CN102018712A - Pharmaceutical composition comprising dextromethorphan, chlorpheniramine and pseudoephedrine and preparation method thereof - Google Patents
Pharmaceutical composition comprising dextromethorphan, chlorpheniramine and pseudoephedrine and preparation method thereof Download PDFInfo
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- CN102018712A CN102018712A CN 201010614716 CN201010614716A CN102018712A CN 102018712 A CN102018712 A CN 102018712A CN 201010614716 CN201010614716 CN 201010614716 CN 201010614716 A CN201010614716 A CN 201010614716A CN 102018712 A CN102018712 A CN 102018712A
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Abstract
The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition formed by mixing dextromethorphan or physiologically acceptable salts thereof, chlorpheniramine or physiologically acceptable salts thereof and pseudoephedrine or physiologically acceptable salts thereof with pharmaceutically acceptable auxiliary materials and a preparation method of the composition. The raw and auxiliary materials are directly subject to powder preforming; or pelletizing is performed by using a pelletizing technology before preforming and/or optional coating. The pharmaceutical composition prepared by the preparation method has obvious slow release effect and ensures that the administration time is reduced, the toxic or side effect is lessened, the symptoms such as cough, rhinobyon, rhinorrhea and sneeze and the like caused by cold and allergy can be relieved.
Description
Technical field
The invention belongs to technical field of medicine, relate to dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine or its physiologically acceptable salt specifically, with the pharmaceutical composition of mixing acceptable accessories formation and the preparation method of said composition.
Background technology
Flu is a kind of respiratory tract commonly encountered diseases that is caused by multiple virus, is main Causative virus with coronavirus and rhinovirus wherein.Clinical manifestation is its feature with nasal obstruction, cough, headache, fever with aversion to cold, general malaise.All can fall ill the whole year, especially to see spring more.Because the course of disease and the character of flu are complicated and changeable, a kind of medicine is difficult to many symptoms of alleviating and depositing, so need to use compound preparation go to alleviate simultaneous different symptoms.
Dextromethorphan, develop by Switzerland Luo Shi (Roche) company, classified as nonprescription drugs by FDA (Food and Drug Adminstration) in 1956, be decided to be non-narcotic medicine in 1961 in world anesthesia meeting, " dextromethorphan is a kind of cough medicine that replaces codeine " thought by World Health Organization (WHO) in 1989.Its antitussive effect and codeine are quite or slightly strong.Be used for cold cough, the cough due to acute/chronic bronchitis, bronchial asthma, pharyngitis, laryngitis, pulmonary tuberculosis and other respiratory inflammations is share the treatment dry cough with antihistaminic.Take no addiction and toleration for a long time, general treatment dosage does not cause respiration inhibition, and toxicity is low, seldom untoward reaction.
Chlorphenamine, be called for short chlorphenamine, be histamine H 1 receptor's antagonist, can be to the telangiectasis due to the antianaphylaxis (histamine), reduce the permeability of blood capillary, panting due to the alleviation bronchial smooth muscle shrinks is applicable to skin allergy: urticaria, eczema, dermatitis, drug eruption, skin pruritus, neurodermatitis, insect bite disease, solar dermatitis.Also can be used for allergic rhinitis, vasomotor rhinitis, medicine and food anaphylaxis.
Pseudoephedrine is a kind of very effectively mucosa Decongestant, is mainly used in clinically because of the acute and chronic that flu, respiratory tract infection etc. cause, the treatment of allergic rhinitis, can alleviate the nasal congestion symptom that flu, allergic rhinitis, rhinitis and sinusitis cause.
The said medicine appropriate proportioning is formed compound recipe, can alleviate the various symptoms of flu.The oral general formulation product of said composition goes on the market at home, as pseudoephedrine hydrochloride oral administration solution, pseudoephedrine hydrochloride chewable tablet, is mainly used in and alleviates flu and the irritated symptoms such as cough, nasal obstruction, rhinorrhea and sneeze that cause, need take every day 3～4 times.For vast flu patient, can often cough night in bed, has influence on own even household's rest.After ordinary preparation was taken before sleeping, drug effect was kept 5～6 hours, and the patient needs take medicine night, has caused great inconvenience.
