Composition for treating helicobacter pylori infection and preparation method thereof

Abstract

The invention discloses a composition for treating helicobacter pylori infection. The composition is prepared from the following raw materials in parts by weight: 0.04 to 0.06 part of active ingredients, 0 to 1 part of gum grease, 0 to 0.5 part of wax liquid, 1 to 0.5 part of sweetening agent and 0.01 to 0.03 part of essence, wherein the effective component is one or more of a compound A, a compound B and a compound C. The invention further discloses a preparation method of the composition for treating helicobacter pylori infection. The composition disclosed by the invention can be used for treating helicobacter pylori infection, the treatment period is very short, and the composition only needs to be taken for two days and is taken once a day; and the composition is used in a solid form in a buccal or chewing manner, so that the effective components can stay in the oral cavity for a long time, and comprehensive sterilization from the oral cavity to the stomach is achieved.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly relates to a composition for treating Helicobacter pylori infection and a preparation method thereof. Background Art

[0002] Clinically, the onset of most patients with gastritis and gastric ulcer is caused by Helicobacter pylori infection. In severe cases, it can also cause diseases such as chronic pharyngitis and oral ulcers. It infects people of different races and regions around the world, and the infection rate increases with age. The infection rate is about 80% in developing countries and about 40% in developed countries. The infection rate in men is slightly higher than that in women, and the infection rate in pets is higher than that in humans. The infection age in China is about 20 years earlier than that in developed countries. The infection rate is 45.4 - 63.6% for people aged 20 - 40, and as high as 78.9% for people over 70. In addition, the infection rate in the northern region of China is higher than that in the southern region.

[0003] Currently, the treatment regimens for positive Helicobacter pylori include two major categories. One category is a regimen mainly based on antibiotics supplemented with acid suppressants (bismuth agents), and the second category is a regimen based on proton pump inhibitors. In addition, there are two other antibiotics, and the most commonly used ones are amoxicillin, metronidazole, etc. The above drugs have a long treatment cycle, require taking many types of medications, and have relatively large side effects on the human body. Summary of the Invention

[0004] Based on the technical problems existing in the background art, the present invention proposes a composition for treating Helicobacter pylori infection and a preparation method thereof. The composition of the present invention can treat Helicobacter pylori infection, and the treatment cycle is very short, only requiring taking the medicine for two days, once a day. And the composition of the present invention is in solid form and is used by buccal administration or chewing, which can make the active ingredients stay in the oral cavity for a long time, so as to achieve comprehensive sterilization from the oral cavity to the stomach.

[0005] The present invention proposes a composition for treating Helicobacter pylori infection, and its raw materials by weight include: 0.04 - 0.06 parts of active ingredient, 0 - 1 part of gum resin, 0 - 0.5 part of wax liquid, 1 - 0.5 parts of sweetener, 0.01 - 0.03 parts of essence; wherein, the active ingredient is one or more of compound A, compound B, and compound C;

[0006] The structural formulas of compound A, compound B, and compound C are as follows:

[0007]

[0008] Preferably, its raw materials by weight include: 0.05 part of active ingredient, 0 - 1 part of gum resin, 0 - 0.5 part of wax liquid, 1 - 0.5 parts of sweetener, 0.02 part of essence.

[0009] Compared with the currently commonly used triple or quadruple antibiotic drugs, which not only damage the stomach but also have a long administration time, the inventors found that when using very small amounts of Compounds A-C, they still have a good effect of killing Helicobacter pylori. Moreover, under the strong acidic conditions of gastric acid, the three compounds can be degraded within a short time, and the degradation products are fatty acid-like / fatty acids and dicationic choline. Compounds A-C are not absorbed by the human body, have no side effects, and do not cause Helicobacter pylori to develop drug resistance. The treatment cycle of the composition of the present invention is very short, only requiring administration for two days, once a day.

[0010] In addition, the acute oral toxicity tests (mice) of Compounds A-C and their degradation products are both greater than 5000 mg / kg, both are actually non-toxic, and have very high safety.

[0011] Preferably, the gum resin is a natural gum or a glycerol resin.

[0012] Preferably, when the gum resin is 0, the wax liquid is 0.

[0013] Preferably, when the gum resin is 0, the sweetener is one or more of sucrose and fructose.

[0014] Preferably, when the weight part of the gum resin is greater than 0, the sweetener is one or more of sorbitol, mannitol, maltitol, and xylitol.

