CN104906577A - Medicinal composition for eradicating helicobacter pylori, and preparation method thereof - Google Patents
Medicinal composition for eradicating helicobacter pylori, and preparation method thereof Download PDFInfo
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- CN104906577A CN104906577A CN201410090187.9A CN201410090187A CN104906577A CN 104906577 A CN104906577 A CN 104906577A CN 201410090187 A CN201410090187 A CN 201410090187A CN 104906577 A CN104906577 A CN 104906577A
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Abstract
The invention relates to a medicinal composition for eradicating helicobacter pylori, and a disease treatment and use method thereof. The medicinal composition contains pronase, a proton pump inhibitor (PPI) and an antibiotic. The medicinal composition can eradicate the helicobacter pylori through the specific use method under a specific dosage, and can prevent and treat various gastric diseases induced by the helicobacter pylori, and gastric mucosa-associated lymph tissue (MALT) lymphomas and stomach cancer. The defects and disadvantages of incomplete treatment, low cure rate and repeated attack of traditional treatment methods are overcome, and the medicinal composition greatly improves the symptoms of clinic patients, mitigates patients' pains, and improves patients' compliance.
Description
Technical field
The invention belongs to medicinal application field, be specifically related to pharmaceutical composition of a kind of eradicate helicobacter pylori and preparation method thereof, and application in its disease of being correlated with at stomach mucosas such as disease of stomach and using method.
Background technology
Helicobacter pylori (being called for short H. pylori) belongs to the spirillum of growth at gastric epithelial, be a kind of microaerobe, research proves that helicobacter pylori infections is the main pathogenic of chronic active gastritis, peptic ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma and gastric cancer.About the relatedness of gastric mucosal lesion and H. pylori, due to H. pylori can be detected specifically at pylorus vestibular portion, thus think that gastric mucosal lesion and H. pylori have very strong dependency.Within 1994, helicobacter pylori is decided to be I class carcinogen by World Health Organization (WHO).The Helicobacter Pylori Infection Rate of China is 40-90%, average out to 59%, and Helicobacter Pylori Infection Rate in all parts of the country exists very big-difference.In recent years because H.Pylori is to problems such as antibiotic drug resistance, the eradication rate of H.Pylori declines year by year.
At present, traditional Therapeutic Method uses antibiotic, the Novel Quinolone class antibiotic etc. such as penicillins, Tetracyclines, Macrolide to remove helicobacter pylori, but its degermation is not enough.Most antibacterial substance can not drive away helicobacter pylori completely from gastric, its reason is that helicobacter pylori easily makes a variation and has tolerance antibacterial on the one hand, be on the other hand, above-mentioned rete malpighii becomes obstacle, does not thus have the medicine of q.s to arrive and infects local.
Gastric epithelial is coated to by hydrophobic thick mucous layer, and hydrophilic low molecular compound is difficult to soak into mucus in a large number and arrives the mucosa local of helicobacter pylori attachment, propagation, is also difficult at mucosa local retention.In addition, breed in the countless gastric pits that helicobacter pylori exists in gastric epithelial, antibacterial is difficult to arrive more.
Although there is now the using method of drug combination, degerming rate has improvement to a certain degree, has occurred high-frequency side effect in contrast, and can not play the effect of elimination, and due to instructions of taking numerous and diverse, be difficult to clear and definite administration.
The present inventor is by discovery of concentrating on studies, and the pharmaceutical composition in case of the present invention can the pharmaceutical composition of eradicate helicobacter pylori safely and effectively at short notice, the gastric mucosa such as peptic ulcer or chronic gastritis relevant disease is had to the effect of prevention and therapy.This pharmaceutical composition overcomes that cure rate in traditional therapy is low, side effect is large, cannot eradicate, the defect of recurrent exerbation, significantly improves the clinical symptoms of patient, alleviates the misery of patient, and convenient drug administration, improves the compliance of patient.。
Summary of the invention
A pharmaceutical composition for eradicate helicobacter pylori, containing pronase, antibiotic and proton pump inhibitor three kinds of components in said composition.
Wherein, the consumption of pronase is 1.3 ~ 5.1mg/kg according to the body surface area relation conversion of man and animal.
Wherein, proton pump inhibitor is selected from any one in omeprazole, lansoprazole, esomeprazole, rabeprazole, pantoprazole; The consumption of proton pump inhibitor is 20-60mg/ time, 1-2 times/day.
