CN112516205A

CN112516205A - Traditional Chinese medicine composition for treating helicobacter pylori infection

Info

Publication number: CN112516205A
Application number: CN202011591670.7A
Authority: CN
Inventors: 黄泰润; 黄德浩; 黄丽玲; 黄辉球; 叶红斌; 刘强
Original assignee: Jiuhui Pharmaceutical Co ltd
Current assignee: Jiuhui Pharmaceutical Co ltd
Priority date: 2020-12-29
Filing date: 2020-12-29
Publication date: 2021-03-19

Abstract

The invention provides a traditional Chinese medicine composition for treating helicobacter pylori infection, which comprises the following components in parts by weight: 27-62 parts of coptis chinensis extract, 27-62 parts of scutellaria baicalensis extract, 27-62 parts of radix paeoniae alba extract, 15-43 parts of pogostemon cablin extract, 60-122 parts of guava leaf extract and 27-62 parts of poria cocos extract. The traditional Chinese medicine composition for treating helicobacter pylori infection is innovatively used for treating the helicobacter pylori infection diseases by compounding the coptis chinensis extract, the scutellaria baicalensis extract, the white paeony root extract, the patchouli extract, the guava leaf extract and the poria cocos extract, has a good inhibiting effect, and is safe and effective as proved by in vitro bacteriostatic tests and animal tests.

Description

Traditional Chinese medicine composition for treating helicobacter pylori infection

Technical Field

The invention relates to the technical field of medicinal preparations, in particular to a traditional Chinese medicine composition for treating helicobacter pylori infection.

Background

Helicobacter pylori (Hp) is a common gram-negative Helicobacter bacterium that inhabits the gastric mucosa, and is a major causative agent of chronic active gastritis, gastric cancer, and arteriosclerotic diseases, as well as a major causative agent of peptic ulcer. The infection of the helicobacter pylori is closely related to the infection of the upper digestive tract and the generation of the B-type gastritis, and is also important related to the generation of lymphoid tissue (MALT) lymphoma and gastric cancer related to gastric mucosa, and is listed as a tumor generation I type pathogen such as the gastric cancer by the world health organization.

The method for treating helicobacter pylori mainly adopts a treatment means of mainly using antibiotics and adding an acid inhibitor and a bismuth agent, and has high bacterial drug resistance rate due to obvious abuse phenomenon of the antibiotics; while gastric acid inhibition also heals 80% of ulcers, but this healing is temporary with a recurrence rate of 66% after half a year and 80% within a year; it can be seen that the current triple therapy is not very effective.

Chinese patent with publication number CN111643544A discloses a traditional Chinese medicine composition for inhibiting helicobacter pylori and a preparation method thereof, and the traditional Chinese medicine composition comprises, by weight, 5-15 parts of Chinese olive, 0-6 parts of sophora flower bud and 0-5 parts of liquorice, has an inhibiting effect on helicobacter pylori antibiotic sensitive strains, and avoids stomach injury due to bitter cold. However, the target of action and therapeutic effect are still under investigation.

Therefore, how to develop a medicament for inhibiting helicobacter pylori with small side effect and good curative effect is a technical problem which needs to be solved urgently in the field.

Disclosure of Invention

In order to solve the problems in the prior art, the invention provides a traditional Chinese medicine composition for treating helicobacter pylori infection, which is innovatively used for treating the helicobacter pylori infection diseases by compounding a coptis extract, a scutellaria extract, a white peony root extract, a patchouli extract, a guava leaf extract and a poria cocos extract, has good inhibition effect, and is safe and effective as proved by in vitro bacteriostatic tests and animal tests.

In order to achieve the purpose, the invention provides the following technical scheme:

a traditional Chinese medicine composition for treating helicobacter pylori infection comprises the following components in parts by weight: 27-62 parts of coptis chinensis extract, 27-62 parts of scutellaria baicalensis extract, 27-62 parts of radix paeoniae alba extract, 15-43 parts of pogostemon cablin extract, 60-122 parts of guava leaf extract and 27-62 parts of poria cocos extract.

