CN102940616A - Ambroxol hydrochloride oral cavity dispersion membrane agent - Google Patents
Ambroxol hydrochloride oral cavity dispersion membrane agent Download PDFInfo
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- CN102940616A CN102940616A CN2012104775448A CN201210477544A CN102940616A CN 102940616 A CN102940616 A CN 102940616A CN 2012104775448 A CN2012104775448 A CN 2012104775448A CN 201210477544 A CN201210477544 A CN 201210477544A CN 102940616 A CN102940616 A CN 102940616A
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- ambroxol hydrochloride
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- oral cavity
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Abstract
Disclosed is an ambroxol hydrochloride oral cavity dispersion membrane agent. The ambroxol hydrochloride oral cavity dispersion membrane agent is composed of an ambroxol hydrochloride film-forming material, purified water, a plasticizer and the like, the ambroxol hydrochloride oral cavity dispersion membrane agent can be rapidly dispersed or dissolved in an oral cavity and used for facilitating the removing of sticky secretions and reducing of mucus retention in the respiratory tract, and the breath state can be improved. The ambroxol hydrochloride oral cavity dispersion membrane agent has the advantages that the membrane is non-irritating, convenient to take and carry about, fast in working, good in taste and particularly suitable for the old and children to take.
Description
Technical field
The present invention relates to a kind of ambroxol hydrochloride oral and disperse membrane, preparation method, and in external character.The said preparation good looking appearance, easy to carry, to take simply, disintegrate is rapid, and the water clothes can disintegrate in the oral cavity, is particularly useful for the patient of old people, children taking and dysphagia thereof.The delay that is used for promoting the eliminating of the inner thick secretions of respiratory tract and reduces mucus improves breath state.
Background technology
The sickness rate of China's diseases of respiratory system and case fatality rate are all high in recent years, and the relevant statistics of health ministry shows that the prevalence of China's respiratory system disease is about about 6.94%, and namely the whole nation has more than 8,000 ten thousand people to suffer from respiratory system disease every year.At present, be China human mortality's the third-largest factor.On age composition, old people and child be the group of people at high risk of respiratory system disease just.Along with China steps into senescence society, the prospect of respiratory system disease medication will be very wide.On Our Country Primary Cities typical hospital market, the respiratory medicine amount of money had accounted for 2.46% share in 2002.Wherein use at most with cough and flu medication, the market share reaches 47.79%, has almost occupied the half of the country of whole respiratory medicine.
In the situation of respiratory tract infection (such as respiratory tract diseases such as chronic bronchitiss), tend to produce a large amount of sputums, respiratory tract is stopped up in the existence of expectorant, cause easily cough, pant, even cause dyspnea, especially the difficulty of spitting often appears in children's and old man, so the application of expectorant is very necessary.And in the principal item of cough and flu medication, ambroxol occupies an important position.
Ambroxol hydrochloride series is to act on clinically at present the strongest expectorant, and is very sure to its curative effect both at home and abroad.Its chemistry of ambroxol hydrochloride by name trans-4-[(2-amino 3,5-dibromo-benzyl) amino] cyclohexanol hydrochloridumi, for white to little yellow crystalline powder, in methanol, dissolve, slightly molten in water, slightly soluble in ethanol.Ambroxol hydrochloride is for clinical quite valued novel phlegm dissolving agent.Main Function is in the respiratory tract secretory cell, regulate the secretion of mucus and serosity material, serous secretion is increased, the polysaccharide fiber of the acidoglycoprotein in can also the cracking sputum, acidic protein is synthetic in inhibition mucous gland and the goblet cell, reduce the viscosity of sputum, sputum is thinned out, be easy to discharge; This medicine also can increase motion frequency and the intensity of respiratory tract cilium simultaneously, promotes sputum to discharge, and increases the respiratory tract self purification, improves breath state.
The kind of domestic listing has syrup, oral administration solution, granule, tablet, oral cavity disintegration tablet, dispersible tablet, chewable tablet, effervescent tablet, capsule, slow releasing tablet, slow releasing capsule, slow-release pill, injection.The administering mode of fast and easy onset reduces phlegm significant for fast treating cough: drug administration by injection is relatively poor for patient's compliance, and stronger untoward reaction is arranged; Oral tablet (conventional tablet, dispersible tablet, effervescent tablet), capsule and granule etc. need to use water delivery service, and in the onset of gastrointestinal tract disintegrate stripping ability, onset is slow, and inconvenience is difficult to be applicable to swallow inconvenient old man and child; Oral administration solution and syrup are rapid-action, but quantitatively and carry inconvenience; And there is complicated process of preparation in oral cavity disintegration tablet, needs special installation, adopts wet granule compression tablet technique preparation commonly used to exist disintegrate slow, the preparation of lyophilization technique exist undesirable, the frangible and easy moisture absorption of outward appearance etc. shortcoming.
