Traditional Chinese medicine composition for resisting helicobacter pylori as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating helicobacter pylori infection and a preparation method and application thereof. According to the traditional Chinese medicine composition disclosed by the invention, active ingredients of honeysuckle and scutellaria baicalensis are taken as extraction raw materials, and active ingredients of honeysuckle and scutellaria baicalensis are enriched by adopting different methods and are compounded according to a specific proportion. Experiments show that the traditional Chinese medicine composition has obvious effects of resisting inflammation, improving gastric motility, easing pain and protecting gastric mucosa, has an obvious curative effect on gastritis related to helicobacter pylori, and has more obvious advantages compared with components with other proportions. Moreover, the composition is obtained by extracting two medicines, has few adverse reactions, improves the compliance of patients, and is suitable for long-term use.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for preventing and treating Helicobacter pylori infection. And its preparation method and application. Background Art

[0002] Helicobacter pylori is a Gram-negative bacillus with multiple flagella on the surface, blunt ends, and spiral bends. It is commonly found on the surface of the gastric mucosa or in the gastric pits, but does not invade the intrinsic glands of the mucosa. It is the only microorganism known to survive in the human stomach.

[0003] Helicobacter pylori is extremely harmful. Almost all infected people will develop chronic active gastritis, and some patients will further develop peptic ulcers, including gastric ulcers and duodenal ulcers. Long-term persistent infection with Helicobacter pylori may also lead to the occurrence of gastric malignancies, such as gastric cancer and gastric mucosa-associated lymphoid tissue lymphoma, posing a serious threat to the patient's life and health.

[0004] Antibiotics are the main means of treating Helicobacter pylori infection. However, due to the widespread use of antibiotics, Helicobacter pylori has developed resistance to a variety of antibiotics. For example, the resistance rate of commonly used antibiotics such as amoxicillin and clarithromycin has increased year by year. In addition, although Western medicine treatment can effectively eliminate Helicobacter pylori to a certain extent, it also brings a series of side effects, such as gastrointestinal reactions such as nausea, vomiting, diarrhea, abdominal pain, and allergic reactions such as headache, dizziness, and rash. These side effects directly affect the quality of life of patients and reduce their compliance.

[0005] Traditional Chinese medicine has obvious advantages in treating Helicobacter pylori infection. It has the characteristics of multi-component and multi-target action. It can not only directly inhibit or kill Helicobacter pylori, but also regulate the body's immune function, improve the microecological environment of the gastrointestinal tract, promote the repair of gastric mucosa, and fundamentally treat Helicobacter pylori infection. The recurrence rate is relatively low. In addition, traditional Chinese medicine has a wide range of sources, is relatively cheap, and has relatively few toxic and side effects. However, the efficacy of traditional Chinese medicine prescriptions for Helicobacter pylori is not ideal, and generally has more medicinal flavors, resulting in poor patient compliance. Therefore, further research and improvement are still needed. Summary of the invention

[0006] In view of this, the present invention provides a composition for resisting Helicobacter pylori, which has less medicinal taste and significant curative effect.

[0007] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0008] A method for preparing a Chinese medicine composition, comprising:

[0009] Take 10 portions of honeysuckle, extract with ethanol, and then flocculate and settle. Collect the filtrate after flocculation and sedimentation, apply it to a macroporous resin column, elute, and dry to obtain extract A.

[0010] Extract 20 parts of honeysuckle with water, apply to cellulose column, elute, and dry to obtain extract B;

[0011] 5 portions of honeysuckle were crushed and then ultrasonically extracted with a low eutectic solvent, and precipitated with alcohol; the precipitate was collected to obtain extract C; the low eutectic solvent consisted of choline chloride, alcohol, butanediol and water;

[0012] The alcohol is ethylene glycol, 1,3-butanediol or 1,4-butanediol;

[0013] Take 15 parts of Scutellaria baicalensis radix and extract with water, then precipitate with acid, wash the precipitate with ethanol until it is neutral, and dry it to obtain extract D;

[0014] 2 to 6 parts of extract A, 3 to 9 parts of extract B, 4 to 10 parts of extract C, and 2 to 8 parts of extract D are mixed to obtain the traditional Chinese medicine composition.