Further, the traditional Chinese medicine composition for treating helicobacter pylori infection comprises the following components in parts by weight: 45 parts of coptis chinensis extract, 45 parts of scutellaria baicalensis extract, 45 parts of radix paeoniae alba extract, 30 parts of pogostemon cablin extract, 90 parts of guava leaf extract and 45 parts of poria cocos extract.

The extraction method of the coptis extract comprises the steps of taking coptis, heating and refluxing for 1-4 hours by using 4-15 times of 5-95% ethanol solution, extracting for 1-4 times, filtering, combining filtrates, recovering ethanol from the filtrate under reduced pressure, concentrating, and drying into fine powder to obtain the coptis extract.

As further description of the technical scheme of the invention, the extraction method of the patchouli extract, the scutellaria baicalensis extract, the white paeony root extract, the poria cocos extract and the guava leaf extract comprises the steps of respectively taking patchouli, scutellaria baicalensis, radix paeoniae alba, poria cocos and guava leaves, decocting for 1-4 hours at 60-100 ℃ by using 4-15 times of purified water or 4-15 times of 5-95% ethanol solution, decocting for 1-4 times, filtering and combining filtrates, and concentrating the filtrate under reduced pressure until the relative density is 1.05-1.25g/cm³Drying at 30-100 deg.C to obtain herba Agastaches extract, Scutellariae radix extract, radix Paeoniae alba extract, Poria extract and folium Psidii Guajavae extract.

As a further description of the technical solution of the present invention, the pogostemon cablin extract, the scutellaria baicalensis extract, the paeonia lactiflora pallas extract, the poria cocos extract and the guava leaf extract are each extracted separately or mixed.

The traditional Chinese medicine composition is prepared by compounding a coptis chinensis extract, a scutellaria baicalensis extract, a white paeony root extract, a poria cocos extract, a patchouli extract and a guava leaf extract. The compound capsule preparation is a commercially available medicine, namely a lian cai zhi xie jiao nang, under the name of Jiuhui pharmaceutical products limited in Huizhou city, and has the functions of clearing away heat and toxic materials, eliminating dampness and relieving diarrhea, and is mainly used for acute infectious diarrhea caused by rotavirus enteritis and diarrheal colibacillosis.

The clinical application of the anti-diarrhea capsule with the fructus psidii guajaponicae for treating acute infectious diarrhea has been for more than twenty years, and the safety of the anti-diarrhea capsule is fully proved; the inventor carries out compounding on a coptis extract, a scutellaria extract, a white peony root extract, a poria cocos extract, a patchouli extract and a guava leaf extract by expanding the clinical indications of the traditional Chinese medicine, optimizes the dosage of the traditional Chinese medicine, and has good effect of resisting helicobacter pylori infection under the original dosage of the traditional Chinese medicine when the traditional Chinese medicine is used for treating the helicobacter pylori infection.

The coptis extract mainly contains berberine, coptisine, methyl coptisine, palmatine, jateorhizine and african tetrandrine, has the function of resisting pathogenic microorganisms, has certain inhibiting and killing functions on helicobacter pylori, and mainly kills bacteria by inhibiting the growth and respiration of the helicobacter pylori and the oxidation process, particularly the deoxidation reaction, of glucose and sugar metabolism intermediate products.

The scutellaria baicalensis extract mainly contains baicalin, and experiments prove that the scutellaria baicalensis extract has a wider antibacterial spectrum and has an inhibiting effect on dysentery bacillus, diphtheria bacillus, pseudomonas aeruginosa and staphylococcus aureus. The inventor finds that the helicobacter pylori has stronger sensitivity to the scutellaria baicalensis extract in-vitro tests, and the scutellaria baicalensis extract has good inhibiting and killing effects on the helicobacter pylori under the condition of normal dosage.

The white peony root extract mainly contains paeoniflorin, oxidized paeoniflorin, albiflorin, benzoylpaeoniflorin and pentagalloyl glucose, has anti-inflammatory activity and antioxidant activity, and can effectively enhance the inhibiting effect on helicobacter pylori by being compounded with the coptis chinensis extract and the scutellaria baicalensis extract.

