CN102973940A - Pharmaceutical composition for inhibiting or killing helicobacter pylori and use thereof - Google Patents
Pharmaceutical composition for inhibiting or killing helicobacter pylori and use thereof Download PDFInfo
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- CN102973940A CN102973940A CN201110258952XA CN201110258952A CN102973940A CN 102973940 A CN102973940 A CN 102973940A CN 201110258952X A CN201110258952X A CN 201110258952XA CN 201110258952 A CN201110258952 A CN 201110258952A CN 102973940 A CN102973940 A CN 102973940A
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- ilaprazole
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Abstract
The invention provides a pharmaceutical composition for inhibiting or killing helicobacter pylori and a use thereof. The pharmaceutical composition comprises: by weight, 3 to 50 parts of ilaprazole or its pharmaceutically acceptable salt/hydrate, 500 to 1500 parts of a beta-lactam antibiotic, 200 to 750 parts of a macrolide antibiotic, and 100 to 500 parts of a bismuth agent. Compared with the composition of omeprazole, the antibiotics and the bismuth agent, the pharmaceutical composition has higher inhibition activity, can effectively inhibit or kill helicobacter pylori, and can be used for treating duodenal ulcer, gastric ulcer and/or chronic gastritis.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of pharmaceutical composition for suppressing or kill helicobacter pylori, particularly relate to a kind of medical composition and its use that comprises ilaprazole for suppressing or kill helicobacter pylori.
Background technology
It is the Important cause of disease of peptic ulcer and chronic gastritis that helicobacter pylori (Hp) infects, and eradicating Hp is the important means of prevention ulcer recurrence and treatment chronic gastritis.The treatment that Hp infects is the emphasis problem of present Hp research field, and Hp eradication therapy scheme mainly comprises three and quadruple chemotherapy.Along with timed transition, Hp is more and more higher to the antibiotic resistant rate, causes the Hp eradication rate more and more lower; Basis at triple therapy increases bismuth, and the eradication rate of Hp Resistant strain can be provided; And acid inhibitor to press down that sour difference on effect and oral cavity Hp infect also be one of factor that affects the conjoint therapy curative effect.So how to improve the Hp eradication rate, the more effective therapeutic scheme of How to choose is current clinician's question of common concern.
Summary of the invention
Therefore, the purpose of this invention is to provide a kind of pharmaceutical composition for suppressing or kill helicobacter pylori.
Another object of the present invention provides the purposes of aforementioned pharmaceutical compositions.
The objective of the invention is to realize by the following technical solutions.
On the one hand, the invention provides a kind of pharmaceutical composition for suppressing or kill helicobacter pylori, wherein calculate by weight, this pharmaceutical composition comprises:
3-50 part ilaprazole or its pharmaceutically acceptable salt, hydrate;
500-1500 part beta-lactam antibiotic;
200-750 part macrolide antibiotics; With
100-500 part bismuth.
In aforementioned pharmaceutical compositions, the pharmaceutically acceptable salt of ilaprazole can be selected from one or more in sodium salt, potassium salt, calcium salt, magnesium salt and the zinc salt of ilaprazole; The hydrate of ilaprazole can be selected from one or more in semihydrate, monohydrate, dihydrate, trihydrate and the tetrahydrate of ilaprazole.
In aforementioned pharmaceutical compositions, beta-lactam antibiotic can be selected from one or more in ampicillin, amoxicillin and the pivampicillin, is preferably the amoxicillin.
In aforementioned pharmaceutical compositions, macrolide antibiotics can be selected from one or more in azithromycin, clarithromycin and the Roxithromycin, is preferably clarithromycin.
In aforementioned pharmaceutical compositions, bismuth can be selected from one or more in citric acid bismuth potassium and the bismuth pectin, is preferably citric acid bismuth potassium.
In a preferred technical scheme, aforementioned pharmaceutical compositions comprises:
5 parts of ilaprazoles or its pharmaceutically acceptable salt, hydrate;
1000 parts of beta-lactam antibiotics;
500 parts of macrolide antibiotics; With
220 parts of bismuth.