[0015] Preferably, the essence is one or more of mint essence, peach essence, and lemon essence.

[0016] Preferably, the wax liquid is beeswax.

[0017] Preferably, when the gum resin is 0, the method of using the composition for treating Helicobacter pylori infection is: hold in the mouth to dissolve the composition, and then swallow it.

[0018] Preferably, when the weight part of the gum resin is greater than 0, the method of using the composition for treating Helicobacter pylori infection is: chew until tasteless and then spit it out.

[0019] Compounds A-C are bitter in taste, and sweeteners are added to improve the taste.

[0020] When using by chewing, when it is tasteless after chewing, it can be considered that Compounds A-C are completely chewed out, and then spit it out.

[0021] Since Helicobacter pylori mainly exists in the stomach, and also exists in the oral cavity and esophagus, therefore, when killing Helicobacter pylori, comprehensive killing from the oral cavity to the stomach should be considered. The existing treatment methods are generally direct perfusion or swallowing, with a very short residence time in the oral cavity, and it is impossible to achieve comprehensive sterilization from the oral cavity to the stomach.

[0022] Through the combination of various raw materials, the composition of the present invention can be used in the form of a solid by buccal or chewing, enabling the active ingredient to stay in the oral cavity for a long time, thereby achieving comprehensive sterilization from the oral cavity to the stomach.

[0023] Moreover, for the composition of the present invention, it only needs to be used on an empty stomach 2 hours before breakfast and used continuously for two days to completely eliminate Helicobacter pylori in the body. The usage period is very short, with little side effect on the human body and remarkable therapeutic effect.

[0024] The gum resin, wax liquid, sweetener, and essence of the present invention are all of pharmaceutical grade.

[0025] The present invention also provides a preparation method of the above composition for treating Helicobacter pylori infection, including Method A or Method B;

[0026] When the gum resin is 0, Method A is adopted, which includes the following steps: taking each raw material and mixing them evenly, heating and melting them evenly to obtain the composition for treating Helicobacter pylori infection;

[0027] When the weight portion of the gum resin is greater than 0, Method B is adopted, which includes the following steps: taking the active ingredient, gum resin, sweetener, and essence and mixing them evenly, heating and expanding, and then adding the wax liquid and mixing evenly to obtain the composition for treating Helicobacter pylori infection.

[0028] Preferably, in both Method A and Method B, it is heated to 140 - 160 °C.

[0029] Beneficial effects:

[0030] The present invention discovers that Compounds A - C still have a good effect of killing Helicobacter pylori when used in very small amounts, and Compounds A - C can be degraded within a short time. The degradation products are fatty acid-like / fatty acids and dicholine. Compounds A - C will not be absorbed by the human body, have no side effects, and will not cause Helicobacter pylori to develop drug resistance; the treatment period of the composition of the present invention is very short, only need to be taken for two days, once a day. In addition, the acute oral toxicity tests (mice) of Compounds A - C and their degradation products are all > 5000 mg / kg, both are actually non-toxic, and the safety is very high.

[0031] In addition, through the selection of appropriate raw materials and their mutual cooperation, the composition of the present invention can be used in the form of a solid by buccal or chewing, enabling the active ingredient to stay in the oral cavity for a long time, thereby achieving comprehensive sterilization from the oral cavity to the stomach. Description of the Drawings

[0032] Figure 1 It is the acute oral toxicity test result of Compound A.

[0033] Figure 2 It is the acute oral toxicity test result of Compound B.

[0034] Figure 3 These are the results of the acute oral toxicity experiment of compound C.

[0035] Figure 4 These are the results of the acute oral toxicity experiment of the degradation product of compound A.

[0036] Figure 5 These are the experimental results of compound A in Experiment 2.

[0037] Figure 6 These are the degradation rate results of compound A, compound C, compound 13, and Ephemora, where C8-S-Br is compound A, C8-S-Br-Me is compound 13, Ephemora is Ephemora, and C10-Cl is compound C.

[0038] Figure 7 These are the results of the acute oral toxicity of Ephemora in mice. Detailed implementation manners

[0039] Next, the technical solutions of the present invention will be described in detail through specific examples.

[0040] Example 1

[0041] A composition for treating Helicobacter pylori infection, the raw materials of which include, by weight: 0.05 g of compound A, 1 g of natural gum, 0.2 g of wax liquid, 0.5 g of xylitol, and 0.02 g of mint essence.