The patchouli extract mainly contains patchouli ketone and patchouli alcohol, and has strong activity for resisting helicobacter pylori in vivo, and simultaneously, in vitro experiments show that the patchouli alcohol has specificity for resisting the helicobacter pylori.

The folium Psidii Guajavae extract is powder component obtained by extracting folium Psidii Guajavae of Myrtaceae with purified water or ethanol of different concentrations, and is rich in flavonoids, especially flavone and flavonol, and other components include dihydroflavon (alcohol), isoflavone, biflavone, flavanol, chalcone, aurone, anthocyanin and neoflavonoid. The flavonoid compound has the effect of inhibiting HP urease. HP urease is a toxic protein secreted by HP, since HP urease not only breaks down urea, but also activates mononuclear phagocytes and stimulates the production of inflammatory cytokines. The guava leaf extract can obviously reduce the expression of HP urease activity and destroy the living environment of HP, so that HP is not easy to fix in the gastric mucosa, and the aim of eradicating helicobacter pylori is fulfilled.

Poria extract for killing leptospira in vitro; in addition, Poria extract has direct relaxation effect on intestinal canal, and can be used for preventing ulcer and reducing gastric acid. The composition can improve the micro-environment of administration, reduce gastric acid, and reduce the activity of helicobacter pylori by making the living environment unsuitable.

The invention also provides a traditional Chinese medicine preparation for treating helicobacter pylori infection, which is prepared into granules, pills, capsules, tablets or oral liquid preparations by adopting the traditional Chinese medicine composition compounded by the coptis extract, the scutellaria extract, the white paeony root extract, the poria cocos extract, the patchouli extract and the guava leaf extract and adding auxiliary materials.

Based on the technical scheme, the invention has the following technical effects:

(1) the traditional Chinese medicine composition for helicobacter pylori infection provided by the invention is innovatively used for treating helicobacter pylori infection diseases by compounding the coptis chinensis extract, the scutellaria baicalensis extract, the white paeony root extract, the pogostemon cablin extract, the guava leaf extract and the poria cocos extract, has a good inhibition effect, and is safe and effective as proved by in vitro bacteriostatic tests and animal tests.

(2) According to the traditional Chinese medicine composition, the guava leaf extract has the effects of inhibiting HP urease, reducing the expression of the activity of the HP urease and destroying the living environment of HP, so that the HP is not easy to fix on gastric mucosa; moreover, the poria cocos extract can reduce gastric acid, improve the micro-environment of medication, and the living environment of the helicobacter pylori becomes unsuitable, so that the helicobacter pylori can be effectively inhibited and killed in a synergistic manner under the antibacterial and bactericidal effects of the coptis chinensis extract, the scutellaria baicalensis extract, the radix paeoniae alba extract and the pogostemon cablin extract, and the effect of treating the helicobacter pylori infection is achieved together.

Detailed Description

In order that the invention may be more fully understood, reference will now be made to the specific embodiments illustrated. The invention provides a preferred embodiment. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Example 1

A traditional Chinese medicine composition for treating helicobacter pylori infection comprises the following components in parts by weight: 45 parts of coptis chinensis extract, 45 parts of scutellaria baicalensis extract, 45 parts of radix paeoniae alba extract, 30 parts of pogostemon cablin extract, 90 parts of guava leaf extract and 45 parts of poria cocos extract.

The extraction method of the Coptidis rhizoma extract comprises extracting Coptidis rhizoma with 4-15 times of 5-95% ethanol under reflux for 1-4 hr for 1-4 times, filtering, mixing filtrates, recovering ethanol from the filtrate under reduced pressure, concentrating, and drying to obtain Coptidis rhizoma extract.

The above herba Agastaches extract, Scutellariae radix extract, radix Paeoniae alba extract, Poria extract and folium Psidii Guajavae extract are prepared by respectively extracting herba Agastaches, Scutellariae radix, radix Paeoniae alba, Poria and folium Psidii Guajavae with 4-15 times of purified water or 4-15 times of 5-95% ethanol solutionDecocting at 60-100 deg.C for 1-4 hr for 1-4 times, filtering, mixing filtrates, and concentrating under reduced pressure to relative density of 1.05-1.25g/cm³Drying at 30-100 deg.C to obtain herba Agastaches extract, Scutellariae radix extract, radix Paeoniae alba extract, Poria extract and folium Psidii Guajavae extract.

