CN104814964A - Medicinal composition for resisting helicobacter pylori and preparation method as well as application thereof - Google Patents
Medicinal composition for resisting helicobacter pylori and preparation method as well as application thereof Download PDFInfo
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- CN104814964A CN104814964A CN201510184789.5A CN201510184789A CN104814964A CN 104814964 A CN104814964 A CN 104814964A CN 201510184789 A CN201510184789 A CN 201510184789A CN 104814964 A CN104814964 A CN 104814964A
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- helicobacter pylori
- stomach helicobacter
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- 238000010998 test method Methods 0.000 description 1
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Abstract
The invention relates to a medicinal composition for resisting helicobacter pylori. The medicinal composition comprises the following components in parts by weight: 50-500 parts of component A, 100-500 parts of component B and 5-50 parts of component C, wherein the component A is amoxicillin; the component B is selected from levofloxacin and pharmaceutically acceptable salts thereof, moxifloxacin and pharmaceutically acceptable salts thereof; the component C is selected from Vonoprazan and pharmaceutically acceptable salts thereof. The invention also provides a preparation method and application of the medicinal composition. The medicinal composition for resisting the helicobacter pylori has a strong effect of resisting the helicobacter pylori and has less adverse reaction and wide application, and the preparation method is simple and is easy to operate.
Description
Technical field
The present invention relates to a kind of antimicrobial agents field, be specifically related to a kind of pharmaceutical composition of anti-stomach Helicobacter pylori, preparation method and application thereof.
Background technology
Stomach Helicobacter pylori, having another name called helicobacter pylori (Helicobacter pylori, H.pylori), is a kind of Grain-negative, the obligate microaerobe of S or arc-shaped bend.H.pylori is the pathogen that infection rate is the highest in the world, and H.pylori infects in global distribution, and this bacterium is infected in the whole world about half population, and China's H.pylori infection rate is higher, is 42% ~ 90%, average 59%.H.pylori is the important pathogenic bacteria of upper digestive disease, the digestive system disease such as chronic gastritis, peptic ulcer, early gastric cancer are postoperative, gastric mucosa associated lymphoid tissue lymphoma all should eradicate H.pylori treatment, the outer disease of many gastrointestinal tract such as unknown cause iron deficiency anemia, idiopathic thrombocytopenic purpura and vitamin B12 deficiency also H.pylori infects relevant, also should eradicate if these patient H.pylor infect.H.pylori infects and can destroy the mucus barrier on gastrointestinal mucosal surface, and and then H+ is constantly to mucosa internal diffusion, causes a series of pathogenesis, finally causes the generation of gastrointestinal tract mucous hyperemia, edema, hemorrhage, rotten to the corn and even ulcer.
But in recent years along with the increase of H.pylori Antibiotic Resistance, traditional standard triple therapy eradication rate drops to less than 70%, and the patient cases of the untoward reaction such as generation is felt sick, discomfort, skin pruritus is more.Therefore, seek best H.pylori eradication program, improve emphasis, difficult point that eradication rate is medical personal.
Summary of the invention
The object of the present invention is to provide the pharmaceutical composition of the anti-stomach Helicobacter pylori that a kind of antibacterial action is strong, untoward reaction is few, the present invention also provides the preparation method and application of this pharmaceutical composition.
For solving the problem, the technical solution adopted in the present invention is as follows:
A pharmaceutical composition for anti-stomach Helicobacter pylori, is characterized in that comprising the following component according to parts by weight: component A 50-500 part, B component 100-500 part and component C 5-50 part;
Described component A is amoxicillin; Described B component is selected from: levofloxacin and pharmaceutically acceptable salt (such as levofloxacin hydrochloride), Moxifloxacin and pharmaceutically acceptable salt (such as moxifloxacin hydrochloride) thereof; Described component C is selected from: Wo Nuolazan and pharmaceutically acceptable form thereof.
Wo Nuolazan (Vonoprazan, TAK-438) be a kind of novel potassium channel blocker (P-CABs), be used for the treatment of Non-erosive gastroesophageal reflux disease, duodenal ulcer, gastric ulcer, erosive esophagitis (curing and maintaining treatment).