[0015] In the present invention, in the preparation of the extract A:

[0016] The flocculant used in the flocculation and sedimentation is selected from chitosan acetic acid solution;

[0017] The macroporous resin column includes HPD600;

[0018] The eluent used for elution is an ethanol solution with a volume fraction of 50%.

[0019] The present invention adopts different extraction methods to enrich and extract two Chinese medicines, honeysuckle and scutellaria, wherein extract A is an organic acid part, extract B is a total polysaccharide part, extract C is a total flavonoid part, and extract D is a baicalin monomer. The four extracts are combined in a specific ratio, and finally the anti-inflammatory, gastric motility, analgesic, and gastric mucosal protective effects are significantly improved, and significant therapeutic effects are shown on gastritis associated with Helicobacter pylori, which has obvious advantages over the prescriptions under other ratios. It is shown that the extracts show obvious synergistic effects on the treatment of Helicobacter pylori and gastritis caused by it under the ratio of the present invention.

[0020] In the present invention, in the preparation of the extract A, after the ethanol extraction and before the flocculation sedimentation, the step of concentrating the ethanol extract to an extract with a relative density of 1.05 to 1.10 is also included.

[0021] In the preparation of the extract B of the present invention, the cellulose column is a DEAE cellulose column, a DEAE-52 cellulose column or a DEAE Sepharose fast flow cellulose column; and the eluent used for elution is a 0.40 mol / L sodium chloride solution.

[0022] In the preparation of the extract C of the present invention, the volume ratio of choline chloride, 1,3-butanediol and water in the deep eutectic solvent is 0.8-1.2:2-6:6-10; in some specific embodiments of the present invention, the volume ratio is 1:4:8. In the present invention, the ultrasonic extraction time is 30 minutes.

[0023] In the preparation of the extract D described in the present invention, after ultrasonic extraction, the extract is subjected to acid precipitation, and the acid precipitation occurs by adjusting the pH of the extract, and then keeping it warm and standing at a certain temperature. In the present invention, the number of acid precipitation is 1 to 2 times, specifically 1 time or 2 times. In the present invention, during the acid precipitation process, the pH of the extract is adjusted by adding hydrochloric acid to adjust the pH of the extract to 1.0 to 2.0, specifically 1.0, 1.5, and 2.0. In the present invention, the insulation temperature is 60 to 80°C, specifically 60°C, 65°C, 70°C, 75°C, and 80°C, and the insulation time is specifically 1 hour, 1.5 hours, and 2 hours. The extract of the pH produces precipitation by standing under the insulation conditions. In the present invention, when the number of acid precipitation is two times, the precipitate of the first acid precipitation is collected, added to water for dissolution, and the pH is adjusted to neutral, and the above acid precipitation operation steps are repeated to perform the second acid precipitation, and the precipitate after the second acid precipitation is eluted with ethanol to neutral, and dried to obtain extract D. In some specific embodiments of the present invention, the acid precipitation specifically includes: adding hydrochloric acid to adjust the pH value to 2.0, keeping warm at 80°C for 2 hours, standing, precipitating, and filtering; collecting the precipitate, adding 5 times the amount of water, stirring evenly, adding 40% sodium hydroxide to adjust the pH value to 7.0, filtering, adding hydrochloric acid to the filtrate to adjust the pH value to 1.0, keeping warm at 60°C for 1 hour, standing, and collecting the precipitate.

[0024] The present invention also provides a traditional Chinese medicine composition prepared by the preparation method.

[0025] Furthermore, the mass fractions of each extract in the traditional Chinese medicine composition are:

[0026] 2-4 parts of extract A, 6 parts of extract B, 7-10 parts of extract C, and 2-5 parts of extract D.

