CN103505404A - Oral liquid preparation with roxithromycin as active component - Google Patents
Oral liquid preparation with roxithromycin as active component Download PDFInfo
- Publication number
- CN103505404A CN103505404A CN201310415702.1A CN201310415702A CN103505404A CN 103505404 A CN103505404 A CN 103505404A CN 201310415702 A CN201310415702 A CN 201310415702A CN 103505404 A CN103505404 A CN 103505404A
- Authority
- CN
- China
- Prior art keywords
- roxithromycin
- oral liquid
- active component
- take according
- acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention discloses an oral liquid preparation with roxithromycin as an active component. The oral liquid preparation is characterized by comprising the roxithromycin, stabilizing agent, solubilizer, pH regulating agent, flavoring agent and water. The oral liquid preparation has active advanced effects of preparing the unstable roxithromycin into the oral liquid preparation, ensuring the bioavailability consistency, largely reducing the risk in clinical application and guaranteeing the clinical effects.
Description
Technical field
Invention relates to a kind of oral liquid that Roxithromycin is active component of take.Belong to medical technical field.
Background technology
Roxithromycin is macrolide antibiotics of new generation, and Main Function is in gram positive bacteria, anaerobe, chlamydia and mycoplasma etc.For the caused infection of sensitive strain, especially upper and lower respiratory tract infection, otorhinolaryngology infection, genitals (except gonococcal infection) and skin infection.
Roxithromycin the principal indications is face, respiratory tract, reproductive system and the skin infection due to sensitive organism.The cure rate 78%～100% that lower respiratory infection is comprised to mycoplasma pneumoniae pneumonia, bacteria clearance reaches 91%～95%.Suitable to the curative effect of acute and chronic non gonococcal urethritis and doxycycline, bacteria clearance reaches 86%～100%.
This product can be used as the prophylactic with epidemic encephalitis patient Close contacts.
There are in the market the solid preparations such as capsule (comprising soft capsule, is oil-soluble substrate), tablet (dispersible tablet), granule, dry suspension.Bioavailability is unstable, causes patient's curative effect of taking medicine also unstable.The impact of bioavailability receptor 1 activity composition stripping, active component stripping is subject to again a lot of other aspect impacts, as preparation disintegration time, the pH value size of Stomach in Patients liquid measure, gastric acid and gastric content etc.If make liquid preparation, just not there is not the problem of stripping, bioavailability is just more stable, and curative effect is also just more definite.
Always untappedly on market going out liquid preparation, is because Roxithromycin is Macrolide, very unstable in aqueous solution, degrades very fast.
Summary of the invention
The object of the invention is just to provide a kind of oral liquid that Roxithromycin is active component of take.
The present invention is achieved by the following technical solutions:
The oral liquid that the Roxithromycin of take is active component, described oral liquid is comprised of Roxithromycin, stabilizing agent, solubilizing agent, PH regulator, correctives and water.
The oral liquid that the Roxithromycin of take is active component, described stabilizing agent is selected from one or more in glycerol, ethanol, propylene glycol, Polyethylene Glycol-300, PEG-4000 and Polyethylene Glycol-600.
The oral liquid that the Roxithromycin of take is active component, described solubilizing agent is selected from one or more in tween 80, beta-schardinger dextrin-, HP-β-CD.
The oral liquid that the Roxithromycin of take is active component, described PH regulator is selected from one or more in hydrochloric acid, phosphoric acid, acetic acid, sodium acetate, citric acid, sour rafter acid disodium, citric acid trisodium, sodium carbonate, sodium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, dihydric phosphate, hydrophosphate, tartaric acid, tartrate, biatrate, aminoacid and salt thereof.
The oral liquid that the Roxithromycin of take is active component, described correctives is selected from one or more in sucrose, steviosin, sorbitol, mannitol, maltose alcohol, glycyrrhizin, aspartame, sucralose, stem tea element, Sodium Cyclamate, essence, vanillin.
The oral liquid that the Roxithromycin of take is active component, oral liquid of the present invention also can contain coloring agent, intercalating agent.
The oral liquid that the Roxithromycin of take is active component, the content of described Roxithromycin is 0.1-7.5%(w/v), preferred 0.25-0.75%(w/v); Stabiliser content is 5%-40%(w/v); Solubilizing agent content is 0.3%-10%(w/v); The content of correctives is 0.1-60%(w/v).
The oral liquid that the Roxithromycin of take is active component, described oral liquid, is used acidity PH regulator, and the PH scope that makes final products is 3.0-7.0
Advantage of the present invention is:
Positive progressive effect of the present invention is: unsettled Roxithromycin, make oral liquid, guaranteed the concordance of bioavailability, be greatly reduced in the risk in clinical practice, guarantee clinical efficacy.
The specific embodiment
Mode below by embodiment further illustrates the present invention, but does not therefore limit the present invention among described scope of embodiments.