Amoxicillin is Penicillin antibiotics, to the Streptococcus such as streptococcus pneumoniae, Hemolytic streptococcus, helicobacter pylori, do not produce not producing lactamase strain and there is good antibacterial activity of the aerobic gram negative bacterium such as the aerobic gram-positive coccus such as penicillinase staphylococcus, enterococcus faecalis, escherichia coli, proteus mirabilis, Salmonella, hemophilus influenza, Diplococcus gonorrhoeae, amoxicillin plays bactericidal action by anti-bacteria Cell wall synthesis, antibacterial can be made to become rapidly spheroid two and dissolve, break.Be mainly used in the respiratory tract infection caused by sensitive organism, the made gastrointestinal ulceration of stomach Helicobacter pylori, urinary tract infection, skin soft-tissue infection and biliary tract infection clinically.
Levofloxacin is the one in quinolones, there is broad-spectrum antibacterial action, antibacterial action is strong, to most enterobacteriaceae lactobacteriaceae, as the gram-negative bacterias such as escherichia coli, Klebsiella, Proteus, Salmonella, Shigella and hemophilus influenza, legionella pneumophilia, Diplococcus gonorrhoeae have stronger antibacterial activity.Also antibacterial action is had to the gram positive bacterias such as staphylococcus aureus, streptococcus pneumoniae, micrococcus scarlatinae and mycoplasma pneumoniae, Chlamydia pneumoniae.
Moxifloxacin is forth generation quinolones broad spectrum antibiotic, is wide spectrum and the 8-methoxy fluoroquinolone class antimicrobial drug with antibacterial activity.Moxifloxacin demonstrates gram positive bacteria, gram-negative bacteria, anaerobe, acid fast bacteria and atypical microorganism in vitro as mycoplasma, chlamydia and legionella have broad spectrum antibiotic activity.Antibacterial mechanisms is interference II, IV topoisomerase.Topoisomerase is control DNA topological sum DNA replication dna, repair and transcribe in key enzyme.Moxifloxacin oral absorbs good, and not easily produces drug resistance, active high in vivo.Be used for the treatment of respiratory system infection, genital system infection, skin soft-tissue infection etc. clinically.
Inventor finds through great many of experiments, component A of the present invention (i.e. amoxicillin), B component (being namely selected from the compositions of one or more materials in levofloxacin and pharmaceutically acceptable salt, Moxifloxacin and pharmaceutically acceptable salt thereof) and component C (being namely selected from the compositions of one or more materials in Wo Nuolazan and pharmaceutically acceptable form thereof) are carried out conbined usage, these three kinds of components create synergism mutually, the effect of the anti-stomach Helicobacter pylori of compositions is been significantly enhanced, and untoward reaction is few.
In the present invention, to be the Wo Nuolazan of described pharmaceutically acceptable form be preferred scheme: the salt of Wo Nuolazan or alkali form; The Wo Nuolazan of further preferred pharmaceutically acceptable form is fumaric acid Wo Nuolazan.
In the present invention, preferred scheme is the following component that described pharmaceutical composition comprises according to parts by weight: component A 125-500 part, B component 300-500 part and component C 5-20 part.
The medicine composition dosage form of the anti-stomach Helicobacter pylori in the present invention is the one in injection, injectable powder, tablet, slow releasing agent, granule, capsule and slow-release micro-pill.In the pharmaceutical composition of the anti-stomach Helicobacter pylori of different dosage form, the gross weight of described component A, B component and component C accounts for the 0.1-99% of whole pharmaceutical composition weight; Further preferred scheme is the 1-60% that the gross weight of described component A, B component and component C accounts for whole pharmaceutical composition weight.
