CN104814964B - A kind of pharmaceutical composition, the preparation method and applications of anti-stomach Helicobacter pylori - Google Patents
A kind of pharmaceutical composition, the preparation method and applications of anti-stomach Helicobacter pylori Download PDFInfo
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- CN104814964B CN104814964B CN201510184789.5A CN201510184789A CN104814964B CN 104814964 B CN104814964 B CN 104814964B CN 201510184789 A CN201510184789 A CN 201510184789A CN 104814964 B CN104814964 B CN 104814964B
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- helicobacter pylori
- amoxicillin
- nuolazan
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- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 claims abstract description 31
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to a kind of pharmaceutical compositions of anti-stomach Helicobacter pylori comprising following component in parts by weight：5 50 parts of 50 500 parts of component A, 100 500 parts of B component and component C；The component A is Amoxicillin；The B component is selected from：Lavo-ofloxacin and its pharmaceutically acceptable salt, Moxifloxacin and its pharmaceutically acceptable salt；The component C is selected from：Wo Nuolazan and its pharmaceutically acceptable form.The present invention also provides the preparation method and application of the pharmaceutical composition.The pharmaceutical composition of the anti-stomach Helicobacter pylori of the present invention, anti-stomach Helicobacter pylori effect is strong, and adverse reaction is few, is widely used, and preparation method is simple, easy to operate.
Description
Technical field
The present invention relates to a kind of antimicrobial agents fields, and in particular to a kind of pharmaceutical composition of anti-stomach Helicobacter pylori
Object, preparation method and applications.
Background technology
Stomach Helicobacter pylori also known as helicobacter pylori (Helicobacter pylori, H.pylori), are a kind of leather
It is blue negative, the obligate microaerobion of S or arc-shaped bend.H.pylori is the highest pathogen of infection rate in the world,
H.pylori infection is in global distribution, about half global population infects this bacterium, and China's H.pylori infection rates are higher, is 42%
~90%, average 59%.H.pylori is the important pathogenic bacteria of disease of upper digestive tract, chronic gastritis, peptic ulcer, early stage stomach
The disease of digestive systems such as postoperative, the gastric mucosa associated lymphoid tissue lymthoma of cancer should all eradicate H.pylori treatments, and unknown cause lacks
Many parenteral diseases such as iron anaemia, Idiopathic Thrombocytopenic Purpura and vitamin B12 deficiency also H.pylori
Infect it is related, if these patients H.pylor infection should also eradicate.H.pylori infection can destroy the viscous of gastrointestinal mucosal surface
Liquid resistant barrier, and then H+ constantly spread into mucous membrane, cause a series of pathogenesis, eventually lead to it is gastrointestinal tract mucous it is congested,
Oedema, bleeding, erosion or even the generation of ulcer.
However, recently as the increase of H.pylori Antibiotic Resistances, under traditional standard triple therapy eradication rate
Drop to 70% hereinafter, and generate the adverse reactions such as nausea, discomfort, pruitus patient cases it is more.Therefore, seek best
H.pylori eradication programs, it is the emphasis of medical personal, difficult point to improve eradication rate.
Invention content
A kind of the purpose of the present invention is to provide antibacterial actions strong, the few anti-stomach Helicobacter pylori of adverse reaction drug
Composition, the present invention also provides the preparation method and application of the pharmaceutical composition.
To solve the above problems, the technical solution adopted in the present invention is as follows：
A kind of pharmaceutical composition of anti-stomach Helicobacter pylori, it is characterised in that including in parts by weight such as the following group
Point：5-50 parts of 50-500 parts of component A, 100-500 parts of B component and component C；
The component A is Amoxicillin；The B component is selected from：Lavo-ofloxacin and its pharmaceutically acceptable salt (such as
Lavo-ofloxacin hydrochloride), Moxifloxacin and its pharmaceutically acceptable salt (such as moxifloxacin hydrochloride)；The component C is selected from：
Wo Nuolazan and its pharmaceutically acceptable form.
Wo Nuolazan (Vonoprazan, TAK-438) is a kind of novel potassium channel blocker (P-CABs), for controlling
Treat Non-erosive gastroesophageal reflux disease, duodenal ulcer, gastric ulcer, erosive esophagitis (healing and maintaining treatment).