Summary of the invention
The preparation that the present invention be directed to above ambroxol hydrochloride is not enough, provide that a kind of volume is little, easy to carry, quantitatively ambroxol hydrochloride oral disperses membrane accurately, can not take in the situation of water having yet, and disintegrate is very fast, the whole dispersing and dissolvings of common diaphragm energy within 0.5 minute, disintegrate faster diaphragm can disintegrate in 10 seconds, and onset is rapid.For child and the patient that can not swallow, only need to place it in the oral cavity and get final product, thereby exempt the misery of injection and the inconvenience of taking.And onset is rapid, and supplementary product consumption is little, and technical process is simple and totle drilling cost is lower, has considerable economic and social benefit.
The purpose of this invention is to provide a kind of ambroxol hydrochloride oral and disperse membrane, preparation method, and in the character of dissolution in vitro.Ambroxol hydrochloride of the present invention disperses membrane, in the oral cavity, disperse or dissolve, it is characterized in that, said preparation is comprised of the ambroxol hydrochloride of physiology effective dose and the carrier that can prepare in right amount the medicine membrane, and described carrier comprises that at least filmogen, plasticizer, wetting agent, opacifier, diluent, correctives and coloring agent form.
Described active constituents of medicine ambroxol hydrochloride is characterized in that, described each preparation finished product, and namely every diaphragm ambroxol-hydrochloride-containing active component ratio is 10mg – 50mg.
The described carrier for preparing the medicine membrane is characterized in that, the described carrier for preparing the medicine membrane comprises filmogen, plasticizer, diluent, coloring agent, correctives, the compositions such as buffer agent.
Described filmogen can be a kind of in the cellulose families such as hypromellose, hyprolose, starch, pregelatinized Starch, rice starch, dextrin, gelatin, Lac, arabic gum, carrageenan, Bletilla glucomannan, agar, alginic acid, zein, polyethylene amine, polyvinyl acetal derivant, polyvinylpyrrolidone (PVP), polyvinyl pyridine derivant, polyvinyl alcohol (PVA), the polyoxyethylene (PEO) and any one compositions.The consumption of filmogen is an extremely crucial parameter, and its ratio in finished product is 10%-80%.
Described plasticizer can be Polyethylene Glycol, glycerol, propylene glycol or any mixture of two or three, and molecular weight polyethylene glycol is preferably 200-3000, and micromolecular Polyethylene Glycol is better for plasticization effect.The plasticizer ratio is preferably the 0.5-5% of filmogen consumption.
Described wetting agent can be mannitol, xylitol, and a kind of in the sorbitol or its be compositions arbitrarily.Wetting agent act on ambient humidity when very low, can keep the hydrone in the membrane.The wetting agent that has also can improve mouthfeel, produces refrigerant sense when taking in mouth.The wetting agent ratio is preferably the 0.1-5% of film weight.
Described diluent can be calcium phosphate, calcium hydrogen phosphate, sodium phosphate, sodium hydrogen phosphate, calcium carbonate, dextrin, cyclodextrin, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose.For the pH value of regulating glue, disintegrate effect etc.The plasticizer ratio is preferably the 0.5-5% of film weight.
Described correctives can be sweeting agent, acidic flavoring agent, aromatic, some macromolecule resin materials a kind of or or its compositions arbitrarily.Wherein sweeting agent can make sucrose, xylitol, saccharin sodium, aspartame, sucralose, acesulfame potassium or cyclamate etc.; Acidic flavoring agent can be citric acid, citric acid, malic acid, ascorbic acid etc.; Aromatic can be oleum Citri sinensis, Oleum menthae, Eucalyptus wet goods.The plasticizer ratio is preferably the 0.5-10% of filmogen consumption.
Described coloring agent is characterized in that, coloring agent can be FD﹠amp; A kind of or mixture in a kind of or mixture in C, dyestuff, color lake, the pigment.The plasticizer ratio is preferably the 0.1-5% of filmogen consumption.