In the present invention, preferred scheme is described pharmaceutical composition is tablet, and described pharmaceutical composition also comprises tablet adjuvant.Wherein adjuvant includes but not limited to: binding agent, such as gelatin, polyvinylpyrrolidone, hydroxypropyl cellulose, hypromellose; Filler, such as lactose, mannitol, microcrystalline Cellulose, corn starch, pregelatinized Starch, sorbitol; Lubricant, such as magnesium stearate; Disintegrating agent, such as carboxymethyl starch sodium, polyvinylpolypyrrolidone; Or the pH adjusting agent pharmaceutically accepted, such as fumaric acid, citric acid.Further preferred scheme is that the pharmaceutical composition of this tablet form is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 50 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.
The present invention also provides the preparation method of the pharmaceutical composition of the anti-stomach Helicobacter pylori of this tablet form, and it comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
In the present invention, preferred scheme is the pharmaceutical composition of described anti-stomach Helicobacter pylori is injection, and described pharmaceutical composition also comprises water for injection and NaCl.As required, the typical additives of the injection such as antiseptic, buffer agent can also be added in the pharmaceutical composition of this injection form.Further preferably the pharmaceutical composition of this injection form is made up of the following component according to parts by weight: Wo Nuolazan 50 parts, 500 parts, amoxicillin, Moxifloxacin 100 parts, NaCl 450 parts and water for injection, and described in the pharmaceutical composition of this injection form, the mass body volume concentrations of amoxicillin is 1g/L.
The present invention also provides the preparation method of the pharmaceutical composition of the anti-stomach Helicobacter pylori of this injection form, it comprises the steps: to have taken each component according to formula ratio, NaCl is dissolved in water for injection, then add component A, B component and component C and be stirred to and dissolve completely, then be filtered to clear and bright, embedding, sterilizing, to obtain final product.
The pharmaceutical composition of anti-stomach Helicobacter pylori of the present invention, can for the preparation of the application for the treatment of in the medicine of the disease such as chronic gastritis, peptic ulcer, stomach function regulating lymphoma mucosa associated lymphoid tissue that caused by stomach Helicobacter pylori.
Compared with prior art, tool of the present invention has the following advantages: the pharmaceutical composition of anti-stomach Helicobacter pylori of the present invention, by to the composition of component A, B component and component C and the selection of proportioning thereof, three is made to create synergism, the anti-stomach Helicobacter pylori effect of the entirety of pharmaceutical composition is strengthened, and untoward reaction is few; Meanwhile, the pharmaceutical composition of anti-stomach Helicobacter pylori of the present invention, the preparation method of its various dosage form is simple, be convenient to explained hereafter; In addition, the pharmaceutical composition of anti-stomach Helicobacter pylori of the present invention, may be used for the disease such as chronic gastritis, peptic ulcer stomach function regulating lymphoma mucosa associated lymphoid tissue that treatment stomach Helicobacter pylori causes.
Below in conjunction with detailed description of the invention, the present invention is described in detail.
Detailed description of the invention
Embodiment 1
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 50 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Embodiment 2
A kind of pharmaceutical composition of anti-stomach Helicobacter pylori of injection form, it is made up of the following component according to parts by weight: Wo Nuolazan 50 parts, 500 parts, amoxicillin, Moxifloxacin 100 parts, NaCl 450 parts and water for injection, and described in the pharmaceutical composition of this injection form, the mass body volume concentrations of amoxicillin is 1g/L.Its preparation method comprises the steps: to have taken each component according to formula ratio, is dissolved in by NaCl in water for injection, and then add Wo Nuolazan, amoxicillin and Moxifloxacin and be stirred to and dissolve completely, be then filtered to clear and bright, embedding, sterilizing, to obtain final product.
Embodiment 3
A pharmaceutical composition for the anti-stomach Helicobacter pylori of slow-release micro-pill form, it is made up of the following component according to parts by weight:
Ball core prescription: Wo Nuolazan 20 parts, 50 parts, amoxicillin, levofloxacin 150 parts, microcrystalline Cellulose 15 parts, hydroxypropyl emthylcellulose 5 parts, 250 parts, water;
Coating prescription: the aqueous ethylcellulose of 25% falls apart liquid 185 parts, 122 parts, water.
