CN1698640A - Compound powder of Roxithromycin and ambroxol hydrochloride sustained adequate for children, its prescription and preparation method - Google Patents
Compound powder of Roxithromycin and ambroxol hydrochloride sustained adequate for children, its prescription and preparation method Download PDFInfo
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- CN1698640A CN1698640A CN 200510073171 CN200510073171A CN1698640A CN 1698640 A CN1698640 A CN 1698640A CN 200510073171 CN200510073171 CN 200510073171 CN 200510073171 A CN200510073171 A CN 200510073171A CN 1698640 A CN1698640 A CN 1698640A
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- roxithromycin
- ambroxol hydrochloride
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Abstract
The invention relates to a compound powder of Roxithromycin and ambroxol hydrochloride sustained adequate for children, its prescription and preparation process, wherein the prescription comprises roxithromycin and ambroxol hydrochloride, pharmaceutically acceptable lubrication flowing aid, high molecular polymer, sweetener and flavoring agent. The invention has the advantages of reduced bitterness, improved patient compliance in medicine administration, high medicine dissolution and biological availability, improved stronger stability, thus is especially suitable for application by children.
Description
Technical field the present invention relates to the Roxithromycin of pharmaceutical suitable child's application and compounding powder and the prescription and the preparation method of ambroxol hydrochloride.
Background technology Roxithromycin (Roxithromycin) is a semi-synthetic macrolide antibiotics, antimicrobial spectrum is similar to erythromycin, but have acidproof stable can be oral, oral administration biaavailability is high, tissue permeability good, long action time, be fit to characteristics such as child's application, be used for the treatment of responsive microbial respiratory tract, urinary tract, skin and soft tissue, department of eye infection 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, Roxithromycin and ambroxol hydrochloride are with taking in the treatment respiratory tract bacterial infection, has synergistic function, ambroxol hydrochloride can improve Roxithromycin 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 Roxithromycin of existing report and the compound preparation of ambroxol hydrochloride have tablet, dispersible 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 Roxithromycin of child's application and the compound preparation of ambroxol hydrochloride clinically.
Summary of the invention the present invention is intended to overcome the Roxithromycin of existing report and compound tablet, dispersible tablet and the capsule of ambroxol hydrochloride is not suitable for the problem that the child uses, prepared and be particularly suitable for the Roxithromycin that the child uses and the compounding powder of ambroxol hydrochloride, be 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 is 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 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.
Roxithromycin and ambroxol hydrochloride bitterness are all heavier, and all difficulty is dissolved in water, and oral solid formulation often drug dissolution is low, and contain ester bond and amido link in the molecule, unstable hydrolysis easily.Thereby how can overcome effectively and cover medicine bitterness, improve medicine dissolution, increase stability of drug, be the key issue that preparation is fit to the compounding powder of Roxithromycin that the child uses and ambroxol hydrochloride.The compounding powder of Roxithromycin of the present invention and ambroxol hydrochloride, by adopting special prescription and preparation technology, alleviate or overcome the bitterness of Roxithromycin 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 Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, contains Roxithromycin and ambroxol hydrochloride in the prescription, also contains pharmaceutically acceptable lubricated fluidizer, high molecular polymer, sweeting agent and fragrant correctives.
The present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, and every bag contains Roxithromycin 10～200mg, best 25～150mg in the prescription, ambroxol hydrochloride 5～35mg, best 10～30mg.
The present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable lubricated fluidizer in the prescription can be micropowder silica gel, sodium lauryl sulphate, polyethylene glycol 6000, Pulvis Talci, calcium carbonate, magnesium oxide, magnesium hydroxide, magnesium carbonate, hydrotalcite, magnesium stearate, aluminium hydroxide, starch, dextrin, pregelatinized Starch, polyethylene glycol 6000, starch, pregelatinized Starch also has the effect of diluent concurrently, can can also mix use by different proportion separately, total consumption is 1～20% of a recipe quantity, be preferably 3～17%, guaranteeing the drug powder good fluidity, easy to manufacture and packing is accurate.
