CN104906577B - A kind of pharmaceutical composition for eradicating helicobacter pylori and preparation method thereof - Google Patents
A kind of pharmaceutical composition for eradicating helicobacter pylori and preparation method thereof Download PDFInfo
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- CN104906577B CN104906577B CN201410090187.9A CN201410090187A CN104906577B CN 104906577 B CN104906577 B CN 104906577B CN 201410090187 A CN201410090187 A CN 201410090187A CN 104906577 B CN104906577 B CN 104906577B
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Abstract
The present invention relates to a kind of pharmaceutical composition for eradicating helicobacter pylori and its treatment disease and application method.Wherein, pronase, proton pump inhibitor are contained in described pharmaceutical composition（PPI）With three kinds of components of antibiotic.The pharmaceutical composition can eradicate helicobacter pylori, prevent and treat the lymphoid tissue of the microbial various disease of stomach of helicobacter pylorus and stomach lining correlation by specific application method and dosage（MALT）Lymthoma, stomach cancer etc..Overcome and the defects of not thorough, cure rate is low, recurrent exerbation and deficiency are treated in traditional therapy, significantly improve the symptom of clinical patients, alleviate the pain of patient, improve the compliance of patient.
Description
Technical field
The invention belongs to medicinal application field, and in particular to a kind of pharmaceutical composition for eradicating helicobacter pylori and its preparation
Method, and its application and application method in the related disease of the stomach such as disease of stomach mucous membrane.
Background technology
Helicobacter pylori（Abbreviation H. pylori）Belong to the spirillum for being grown in gastric epithelial, be a kind of microaerobion,
Research has shown that helicobacter pylori infections are chronic active gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue（MALT）Leaching
The main pathogenic of bar knurl and stomach cancer.On the relevance of gastric mucosal lesion and H. pylori, due in pylorus vestibular portion energy
H. pylori are specifically detected, it is thus regarded that gastric mucosal lesion and H. pylori have very strong correlation.1994
Helicobacter pylori is set to I class procarcinogen by the World Health Organization.The Helicobacter Pylori Infection Rate in China is 40-90%, average out to
59%, there is very big difference in Helicobacter Pylori Infection Rate in all parts of the country.In recent years because H.Pylori is to the drug resistance of antibiotic
The problems such as, H.Pylori eradication rate declines year by year.
At present, traditional treatment method is using antibiotic, new quinoline promises such as penicillins, Tetracyclines, macrolideses
Ketone antibiotic etc. removes helicobacter pylori, but its degermation deficiency.Most antibacterial substances can not be out of stomach completely
Drive away helicobacter pylori, on the one hand its reason is that helicobacter pylori easily makes a variation and has tolerance antiseptic, on the other hand
It is, above-mentioned rete malpighii turns into obstacle, thus reaches infection part without the medicine of sufficient amount.
Gastric epithelial is coated to by hydrophobic thick mucous layer, and hydrophilic low molecular compound is difficult largely to be impregnated with to glue
Liquid and to reach helicobacter pylori attachment, the mucous membrane of propagation local, it is also difficult in mucous membrane local retention.In addition, helicobacter pylori exists
Breed present in gastric epithelial in countless foveolae gastricaes, antiseptic is more difficult to reach.
Although now with the application method of drug combination, degerming rate has a certain degree of improvement, occurs in contrast
High-frequency side effect, and elimination can not be played a part of, and because instructions of taking is numerous and diverse, it is difficult to clearly be administered.
The present inventor has found that the pharmaceutical composition in case of the present invention can be safe and effective in a short time by concentrating on studies
Ground eradicate helicobacter pylori pharmaceutical composition, to the gastric mucosa such as peptic ulcer or chronic gastritis relevant disease have prevention and
The effect for the treatment of.The pharmaceutical composition overcomes in traditional therapy that cure rate is low, side effect is big, can not eradicate, send out repeatedly
The defects of making, the clinical symptoms of patient are significantly improved, alleviate the pain of patient, and convenient drug administration, improve patient
Compliance..