The above herba Agastaches extract, Scutellariae radix extract, radix Paeoniae alba extract, Poria extract and folium Psidii Guajavae extract are extracted respectively, independently or in combination.

Example 2A Chinese medicinal composition capsule for the treatment of helicobacter pylori

Taking 450g of coptis chinensis, adding 10 times of 70% ethanol solution, and heating and refluxing for extraction for 3 times, wherein each time is 1 hour. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain fine powder of Coptidis rhizoma extract.

Adding 70% ethanol solution 10 times the weight of Scutellariae radix 420g, and extracting under reflux for 1 hr for 3 times. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain Scutellariae radix extract fine powder.

Adding 10 times of 70% ethanol solution into 420g of radix Paeoniae alba, and extracting under reflux for 1 hr for 3 times. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain radix Paeoniae alba extract fine powder.

Adding 10 times of 70% ethanol solution into 420g of Poria, and extracting under reflux for 1 hr for 3 times. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain Poria extract fine powder.

Adding 10 times of water into 250g of herba Agastaches, decocting for 2 times, each time for 1.5 hr, mixing decoctions, filtering, and concentrating the filtrate under reduced pressure to relative density of 1.10g/cm³Oven drying at 60 deg.C, and making into fine powder of herba Agastaches extract.

Collecting folium Psidii Guajavae 800g, adding 10 times of water, decocting for 2 times, each time for 1.5 hr, mixing decoctions, filtering, and concentrating the filtrate under reduced pressure to relative density of 1.10g/cm³Oven drying at 60 deg.C, and making into fine powder of folium Psidii Guajavae extract.

Mixing Coptidis rhizoma extract fine powder, Scutellariae radix extract fine powder, radix Paeoniae alba extract fine powder, Poria extract fine powder, herba Agastaches extract fine powder and folium Psidii Guajavae extract fine powder, grading, and making into capsule.

Example 3A Chinese medicinal composition powder for the treatment of helicobacter pylori

360g of coptis chinensis, 540g of scutellaria baicalensis, 400g of radix paeoniae alba and 500g of poria cocos are respectively added into 6 times of 85% ethanol solution, and the mixture is heated, refluxed and extracted for 2 times, and each time lasts for 3 hours. Filtering, mixing filtrates, recovering ethanol under reduced pressure, spray drying the concentrated solution to obtain fine powder, and mixing the four fine powders to obtain fine powder A. Adding 7 times of water into 240g of patchouli and 1100g of guava leaves, decocting for 1 time and 4 hours, mixing the decoctions, filtering, and concentrating the filtrate under reduced pressure to relative density of 1.12g/cm³Drying at 60 deg.C, and making into fine powder B. Pulverizing the fine powder A and B, sieving, mixing, and packaging.

Example 4A Chinese medicinal composition granule for the treatment of helicobacter pylori

Taking 540g of coptis chinensis, 360g of scutellaria baicalensis, 360g of radix paeoniae alba and 300g of poria cocos, respectively adding 15 times of 50% ethanol solution, and heating and refluxing for extraction for 1 time and 4 hours. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain fine powder A. Collecting herba Agastaches 380g and folium Psidii Guajavae 700g, adding 12 times of water, decocting for 3 times, each time for 1.5 hr, mixing decoctions, filtering, and concentrating the filtrate under reduced pressure to relative density of 1.16g/cm³Drying at 60 deg.C, and making into fine powder B. Mixing fine powder A, fine powder B and adjuvants, granulating, drying, grading, and packaging.