Amoxicillin is penicillin antibiotics, to the streptococcuses such as streptococcus pneumonia, hemolytic streptococcus, pylorus spiral
Bacillus, the aerobic gram-positive coccus such as do not produce penicillase staphylococcus, enterococcus faecalis, escherichia coli, proteus mirabilis,
The aerobic gram negative bacterium such as Salmonella, haemophilus influenzae, NEISSERIA GONORRHOEAE does not produce lactamase strain and with good
Antibacterial activity, Amoxicillin play bactericidal effect by inhibiting bacteria cell wall synthesis, bacterium can be made to rapidly become orbicule
Two dissolvings, rupture.Clinically it is mainly used for the respiratory tract infection caused by sensitive bacteria, the made gastrointestinal tract of stomach Helicobacter pylori is burst
Ulcer, urethral infection, skin soft-tissue infection and infection of biliary tract.
Lavo-ofloxacin is one kind in quinolone drugs, has broad-spectrum antibacterial action, antibacterial action is strong, to most intestines
Bacteriaceae bacterium, such as escherichia coli, Klebsiella, Proteus, Salmonella, Shigella and the bloodthirsty bar of influenza
The gram-negative bacterias such as bacterium, legionella pneumophilia, NEISSERIA GONORRHOEAE have stronger antibacterial activity.To staphylococcus aureus, pneumonia chain
The gram positive bacterias such as coccus, micrococcus scarlatinae and mycoplasma pneumoniae, chlamydia pneumoniae also have antibacterial action.
Moxifloxacin is forth generation quinolones broad spectrum antibiotic, is wide spectrum and the 8- methoxyl group fluorine quinolines with antibacterial activity
Promise ketone antimicrobial.Moxifloxacin is shown in vitro to gram positive bacteria, gram-negative bacteria, anaerobic bacteria, acid fast bacteria and SARS
Type microorganism such as mycoplasma, Chlamydia and Legionella have broad spectrum antibiotic activity.Antibacterial mechanisms are II, IV topoisomerase of interference.
Topoisomerase is the key enzyme controlled in DNA topologys and DNA replication dna, reparation and transcription.Moxifloxacin oral absorbs well, and
It is not likely to produce drug resistance, activity is high in vivo.It is clinically used to treat soft group of infection in respiratory system, genital system infection, skin
Knit infection etc..
Inventor has found by many experiments, and the component A (i.e. Amoxicillin) of the present invention, B component (are selected from left oxygen fluorine
One or more of husky star and its pharmaceutically acceptable salt, Moxifloxacin and its pharmaceutically acceptable salt substance
Composition) and component C (the i.e. combination selected from one or more of Wo Nuolazan and its pharmaceutically acceptable form substance
Object) it is used in combination, which mutually produces synergistic effect so that the work of the anti-stomach Helicobacter pylori of composition
With beening significantly enhanced, and adverse reaction is few.
In the present invention, preferred scheme is that the Wo Nuolazan of the pharmaceutically acceptable form is：The salt of Wo Nuolazan or
Alkali form；The Wo Nuolazan of further preferred pharmaceutically acceptable form is Vonoprazan fumarate.
In the present invention, preferred scheme is the following component that described pharmaceutical composition includes in parts by weight：Component A
5-20 parts of 125-500 parts, 300-500 parts of B component and component C.
The medicine composition dosage form of anti-stomach Helicobacter pylori in the present invention is injection, powder-injection, tablet, sustained release
One kind in agent, granule, capsule and sustained release pellet.In the pharmaceutical composition of the anti-stomach Helicobacter pylori of different dosage forms
In, the total weight of the component A, B component and component C accounts for the 0.1-99% of entire pharmaceutical composition weight；Further preferred
Scheme is that the total weight of the component A, B component and component C accounts for the 1-60% of entire pharmaceutical composition weight.
In the present invention, preferred scheme is that described pharmaceutical composition is tablet, and described pharmaceutical composition further includes that tablet is used
Auxiliary material.Wherein auxiliary material includes but not limited to：Adhesive, such as gelatin, polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl first
Cellulose；Filler, such as lactose, mannitol, microcrystalline cellulose, cornstarch, pregelatinized starch, sorbierite；Lubricant, example
Such as magnesium stearate；Disintegrant, such as sodium carboxymethyl starch, crospovidone；Or the pH adjusting agent pharmaceutically received, such as rich horse
Acid, citric acid.Further preferred scheme is the pharmaceutical composition of the tablet form by following component system in parts by weight
At：10 parts of Wo Nuolazan, 50 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate, gather
Tie up 5 parts of 30 parts of ketone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.
