CN103301467A - Stable taste-masking ambroxol hydrochloride compound and preparation method thereof - Google Patents
Stable taste-masking ambroxol hydrochloride compound and preparation method thereof Download PDFInfo
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- CN103301467A CN103301467A CN2013102458236A CN201310245823A CN103301467A CN 103301467 A CN103301467 A CN 103301467A CN 2013102458236 A CN2013102458236 A CN 2013102458236A CN 201310245823 A CN201310245823 A CN 201310245823A CN 103301467 A CN103301467 A CN 103301467A
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- ambroxol hydrochloride
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Abstract
The invention relates to a stable taste-masking ambroxol hydrochloride compound and a preparation method thereof. The medicine compound comprises ambroxol hydrochloride and a taste-masking agent, wherein the taste-masking agent is polacrilex IRP64, polacrilin potassium IRP88 and sodium polystyrenesulfonate IRP69. The medicine compound is selectively added with other pharmaceutically acceptable auxiliary materials to be further prepared into granules, chewable tablets, orally disintegrating tablets, oral cavity dispersion film agents and the like; the stable taste-masking ambroxol hydrochloride compound is pleasant in mouth feel, rapid to absorb, stable in quality, and simple and feasible in preparation process, the large-scale production is realized by using regular pharmaceutical equipment.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to ambroxol hydrochloride medicinal composition of a kind of stable taste masking and preparation method thereof.
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 national main cities typical hospital market, use at most with cough and flu medication.And in the principal item of cough and flu medication, ambroxol hydrochloride occupies an important position.
Ambroxol hydrochloride series is to act on the strongest expectorant at present clinically, and is very sure to its curative effect both at home and abroad.Ambroxol hydrochloride is for clinical quite valued novel phlegm dissolving agent.Mainly act on 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.
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.
Make things convenient for the administering mode of quick acting to reduce phlegm significant for quick treatment cough.But because the ambroxol hydrochloride bitter in the mouth, so when the chewable tablet rapid, rapid-action in the preparation disintegrate, that bioavailability is high, oral cavity disintegration tablet, oral cavity disperseed dosage form such as membrane, covering its bitterness was the task of top priority.
Patent CN102846581A discloses instant membrane of a kind of ambroxol hydrochloride oral and preparation method thereof, relates to odor mask in preparation process.Used odor mask is Andrea Pollack phosphorus potassium, and by weight, its consumption is preferably 1-2 times of ambroxol hydrochloride.
Compare with above-mentioned patent, medicinal composition of the present invention has adopted less amount to gather Garrick woods IRP64, Andrea Pollack phosphorus potassium IRP88, kayexalate IRP69 etc. to the ambroxol hydrochloride taste masking, and is prepared into qualified oral solid formulation by adding other pharmaceutic adjuvants.
Summary of the invention
One of purpose of the present invention is to provide a kind of ambroxol hydrochloride medicinal composition of stable taste masking, and it contains ambroxol hydrochloride, odor mask.
The present invention adopts poly-Garrick woods IRP64, Andrea Pollack phosphorus potassium IRP88, kayexalate IRP69 etc. to be used for covering the bitterness of ambroxol hydrochloride as odor mask, make this medicinal composition taste pleasant, the oral solid formulation mouthfeel of preparation is good, is conducive to improve the especially compliance of person in middle and old age, child patient medication of patient.
The invention provides a kind of ambroxol hydrochloride medicinal composition, its composition and part by weight are as follows:
1 part of ambroxol hydrochloride, odor mask 1/2-4 part.
Described odor mask is poly-Garrick woods IRP64, Andrea Pollack phosphorus potassium IRP88, kayexalate IRP69, in a kind of, preferred poly-Garrick woods; By weight, its consumption is 1/2 times-4 times of principal agent, preferred 1/2 times-1 times.
The preparation method of ambroxol hydrochloride medicinal composition of the present invention comprises the steps: that (1) is settled to an amount of scale with the 1M sodium hydroxide solution with purified water; (2) add an amount of odor mask, stir 2h; (3) in above-mentioned sample, add ambroxol hydrochloride, stirred for several hour; (4) sucking filtration cleans filter cake 3 times; (5) medicinal composition behind the sucking filtration is put into 60 ℃ of baking ovens dryings, namely.
Ambroxol hydrochloride medicinal composition of the present invention, selectivity adds other pharmacy acceptable auxiliary, comprise diluent, disintegrating agent, binding agent, lubricant, filmogen, essence, sweeting agent etc., can be prepared into granule, chewable tablet, oral cavity disintegration tablet, oral cavity dispersion membrane.Because it is fast to have good mouthfeel, steady quality, medicine dissolution rate, is conducive to the absorption of gastrointestinal mucosa.Above-mentioned preparation is specially adapted to child, old man, improves compliance of patients.And preparation technology is simple, and pharmaceutical equipment is general, can realize large-scale production.Has considerable economic and social benefit.
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.So, under method prerequisite of the present invention, simple modifications of the present invention is all belonged to the scope of protection of present invention.