EXAMPLE 5A Chinese medicinal composition tablet for the treatment of helicobacter pylori

Respectively adding 420g of coptis chinensis, 450g of scutellaria baicalensis, 380g of radix paeoniae alba and 400g of poria cocos into 8 times of 75% ethanol solution, and heating and refluxing for extraction for 4 times, wherein each time is 1 hour. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain fine powder A. Decocting herba Agastaches 350g and folium Psidii Guajavae 1000g with 15 times of water for 2 times (1.5 hr each time), mixing decoctions, filtering, and concentrating the filtrate under reduced pressure to relative density of 1.15g/cm³Drying at 60 deg.C, and making into fine powder B. Mixing the fine powder A,Mixing the fine powder B and adjuvants, granulating, drying, grading, tabletting, and coating.

Example 6A Chinese medicinal composition pill for the treatment of helicobacter pylori

Taking 400g of coptis chinensis, 800g of scutellaria baicalensis, 600g of radix paeoniae alba and 4500g of poria cocos, respectively adding 6 times of 80% ethanol solution, and heating and refluxing for extraction for 4 times, wherein each time lasts for 1.5 hours. Filtering, mixing filtrates, recovering ethanol under reduced pressure, and spray drying the concentrated solution to obtain fine powder A. Collecting 250g of herba Agastaches and 800g of folium Psidii Guajavae, adding 6 times of water, decocting for 3 times, each time for 1.5 hr, mixing decoctions, filtering, and concentrating the filtrate under reduced pressure to relative density of 1.13g/cm³Drying at 60 deg.C, and making into fine powder B. Pulverizing the fine powder A and the fine powder B, sieving, mixing with adjuvants, and making into pill.

Example 7A Chinese medicinal composition oral liquid for the treatment of helicobacter pylori

Taking 300g of patchouli and 900g of guava leaves, adding 10 times of water, decocting for 2 times, each time for 1.5 hours, combining the decoctions, and filtering to prepare a liquid medicine B for later use.

Taking 450g of coptis chinensis, 450g of scutellaria baicalensis, 450g of radix paeoniae alba and 450g of poria cocos, adding 70% ethanol solution in an amount which is 10 times that of the coptis chinensis, heating and refluxing for 3 times, each time for 1.5 hours, filtering, combining filtrates, recovering ethanol under reduced pressure, adding the liquid medicine B, concentrating under reduced pressure to obtain an extract, diluting with a proper amount of purified water, refrigerating, filtering, adding a flavoring agent, a smell correcting agent, a coloring agent, a preservative and the like, adding a proper amount of purified water to 1000ml, refrigerating, filtering, and packaging to obtain the traditional Chinese medicine.

Example 8 in vitro anti-helicobacter pylori assay

(1) Strain culture and test solution preparation: culturing helicobacter pylori (Hp) by broth dilution method, ultrasonically dissolving sample with brain heart extract Broth (BHI), vortex mixing, centrifuging at 12000rpm for 5min, and filtering with 0.22 μm filter membrane; the Chinese medicinal composition capsule for treating helicobacter pylori of the embodiment 2 is dissolved by ethanol, and is prepared into liquid medicines with a plurality of concentration gradients of 1280 mu g/ml, 640 mu g/ml, 320 mu g/ml, 160 mu g/ml, 80 mu g/ml and 40 mu g/ml by a two-fold dilution method.

(2) Preparing a reference substance solution: a commercially available clarithromycin capsule (Jiangsu Fubang pharmaceutical Co., Ltd.) was selected and dissolved in ethanol to prepare a stock solution, which was diluted to a plurality of corresponding concentration gradients when used.

(3) And sucking 50 mul of the prepared liquid medicine, adding the liquid medicine into a 96-well plate, setting at least 3 multiple wells for each medicine concentration, and setting a negative control well (only containing the medicine and not inoculating the strain) and a growth control well (only inoculating the strain and not containing any medicine). Taking out the strain from the incubator, scraping the lawn into broth with a moistened sterilized cotton swab, adjusting the turbidity of the bacterial suspension to 1McF with BHI containing 20% FBS, diluting by 10 times, and inoculating into the drug-containing 96-well plate; the final turbidity of the bacterial suspension in the 96-well plate was about 1X 10⁶CFU/ml), the 96-well plate was immediately placed in an incubator, and the results were taken out after culturing at 37 ℃ under microaerophilic conditions for 72 hours with shaking at 150 rpm.

