CN100450548C - Oral patches containing pdacrilin resin composition and its preparing method - Google Patents
Oral patches containing pdacrilin resin composition and its preparing method Download PDFInfo
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- CN100450548C CN100450548C CNB2006101613605A CN200610161360A CN100450548C CN 100450548 C CN100450548 C CN 100450548C CN B2006101613605 A CNB2006101613605 A CN B2006101613605A CN 200610161360 A CN200610161360 A CN 200610161360A CN 100450548 C CN100450548 C CN 100450548C
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Abstract
An oral plaster contains proportionally the Balakelin resin composition, at least one biologically acceptable water-soluble polymer (the mixture of hydroxypropyl methylcellulose and maltose dextrin), and one of sorbitol, mannitol, xylitol and their mixture. Its preparing process is also disclosed.
Description
Technical field
Mouth paster of a kind of polacrilin resin combination of the present invention and preparation method thereof relates to a kind of mouth paster that contains polacrilin resin combination and the acceptable water-soluble polymer of at least a biology and preparation method thereof, have easy to carry than common oral preparation, mouthfeel is good, the compliance of taking medicine is good, characteristics such as onset is rapid are more conducive to treatment of diseases.
Background technology
The medicine of some diseases needs quick acting, such as removing cold symptoms medicine (for example pseudoephedrine, aspirin, acetaminophen and chlorphenamine maleate etc.), be used for the analgesic medicine, the medicine (for example Ondansetron Hydrochloride) of treatment vomiting, and ED medicine sildenafil citrate.Common, the most complete by the mode quick acting and the drug utilization of injection, but because drug administration by injection has misery, the patient is difficult to accept, often administration is especially true.Oral administration is the most acceptable administering mode of patient, maximum in the oral Preparation is conventional tablet, capsule and pill, conventional tablet, capsule and pill must first disintegrate under one's belt could begin to discharge medicine, onset is slow, bioavailability is low, need to use water delivery service, very inconvenient, the patient of old man, child and dysphagia is difficult to take.Oral liquid is as another kind of oral Preparation, though but quick acting needs soupspoon or glass when taking, take inconvenience especially under the situations such as driving, also be unfavorable for quantitatively taking, and carry also inconvenient simultaneously.The oral cavity disintegration tablet of later exploitation and oral instant-dissolving tablet then exist preparation technology complicated, need special installation, adopt the wet granule compression tablet prepared to exist disintegrate slow, and there is the shortcoming of undesirable, the frangible and easy moisture absorption of outward appearance in the lyophilization prepared.These defectives of oral Preparation make many medicine medication poor compliance, and then cause disease in time not treat, and have increased the weight of patient's misery.
At present, the polacrilin resin only limits to carry out flavoring as the carrier of oral sustained-release preparation Chinese medicine active component with to oral liquid Chinese medicine active component, does not have the polacrilin resin to be used for the report of mouth paster.
Summary of the invention
The objective of the invention is provides mouth paster of a kind of polacrilin resin combination and preparation method thereof at the above weak point of oral Preparation, this mouth paster is easy to carry, onset is rapid, can under anhydrous situation, take,, have good mouthfeel because the polacrilin resin combination has been covered the bitterness of active constituents of medicine, promoted patient's medication compliance greatly, help the timely treatment of disease, alleviated patient's misery, have considerable economic and social benefit.
A kind of mouth paster of polacrilin resin combination, it is characterized in that containing the polacrilin resin combination, and the acceptable water-soluble polymer of at least a biology, wherein the polacrilin resin combination is meant polacrilin resin and at least a active constituents of medicine material in conjunction with gained, its content is 0.1～80% of described mouth paster weight, and the content of biological acceptable water-soluble polymer is 20～99.9% of described mouth paster weight.
The chemical name of described polacrilin resin is: methacrylic acid and divinyl benzene polymers, and structural formula is:
Described active constituents of medicine is selected from a kind of or mixture in other form salt of dextromethorphan hydrobromide, diphhydramine hydrochloride, ambroxol hydrochloride, pseudoephedrine, aspirin, acetaminophen, chlorphenamine maleate, phenylephrine, sildenafil citrate and these active constituents of medicine.
