CN100553635C - Contain the pharmaceutical composition and the application thereof of amoxicillin, ambroxol and beta lactamase restrainer - Google Patents
Contain the pharmaceutical composition and the application thereof of amoxicillin, ambroxol and beta lactamase restrainer Download PDFInfo
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- CN100553635C CN100553635C CNB2007100527202A CN200710052720A CN100553635C CN 100553635 C CN100553635 C CN 100553635C CN B2007100527202 A CNB2007100527202 A CN B2007100527202A CN 200710052720 A CN200710052720 A CN 200710052720A CN 100553635 C CN100553635 C CN 100553635C
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- amoxicillin
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Abstract
The present invention relates to a kind of pharmaceutical composition, comprise amoxicillin or amoxicillin sodium salt and beta lactamase restrainer and the ambroxol or the ambroxol hydrochloride of effective drug dose.Pharmaceutical composition of the present invention shows significant synergism, the activity that can effectively suppress beta-lactamase, strengthen the antibacterial activity of amoxicillin, solve the drug resistance problem, increase the drug level of antibiotic in respiratory tract, strengthen antibacterial action, the intensive treatment achievement, improve curative effect, shorten the course of disease, and have advantages such as dosage is accurate, clinical practice is convenient.The present invention to respiratory tract disease as acute and chronic respiratory tract infection with abnormal secretion, the particularly acute attack of acute bronchitis, asthmatic bronchitis, chronic bronchitis, bronchiectasis and bronchial asthma, and otitis media, pharyngitis, sinusitis, pneumonia and tonsillitis have therapeutical effect preferably.
Description
Technical field
The invention belongs to medical technical field, relate to the pharmaceutical composition and the application in preparation treatment respiratory tract disease, otitis media or tonsillitic medicine thereof that contain amoxicillin, ambroxol and beta lactamase restrainer specifically.
Background technology
The acute attack of respiratory tract disease such as acute bronchitis, asthmatic bronchitis, chronic bronchitis, bronchiectasis and bronchial asthma, and otitis media, pharyngitis, sinusitis, pneumonia and tonsillitis etc., it is common multiple disease, worldwide its M ﹠ M all shows a rising trend, common sympton shows as cough, expectoration or with breathing hard, pant etc., and severe patient may concurrent emphysema, pulmonary heart disease etc.Wherein, cough, breathe heavily, expectorant, inflammation shape usually exist simultaneously, reciprocal causation, often share expectorant and antimicrobial drug clinically to reach therapeutic purposes.
The amoxicillin is one of antibiotic that is most widely used clinically at present, can effectively kill the various pathogenic bacterium that cause respiratory tract disease, be applicable to the treatment of respiratory tract infection due to the sensitive organisms such as the responsive golden Portugal of hammer mushroom, streptococcus pneumoniae, benzylpenicillin bacterium, hemophilus influenza.Ambroxol hydrochloride is a respiratory mucus regulator of new generation, has superior expectorant effect, and the synthetic of alveolar surfactant and secretion had significant facilitation, be widely used in the lung of respiratory tract abnormal secretion, the treatment of eliminating the phlegm of disease of bronchus now, be applicable to thick sputum that acute and chronic bronchitis, bronchial asthma, bronchiectasis, pulmonary tuberculosis etc. cause, dys-expectoration etc.
Ambroxol can increase the concentration of antibiotic such as amoxicillin, cefuroxime, erythromycin, doxycycline in lung tissue, strengthens antibiotic respiratory tract antibacterial effect, accelerates symptom and eliminates.Existing in the market amoxicillin/ambroxol hydrochloride compound oral formulations, the various diseases due to the treatment respiratory tract infection of starting with from control infection and two aspects of eliminating the phlegm.Amoxicillin Sodium/ambroxol hydrochloride powder pin is also applied for a patent (CN200610066946.3: prescription of amoxicillin sodium for injection ambroxol hydrochloride powder pin and preparation method thereof).But, have amoxicillin/ambroxol product and technology now, fail to provide the excellent means of a solution or reply amoxicillin drug resistance problem, to give full play to the effect of amoxicillin/ambroxol in treatment of respiratory diseases.