The content of the invention
A kind of pharmaceutical composition for eradicating helicobacter pylori, contains pronase, antibiotic and proton in said composition
Three kinds of components of pump inhibitor.
Wherein, the dosage of pronase is 1.3 ~ 5.1mg/kg according to the conversion of the body surface area relation of people and animal.
Wherein, proton pump inhibitor is in Omeprazole, Lansoprazole, esomeprazole, Rabeprazole, Pantoprazole
Any one；The dosage of proton pump inhibitor is 20-60mg/ times, 1-2 times/day.
Wherein, antibiotic is selected from Amoxicillin, CLA, metronidazole, furazolidone, tetracycline, lavo-ofloxacin, not
Any one or two kinds in Xisha star, Tinidazole combine；The dosage of antibiotic is 100mg ~ 1g/ times, 1-2 times/day.
The pharmaceutical composition can eradicate helicobacter pylori, available for the microbial disease of prevention and treatment helicobacter pylorus and
Its symptom.
The pharmaceutical composition can be used for prevention and treatment helicobacter pylori to cause chronic active gastritis, indigestion, disappear
Peptic-ulcer, gastric mucosa-associated lymphoid tissue（MALT）Lymthoma, Gastric hyperplastic polyps and stomach cancer.
For medication first to give proton pump inhibitor, interval gives pronase and antibiotic after 15 to 30 minutes.
Figure of description
The comparison of the traditional treatment method antibiotic administration of accompanying drawing 1 and pharmaceutical composition of the present invention administration eradication rate.
Embodiment
The embodiment of form by the following examples, is described in further detail to present disclosure.But
This should not be interpreted as the scope of the present invention and be only limitted to following examples.All technical schemes realized based on present disclosure
Belong to the scope of the present invention.Obviously, according to present disclosure, according to the ordinary technical knowledge and customary means of this area,
On the premise of the basic fundamental thought of the present invention is not departed from, the modification, replacement or change of other diversified forms can also be made.
Embodiment 1：
Drug regimen：Pronase shares with Omeprazole, Amoxicillin, CLA
Test method：
Mongolian gerbil, male, 132,6 ~ 8 week old, 40~70g of body weight.Wherein 122 infectionH.Pylori, residue 10
Only do not infect, as being uninfected by compareing.10 gerbil jirds, detection are put to death in infection after 28 daysH.PyloriInfection rate, infection rate >=
Modeling success, can be grouped and be tested when 90%.
After confirmation is infected successfully, residue is infected into successful 92 animals and is divided into 5 groups, as shown in table 1.Prohibit before animal administration
Food, it can't help water, medication is that first gavage gives Omeprazole, and gavage gives MS solution and antibiotic after 0.5h, upper and lower daily
Noon is respectively administered once, successive administration 7 days.
Detect within 28 days after drug withdrawalH.pyloriColonisation, Testing index be tissue cultures, rapid urease test and
Real-time PCR are detected.Tissue cultures are positive, or tissue cultures feminine gender but rapid urease test and Real-time
When PCR testing results are the positive, confirmH.pyloriInfection is positive.
The animal packet administrations that table 1 shares with Omeprazole, Amoxicillin, CLA
Result of the test：
For confirmingH.pylori10 gerbil jirds of infection rate areH.pyloriInfection is positive, infection rate 100%, table
The gerbil jird of bright subinfection can be used for testing.
Detect within 28 days after last doseH.pyloriInfection rate, find pronase and Amoxicillin and CLA
Combination, it can increase to treatmentH.pyloriThe eradication rate of infection, and be in obvious dose-dependence.The wherein root of high dose group
Except rate is up to 90%, the antibiotic control group of same doseH.pyloriEradication rate is only 40%, in, the eradication rate of low dose group point
Wei 70% and 75%（Table 2）.Throughχ 2Inspection statistics are analyzed, antibiotics alone treatment group（I groups）It is high with antibiotic+pronase
Dosage group（IV groups）Compare with significant difference（P<0.05）.