[0027] Furthermore, the mass fraction of each extract in the traditional Chinese medicine composition is specifically:

[0028] Composition 2: 2 parts of extract A, 6 parts of extract B, 7 parts of extract C, 5 parts of extract D

[0029] or:

[0030] Composition 5: 4 parts of extract A, 6 parts of extract B, 10 parts of extract C, and 2 parts of extract D.

[0031] The present invention also provides the use of the Chinese medicine composition in preparing a drug for preventing and treating Helicobacter pylori infection, or in preparing a drug for preventing and treating gastritis caused by Helicobacter pylori infection; the Chinese medicine composition is selected from any one of the following:

[0032] (1) The Chinese medicine composition prepared by the above preparation method of the present invention;

[0033] (2) Silver and yellow granules.

[0034] The Yinhuang granules are prepared from honeysuckle extract and scutellaria baicalensis extract, which can be common commercial products or self-prepared. The specific preparation method includes: preparing honeysuckle extract by water extraction, and preparing scutellaria baicalensis extract by water extraction and acid precipitation; taking 10 parts of honeysuckle extract and 4 parts of scutellaria baicalensis extract, and then preparing Yinhuang granules by conventional granule preparation process in the field according to the standards of the Chinese Pharmacopoeia. The honeysuckle extract and scutellaria baicalensis extract can be prepared according to the following method:

[0035] Preparation of honeysuckle extract: Take 10 parts of honeysuckle, add 8 times the amount of water and boil twice, each time for 1 hour, combine the filtrates, concentrate to 70 degrees Celsius, and the dry paste with a relative density of 1.15-1.20 is crushed and set aside.

[0036] Preparation of Scutellaria baicalensis extract: Take 10 parts of Scutellaria baicalensis, add 10 times of water, decoct twice, 1 hour each time, combine the decoctions, concentrate to an extract with a relative density of 1.10-1.15, adjust the pH value to 1.0-2.0 with hydrochloric acid, keep warm at 80°C, let stand, filter, add 10 times of water to the precipitate and stir evenly, adjust the pH value to 7.0 with 40% sodium hydroxide solution, add an equal amount of ethanol, stir to dissolve, filter, adjust the pH value of the filtrate to 1.0-2.0 with hydrochloric acid, keep warm at 60°C, let stand, filter, wash the precipitate with appropriate amount of water in turn until the pH value reaches neutral, and dry under reduced pressure to obtain.

[0037] In the above application, the prevention and treatment includes at least one of anti-inflammation, improving gastric motility, analgesia or protecting gastric mucosa.

[0038] The experimental results show that the compositions 1 to 9 prepared by combining extracts A to D according to the ratios described in the present invention can significantly reduce the expression levels of IL-1β, IL-6, and TNF-α in mouse serum; increase the expression levels of MTL and Pepsin; reduce the number of mouse twisting, reduce gastric mucosal epithelial edema, ulcers, and ulcer sites, thereby reducing the gastric mucosal injury index (UI), and the above effects are significantly better than the comparative example compositions, among which composition 5 has the best effect. The results show that the compositions 1 to 9 of the present invention have good anti-inflammatory, gastric motility-enhancing, analgesic or gastric mucosal protection effects on gastric mucosa, and have significant therapeutic effects on the treatment of Helicobacter pylori-related gastritis.

[0039] The present invention also provides a medicine for preventing and treating Helicobacter pylori infection, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

[0040] The present invention also provides a method for preventing and treating Helicobacter pylori or preventing and treating gastritis caused by Helicobacter pylori, which comprises: administering the Chinese medicine composition or the medicine of the present invention.