[0042] The preparation method of the above composition for treating Helicobacter pylori infection includes the following steps: Take compound A, natural gum, xylitol, and mint essence and add them to a blender, stir and mix evenly to obtain a paste, then heat it to 140-160 °C to make the paste expand, then add the wax liquid, stir and mix evenly to make it elastic and easy to chew in the mouth, then add it to a mold to form, and then cool and shape to obtain the composition for treating Helicobacter pylori infection.

[0043] The preparation method of the above compound A includes the following steps:

[0044] Add 0.02 mol of dimethylaminoethyl acrylate, 0.02 mol of 1-octanethiol, 0.01 mol of 1,3-dibromopropane, and 10 mL of ethanol to a single-neck flask, stir at 60 °C under normal pressure for 12 h, then distill off the solvent under reduced pressure, wash it with acetone 2-3 times, and then freeze-dry to obtain compound A.

[0045] Example 2

[0046] A composition for treating Helicobacter pylori infection, the raw materials of which include, by weight: 0.05 g of compound B, 1 g of glycerol resin, 0.2 g of wax liquid, 0.5 g of sorbitol, and 0.02 g of lemon essence.

[0047] The preparation method of the above composition for treating Helicobacter pylori infection includes the following steps: Add compound B, glycerol resin, sorbitol, and mint essence into a blender, stir and mix evenly to obtain a paste, then heat it to 140 - 160 °C to make the paste expand, then add the wax liquid, stir and mix evenly to make it elastic and easy to chew in the mouth, then add it into a mold to form, and then cool and set to obtain the composition for treating Helicobacter pylori infection.

[0048] The preparation method of the above compound B includes the following steps:

[0049] Add 0.02 mol of dimethylaminoethyl acrylate, 0.02 mol of 1-octanethiol, 0.01 mol of 1,3-dichloropropane, and 10 mL of ethanol into a single-neck flask, stir at normal pressure at 60 °C for 12 h, then distill off the solvent under reduced pressure, wash with acetone 2 - 3 times, and then freeze-dry to obtain compound B.

[0050] Example 3

[0051] A composition for treating Helicobacter pylori infection, the raw materials of which include, by weight: 0.05 g of compound C, 1 g of glycerol resin, 0.2 g of wax liquid, 0.5 g of mannitol, and 0.02 g of mint essence.

[0052] The preparation method of the above composition for treating Helicobacter pylori infection includes the following steps: Add compound C, glycerol resin, mannitol, and mint essence into a blender, stir and mix evenly to obtain a paste, then heat it to 140 - 160 °C to make the paste expand, then add the wax liquid, stir and mix evenly to make it elastic and easy to chew in the mouth, then add it into a mold to form, and then cool and set to obtain the composition for treating Helicobacter pylori infection.

[0053] The preparation method of the above compound C includes the following steps:

[0054] Add 0.1 mol of capric acid to a four-necked flask equipped with a magnetic stir bar, insert a thermometer, set up a fractional distillation apparatus, set the oil bath to 70 °C, heat and stir until the capric acid is completely melted, then add a certain amount of p-toluenesulfonic acid and hypophosphorous acid as catalysts, introduce nitrogen for protection, and use a constant pressure funnel to dropwise add 0.18 mol of N,N-dimethylethanolamine. Then raise the temperature to 160 °C and stir for the esterification reaction. During this period, measure the acid value every hour. When the change in acid value is not significant after 7 h of reaction, stop the reaction; cool to room temperature, add a 50 wt% aqueous potassium hydroxide solution, stir at 75 °C for 30 min to remove impurities, then transfer to a pear-shaped separatory funnel, add CCl4 for extraction, let stand for 12 h, take the lower layer liquid, and rotary evaporate to remove CCl4 to obtain the intermediate product;

[0055] Add the intermediate product, 1,3-dichloropropane, and isopropanol to a three-necked flask equipped with a thermometer and a reflux device in sequence. After stirring at room temperature for 15 min, measure the initial amine value; raise the temperature of the system to 100 °C and reflux and stir for 6 h, measuring the amine value once every hour during this period; after the reaction is completed, distill off isopropanol under reduced pressure to obtain the crude product; recrystallize with a mixed solvent of isopropanol and ethyl acetate to obtain compound C.

[0056] Example 4

[0057] A composition for treating Helicobacter pylori infection, the raw materials of which include, by weight: 0.02 g of compound A, 0.02 g of compound B, 0.01 g of compound C, 1 g of natural gum, 0.2 g of wax liquid, 0.5 g of maltitol, and 0.02 g of peach essence.