Embodiment 1
Preparation method: it is appropriate to get purified water, changes into 80% syrup with sucrose, standby; Get Roxithromycin, glycerol, Polyethylene Glycol-300, beta-schardinger dextrin-, citric acid, add suitable quantity of water and make dissolve complete, with sodium bicarbonate, regulate pH value to make into 3.0, add the syrup preparing, stir evenly, add purified water and make into 1000ml, fill and get final product.
The Roxithromycin oral administration solution that the present embodiment is made, records under Roxithromycin raw material related substance method item and detects according to Chinese Pharmacopoeia version II portion in 2010: total impurities is 2.7%, and it is 0.87% that maximum is singly mixed.
Embodiment 2
| Component | Gram |
| Roxithromycin | 75 |
| Ethanol | 50 |
| HP-β-CD | 100 |
| Citric acid | 5 |
| Sodium bicarbonate | In right amount |
| Steviosin | 3 |
| Flavoring orange essence | 2 |
| By purified water, be mixed with | 1000ml |
Preparation method: by Roxithromycin, with dissolve with ethanol, standby; Get HP-β-CD, citric acid, steviosin, by appropriate purified water, make to dissolve, add the Roxithromycin alcoholic solution preparing, add purified water and be diluted to about 800ml, add flavoring orange essence, with sodium bicarbonate, regulating pH value is 6.2, add purified water to 1000ml, fill, obtains.
The Roxithromycin oral administration solution that the present embodiment is made, records under Roxithromycin raw material related substance method item and detects according to Chinese Pharmacopoeia version II portion in 2010: total impurities is 3.1%, and it is 0.95% that maximum is singly mixed.
Embodiment 3
Preparation method: get Roxithromycin, glycerol, propylene glycol, beta-schardinger dextrin-, tartaric acid, add appropriate purified water and make to dissolve, regulate pH value to 5.1 with sodium carbonate, then add purified water and be diluted to 1000ml, stir evenly, fill, obtains.
The Roxithromycin oral administration solution that the present embodiment is made, records under Roxithromycin raw material related substance method item and detects according to Chinese Pharmacopoeia version II portion in 2010: total impurities is 2.3%, and it is 0.68% that maximum is singly mixed.
Embodiment 4
| Component | Gram |
| Roxithromycin | 7.5 |
| Glycerol | 100 |
| Polyethylene Glycol-600 | 100 |
| HP-β-CD | 10 |
| Tartaric acid | 5 |
| Sodium hydroxide | In right amount |
| Sucralose | 3 |
| Fructus Persicae taste essence | 1 |
| By purified water, be mixed with | 1000ml |
Preparation method: get Roxithromycin, glycerol, Polyethylene Glycol-600, HP-β-CD, tartaric acid, sucralose, add purified water and make in right amount to dissolve, regulate pH value to 7.0 with sodium hydroxide, add Fructus Persicae taste essence, add purified water to 1000ml, stir, fill, obtains.
The Roxithromycin oral administration solution that the present embodiment is made, records under Roxithromycin raw material related substance method item and detects according to Chinese Pharmacopoeia version II portion in 2010: total impurities is 2.5%, and it is 0.77% that maximum is singly mixed.
Embodiment 5
| Component | Gram |
| Roxithromycin | 7.5 |
| Ambroxol hydrochloride | 1.5 |
| Glycerol | 100 |
| Polyethylene Glycol-600 | 100 |
| HP-β-CD | 10 |
| Tartaric acid | 5 |
| Sodium hydroxide | In right amount |
| Sucralose | 3 |
| Fructus Persicae taste essence | 1 |
| By purified water, be mixed with | 1000ml |
Preparation method: get Roxithromycin, ambroxol hydrochloride, glycerol, Polyethylene Glycol-600, HP-β-CD, tartaric acid, sucralose, adding purified water makes to dissolve in right amount, with sodium hydroxide, regulate pH value to 7.0, add Fructus Persicae taste essence, add purified water to 1000ml, stir, fill, obtains.
The Roxithromycin oral administration solution that the present embodiment is made, records under Roxithromycin raw material related substance method item and detects according to Chinese Pharmacopoeia version II portion in 2010: total impurities is 3.1%, and it is 0.82% that maximum is singly mixed.
Embodiment 6
Preparation method: get azithromycin, glycerol, Polyethylene Glycol-600, HP-β-CD, tartaric acid, sucralose, add purified water and make in right amount to dissolve, regulate pH value to 7.0 with sodium hydroxide, add Fructus Persicae taste essence, add purified water to 1000ml, stir, fill, obtains.
Embodiment 7
| Component | Gram |
| Erythromycin | 7.5 |
| Glycerol | 100 |
| Polyethylene Glycol-600 | 100 |
| HP-β-CD | 10 |
| Tartaric acid | 5 |
| Sodium hydroxide | In right amount |
| Sucralose | 3 |
| Fructus Persicae taste essence | 1 |
| By purified water, be mixed with | 1000ml |
Preparation method: get erythromycin, glycerol, Polyethylene Glycol-600, HP-β-CD, tartaric acid, sucralose, add purified water and make in right amount to dissolve, regulate pH value to 7.0 with sodium hydroxide, add Fructus Persicae taste essence, add purified water to 1000ml, stir, fill, obtains.
