CN1931148A - Prepn process of levofloxacin lactate oral film - Google Patents
Prepn process of levofloxacin lactate oral film Download PDFInfo
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- CN1931148A CN1931148A CN 200610116702 CN200610116702A CN1931148A CN 1931148 A CN1931148 A CN 1931148A CN 200610116702 CN200610116702 CN 200610116702 CN 200610116702 A CN200610116702 A CN 200610116702A CN 1931148 A CN1931148 A CN 1931148A
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Abstract
The present invention is preparation process of levofloxacin lactate oral film and belongs to the field of medicine preparing technology. The levofloxacin lactate oral film consists of medicine layer and protecting layer. The medicine layer has matrix comprising PVA and sodium carboxymethyl cellulose in the weight ratio of 2 to 1, and the effective medicine components comprising levofloxacin lactate, dexamethasone acetate and vitamin B2. The protecting layer is PVA. The effective components in the medicine layer may be also bioactive matter lysozyme or antibiotic peptide and vitamin B2. The levofloxacin lactate oral film may be applied directly onto the wound surface of oral cavity ulcer, and has prolonged treating period. The protecting layer can protect the medicine layer against the elution of saliva so as to raise the treating effect.
Description
Technical field
The present invention relates to a kind of preparation method of levofloxacin lactate oral film, belong to the pharmaceutical products manufacturing process technology field.
Background technology
Oral ulcer is a kind of modal disease of cari oris mucosa, the high and very easily recurrence of sickness rate.The present effective powder of topical therapeutic, unguentum etc., but owing to action time in the oral cavity is shorter, curative effect is still not ideal enough; Seeking suitable drug and selecting in the treatment practice process of most preferred dosage form, the medicine film preparation more and more comes into one's own with its unique administering mode and definite curative effect.
The medicine film preparation is the novel form that begins to grow up the sixties, and is applied to oral ulcer very soon.Oral ulcer medicine film develops into duplicature, composite membrane by monofilm at present.Because the flushing that is subjected to saliva is easily broken comes off, with short, also make troubles to patient when the ulcer local action by medicine in application for monolayer medicine film.Duplicature contains medicine layer and sealing coat, utilizes sealing coat or protective layer, makes medicine layer can avoid the flushing of saliva to medicine.
Summary of the invention
The purpose of this invention is to provide a kind of preparation method with levofloxacin lactate oral film curative effect, that be convenient to use.
A kind of levofloxacin lactate oral film of the present invention, it is characterized in that having the medicine layer and the protective layer of double-decker form: medicine layer is made up of substrate and active drug, and the composition of substrate and weight ratio thereof are: polyvinyl alcohol: sodium carboxymethyl cellulose=2: 1; The composition of active drug and weight percentage thereof are: levofloxacin lactate 1.0～2.0%, dexamethasone acetate 97.5～98.5%, vitamin B
20.5～0.8%; The composition of protective layer is a polyvinyl alcohol.
The preparation method of levofloxacin lactate oral film of the present invention is characterized in that having following technical process and step:
(a) preparation of medicine tunic: the paraffin that takes a morsel, evenly is applied on this glass sheet behind the heating and melting as remover, treats that it is standby after solidifying; By above-mentioned prescription, weighing polyvinyl alcohol also adds a small amount of distilled water, after heating is melted fully, adds sodium carboxymethyl cellulose again, levofloxacin lactate, dexamethasone acetate, vitamin B2, and add micro-glycerol as plasticizer; Stir then, obtain orange-yellow pastille glue; This pastille glue is tiled on the above-mentioned plate glass that scribbles paraffin, and natural air drying obtains the medicine tunic, and is stand-by;
(b) protection tunic preparation: take by weighing a certain amount of polyvinyl alcohol, adding distil water, and the heating melt fully after, add a little glycerol, stir, this glue is tiled on the above-mentioned medicine tunic that makes then, behind natural air drying, make oral film at last.
Among the present invention in the oral film medicine tunic used levofloxacin lactate be the ofloxacin levo form, its antibacterial activity in vitro is about the twice of ofloxacin.Its mechanism of action is by suppressing the activity of DNA of bacteria gyrase, stops closing of DNA of bacteria to treat and duplicate and causes antibacterial death.Dexamethasone acetate used in the medicine tunic is a glucocorticoid medicine, has antiinflammatory, anti-allergic effects, can eliminate the oral ulcer that local non-infectious inflammation causes.Vitamin B2 in the medicine tunic has the effect of the wound healing of promotion, and can play the coloring agent effect, and just double-deck pad pasting can not paste instead.
