CN101766608B - 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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- CN101766608B CN101766608B CN 200810246733 CN200810246733A CN101766608B CN 101766608 B CN101766608 B CN 101766608B CN 200810246733 CN200810246733 CN 200810246733 CN 200810246733 A CN200810246733 A CN 200810246733A CN 101766608 B CN101766608 B CN 101766608B
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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 ofly take pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt as the slow releasing preparation of active component, 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 saying without specific therapy, therefore virus is firm then unnecessary, can only adopt symptomatic treatment to impel many remissions of flu.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 the ingredients compound recipe of different curative effects to be used for alleviating simultaneous different symptoms.There is multiple symptom such as patient, particularly at common cold initial stage, then suits the medicine to the illness and use suitable compound preparation than more suitable with several individual event medicines, sometimes also more economical.
Pseudoephedrine claims again d-pseudephedrine, is the optical isomer of ephedrine, and the two is by extracting gained in Herba Ephedrae or the ephedra equisetina grass, but present synthetic.Pseudoephedrine is by stimulating SNE to discharge norepinephrine, indirectly play sympatheticomimetic action, its preventing respiratory is identical with effect and the ephedrine of nasal congestion, but boosting only is 1/5 of 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 smooth breathing, be used for 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 belongs to the antihistamine drug of early stage classics mainly with the treatment anaphylactic disease, is used for the treatment of clinically anaphylactic disease, for example: seasonality and chronic rhinitis, urticaria and pruritus.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 clinic symptom of alleviating above-mentioned disease are such as symptoms such as sneeze, rhinorrhea, nasal obstructions.Since pseudoephedrine and chlorphenamine using dosage, rate of release, and the difference of the aspects such as absorbance need to provide a kind of both releases, absorption to reach synchronously, in order to 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:
Slow releasing preparation take pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt as active component of the present invention, it is characterized in that, described delivery system is comprised of ball core and/or the coating that can make sustained release, 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, new yellow, the light blue of red, the lemon yellow of red, the red pigment of cowberry of red, beet red, lac, capsanthin, red rice, sunset yellow, indigo, 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 effect of performance compound medicine Synergistic, and the release of three kinds of active component of slow releasing preparation of the present invention, absorb and 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, namely 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 the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) pseudoephedrine hydrochloride in the 0.1mol/L hydrochloric acid solution.
Fig. 2 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) chlorphenamine maleate in the 0.1mol/L hydrochloric acid solution.
Fig. 3 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) pseudoephedrine hydrochloride in the pH6.8 phosphate buffer.
Fig. 4 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) chlorphenamine maleate in the pH6.8 phosphate buffer.
Fig. 5 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) pseudoephedrine hydrochloride in water.
Fig. 6 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) chlorphenamine maleate in water.
Fig. 7 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) pseudoephedrine hydrochloride in pH4.0 citric acid-sodium hydrogen phosphate buffer.
Fig. 8 is the compound pseudoephedrine hydrochloride slow release capsule of embodiment 2 preparations and the release profiles comparison diagram of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) chlorphenamine maleate in pH4.0 citric acid-sodium hydrogen phosphate buffer.
The specific embodiment
By following examples of the present invention doing further as the slow releasing preparation of active component take, pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt specified, but not as limitation of the present invention.
Prescription:
Pseudoephedrine hydrochloride 90g
Chlorphenamine maleate 4g
Hydroxypropyl methylcellulose K4M 50g
Microcrystalline Cellulose 80g
5% PVP K30 aqueous solution is an amount of
Magnesium stearate is an amount of
Pure water is an amount of
Make 1000 (grains)
Preparation method:
(1) preparation hydroxypropyl methylcellulose, the microcrystalline Cellulose of granule sieve respectively mix homogeneously.Add successively again pseudoephedrine hydrochloride, chlorphenamine maleate, abundant mixing, take 5% PVP K30 aqueous solution as binding agent soft material processed, 20 mesh sieves wet granular processed, 50 ℃ of dryings, 20 mesh sieve granulate, for subsequent use.
(2) in (1) gained granule, add an amount of magnesium stearate, mix homogeneously, tabletting namely gets tablet.
(3) get (1) gained particle packing in the hungry area softgel shell, namely 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 hypromellose E5 1% aqueous solution of hydrochloric pseudoephedrine 40%, and is for subsequent use.
1.3 get the aqueous dispersion that the Sulisi thin up becomes to include solid content 15%, shake up for subsequent use.
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, carry out the end with the upper drug solns for preparing and spray medicine, 43 ± 2 ℃ of control temperature of charge have sprayed an amount of purified water detergent line of rear usefulness.
Approximately 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 approximately and 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 approximately and 3% can finish.
1.8 solidify: get and make micropill and place under 60 ℃ of conditions, leave standstill and solidified one hour, and get final product.
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 for subsequent use.
Place fluid bed 2.3 get fine pellet core, carry out the end with the solution for preparing and spray medicine, 53 ± 2 ℃ of control temperature of charge have sprayed an amount of purified water detergent line of rear usefulness.
2.4 continue spray 10% hypromellose E5 aqueous solution, 43 ± 2 ℃ of control temperature of charge, coating increase weight approximately 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 for subsequent use.
3.2 get light water dissolubility coating powder (white), water is mixed with white water dissolubility 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 approximately and 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 approximately and 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, and get final product.