Since last century, used penicillin the forties, numerous antibiotic extensive uses, bacterial drug resistance has become one of clinical treatment and has threatened greatly.For many years, people attempt to seek from many aspects the Production by Bacteria enzyme drug resistance problem that solves.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of pharmaceutical composition that contains amoxicillin, ambroxol and beta lactamase restrainer is provided, be used for the treatment of respiratory tract disease, amoxicillin/ambroxol compound preparation can solve the drug resistance problem of antibacterial to the amoxicillin effectively relatively, increase the drug level of antibiotic in respiratory tract, strengthen antibacterial action, the intensive treatment achievement improves curative effect, shorten the course of disease, and have advantages such as dosage is accurate, clinical practice is convenient.
Technical scheme provided by the invention is: a kind of pharmaceutical composition that contains amoxicillin, ambroxol and beta lactamase restrainer comprises amoxicillin or amoxicillin sodium salt and beta lactamase restrainer and the ambroxol or the ambroxol hydrochloride of effective drug dose.
Wherein, be amoxicillin or amoxicillin sodium salt in the weight proportion of composing of each medicine of active component: beta lactamase restrainer=2～15: 1, amoxicillin or amoxicillin sodium salt: ambroxol or ambroxol hydrochloride=10～30: 1.
Above-mentioned amoxicillin comprises Utimox and anhydrous amoxicillin.
Described beta lactamase restrainer can be but is not limited only to clavulanic acid, clavulanic acid potassium salt, Tazobactam Sodium, Tazobactam Sodium sodium salt, sulbactam or sulbactam sodium salt.
Pharmaceutical composition of the present invention is to be fit to medicinal any dosage form.
Aforementioned pharmaceutical compositions contains acceptable auxiliary on the pharmaceutics.
Acceptable auxiliary comprises diluent, binding agent, disintegrating agent, lubricant, enteric material, slow-release material, correctives, oral liquid solvent, suspending agent, stabilizing agent, injection solvent, cosolvent, acid-base modifier, freeze drying protectant and/or antioxidant on the above-mentioned pharmaceutics.
The described pharmaceutical composition that contains amoxicillin, ambroxol and beta lactamase restrainer, acceptable auxiliary on other pharmaceutics, according to method in pharmacy, be prepared as including, but not limited to dosage forms such as tablet, powder, slow releasing tablet, enteric coatel tablets, chewable tablet, effervescent tablet, capsule, enteric coated capsule, granule, syrup, suspensoid, dry suspension, injection, aseptic powder injection, freeze-dried powders, with oral or injection administration.Acceptable auxiliary on the described pharmaceutics comprises diluent, binding agent, disintegrating agent, lubricant, enteric material, slow-release material, correctives, oral liquid solvent, suspending agent, stabilizing agent, injection solvent, cosolvent, acid-base modifier, freeze drying protectant, antioxidant etc.
Aforementioned pharmaceutical compositions of the present invention for respiratory tract disease as acute and chronic respiratory tract infection with abnormal secretion, the particularly acute attack of acute bronchitis, asthmatic bronchitis, chronic bronchitis, bronchiectasis and bronchial asthma, and otitis media, pharyngitis, sinusitis, pneumonia or tonsillitis have good therapeutic effect.
Pharmaceutical composition of the present invention and not compositions antibacterial activity in vitro comparison, pharmaceutical composition of the present invention shows significant synergism, the activity that can effectively suppress beta-lactamase strengthens the antibacterial activity of amoxicillin, solves the drug resistance problem, increase the drug level of antibiotic in respiratory tract, strengthen antibacterial action, the intensive treatment achievement improves curative effect, shorten the course of disease, and have advantages such as dosage is accurate, clinical practice is convenient.
The specific embodiment
Following examples only are further detailed the present invention, should not be construed as the present invention is further limited.