[0058] The preparation method of the above composition for treating Helicobacter pylori infection includes the following steps: Take compound A, compound B, compound C, natural gum, maltitol, and mint essence and add them to a blender, stir and mix well to obtain a paste, then heat to 140 - 160 °C to make the paste expand, then add the wax liquid, stir and mix well to make it elastic and easy to chew in the mouth, then add it to a mold to form, and then cool and set to obtain the composition for treating Helicobacter pylori infection.

[0059] The preparation methods of the above compounds A, B, and C are the same as those in Examples 1 - 3.

[0060] Example 5

[0061] A composition for treating Helicobacter pylori infection, the raw materials of which include, by weight: 0.05 g of compound A, 1 g of sucrose, and 0.02 g of mint essence.

[0062] The preparation method of the above composition for treating Helicobacter pylori infection comprises the following steps: Take compound A, sucrose, and mint essence, add them to a blender, stir and mix evenly, then heat to 140 - 160 °C, add them into a mold to form, and then cool and set to obtain the composition for treating Helicobacter pylori infection.

[0063] The preparation method of the above compound A is the same as the preparation method in Example 1.

[0064] Example 6

[0065] A composition for treating Helicobacter pylori infection, its raw materials by weight include: 0.05 g of compound B, 1 g of fructose, and 0.02 g of mint essence.

[0066] The preparation method of the above composition for treating Helicobacter pylori infection comprises the following steps: Take compound B, fructose, and mint essence, add them to a blender, stir and mix evenly, then heat to 140 - 160 °C, add them into a mold to form, and then cool and set to obtain the composition for treating Helicobacter pylori infection.

[0067] The preparation method of the above compound B is the same as the preparation method in Example 2.

[0068] Comparative Example 1

[0069] Prepare compound 13

[0070] Replace "dimethylaminoethyl acrylate" with "dimethylaminoethyl methacrylate", and prepare compound 13 according to the method of compound A for the rest.

[0071] The structural formula of compound 13 is:

[0072] Comparative Example 2

[0073] Prepare compound 14

[0074] Replace "capric acid" with "lauric acid", and prepare compound 14 according to the method of compound C for the rest.

[0075] The structural formula of compound 14 is:

[0076] Comparative Example 3

[0077] Prepare compound 15

[0078] Replace "1-octanethiol" with "tetradecyl mercaptan", and prepare compound 15 according to the method of compound A.

[0079] The structural formula of compound 15 is:

[0080] Comparative Example 4

[0081] Preparation of Compound 16

[0082] Replace "1,3-dibromopropane" with "1,7-dibromoheptane", and Compound 16 was prepared according to the method of Compound A.

[0083] The structural formula of Compound 16 is:

[0084] Comparative Example 5

[0085] Preparation of Compound 17

[0086] Replace "decanoic acid" with "nonanoic acid", and Compound 17 was prepared according to the method of Compound C for the rest.

[0087] The structural formula of Compound 17 is:

[0088] Comparative Example 6

[0089] Dodecyldimethylbenzylammonium chloride and dioctyldimethylammonium chloride were mixed in a weight ratio of 1:1 to obtain a bactericide.

[0090] Comparative Examples 7-11 are commercially available chitosan quaternary ammonium salts, benzalkonium chloride, didodecyldimethylammonium chloride, benzethonium chloride, and Evomorax in sequence.

[0091] Experiment 1

[0092] In order to investigate the toxicological properties of Compounds A-C and the toxicological properties of the degradation products of Compound A (the structural formula of the degradation products is ), the Anhui Provincial Center for Disease Control and Prevention was entrusted to conduct experiments using the Horn method in accordance with the "Procedures and Methods for Toxicological Evaluation of Disinfectants Safety (GB / T38496.6.1-2020)" and the SOP system of the center.

[0093] The experimental results were as follows: According to the acute toxicity evaluation criteria of the "Procedures and Methods for Toxicological Evaluation of Disinfectants Safety (GB / T38496.6.1-2020)", the acute oral toxicity tests (mice) of Compounds A-C and the degradation products of Compound A were all > 5000 mg / kg, and they were all actually non-toxic (the results are as Figures 1-4 shown), with high safety and low safety risks when applied to humans.

[0094] For the existing benzalkonium chloride, didodecyldimethylammonium chloride, and benzethonium chloride, the acute oral toxicity tests of their raw materials were all < 500 mg / kg, and they were of medium toxicity. See Table 1 for details.