When the growth control is obviously turbid, the result can be used, and the drug concentration when the bacterial turbidity is obviously reduced is the minimum inhibitory concentration MIC when the result is observed from bottom to top by naked eyes. A clarithromycin solution was used as a positive control for each experiment. The results are shown in Table 1 for the survival of Hp in different gradient concentrations of the drug solution.

TABLE 1Hp survival at different concentration gradients

Note: "-" no bacterial growth; "+" has bacteria growing

The experimental results of table 1 show that: clarithromycin is used as a positive control, the MIC of the Clarithromycin is 0.016 mu g/ml, and the traditional Chinese medicine composition capsule in the example 2 has the same bacteriostatic action with the Clarithromycin at the MIC concentration of 320 mu g/ml.

EXAMPLE 9 Single-component anti-helicobacter pylori test of Chinese medicinal composition

As can be seen from table 1, the minimum inhibitory concentration MIC of the drug concentration of the Chinese medicinal composition capsule is 320 μ g/ml, the minimum inhibitory concentration measurements were performed according to the components of each Chinese medicinal extract of the prescription, and the inhibitory effects of each component used alone were compared, and a plurality of concentration-gradient drugs were prepared by ultrasonic dissolving the coptis root extract, the scutellaria root extract, the white peony root extract, the patchouli extract, the guava leaf extract and the poria cocos extract with brain-heart infusion Broth (BHI), vortexing and mixing them, centrifuging at 12000rpm for 5min, passing through 0.22 μm filter membrane, and using a two-fold dilution method, and the experimental method was the same as the preparation method of example 8. The results are shown in Table 2 for MIC measurements of the single components of the Chinese medicinal composition.

TABLE 2 MIC assay for a single component of a Chinese medicinal composition

Note: "-" no bacterial growth; "+" has bacteria growing

The single-component MIC determination results of the traditional Chinese medicine compositions in table 2 show that each component of the traditional Chinese medicine extract has an antibacterial effect only when being tested separately, and the minimum antibacterial concentration used separately is several times higher than the minimum antibacterial concentration of the traditional Chinese medicine composition, while the traditional Chinese medicine composition capsule for treating helicobacter pylori of example 2 has a more significant antibacterial effect at the same concentration, and the capsule has a synergistic effect on treating Hp infection and can significantly improve the effect of resisting helicobacter pylori infection.

Example 10 comparative test against helicobacter pylori infection

(1) Test drugs: the Chinese medicinal compositions of different dosage forms of example 2 to example 7 were taken respectively and administered at an administration dose of 225mg/kg/d to serve as test medicaments 1 to 6.

A. Control drug 1: taking 430g of Chinese medicinal material coptis root, heating and refluxing for 2.5 hours by using 10 times of 70% ethanol solution, extracting for 3 times, filtering, combining filtrates, recovering ethanol from the filtrate under reduced pressure, and spray-drying the concentrated solution into fine powder with the administration dosage of 225mg/kg/d for administration, wherein the control medicament 1 is prepared.

B. Control drug 2: taking 500g of traditional Chinese medicine scutellaria baicalensis, using 8 times of 75% ethanol solution, heating and refluxing for 2 hours, extracting for 2 times, filtering, combining filtrates, recovering ethanol from the filtrate under reduced pressure, and spray-drying the concentrated solution into fine powder with the administration dosage of 225mg/kg/d for administration as a control drug 2.

C. Control drug 3: heating and refluxing 365g of Chinese medicinal material white paeony root with 7 times of 85% ethanol solution for 2 hours, extracting for 2 times, filtering, combining filtrates, recovering ethanol from the filtrate under reduced pressure, and spray-drying the concentrated solution into fine powder with the administration dosage of 225mg/kg/d for administration as a control medicament 3.

D. Control drug 4: heating and refluxing 1095g of traditional Chinese medicine Poria with 6 times of 70% ethanol solution for 1 hr, extracting for 3 times, filtering, mixing filtrates, recovering ethanol from the filtrate under reduced pressure, spray drying the concentrated solution to obtain fine powder with dosage of 225mg/kg/d, and administering as control drug 4.

