patient recruitment was conducted in a domestic clinical center. 120 patients with chronic gastritis were randomly divided into 4 groups, 30 people in each group, and the Chinese medicine compositions prepared by Example 1 and Comparative Examples 1-3 were taken respectively. There was no statistically significant difference in age, gender, course of disease, etc. between the patients in each group, and they were comparable.

[0087] 2. Diagnostic criteria: The criteria for determining syndrome efficacy and clinical symptom scoring are formulated based on the "Guiding Principles for Clinical Research of New Chinese Medicines" of the Ministry of Health and the "Diagnosis and Efficacy Criteria for TCM Diseases and Syndromes" of the State Administration of Traditional Chinese Medicine.

[0088] 3. Inclusion criteria: ① Endoscopic examination meets the diagnostic criteria for chronic gastritis; ② Symptoms include epigastric pain, bloating, acid reflux, poor appetite, loose stools, fatigue, etc.; the course of disease is more than 2 months; ③ Meet the syndrome differentiation criteria for spleen and stomach damp-heat; ④ Age 20 to 65 years old, regardless of gender; ⑤ The patient agrees to cooperate with the treatment of this plan, and the informed consent signed by the patient is obtained.

[0089] 4. Exclusion criteria: ① Gastritis caused by long-term use of non-steroidal anti-inflammatory drugs, ethanol intake, and other types of gastritis such as autoimmune gastritis; ② Patients with a history of gastrointestinal surgery; ③ Patients with peptic ulcer, gastric polyps, and gastrointestinal tumors; ④ Patients with severe liver, kidney, heart and lung dysfunction, and patients with other internal and external diseases requiring emergency treatment; ⑤ Pregnant or lactating women; ⑥ Patients with mental illness, depression, and abnormal cognitive function; ⑦ Severe allergic constitution, allergic to the known drug ingredients in this study.

[0090] 5. Efficacy criteria: "None, mild, moderate, severe" are recorded as "0, 1, 2, 3 points" respectively. The patient's epigastric pain, bloating, acid reflux, poor appetite, loose stools, fatigue and other symptoms are scored before and after treatment, and the total score is calculated. The proportion of total score reduction after treatment is calculated according to the following formula. Total score reduction ratio = (total score before treatment - total score after treatment) / total score before treatment × 100%. According to the proportion of total score reduction, combined with the results of gastroscopy, the efficacy is divided into cured, markedly effective, effective and ineffective.

[0091] Among them, cured: after treatment, the total score of the main clinical symptoms decreased by ≥75%, active inflammation disappeared in gastroscopy examination, and chronic inflammation improved;

[0092] Markedly effective: 75% > The total score of the main clinical symptoms decreased by ≥55% after treatment. Gastroscopy showed that the acute inflammation of the mucosa basically disappeared, and the chronic inflammation improved.

[0093] Effective: 55% > After treatment, the total score of the main clinical symptoms decreased by ≥40%, the scope of mucosal lesions in gastroscopy was reduced by more than 1 / 2, and the inflammation was alleviated;

[0094] Ineffective: After treatment, the total score of the main clinical symptoms decreased by less than 40%, or the symptoms worsened.

[0095] 6. Medication method: Patients in each group take the corresponding group of Chinese medicine combination once in the morning and evening every day, with each dose of 18.4g. Ten days is one course of treatment, and one course of treatment is completed.

[0096] Test results: See Table 2.

[0097] Table 2. Statistical data of Experiment 3

[0098]

[0099] Test results: According to Example 1 combined with the data in Table 1 and Figure 2 It can be seen that the effective rate of the Chinese medicine composition prepared by the present invention in treating chronic gastritis is as high as 93.3%, and the therapeutic effect is remarkable.

[0100] By combining the data in Table 1 and Comparative Examples 1-3 Figure 2 It can be seen that in the preparation of modified β-cyclodextrin, the addition of polylactic acid-glycolic acid copolymer can improve the efficacy (effectiveness) of the final Chinese medicine composition for treating chronic gastritis; the addition of sodium bicarbonate can also improve the efficacy (effectiveness) of the final Chinese medicine composition for treating chronic gastritis; and there is a synergistic effect between the two, which can synergistically improve the efficacy (effectiveness) of the prepared Chinese medicine composition for treating chronic gastritis.