Compare with ordinary preparation, slow releasing tablet has the minimizing administration number of times, and the back blood drug level of taking medicine is steady, and toxic and side effects is little, takes characteristics such as safety.In the compound slow release preparation (CN101596157A) of disclosed a kind of pseudoephedrine, chlorphenamine and dextromethorphan, there is following defective in the slow releasing preparation of preparation:
(1), selected the high viscosity framework material for use, expand rapidly and the group of sticking into after meeting water, because material is very sticking, very easily be bonded on the screen cloth of stirring paddle and granulation machine during the preparation soft material, therefore granulation is difficult, yield is extremely low and the gained granule is inhomogeneous, is difficult for oven dry when dry, is difficult to realize industrialization;
(2), technology is too complicated, needs multistep to prepare granule, coating, tabletting process, is not suitable for extensive industrialization operation;
(3), dextromethorphan, chlorphenamine, pseudoephedrine discharge too fast (even surpassing 50%) at the initial stage of taking medicine, and almost reaches fully to discharge, and do not meet the specification requirement of slow releasing preparation exploitation, can not realize taking in one day 2 times.
At the problem that exists in the above-mentioned compound slow release preparation, it is simple relatively to the invention provides a kind of manufacturing process, does not need complex device, can realize on most of tablet manufacturing lines, is easy to the slow releasing preparation of being accepted by production unit and Producer.The present invention selects for use the ethanol of higher concentration to do binding agent, prepares soft material, granulate, oven dry on the general granulator in tablet workshop, and whole material is evenly distributed, good fluidity, is convenient to tabletting; The present invention also provides the fusion method one-step palletizing, has reduced the use of binding agent, has better saved cost and energy consumption.Slow releasing preparation of the present invention, dextromethorphan, chlorphenamine, the pseudoephedrine that aspects such as rate of release, absorbance, using dosage all be there are differences reached synchronous release and absorbed, and cooperative compensating has reduced the medication number of times, only need take medicine 1～2 time, and improve patient's compliance in one day.
Summary of the invention
In view of above-mentioned compound slow release preparation deficiency, the object of the invention has provided a kind of dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine or its physiologically acceptable salt, with the pharmaceutical composition of mixing acceptable accessories formation; All active component of said composition all are slow release and discharge, and only need take medicine 1～2 time in one day, have improved compliance of patients, have improved patient's quality of life.
The preparation method of the aforementioned pharmaceutical compositions that another object of the present invention provides.
For reaching above-mentioned purpose, a kind of pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine of the present invention, adopt following technical scheme:
Pharmaceutical composition of the present invention, by active component dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine or its physiologically acceptable salt, and medicine acceptable carrier or adjuvant composition, form as framework material, diluent, binding agent, lubricant;
The physiologically acceptable salt of dextromethorphan of the present invention comprises acylate or inorganic acid salt, wherein preferred hydrobromate; The physiologically acceptable salt of chlorphenamine comprises acylate or inorganic acid salt, wherein is preferably maleate; The physiologically acceptable salt of pseudoephedrine comprises acylate or inorganic acid salt, wherein is preferably hydrochlorate or sulfate;
The composition quality of pharmaceutical composition of the present invention is composed as follows:
| Dextromethorphan or its physiologically acceptable salt | 5～20％ |
| Chlorphenamine or its physiologically acceptable salt | 1～5％ |
| Pseudoephedrine or its physiologically acceptable salt | 15～60％ |
| Framework material | 20～50％ |
| Diluent | 5～40％ |
| Binding agent | 0.1～60％ |
| Lubricant | 0.5～2.5% |
| Coating material | 0.1～5％ |
Framework material both can be a cellulose derivative, as ethyl cellulose, methylcellulose, hyprolose, hypromellose, carboxymethyl cellulose etc.; Can be biodegradation material again, comprise materials such as waxiness, fatty acid and esters thereof, as Cera Flava, stearic acid, glyceryl monostearate, Brazil wax, hexadecanol, octadecanol etc.; Also can be acrylic polymer, as carbomer, Carbopol
, acrylic resin etc.; Can also be that other have the material that delays the drug release effect, as sodium alginate, guar gum, pectin, chitosan, polyvinyl alcohol, poly-monosilane etc.; Various framework materials also can mix use and make mixed matrix type slow releasing tablet; The preferred hypromellose of framework material that compound slow-release tablet of the present invention is used.