The present invention also provides the preparation methods of the pharmaceutical composition of the anti-stomach Helicobacter pylori of the tablet form comprising
Following steps：Weighed each component according to formula ratio, be uniformly mixed, then used wet granulation, it is dry, tabletting to get.
In the present invention, preferred scheme is that the pharmaceutical composition of the anti-stomach Helicobacter pylori is injection, the medicine
Compositions further include water for injection and NaCl.As needed, it can also be added in the pharmaceutical composition of the injection form anti-
The typical additives of the injections such as rotten agent, buffer.Further preferably the pharmaceutical composition of the injection form by according to
The following component of parts by weight meter is made：50 parts of Wo Nuolazan, 500 parts of Amoxicillin, 100 parts of Moxifloxacin, 450 parts of NaCl and
Water for injection, the mass-volume concentration of Amoxicillin described in the pharmaceutical composition of the injection form are 1g/L.
The present invention also provides the preparation method of the pharmaceutical composition of the anti-stomach Helicobacter pylori of the injection form, packets
Include following steps：Each component has been weighed according to formula ratio, NaCl has been dissolved in water for injection, component A, B component is then added
With component C and stir to being completely dissolved, then filter to clear and bright, embedding, sterilizing to get.
The pharmaceutical composition of the anti-stomach Helicobacter pylori of the present invention can prepared for treating by stomach Helicobacter pylori
Application in the drugs of diseases such as caused chronic gastritis, peptic ulcer and gastric mucosa associated lymphoid tissue lymthoma.
Compared with prior art, the invention has the advantages that：The pharmaceutical composition of the anti-stomach Helicobacter pylori of the present invention
Object passes through the selection of ingredient and its proportioning to component A, B component and component C so that three produces synergistic effect so that medicine
The anti-stomach Helicobacter pylori effect enhancing of entirety of compositions, and adverse reaction is few；Meanwhile anti-stomach pylorus spiral shell of the invention
The pharmaceutical composition of swing arm bacterium, the preparation methods of various dosage forms is simple, is convenient for technique productions；In addition, the present invention's is anti-
The pharmaceutical composition of stomach Helicobacter pylori can be used for chronic gastritis caused by treating stomach Helicobacter pylori, digestibility is burst
The diseases such as ulcer and gastric mucosa associated lymphoid tissue lymthoma.
The present invention is described in detail With reference to embodiment.
Specific implementation mode
Embodiment 1
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：10 parts of Wo Nuolazan, 50 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate,
5 parts of 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：According to
Side's amount has weighed each component, is uniformly mixed, and then uses wet granulation, dry, tabletting to get.
Embodiment 2
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of injection form, by parts by weight such as the following group
Divide and is made：50 parts of Wo Nuolazan, 500 parts of Amoxicillin, 100 parts of Moxifloxacin, 450 parts of NaCl and water for injection, in the injection
The mass-volume concentration of Amoxicillin described in the pharmaceutical composition of dosage form formula is 1g/L.Preparation method includes the following steps：
Each component has been weighed according to formula ratio, NaCl has been dissolved in water for injection, Wo Nuolazan, Amoxicillin and Moses is then added
Husky star is simultaneously stirred to being completely dissolved, and is then filtered to clear and bright, embedding, sterilizing to get.
Embodiment 3
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of sustained release pellet form is as follows by parts by weight
Component is made：
Capsule core prescription：20 parts of Wo Nuolazan, 50 parts of Amoxicillin, 150 parts of lavo-ofloxacin, 15 parts of microcrystalline cellulose, hydroxyl
5 parts of propyl methocel, 250 parts of water；
It is coated prescription：185 parts of 25% aqueous ethylcellulose dispersion liquid, 122 parts of water.
Preparation method is：Microcrystalline cellulose, Wo Nuolazan, Amoxicillin, lavo-ofloxacin crushed in advance respectively
100 mesh sieve, and are weighed by capsule core prescription, are uniformly mixed, hypromellose aqueous solution does adhesive, pellet processed, by it in 50
The piller of 20~30 mesh is selected in~60 DEG C of dryings, spare；
The pellet that will be prepared and choose, sets in fluid bed, mode is sprayed the bottom of using, by hot-air suspension fluidization, into wind-warm syndrome
Degree is 55 DEG C, and when material bed tempertaure controls 30 DEG C, adjusting peristaltic pump makes it provide coating solution, atomization by the speed of 5g slurries per minute
Pressure 2bar starts continuously to whitewash to the piller of fluidisation, after whitewashing, reduces air quantity, makes pellet under slight boiling condition in 40
DEG C dry a moment.Taking-up is placed in 40 DEG C of baking ovens 24 hours dry, weightening about 18%, measure content to get.
