CN101766608A - Compound pseudoephedrine hydrochloride slow release preparation and preparing method thereof - Google Patents
Compound pseudoephedrine hydrochloride slow release preparation and preparing method thereof Download PDFInfo
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- CN101766608A CN101766608A CN 200810246733 CN200810246733A CN101766608A CN 101766608 A CN101766608 A CN 101766608A CN 200810246733 CN200810246733 CN 200810246733 CN 200810246733 A CN200810246733 A CN 200810246733A CN 101766608 A CN101766608 A CN 101766608A
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Abstract
The invention relates to a slow release preparation which uses pseudoephedrine or physiologically acceptable salts and chlorpheniramine or physiologically acceptable salts as active ingredients. The preparation is characterized in that the slow release system comprises a pill core and/or a coating which enable drugs to slowly release; and all active ingredients are stored in the pill core. The slow release preparation can not only fully overcome the symptoms related to colds and play the synergic effect of the compound drugs, but also realize synchronization of release and absorption of three active ingredients and achieve the expected drug releasing activity inside or outside the body. The administration times can be reduced by the drug releasing activity (from four times one day to twice one day, i.e. taking once respectively on morning and at night). The invention has the advantages of few drug taking times, slow release of the drugs in the body, stable blood and drug concentration, small fluctuation, high biological utilization degree and high safety.
Description
Technical field
The present invention relates to a kind of slow releasing preparation that is active component with pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt, belong to field of medicaments.
Background technology
Flu is the upper respiratory tract mucosa infection that is caused by a lot of dissimilar viruses, and its cardinal symptom often is nasal obstruction, sneeze, slight throat pain and heating etc., and systemic symptom has whole body discomfort, headache and myalgia etc.Because of no specific therapy can be sayed,, can only adopt symptomatic treatment to impel many remissions of flu so virus is firm then unnecessary.Because therefore the many symptoms that also do not have a kind of agents alleviate and deposit have various compound preparations to go on the market successively.These compound preparations select for use the medicine composition compound recipe of different curative effects to be used to alleviate simultaneous different symptoms.There is multiple symptom as patient,, then suits the medicine to the illness and use suitable compound preparation than more suitable with several individual event medicines, also more economical sometimes particularly at common cold initial stage.
Pseudoephedrine claims d-pseudephedrine again, is the optical isomer of ephedrine, and the two is by extracting gained in Herba Ephedrae or the ephedra equisetina grass, but synthetic at present.Pseudoephedrine discharges norepinephrine by stimulating SNE, play sympatheticomimetic action indirectly, its preventing respiratory is identical with the effect and the ephedrine of nasal congestion, but boosting only is 1/5 of an ephedrine, strengthening heart rate and pressor effect only is 1/4 of ephedrine, aspect the expansion bronchus smooth muscle only be its 1/2.The pseudoephedrine vasoconstrictive has certain selectivity, mainly shrinks the upper respiratory tract blood vessel and makes and breathe unobstructedly, is used to shrink nasal mucosa vessels alleviating the nasal obstruction symptom, and is evident in efficacy and side effect is little, in the use usually with its hydrochlorate or sulfate.
Chlorphenamine is H
1Receptor antagonist, the antihistamine drug that belongs to early stage classics is used for the treatment of anaphylactic disease, for example: seasonality and chronic rhinitis, urticaria and pruritus clinically mainly with the treatment anaphylactic disease.Usually show in various degree like sympathetic, medmain, calmness and similar cholinolytic side effect, can cause feel sleepy, xerostomia, the dimness of vision etc., common its maleate of using in the use.
Pseudoephedrine and chlorphenamine are prepared into slow releasing preparation, can alleviate owing to heating, headache, upper airway symptoms and the sinusitis that common cold, influenza cause, the various symptoms due to the pollinosis, particularly suitable and the early stage clinical symptoms of alleviating above-mentioned disease are as symptoms such as sneeze, rhinorrhea, nasal obstructions.Since pseudoephedrine and chlorphenamine using dosage, rate of release, and the difference of aspects such as absorbance need provide a kind of both releases, absorption to reach synchronously, so that better play synergistic compound preparation, reduces the medication number of times and makes things convenient for patient's medication.