Diluent comprises one or more mixing wherein such as microcrystalline Cellulose, each kind of starch, lactose, sucrose, mannitol; Diluent also comprises the porogen of scalable drug release rate, as fructose, sorbitol, electrolytes material (as sodium chloride, potassium chloride, calcium hydrogen phosphate etc.), Polyethylene Glycol (as PEG4000, PEG6000), polyvidone, polyvinylpyrrolidone, water soluble surfactant active's (as sodium lauryl sulphate, dodecyl sodium sulfate) etc.
Binding agent comprises mixed solution, polyvinylpyrrolidone, the dry powder of polyvidone cellulose derivative or the mixed solution of its water and alcohol etc. of water or alcohol, water and alcohol.
Lubricant is one or more mixing such as magnesium stearate, calcium stearate, Pulvis Talci, micropowder silica gel, sodium lauryl sulphate, Stepanol MG.
Coating material comprises cellulose derivative (as one or more mixing such as methylcellulose, hyprolose, hypromellose, ethyl cellulose), titanium dioxide, Polyethylene Glycol, Oleum Ricini, Methyl Benzene-o-dicarboxylate etc.Preferred Opadry model opadry II.
A kind of preparation of drug combination method that comprises dextromethorphan, chlorphenamine and pseudoephedrine, the method for preparing pharmaceutical composition of the present invention comprises: mixing after raw and auxiliary material is sieved respectively, form by direct compression of full-powder, label carries out coating; Or earlier supplementary material is sieved respectively, make granule behind the part mixing, and then add remaining supplementary material, tablet forming again behind the mixing.Method of granulating comprises dry method, wet granulation, fusing or melt granulation, fluid bed one-step palletizing etc.; Press sheet suitably coating with shading or protection against the tide.
Pharmaceutical composition according to the present invention's preparation, at water, hydrochloric acid solution (1 → 1000, the hydrochloric acid solution of various concentration such as 6 → 1000 or 9 → 1000), pH6.8 and pH7.4 buffer solution (pressing the preparation of Chinese Pharmacopoeia method) or mimic physiological environment are (in the simulated gastric fluid 1～2 hour, change simulated intestinal fluid again over to) in, dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine hydrochloride or its physiologically acceptable salt have following release characteristics respectively:
| Time | Dextromethorphan or its physiologically acceptable salt accumulation burst size | Chlorphenamine or its physiologically acceptable salt accumulation burst size | Pseudoephedrine hydrochloride or its physiologically acceptable salt accumulation burst size |
| 1h | ≤25% | ≤20% | ≤20% |
| 2h | 20%~40% | 15%~40% | 20%~40% |
| 4h | 50%~80% | 40%~70% | 50%~80% |
| 8h | ≥80% | ≥75% | ≥80% |
This shows that pharmaceutical composition provided by the invention can not only be brought into play synergistic function, and three kinds of active component can discharge the drug release behavior of acquisition institute's phase synchronously.Medicine continues to discharge more than 4 hours, and only need take 1～2 every day, reduced administration number of times, improved patient's compliance, and the relative general formulation of blood drug level is steady in the body, and the bioavailability height has reduced toxic and side effects.