Embodiment 4
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：5 parts of Vonoprazan fumarate, 200 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 200 parts of Moxifloxacin, microcrystalline cellulose
10 parts of 125 parts, 600 parts of lactose monohydrate, 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Its preparation side
Method includes the following steps：Each component has been weighed according to formula ratio, has been uniformly mixed, wet granulation is then used, dry, tabletting, i.e.,
.
Embodiment 5
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：50 parts of Wo Nuolazan, 500 parts of Amoxicillin, 500 parts of lavo-ofloxacin, 465 parts of microcrystalline cellulose, lactose monohydrate 1050
Part, 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and 65 parts of magnesium stearate.Preparation method includes the following steps：It presses
Weighed each component according to formula ratio, be uniformly mixed, then used wet granulation, it is dry, tabletting to get.
Embodiment 6
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：20 parts of Wo Nuolazan, 500 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 465 parts of microcrystalline cellulose, lactose monohydrate 1050
Part and 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose, 70 parts of magnesium stearate.Preparation method includes the following steps：It presses
Weighed each component according to formula ratio, be uniformly mixed, then used wet granulation, it is dry, tabletting to get.
Embodiment 7
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：20 parts of Wo Nuolazan, 500 parts of Amoxicillin, 400 parts of Moxifloxacin, 470 parts of microcrystalline cellulose, 1000 parts of lactose monohydrate,
65 parts of 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：According to
Side's amount has weighed each component, is uniformly mixed, and then uses wet granulation, dry, tabletting to get.
Comparative example 1
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：It is 10 parts of Wo Nuolazan, 150 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate, 30 parts of povidone, low
Replace 5 parts of 20 parts of hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：Each group has been weighed according to formula ratio
Point, be uniformly mixed, then use wet granulation, it is dry, tabletting to get.
Comparative example 2
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：10 parts of Wo Nuolazan, it 150 parts of Amoxicillin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate, 30 parts of povidone, low takes
For 5 parts of 20 parts of hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：Each group has been weighed according to formula ratio
Point, be uniformly mixed, then use wet granulation, it is dry, tabletting to get.
Comparative example 3
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：10 parts of Wo Nuolazan, 50 parts of Amoxicillin, 100 parts of Ciprofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate, gather
Tie up 5 parts of 30 parts of ketone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：According to formula
Amount has weighed each component, is uniformly mixed, and then uses wet granulation, dry, tabletting to get.
Comparative example 4
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：10 parts of Wo Nuolazan, 50 parts of ampicillin, 100 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate,
5 parts of 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：According to
Side's amount has weighed each component, is uniformly mixed, and then uses wet granulation, dry, tabletting to get.
Comparative example 5
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：10 parts of Wo Nuolazan, 40 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate,
5 parts of 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：According to
Side's amount has weighed each component, is uniformly mixed, and then uses wet granulation, dry, tabletting to get.
Comparative example 6
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：60 parts of Wo Nuolazan, 50 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, 350 parts of lactose monohydrate,
5 parts of 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes the following steps：According to
Side's amount has weighed each component, is uniformly mixed, and then uses wet granulation, dry, tabletting to get.
Comparative example 7
A kind of pharmaceutical composition of the anti-stomach Helicobacter pylori of tablet form, by following component in parts by weight
It is made：20 parts of esomeprazole, 500 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 580 parts of microcrystalline cellulose, lactose monohydrate
15 parts of 1150 parts, 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.Preparation method includes following step
Suddenly：Weighed each component according to formula ratio, be uniformly mixed, then used wet granulation, it is dry, tabletting to get.
Experimental example
1 case selection：Select in October, 2012 in January, 2014 in No.1 Hospital Affiliated to Zhongshan Univ., the second hospital and
The medical patient of third hospital GI Medicine, totally 1080.
1.1 inclusion criteria：1. being ready that with merging follow-up can be carried out, the age between 18~75 years old, is demonstrate,proved through gastroscope and pathology
Actually chronic active gastritis (including：Gastric mucosal erosion, in~severe atrophy, in~severe intestines, atypical hyperplasia), digestion
Property ulcer, functional dyspepsia FD (diagnostic criteria reference《The RomeⅢdiagnostic criteria of Functional Gastrointestinal Disease》)；2. warp before selected
Stomach lining rapid urease test (RUT) or 14C- urea breath tests (14C-UBT) turn out to be H.pylori positives；3. both
It is past not receive regular H.pylori eradication therapies.