Summary of the invention
The purpose of this invention is to provide and a kind ofly can overcome the relevant symptom of flu comprehensively, and all active component all are the compound preparation that slow release discharges.Technical solution of the present invention is as follows:
The slow releasing preparation that is active component with pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt of the present invention, it is characterized in that, described delivery system is made up of ball core and/or coating that drug slow is discharged, and described active component all is present in the ball core.
Slow releasing preparation of the present invention contains pseudoephedrine or its physiologically acceptable salt 30～360mg, preferred 60～240mg in each dosage unit.Chlorphenamine or its physiologically acceptable salt 1～36mg, preferred 2～12mg.
The physiologically acceptable salt of pseudoephedrine of the present invention and the physiologically acceptable salt of chlorphenamine, comprise acylate or inorganic acid salt, wherein the physiologically acceptable salt of pseudoephedrine is preferably hydrochlorate or sulfate, and the physiologically acceptable salt of described chlorphenamine is preferably maleate.
Ball core of the present invention is by hydroxypropyl methylcellulose, the Sulisi aqueous dispersion, the water solublity coating powder, polyvinylpyrrolidone, ethyl cellulose, methylcellulose, Hydroxypropyl Methylcellulose Phathalate, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl-cellulose, hexadecanol, Rikemal B 200, stearic acid, glyceryl monostearate, Brazil wax, hydroxy methocel, polyvinyl alcohol, poly-phthalic acid vinyl acetate, polystyrene, carbopol, polrvinyl chloride, octadecanol, diethyl phthalate, dioctyl phthalate, Polyethylene Glycol, sodium alginate, chitosan, gelatin, Lac, pectin, guar gum, sucrose, lactose, starch, dextrin, Icing Sugar, low-substituted hydroxypropyl cellulose, cross linked polyvinyl pyrrolidone, cross-linking sodium carboxymethyl cellulose, mannitol, microcrystalline Cellulose, pregelatinized Starch, in the titanium dioxide one or more are made.
During coating of the present invention is compared by ethyl cellulose, starch, Aquacoat, methylcellulose, acrylic resin, Opadry, Su Li one or more are made.
Preparation of the present invention contain lubricant by magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, month hang in the pure magnesium sulfate one or more.
Preparation of the present invention contains wetting agent by in water, ethanol, dehydrated alcohol, chloroform, acetone, polyvidone, crospolyvinylpyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families one or more.
Preparation of the present invention contains coloring agent by ferrum oxide, amaranth, carmine, erythrosine, newly red, the lemon yellow of red, the red pigment of cowberry of red, beet red, lac, capsanthin, red rice, sunset yellow, indigo Huang, light blue, and one or more are made for the various pigments that strengthen the acid pigment of above-mentioned water solublity dispersibility in oils and fats.
The release characteristic of pseudoephedrine or its physiologically acceptable salt is in the preparation of the present invention: 1h:20-65%, 2h:40-85%, 4h:60-90%, 8h: be not less than 70%.
The release characteristic of chlorphenamine or its physiologically acceptable salt is in the preparation of the present invention: 1h:30-65%, 2h:40-80%, 4h:60-90%, 8h: be not less than 80%.
Preparation of the present invention is tablet, granule, capsule.
Slow releasing preparation of the present invention, can not only overcome the relevant symptom of flu comprehensively, the performance synergistic interaction effect of compound drugs, and the release of three kinds of active component of slow releasing preparation of the present invention, absorb and to reach synchronously, it obtains desired drug release behavior in vivo and in vitro.Such drug release behavior can reduce takes number of times (by original 4 times on the one reduce to a day twice, promptly take night and morning).Therefore this preparation has the advantages that the medication number of times is few, medicine slowly discharges in vivo, blood drug level is steady, fluctuation is little, bioavailability is high, safe.
Description of drawings
Fig. 1 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of pseudoephedrine hydrochloride in the 0.1mol/L hydrochloric acid solution of embodiment 2 preparations.
Fig. 2 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of chlorphenamine maleate in the 0.1mol/L hydrochloric acid solution of embodiment 2 preparations.
Fig. 3 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of pseudoephedrine hydrochloride in the pH6.8 phosphate buffer of embodiment 2 preparations.
Fig. 4 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of chlorphenamine maleate in the pH6.8 phosphate buffer of embodiment 2 preparations.
Fig. 5 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of pseudoephedrine hydrochloride in water of embodiment 2 preparations.