Each group when table 2 shares with Omeprazole, Amoxicillin, CLAH.pyloriInfection rate
Embodiment 2
Drug regimen：Pronase shares with Omeprazole, metronidazole
Test method is similar to Example 1, wherein mongolian gerbil 62（6 ~ 8 week old, 45~72g of body weight.）, infection 56
Only, residue 6 is only used as being uninfected by control group, and infection puts to death 6 gerbil jirds after 28 days, confirms infection rate, and remaining 50 animals are divided into 5
Group, i.e. antibiotic control group（I groups）, pronase（Low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only）With Aomei
Draw azoles, metronidazole combination group（Omeprazole 0.24mg/, metronidazole 0.5mg/ are only）（II, III, IV group）, do not treat control
Group, every group 10.With embodiment 1, result of the test is as shown in table 3 for medication and Testing index.
Each group when table 3 shares with Omeprazole, metronidazoleH.pyloriInfection rate
Embodiment 3
Drug regimen：Pronase shares with Omeprazole, furazolidone
Test method is similar to Example 1, wherein mongolian gerbil 66（6 ~ 8 week old, 50~75g of body weight.）, infection 61
Only, residue 5 is only used as being uninfected by control group, and infection puts to death 6 gerbil jirds after 28 days, confirms infection rate, and remaining 55 animals are divided into 5
Group, i.e. antibiotic control group（I groups）, pronase（Low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only）With Aomei
Draw azoles, furazolidone combination group（Omeprazole 0.24mg/, furazolidone 0.1mg/ are only）（II, III, IV group）, do not treat pair
According to group, every group 11.With embodiment 1, result of the test is as shown in table 4 for medication and Testing index.
Each group when table 4 shares with Omeprazole, furazolidoneH.pyloriInfection rate
Embodiment 4
Drug regimen：Pronase shares with Lansoprazole, metronidazole, Amoxicillin
Test method is similar to Example 1, wherein mongolian gerbil 89（6 ~ 8 week old, 43~81g of body weight.）, infection 85
Only, residue 4 is only used as being uninfected by control group, and infection puts to death 5 gerbil jirds after 28 days, confirms infection rate, and remaining 80 animals are divided into 5
Group, i.e. antibiotic control group（I groups）, pronase（Low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only）With blue rope
Draw azoles, metronidazole, Amoxicillin combination group（Lansoprazole 0.15mg/, metronidazole 0.3mg/, Amoxicillin 0.4mg/ are only）
（II, III, IV group）, do not treat control group, every group 16.Medication and Testing index are the same as embodiment 1, result of the test such as table 5
It is shown.
Each group when table 5 shares with Lansoprazole, metronidazole, AmoxicillinH.pyloriInfection rate
Embodiment 5
Drug regimen：Pronase shares with esomeprazole, Tinidazole, furazolidone
Test method is similar to Example 1, wherein mongolian gerbil 86（6 ~ 8 week old, 44~85g of body weight.）, infection 81
Only, residue 5 is only used as being uninfected by control group, and infection puts to death 6 gerbil jirds after 28 days, confirms infection rate, and remaining 75 animals are divided into 5
Group, i.e. antibiotic control group（I groups）, pronase（Low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only）With Esso
Azoles, Tinidazole, furazolidone combination group are drawn by U.S.（Esomeprazole 0.15mg/, Tinidazole 0.4mg/, furazolidone
0.1mg/ is only）（II, III, IV group）, do not treat control group, every group 15.Medication and Testing index are the same as embodiment 1, experiment
As a result it is as shown in table 6.