In a preferred technical scheme, aforementioned pharmaceutical compositions comprises:
5 parts of ilaprazoles;
1000 parts of amoxicillin;
500 parts of clarithromycins; With
220 parts of citric acid bismuth potassium.
Aforementioned pharmaceutical compositions also comprises pharmaceutically acceptable carrier and/or excipient.
On the other hand, the invention provides the purposes of aforementioned pharmaceutical compositions in the medicine of preparation treatment duodenal ulcer, gastric ulcer and/or chronic gastritis.
Bacteriostatic experiment proves, active high than omeprazole in the prior art and these antibiotic medicines, bismuth coupling of the inhibition activity of pharmaceutical composition that the present invention includes ilaprazole, beta-lactam antibiotic (for example amoxicillin), macrolide antibiotics (for example clarithromycin) and bismuth (for example citric acid bismuth potassium).And the toleration of tetrad treatment that contains ilaprazole is good, and its untoward reaction kind is few, frequency is low.
The specific embodiment
Referring to specific embodiment the present invention is described.It will be appreciated by those skilled in the art that these embodiment only are used for explanation the present invention, the scope that it does not limit the present invention in any way.
Embodiment 1: comprise the research of the pharmaceutical composition anti-helicobactor pylori activity of ilaprazole
Present embodiment is investigated the curative effect of 7 days therapy first-line treatments of tetrad helicobacter pylori infections of the pharmaceutical composition that comprises ilaprazole, and has carried out comparative study with 7 days therapies of other tetrads.
1, research design
1.1 research method
This research is the at random parallel control research of national multicenter, object of study is to accept duodenal ulcer (Du) or the Patients with Chronic Gastritis that gastroscopy is diagnosed as the Hp positive because of the upper gastrointestinal symptom, in 10 the center (First Affiliated Hospital Of Nanchang University in the whole nation, Hospital of Southern Medical University, General Hospital of Beijing Military Command, First Attached Hospital, Anhui Medical Univ., Aerospace Central Hospital of Peking University, Nanjing No.1 Hospital, the Jiangsu Prov. People's Hospital, Xi-an City Central Hospital, Attached Tongji Hospital, Tongji Univ., biochip Shanghai National Engineering Research Centre) 1320 routine patients is carried out the Hp eradication therapy, and carry out Hp drug sensitivity test and Hp drug resistant gene and detect and saliva of buccal cavity Hp treating failed patient, infect with Hp with the drug resistance situation of understanding the Hp strains and oral cavity Hp and eradicate failed relation.
1.2 case is selected
1.2.1 inclusion criteria:
(1) chronic gastritis of the Hp positive or duodenal ulcer patients.
(2) duodenal ulcer patients by stages: active stage, healing stage, cicatricial phase, white speckle sample ulcer all can.
(3) all those selected diagnosis all must obtain by gastroscopy.
(4) 1 all interior urea breath test positives before and after rapid urease test or the gastroscope.
(5) at 18～70 years old age, the men and women does not limit.
(6) previously do not accept regular Hp eradication therapy.
(7) signature Informed Consent Form.
1.2.2 exclusion standard:
(1) treatment used antibiotic, bismuth or treatment front 2 weeks to use H in front 4 weeks
2Receptor blocking agent (H
2RA) and proton pump inhibitor (PPI) person.
(2) gestation or women breast-feeding their children.
(3) patient exists other serious disease that affects this research evaluation such as serious hepatopathy, heart disease, nephropathy, malignant tumor and alcoholism illness simultaneously.
(4) to this institute medicine allergy sufferers.
(5) in front 3 months with drugs, participated in other medicines research.
(6) patient can not the own main suit of correction, such as psychosis, serious neurosis, and can not this experimenter of cooperation.
1.2.3 termination test standard:
(1) serious side effects appears in duration of test, and patient can't anti-receptor.
(2) patient Other diseases occurs and disturbs this experimenter during the treatment.
(3) lose visit.
(4) gestation during the treatment.