Fig. 6 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of chlorphenamine maleate in water of embodiment 2 preparations.
Fig. 7 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of pseudoephedrine hydrochloride in pH4.0 citric acid-sodium hydrogen phosphate buffer of embodiment 2 preparations.
Fig. 8 is compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) release profiles comparison diagram of chlorphenamine maleate in pH4.0 citric acid-sodium hydrogen phosphate buffer of embodiment 2 preparations.
The specific embodiment
By following examples the slow releasing preparation that is active component with, pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt of the present invention is done further to specify, but not as limitation of the present invention.
Prescription:
Pseudoephedrine hydrochloride 90g
Chlorphenamine maleate 4g
Hydroxypropyl methylcellulose K4M 50g
Microcrystalline Cellulose 80g
5% 30 POVIDONE K 30 BP/USP, 30 aqueous solutions are an amount of
Magnesium stearate is an amount of
Pure water is an amount of
Make 1000 (grains)
Preparation method:
(1) particulate preparation hydroxypropyl methylcellulose, microcrystalline Cellulose sieve mix homogeneously respectively.Add pseudoephedrine hydrochloride, chlorphenamine maleate more successively, fully mixing is a binding agent system soft material with 5% 30 POVIDONE K 30 BP/USP, 30 aqueous solutions, 20 mesh sieve system wet granulars, and 50 ℃ of dryings, 20 mesh sieve granulate, standby.
(2) in (1) gained granule, add an amount of magnesium stearate, mix homogeneously, tabletting promptly gets tablet.
(3) get (1) gained particle packing in the hungry area softgel shell, promptly get capsule.
Prescription:
Pseudoephedrine hydrochloride 90g
Chlorphenamine maleate 4g
Fine pellet core 95g
Hydroxypropyl methylcellulose E5 7g
Sulisi 20g
Light water dissolubility coating powder (redness) 5.0g
Light water dissolubility coating powder (white) 0.2g
Water is an amount of
Make 1000
Preparation method:
The preparation of 1 pseudoephedrine hydrochloride slow release micropill
1.1 water is prepared 10% hypromellose E5 aqueous solution.
1.2 preparation contains the hypromellose E51% aqueous solution of hydrochloric pseudoephedrine 40%, and is standby.
1.3 get the aqueous dispersion that the Sulisi thin up becomes to include solid content 15%, shake up standby.
1.4 get light water dissolubility coating powder (redness), water is mixed with red water solublity coating solution.
Place fluid bed 1.5 get fine pellet core, the last drug solns that usefulness prepares carries out the end and sprays medicine, and 43 ± 2 ℃ of control temperature of charge have sprayed back with an amount of purified water detergent line.
About 2% end 1.6 continuation spray 10% hypromellose E5 aqueous solution, 43 ± 2 ℃ of control temperature of charge, coating increase weight.
1.7 carry out end spray coating with dilution 15% aqueous dispersion, control 35 ± 2 ℃ of temperature of charge, coating increases weight and about 12% can finish, with an amount of purified water detergent line, get red water solublity coating solution, carry out the micropill colouring, temperature of charge is controlled at 43 ± 2 ℃, and coating increases weight and about 3% can finish.
1.8 solidify: get and make micropill and place under 60 ℃ of conditions, leave standstill and solidified one hour, promptly.
2 chlorphenamine maleate medicine-feeding micropill
2.1 water is prepared 10% hypromellose E5 aqueous solution.
2.2 preparation contains the aqueous solution of chlorphenamine maleate 17.5% hypromellose E5 0.5%, and is standby.
Place fluid bed 2.3 get fine pellet core, the solution that usefulness prepares carries out the end and sprays medicine, and 53 ± 2 ℃ of control temperature of charge have sprayed back with an amount of purified water detergent line.
2.4 continue spray 10% hypromellose E5 aqueous solution, 43 ± 2 ℃ of control temperature of charge, coating increases weight about 2%.
3 chlorphenamine maleate fast release micropills
3.1 get the aqueous dispersion that the Sulisi thin up becomes to include solid content 15%, shake up standby.
3.2 get light water dissolubility coating powder (white), water is mixed with white water solublity coating solution.