Wherein, antibiotic is selected from amoxicillin, clarithromycin, metronidazole, furazolidone, tetracycline, levofloxacin, Moxifloxacin, tinidazole any one or two kinds combine; Antibiotic consumption is 100mg ~ 1g/ time, 1-2 times/day.
This pharmaceutical composition can eradicate helicobacter pylori, can be used for the microbial disease of prevention and therapy helicobacter pylorus and symptom thereof.
This pharmaceutical composition can be used for prevention and therapy helicobacter pylori and causes chronic active gastritis, dyspepsia, peptic ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, Gastric hyperplastic polyps and gastric cancer.
Medication be first give and proton pump inhibitor, interval after 15 to 30 minutes give and pronase and antibiotic.
figure of description
The traditional Therapeutic Method antibiotic administration of accompanying drawing 1 compares with pharmaceutical composition administration eradication rate of the present invention.
detailed description of the invention
The detailed description of the invention of form by the following examples, is described in further detail content of the present invention.But this should be interpreted as scope of the present invention is only limitted to following examples.All technical schemes realized based on content of the present invention all belong to scope of the present invention.Obviously, according to content of the present invention, according to ordinary technical knowledge and the customary means of this area, under the prerequisite not departing from basic fundamental thought of the present invention, the amendment of other various ways, replacement or change can also be made.
Embodiment 1:
Drug regimen: pronase and omeprazole, amoxicillin, clarithromycin share
Test method:
Mongolian gerbil, male, 132,6 ~ 8 week age, body weight 40 ~ 70g.Wherein 122 infection
h.Pylori, remain 10 and do not infect, as not infecting contrast.Infect and put to death 10 gerbil jirds afterwards in 28 days, detect
h.Pyloriinfection rate, during infection rate>=90% modeling success, can divide into groups to test.
Confirm to infect successfully, residue is infected successful 92 animals and is divided into 5 groups, as shown in table 1.Fasting before animals administer, can't help water, and medication is that first gavage gives omeprazole, and after 0.5h, gavage gives MS solution and antibiotic, every day at upper and lower noon each administration 1 time, successive administration 7 days.
Within after drug withdrawal 28 days, detect
h.pyloricolonisation, Testing index is that tissue culture, rapid urease test and Real-time PCR detect.Tissue culture is positive, or tissue culture is negative but rapid urease test and Real-time PCR testing result are the positive time, confirmation
h.pyloriinfect positive.
The animal that table 1 and omeprazole, amoxicillin, clarithromycin share divides into groups administrations
Result of the test:
For confirming
h.pylori10 gerbil jirds of infection rate are
h.pyloriinfect positive, infection rate is 100%, shows that the gerbil jird of this subinfection can be used for test.
Within after last administration 28 days, detect
h.pyloriinfection rate, find pronase and amoxicillin and clarithromycin coupling, can increase treatment
h.pylorithe eradication rate infected, and in obvious dose-dependence.Wherein the eradication rate of high dose group reaches 90%, the antibiotic matched group of same dose
h.pylorieradication rate is only 40%, in, the eradication rate of low dose group be respectively 70% and 75%(table 2).Warp
χ 2inspection statistics is analyzed, and antibiotics alone treatment group (I group) compares with antibiotic+pronase high dose group (IV group) and has significant difference (P<0.05).
Respectively organize when table 2 and omeprazole, amoxicillin, clarithromycin share
h.pyloriinfection rate
| Grouping | Number of animals | Infection rate | Eradication rate |
| I group * | 20 | 50%（10/20） | 40% |
| II group | 20 | 40%（8/20） | 70% |
| III group | 20 | 35%（7/20） | 75% |
| IV group | 20 | 20%（4/20） | 90% |
| Do not treat matched group | 12 | 100%（12/12） | 0% |
Embodiment 2
Drug regimen: pronase and omeprazole, metronidazole share
Test method is similar to Example 1, wherein mongolian gerbil 62 (6 ~ 8 week age, body weight 45 ~ 72g.), infect 56, remain 6 conducts and do not infect matched group, infect and put to death 6 gerbil jirds afterwards in 28 days, confirm infection rate, remain 50 animals and be divided into 5 groups, namely antibiotic matched group (I group), pronase (low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only) with omeprazole, metronidazole combination group (omeprazole 0.24mg/ only, metronidazole 0.5mg/ only) (II, III, IV group), do not treat matched group, often organize 10.Medication and Testing index are with embodiment 1, and result of the test is as shown in table 3.