Embodiment 1
With poly-Garrick woods IRP64 and ambroxol hydrochloride reaction, the preparation medicinal composites is according to the ratio experiment (by weight) of 1:1.
Ambroxol hydrochloride 5.0g
Poly-Garrick woods IRP64 5.0g
Water is to 1000ml
Preparation technology is as follows:
(1) sodium hydroxide solution with the 1M of 50ml is diluted to 1000ml with purified water, adds the poly-Garrick woods IRP64 resin of recipe quantity, mixing 1 hour;
(2) ambroxol hydrochloride of adding recipe quantity, stirring is spent the night;
(3) sucking filtration cleans filter cake according to the ratio of 10:1 with purified water;
(4) filter cake is placed in 60 ℃ the baking oven dry.
(5) calculate drug loading and mouthfeel.
Embodiment 2
With Andrea Pollack phosphorus potassium IRP88 and ambroxol hydrochloride reaction, the preparation medicinal composites is according to the ratio experiment (by weight) of 1:1.
Ambroxol hydrochloride 5.0g
Andrea Pollack phosphorus potassium IRP88 5.0g
Water is to 1000ml
Preparation technology is as follows:
(1) get purified water 1000ml, add the Andrea Pollack phosphorus potassium IRP88 of recipe quantity, and the ambroxol hydrochloride of recipe quantity, stirring is spent the night;
(2) sucking filtration cleans filter cake according to the ratio of 10:1 with purified water;
(3) filter cake is placed in 60 ℃ the baking oven dry.
(4) calculate drug loading and mouthfeel.
Embodiment 3
With kayexalate IRP69 and ambroxol hydrochloride reaction, the preparation medicinal composites is according to the ratio experiment (by weight) of 1:1.
Ambroxol hydrochloride 5.0g
Kayexalate IRP69 5.0g
Water is to 1000ml
Preparation technology is as follows:
(1) get purified water 1000ml, add the kayexalate IRP69 of recipe quantity, and the ambroxol hydrochloride of recipe quantity, stirring is spent the night;
(2) sucking filtration cleans filter cake according to the ratio of 10:1 with purified water;
(3) filter cake is placed in 60 ℃ the baking oven dry.
(4) calculate drug loading and mouthfeel.
Quality evaluation:
Assess sample is ambroxol hydrochloride complex prepared among the embodiment 1-3
1. the mouthfeel evaluation of ambroxol hydrochloride
Table 1 ambroxol hydrochloride medicinal composition mouthfeel is estimated
Annotate: +++: fabulous; ++: good; +: general;-: relatively poor.
Use poly-Garrick woods IRP64 resin drug prepared complex among conclusion: the embodiment 1, no bitterness, mouthfeel is better; Use Andrea Pollack phosphorus potassium IRP88 resin drug prepared complex among the embodiment, no bitterness, mouthfeel is better; With kayexalate IRP69 resin drug prepared complex, bitterness is slightly arranged among the embodiment, mouthfeel is general.
2. the drug loading evaluation of ambroxol hydrochloride
Table 1 ambroxol hydrochloride medicinal composition drug loading
Use poly-Garrick woods IRP64 resin drug prepared complex among conclusion: the embodiment 1, the drug loading maximum; Secondly be Andrea Pollack phosphorus potassium IRP88 resin drug prepared complex; Be kayexalate IRP69 resin drug prepared complex at last.Therefore poly-Garrick woods IRP64 resin is preferred taste masking resin.
Embodiment 4
With the reaction of poly-Garrick woods IRP64 and ambroxol hydrochloride, preparation medicinal composites, experimentize (by weight) according to the ratio of 1:2,1:1,2:1,3:1,4:1.
Ambroxol hydrochloride 5.0g
Water is to 1000ml
Preparation technology is as follows:
(1) sodium hydroxide solution with the 1M of 50ml is diluted to 1000ml with purified water, add recipe quantity poly-Garrick woods IRP64 resin (be respectively 2.5g, 5.0g, 10.0g, 15.0g), mixing 1 hour;
(2) ambroxol hydrochloride of adding recipe quantity, stirring is spent the night;
(3) sucking filtration cleans filter cake according to the ratio of 10:1 with purified water;
(4) filter cake is placed in 60 ℃ the baking oven dry.
(5) calculate drug loading and mouthfeel.
Quality evaluation:
The drug loading evaluation of ambroxol hydrochloride
Table 1 ambroxol hydrochloride medicinal composition drug loading
Conclusion: have and go up table as can be known: the ratio of poly-Garrick woods IRP64 and ambroxol hydrochloride is along with the increase of amount of resin, and drug loading increases to some extent.But because the dosage of ambroxol hydrochloride is very big, as if other ratios of employing, may increase the amount of other pharmaceutic adjuvants.Be in security consideration, adopt the ratio of 1:2, test.
Embodiment 5
Adopt ambroxol hydrochloride of the present invention-poly-Garrick woods complex to prepare ambroxol hydrochloride oral and disperse membrane.