3.3 getting chlorphenamine maleate medicine-feeding micropill puts in the fluid bed, carry out end spray coating with the good aqueous dispersion of dilution, 37 ± 2 ℃ of control temperature of charge, coating increases weight and about 2% can finish by weight, with an amount of purified water detergent line, extracting waste water solublity coating solution, temperature of charge are controlled at 43 ± 2 ℃, and coating increases weight and about 3% can finish.
3.4 solidify: get and make micropill and place under 60 ℃ of conditions, leave standstill and solidified one hour, collect 20～30 purpose micropills, promptly.
4 chlorphenamine maleate slow-release micro-pill
4.1 get the aqueous dispersion that the Sulisi thin up becomes to include solid content 15%, shake up standby.
4.2 get light water dissolubility coating powder (white), water is mixed with white water solublity coating solution.
4.3 getting chlorphenamine maleate medicine-feeding micropill puts in the fluid bed, carry out end spray coating with the good Aquacoat of dilution, 37 ± 2 ℃ of control temperature of charge, coating increases weight and about 8% can finish by weight, with an amount of purified water detergent line, extracting waste water solublity coating solution, temperature of charge are controlled at 43 ± 2 ℃, and coating increases weight and about 3% can finish.
4.4 solidify: get and make micropill and place under 60 ℃ of conditions, leave standstill and solidified one hour, collect 20～30 purpose micropills, promptly.
5 whole mixing are got the pseudoephedrine hydrochloride slow release micropill according to the intermediate testing result, and chlorphenamine maleate fast release micropill and slow-release micro-pill respectively feed intake by 50% of labelled amount, feed intake according to configuration proportion, mix eventually.
6 adorn capsule No. 2, promptly.
In order further to investigate release in vitro effect of the present invention, we are according to drug release determination method (two appendix XD first methods of Chinese Pharmacopoeia version in 2005), apparatus is pressed dissolution method second subtraction unit, has measured the capsular release in vitro degree of compound pseudoephedrine hydrochloride slow release of the embodiment of the invention 2 preparations.
0.1mol/L hydrochloric acid solution 500ml with the degassing is a dissolution medium, and rotating speed is that per minute 100 changes, and operation in the time of 1,2,4 and 8 hour, is respectively got the about 5ml of solution in accordance with the law, filters, and discards filtrate just, gets subsequent filtrate, as need testing solution.Precision takes by weighing pseudoephedrine hydrochloride 18.0mg, puts in the 100ml measuring bottle, adds the about 70ml of hydrochloric acid solution of 0.1mol/L, and jolting makes dissolving; Other precision takes by weighing the about 20mg of chlorphenamine maleate and puts in the 50ml measuring bottle, adds the 0.1mol/L hydrochloric acid solution and is diluted to scale, shakes up, precision is measured 2ml, moves in the pseudoephedrine hydrochloride reference substance solution, adds the 0.1mol/L hydrochloric acid solution to scale, shake up, in contrast product solution.According to the chromatographic condition under the assay item, precision is measured reference substance solution and each 40 μ l of need testing solution, inject chromatograph of liquid respectively, number of theoretical plate must not be less than 4000 by pseudoephedrine hydrochloride, with each active component peak area, calculate the stripping quantity of every capsules by external standard method respectively at different time.Every of this product was at 1,2,4 and 8 hour stripping quantity.
According to the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparation and compound pseudoephedrine hydrochloride slow release capsule (contac newly) in different pH value release medium the release profiles comparative study the results are shown in accompanying drawing.
Result of the test shows that the compound pseudoephedrine hydrochloride slow release capsule and compound pseudoephedrine hydrochloride slow release capsule (new contac) the release in vitro behavior that prepare according to embodiment 2 have concordance.
Claims (11)
1. compound slow release preparation that is active component with pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt, it comprises a kind of delivery system, it is characterized in that: described delivery system is made up of ball core and/or coating that drug slow is discharged, and described active component all is present in the ball core.
2. compound slow release preparation according to claim 1 is characterized in that: pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt all are slow release and discharge.
3. compound slow release preparation according to claim 1, it is characterized in that: contain pseudoephedrine or its physiologically acceptable salt 30～360mg in each dosage unit, preferred 60～240mg, chlorphenamine or its physiologically acceptable salt 1～36mg, preferred 2～12mg.