The present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable 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 bitterness of medicine.
The present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable 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 bitterness of medicine effectively.
The present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable 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.
Preparation the present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, can adopt following two kinds of methods.First method is to adopt the special prescription of covering bitter taste of drug and common preparation method preparation, earlier other medicine and the adjuvant that contains moisture except that spice is dried to moisture below 1% in advance, be ground into the above fine powder of 80～100 orders, then by behind the dilution method mix homogeneously that progressively increases step by step, can pack packing on request, every packed amount 1～5g.Second method is to use in beta-schardinger dextrin-, hydroxyethyl-, the HP-etc. any one according to any one inclusion method such as common solvent method, polishing, freeze-drying, spray drying method, ultrasonic method Roxithromycin and ambroxol hydrochloride to be carried out enclose, and the proportioning of Roxithromycin and ambroxol hydrochloride and cyclodextrin inclusion compound agent can be 1: 1～and 50.Specifically be to get beta-schardinger dextrin-to add suitable quantity of water, heating, make saturated solution, stir the alcoholic solution that slowly drips Roxithromycin and ambroxol hydrochloride down fast, stop heating, continue to stir more than 2 hours, cooling, sucking filtration, washing, vacuum drying is pulverized and is promptly got Roxithromycin and ambroxol hydrochloride cyclodextrin clathrate powder wood.And then add different adjuvants respectively, prepare the compounding powder of Roxithromycin and ambroxol hydrochloride by above-mentioned first kind of preparation method.
The present invention is fit to the Roxithromycin of child's application and the compounding powder of ambroxol hydrochloride, be applicable to the treatment of the infectious disease that causes by sensitive strain, acute attack, bronchopneumonia, the microbial pneumonia of typical cause of disease, bronchial asthma, bronchiectasis, sinusitis and otitis media as acute bronchitis, chronic bronchitis, 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 Roxithromycin and ambroxol hydrochloride:
Prescription: Roxithromycin 50g
Ambroxol hydrochloride 10g
Magnesium oxide 2g
Sodium lauryl sulphate 1g
Hyprolose 10g
Xanthan gum 10g
Spice 30g
Aspartame 3g
Sucrose 1384g
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 compounding powder of Roxithromycin and ambroxol hydrochloride:
Prescription: Roxithromycin 150g
Ambroxol hydrochloride 30g
Beta-schardinger dextrin-900g
Hyprolose 10g
Micropowder silica gel 10g
Spice 30g
Saccharin sodium 2g
Sucrose 868g
Make 1000 bags
Preparation method: get beta-schardinger dextrin-and be added to and make saturated solution in the purified water, stir the alcoholic solution that adds Roxithromycin and ambroxol hydrochloride down fast, thermal agitation is 2 hours a little, cooled off 5 hours, sucking filtration, washing, vacuum drying is pulverized and is promptly got Roxithromycin and ambroxol hydrochloride Benexate Hydrochloride powder.And then add the adjuvant fine powder respectively, and mix homogeneously, packing is promptly.
The product that makes by above-mentioned prescription and preparation method meets the prescription of Chinese Pharmacopoeia to powder.
Claims (8)
1, is fit to the Roxithromycin of child's application and compounding powder and the prescription and the preparation method of ambroxol hydrochloride.
2, the Roxithromycin of the described suitable child's application of claim 1 and claim 2 and the compounding powder of ambroxol hydrochloride, contain Roxithromycin 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 bitterness of Roxithromycin and ambroxol effectively, have improved the compliance of patient's medication, are particularly suitable for the child and use, and drug dissolution and bioavailability height, stability are by force simultaneously.
3, claim 1 is to the Roxithromycin of the described suitable child's application of claim 3 and the compounding powder of ambroxol hydrochloride, and every bag contains Roxithromycin 10～200mg, best 25～150mg in the prescription, ambroxol hydrochloride 5～35mg, best 10～30mg.