[0041] The Chinese medicine composition of the present invention uses the original drug of Yinhuang granules as the extraction raw material, adopts different methods to enrich the effective components of honeysuckle and scutellaria, and compound them according to a specific ratio. Experiments show that the Chinese medicine composition has obvious anti-inflammatory, gastric motility-enhancing, analgesic, and gastric mucosal protection effects, has a significant therapeutic effect on Helicobacter pylori-related gastritis, and has a more obvious advantage than other prescriptions under other ratios. In addition, the composition of the present invention is obtained by extracting two medicinal flavors, has few adverse reactions, improves patient compliance, and is suitable for long-term use. DETAILED DESCRIPTION

[0042] The present invention provides a Chinese medicine composition for preventing and treating infection of Helicobacter pylori, and a preparation method and application thereof. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It is particularly important to point out that all similar substitutions and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0043] The test materials used in the present invention are all common commercial products and can be purchased in the market.

[0044] The present invention provides a method for preparing a Chinese medicine composition, comprising:

[0045] Take 10 portions of honeysuckle, extract with ethanol, and then flocculate and settle. Collect the filtrate after flocculation and sedimentation, apply it to a macroporous resin column, elute, and dry to obtain extract A.

[0046] Extract 20 parts of honeysuckle with water, apply to cellulose column, elute, and dry to obtain extract B;

[0047] 5 portions of honeysuckle were crushed and then ultrasonically extracted with a low eutectic solvent, and precipitated with alcohol; the precipitate was collected to obtain extract C; the low eutectic solvent consisted of choline chloride, alcohol, butanediol and water;

[0048] The alcohol is ethylene glycol, 1,3-butanediol or 1,4-butanediol;

[0049] Take 15 parts of Scutellaria baicalensis radix and extract with water, then precipitate with acid, wash the precipitate with ethanol until it is neutral, and dry it to obtain extract D;

[0050] 2 to 6 parts of extract A, 3 to 9 parts of extract B, 4 to 10 parts of extract C, and 2 to 8 parts of extract D are mixed to obtain the traditional Chinese medicine composition.

[0051] In some specific embodiments of the present invention, the preparation methods of the extracts of the present invention are as follows:

[0052] Preparation of Extract A:

[0053] Take 10 parts of honeysuckle, add 10 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate to an extract with a relative density of 1.05-1.10, add 2 parts of chitosan acetic acid solution, the chitosan acetic acid ratio is 20:1, stir rapidly for 30 minutes, let it stand for 6 hours and then filter, the filtrate is concentrated to 0.1 parts of honeysuckle medicinal material / ml medicinal solution, citric acid is added to adjust the pH to 2.0, apply it to an HPD600 macroporous resin column, use 2 times the column volume of water and 4 times the column volume of 10% ethanol to remove impurities, elute with 5 times the column volume of 50% ethanol, collect the eluate, and freeze-dry to obtain extract A.

[0054] Preparation of Extract B:

[0055] Take 20 parts of honeysuckle, add 20 times the amount of water, extract twice, each time for 1 hour, combine the decoctions, filter, concentrate the filtrate to 0.05 parts of honeysuckle medicinal materials / ml medicinal solution, apply it to a DEAE-52 cellulose column, elute with 5 times the column volume of 0.40 mol / L sodium chloride solution, collect the eluate, freeze-dry, and obtain a traditional Chinese medicine extract B with anti-Helicobacter pylori activity.

[0056] Preparation of Extract C:

[0057] Take 5 parts of honeysuckle, grind them into fine powder, add 10 times the mixed aqueous solution of choline chloride and 1,3-butanediol, the ratio of choline chloride-1,3-butanediol-water is 3:1:6, after ultrasonic extraction for 30 minutes, filter, add ethanol to the alcohol concentration reaches 80%, after alcohol precipitation for 24 hours, centrifuge at 5000r / min for 15 minutes, take the precipitate, add 5 times the amount of water to re-dissolve, freeze-dry, and obtain a traditional Chinese medicine extract C with anti-Helicobacter pylori properties.

[0058] Preparation of Extract D:

[0059] Take 15 parts of Scutellaria baicalensis, add 10 times the amount of water, extract twice, each time for 1 hour, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80°C for 2 hours, let it stand, precipitate, filter, add 5 times the amount of water to the precipitate and stir evenly, add 40% sodium hydroxide to adjust the pH value to 7.0, filter, add hydrochloric acid to the filtrate to adjust the pH value to 1.0, keep warm at 60°C for 1 hour, let it stand, filter, elute the precipitate with 65% ethanol to neutral, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract D with anti-Helicobacter pylori activity.