Every contains the 15mg ambroxol hydrochloride, and 1000 ambroxol hydrochloride orals disperse the composed as follows of membrane:
Prescription:
Technology:
In the water-soluble solution of glycerol, xylitol, sucralose with above-mentioned amount, treat to dissolve the back adds recipe quantity under the state that stirs hypromellose (K15M, E50) fully earlier, fully dispersed with stirring obtains sol solution.The ambroxol hydrochloride complex that adds recipe quantity again stirs.The degassing or standing over night are except bubble.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.
Quality evaluation:
Ambroxol hydrochloride oral disperses the membrane mouthfeel good, disperses rapidly in the oral cavity.
Embodiment 6
Adopt ambroxol hydrochloride of the present invention-poly-Garrick woods complex to prepare Orally disintegrating tablet of ambroxol hydrochloride.
Every contains the 15mg ambroxol hydrochloride, 1000 Orally disintegrating tablet of ambroxol hydrochloride composed as follows:
Prescription:
Preparation technology:
(1) with ambroxol hydrochloride complex, mannitol, polyvidone, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, sucralose, that fragrant citrus essence is crossed 80 mesh sieves is standby;
(2) ambroxol hydrochloride complex, mannitol, polyvidone, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, the sucralose that takes by weighing recipe quantity mixes;
(3) cross 20 mesh sieves and granulate 60 ℃ of dryings, 16 mesh sieve granulate;
(4) carboxymethyl starch sodium, fragrant citrus essence, the magnesium stearate of adding recipe quantity, mix homogeneously;
(5) tabletting.
Quality evaluation:
The Orally disintegrating tablet of ambroxol hydrochloride mouthfeel is good, disintegrate rapidly in the oral cavity.
Embodiment 7
Adopt ambroxol hydrochloride of the present invention-poly-Garrick woods complex to prepare ambroxol hydrochloride granula.
Every bag contains the 15mg ambroxol hydrochloride, 1000 ambroxol hydrochloride granulas composed as follows:
Prescription:
Technology:
(1) it is standby ambroxol hydrochloride complex, sorbitol, sucrose to be crossed 80 mesh sieves; The hypromellose aqueous solution of preparation 2.0% is standby as binding agent;
(2) take by weighing ambroxol hydrochloride complex, sorbitol, the sucrose of recipe quantity, cross 20 eye mesh screens and granulate, 60 ℃ of dryings are used 16 eye mesh screens, granulate;
(3) packing.
Quality evaluation:
The ambroxol hydrochloride granula flavor is sweet, and mouthfeel is pleasant.
Claims (5)
1. the ambroxol hydrochloride medicinal composition of a stable taste masking is characterized in that also comprising odor mask except containing ambroxol hydrochloride, and its odor mask is poly-Garrick woods IRP64, Andrea Pollack phosphorus potassium IRP88, kayexalate IRP69.
2. ambroxol hydrochloride medicinal composition according to claim 1 is characterized in that: a kind of among poly-Garrick woods IRP64, Andrea Pollack phosphorus potassium IRP88, the kayexalate IRP69 of described odor mask, preferably poly-Garrick woods IRP64; By weight, its consumption is 1/2 times-4 times of principal agent, preferred 1/2 times-1 times.
3. ambroxol hydrochloride medicinal composition according to claim 1, its feature its preparation method is as follows:
The 1M sodium hydroxide solution is settled to an amount of scale with purified water; Add an amount of poly-Garrick woods IRP64, stir 2h; In above-mentioned sample, add ambroxol hydrochloride, stirred for several hour; Sucking filtration cleans filter cake 3 times; It is dry that medicinal composition behind the sucking filtration is put into 60 ℃ of baking ovens, namely.
4. ambroxol hydrochloride complex according to claim 1 is characterized in that: optionally add suitable pharmaceutic adjuvant, can further be prepared into granule, chewable tablet, oral cavity disintegration tablet, oral cavity dispersion membrane.
5. ambroxol hydrochloride complex according to claim 4, it is characterized in that: described pharmaceutic adjuvant comprises diluent, disintegrating agent, binding agent, lubricant, filmogen, essence, sweeting agent etc.
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| CN2013102458236A CN103301467A (en) | 2013-06-20 | 2013-06-20 | Stable taste-masking ambroxol hydrochloride compound and preparation method thereof |
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| CN2013102458236A CN103301467A (en) | 2013-06-20 | 2013-06-20 | Stable taste-masking ambroxol hydrochloride compound and preparation method thereof |
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Cited By (3)
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| CN104490807A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Ambroxol hydrochloride composition chewable tablet and preparation method thereof |
| CN104606166A (en) * | 2015-02-04 | 2015-05-13 | 上海华源安徽仁济制药有限公司 | Compound cefalexin capsule 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 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104490807A (en) * | 2014-12-05 | 2015-04-08 | 海南卫康制药(潜山)有限公司 | Ambroxol hydrochloride composition chewable tablet and preparation method thereof |
| CN104606166A (en) * | 2015-02-04 | 2015-05-13 | 上海华源安徽仁济制药有限公司 | Compound cefalexin capsule 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 |
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