Embodiment 1 amoxicillin+clavulanate potassium+ambroxol hydrochloride sheet, every contains amoxicillin 250mg, clavulanic acid 125mg and ambroxol hydrochloride 15mg, prepares 1000 altogether.
Amoxicillin 250g
Clavulanate potassium 125g (in clavulanic acid)
Ambroxol hydrochloride 15g
Microcrystalline Cellulose 70g
Micropowder silica gel 10g
Cross-linked carboxymethyl cellulose sodium 6g
Magnesium stearate 9g
Make 1000
Preparation method: amoxicillin powder, clavulanate potassium powder and the ambroxol hydrochloride powder mixes of getting recipe quantity are even, and with dry respectively 100 mesh sieves of also crossing of each adjuvant, various adjuvants add in the three component mixed powders by the equivalent incremental method, direct powder compression, coating.
Embodiment 2 amoxicillin+clavulanic acid+ambroxol sheet, every contains amoxicillin 250mg, clavulanic acid 62.5mg, and ambroxol 15mg prepares 1000 altogether.
Amoxicillin 250g
Clavulanic acid 62.5g
Ambroxol 15g
Microcrystalline Cellulose 50g
Micropowder silica gel 8g
Cross-linked carboxymethyl cellulose sodium 4g
Magnesium stearate 6g
Make 1000
Preparation method: amoxicillin powder, clavulanic acid powder and the ambroxol powder mixes of getting recipe quantity are even, and with dry 100 mesh sieves of also crossing of each adjuvant difference, the dry-pressing on dried crowded type granulation machine of various adjuvants and three component mixed powders is made granule, tabletting, coating.
Embodiment 3 Amoxicillin Sodiums+clavulanate potassium+ambroxol hydrochloride capsule, every contains amoxicillin 250mg, clavulanic acid 125mg and ambroxol hydrochloride 15mg, prepares 1000 altogether.
Amoxicillin Sodium 250g (in the amoxicillin)
Clavulanate potassium 125g (in clavulanic acid)
Ambroxol hydrochloride 15g
Microcrystalline Cellulose 70g
Micropowder silica gel 10g
Cross-linked carboxymethyl cellulose sodium 6g
Magnesium stearate 9g
Make 1000
Preparation method: Amoxicillin Sodium powder, clavulanate potassium powder and the ambroxol hydrochloride powder mixes of getting recipe quantity are even; with dry respectively 100 mesh sieves of also crossing of each adjuvant; various adjuvants and three component mixed powders are that granule is made in dry-pressing on the crowded type granulation machine, pour into capsule.
Embodiment 4 Amoxicillin Sodiums+clavulanate potassium+ambroxol hydrochloride granule, every bag contains amoxicillin 875mg, clavulanic acid 125mg and ambroxol hydrochloride 30mg, prepares 1000 bags altogether.
Amoxicillin Sodium 875g (in the amoxicillin)
Clavulanate potassium 125g (in clavulanic acid)
Ambroxol hydrochloride 30g
Microcrystalline Cellulose 240g
Micropowder silica gel 10g
Cross-linked carboxymethyl cellulose sodium 25g
Magnesium stearate 15g
Make 1000 bags
Preparation method: Amoxicillin Sodium powder, clavulanate potassium powder and the ambroxol hydrochloride powder mixes of getting recipe quantity are even; with dry respectively 100 mesh sieves of also crossing of each adjuvant; the dry-pressing on dried crowded type granulation machine of various adjuvants and three component mixed powders is made granule, packing.
Embodiment 5 amoxicillin+clavulanate potassium+ambroxol hydrochloride dry suspension, every bag contains amoxicillin 600mg, clavulanic acid 42.9mg and ambroxol hydrochloride 30mg, prepares 1000 bags altogether.