Respectively organize when table 3 and omeprazole, metronidazole share
h.pyloriinfection rate
| Grouping | Number of animals | Infection rate | Eradication rate |
| I group | 10 | 50%（5/10） | 40% |
| II group | 10 | 60%（6/10） | 60% |
| III group | 10 | 50%（5/10） | 70% |
| IV group | 10 | 40%（4/10） | 80% |
| Do not treat matched group | 10 | 100%（10/10） | 0 % |
| Do not infect contrast | 6 | 0（0/6） | -- |
Embodiment 3
Drug regimen: pronase and omeprazole, furazolidone share
Test method is similar to Example 1, wherein mongolian gerbil 66 (6 ~ 8 week age, body weight 50 ~ 75g.), infect 61, remain 5 conducts and do not infect matched group, infect and put to death 6 gerbil jirds afterwards in 28 days, confirm infection rate, remain 55 animals and be divided into 5 groups, namely antibiotic matched group (I group), pronase (low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only) with omeprazole, furazolidone combination group (omeprazole 0.24mg/ only, furazolidone 0.1mg/ only) (II, III, IV group), do not treat matched group, often organize 11.Medication and Testing index are with embodiment 1, and result of the test is as shown in table 4.
Respectively organize when table 4 and omeprazole, furazolidone share
h.pyloriinfection rate
| Grouping | Number of animals | Infection rate | Eradication rate |
| I group | 11 | 54.5%（6/11） | 35.5% |
| II group | 11 | 45.5%（5/11） | 64.5% |
| III group | 11 | 45.5%（5/11） | 74.5% |
| IV group | 11 | 36.4%（4/11） | 93.6% |
| Do not treat matched group | 11 | 100%（11/11） | 0 % |
| Do not infect contrast | 5 | 0（0/5） | -- |
Embodiment 4
Drug regimen: pronase and lansoprazole, metronidazole, amoxicillin are share
Test method is similar to Example 1, wherein mongolian gerbil 89 (6 ~ 8 week age, body weight 43 ~ 81g.), infect 85, remain 4 conducts and do not infect matched group, infect and put to death 5 gerbil jirds afterwards in 28 days, confirm infection rate, remain 80 animals and be divided into 5 groups, namely antibiotic matched group (I group), pronase (low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only) with lansoprazole, metronidazole, amoxicillin combination group (lansoprazole 0.15mg/ only, metronidazole 0.3mg/ only, amoxicillin 0.4mg/ only) (II, III, IV group), do not treat matched group, often organize 16.Medication and Testing index are with embodiment 1, and result of the test is as shown in table 5.
Respectively organize when table 5 and lansoprazole, metronidazole, amoxicillin are share
h.pyloriinfection rate
| Grouping | Number of animals | Infection rate | Eradication rate |
| I group | 16 | 50%（8/16） | 40% |
| II group | 16 | 43.8%（7/16） | 66.2% |
| III group | 16 | 31.2%（5/16） | 78.8% |
| IV group | 16 | 25%（4/16） | 85% |
| Do not treat matched group | 16 | 93.8%（15/16） | 6.2% |
| Do not infect contrast | 5 | 0（0/5） | -- |
Embodiment 5
Drug regimen: pronase and esomeprazole, tinidazole, furazolidone share
Test method is similar to Example 1, wherein mongolian gerbil 86 (6 ~ 8 week age, body weight 44 ~ 85g.), infect 81, remain 5 conducts and do not infect matched group, infect and put to death 6 gerbil jirds afterwards in 28 days, confirm infection rate, remain 75 animals and be divided into 5 groups, namely antibiotic matched group (I group), pronase (low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only) with esomeprazole, tinidazole, furazolidone combination group (esomeprazole 0.15mg/ only, tinidazole 0.4mg/ only, furazolidone 0.1mg/ only) (II, III, IV group), do not treat matched group, often organize 15.Medication and Testing index are with embodiment 1, and result of the test is as shown in table 6.