Claims (8)
1. the oral liquid that the Roxithromycin of take is active component, is characterized in that described oral liquid is comprised of Roxithromycin, stabilizing agent, solubilizing agent, PH regulator, correctives and water.
2. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that described stabilizing agent is selected from one or more in glycerol, ethanol, propylene glycol, Polyethylene Glycol-300, PEG-4000 and Polyethylene Glycol-600.
3. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that described solubilizing agent is selected from one or more in tween 80, beta-schardinger dextrin-, HP-β-CD.
4. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that described PH regulator is selected from one or more in hydrochloric acid, phosphoric acid, acetic acid, sodium acetate, citric acid, sour rafter acid disodium, citric acid trisodium, sodium carbonate, sodium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, dihydric phosphate, hydrophosphate, tartaric acid, tartrate, biatrate, aminoacid and salt thereof.
5. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that described correctives is selected from one or more in sucrose, steviosin, sorbitol, mannitol, maltose alcohol, glycyrrhizin, aspartame, sucralose, stem tea element, Sodium Cyclamate, essence, vanillin.
6. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that oral liquid of the present invention also can contain coloring agent, intercalating agent.
7. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that the content of described Roxithromycin is 0.1-7.5%(w/v), preferred 0.25-0.75%(w/v); Stabiliser content is 5%-40%(w/v); Solubilizing agent content is 0.3%-10%(w/v); The content of correctives is 0.1-60%(w/v).
8. a kind of oral liquid that Roxithromycin is active component of take according to claim 1, is characterized in that described oral liquid, uses acidity PH regulator, and the PH scope that makes final products is 3.0-7.0.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310415702.1A CN103505404A (en) | 2013-09-12 | 2013-09-12 | Oral liquid preparation with roxithromycin as active component |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310415702.1A CN103505404A (en) | 2013-09-12 | 2013-09-12 | Oral liquid preparation with roxithromycin as active component |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103505404A true CN103505404A (en) | 2014-01-15 |
Family
ID=49889180
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310415702.1A Pending CN103505404A (en) | 2013-09-12 | 2013-09-12 | Oral liquid preparation with roxithromycin as active component |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103505404A (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1531931A (en) * | 2003-03-24 | 2004-09-29 | 北京东方天翔医药技术开发有限公司 | Method for improving solubility of clarithromycin |
-
2013
- 2013-09-12 CN CN201310415702.1A patent/CN103505404A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1531931A (en) * | 2003-03-24 | 2004-09-29 | 北京东方天翔医药技术开发有限公司 | Method for improving solubility of clarithromycin |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103052384A (en) | Aqueous composition comprising bromhexine | |
| ES2667331T3 (en) | Phenylephrine compositions useful for the treatment of respiratory diseases | |
| US6599883B1 (en) | Nasal delivery of xylitol | |
| CN102159184B (en) | Liquid pharmaceutical formulation containing paracetamol | |
| AU2011225810B2 (en) | Rifaximin ready-to-use suspension | |
| NZ594592A (en) | Paediatric solutions comprising a beta-blocker | |
| US7776831B2 (en) | Use of antifungal compositions to treat upper gastrointestinal conditions | |
| CN106727291B (en) | Tomoxetine hydrochloride oral solution and preparation method thereof | |
| A Satyanarayana et al. | Gels and jellies as a dosage form for dysphagia patients: a review | |
| CN111150729B (en) | Film forming composition and application thereof | |
| EP3003384A1 (en) | Oral solution comprising atomoxetine hydrochloride | |
| JP2009067790A (en) | Jelly-like preparation obtained by masking unpleasant taste of ecabet sodium granule | |
| CN103432105A (en) | Meclozine oral film and preparation method thereof | |
| CN102940616A (en) | Ambroxol hydrochloride oral cavity dispersion membrane agent | |
| ES2781755T3 (en) | Pharmaceutical composition in the form of an oral suspension comprising a flavonoic fraction and xanthan gum | |
| CN103505404A (en) | Oral liquid preparation with roxithromycin as active component | |
| CN106361689A (en) | Fudosteine oral solution and preparation method thereof | |
| CN103054813A (en) | Azithromycin oral sustained-release dry suspension and preparation method thereof | |
| CN103505733A (en) | Oral liquid preparation with macrolides medicine as active component | |
| KR102447263B1 (en) | Cough medicine containing ambroxol hydrochloride | |
| JP2021502398A (en) | Carbocisteine aerosol inhalation solution preparation and its manufacturing method | |
| JP5611672B2 (en) | Oral jelly | |
| EP2883540B1 (en) | Fast-dissolving oral film preparation comprising aripiprazole | |
| CN112438947A (en) | Carbocisteine oral solution and preparation method thereof | |
| CN102485242B (en) | Chinese medicinal composition for dispelling wind, clearing heat, removing toxins, and benefiting throat, and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20140115 |