Each group when table 6 shares with esomeprazole, Tinidazole, furazolidoneH.pyloriInfection rate
Embodiment 6
Drug regimen：Pronase shares with esomeprazole, CLA, lavo-ofloxacin
Test method is similar to Example 1, wherein mongolian gerbil 83（6 ~ 8 week old, 47~80g of body weight.）, infection 76
Only, residue 7 is only used as being uninfected by control group, and infection puts to death 6 gerbil jirds after 28 days, confirms infection rate, and remaining 70 animals are divided into 5
Group, i.e. antibiotic control group（I groups）, pronase（Low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only）With Esso
Azoles, CLA, lavo-ofloxacin combination group are drawn by U.S.（Esomeprazole 0.15mg/, CLA 0.3mg/, left oxygen fluorine
Husky star 0.5mg/ is only）（II, III, IV group）, do not treat control group, every group 14.Medication and Testing index with embodiment 1,
Result of the test is as shown in table 7.
Each group when table 7 shares with esomeprazole, CLA, lavo-ofloxacinH.pyloriInfection rate
Claims (3)
1. a kind of pharmaceutical composition for eradicating deep and remote sieve door bacillus, it is characterised in that contain pronase and Aomei in said composition
Draw azoles, furazolidone to share, wherein the dosage of pronase according to the conversion of the body surface area relation of people and animal for 1.3 ~
5.1mg/kg, the dosage of Omeprazole are 20-60mg/ time, 1-2 times/day, the dosage of furazolidone be 100mg ~ 1g/ times,
1-2 times/day.
2. a kind of pharmaceutical composition for eradicating deep and remote spiral shell door rod bacterium, it is characterised in that contain pronase and Esso in said composition
U.S. draws azoles, Tinidazole, furazolidone to share, and wherein the dosage of pronase is converted according to the body surface area relation of people and animal
For 1.3 ~ 5.1mg/kg, the dosage of esomeprazole is 20-60mg/ times, 1-2 times/day, Tinidazole and furazolidone
Dosage and be 100mg ~ 1g/ times, 1-2 times/day.
3. a kind of pharmaceutical composition for eradicating deep and remote spiral shell door rod bacterium, it is characterised in that contain pronase and Esso in said composition
U.S. draws azoles, CLA, lavo-ofloxacin to share, and wherein the dosage of pronase is according to people and the body surface area relation of animal
Convert as 1.3 ~ 5.1mg/kg, the dosage of esomeprazole is 20-60mg/ times, 1-2 times/day, CLA and left oxygen
The dosage of Flucloxacillin and be 100mg ~ 1g/ times, 1-2 times/day.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5618564A (en) * | 1995-06-14 | 1997-04-08 | Ken Kimura | Composition for the treatment of helicobacter pylori infection |
| WO2007030307A2 (en) * | 2005-09-01 | 2007-03-15 | Allergan, Inc. | Method of treating glaucoma |
-
2014
- 2014-03-13 CN CN201410090187.9A patent/CN104906577B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5618564A (en) * | 1995-06-14 | 1997-04-08 | Ken Kimura | Composition for the treatment of helicobacter pylori infection |
| WO2007030307A2 (en) * | 2005-09-01 | 2007-03-15 | Allergan, Inc. | Method of treating glaucoma |
Non-Patent Citations (3)
| Title |
|---|
| 链霉蛋白酶协同三联疗法根除幽门螺杆菌的疗效观察;吴海武 等;《贵阳中医学院学报》;20131231;第35卷(第6期);第152页左栏第1段，"1.3 治疗方法"，153页"3 结果"进而"4 讨论"部分 * |
| 链霉蛋白酶联合三联疗法对幽门螺杆菌根除率的影响;刘庆东;《万方学位论文数据库》;20131008;"中文论著摘要"部分 * |
| 链霉蛋白酶联合三联疗法根除幽门螺杆菌的临床观察;宋斌 等;《吉林医学》;20120831;第33卷(第22期);第4786页"摘要"部分 * |
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