1.2 exclusion criteria：1. treating first 2 weeks used proton pump inhibitors (PPI), H2 receptor blocker (H2RA) and non-steroid
Body anti-inflammatory drugs (NSAID) person treats preceding 4 weeks used antibacterials or bismuth agent person；2. there are the serious heart, brain, pulmonary disease, livers
Renal insufficiency person；3. gestation or women breast-feeding their children；4. to this research institute drug allergy sufferers.
1.3 terminate research standard：1. sb.'s illness took a turn for the worse or severe complication occurs；2. occurring during treatment serious bad anti-
It answers, it can not resistance to receptor；3. other diseases occur during treatment interferes this observation；4. lost to follow-up；5. gestation during treatment.
1.4 ordinary circumstance：Enter 1080 patients of group altogether, wherein man 532, female 548, average age 49 years old (18~75
Year), wherein patients with functional dyspepsia 376, chronic active gastritis 380, peptic ulcer 324.
2.1 groupings and test method：Above-mentioned 1080 patients are randomly divided into 12 groups by selected sequence, every group of 90 people,
Then this 12 groups of patients the anti-stomach H. pylori of tablet form made from embodiment 1,4-7 and comparative example 1-7 has been taken into respectively
The pharmaceutical composition of bacterium, the dose that each patient takes are calculated as 20mg/ days with Wo Nuolazan or esomeprazole, the course for the treatment of 14
It.After 14 days, every group of ulcers continue to take, and are calculated as 10mg/ days with Wo Nuolazan or esomeprazole, patients w ith peptic ulcer disease
Duration is 6-8 weeks, and duodenum ulcer patient's duration is 4-6 weeks；All patients forbid drinking during taking medicine.
2.2 observation of curative effect：The course for the treatment of terminates and checks 14C-UBT after deactivating all drugs at least 4 weeks, and as a result feminine gender is considered as
H.Pylori is eradicated successfully, and being considered as H.Pylori if the positive eradicates failure.And record drug of the patient in drug administration process not
Good reaction, compliance and safety of the assessment patient to various therapeutic schemes.
2.3 statistical method：It is analyzed using SPSS13.0 statistical softwares, more comparison among groups are using single factor test variance point
Chi-square criterion is analysed, P ＜ 0.05 are that difference is statistically significant.
As a result：
1, ordinary circumstance：A, between B, C group patient in age, gender, classification of diseases and tobacco smoking status difference without statistics
Learn meaning (P>0.05).
2, H.pylori eradication rates and adverse reaction result：According to 2.2 observation of curative effect as a result, simultaneously remembering over the course for the treatment of
Whether record patient there is adverse reaction (such as nausea, uncomfortable, pruitus), such symptom such as occurs, stops the administration of the patient,
Concrete outcome refers to the following table 1：
Table 1：H.pylori eradication rates, adverse reaction number data statistic
| Group | Number lost to follow-up | It eradicates successfully | Eradication rate | Nausea, discomfort | Pruitus |
| Embodiment 1 | 2 | 74 | 84.1% | 1 | 1 |
| Embodiment 4 | 1 | 75 | 84.3% | 0 | 1 |
| Embodiment 5 | 2 | 75 | 85.2% | 1 | 0 |
| Embodiment 6 | 1 | 78 | 87.6% | 0 | 1 |
| Embodiment 7 | 2 | 79 | 89.8% | 1 | 0 |
| Comparative example 1 | 1 | 62 | 69.7% | 4 | 5 |
| Comparative example 2 | 3 | 59 | 67.8% | 4 | 6 |
| Comparative example 3 | 2 | 58 | 65.9% | 3 | 7 |
| Comparative example 4 | 3 | 60 | 69.0% | 6 | 2 |
| Comparative example 5 | 2 | 61 | 69.3% | 5 | 4 |
| Comparative example 6 | 1 | 59 | 66.3% | 7 | 3 |
| Comparative example 7 | 2 | 63 | 71.5% | 6 | 4 |
Note：In upper table, nausea is uncomfortable, and pruitus statistical number of person includes while generating the feelings of above two adverse reaction
Shape.
The pharmaceutical composition of anti-stomach Helicobacter pylori using the present invention, right it can be seen from data in upper table 1
H.pylori eradication rates are apparently higher than comparative example, and the case number of adverse reaction is also significantly lower than comparative example, it is seen that this hair
The component A of bright use, the composition of B component and component C, three produce synergistic effect so that its anti-stomach H. pylori
Bacterium, which acts on, to be remarkably reinforced, and adverse reaction is few.
