CN1872055A - Compound preparation of amoxicillin and ambroxol hydrochloride suitable to use for children, prescription and preparation method - Google Patents
Compound preparation of amoxicillin and ambroxol hydrochloride suitable to use for children, prescription and preparation method Download PDFInfo
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- CN1872055A CN1872055A CN 200510073169 CN200510073169A CN1872055A CN 1872055 A CN1872055 A CN 1872055A CN 200510073169 CN200510073169 CN 200510073169 CN 200510073169 A CN200510073169 A CN 200510073169A CN 1872055 A CN1872055 A CN 1872055A
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- amoxicillin
- ambroxol hydrochloride
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Abstract
A compound medicine in the form of powder or particle suitable for children is prepared from amoxycillin, ambroxol hydrochloride and the pharmacologically acceptable auxiliaries including flow assistant lubricant, high-molecular polymer, sweetener and fragrant flavouring. Its preparing process is also disclosed.
Description
Technical field the present invention relates to the amoxicillin of pharmaceutical suitable child's application and compound preparation and the prescription and the preparation method of ambroxol hydrochloride.
Background technology amoxicillin (Amoxicillin) is the wide spectrum semisynthetic penicillin, for Hemolytic streptococcus, Streptococcus viridans, streptococcus pneumoniae, the responsive staphylococcus aureus of benzylpenicillin, gonococcus, hemophilus influenza, enterococcus, Salmonella, Bacillus typhi and Bacillus proteus etc. antibacterial action is arranged all.This product is acidproof can be oral, oral post-absorption is good, and unable to take food thing influence, be used for upper respiratory tract infection, pharyngitis, tonsillitis, acute/chronic bronchitis, pneumonia, bronchiectasis, urinary tract infection, skin and soft tissue infection etc. that this product sensitive bacterial is caused clinically, curative effect is better, is the infection medicine of using always.Ambroxol hydrochloride (Ambroxol Hydrochloride) is a bromhexine metabolite in vivo, have the phlegm dissolving effect, thereby can make the how sticking fibrous fracture dilution sputum of apoplexy due to phlegm, and by suppressing the synthetic expectorant viscosity that reduces of glycoprotein, making expectorant be convenient to discharge, is the expectorant of using always.
Above-mentioned two kinds of medicines because of safe and effective, untoward reaction is few, in treatment use in conjunction usually during respiratory system infection.Existing pharmacology and clinical data show, amoxicillin and ambroxol hydrochloride are with taking in the treatment respiratory tract bacterial infection, has synergistic function, ambroxol hydrochloride can improve the amoxicillin and reach intrabronchial drug level in lung, reduced drug treatment, avoided infecting the caused violent cough of stimulation, made better efficacy when the treatment respiratory tract infection.
The amoxicillin of existing report and the compound preparation of ambroxol hydrochloride have tablet and capsule.Tablet and capsule are not suitable for the child and use, and to the child, divided dose is not accurate enough when taking.Because the sickness rate of childrens respiratory tract infection is higher, thereby very need to be fit to the amoxicillin of child's application and the compound preparation of ambroxol hydrochloride clinically.
Summary of the invention the present invention is intended to overcome the amoxicillin of existing report and the compound tablet and the capsule of ambroxol hydrochloride is not suitable for the problem that the child uses, prepared and be particularly suitable for the amoxicillin that the child uses and the compound preparation of ambroxol hydrochloride, dosage form comprises powder and granule, is characterized in:
(1) stability is better.Because no matter powder is being made or in storage process, all is being in dry anhydrous state all the time, and packing is tight, avoids contacting with dampness with air, thereby stable than tablet.
(2) though powder and granule are solid preparation, it is when adding mixing in water for oral taking that is formed solution, thus than tablet and capsule good absorbing, rapid-action, bioavailability is high.
(3) suitable crowd is wider.When powder and granule added mixing in water for oral taking, mouthfeel was good, and patient is willing to accept, and was particularly suitable for the child and used, but also make things convenient for the patient of old people and dysphagia to use.
(4) produce, transport, preserve, carry and use more convenient.