The substance weight proportioning of polacrilin resin and active constituents of medicine is 1: 0.1～1, preferably 1: 0.4～0.7, and most preferred is 1: 0.5～0.6.
The acceptable water-soluble polymer of described biology is selected from a kind of or mixture in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, maltodextrin, amylopectin, hydroxyethyl-cellulose, polyvinyl alcohol, pectin, chondrus ocellatus Holmes polysaccharide, sodium alginate, potassium alginate, carboxymethyl cellulose, polyvidone, elsinan, Pullulan, xanthan gum, agar, gelatin, chitosan, the chitin.
Further experiment shows, the acceptable water-soluble polymer of described biology is a kind of or mixture in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, the maltodextrin preferably, is more preferably the mixture of hydroxypropyl emthylcellulose and maltodextrin.
Further experiment shows, described hydroxypropyl emthylcellulose preferred viscosities is less than the hydroxypropyl emthylcellulose of 60 centipoises, be more preferably the hydroxypropyl emthylcellulose of 3～15 centipoises, when hydroxypropyl emthylcellulose and maltodextrin weight proportion are 1: 0.1～2,, best preparation effect is arranged at preferably 1: 0.3～0.7 o'clock.
In order further to improve mouth paster melting and mouthfeel, we have added a kind of or mixture in the sorbitol, mannitol, xylitol of described mouth paster weight 5～30%, and find that sorbitol is optimum among the three.
The mouth paster of a kind of polacrilin resin combination of the present invention, its component can also comprise:
Account for 0.1～30% at least a flavoring agent of described mouth paster weight;
Account for 0.01～5% at least a coloring agent of described mouth paster weight;
Account for 0.1～5% at least a plasticizer of described mouth paster weight;
Account for 0.1～5% at least a antiseptic of described mouth paster weight;
Account for 0.1～10% at least a saliva stimulant of described mouth paster weight;
Account for 0.1～20% at least a disintegrating agent of described mouth paster weight;
Account for 0.1～20% water of described mouth paster weight.
Described flavoring agent is selected from a kind of or mixture in aspartame, sucralose, stevioside, glycyrrhizin, saccharin sodium, glucide, fructose, sucrose, maltose, essence, spice, the sodium glutamate.
Described coloring agent is selected from FD﹠amp; A kind of or mixture in C dyestuff, color lake, the pigment.
Described plasticizer is selected from a kind of or mixture in Polyethylene Glycol, glycerol, mono glycerinate, diglyceride, the polyethylene glycol oxide sorbitol ester.
Described antiseptic is selected from a kind of or mixture in methyl hydroxybenzoate, ethyl hydroxybenzoate, sodium benzoate, the potassium sorbate.
Described saliva stimulant is selected from a kind of or mixture in citric acid, tartaric acid, lactic acid, the fumaric acid.
Described disintegrating agent is selected from a kind of or mixture in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, the pregelatinized Starch.
The water that contains mouth paster weight 0.1～20% can guarantee that mouth paster has the intensity and the toughness of suitable cutting packing.
A kind of preparation method of mouth paster of polacrilin resin combination is to take following scheme to realize:
Get the polacrilin resin, join in the sodium hydroxide solution of 1.0mol/L, stirred 1～3 hour, sucking filtration is waited to drain the back and is slowly washed filter bed with deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 1.0mol/L again, stirs sucking filtration 1～3 hour, drain the back and slowly wash filter bed, drain standby with deionized water;
Other thing active component of getting it filled, wherein the substance weight proportioning of polacrilin resin and active constituents of medicine is 1: 0.1～1, adds deionized water, adds the above-mentioned polacrilin resin of draining again, 50～80 ℃ of insulations, stirred 6～10 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with deionized water, drain back reuse ethanol and slowly wash filter bed, continue to drain, the gained solid is put vacuum drying under 40～60 ℃ of environment, promptly gets the polacrilin resin combination;
Water soluble ingredient that will be except that water-soluble polymer is soluble in water, obtains aqueous solution;
The acceptable water-soluble polymer of at least a biology is joined in the aqueous solution under stirring, and fully dispersed with stirring obtains polymer gel;
Add plasticizer and stir at above-mentioned polymer gel;
Add polacrilin resin combination and other components and stir and obtain polacrilin resin combination gel;
The degassing, uniformly with polacrilin resin combination gel coating on flat board;
Air blast heat drying, heat drying temperature are 40～90 ℃, and intermediate detects, and cut, and pack, and promptly obtain the mouth paster of described polacrilin resin combination.