When the medicine levofloxacin lactate in the pad pasting replaces with lysozyme or antibacterial peptide,, bactericidal action is arranged because lysozyme or antibacterial peptide are bioactive substance, nontoxic to human body, be specially adapted to crowds such as juvenile.
The specific embodiment
After now specific embodiments of the invention further being described in.
Embodiment 1
In the present embodiment, oral film has medicine layer and protective layer double-decker form.Medicine layer is made up of substrate and active drug.Matrix components is polyvinyl alcohol (PVC) and sodium carboxymethyl cellulose (CMC-Na); Its both weight proportions: PVA: CMC-Na=2: 1.The composition of active drug and weight percentage thereof are: levofloxacin lactate 1.35%, dexamethasone acetate 98%, vitamin B
20.65%.Protective layer then adopts PVC.
The preparation process and the step of present embodiment are taken off:
(1) preparation of medicine tunic: the paraffin that takes a morsel, evenly is applied on this glass sheet behind the heating and melting as remover, treats that it is standby after solidifying; By above-mentioned prescription, take by weighing PVA 0.4g, after PVA is added the heating of 10ml distilled water and melts fully, add CMC-Na 0.2g, levofloxacin lactate 10mg, dexamethasone acetate 750mg, vitamin B
25mg, and add 0.15ml glycerol as plasticizer; In constant temperature blender with magnetic force, stir then, obtain orange-yellow pastille glue; This pastille glue is tiled on the above-mentioned plate glass that scribbles paraffin, and natural air drying obtains the medicine tunic; Stand-by;
(2) protection tunic preparation: take by weighing PVA 0.8g, add the 20ml distilled water, and the heating melt fully after, add 0.3ml glycerol, stir, this glue is tiled on the above-mentioned medicine tunic that makes then, and about making edge that glue spreads out area greater than medicine layer film edge 5mm; Behind the natural air drying, demoulding on glass plate is pruned cutting, finally makes oral film.
The detection of the oral film that present embodiment is made:
1, adhesiveness detects: pad pasting is attached on the Radix Polygalae Crotalarioidis mucosa, puts into 37 ℃ of water, keep constant temperature, pad pasting came off after 90 minutes.
2, melting property detection: (1) puts into 37 ℃ of water with pharmaceutical film, keeps constant temperature, after 5 minutes, and the pharmaceutical film deliquescing, part is melted; After 10 minutes, major part is melted, and the cotton-shaped PVA of small part is arranged in the water.(2) double-deck pad pasting is put into 37 ℃ of water, kept constant temperature, after 10 minutes, do not see variation.
3, bactericidal properties detects: shop LB antibacterial culturing flat board, pad pasting is cut into the about 22mm picture of diameter, and being positioned over to cultivate has on the flat board of lactobacillus; Cultivated 3 days down at 37 ℃, finding does not have bacterial growth around this pad pasting, illustrates that it has antibacterial action.
Embodiment 2
In the present embodiment, oral film has medicine layer and protective layer double-decker form.Medicine layer is made up of substrate and active drug.Matrix components is polyvinyl alcohol (PVC) and sodium carboxymethyl cellulose (CMC-Na); Its both weight proportions: PVA: CMC-Na=2: 1.The composition of active drug and weight percentage thereof are: lysozyme 99.35%, vitamin B
20.65%.Protective layer then adopts PVC.
The preparation process and the step of present embodiment are taken off:
(1) preparation of medicine tunic: the paraffin that takes a morsel, evenly is applied on this glass sheet behind the heating and melting as remover, treats that it is standby after solidifying; By above-mentioned prescription, take by weighing PVA 0.4g, after PVA is added the heating of 10ml distilled water and melts fully, add CMC-Na 0.2g, lysozyme 760mg; , vitamin B
25mg, and add 0.15ml glycerol as plasticizer; In constant temperature blender with magnetic force, stir then, obtain orange-yellow pastille glue; This pastille glue is tiled on the above-mentioned plate glass that scribbles paraffin, and natural air drying obtains the medicine tunic; Stand-by;
(2) protection tunic preparation: take by weighing PVA 0.8g, add the 20ml distilled water, and the heating melt fully after, add 0.3ml glycerol, stir, this glue is tiled on the above-mentioned medicine tunic that makes then, and about making edge that glue spreads out area greater than medicine layer film edge 5mm; Behind the natural air drying, demoulding on glass plate is pruned cutting, finally makes oral film.
The detection of the oral film that present embodiment is made:
1, adhesiveness detects: pad pasting is attached on the Radix Polygalae Crotalarioidis mucosa, puts into 37 ℃ of water, keep constant temperature, pad pasting came off after 90 minutes.