For embodiment 2, embodiment 3 combination to chronic active gastritis, peptic ulcer and functional dyspepsia FD
The eradication rate of disease, 180 patients of inventor couple test, and recovery from illness (i.e. chronic active stomach is detected whether after 2 week
Whether scorching, peptic ulcer and functional dyspepsia FD disease are eradicated)；For the embodiment of the present invention 2 injection form it is anti-
The pharmaceutical composition of stomach Helicobacter pylori, to chronic active gastritis, peptic ulcer and functional dyspepsia FD disease
Eradication rate reach 94.8%, do not occur adverse reaction case；The anti-stomach pylorus spiral shell of the sustained release pellet form of the embodiment of the present invention 3
The pharmaceutical composition of swing arm bacterium, to the eradication rate of chronic active gastritis, peptic ulcer and functional dyspepsia FD disease
Reach 89.5%, does not occur adverse reaction case.As it can be seen that the pharmaceutical composition of anti-stomach Helicobacter pylori using the present invention
Anti- stomach Helicobacter pylori effect, adverse reaction are few.
The above embodiment is only the preferred embodiment of the present invention, and the scope of protection of the present invention is not limited thereto,
The variation and replacement for any unsubstantiality that those skilled in the art is done on the basis of the present invention belong to institute of the present invention
Claimed range.
Claims (8)
1. a kind of pharmaceutical composition of anti-stomach Helicobacter pylori, it is characterised in that including following component in parts by weight：
10 parts of Wo Nuolazan, 50 parts of Amoxicillin, 100 parts of lavo-ofloxacin；Or
50 parts of Wo Nuolazan, 500 parts of Amoxicillin, 100 parts of Moxifloxacin；Or
20 parts of Wo Nuolazan, 50 parts of Amoxicillin, 150 parts of lavo-ofloxacin；Or
5 parts of Vonoprazan fumarate, 200 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 200 parts of Moxifloxacin；Or
50 parts of Wo Nuolazan, 500 parts of Amoxicillin, 500 parts of lavo-ofloxacin；Or
20 parts of Wo Nuolazan, 500 parts of Amoxicillin, 100 parts of lavo-ofloxacin；Or
20 parts of Wo Nuolazan, 500 parts of Amoxicillin, 400 parts of Moxifloxacin.
2. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, it is characterised in that：The pharmaceutical composition
The dosage form of object is one kind of powder-injection, tablet, sustained release agent, granule and capsule.
3. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, it is characterised in that：The pharmaceutical composition
The dosage form of object is sustained release pellet.
4. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, it is characterised in that：The pharmaceutical composition
Object is tablet, and described pharmaceutical composition further includes tablet auxiliary material.
5. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 4, it is characterised in that by according to parts by weight
The following component of meter is made：10 parts of Wo Nuolazan, 50 parts of Amoxicillin, 100 parts of lavo-ofloxacin, 65 parts of microcrystalline cellulose, one
5 parts of 350 parts of water and milk sugar, 30 parts of povidone, 20 parts of low-substituted hydroxypropyl cellulose and magnesium stearate.
6. a kind of preparation method of the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 4, feature exist
In including the following steps：Each component has been weighed according to formula ratio, has been uniformly mixed, wet granulation is then used, dry, tabletting, i.e.,
.
7. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, it is characterised in that：The pharmaceutical composition
Object is injection, and described pharmaceutical composition further includes water for injection and NaCl.
8. a kind of drawn in preparation treatment by stomach Helicobacter pylori according to claim 1-5,7 any one of them pharmaceutical composition
Application in the drug of the chronic gastritis, peptic ulcer and the gastric mucosa associated lymphoid tissue lymthoma that rise.
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| JP2000080031A (en) * | 1997-09-17 | 2000-03-21 | Eisai Co Ltd | Antimicrobial agent |
| PE20110009A1 (en) * | 2005-08-30 | 2011-01-31 | Takeda Pharmaceutical | DERIVATIVES OF PIRROL AS INHIBITORS OF ACID SECRETION |
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| WO2005074898A2 (en) * | 2004-01-28 | 2005-08-18 | Altana Pharma Ag | Composition comprising (s) pantoprazole and an antibiotic for treating helicobacter pylori |
| WO2014003199A1 (en) * | 2012-06-27 | 2014-01-03 | Takeda Pharmaceutical Company Limited | Liquid preparations of amines and organic acids stabilized by salts |
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