The specific embodiment
For further understanding feature of the present invention, technological means and the specific purposes that reached, function, resolve the advantages and spirit of the present invention, be described further by the pharmaceutical composition that is active component to of the present invention kind of dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine or its physiologically acceptable salt below in conjunction with embodiment, embodiment is only used for explaining, and means that never it limits the scope of the invention by any way.
Embodiment one:
The composition quality of pharmaceutical composition is composed as follows:
| Dextromethorphan hydrobromide | 30g |
| Chlorphenamine maleate | 8g |
| Pseudoephedrine hydrochloride | 90g |
| Hypromellose | 70g |
| Microcrystalline Cellulose | 25g |
| Lactose | 50g |
| Macrogol 4000 | 2g |
| Polyvidone | 2.5g |
| Magnesium stearate | 2g |
| Micropowder silica gel | 1g |
| 75% ethanol | 75g |
| opadry?Ⅱ | 18g |
| Water | 100g |
| ? | Make 1000 |
Preparation technology:
Polyvidone 2.5g is added in 75g 75% alcoholic solution, be stirred to dissolve fully binding agent, standby; Dextromethorphan hydrobromide 30g, chlorphenamine maleate 8g, pseudoephedrine hydrochloride 90g cross 80 mesh sieves respectively.After getting chlorphenamine maleate and 2g Macrogol 4000 mixing, cross 60 mesh sieves, again with 25g microcrystalline Cellulose mixing with the dextromethorphan hydrobromide mixing, add 50g lactose, 70g hypromellose and pseudoephedrine hydrochloride mixing respectively, cross 40 mesh sieves, mixing adds above-mentioned binding agent system soft material; Granulate, 60 ℃ of dryings, oven dry, 24 mesh sieve granulate add magnesium stearate 2g, micropowder silica gel 1g mixing, and tabletting gets label, and is standby.Get in the 18g coating powder opadry II adding 100g purified water and disperse fully, standby.Label is placed the high-efficiency coating pot, get the coating solution coating, weightening finish stops coating after 2%, after the drying promptly.
Extracorporeal releasing test
Method: get this product, with reference to drug release determination method (two appendix ⅹ of Chinese Pharmacopoeia version in 2010 D, first method), adopt the device of dissolution second method, with water is release medium, rotating speed 75 commentaries on classics/min, get solution 5ml respectively at 1 hour, 2 hours, 4 hours and 8 hours and filter, and in stripping rotor, add same solvent 5ml immediately.Get subsequent filtrate and measure with high performance liquid chromatography, the result is as follows:
| Time | Dextromethorphan hydrobromide cumulative release amount | Chlorphenamine maleate cumulative release amount | Pseudoephedrine hydrochloride cumulative release amount |
| 1h | 21.5% | 17.1% | 15.5% |
| 2h | 36.9% | 32.9% | 29.9% |
| 4h | 63.4% | 60.1% | 66.7% |
| 8h | 89.9% | 85.6% | 90.7% |
Above test data shows: the pharmaceutical composition in the embodiment of the invention, in carrying out the test of release in vitro degree, drug release feature meets the regulation of the Chinese Pharmacopoeia relevant slow releasing preparation of version appendix in 2010, has tangible slow releasing function.
Embodiment two:
The composition quality of pharmaceutical composition is composed as follows:
| Dextromethorphan hydrobromide | 45g |
| Chlorphenamine maleate | 12g |
| Pseudoephedrine hydrochloride | 90g |
| Octadecanol | 100g |
| Sodium chloride | 5g |
| Potassium chloride | 3g |
| Magnesium stearate | 3g |
| ? | Make 1000 |
Preparation technology:
Sodium chloride 5g and potassium chloride 3g mixing add the 45g dextromethorphan hydrobromide behind the adding 8g chlorphenamine maleate mixing, cross 60 mesh sieves, are suspended in the fused octadecanol of 100g again with behind the 90g pseudoephedrine hydrochloride mixing, push the granulation of 24 mesh sieves fast after the cooling.Add magnesium stearate 3g, mixing, tabletting are promptly.