E. Control drug 5: decocting herba Agastaches 300g with 12 times of water at 80 deg.C for 1.5 hr for 2 times, filtering, mixing filtrates, and concentrating the filtrate under reduced pressure to relative density of 1.10-1.16g/cm³Oven drying at 30-80 deg.C to obtain fine powder, and administering at dosage of 225mg/kg/d as control drug 5.

F. Control drug 6: decocting 900g of folium Psidii Guajavae with 6 times of water at 85 deg.C for 2.5 hr for 2 times, filtering, mixing filtrates, and concentrating under reduced pressure to relative density of 1.10-1.16g/cm³Oven drying at 30-80 deg.C to obtain fine powder, and administering at dosage of 225mg/kg/d as control drug 6.

(2) Preparation of Hp-infected mouse model: after the mice are taken for adaptive feeding for 1 day, the mice are fasted and are forbidden to drink water for 12 hours, each mouse is injected with 0.2ml of ethanol for disinfection in a gastric lavage mode, and normal diet drinking water is recovered after 3 hours. After the pretreated mice are fasted and water-deprived for 12 hours, the stomach-feeding Hp suspension is 0.5ml (the bacterial liquid number is 1 multiplied by 10)⁶CFU/ml), repeated once every 12h for a total of four times. Recovering drinking water after 2h after last gastric lavage. 5 mice were sacrificed at random after 5 weeks and antral tissues were taken for urease, bacteriological smear examination and histological examination to determine whether or not Hp was successfully infected;

(3) animal grouping and administration: the modeled mice were randomly divided into 13 groups of 10 mice each, 1-6 groups (administration dose of 225mg/kg/d) and control groups, and normal groups (mice in the normal groups were treated by feeding them adaptively for 1 day, fasting and depriving water for 12 hours, injecting 0.2ml ethanol per mouse for sterilization, and recovering normal drinking water after 3 hours.)

The test drug group and the control drug group are administered with 0.4ml of pure water to each mouse by intragastric administration, and the control group and the normal group are administered with 0.4ml of normal saline each time for five weeks. During the test period, no death of the mice was observed.

(4) Detection indexes are as follows: stopping feeding water for 24 hr after last administration/physiological saline, killing animal, cutting open along stomach greater curvature, cleaning residue with sterile physiological saline, cutting antrum along longitudinal axis, dividing antrum into three parts, and using one part for PGE₂And urease test; one part is used for histological examination, stomach tissues are fixed by formaldehyde, and tissue sections are divided into HE staining and Giemsa staining; and the third part is used for smear microscopy, the mucosa surface of the antrum of the stomach of the mouse is pasted on a glass slide for smear, and the microscopic examination is carried out after gram staining.

Wherein the stomach tissue homogenates PGE₂And (3) content detection: weighing mouse stomach tissue, shearing, and adding normal saline according to the proportion of 10mL/g for homogenization to obtain stomach tissue homogenate. The sample diluent is used as a blank control, 50 μ L of each standard sample is sequentially added into the wells, and 50 μ L of the sample is added to each of the other wells. 10 μ L of biotin labeling solution was added to the sample wells, 100 μ L of enzyme labeling solution was added to the standard wells and the sample wells, and incubation was carried out at 37 ℃ for 60 min. After washing with the washing solution for 5 times, 50. mu.L of the substrate A, B solution was added to each well, and the reaction was incubated for 15min at 36 ℃ in the absence of light. The reaction was stopped by adding 50. mu.L of stop solution to each well. The OD at 450nm was measured. The concentration of the sample was calculated according to the standard curve regression equation.

And (3) measuring the urease content: adding the gastric tissue homogenate into a 96-well plate, and repeating two holes; and after the addition, performing incubation treatment, namely covering a sealing film to seal the pore plate, incubating for 24h in a constant temperature box at 37 ℃, adding a urea reagent into the corresponding pore plate after the incubation, wherein the urea reagent is 50 ml/pore, incubating for 30min in the constant temperature box at 37 ℃ for color development, reading at a wavelength of 578 nm, and recording the OD value of each group.

The detection results are shown in Table 3 for PGE corresponding to different drugs₂Urease content and clearance of Hp.