2, melting property detection: (1) puts into 37 ℃ of water with pharmaceutical film, keeps constant temperature, after 5 minutes, and the pharmaceutical film deliquescing, part is melted; After 10 minutes, major part is melted, and the cotton-shaped PVA of small part is arranged in the water.(2) double-deck pad pasting is put into 37 ℃ of water, kept constant temperature, after 10 minutes, do not see variation.
3, bactericidal properties detects: shop LB antibacterial culturing flat board, pad pasting is cut into the about 22mm picture of diameter, and being positioned over to cultivate has on the flat board of lactobacillus; Cultivated 1 day down at 37 ℃, finding does not have bacterial growth around this pad pasting, illustrates that it has antibacterial action.
Embodiment 3
In the present embodiment, oral film has medicine layer and protective layer double-decker form.Medicine layer is made up of substrate and active drug.Matrix components is polyvinyl alcohol (PVC) and sodium carboxymethyl cellulose (CMC-Na); Its both weight proportions: PVA: CMC-Na=2: 1.The composition of active drug and weight percentage thereof are: antibacterial peptide 99.35%, vitamin B
20.65%.Protective layer then adopts PVC.
The preparation process and the step of present embodiment are taken off:
(1) preparation of medicine tunic: the paraffin that takes a morsel, evenly is applied on this glass sheet behind the heating and melting as remover, treats that it is standby after solidifying; By above-mentioned prescription, take by weighing PVA 0.4g, after PVA is added the heating of 10ml distilled water and melts fully, add CMC-Na 0.2g, antibacterial peptide 760mg; , vitamin B
25mg, and add 0.15ml glycerol as plasticizer; In constant temperature blender with magnetic force, stir then, obtain orange-yellow pastille glue; This pastille glue is tiled on the above-mentioned plate glass that scribbles paraffin, and natural air drying obtains the medicine tunic; Stand-by;
(2) protection tunic preparation: take by weighing PVA 0.8g, add the 20ml distilled water, and the heating melt fully after, add 0.3ml glycerol, stir, this glue is tiled on the above-mentioned medicine tunic that makes then, and about making edge that glue spreads out area greater than medicine layer film edge 5mm; Behind the natural air drying, demoulding on glass plate is pruned cutting, finally makes oral film.
The detection of the oral film that present embodiment is made:
1, adhesiveness detects: pad pasting is attached on the Radix Polygalae Crotalarioidis mucosa, puts into 37 ℃ of water, keep constant temperature, pad pasting came off after 90 minutes.
2, melting property detection: (1) puts into 37 ℃ of water with pharmaceutical film, keeps constant temperature, after 5 minutes, and the pharmaceutical film deliquescing, part is melted; After 10 minutes, major part is melted, and the cotton-shaped PVA of small part is arranged in the water.(2) double-deck pad pasting is put into 37 ℃ of water, kept constant temperature, after 10 minutes, do not see variation.
3, bactericidal properties detects: shop LB antibacterial culturing flat board, pad pasting is cut into the about 22mm picture of diameter, and being positioned over to cultivate has on the flat board of lactobacillus; Cultivated 1 day down at 37 ℃, finding does not have bacterial growth around this pad pasting, illustrates that it has antibacterial action.
Claims (5)
1. levofloxacin lactate oral film, the medicine layer and the protective layer that it is characterized in that having the double-decker form: medicine layer is made up of substrate and active drug, and the composition of substrate and weight ratio thereof are: polyvinyl alcohol: sodium carboxymethyl cellulose=2: 1; The composition that the composition of active drug is divided into active drug comprises that levofloxacin lactate, lysozyme, antibacterial peptide or other bioactive ingredients engulf phage or the genomic medicine of oral cavity bacterium; The composition of protective layer is a polyvinyl alcohol.