3. test grouping
The selected sum of plan: 1320 examples (Du 660 examples, chronic gastritis 660 examples)
Be divided at random following six groups: every group of 220 example (wherein Du 110 examples, chronic gastritis 110 examples)
A group: ilaprazole 5mg+ amoxicillin+clarithromycin+bismuth potassium citrate, 7 days courses for the treatment of;
B group: ilaprazole 10mg+ amoxicillin+clarithromycin+bismuth potassium citrate, 7 days courses for the treatment of;
C group: omeprazole 5mg+ amoxicillin+clarithromycin+bismuth potassium citrate, 7 days courses for the treatment of;
D group: omeprazole 10mg+ amoxicillin+clarithromycin+bismuth potassium citrate, 7 days courses for the treatment of;
E group: esomeprazole 5mg+ amoxicillin+clarithromycin+bismuth potassium citrate, 7 days courses for the treatment of;
F group: amoxicillin+clarithromycin+bismuth potassium citrate, 7 days courses for the treatment of.
A-E group Du, Hp give ilaprazole 5mg qd (once a day), ilaprazole 10mg qd, omeprazole 5mg qd, omeprazole 10mg qd, esomeprazole 5mgqd, 14 days courses for the treatment of after eradicating and finishing the course for the treatment of.
The dosage of amoxicillin, clarithromycin and bismuth potassium citrate is in above-mentioned each group:
Amoxicillin 1000mg Bid; Clarithromycin 500mg Bid; Bismuth potassium citrate 220mg Bid.
Wherein:
Ilaprazole: beautiful pearl Pharmaceutical Group, one beautiful peace
Omeprazole: AstraZeneca pharmaceutical Co. Ltd, losec
Esomeprazole: AstraZeneca pharmaceutical Co. Ltd, anti-letter
Amoxicillin: federal pharmacy, amoxicillin
Clarithromycin: beautiful pearl Pharmaceutical Group, clarithromycin
Bismuth potassium citrate: beautiful pearl Pharmaceutical Group, bismuth potassium citrate.
4. observation index
(1) each treatment group Hp eradication rate relatively
(2) estimate the remission rate (seeing the acquaintance form for details) for the treatment of rear 1 week, 3 weeks and finishing rear 4 weeks the course for the treatment of.
(3) observe each treatment group and treat failed patient Hp elimination Resistant strain distribution situation, understand the Hp Resistant strain to the impact of Hp eradication therapy scheme.
(4) estimate in the relation of oral cavity Hp and gastric Hp and the oral cavity Hp to the impact of Hp eradication rate.
(5) statistics is respectively organized the incidence rate of untoward reaction.
5.Hp infect and the elimination diagnostic method
(1) Hp Infect And Diagnose method: rapid urease test sun domestic animal or gastroscope front and back interior breath test positive of 1 week can be judged as the Hp infection under all scopes.
(2) Hp eradicates determination methods: in 4 weeks after patient's drug withdrawal, carry out
13C-urea breath test, negative patient are judged as Hp and eradicate.(detectable adopts the reagent of Hai Dewei company, and is unified to buy and provide by the person of research organization)
6.Hp drug resistant gene chip detection and drug sensitive test
Hp eradication therapy loser is done the gastroscope check, and get the Gastric mucosa biopsy specimen, send biochip Shanghai National Engineering Research Centre to detect, detect Hp to the drug resistant gene situation of common antibiotics, and the collection tissue carries out external antibacterial culturing and drug sensitivity test simultaneously.
7. Kou chamber You Men Luo Defend bacterium saliva is detected
(1) to all 1320 examples those selected, all before treatment and treatment finish after in the 4 week row oral cavities Hp saliva detect, to assess Hp dependency in gastric Hp and the oral cavity.Require in addition each center provide 10 routine negative control results (mean 1320 examples beyond those selected and also the patient that is the 14C-UBT feminine gender go simultaneously oral cavity Hp and detect).