Ambroxol hydrochloride oral of the present invention disperses the preparation method of membrane, comprise the steps: the glue of (1) preparation modest viscosity: plasticizer is joined in the moderate filmogen aqueous solution of weight content, if produce bubble in the solution, then place and spend the night or vacuum defoamation; (2) diluent, wetting agent, correctives etc. are joined in the above-mentioned filmogen solution; Also can prepare separately the solution that contains diluent, wetting agent, correctives, again with above-mentioned glue mixing.(3) with mixed solution coat on certain lining material (such as the PET thin film), by adding heat abstraction moisture, glue film forming immediately; (4) be cut to the suitable sheet of shape size; (5) carry out unit dose package.
Described ambroxol hydrochloride membrane is characterized in that rapidly disintegrate then disperses or dissolves in the oral cavity, and the disintegration rate of diaphragm has direct effect for the curative effect of medicine, and the investigation index of estimating its disintegration rate is disintegration.Diaphragm disintegration time in 37 ℃ water of the present invention's preparation reached the purpose of rapid onset less than 0.5 minute.
The specific embodiment
Come to disperse membrane to do further to ambroxol hydrochloride oral of the present invention by following examples and specify, but be not limited in following examples.
Embodiment 1
Prescription:
Technique:
In the water-soluble solution of cetomacrogol 1000, propylene glycol with above-mentioned amount, add until completely dissolved the polyvinyl alcohol of recipe quantity under the state that stirs first, fully dispersed with stirring obtains sol solution.Adding ambroxol hydrochloride stirs again.Degassed or hold over night bubble removing.This sol solution is applied on the PET thin film.
Coating easily, and is even; The diaphragm that cutting obtains, the shape that is translucent, pliability is better, and disintegrate is slow, and mouthfeel is poor, sticks to one's teeth.
Embodiment 2
Prescription:
Technique:
With in the water-soluble solution of the glycerol of above-mentioned amount, add until completely dissolved the hypromellose of recipe quantity under the state that stirs first, fully dispersed with stirring obtains sol solution.Adding ambroxol hydrochloride stirs again.Degassed or hold over night bubble removing.This sol solution is applied on the PET thin film.
The coating difficulty, inhomogeneous; The diaphragm that cutting obtains, the shape that is translucent, pliability is better, and disintegrate is slow, and mouthfeel is poor, sticks to one's teeth.Place a period of time, find that membrane surface has grease.
Embodiment 3
Prescription:
Technique:
With in the water-soluble solution of the propylene glycol of above-mentioned amount, add until completely dissolved the hypromellose of recipe quantity under the state that stirs first, fully dispersed with stirring obtains sol solution.The ambroxol hydrochloride, hydroxypropyl cellulose and the microcrystalline Cellulose ph101 that add recipe quantity stir again.Degassed or hold over night bubble removing.This sol solution is applied on the PET thin film.
The coating difficulty, inhomogeneous; The diaphragm that cutting obtains, the graininess that is translucent, pliability is better, and disintegrate is slow, and mouthfeel is general, sticks to one's teeth.
Embodiment 4
Prescription:
Technique:
With in the water-soluble solution of the propylene glycol of above-mentioned amount, add until completely dissolved the hypromellose of recipe quantity under the state that stirs first, fully dispersed with stirring obtains sol solution.The ambroxol hydrochloride, hydroxypropyl cellulose, microcrystalline Cellulose ph101, mannitol and the sorbitol that add recipe quantity stir again.Degassed or hold over night bubble removing.This sol solution is applied on the PET thin film.
Coating easily, and is even; The diaphragm that cutting obtains, the graininess that is translucent, poor in flexibility, disintegrate is very fast, and mouthfeel is better.Diaphragm is frangible.The long-time placement found the glue layering.
Embodiment 5
Prescription:
Technique:
(1) heat-obtaining purified water 30ml, propylene glycol, the PEG400 of adding recipe quantity, water-bath (70 ℃) stirring and dissolving.After all dissolving, add 30.0g low viscosity hypromellose and disperse.(2) after above-mentioned low viscosity hypromellose is uniformly dispersed, add 20ml70 ℃ hot purified water, water-bath (70 ℃) is stirred, and adds the high viscosity hypromellose, and 70 ℃ of water-baths stir, after the hypromellose dissolving.Cooling and hold over night.(3) get the 50ml purified water, dissolve successively sorbitol, microcrystalline Cellulose PH101, hyprolose, aspartame, strawberry essence, red color lake and the ambroxol hydrochloride of recipe quantity after, with solution (2) mix homogeneously.(4) coating machine that divides department to produce with German Optimags carries out the coating of glue, and glue-coating and is dried at 60 ℃ on the PET thin film.(7) cutting, packing.