[0095] Table 1 Acute Oral Toxicity of Various Quaternary Ammonium Salts in Mice

[0096]

[0097]

[0098] Note: a) Extremely toxic: LD 50 < 1 mg / kg, b) Highly toxic: LD 50 = 1 - 50 mg / kg, c) Moderately toxic: LD 50 = 51 - 500 mg / kg, d) Slightly toxic: LD 50 = 501 - 5000 mg / kg, e) Non-toxic: LD 50 > 5000 mg / kg.

[0099] Experiment 2

[0100] The experiment on killing Helicobacter pylori in simulated gastric acid for compounds A - C was carried out, and the results are shown in Table 2 and Figure 5 as follows.

[0101] The method for the experiment on killing Helicobacter pylori in simulated gastric acid was as follows: Compounds A - C were taken and placed in simulated gastric acid at 37°C for 2 h respectively, and their bactericidal effects on Helicobacter pylori were investigated. The concentrations of compounds A - C were the same, all being 0.1% w / w.

[0102] Table 2 Detection Results

[0103]

[0104] It can be seen from Table 2 that compounds A - C have good effects on killing Helicobacter pylori, and the bactericidal rate reaches 99.9999% after 2 h at a concentration of 0.1% w / w.

[0105] Experiment 3

[0106] The experiment on killing Helicobacter pylori in simulated gastric acid for compounds A - C was carried out and compared with Comparative Examples 1 - 11, and the results are shown in Table 3.

[0107] The method for the experiment on killing Helicobacter pylori in simulated gastric acid was as follows: Compounds A - C and Comparative Examples 1 - 11 were taken and placed in simulated gastric acid at 37°C for 2 h respectively, and were serially diluted in a two-fold manner starting from 0.1% w / w. The minimum concentration to achieve a bactericidal rate of 99.999% was taken as the minimum bactericidal concentration of the compound, and the 2 h minimum bactericidal concentrations of compounds A - C and Comparative Examples 1 - 11 against Helicobacter pylori were compared.

[0108] Table 3 Detection Results of Minimum Bactericidal Concentration

[0109]

[0110]

[0111] As can be seen from Table 3: Compounds A-C have a good effect on killing Helicobacter pylori, and their minimum bactericidal concentration is much lower than that of Compounds 13-17 (Comparative Examples 1-5); it is also much lower than that of commercially available quaternary ammonium salts (Comparative Examples 6-11); this shows that the ability of Compounds A-C to kill Helicobacter pylori is significantly higher than that of Comparative Examples 1-11.

[0112] From the comparison between Compounds A-B and Compounds 14-16, it can be seen that when sulfur element is not contained, even if the alkyl chain lengths on both sides of Compound 14 are the same as those of Compound B, its effect on killing Helicobacter pylori will still be greatly reduced; while when sulfur element is contained, the alkyl chain lengths on both sides of Compound 15 are too long, and the alkyl chain length in the middle of Compound 16 is too long, and their effects on killing Helicobacter pylori will both be greatly reduced.

[0113] From the comparison between Compound C and Compounds 14 and 17, it can be seen that when the alkyl chain lengths on both sides of Compounds 14 and 17 are too long or too short, their effects on killing Helicobacter pylori will also be greatly reduced.

[0114] Experiment 4

[0115] Take Compound A, Compound C, Compound 13, and Ephemora, and investigate their degradation rates respectively. The specific investigation method is as follows: Take the above-mentioned substances and prepare solutions with a mass fraction of 1 wt% in pond water respectively. Regularly take samples and detect the ratio of the peak integration areas of the trimethyl hydrogen at the quaternary ammonium salt end (the retention times of the trimethyl hydrogen at the quaternary ammonium salt end before and after degradation are different) before and after degradation by nuclear magnetic resonance hydrogen spectrum, and calculate the degradation rate. The results are as Figure 6 shown.

[0116] The structural formula of Ephemora is as follows:

[0117]

[0118] Figure 6 are the degradation rate results of Compound A, Compound C, Compound 13, and Ephemora, where C8-S-Br is Compound A, C8-S-Br-Me is Compound 13, Ephemora is Ephemora, and C10-Cl is Compound C.

[0119] Referring to "Procedures and Methods for Toxicological Evaluation of the Safety of Disinfectants (GB / T 38496.6.1-2020)", acute oral toxicity tests of Ephemora on mice were carried out, and the results are as Figure 7 shown.

[0120] Figure 7 are the results of acute oral toxicity of Ephemora on mice.