Its preparation method is: respectively microcrystalline Cellulose, Wo Nuolazan, amoxicillin, levofloxacin were pulverized 100 mesh sieves in advance, take by ball core prescription, mix homogeneously, hydroxypropyl methylcellulose aqueous solution does binding agent, micropill processed, by it in 50 ~ 60 DEG C of dryings, select 20 ~ 30 object pillers, for subsequent use;
To prepare and the micropill chosen, put in fluid bed, adopt end spray mode, by hot-air suspension fluidization, inlet temperature is 55 DEG C, when material bed tempertaure controls 30 DEG C, peristaltic pump is regulated to make it provide coating solution by the speed of 5g serosity per minute, atomizing pressure 2bar, start to whitewash continuously to the piller of fluidisation, after whitewashing terminates, reduce air quantity, make micropill under slight boiling condition 40 DEG C of dry a moments.Taking-up to be placed in 40 DEG C of baking ovens dry 24 hours, weightening finish about 18%, measures content, to obtain final product.
Embodiment 4
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: fumaric acid Wo Nuolazan 5 parts, 200 parts, amoxicillin, levofloxacin 100 parts, Moxifloxacin 200 parts, microcrystalline Cellulose 125 parts, lactose monohydrate 600 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 10 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Embodiment 5
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 50 parts, 500 parts, amoxicillin, levofloxacin 500 parts, microcrystalline Cellulose 465 parts, lactose monohydrate 1050 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 65 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Embodiment 6
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 20 parts, 500 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 465 parts, lactose monohydrate 1050 parts and, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts of magnesium stearate 70 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Embodiment 7
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 20 parts, 500 parts, amoxicillin, Moxifloxacin 400 parts, microcrystalline Cellulose 470 parts, lactose monohydrate 1000 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 65 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 1
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, levofloxacin 150 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 2
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 150 parts, amoxicillin, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 3
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 50 parts, amoxicillin, ciprofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 4
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 50 parts, ampicillin, levofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 5
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 40 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 6
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: Wo Nuolazan 60 parts, 50 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Comparative example 7
A pharmaceutical composition for the anti-stomach Helicobacter pylori of tablet form, it is made up of the following component according to parts by weight: esomeprazole 20 parts, 500 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 580 parts, lactose monohydrate 1150 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 15 parts.Its preparation method comprises the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
Experimental example
1 case selection: select the patient that year January in October, 2012 to 2014 goes to a doctor in No.1 Hospital Affiliated to Zhongshan Univ., the second hospital and the 3rd hospital's Digestive System Department, totally 1080 examples.
1.1 inclusion criterias: be 1. ready coordinate and can follow up a case by regular visits to, age between 18 ~ 75 years old, through gastroscope and proved by pathology be chronic active gastritis (comprising: gastric mucosal erosion, in ~ severe atrophy, in ~ severe intestinal, atypical hyperplasia), peptic ulcer, functional dyspepsia (diagnostic criteria with reference to " RomeⅢdiagnostic criteria of functional gastrointestinal disorder "); 2. H.pylori positive is turned out to be through gastric mucosa rapid urease test (RUT) or 14C-urea breath test (14C-UBT) before being selected in; 3. previously regular H.pylori eradication therapy was not accepted.
1.2 exclusion standards: 1. proton pump inhibitor (PPI), H2 receptor blocking agent (H2RA) and nonsteroidal antiinflammatory drug (NSAID) person were used in treatment for first 2 weeks, treated and used antibacterials or bismuth person in first 4 weeks; 2. there is the serious heart, brain, pulmonary disease, hepatic and kidney function obstacle person; 3. gestation or women breast-feeding their children; 4. to this institute medicine allergy sufferers.
1.3 stop research standard: 1. sb.'s illness took a turn for the worse or occur severe complication; 2. there is serious adverse reaction in treatments period, cannot resistance to receptor; 3. treatments period occurs that other diseases disturbs this observation; 4. lost to follow-up; 5. treatments period gestation.
1.4 ordinary circumstances: enter the routine patient of group 1080 altogether, wherein man 532 example, female 548 example, 49 years old mean age (18 ~ 75 years old), wherein patients with functional dyspepsia 376 example, chronic active gastritis 380 example, peptic ulcer 324 example.