Amoxicillin and ambroxol hydrochloride all have peculiar taste, and or difficulty be dissolved in water, oral solid formulation often drug dissolution is low, or contains amido link in the molecule, unstable hydrolysis easily.Thereby how can overcome and cover the peculiar taste of medicine, the dissolution that improves medicine, increase stability of drug effectively, be that preparation is fit to amoxicillin and the compounding powder of ambroxol hydrochloride and the key issue of granule that the child uses.The compounding powder of amoxicillin of the present invention and ambroxol hydrochloride and granule, by adopting special prescription and preparation technology, alleviate or overcome the peculiar taste of amoxicillin and ambroxol hydrochloride effectively, improved the compliance of patient's medication, be particularly suitable for the child and use, drug dissolution and bioavailability height, stability are by force simultaneously.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, contain amoxicillin and ambroxol hydrochloride in the prescription, also contain pharmaceutically acceptable lubricated fluidizer, high molecular polymer, sweeting agent and fragrant correctives, granule also contains adhesive.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, and every bag contains amoxicillin 50～550mg, best 100～500mg in the prescription, ambroxol hydrochloride 5～60mg, best 15～30mg.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, lubricated fluidizer in the prescription can be micropowder silica gel, polyethylene glycol 6000, Pulvis Talci, starch, dextrin, pregelatinized Starch, polyethylene glycol 6000, starch, pregelatinized Starch also have the effect of diluent concurrently, can can also mix use by different proportion separately, total consumption be recipe quantity 1～20%, be preferably 3～17%, guaranteeing the drug powder good fluidity, easy to manufacture and packing is accurate.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, high molecular polymer in the prescription can be 30 POVIDONE K 30 BP/USP 30, hyprolose, hypromellose, carmethose, beta-schardinger dextrin-, xanthan gum, carbomer, alginate, arabic gum, phospholipid etc., total consumption is 1～20%, best 4%～16% of a recipe quantity, can can also mix use by different proportion separately, promoting the medicine stripping, and help to overcome the peculiar taste of medicine.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, sweeting agent in the prescription can be sucrose, glucose, xylitol, sorbitol, mannitol, lactose, glycyrrhetate, steviosin, saccharin sodium, aspartame etc., sucrose, glucose, xylitol, sorbitol, mannitol, lactose also have the effect of diluent concurrently, can can also mix use by different proportion separately, total consumption be recipe quantity 30～90%, best 40～85%, to correct the peculiar taste of medicine effectively.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, fragrant correctives in the prescription can be natural and synthetic spice, spice such as optional majority kind taste such as Fructus Musae, Herba Menthae, Fructus Mali pumilae, Fructus Citri tangerinae, Fructus Fragariae Ananssae, chocolate, Rhizoma et radix valerianae, Fructus Vitis viniferae, Fructus Pruni pseudocerasi, also can add aminoacid such as sodium glutamate etc., can can also mix use by different proportion separately, total consumption is 0.5～15%, best 2～10% of a recipe quantity, so that the powder that makes is fragrant and sweet good to eat, patient takes like a shot.
The present invention is fit to the amoxicillin of child's application and the compound granular agent of ambroxol hydrochloride, adhesive in the prescription can be gelatinized corn starch, 30 POVIDONE K 30 BP/USP 30 alcohol-water solution, hypromellose aqueous solution, syrup etc., can be separately, also can mix use in varing proportions, total consumption is 3～15%, best 5～10% of a recipe quantity.
Preparation the present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, can adopt the special prescription of covering the medicine peculiar taste and common preparation method preparation.Preparation powder is dried to moisture below 1% in advance with other medicine and the adjuvant that contains moisture except that spice earlier, be ground into the above fine powder of 80～100 orders, by behind the dilution method mix homogeneously that progressively increases step by step, can pack packing on request then, every packed amount 1～5g.The preparation granule is on the basis of preparation powder, adds suitable adhesive and makes granule, and dry wet particle, granulate adds the essence mix homogeneously, can pack packing on request, every bag of 1～5g.
The present invention is fit to the amoxicillin of child's application and the compounding powder and the granule of ambroxol hydrochloride, be applicable to the treatment of the infectious disease that causes by sensitive strain, 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, also be applicable to otitis media, pharyngitis, pneumonia and tonsillitis, during application medicine is added in a certain amount of eliminating cold for resuscitation water and dissolves suspendible, can take.