Amoxicillin 600g
Clavulanate potassium 42.9g (in clavulanic acid)
Ambroxol hydrochloride 30g
Microcrystalline Cellulose 80g
Micropowder silica gel 40g
Xanthan gum 20g
Saccharin sodium 6g
Make 1000 bags
Preparation method: amoxicillin powder, clavulanate potassium powder and the ambroxol hydrochloride powder mixes of getting recipe quantity are even, and each adjuvant difference drying is also crossed sieve, various adjuvants and three component mixed powder mix homogeneously, packing No. five.
Embodiment 6 injection amoxicillin+clavulanate potassium+ambroxol hydrochlorides, every contains amoxicillin 500mg, clavulanic acid 250mg and ambroxol hydrochloride 30mg, prepares 1000 altogether.
Amoxicillin (aseptic powder) 500g
Clavulanate potassium (aseptic powder) 250g (in clavulanic acid)
Ambroxol hydrochloride (aseptic powder) 30
Make 1000
Preparation method: precision takes by weighing three component aseptic powder, mix homogeneously, packing, gland respectively under aseptic condition.
Embodiment 7 amoxicillin+clavulanate potassium+ambroxol hydrochloride lyophilized injection, every contains amoxicillin 875mg, clavulanic acid 125mg and ambroxol hydrochloride 30mg, prepares 1000 altogether.
Amoxicillin (aseptic powder) 875g
Clavulanate potassium (aseptic powder) 125g (in clavulanic acid)
Ambroxol hydrochloride 30g
Mannitol 10g
Make 1000
Preparation method: get ambroxol hydrochloride, the mannitol of recipe quantity, add in the water for injection, stirring down, the adding sodium sulfite makes material dissolution and regulates pH4.0～5.5, added needle-use activated carbon 30 minutes, the filtering active carbon, medical filtration, filtrate is packed in the pallet, place the freezer dryer lyophilization, under aseptic condition, pulverize dried frozen aquatic products, cross 180 mesh sieves, with amoxicillin aseptic powder, the clavulanate potassium aseptic powder mix homogeneously of recipe quantity, packing, gland.
Embodiment 8 injection amoxicillin+Tazobactam Sodium+ambroxol hydrochlorides, every contains amoxicillin 500mg, Tazobactam Sodium 100mg and ambroxol hydrochloride 30mg, prepares 1000 altogether.
Amoxicillin (aseptic powder) 500g
Tazobactam Sodium (aseptic powder) 100g
Ambroxol hydrochloride (aseptic powder) 30g
Make 1000
Preparation method: precision takes by weighing three component aseptic powder, mix homogeneously, packing, gland respectively under aseptic condition.
Embodiment 9 amoxicillin sodium for injection+sodium-tazobactam+ambroxol hydrochloride, every contains amoxicillin 500mg, Tazobactam Sodium 250mg and ambroxol hydrochloride 30mg, prepares 1000 altogether.
Amoxicillin Sodium (aseptic powder) 500g (in the amoxicillin)
Sodium-tazobactam (aseptic powder) 250g (in Tazobactam Sodium)
Ambroxol hydrochloride (aseptic powder) 30g
Make 1000
Preparation method: precision takes by weighing three component aseptic powder, mix homogeneously, packing, gland respectively under aseptic condition.
Embodiment 10 amoxicillin sodium for injection+sulbactam sodium+ambroxol hydrochloride, every contains amoxicillin 500mg, sulbactam 100mg and ambroxol hydrochloride 30mg, prepares 1000 altogether.
Amoxicillin Sodium (aseptic powder) 500g (in the amoxicillin)
Sulbactam sodium (aseptic powder) 100g (in sulbactam)
Ambroxol hydrochloride (aseptic powder) 30g
Make 1000
Preparation method: precision takes by weighing three component aseptic powder, mix homogeneously, packing, gland respectively under aseptic condition.
Embodiment 11 injection amoxicillin+sulbactam+ambroxol hydrochlorides, every contains amoxicillin 500mg, sulbactam 250mg and ambroxol hydrochloride 30mg, prepares 1000 altogether.