TABLE 3 PGE for different drugs₂Determination of urease content and Hp clearance

As can be seen from Table 3, the PGE values of the test drugs 1 to 6 corresponding to the different dosage forms of the Chinese medicinal compositions of examples 2 to 7 are compared with those of the control drugs 1 to 6₂The content is below 50pg/mL, which shows that the prostaglandin E2 is reduced under the action of the test medicament; the clearance rate of Hp infection reaches more than 70%, and the clearance rate of the test drug 1-the test drug 6 is higher than that of the control drug 1-the control drug 6; the clearance effect of the test drug 2 is slightly poor, but the difference is not large, and the test drugs 1,3-6 have no significant difference.

In the contrast drugs, the contrast drug 1 is relatively better than the contrast drug 2-the contrast drug 6 in the clearance of Hp, but has no obvious difference, the clearance of Hp is less than 50%, and the clearance of Hp corresponding to a single traditional Chinese medicine component does not reach the target anti-Hp infection effect. When the traditional Chinese medicine components are mixed to form the traditional Chinese medicine compositions of different dosage forms of the embodiment 2 to the embodiment 7, namely the corresponding test medicines 1 to 6, the Hp infection resisting effect can be more remarkable. Therefore, under the antibacterial and bactericidal effects of the coptis chinensis extract, the scutellaria baicalensis extract, the white paeony root extract and the patchouli extract, the helicobacter pylori is effectively inhibited and killed in a synergistic manner, and the effect of treating the helicobacter pylori infection is exerted together.

The foregoing is merely exemplary and illustrative of the structures of the present invention, which are described in some detail and detail, and are not to be construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications are possible without departing from the inventive concept, and such obvious alternatives fall within the scope of the invention.

Claims

1. A traditional Chinese medicine composition for treating helicobacter pylori infection is characterized by comprising the following components in parts by weight: 27-62 parts of coptis chinensis extract, 27-62 parts of scutellaria baicalensis extract, 27-62 parts of radix paeoniae alba extract, 15-43 parts of pogostemon cablin extract, 60-122 parts of guava leaf extract and 27-62 parts of poria cocos extract.

2. The traditional Chinese medicine composition according to claim 1, which comprises the following components in parts by weight: 45 parts of coptis chinensis extract, 45 parts of scutellaria baicalensis extract, 45 parts of radix paeoniae alba extract, 30 parts of pogostemon cablin extract, 90 parts of guava leaf extract and 45 parts of poria cocos extract.

3. The Chinese medicinal composition according to claim 1, wherein the Coptidis rhizoma extract is obtained by extracting Coptidis rhizoma with 4-15 times of 5-95% ethanol under reflux for 1-4 hr for 1-4 times, filtering, mixing filtrates, recovering ethanol from filtrate under reduced pressure, concentrating, and drying to obtain Coptidis rhizoma extract.

4. The Chinese medicinal composition according to claim 1, wherein the extracts of pogostemon cablin, scutellaria baicalensis, paeonia lactiflora pallas, poria cocos and guava leaves are extracted by decocting pogostemon cablin, scutellaria baicalensis, paeonia lactiflora, poria cocos and guava leaves respectively with 4-15 times of purified water or 4-15 times of 5-95% ethanol solution at 60-100 ℃ for 1-4 hours for 1-4 times, filtering, combining filtrates, and concentrating the filtrate under reduced pressure to a relative density of 1.05-1.25g/cm³Drying at 30-100 deg.C to obtain herba Agastaches extract, Scutellariae radix extract, radix Paeoniae alba extract, Poria extract and folium Psidii Guajavae extract.

5. The composition of claim 4, wherein the extracts of Pogostemon cablin, Scutellaria baicalensis, Paeonia lactiflora, Poria cocos, and Psidium guajava are extracted individually or in combination.

6. A traditional Chinese medicine preparation for treating helicobacter pylori infection is characterized in that a granule, a pill, a capsule, a tablet or an oral liquid preparation is prepared by adopting the traditional Chinese medicine composition as claimed in any one of claims 1 to 5 and adding auxiliary materials.