Extracorporeal releasing test
Method: get this product, with reference to drug release determination method (two appendix ⅹ of Chinese Pharmacopoeia version in 2010 D, first method), adopt the device of dissolution second method, with 0.1mol/L hydrochloric acid is release medium, rotating speed 75 commentaries on classics/min, get solution 5ml respectively at 1 hour, 2 hours, 4 hours and 8 hours and filter, and in stripping rotor, add same solvent 5ml immediately.Get subsequent filtrate and measure with high performance liquid chromatography, the result is as follows:
| Time | Dextromethorphan hydrobromide cumulative release amount | Chlorphenamine maleate cumulative release amount | Pseudoephedrine hydrochloride cumulative release amount |
| 1h | 18.5% | 12.8% | 16.8% |
| 2h | 31.9% | 26.9% | 30.9% |
| 4h | 65.4% | 60.3% | 69.1% |
| 8h | 90.9% | 84.6% | 89.5% |
Above test data shows: the pharmaceutical composition in the embodiment of the invention, in carrying out the test of release in vitro degree, drug release feature meets the regulation of the Chinese Pharmacopoeia relevant slow releasing preparation of version appendix in 2010, has tangible slow releasing function.
Embodiment three:
The composition quality of pharmaceutical composition is composed as follows:
| Dextromethorphan hydrobromide | 45g |
| Chlorphenamine maleate | 12g |
| Pseudoephedrine hydrochloride | 135g |
| Carbomer | 70g |
| Microcrystalline Cellulose | 50g |
| Polyvidone | 2g |
| Magnesium stearate | 1.5g |
| Pulvis Talci | 1.5g |
| Dehydrated alcohol | 100g |
| opadry?Ⅱ | 10g |
| Water | 50g |
| ? | Make 1000 |
Preparation technology:
Dextromethorphan hydrobromide 30g, chlorphenamine maleate 8g, pseudoephedrine hydrochloride 90g cross 80 mesh sieves respectively.Chlorphenamine maleate and 2g polyvidone mixing are with the dextromethorphan hydrobromide mixing, again with 50g microcrystalline Cellulose mixing, cross 60 mesh sieves, placing in the fluid bed, is wetting agent with the 100g dehydrated alcohol, and a step is made granule, at the fluid bed inner drying, cross 24 mesh sieve granulate, add 1.5g magnesium stearate, 1.5g Pulvis Talci mixing, tabletting, get label, standby.The opadry II of getting 10g adds in the 50g purified water, disperses fully, and is standby.Label places the high-efficiency coating pot, gets the coating solution coating, and weightening finish stops coating after 3%, after the drying promptly.
Extracorporeal releasing test
Method: get this product, with reference to drug release determination method (two appendix ⅹ of Chinese Pharmacopoeia version in 2010 D, first method), adopt the device of dissolution second method, with pH 6.8 phosphate buffers is release medium, rotating speed 75 commentaries on classics/min, get solution 5ml respectively at 1 hour, 2 hours, 4 hours and 8 hours and filter, and in stripping rotor, add same solvent 5ml immediately.Get subsequent filtrate and measure with high performance liquid chromatography, the result is as follows:
| Time | Dextromethorphan hydrobromide cumulative release amount | Chlorphenamine maleate cumulative release amount | Pseudoephedrine hydrochloride cumulative release amount |
| 1h | 20.1% | 10.7% | 12.3% |
| 2h | 31.7% | 21.9% | 32.1% |
| 4h | 58.4% | 46.0% | 66.9% |
| 8h | 87.0% | 78.2% | 91.1% |
Above test data shows: the pharmaceutical composition in the embodiment of the invention, in carrying out the test of release in vitro degree, drug release feature meets the regulation of the Chinese Pharmacopoeia relevant slow releasing preparation of version appendix in 2010, has tangible slow releasing function.