[0101] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

[0102] In addition, various embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the present invention, they should also be regarded as the contents disclosed by the present invention.

Claims

1. A Chinese medicine composition for treating gastritis in traditional Chinese medicine, characterized in that: The raw material components are calculated by weight: 48-52 parts of Magnolia officinalis-Scutellaria baicalensis extract, 12-16 parts of Citron, 3-7 parts of Citrus aurantium, 8-12 parts of Alpinia galanga, 6-10 parts of Alpinia officinalis, 4-8 parts of Linderae serrata, 6-8 parts of Aucklandia lappa and 3-5 parts of Bletilla striata.

2. The Chinese medicine composition for treating gastritis in traditional Chinese medicine according to claim 1, characterized in that: The preparation method of the Magnolia Bark-Scutellaria Baicalensis Extract is as follows: A1. Mix 1 part of Magnolia officinalis and 0.6-0.8 part of Scutellaria baicalensis by weight, dry to constant weight, grind, and pass through a 60-100 mesh sieve to obtain a mixed powder; A2, add 10-20 parts of ethanol solution to the mixed powder obtained in A1, soak for 60-120 minutes, decoct for 1-1.5 hours, filter and obtain an extract; A3. Cool the extract obtained in A2 to room temperature, add 0.8-1.2 parts of modified β-cyclodextrin, stir and mix, concentrate and dry to obtain Magnolia officinalis-Scutellaria baicalensis extract.

3. The Chinese medicine composition for treating gastritis in traditional Chinese medicine according to claim 2, characterized in that: In A1, the drying temperature is 70-90°C.

4. The Chinese medicine composition for treating gastritis in traditional Chinese medicine according to claim 2, characterized in that: In A2, the volume fraction of the ethanol solution is 50-70%.

5. The Chinese medicine composition for treating gastritis in traditional Chinese medicine according to claim 2, characterized in that: In A3, stir at a constant speed of 180-200 r / min for 2-2.5 h.

6. The Chinese medicine composition for treating gastritis in traditional Chinese medicine according to claim 2, characterized in that: In A3, the preparation method of the modified β-cyclodextrin is as follows: B1. Add 5 parts of β-cyclodextrin to 80-120 parts of water by weight and stir evenly to obtain Liquid A; B2, dissolving 1 part of polylactic acid-co-glycolic acid in 4-6 parts of dichloromethane, stirring evenly to obtain liquid B; B3. Add the liquid B obtained in B2 to the liquid A obtained in B1, stirring while adding. After the addition is completed, continue stirring for 1-2 hours, then heat and evaporate to a paste. After cooling to room temperature, add 0.02-0.04 parts of sodium bicarbonate, stir for 20-40 minutes, then dry, crush, and pass through a 40-80 mesh sieve to obtain modified β-cyclodextrin.

7. The Chinese medicine composition for treating gastritis in traditional Chinese medicine according to claim 6, characterized in that: The stirring speed in B1, B2 and B3 is 150-180 r / min.

8. A method for preparing a Chinese medicine composition for treating gastritis in traditional Chinese medicine according to any one of claims 1 to 7, characterized in that: The method comprises the following steps: mixing Magnolia officinalis-Scutellaria baicalensis extract, Citron, Citrus aurantium, Alpinia officinalis, Alpinia officinalis, Linderae strychni, Aucklandia lappa and Bletilla striata, putting the mixture into a vacuum oven, drying the mixture to a constant weight, crushing and grinding the mixture, and passing the mixture through a sieve of 80-120 meshes to obtain a Chinese medicine composition for treating gastritis in internal medicine of traditional Chinese medicine.

9. The method for preparing the Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine according to claim 8, characterized in that: The vacuum oven is controlled at 60-80°C.

10. The method for preparing the Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine according to claim 8, characterized in that: The Chinese medicine composition for treating gastritis in traditional Chinese medicine internal medicine is made into an oral preparation, which is any one of pills, powders, granules, capsules and tablets.

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