[0060] The Chinese medicine composition of the present invention uses the original drug of Yinhuang granules as the extraction raw material, adopts different methods to enrich the effective components of honeysuckle and scutellaria, and compound them according to a specific ratio. Experiments show that the Chinese medicine composition has obvious anti-inflammatory, gastric motility-enhancing, analgesic, and gastric mucosal protection effects, has a significant therapeutic effect on Helicobacter pylori-related gastritis, and has a more obvious advantage than other prescriptions under other ratios. In addition, the composition of the present invention is obtained by extracting two medicinal flavors, has few adverse reactions, improves patient compliance, and is suitable for long-term use.

[0061] The present invention will be further described below in conjunction with embodiments:

[0062] Example 1 Preparation methods of each extract

[0063] Extract A: Take 10 parts of honeysuckle, add 10 times the amount of 70% ethanol to extract twice, the first time for 2 hours, the second time for 1 hour, combine the alcohol extracts, recover the ethanol, concentrate to an extract with a relative density of 1.05-1.10, add 2 parts of chitosan acetic acid solution, the chitosan acetic acid ratio is 20:1, quickly stir for 30 minutes, let it stand for 6 hours and then filter, the filtrate is concentrated to 0.1 parts of honeysuckle medicinal material / ml medicinal solution, citric acid is added to adjust the pH to 2.0, and apply it to an HPD600 macroporous resin column. After removing impurities with 2 times the column volume of water and 4 times the column volume of 10% ethanol, it is eluted with 5 times the column volume of 50% ethanol, the eluate is collected, and freeze-dried to obtain a traditional Chinese medicine extract A with anti-Helicobacter pylori properties.

[0064] Extract B: Take 20 parts of honeysuckle, add 20 times the amount of water, extract twice, 1 hour each time, combine the decoctions, filter, concentrate the filtrate to 0.05 parts of honeysuckle medicinal materials / ml medicinal solution, apply it to a DEAE-52 cellulose column, elute with 5 times the column volume of 0.40 mol / L sodium chloride solution, collect the eluate, freeze-dry, and obtain a traditional Chinese medicine extract B with anti-Helicobacter pylori activity.

[0065] Extract C: Take 5 parts of honeysuckle, grind them into fine powder, add 10 times the mixed aqueous solution of choline chloride and 1,3-butanediol, the ratio of choline chloride-1,3-butanediol-water is 3:1:6, after ultrasonic extraction for 30 minutes, filter, add ethanol to the alcohol concentration reaches 80%, after alcohol precipitation for 24 hours, centrifuge at 5000r / min for 15 minutes, take the precipitate, add 5 times the amount of water to dissolve, freeze-dry, and obtain a traditional Chinese medicine extract C with anti-Helicobacter pylori properties.

[0066] Extract D: Take 15 parts of Scutellaria baicalensis, add 10 times the amount of water, extract twice, each time for 1 hour, concentrate to an extract with a relative density of 1.05-1.10, add hydrochloric acid to adjust the pH value to 2.0, keep warm at 80°C for 2 hours, let stand, precipitate, filter, add 5 times the amount of water to the precipitate and stir evenly, add 40% sodium hydroxide to adjust the pH value to 7.0, filter, add hydrochloric acid to the filtrate to adjust the pH value to 1.0, keep warm at 60°C for 1 hour, let stand, filter, elute the precipitate with 65% ethanol to neutral, recover the ethanol, freeze-dry, and obtain a Chinese medicine extract D with anti-Helicobacter pylori activity.

[0067] Example 2 Composition of the present invention

[0068] Extracts A to D were prepared according to Example 1, and compositions 1 to 9 of the present invention were prepared by mixing the extracts according to the ratios shown in Table 1.