Embodiment four:
The composition quality of pharmaceutical composition is composed as follows:
| Dextromethorphan hydrobromide | 30g |
| Chlorphenamine maleate | 8g |
| Pseudoephedrine hydrochloride | 90g |
| Calcium hydrogen phosphate | 10g |
| Microcrystalline Cellulose | 50g |
| Lactose | 75g |
| Hydroxypropyl cellulose | 5g |
| Hydroxypropyl emthylcellulose | 100g |
| Magnesium stearate | 4g |
| Dehydrated alcohol | 200g |
| ? | Make 1000 |
Preparation technology:
Dextromethorphan hydrobromide 30g, chlorphenamine maleate 8g, pseudoephedrine hydrochloride 90g cross 80 mesh sieves respectively.The 5g hypromellose adds in the 200g dehydrated alcohol, stirs, and makes binder solution after making dissolving fully, and is standby.Add the dextromethorphan hydrobromide mixing behind chlorphenamine maleate and the 10g calcium hydrogen phosphate mixing, add 50g microcrystalline Cellulose, pseudoephedrine hydrochloride, 75g lactose, 100g hydroxypropyl emthylcellulose mixing more successively, add binder solution system soft material; Soft material is through 16 mesh sieve system wet granulars, drying, and 18 mesh sieve granulate add the 4g magnesium stearate, mixing, tabletting, promptly.
Extracorporeal releasing test
Method: get this product, with reference to drug release determination method (two appendix ⅹ of Chinese Pharmacopoeia version in 2010 D, first method), adopt the device of dissolution second method, with 0.1mol/L hydrochloric acid is release medium, rotating speed 75 commentaries on classics/min changed release medium into pH 6.8 phosphate buffers continuation mensuration rapidly after the sampling respectively at 1 hour, 2 hours, in 4 hours and sampling respectively in 8 hours, measure with high performance liquid chromatography, the result is as follows:
| Time | Dextromethorphan hydrobromide cumulative release amount | Chlorphenamine maleate cumulative release amount | Pseudoephedrine hydrochloride cumulative release amount |
| 1h | 12.5% | 10.8% | 11.0% |
| 2h | 27.3% | 23.6% | 25.1% |
| 4h | 55.8% | 47.2% | 60.1% |
| 8h | 86.0% | 82.9% | 87.3% |
Above test data shows: the pharmaceutical composition in the embodiment of the invention, in carrying out the test of release in vitro degree, drug release feature meets the regulation of the Chinese Pharmacopoeia relevant slow releasing preparation of version appendix in 2010, has tangible slow releasing function.
The present invention relates to dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine or its physiologically acceptable salt, with the pharmaceutical composition of mixing acceptable accessories formation and the preparation method of said composition.Can be with the direct pressed powder of supplementary material; Or by granulation technique granulation back tabletting and/or optional coating method.Pharmaceutical composition by this method preparation has tangible slow releasing function, reduces medicining times, reduces toxic and side effects, can alleviate flu and the irritated symptoms such as cough, nasal obstruction, rhinorrhea and sneeze that cause.
The above embodiment has only expressed part embodiment of the present invention, and it describes comparatively concrete and detailed, but can not therefore be interpreted as limitation of the scope of the invention.Should be pointed out that for the person of ordinary skill of the art without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, protection scope of the present invention should be as the criterion with claims.
Claims (8)
1. a pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine is characterized in that: comprise effective active component dextromethorphan or its physiologically acceptable salt, chlorphenamine or its physiologically acceptable salt, pseudoephedrine or its physiologically acceptable salt and acceptable accessories composition;
The physiologically acceptable salt of described dextromethorphan is dextromethorphan hydrobromide; The physiologically acceptable salt of chlorphenamine is chlorphenamine maleate; The physiologically acceptable salt of pseudoephedrine is pseudoephedrine hydrochloride;
The composition quality of described pharmaceutical composition is composed as follows:
Dextromethorphan or its physiologically acceptable salt 5～20%
Chlorphenamine or its physiologically acceptable salt 1～5%
Pseudoephedrine or its physiologically acceptable salt 15～60%
Framework material 20～50%
Diluent 5～40%
Binding agent 0.1～60%
Lubricant 0.5～2.5%
Coating material 0.1～5%.