Coating easily, and is even; The diaphragm that cutting obtains takes on a red color, and pliability is better, and disintegrate is slow, and mouthfeel is better.
Embodiment 6
Prescription:
Technique:
(1) heat-obtaining purified water 30ml, the propylene glycol of adding recipe quantity, water-bath (70 ℃) stirring and dissolving.After all dissolving, add 30.0g low viscosity hypromellose and disperse.(2) after above-mentioned low viscosity hypromellose is uniformly dispersed, add 20ml70 ℃ hot purified water, water-bath (70 ℃) is stirred, and adds the high viscosity hypromellose, and 70 ℃ of water-baths stir, after hypromellose dissolves fully.Cooling and hold over night.(3) get the 50ml purified water, dissolve successively mannitol, microcrystalline Cellulose PH101, hyprolose, pregelatinized Starch, sucralose, fragrant citrus essence, red color lake and the ambroxol hydrochloride of recipe quantity after, with solution (2) mix homogeneously.(4) coating machine that divides department to produce with German Optimags carries out the coating of glue, and glue-coating and is dried at 60 ℃ on the PET thin film.(7) cutting, packing.
Coating easily, and is even; The diaphragm that cutting obtains takes on a red color, and pliability is better, and disintegrate is very fast, and mouthfeel is better.
Embodiment 7
Ambroxol hydrochloride oral disperses the disintegration time mensuration method of membrane: appoint 10 of the films of getting it filled, get a slice at every turn, clip one side of medicine film with clip, immerse together with clip in 37 ℃ the water-bath, use manual time-keeping, the time of dialysis clip is disintegration to diaphragm from being immersed in the water dissolving.
Be respectively 40 ± 10s the disintegration of embodiment 1-5,50 ± 5s, 30 ± 10s, 45 ± 10s, 20 ± 10s.
Embodiment 8
Thickness measuring (adopting the film sample of embodiment 5)
The ambroxol hydrochloride membrane of getting after the cutting is an amount of, cuts 5 on the sample of 20mm * 30mm, and the sample edge must be level and smooth, non-notch and damage.Be the gage measuring sample thickness of 0.001mm with precision, each sample should be measured 3 points, gets arithmetic mean of instantaneous value.
Measurement result sees Table 1.
The prepared thickness of sample of presentation of results: embodiment 5 is even.
The phlegm-dispelling functions of 9 pairs of mices of embodiment
The phenol red drainage method of mice: 60 of XII healthy male mices, be divided into 3 groups, be respectively model control group (normal saline), Ambroxol Hydrochloride Tablets (30mg) group, ambroxol hydrochloride oral dispersion membrane (30mg) group, oral cavity dispersion membrane group is by the oral film administration, other two groups of equal gastric infusions, the administration volume is identical.Administration 30min pneumoretroperitoneum is injected 5% phenol red solution 0.5mL, every 30min mice is died of asphyxiation again, cut the trachea section to the trachea crotch from thyroid cartilage, be soaked in the 30min that vibrates in the 1mL normal saline, then add 5%NaOH0,1mL gets and is soaked in spectrophotometer wavelength 546nm place mensuration optical density, compare with phenol red standard curve, obtain its phenol red amount.
The result:
Each ambroxol administration group all can increase the phenol red excretion of mice trachea, but the phlegm-dispelling functions of ambroxol hydrochloride oral dispersion membrane group is aobvious
Work is higher than ambroxol tablets.See Table 1
The phlegm-dispelling functions (X ± S, N=20) of table 1 pair mice
Claims (5)
1. the membrane of dispersing and dissolving in the oral cavity take ambroxol hydrochloride as main active, it is characterized in that, said preparation is comprised of the ambroxol hydrochloride of physiology effective dose and the carrier that can prepare in right amount the medicine membrane, and this carrier comprises filmogen, plasticizer, wetting agent, diluent etc.
2. membrane claimed in claim 1 is characterized in that, described each preparation unit's ambroxol-hydrochloride-containing ratio is 10mg-50mg.
3. membrane claimed in claim 1 is characterized in that, described carrier comprises that at least filmogen, plasticizer, wetting agent, opacifier, diluent, correctives and coloring agent form.