[0069] Table 1 Composition formula of the present invention

[0070]

[0071] Comparative Examples 1 to 3 Compositions

[0072] Table 2 Formula of the compositions of Comparative Examples 1 to 3

[0073]

[0074] Example 3

[0075] Take the composition of Example 2, add an appropriate amount of lactose, and prepare 1000 tablets.

[0076] Comparative experimental study on the efficacy of test case extracts

[0077] 1. Experimental methods

[0078] 1. Experimental grouping, establishment of spleen and stomach damp-heat syndrome model of Helicobacter pylori-related gastritis, and drug administration

[0079] 160 ICR mice, half male and half female, with a body weight of 18-22g, were randomly divided into a blank group, a model group, a Chinese medicine positive group (Yinhuang granules, a dose of 25g / kg), a Western medicine positive group (clarithromycin, a dose of 0.40g / kg), a drug group 1, a drug group 2, a drug group 3, a drug group 4, a drug group 5, a drug group 6, a drug group 7, a drug group 8, a drug group 9, a drug group 10, a drug group 11, and a drug group 12, with 10 mice in each group. The blank group was given ordinary feed to eat freely, and the model group was given a high-sugar and high-fat feed, and 150g / L honey water was given freely to drink. At the same time, a concentration of 1×10 9 CFU / mL of Hp bacterial solution was gavaged every other day for 4 times in succession. The model was completed after two weeks of bacterial colonization. After the model was successfully established, gavage administration began. The model group and the control group were gavaged with equal amounts of normal saline. The mice in the drug administration group were gavaged once a day at a dose of 25g / kg for 40 consecutive days.

[0080] 130 SPF SD male rats with a body weight of 200-230 g were randomly divided into a blank group, a model group, a Chinese medicine positive group (Yinhuang granules, a dose of 25 g / kg), a Western medicine positive group (clarithromycin, a dose of 0.40 g / kg), a drug administration group 1 (composition 1, a dose of 25 g / kg), a drug administration group 2 (composition 2, a dose of 25 g / kg), a drug administration group 3 (composition 3, a dose of 25 g / kg), a drug administration group 4 (composition 4, a dose of 25 g / kg), and a drug administration group 5 (composition 5, the dosage is 25g / kg), administration group 6 (composition 6, the dosage is 25g / kg), administration group 7 (composition 7, the dosage is 25g / kg), administration group 8 (composition 8, the dosage is 25g / kg), administration group 9 (composition 9, the dosage is 25g / kg), administration group 10 (composition of comparative example 1, the dosage is 25g / kg), administration group 11 (composition of comparative example 2, the dosage is 25g / kg), administration group 12 (composition of comparative example 3, the dosage is 25g / kg), 10 rats in each group. Administration groups 1 to 9 were given compositions 1 to 9 in Table 1. Except for the blank group, the remaining groups were constructed into a rat model of Hp-related gastritis: the rats were fasted for 12h, gavaged with NaHCO3 + anti-inflammatory analgesic 0.5mL / rat, fasted for 6h, and the content was 10 9 CFU / mL of Hp bacterial solution was gavaged (1.5mL / rat), and then the rats were fasted and deprived of water for 4 hours before returning to normal feeding, once every other day for 10 days, and then returning to normal feeding. The rats in the drug administration group were gavaged once a day after modeling, with a dose of 25g / kg, and the model group and the control group were gavaged with an equal amount of normal saline for 40 consecutive days.

[0081] 2. Analgesic effect in each group of mice

[0082] One hour after the last drug administration, 0.6% glacial acetic acid (0.1 mL / 10 g) was injected intraperitoneally. The number of writhing times of the mice within 15 minutes after drug administration was recorded, and the writhing inhibition rate was calculated: writhing inhibition rate = (number of writhing times in the blank group - number of writhing times in the drug administration group) / number of writhing times in the blank group × 100%.