4. according to the described compound slow release preparation of claim 1～3, it is characterized in that: the physiologically acceptable salt of described pseudoephedrine and the physiologically acceptable salt of chlorphenamine, comprise acylate or inorganic acid salt, wherein the physiologically acceptable salt of pseudoephedrine is preferably hydrochlorate or sulfate, and the physiologically acceptable salt of described chlorphenamine is preferably maleate.
5. according to the described compound slow release preparation of claim 1～4, it is characterized in that: described ball core is by hydroxypropyl methylcellulose, the Sulisi aqueous dispersion, the water solublity coating powder, polyvinylpyrrolidone, ethyl cellulose, methylcellulose, Hydroxypropyl Methylcellulose Phathalate, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl-cellulose, hexadecanol, Rikemal B 200, stearic acid, glyceryl monostearate, Brazil wax, hydroxy methocel, polyvinyl alcohol, poly-phthalic acid vinyl acetate, polystyrene, carbopol, polrvinyl chloride, octadecanol, diethyl phthalate, dioctyl phthalate, Polyethylene Glycol, sodium alginate, chitosan, gelatin, Lac, pectin, guar gum, sucrose, lactose, starch, dextrin, Icing Sugar, low-substituted hydroxypropyl cellulose, cross linked polyvinyl pyrrolidone, cross-linking sodium carboxymethyl cellulose, mannitol, microcrystalline Cellulose, pregelatinized Starch, in the titanium dioxide one or more are made.
6. according to the described compound slow release preparation of claim 1～5, it is characterized in that: one or more during described coating is compared by ethyl cellulose, starch, Aquacoat, methylcellulose, acrylic resin, Opadry, Su Li are made.
7. according to the described compound slow release preparation of claim 1～6, be characterised in that: described preparation contain lubricant by magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, month hang in the pure magnesium sulfate one or more.
8. according to the described compound slow release preparation of claim 1～7, be characterised in that: described preparation contains wetting agent by in water, ethanol, dehydrated alcohol, chloroform, acetone, polyvidone, crospolyvinylpyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families one or more.
9. according to the described compound slow release preparation of claim 1～8, be characterised in that: described preparation contains coloring agent by ferrum oxide, amaranth, carmine, erythrosine, newly red, the lemon yellow of red, the red pigment of cowberry of red, beet red, lac, capsanthin, red rice, sunset yellow, indigo Huang, light blue, and one or more are made for the various pigments that strengthen the acid pigment of above-mentioned water solublity dispersibility in oils and fats.
10. according to the described compound slow release preparation of claim 1～9, it is characterized in that:
The release characteristic of pseudoephedrine or its physiologically acceptable salt is: 1h:20～65%, 2h:40～85%, 4h:60～90%, 8h: be not less than 70%.
The release characteristic of chlorphenamine or its physiologically acceptable salt is: 1h:30～65%, 2h:40～80%, 4h:60～90%, 8h: be not less than 80%.
11. according to the described compound slow release preparation of claim 1～10, it is characterized in that: described preparation is tablet, granule, capsule.
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| CN 200810246733 CN101766608B (en) | 2008-12-30 | 2008-12-30 | Compound pseudoephedrine hydrochloride slow release preparation and preparing method thereof |
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| CN 200810246733 CN101766608B (en) | 2008-12-30 | 2008-12-30 | Compound pseudoephedrine hydrochloride slow release preparation and preparing method thereof |
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| CN101766608B CN101766608B (en) | 2013-02-27 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012139262A1 (en) * | 2011-04-13 | 2012-10-18 | 赛乐医药科技(上海)有限公司 | Sustained-release preparation of compound methoxyphenamine |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1476898A (en) * | 2002-08-23 | 2004-02-25 | 涛 吴 | Compound skeleton tablet capable of prolonging release after oral administrationi for curing common cold |
| JP2007504239A (en) * | 2003-09-03 | 2007-03-01 | マリンクロッド・インコーポレイテッド | Granular sustained-release preparation and production thereof |
| CN100352507C (en) * | 2005-08-18 | 2007-12-05 | 西安东盛集团有限公司 | Osmotic pump controlled release formulation containing two active constituents of medicine and process for preparing the same |
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- 2008-12-30 CN CN 200810246733 patent/CN101766608B/en active Active
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012139262A1 (en) * | 2011-04-13 | 2012-10-18 | 赛乐医药科技(上海)有限公司 | Sustained-release preparation of compound methoxyphenamine |
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