Specific embodiment the present invention can be illustrated with following exemplary embodiments.
Embodiment 1, the compounding powder of amoxicillin and ambroxol hydrochloride:
Prescription: amoxicillin 125g
Ambroxol hydrochloride 15g
Beta-schardinger dextrin-90g
Micropowder silica gel 14g
Hyprolose 7.5g
Xanthan gum 15g
Spice 30g
Aspartame 3.5g
Sucrose 1200g
Make 1000 bags
Preparation method: all supplementary materials are dried to moisture below 1% except that spice, are ground into 80～100 order fine powders.Take by weighing in the prescription each supplementary material fine powder by the dilution method mix homogeneously that progressively increases step by step, packing promptly.
Embodiment 2, the compound granular agent of amoxicillin and ambroxol hydrochloride:
Prescription: amoxicillin 250g
Ambroxol hydrochloride 15g
Dextrin 50g
Hyprolose 20g
Xanthan gum 20g
Glycyrrhetate 5g
Spice 40g
Sucrose 1590g
Gelatinized corn starch is an amount of
Make 1000 bags
Preparation method: all supplementary materials are dried to moisture below 1% except that spice, are ground into 80～100 order fine powders.Take by weighing amoxicillin in the prescription, ambroxol hydrochloride, dextrin, hyprolose, xanthan gum, glycyrrhetate, sucrose, by the dilution method mix homogeneously that progressively increases step by step, make suitable soft material in right amount with 10% gelatinized corn starch, granulate with 16 order nylon wires, wet granular evenly spreads out in basin, in 60 ℃ of quick aeration-dryings, control moisture 1～2%.In dried granule, add spice, mixing, with 14 order nylon wire granulate, the pack packing is promptly behind the mix homogeneously.
The product that makes by above-mentioned prescription and preparation method meets the prescription of Chinese Pharmacopoeia to powder and granule.
Claims (10)
1, is fit to the amoxicillin of child's application and compound preparation and the prescription and the preparation method of ambroxol hydrochloride.
2, the amoxicillin of the described suitable child's application of claim 1 and the compound preparation of ambroxol hydrochloride, dosage form comprises powder and granule.
3, the amoxicillin of the described suitable child's application of claim 1 and claim 2 and the compounding powder and the granule of ambroxol hydrochloride, contain amoxicillin and ambroxol hydrochloride in the prescription, also contain pharmaceutically acceptable lubricated fluidizer, high molecular polymer, sweeting agent and fragrant correctives.Characteristics are to adopt special prescription and preparation technology, alleviate or overcome the peculiar taste of amoxicillin and ambroxol hydrochloride effectively, improved the compliance of patient's medication, be particularly suitable for the child and use, drug dissolution and bioavailability height, stability are by force simultaneously.
4, claim 1 is to the amoxicillin of the described suitable child's application of claim 3 and the compounding powder and the granule of ambroxol hydrochloride, every bag contains amoxicillin 50～550mg, best 100～500mg in the prescription, ambroxol hydrochloride 5～60mg, best 15～30mg.
5, claim 1 is to the amoxicillin of the described suitable child's application of claim 3 and the compounding powder and the granule of ambroxol hydrochloride, lubricated fluidizer in the prescription can be micropowder silica gel, polyethylene glycol 6000, Pulvis Talci, starch, dextrin, pregelatinized Starch, polyethylene glycol 6000, starch, pregelatinized Starch also have the effect of diluent concurrently, can can also mix use by different proportion separately, total consumption be recipe quantity 1～20%, be preferably 3～17%, guaranteeing the drug powder good fluidity, easy to manufacture and packing is accurate.
6, claim 1 is to the amoxicillin of the described suitable child's application of claim 3 and the compounding powder and the granule of ambroxol hydrochloride, high molecular polymer in the prescription can be 30 POVIDONE K 30 BP/USP 30, hyprolose, hypromellose, carmethose, beta-schardinger dextrin-, xanthan gum, carbomer, alginate, arabic gum, phospholipid etc., total consumption is 1～20%, best 4%～16% of a recipe quantity, can can also mix use by different proportion separately, promoting the medicine stripping, and help to overcome the peculiar taste of medicine.