[0083] 3. Detection of MTL, pepsin, IL-1β, IL-6, and TNF-α in mouse serum

[0084] Blood was collected from mouse eyeballs and centrifuged at 3500 r / min for 10 min. Serum was separated and stored in a -20°C refrigerator. The expression levels of motilin (MTL), pepsin, IL-1β, IL-6, and TNF-α were detected according to the instructions of the kit.

[0085] 4. Gastric mucosal injury index (UI) assessment

[0086] Rats in each group were anesthetized by inhalation of ether, fixed in supine position, and the gastric tissue was quickly removed. The stomach was cut open from the greater curvature of the stomach, rinsed with saline, and wiped with cotton swabs to observe gastric mucosal edema, congestion, and ulcers. UI was evaluated according to the GUTH method: the sum of the lengths of gastric mucosal lesions was counted, ≤1mm was recorded as 1 point; 1mm~≤2mm was recorded as 2 points; 2mm~≤3mm was recorded as 3 points; 3mm~≤4mm was recorded as 4 points; >4mm was recorded as 5 points; if the lesion width was >2mm, the UI value was doubled. After the gastric tissue was homogenized after the test, it was stored in a -80℃ refrigerator.

[0087] (II) Results Analysis

[0088] 1. Contents of IL-1β, IL-6 and TNF-α in serum of mice in each group

[0089] Compared with the blank group, the expression levels of IL-1β, IL-6, and TNF-α in the serum of mice in the Chinese medicine positive group, the western medicine positive group, the drug administration group 2, and the drug administration group 5 were significantly reduced, which was extremely significant (P<0.001, P<0.01). From the expression levels of IL-1β, IL-6, and TNF-α in the serum of mice, the drug administration group 5 was superior to the other drug administration groups, as shown in Table 3.

[0090] Table 3 Expression levels of IL-1β, IL-6 and TNF-α in the serum of mice in each group

[0091] ( n=10)

[0092]

[0093] Note: Compared with the blank group, ###P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0094] 2. Comparison of MTL and Pepsin levels in the serum of mice in each group

[0095] Compared with the blank group, the MTL level in the model group decreased (P<0.05); compared with the model group, the MTL level in the Chinese medicine positive group, the Western medicine positive group, the drug administration group 1, the drug administration group 2, the drug administration group 3, and the drug administration group 5 increased significantly (P<0.05, P<0.001), and the Pepsin level in the Chinese medicine positive group, the Western medicine positive group, the drug administration group 2, and the drug administration group 5 increased in a dose-dependent manner (P<0.01, P<0.001). From the perspective of MTL and Pepsin expression levels, the Chinese medicine positive group, the Western medicine positive group, and the drug administration group 5 were superior to the other drug administration groups. See Table 4.

[0096] Table 4 Comparison of MTL and Pepsin levels in the serum of mice in each group

[0097] ( n=10)

[0098]

[0099] Note: Compared with the blank group, ## P<0.01, ### P<0.001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0100] 3. Comparison of the number of writhing times and writhing inhibition rate among the mice in each group

[0101] Compared with the blank group, the number of writhing times of mice in the Chinese medicine positive group, the Western medicine positive group, the drug administration group 2, the drug administration group 5, and the drug administration group 6 was significantly reduced (P<0.001), and the writhing inhibition rate was higher than that of other drug administration groups. From the results of the number of writhing times and the writhing inhibition rate of mice, it can be seen that the writhing inhibition rate of drug administration group 5 is better than that of other drug administration groups, as shown in Table 5.

[0102] Table 5 Comparison of writhing times and writhing inhibition rates in each group of mice

[0103] ( n=10)

[0104]

[0105] Note: Compared with the blank group, *P<0.05, **P<0.01, ***P<0.001.