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 for subsequent use.
4.2 get light water dissolubility coating powder (white), water is mixed with white water dissolubility 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 approximately and 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 approximately and 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, and get final product.
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, and are mixed eventually.6 fill capsule No. 2, and get final product.
In order further to investigate release in vitro effect of the present invention, we are according to drug release determination method (two appendix XD of Chinese Pharmacopoeia version in 2005 first method), apparatus is pressed dissolution method the second subtraction unit, has measured the vitro release of the compound pseudoephedrine hydrochloride slow release capsule of the embodiment of the invention 2 preparations.
Take degassed 0.1mol/L hydrochloric acid solution 500ml as dissolution medium, rotating speed is that per minute 100 turns, and operation in the time of 1,2,4 and 8 hour, is respectively got approximately 5ml of solution in accordance with the law, filters, and discards just filtrate, gets subsequent filtrate, as need testing solution.Precision takes by weighing pseudoephedrine hydrochloride 18.0mg, puts in the 100ml measuring bottle, and the hydrochloric acid solution that adds 0.1mol/L is 70ml approximately, and jolting makes dissolving; In addition precision take by weighing chlorphenamine maleate approximately 20mg put in the 50ml measuring bottle, add the 0.1mol/L hydrochloric acid solution and be diluted to scale, shake up, precision measures 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 measures reference substance solution and each 40 μ l of need testing solution, respectively in the injection liquid chromatography, number of theoretical plate must not be less than 4000 by pseudoephedrine hydrochloride, with each active component peak area, calculate respectively every capsules at the stripping quantity of different time by external standard method.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 (New contac capsule) in different pH value release medium the release profiles comparative study the results are shown in accompanying drawing.
Result of the test shows, has concordance according to compound pseudoephedrine hydrochloride slow release capsule and the behavior of compound pseudoephedrine hydrochloride slow release capsule (New contac capsule) release in vitro of embodiment 2 preparations.
Claims (12)
1. compound slow release preparation take pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt as active component, it comprises a kind of delivery system, it is characterized in that: described delivery system is comprised of ball core and/or the coating that can make sustained release, and described active component all is present in the ball core; Wherein, pseudoephedrine or its physiologically acceptable salt and chlorphenamine or its physiologically acceptable salt all are slow release and discharge synchronously.
2. compound slow release preparation according to claim 1 is characterized in that: contain pseudoephedrine or its physiologically acceptable salt 30～360mg in each dosage unit, chlorphenamine or its physiologically acceptable salt 1～36mg.
3. compound slow release preparation according to claim 2, it is characterized in that: described pseudoephedrine or its physiologically acceptable salt are 60～240mg, described chlorphenamine or its physiologically acceptable salt are 2～12mg.
4. compound slow release preparation according to claim 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.
5. compound slow release preparation according to claim 4, it is characterized in that: the physiologically acceptable salt of described pseudoephedrine is hydrochlorate or sulfate, the physiologically acceptable salt of described chlorphenamine is maleate.
6. compound slow release preparation according to claim 5, 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.
7. compound slow release preparation according to claim 6 is characterized in that: described coating is made by in ethyl cellulose, starch, Aquacoat, methylcellulose, acrylic resin, Opadry, the Sulisi one or more.
8. want 7 described compound slow release preparations according to right, be characterised in that: described preparation also contains lubricant, and described lubricant is selected from one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, the magnesium laurylsulfate.
9. compound slow release preparation according to claim 8, be characterised in that: described preparation also contains wetting agent, and described wetting agent is selected from one or more in water, ethanol, dehydrated alcohol, chloroform, acetone, polyvidone, crospolyvinylpyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families.
10. compound slow release preparation according to claim 9, be characterised in that: described preparation contains coloring agent by ferrum oxide, amaranth, carmine, erythrosine, new yellow, the light blue of red, the lemon yellow of red, the red pigment of cowberry of red, beet red, lac, capsanthin, red rice, sunset yellow, indigo, 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.
11. compound slow release preparation according to claim 10 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%.
12. each described compound slow release preparation according to claim 1～11, 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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| CN101766608A CN101766608A (en) | 2010-07-07 |
| CN101766608B true CN101766608B (en) | 2013-02-27 |
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| CN102210687B (en) * | 2011-04-13 | 2013-05-15 | 赛乐医药科技(上海)有限公司 | Compound methoxyphenamine sustained release preparation |
Citations (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 |
| CN1733308A (en) * | 2005-08-18 | 2006-02-15 | 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 |
| CN1845722A (en) * | 2003-09-03 | 2006-10-11 | 马林克罗特公司 | Granular sustained release preparation and production thereof |
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2008
- 2008-12-30 CN CN 200810246733 patent/CN101766608B/en active Active
Patent Citations (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 |
| CN1845722A (en) * | 2003-09-03 | 2006-10-11 | 马林克罗特公司 | Granular sustained release preparation and production thereof |
| CN1733308A (en) * | 2005-08-18 | 2006-02-15 | 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 |
Non-Patent Citations (1)
| Title |
|---|
| 吕长淮.复方盐酸伪麻黄碱缓释胶囊的薄层色谱鉴别方法.《安徽医药》.2007,第11卷(第11期),第1004-1005页. * |
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