[0121] From Figures 6-7It can be seen that when there is a branched alkyl group beside the ester group, its degradation rate will be significantly reduced; and the acute oral toxicity of Evomorla in male mice LD 50 = 2710 mg / kg, which belongs to low toxicity; the acute oral toxicity of Evomorla in female mice LD 50 = 1710 mg / kg, which belongs to low toxicity; it can be known that the toxicity of Evomorla is higher than that of compounds A and C (practically non-toxic).

[0122] The inventors have found through research that when there is a branched alkyl group (such as a methyl group) beside the ester group, it will reduce its degradation rate in the body, thereby increasing its toxicity;

[0123] The present invention discovers that compounds A, B, and C have specific structures, can achieve efficient sterilization in the body while being rapidly degraded, and enable the degradation products to be rapidly excreted from the body without residue in the body. Moreover, compounds A, B, and C and their degradation products are all practically non-toxic, with high safety, and have a low safety risk when applied to the human body.

[0124] Experiment 5

[0125] Patients with a positive Helicobacter pylori test, aged 30 - 45 years old, were selected. The Helicobacter pylori of the patients was detected by C13 breath test. Then, the composition of Example 1 was used on an empty stomach 2 hours before breakfast, chewed until tasteless, and then spit out, once a day for 2 consecutive days. After stopping the drug for 3 days, the C13 breath test was performed again. The test results are shown in Table 4.

[0126] Table 4 Test Results

[0127]

[0128]

[0129] Note: DOB < 4.0 is negative; DOB ≥ 4.0 is positive.

[0130] It can be seen from Table 4 that the composition of the present invention has a good therapeutic effect on Helicobacter pylori infection, and the treatment period is very short, only requiring taking the medicine for two days, once a day.

[0131] The above is only the preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention, according to the technical solution of the present invention and its inventive concept, makes equivalent substitutions or changes, and should be covered by the protection scope of the present invention.

Claims

1. A composition for treating Helicobacter pylori infection, characterized in that: The raw materials include, by weight: 0.04-0.06 parts of active ingredients, 0-1 parts of gum, 0-0.5 parts of wax liquid, 1-0.5 parts of sweetener, and 0.01-0.03 parts of flavor; wherein the active ingredients are one or more of compound A, compound B, and compound C; The structural formulas of compound A, compound B and compound C are shown below: Compound A; Compound B; Compound C.

2. The composition for treating Helicobacter pylori infection according to claim 1, characterized in that: Gum is a natural gum or glycerin resin.

3. The composition for treating Helicobacter pylori infection according to claim 1 or 2, characterized in that: When the gum is 0, the wax liquid is 0.

4. The composition for treating Helicobacter pylori infection according to any one of claims 1 to 3, characterized in that: When the amount of gum is 0, the sweetener is one or more of sucrose and fructose.

5. The composition for treating Helicobacter pylori infection according to any one of claims 1 to 4, characterized in that: When the weight portion of the gum is greater than 0, the sweetener is one or more of sorbitol, mannitol, maltitol and xylitol.

6. The composition for treating Helicobacter pylori infection according to any one of claims 1 to 5, characterized in that: The flavor is one or more of mint flavor, peach flavor, and lemon flavor; preferably, the wax liquid is beeswax.

7. The composition for treating Helicobacter pylori infection according to any one of claims 1 to 6, characterized in that: When the content of the gum is 0, the method for using the composition for treating Helicobacter pylori infection is: orally dissolve the composition and then swallow it.

8. The composition for treating Helicobacter pylori infection according to any one of claims 1 to 7, characterized in that: When the weight of the gum is greater than 0, the method of using the composition for treating Helicobacter pylori infection is: chewing until it has no taste and then spitting it out.

9. A method for preparing a composition for treating Helicobacter pylori infection according to any one of claims 1 to 8, characterized in that: Including method A or method B; When the amount of the gum is 0, method A is used, comprising the following steps: mixing the raw materials, heating and melting the raw materials to obtain a composition for treating Helicobacter pylori infection; When the weight of the gum is greater than 0, method B is used, including the following steps: taking the active ingredient, gum, sweetener, and flavor, mixing them evenly, heating them to expand, and then adding the wax liquid to mix evenly to obtain a composition for treating Helicobacter pylori infection.

10. The method for preparing the composition for treating Helicobacter pylori infection according to claim 9, characterized in that: In both method A and method B, the temperature is heated to 140-160°C.

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