2.1 grouping and test methods: above-mentioned 1080 patients are divided into 12 groups at random by selected order, often organize 90 people, then these 12 groups of patients have been taken embodiment 1 respectively, the pharmaceutical composition of the anti-stomach Helicobacter pylori of the tablet form that 4-7 and comparative example 1-7 obtains, the dose that each patient takes counts 20mg/ days with Wo Nuolazan or esomeprazole, and the course for the treatment of is 14 days.After 14 days, the ulcers often organized continues to take, and counts 10mg/ days with Wo Nuolazan or esomeprazole, and the patients w ith peptic ulcer disease persistent period is 6-8 week, and duodenum infections patient's persistent period is 4-6 week; All patients, during taking medicine, forbid drinking.
2.2 observation of curative effect: terminate the course for the treatment of and check 14C-UBT after all medicine at least 4 weeks of stopping using, result feminine gender is considered as H.Pylori and eradicates successfully, eradicates unsuccessfully if the positive is considered as H.Pylori.And the adverse effect of record patient in drug administration process, assess patient is to the compliance of various therapeutic scheme and safety.
2.3 statistical methods: application SPSS13.0 statistical software analyzes, and compares and adopt one factor analysis of variance chi-square criterion between many groups, P < 0.05 has statistical significance for difference.
Result:
1, ordinary circumstance: between A, B, C group, patient is at age, sex, classification of diseases and the equal not statistically significant of tobacco smoking status difference (P>0.05).
2, H.pylori eradication rate and untoward reaction result: according to the result of 2.2 observation of curative effect, and whether record patient there is untoward reaction (as nauseating, uncomfortable, skin pruritus) over the course for the treatment of, as there is this type of symptom, stop the administration of this patient, concrete outcome refers to following table 1:
Table 1:H.pylori eradication rate, untoward reaction number data statistic
| Group | Number lost to follow-up | Eradicate successfully | Eradication rate | Nauseating, uncomfortable | Skin pruritus |
| 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, feel sick uncomfortable, skin pruritus statistical number of person comprises the situation simultaneously producing above-mentioned two kinds of untoward reaction.
As can be seen from data in upper table 1, adopt the pharmaceutical composition of anti-stomach Helicobacter pylori of the present invention, its to H.pylori eradication rate apparently higher than comparative example, and the case number of untoward reaction is also starkly lower than comparative example, the compositions of the component A that visible the present invention adopts, B component and component C, three creates synergism, its anti-stomach Helicobacter pylori effect is obviously strengthened, and untoward reaction is few.
For the combination of embodiment 2, embodiment 3 to the eradication rate of chronic active gastritis, peptic ulcer and functional dyspepsia disease, whether inventor tests 180 patients, detect fully recover (namely whether chronic active gastritis, peptic ulcer and functional dyspepsia disease are eradicated) after 2 week; For the pharmaceutical composition of the anti-stomach Helicobacter pylori of the injection form of the embodiment of the present invention 2, it reaches 94.8% to the eradication rate of chronic active gastritis, peptic ulcer and functional dyspepsia disease, does not occur untoward reaction case; The pharmaceutical composition of the anti-stomach Helicobacter pylori of the slow-release micro-pill form of the embodiment of the present invention 3, it reaches 89.5% to the eradication rate of chronic active gastritis, peptic ulcer and functional dyspepsia disease, does not occur untoward reaction case.Visible, adopt the anti-stomach Helicobacter pylori effect of the pharmaceutical composition of anti-stomach Helicobacter pylori of the present invention, untoward reaction is few.
Above-mentioned embodiment is only the preferred embodiment of the present invention; can not limit the scope of protection of the invention with this, change and the replacement of any unsubstantiality that those skilled in the art does on basis of the present invention all belong to the present invention's scope required for protection.
Claims (10)
1. a pharmaceutical composition for anti-stomach Helicobacter pylori, is characterized in that comprising the following component according to parts by weight: component A 50-500 part, B component 100-500 part and component C 5-50 part;
Described component A is amoxicillin; Described B component is selected from: levofloxacin and pharmaceutically acceptable salt, Moxifloxacin and pharmaceutically acceptable salt thereof; Described component C is selected from: Wo Nuolazan and pharmaceutically acceptable form thereof.
2. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, is characterized in that the Wo Nuolazan of described pharmaceutically acceptable form is: the salt of Wo Nuolazan or alkali form.
3. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, is characterized in that comprising the following component according to parts by weight: component A 125-500 part, B component 300-500 part and component C 5-20 part.
4. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, is characterized in that: the dosage form of described pharmaceutical composition is the one in injection, injectable powder, tablet, slow releasing agent, granule, capsule and slow-release micro-pill.
5. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, is characterized in that: described pharmaceutical composition is tablet, and described pharmaceutical composition also comprises tablet adjuvant.
6. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 5, is characterized in that being made up of the following component according to parts by weight: Wo Nuolazan 10 parts, 50 parts, amoxicillin, levofloxacin 100 parts, microcrystalline Cellulose 65 parts, lactose monohydrate 350 parts, polyvidone 30 parts, low-substituted hydroxypropyl cellulose 20 parts and magnesium stearate 5 parts.
7. a preparation method for the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 6, is characterized in that comprising the steps: to have taken each component, mix homogeneously according to formula ratio, then adopts wet granulation, and dry, tabletting, to obtain final product.
8. the pharmaceutical composition of anti-stomach Helicobacter pylori according to claim 1, is characterized in that: described pharmaceutical composition is injection, and described pharmaceutical composition also comprises water for injection and NaCl.
9. the preparation method of the pharmaceutical composition of an anti-stomach Helicobacter pylori according to claim 8, it is characterized in that comprising the steps: to have taken each component according to formula ratio, NaCl is dissolved in water for injection, then add component A, B component and component C and be stirred to and dissolve completely, then be filtered to clear and bright, embedding, sterilizing, to obtain final product.
10. according to a claim 1-6, the pharmaceutical composition described in 8 any one, the application in the medicine of its chronic gastritis caused by stomach Helicobacter pylori in preparation treatment, peptic ulcer stomach function regulating lymphoma mucosa associated lymphoid tissue.
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| WO2019071290A1 (en) * | 2017-10-15 | 2019-04-18 | Centre For Digestive Diseases | Compositions and methods for treating, ameliorating and preventing h. pylori infections |
| WO2020210878A1 (en) * | 2019-04-18 | 2020-10-22 | Borody Thomas J | Compositions and methods for treating, ameliorating and preventing h. pylori infections |
| CN112933091A (en) * | 2020-09-07 | 2021-06-11 | 天地恒一制药股份有限公司 | Pharmaceutical composition for resisting gastric acid diseases and application |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019071290A1 (en) * | 2017-10-15 | 2019-04-18 | Centre For Digestive Diseases | Compositions and methods for treating, ameliorating and preventing h. pylori infections |
| CN110366415A (en) * | 2017-10-15 | 2019-10-22 | 消化系统疾病中心 | For treating, mitigating and preventing the composition and method of helicobacter pylori infections |
| US11033536B2 (en) | 2017-10-15 | 2021-06-15 | Centre For Digestive Dieases | Compositions and methods for treating, ameliorating and preventing H. pylori infections |
| US11833140B2 (en) | 2017-10-15 | 2023-12-05 | Centre For Digestive Diseases | Compositions and methods for treating, ameliorating and preventing H. pylori infections |
| WO2020210878A1 (en) * | 2019-04-18 | 2020-10-22 | Borody Thomas J | Compositions and methods for treating, ameliorating and preventing h. pylori infections |
| CN112933091A (en) * | 2020-09-07 | 2021-06-11 | 天地恒一制药股份有限公司 | Pharmaceutical composition for resisting gastric acid diseases and application |
| CN112933091B (en) * | 2020-09-07 | 2023-01-06 | 天地恒一制药股份有限公司 | Pharmaceutical composition for resisting gastric acid diseases and application |
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|---|---|
| CN104814964B (en) | 2018-07-31 |
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