(2) Hp saliva in Hp eradication therapy loser (referring to check still positive person of 14C-UBT after the treatment) or the 14C-UBT positive companion oral cavity is detected the positive, then enter rescue therapy.Hp saliva is detected and whether to be needed simultaneously doing oral cavity scaling when being rescue therapy for the loser theoretical foundation is provided in the oral cavity.
(3) Hp detects the Hp saliva quick-detecting board that adopts without exception U.S. sharp Tag diagnostic reagent company in the oral cavity.
8. untoward reaction assessment
Fill in patient CRF table, before treatment, rear 7 days for the treatment of, treat behind rear 21 days, drug withdrawal and the patient to be followed up a case by regular visits to the information such as itemized record patient's symptom and improvement situation thereof, the situation of taking medicine, untoward reaction in 28 days.
9. statistical procedures
(1) selection of statistical data analysis:
Intentional analysis (Intention-to-treat): all through randomized grouping, and are analyzed with all cases of a medicine at least.Intentional analysis carries out for curative effect and adverse events.For the case-data of failing to observe whole therapeutic processes, carry over the test final result to last observed data;
Meet scheme data analysis (Per-Protocol population): all Pass Test schemes, compliance are good, duration of test does not take the case of forbidding medication, finishing CRF regulation fill substance, and its curative effect is carried out statistical analysis.
(2) statistical analysis plan:
Statistical analysis will adopt SAS 8.2 statistical analysis softwares to calculate.All statistical test all adopt two-sided test, and the P value is less than or equal to 0.05 difference that will be considered to check statistical significance.
The harmony of the pathologic basis value the when ordinary circumstance when entering to organize for the experimenter and baseline compares between organizing; To following up a case by regular visits to each time point symptom, between organizing, pathological change compares.For measurement data, meet the employing variance analysis method of parametric test condition; Adopt the rank test of many groups to finish analysis for the measurement data that does not meet the parametric test condition and ranked data.Meet x for enumeration data
2The employing x of test condition
2Check does not meet x
2The accurate probabilistic method check of the row of test condition.
For the Hp eradication rate, adopt the CMH-x by the center layering
2Check is compared between organizing.And adopt the Mantel-Haensze method to calculate every group of efficient 95% credibility interval, reach 95% credibility interval of eradication rate difference between group.
10. result of study
10.1 result
(1) antibacterial and therapeutic effect:
The A group: the overall eradication rate 90.1% of helicobacter pylori infections, wherein the Patients with Chronic Gastritis eradication rate 89.5%, duodenal ulcer patients eradication rate 92.7%.
The B group: the overall eradication rate 80.4% of helicobacter pylori infections, wherein the Patients with Chronic Gastritis eradication rate 82.4%, duodenal ulcer patients eradication rate 90.2%.
The C group: the overall eradication rate 78.4% of helicobacter pylori infections, wherein the Patients with Chronic Gastritis eradication rate 67.7%, duodenal ulcer patients eradication rate 65.0%.
The D group: the overall eradication rate 81.6% of helicobacter pylori infections, wherein the Patients with Chronic Gastritis eradication rate 70.1%, duodenal ulcer patients eradication rate 69.3%.
The E group: the overall eradication rate 88.0% of helicobacter pylori infections, wherein the Patients with Chronic Gastritis eradication rate 79.2%, duodenal ulcer patients eradication rate 71.9%.
The F group: the overall eradication rate 66.8% of helicobacter pylori infections, wherein the Patients with Chronic Gastritis eradication rate 67.7%, duodenal ulcer patients eradication rate 52.2%.
(2) untoward reaction
Ilaprazole is that the safety of 7 days therapy first-line treatments of tetrad helicobacter pylori infections on basis is good, and overall adverse reaction rate 5.0% is without statistical discrepancy.
10.2 conclusion
As from the foregoing, contain effectively eradicate helicobacter pylori of ilaprazole tetrad one all therapies, its eradication rate reaches 90.1%, far above omeprazole+amoxicillin+clarithromycin+bismuth potassium citrate group, esomeprazole+amoxicillin+clarithromycin+bismuth potassium citrate group and amoxicillin+clarithromycin+bismuth potassium citrate group, and the therapeutic effect of chronic gastritis and duodenal ulcer also is better than other groups.In addition, safety evaluation shows that the toleration that contains the treatment of ilaprazole tetrad is good, and its untoward reaction kind is few, frequency is low.