7, claim 1 is to the amoxicillin of the described suitable child's application of claim 3 and the compounding powder and the granule of ambroxol hydrochloride, sweeting agent in the prescription can be sucrose, glucose, xylitol, sorbitol, mannitol, lactose, glycyrrhetate, steviosin, saccharin sodium, aspartame etc., sucrose, glucose, xylitol, sorbitol, mannitol, lactose also have the effect of diluent concurrently, can can also mix use by different proportion separately, total consumption be recipe quantity 30～90%, best 40～85%, to correct the peculiar taste of medicine effectively.
8, claim 1 is to the amoxicillin of the described suitable child's application of claim 3 and the compounding powder and the granule of ambroxol hydrochloride, fragrant correctives in the prescription can be natural and synthetic spice, spice such as optional majority kind taste such as Fructus Musae, Herba Menthae, Fructus Mali pumilae, Fructus Citri tangerinae, Fructus Fragariae Ananssae, chocolate, Rhizoma et radix valerianae, Fructus Vitis viniferae, Fructus Pruni pseudocerasi, also can add aminoacid such as sodium glutamate etc., can can also mix use by different proportion separately, total consumption is 0.5～15%, best 2～10% of a recipe quantity, so that the powder that makes is fragrant and sweet good to eat, patient takes like a shot.
9, claim 1 is to the amoxicillin of the described suitable child's application of claim 3 and the compound granular agent of ambroxol hydrochloride, adhesive in the prescription can be gelatinized corn starch, 30 POVIDONE K 30 BP/USP 30 alcohol-water solution, hypromellose aqueous solution, syrup etc., can be separately, also can mix use in varing proportions, total consumption is 3～15%, best 5～10% of a recipe quantity.
10, claim 1 can adopt the special prescription of covering the medicine peculiar taste and common preparation method preparation to described compounding powder and the granule of being made up of amoxicillin and ambroxol hydrochloride of claim 3.Preparation powder is dried to moisture below 1% in advance with other medicine and the adjuvant that contains moisture except that spice earlier, be ground into the above fine powder of 80～100 orders, by behind the dilution method mix homogeneously that progressively increases step by step, can pack packing on request then, every packed amount 1～5g.The preparation granule is on the basis of preparation powder, adds suitable adhesive and makes granule, and dry wet particle, granulate adds the essence mix homogeneously, can pack packing on request, every bag of 1～5g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510073169 CN1872055A (en) | 2005-06-01 | 2005-06-01 | Compound preparation of amoxicillin and ambroxol hydrochloride suitable to use for children, prescription and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510073169 CN1872055A (en) | 2005-06-01 | 2005-06-01 | Compound preparation of amoxicillin and ambroxol hydrochloride suitable to use for children, prescription and preparation method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784141A (en) * | 2012-07-24 | 2012-11-21 | 宋金春 | Solid preparation of ambroxol hydrochloride and amoxicillin, and prescription and preparation method thereof |
| CN104902876A (en) * | 2012-11-30 | 2015-09-09 | 葛兰素史克公司 | Novel pharmaceutical composition |
| CN107088193A (en) * | 2016-02-17 | 2017-08-25 | 康芝药业股份有限公司 | A kind of amoxicillin dry suspensoid agent |
-
2005
- 2005-06-01 CN CN 200510073169 patent/CN1872055A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102784141A (en) * | 2012-07-24 | 2012-11-21 | 宋金春 | Solid preparation of ambroxol hydrochloride and amoxicillin, and prescription and preparation method thereof |
| CN104902876A (en) * | 2012-11-30 | 2015-09-09 | 葛兰素史克公司 | Novel pharmaceutical composition |
| CN104902876B (en) * | 2012-11-30 | 2018-01-19 | 葛兰素史克公司 | New pharmaceutical composition |
| CN107970214A (en) * | 2012-11-30 | 2018-05-01 | 葛兰素史克公司 | New pharmaceutical composition |
| CN107088193A (en) * | 2016-02-17 | 2017-08-25 | 康芝药业股份有限公司 | A kind of amoxicillin dry suspensoid agent |
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