2. a kind of pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine according to claim 1 is characterized in that: described framework material can be ethyl cellulose, methylcellulose, hyprolose, hypromellose, carboxymethyl cellulose, Cera Flava, stearic acid, glyceryl monostearate, Brazil wax, hexadecanol, octadecanol, carbomer, acrylic resin, sodium alginate, guar gum, pectin, chitosan, polyvinyl alcohol, gather a kind of of monosilane or several mixing.
3. a kind of pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine according to claim 1 is characterized in that: described diluent comprises wherein a kind of such as microcrystalline Cellulose, starch, lactose, sucrose, mannitol, fructose, sorbitol, electrolytes material, Polyethylene Glycol, polyvidone, polyvinylpyrrolidone, water soluble surfactant active or several mixing.
4. a kind of pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine according to claim 1 is characterized in that: described binding agent comprises mixed solution, polyvinylpyrrolidone, polyvidone, the dry powder of cellulose derivative or the mixed solution of its water and alcohol of water or alcohol, water and alcohol.
5. a kind of pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine according to claim 1 is characterized in that: described lubricant comprises a kind of or several mixing such as magnesium stearate, calcium stearate, Pulvis Talci, micropowder silica gel, sodium lauryl sulphate, Stepanol MG.
6. a kind of pharmaceutical composition that comprises dextromethorphan, chlorphenamine and pseudoephedrine according to claim 1 is characterized in that: described coating material comprise titanium dioxide, Polyethylene Glycol, Oleum Ricini, Methyl Benzene-o-dicarboxylate, methylcellulose, hyprolose, hypromellose, ethyl cellulose wherein a kind of or several.
7. preparation of drug combination method that comprises dextromethorphan, chlorphenamine and pseudoephedrine is characterized in that the composition quality of described pharmaceutical composition is composed as follows:
Dextromethorphan or its physiologically acceptable salt 5～20%
Chlorphenamine or its physiologically acceptable salt 1～5%
Pseudoephedrine or its physiologically acceptable salt 15～60%
Framework material 20～50%
Diluent 5～40%
Binding agent 0.1～60%
Lubricant 0.5～2.5%
Coating material 0.1～5%;
Described preparation method comprises following method:
1., direct powder compression: with supplementary material sieve respectively the back mixing, by direct compression of full-powder;
2., granulating tabletting process: earlier supplementary material is sieved respectively, granulate behind the part mixing, and then add remaining supplementary material, tablet forming again behind the mixing;
3. or with the 1. middle preparation label of said method carry out coating.
8. a kind of preparation of drug combination method that comprises dextromethorphan, chlorphenamine and pseudoephedrine according to claim 1, it is characterized in that: described method of granulating comprises dry method, wet granulation, fusing or melt granulation, fluid bed one-step palletizing.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114073690A (en) * | 2020-08-10 | 2022-02-22 | 江苏长泰药业有限公司 | Amino acid-containing anti-extraction pharmaceutical composition and preparation thereof |
| CN114073689A (en) * | 2020-08-10 | 2022-02-22 | 江苏长泰药业有限公司 | Anti-extraction pharmaceutical composition and preparation thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114073690A (en) * | 2020-08-10 | 2022-02-22 | 江苏长泰药业有限公司 | Amino acid-containing anti-extraction pharmaceutical composition and preparation thereof |
| CN114073689A (en) * | 2020-08-10 | 2022-02-22 | 江苏长泰药业有限公司 | Anti-extraction pharmaceutical composition and preparation thereof |
| CN114073689B (en) * | 2020-08-10 | 2024-01-12 | 江苏长泰药业有限公司 | Extraction-preventing pharmaceutical composition and preparation thereof |
| CN114073690B (en) * | 2020-08-10 | 2024-01-12 | 江苏长泰药业有限公司 | Extraction-preventing pharmaceutical composition containing amino acid and preparation thereof |
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Open date: 20110420 |