Amoxicillin (aseptic powder) 500g
Sulbactam (aseptic powder) 250g
Ambroxol hydrochloride (aseptic powder) 30g
Make 1000
Preparation method: precision takes by weighing three component aseptic powder, mix homogeneously, packing, gland respectively under aseptic condition.
The invention is not restricted to above-described embodiment.
This pharmaceutical composition of table 1 antibacterial activity in vitro comparative test (MIC
50Mg/L)
Table 1 data declaration: with amoxicillin+ambroxol+clavulanic acid (16: 1: 8) is example, and its activity to meningococcus, colon bacillus, staphylococcus aureus, streptococcus pneumoniae, Bacillus proteus, hemophilus influenza is respectively amoxicillin+ambroxol (16: 1), amoxicillin+clavulanic acid (2: 1) 64 times, 32 times; 64 times, 16 times; 32 times, 8 times; 64 times, 8 times; 128 times, 64 times; 16 times, 8 times, antibiotic synergism is very remarkable.The combination of other three components shows consistent effect in the table.
Claims (6)
1. pharmaceutical composition that contains amoxicillin, ambroxol and beta lactamase restrainer comprises amoxicillin or amoxicillin sodium salt and beta lactamase restrainer and the ambroxol or the ambroxol hydrochloride of effective drug dose; Weight proportion of composing in each medicine of active component is amoxicillin or amoxicillin sodium salt: beta lactamase restrainer=2～15: 1, and amoxicillin or amoxicillin sodium salt: ambroxol or ambroxol hydrochloride=10～30: 1.
2. pharmaceutical composition as claimed in claim 1 is characterized in that: the amoxicillin is Utimox or anhydrous amoxicillin.
3. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that: beta lactamase restrainer is clavulanic acid, clavulanic acid potassium salt, Tazobactam Sodium, Tazobactam Sodium sodium salt, sulbactam or sulbactam sodium salt.
4. pharmaceutical composition as claimed in claim 1 or 2 is characterized in that: described pharmaceutical composition is to be fit to medicinal any dosage form.
5. pharmaceutical composition as claimed in claim 4 is characterized in that: contain acceptable auxiliary on the pharmaceutics.
6. pharmaceutical composition as claimed in claim 5 is characterized in that: acceptable auxiliary comprises diluent, binding agent, disintegrating agent, lubricant, enteric material, slow-release material, correctives, oral liquid solvent, suspending agent, stabilizing agent, injection solvent, cosolvent, acid-base modifier, freeze drying protectant and/or antioxidant on the pharmaceutics.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100527202A CN100553635C (en) | 2007-07-12 | 2007-07-12 | Contain the pharmaceutical composition and the application thereof of amoxicillin, ambroxol and beta lactamase restrainer |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100527202A CN100553635C (en) | 2007-07-12 | 2007-07-12 | Contain the pharmaceutical composition and the application thereof of amoxicillin, ambroxol and beta lactamase restrainer |
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| CN102846605B (en) * | 2012-08-03 | 2015-03-25 | 九江大成制药有限公司 | Medicinal composition, as well as preparation process and application thereof |
| CN106474122B (en) * | 2016-09-07 | 2020-04-14 | 湘北威尔曼制药股份有限公司 | Pharmaceutical composition of amoxicillin and clavulanate potassium and application thereof |
| CN107261108B (en) * | 2017-07-04 | 2020-08-14 | 江西傲新生物科技有限公司 | Long-acting amoxicillin and colistin sulfate injection and preparation method thereof |
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Non-Patent Citations (2)
| Title |
|---|
| 沐舒坦辅助治疗儿童慢性鼻窦炎的临床研究. 高鸿明，吴树浓，卢坚，邹健华，黄俊逸.国际医药卫生导报，第11卷第2005年第08期. 2005 |
| 沐舒坦辅助治疗儿童慢性鼻窦炎的临床研究. 高鸿明，吴树浓，卢坚，邹健华，黄俊逸.国际医药卫生导报，第11卷第2005年第08期. 2005 * |
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