4, claim 1 is to the Roxithromycin of the described suitable child's application of claim 3 and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable lubricated fluidizer in the prescription can be micropowder silica gel, sodium lauryl sulphate, polyethylene glycol 6000, Pulvis Talci, calcium carbonate, magnesium oxide, magnesium hydroxide, magnesium carbonate, hydrotalcite, magnesium stearate, aluminium hydroxide, starch, pregelatinized Starch, polyethylene glycol 6000, starch, pregelatinized Starch also has the effect of diluent concurrently, can can also mix use by different proportion separately, total consumption is 1～20% of a recipe quantity, be preferably 3～17%, guaranteeing the drug powder good fluidity, easy to manufacture and packing is accurate.
5, claim 1 is to the Roxithromycin of the described suitable child's application of claim 3 and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable 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 bitterness of medicine.
6, claim 1 is to the Roxithromycin of the described suitable child's application of claim 3 and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable 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 bitterness of medicine effectively.
7, claim 1 is to the Roxithromycin of the described suitable child's application of claim 3 and the compounding powder of ambroxol hydrochloride, pharmaceutically acceptable 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.
8, claim 1 is to the described compounding powder of being made up of Roxithromycin and ambroxol hydrochloride of claim 3, there are two kinds described in its preparation method such as summary of the invention and the specific embodiment, first method is to adopt the special prescription of covering bitter taste of drug, earlier other medicine and the adjuvant that contains moisture except that spice is dried to moisture below 1% in advance, be ground into the above fine powder of 80～100 orders, then by behind the dilution method mix homogeneously that progressively increases step by step, can pack packing on request, the every bag 1～5g of loading amount.Second method is to adopt in beta-schardinger dextrin-, hydroxyethyl-, the HP-etc. any one according to any one inclusion method such as common solvent method, polishing, freeze-drying, spray drying method, ultrasonic method Roxithromycin and ambroxol hydrochloride to be carried out enclose, and then add different adjuvants respectively, by above-mentioned first kind of preparation method preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510073171 CN1698640A (en) | 2005-06-01 | 2005-06-01 | Compound powder of Roxithromycin and ambroxol hydrochloride sustained adequate for children, its prescription and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510073171 CN1698640A (en) | 2005-06-01 | 2005-06-01 | Compound powder of Roxithromycin and ambroxol hydrochloride sustained adequate for children, its prescription and preparation method |
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| CN1698640A true CN1698640A (en) | 2005-11-23 |
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| CN 200510073171 Pending CN1698640A (en) | 2005-06-01 | 2005-06-01 | Compound powder of Roxithromycin and ambroxol hydrochloride sustained adequate for children, its prescription and preparation method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101019876B (en) * | 2006-02-13 | 2010-05-12 | 北京国联诚辉医药技术有限公司 | Compound roxithromycin dispersing tablet |
| CN101816672A (en) * | 2010-03-27 | 2010-09-01 | 海南康芝药业股份有限公司 | Composition containing roxithromycin and ambroxol and preparation method thereof |
| CN101045063B (en) * | 2006-03-28 | 2011-01-26 | 广州朗圣药业有限公司 | Clarithromycin water soluble preparation for injection use |
-
2005
- 2005-06-01 CN CN 200510073171 patent/CN1698640A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101019876B (en) * | 2006-02-13 | 2010-05-12 | 北京国联诚辉医药技术有限公司 | Compound roxithromycin dispersing tablet |
| CN101045063B (en) * | 2006-03-28 | 2011-01-26 | 广州朗圣药业有限公司 | Clarithromycin water soluble preparation for injection use |
| CN101816672A (en) * | 2010-03-27 | 2010-09-01 | 海南康芝药业股份有限公司 | Composition containing roxithromycin and ambroxol and preparation method thereof |
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