4. the filmogen of claim 3, it is characterized in that described filmogen can be a kind of in the cellulose families such as hypromellose, hyprolose, starch, pregelatinized Starch, rice starch, dextrin, gelatin, Lac, arabic gum, carrageenan, Bletilla glucomannan, agar, alginic acid, zein, polyethylene amine, polyvinyl acetal derivant, polyvinylpyrrolidone (PVP), polyvinyl pyridine derivant, polyvinyl alcohol (PVA), the polyoxyethylene (PEO) or its compositions arbitrarily; Described plasticizer can be arbitrarily compositions of a kind of in Polyethylene Glycol, glycerol, the propylene glycol or its; Described wetting agent can be arbitrarily compositions of a kind of in mannitol, xylitol, the sorbitol or its; Described opacifier can be titanium dioxide etc.; Described diluent can be calcium phosphate, calcium hydrogen phosphate, sodium phosphate, sodium hydrogen phosphate, calcium carbonate, dextrin, cyclodextrin, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose; Described correctives can be sucrose, maltose, glucose, fructose, lactose, sucralose, stevioside, citric acid, tartaric acid, lactic acid, a kind of or mixture in a kind of or mixture in Flos Chrysanthemi sound, glycyrrhizin rope, glucide pay, glucide, fructose, maltose, essence, spice, the sodium glutamate; Described coloring agent can be FD﹠amp; A kind of or mixture in a kind of or mixture in C, dyestuff, color lake, the pigment.
5. the described arbitrary membrane of claim 1-4, the purposes in the preparation expelling phlegm drugs.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104775448A CN102940616A (en) | 2012-11-21 | 2012-11-21 | Ambroxol hydrochloride oral cavity dispersion membrane agent |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104775448A CN102940616A (en) | 2012-11-21 | 2012-11-21 | Ambroxol hydrochloride oral cavity dispersion membrane agent |
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| CN102940616A true CN102940616A (en) | 2013-02-27 |
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| CN2012104775448A Pending CN102940616A (en) | 2012-11-21 | 2012-11-21 | Ambroxol hydrochloride oral cavity dispersion membrane agent |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104257635A (en) * | 2014-09-17 | 2015-01-07 | 中国人民解放军第三军医大学 | Oral instant ambroxol hydrochloride film preparation and preparation method thereof |
| CN104434886A (en) * | 2014-11-18 | 2015-03-25 | 段珍波 | Risperidone oral rapidly disintegrating film preparation and preparation method thereof |
| CN104958280A (en) * | 2015-08-04 | 2015-10-07 | 合肥华方医药科技有限公司 | Ambroxol hydrochloride oral instant dissolving film and preparation method thereof |
| US20170189330A1 (en) * | 2014-05-23 | 2017-07-06 | Boehringer Ingelheim International Gmbh | Cough syrup containing ambroxol hydrochloride |
| WO2024104349A1 (en) * | 2022-11-14 | 2024-05-23 | 上海云晟研新生物科技有限公司 | Ambroxol oral dissolving film composition, preparation method therefor, and use thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20170189330A1 (en) * | 2014-05-23 | 2017-07-06 | Boehringer Ingelheim International Gmbh | Cough syrup containing ambroxol hydrochloride |
| EP3145491B1 (en) * | 2014-05-23 | 2021-04-21 | Sanofi-Aventis Deutschland GmbH | Cough syrup containing ambroxol hydrochloride |
| CN104257635A (en) * | 2014-09-17 | 2015-01-07 | 中国人民解放军第三军医大学 | Oral instant ambroxol hydrochloride film preparation and preparation method thereof |
| CN104434886A (en) * | 2014-11-18 | 2015-03-25 | 段珍波 | Risperidone oral rapidly disintegrating film preparation and preparation method thereof |
| CN104958280A (en) * | 2015-08-04 | 2015-10-07 | 合肥华方医药科技有限公司 | Ambroxol hydrochloride oral instant dissolving film and preparation method thereof |
| CN104958280B (en) * | 2015-08-04 | 2018-02-27 | 合肥华方医药科技有限公司 | Ambroxol hydrochloride oral dissolving films and preparation method thereof |
| WO2024104349A1 (en) * | 2022-11-14 | 2024-05-23 | 上海云晟研新生物科技有限公司 | Ambroxol oral dissolving film composition, preparation method therefor, and use thereof |
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Application publication date: 20130227 |