[0106] 4. Comparison of UI among rats in each group

[0107] There was no damage to the gastric mucosa of the rats in the blank group; compared with the blank group, the gastric mucosal epithelium of the rats in the model group was edematous and congested, the ulcer was severe, and the UI was increased (P<0.05); compared with the model group, the ulcer sites of the rats in the Chinese medicine positive group, the Western medicine positive group, the drug administration group 1, the drug administration group 2, and the drug administration group 5 were reduced, the edema was improved, and the UI decreased in a dose-dependent manner (P<0.001), among which the drug administration group 5 was superior to the other drug administration groups, as shown in Table 6.

[0108] Table 6 Comparison of gastric mucosal injury index (UI) of rats in each group

[0109] ( n=10)

[0110]

[0111] Note: Compared with the blank group, # P<0.05; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0112] The above results show that compositions 1 to 9 of the present invention have obvious anti-inflammatory, gastric motility improving, analgesic and gastric mucosal protective effects, and the effects are significantly better than those of groups 10 to 11. Among them, composition 5 has the best effect and has obvious advantages in treating Helicobacter pylori-related gastritis.

[0113] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A method for preparing a Chinese medicine composition, characterized in that: include: Take 10 portions of honeysuckle, extract with ethanol, and then flocculate and settle. Collect the filtrate after flocculation and sedimentation, apply it to a macroporous resin column, elute, and dry to obtain extract A. Extract 20 parts of honeysuckle with water, apply to cellulose column, elute, and dry to obtain extract B; 5 parts of honeysuckle were crushed and ultrasonically extracted with a deep eutectic solvent and precipitated with alcohol; collecting the precipitate to obtain extract C; the deep eutectic solvent consists of choline chloride, alcohol, butanediol and water; The alcohol is ethylene glycol, 1,3-butanediol or 1,4-butanediol; Take 15 parts of Scutellaria baicalensis radix and extract with water, then precipitate with acid, wash the precipitate with ethanol until it is neutral, and dry it to obtain extract D; 2 to 6 parts of extract A, 3 to 9 parts of extract B, 4 to 10 parts of extract C, and 2 to 8 parts of extract D are mixed to obtain the traditional Chinese medicine composition.

2. The preparation method according to claim 1, characterized in that: In the preparation of the extract A, the flocculant used in the flocculation and sedimentation is chitosan acetic acid solution; The macroporous resin column includes HPD600; The eluent used for elution is an ethanol solution with a volume fraction of 50%.

3. The preparation method according to claim 1 or 2, characterized in that: After the ethanol extraction and before the flocculation sedimentation, the method further comprises the step of concentrating the ethanol extract to an extract with a relative density of 1.05 to 1.

10.

4. The preparation method according to claim 1, characterized in that: In the preparation of the extract B, the cellulose column includes a DEAE cellulose column, a DEAE-52 cellulose column or a DEAE Sepharosefast flow cellulose column.

5. The preparation method according to claim 1, characterized in that: In the preparation of the extract C, in the deep eutectic solvent, the volume ratio of choline chloride, alcohol and water is 0.8-1.2:2-6:6-10; The ultrasonic extraction time is 30 min.

6. The preparation method according to claim 1, characterized in that: In the preparation of the extract D, the acid precipitation specifically includes: adding hydrochloric acid to adjust the pH value to 1.0-2.0, keeping warm at 60-80° C. for 1-2 hours, standing and precipitating.

7. A Chinese medicine composition prepared by the preparation method according to any one of claims 1 to 6.

8. The Chinese medicine composition according to claim 7, characterized in that: The weight parts of each extract are: 2-4 parts of extract A, 6 parts of extract B, 7-10 parts of extract C, and 2-5 parts of extract D.

9. Use of a Chinese medicine composition in the preparation of a drug for preventing and treating Helicobacter pylori infection, or in the preparation of a drug for preventing and treating gastritis caused by Helicobacter pylori infection; The Chinese medicine composition is selected from any one of the following: (1) A Chinese medicine composition prepared by the preparation method according to any one of claims 1 to 6 or a Chinese medicine composition according to any one of claims 7 to 8; (2) Silver and yellow granules.

10. A drug for preventing and treating Helicobacter pylori, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 8 to 9 and pharmaceutically acceptable excipients.

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