Claims (9)
1. a pharmaceutical composition that is used for suppressing or killing helicobacter pylori wherein calculates by weight, and this pharmaceutical composition comprises:
3-50 part ilaprazole or its pharmaceutically acceptable salt, hydrate;
500-1500 part beta-lactam antibiotic;
200-750 part macrolide antibiotics; With
100-500 part bismuth.
2. pharmaceutical composition according to claim 1 is characterized in that, the pharmaceutically acceptable salt of described ilaprazole is selected from one or more in the sodium salt of ilaprazole, potassium salt, calcium salt, magnesium salt and the zinc salt; The hydrate of described ilaprazole is selected from one or more in semihydrate, monohydrate, dihydrate, trihydrate and the tetrahydrate of ilaprazole.
3. pharmaceutical composition according to claim 1 and 2 is characterized in that, described beta-lactam antibiotic is selected from one or more in ampicillin, amoxicillin and the pivampicillin, is preferably the amoxicillin.
4. each described pharmaceutical composition in 3 according to claim 1 is characterized in that described macrolide antibiotics is selected from one or more in azithromycin, clarithromycin and the Roxithromycin, is preferably clarithromycin.
5. each described pharmaceutical composition in 4 according to claim 1 is characterized in that described bismuth is selected from one or more in citric acid bismuth potassium and the bismuth pectin, is preferably citric acid bismuth potassium.
6. each described pharmaceutical composition in 5 according to claim 1 is characterized in that described pharmaceutical composition comprises:
5 parts of ilaprazoles or its pharmaceutically acceptable salt, hydrate;
1000 parts of beta-lactam antibiotics;
500 parts of macrolide antibiotics; With
220 parts of bismuth.
7. each described pharmaceutical composition in 6 according to claim 1 is characterized in that described pharmaceutical composition comprises:
5 parts of ilaprazoles;
1000 parts of amoxicillin;
500 parts of clarithromycins; With
220 parts of citric acid bismuth potassium.
8. each described pharmaceutical composition in 7 according to claim 1 is characterized in that described pharmaceutical composition also comprises pharmaceutically acceptable carrier and/or excipient.
9. the purposes of each described pharmaceutical composition in the medicine of preparation treatment duodenal ulcer, gastric ulcer and/or chronic gastritis in 8 according to claim 1.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201110258952XA CN102973940A (en) | 2011-09-02 | 2011-09-02 | Pharmaceutical composition for inhibiting or killing helicobacter pylori and use thereof |
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| CN201110258952XA CN102973940A (en) | 2011-09-02 | 2011-09-02 | Pharmaceutical composition for inhibiting or killing helicobacter pylori and use thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104887674A (en) * | 2015-05-12 | 2015-09-09 | 上海信谊万象药业股份有限公司 | Solid preparation containing omeprazole and preparation method thereof |
| CN105362822A (en) * | 2015-12-22 | 2016-03-02 | 徐士杰 | Medicine for treating acne and preparation method thereof |
| WO2023165619A1 (en) * | 2022-03-04 | 2023-09-07 | 丽珠医药集团股份有限公司 | Use of ilaprazole in regulating intestinal microecology |
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2011
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| CN1147380A (en) * | 1995-10-09 | 1997-04-16 | 张晓安 | Medicine compound for gastric and duodenal ulcer |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104887674A (en) * | 2015-05-12 | 2015-09-09 | 上海信谊万象药业股份有限公司 | Solid preparation containing omeprazole and preparation method thereof |
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| CN105362822A (en) * | 2015-12-22 | 2016-03-02 | 徐士杰 | Medicine for treating acne and preparation method thereof |
| WO2023165619A1 (en) * | 2022-03-04 | 2023-09-07 | 丽珠医药集团股份有限公司 | Use of ilaprazole in regulating intestinal microecology |
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Application publication date: 20130320 |