Respectively organize when table 6 and esomeprazole, tinidazole, furazolidone share
h.pyloriinfection rate
| Grouping | Number of animals | Infection rate | Eradication rate |
| I group | 15 | 53.3%（8/15） | 46.7% |
| II group | 15 | 46.7%（7/15） | 63.3% |
| III group | 15 | 33.3%（5/15） | 76.7% |
| IV group | 15 | 26.7%（4/15） | 83.3% |
| Do not treat matched group | 15 | 100%（15/15） | 0 % |
| Do not infect contrast | 5 | 0（0/5） | -- |
Embodiment 6
Drug regimen: pronase and esomeprazole, clarithromycin, levofloxacin share
Test method is similar to Example 1, wherein mongolian gerbil 83 (6 ~ 8 week age, body weight 47 ~ 80g.), infect 76, remain 7 conducts and do not infect matched group, infect and put to death 6 gerbil jirds afterwards in 28 days, confirm infection rate, remain 70 animals and be divided into 5 groups, namely antibiotic matched group (I group), pronase (low 1.6 mg/ only, in 3.2 mg/ only, high 6.4 mg/ only) with esomeprazole, clarithromycin, levofloxacin combination group (esomeprazole 0.15mg/ only, clarithromycin 0.3mg/ only, levofloxacin 0.5mg/ only) (II, III, IV group), do not treat matched group, often organize 14.Medication and Testing index are with embodiment 1, and result of the test is as shown in table 7.
Respectively organize when table 7 and esomeprazole, clarithromycin, levofloxacin share
h.pyloriinfection rate
| Grouping | Number of animals | Infection rate | Eradication rate |
| I group | 14 | 42.9%（6/14） | 47.1% |
| II group | 14 | 35.7%（5/14） | 74.3% |
| III group | 14 | 35.7%（5/14） | 84.3% |
| IV group | 14 | 21.4%（3/14） | 88.6% |
| Do not treat matched group | 14 | 92.9%（13/14） | 7.1 % |
| Do not infect contrast | 7 | 0（0/7） | -- |
Claims (8)
1. a pharmaceutical composition for eradicate helicobacter pylori, is characterized in that, containing pronase, antibiotic and proton pump inhibitor three kinds of components in said composition.
2. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to claim 1, is characterized in that, the consumption of pronase is 1.3 ~ 5.1mg/kg according to the body surface area relation conversion of man and animal.
3. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to claim 1, is characterized in that, proton pump inhibitor be selected from omeprazole, lansoprazole, esomeprazole, rabeprazole, pantoprazole any one; Wherein, the consumption of proton pump inhibitor is 20-60mg/ time, 1-2 times/day.
4. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to claim 1, it is characterized in that, any one or two kinds that antibiotic is selected from amoxicillin, clarithromycin, metronidazole, furazolidone, tetracycline, levofloxacin, Moxifloxacin, tinidazole combine; Wherein, antibiotic consumption is 100mg ~ 1g/ time, 1-2 times/day.
5. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to Claims 1-4, is characterized in that, this pharmaceutical composition can eradicate helicobacter pylori.
6. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to claim 5, is characterized in that this pharmaceutical composition can be used for the microbial disease of prevention and therapy helicobacter pylorus and symptom thereof.
7. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to claim 5, is characterized in that this pharmaceutical composition can be used for prevention and therapy helicobacter pylori and causes chronic active gastritis, dyspepsia, peptic ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, Gastric hyperplastic polyps and gastric cancer.
8. the pharmaceutical composition of a kind of eradicate helicobacter pylori according to Claims 1-4, the medication that it is characterized in that this pharmaceutical composition for first giving and proton pump inhibitor, interval give after 15 to 30 minutes simultaneously to and pronase and antibiotic.
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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 |
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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 (4)
| Title |
|---|
| 刘庆东: "链霉蛋白酶联合三联疗法对幽门螺杆菌根除率的影响", 《万方学位论文数据库》 * |
| 吴海武 等: "链霉蛋白酶协同三联疗法根除幽门螺杆菌的疗效观察", 《贵阳中医学院学报》 * |
| 宋斌 等: "链霉蛋白酶联合三联疗法根除幽门螺杆菌的临床观察", 《吉林医学》 * |
| 田雪丽 等: "链霉蛋白酶对胃组织中治疗幽门螺杆菌药物浓度的影响", 《中华内科杂志》 * |
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