2. the composition of the active drug of claim 1 is that the composition and the weight percentage thereof of active drug are: levofloxacin lactate 1.0～2.0%, dexamethasone acetate 97.5～98.5%, vitamin B
20.5～0.8%;
3. the composition of the active drug of claim 1 is that the composition and the weight percentage thereof of active drug are: lysozyme 99.2～99.5%, vitamin B
20.5～0.8%;
4. the composition of the active drug of claim 1 is that the composition and the weight percentage thereof of active drug are: antibacterial peptide 99.2～99.5%, vitamin B
20.5～0.8%;
5. the preparation method of a kind of levofloxacin lactate oral film of claim 1 is characterized in that having following technical process and step:
(a) preparation of medicine tunic: the paraffin that takes a morsel, evenly is applied on this glass sheet behind the heating and melting as remover, treats that it is standby after solidifying; By above-mentioned prescription, weighing polyvinyl alcohol also adds a small amount of distilled water, after heating is melted fully, adds sodium carboxymethyl cellulose again, levofloxacin lactate, dexamethasone acetate, vitamin B2, and add micro-glycerol as plasticizer; Stir then, obtain orange-yellow pastille glue; This pastille glue is tiled on the above-mentioned plate glass that scribbles paraffin, and natural air drying obtains the medicine tunic, and is stand-by;
(b) if effective ingredient is bioactive ingredients lysozyme or antibacterial peptide or phage, the preparation of (a) step medicine tunic then in the above should be: the paraffin that takes a morsel, evenly is applied on this glass sheet behind the heating and melting as remover, treats that it is standby after solidifying; By above-mentioned prescription, weighing polyvinyl alcohol also adds a small amount of distilled water, after heating is melted fully, adds sodium carboxymethyl cellulose again, lysozyme or antibacterial peptide or phage, vitamin B2, and add micro-glycerol as plasticizer; Stir then, obtain orange-yellow pastille glue; This pastille glue is tiled on the above-mentioned plate glass that scribbles paraffin, and natural air drying obtains the medicine tunic, and is stand-by;
(c) protection tunic preparation: take by weighing a certain amount of polyvinyl alcohol, adding distil water, and the heating melt fully after, add a little glycerol, stir, this glue is tiled on the above-mentioned medicine tunic that makes then, behind natural air drying, make oral film at last.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610116702 CN1931148A (en) | 2006-09-28 | 2006-09-28 | Prepn process of levofloxacin lactate oral film |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610116702 CN1931148A (en) | 2006-09-28 | 2006-09-28 | Prepn process of levofloxacin lactate oral film |
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| Publication Number | Publication Date |
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| CN1931148A true CN1931148A (en) | 2007-03-21 |
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ID=37877271
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|---|---|---|---|
| CN 200610116702 Pending CN1931148A (en) | 2006-09-28 | 2006-09-28 | Prepn process of levofloxacin lactate oral film |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142562A (en) * | 2013-03-26 | 2013-06-12 | 钟春燕 | Sustained-release sticking film for treating oral ulcer |
| CN104257636A (en) * | 2014-09-26 | 2015-01-07 | 天津市聚星康华医药科技有限公司 | Lysozyme oral mucoadhesive films and preparation method thereof |
| CN104306356A (en) * | 2014-10-29 | 2015-01-28 | 成都山信药业有限公司 | Slow-release film agent of isegenan |
| CN104490851A (en) * | 2014-12-31 | 2015-04-08 | 成都山信药业有限公司 | Iseganan quick-release film agent |
| CN106109445A (en) * | 2016-06-22 | 2016-11-16 | 佛山市高明绿化纳新材料有限公司 | A kind of long-acting slow-release film for treating oral ulcer and preparation method thereof |
| CN110151998A (en) * | 2019-05-15 | 2019-08-23 | 南京华开生物科技有限公司 | A kind of canker sore repair membrane and preparation method thereof |
-
2006
- 2006-09-28 CN CN 200610116702 patent/CN1931148A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142562A (en) * | 2013-03-26 | 2013-06-12 | 钟春燕 | Sustained-release sticking film for treating oral ulcer |
| CN103142562B (en) * | 2013-03-26 | 2015-03-25 | 钟春燕 | Sustained-release sticking film for treating oral ulcer |
| CN104257636A (en) * | 2014-09-26 | 2015-01-07 | 天津市聚星康华医药科技有限公司 | Lysozyme oral mucoadhesive films and preparation method thereof |
| CN104306356A (en) * | 2014-10-29 | 2015-01-28 | 成都山信药业有限公司 | Slow-release film agent of isegenan |
| CN104306356B (en) * | 2014-10-29 | 2017-05-24 | 成都山信药业有限公司 | Slow-release film agent of isegenan |
| CN104490851A (en) * | 2014-12-31 | 2015-04-08 | 成都山信药业有限公司 | Iseganan quick-release film agent |
| CN104490851B (en) * | 2014-12-31 | 2017-05-24 | 成都山信药业有限公司 | Iseganan quick-release film agent |
| CN106109445A (en) * | 2016-06-22 | 2016-11-16 | 佛山市高明绿化纳新材料有限公司 | A kind of long-acting slow-release film for treating oral ulcer and preparation method thereof |
| CN110151998A (en) * | 2019-05-15 | 2019-08-23 | 南京华开生物科技有限公司 | A kind of canker sore repair membrane and preparation method thereof |
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