A kind of mouth paster of polacrilin resin combination, contain polacrilin resin combination and the acceptable water-soluble polymer of at least a biology, wherein the content of polacrilin resin combination is 0.1～80% of mouth paster weight, and the content of biological acceptable water-soluble polymer is 20～99.9% of mouth paster weight.The substance weight proportioning of polacrilin resin and active constituents of medicine is 1: 0.1～1, preferably 1: 0.4～0.7, and most preferred is 1: 0.5～0.6.Biological acceptable water-soluble polymer is the mixture of hydroxypropyl emthylcellulose and maltodextrin preferably, and weight proportion is 1: 0.1～2, and preferably 1: 0.3～0.7.Also a kind of or mixture of the sorbitol by adding mouth paster weight 5～30%, mannitol, xylitol has significantly improved mouth paster melting and mouthfeel.This mouth paster is easy to carry, onset is rapid, can under anhydrous situation, take,, have good mouthfeel because the polacrilin resin combination has been covered the bitterness of active constituents of medicine, promoted patient's medication compliance greatly, the patient of suitable especially child old man and dysphagia takes medicine, and steady quality helps the timely treatment of disease, alleviate patient's misery, had considerable economic and social benefit.
The specific embodiment
Further specify the present invention below by embodiment.Should correct understanding be: embodiments of the invention are only used for the present invention is described and provide, rather than limitation of the present invention, 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:
Get 100g polacrilin resin, join in the sodium hydroxide solution of 1L 1.0mol/L, stirred 2 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with the 2L deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 2L 1.0mol/L again, stirs sucking filtration 2 hours, drain the back and slowly wash filter bed, drain standby with the 4L deionized water.
Other gets the 100g diphhydramine hydrochloride, add the 1L deionized water, add the above-mentioned polacrilin resin of draining again, 60 ℃ of insulations were stirred 7 hours, sucking filtration, wait to drain the back and slowly wash filter bed, drain back reuse 1L ethanol and slowly wash filter bed, continue to drain with the 4L deionized water, the gained solid is put vacuum drying under 50 ℃ of environment, promptly gets polacrilin resin/diphhydramine hydrochloride composition I.
Embodiment 2:
Get 100g polacrilin resin, join in the sodium hydroxide solution of 1L 1.0mol/L, stirred 2 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with the 2L deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 2L 1.0mol/L again, stirs sucking filtration 2 hours, drain the back and slowly wash filter bed, drain standby with the 4L deionized water.
Other gets the 50g diphhydramine hydrochloride, add the 1L deionized water, add the above-mentioned polacrilin resin of draining again, 60 ℃ of insulations were stirred 6 hours, sucking filtration, wait to drain the back and slowly wash filter bed, drain back reuse 1L ethanol and slowly wash filter bed, continue to drain with the 4L deionized water, the gained solid is put vacuum drying under 50 ℃ of environment, promptly gets polacrilin resin/diphhydramine hydrochloride composition I I.
Embodiment 3:
Get 100g polacrilin resin, join in the sodium hydroxide solution of 1L 1.0mol/L, stirred 2 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with the 2L deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 2L 1.0mol/L again, stirs sucking filtration 1 hour, drain the back and slowly wash filter bed, drain standby with the 4L deionized water.
Other gets the 200g dextromethorphan hydrobromide, add the 1L deionized water, add the above-mentioned polacrilin resin of draining again, 80 ℃ of insulations were stirred 9 hours, sucking filtration, wait to drain the back and slowly wash filter bed, drain back reuse 1L ethanol and slowly wash filter bed, continue to drain with the 4L deionized water, the gained solid is put vacuum drying under 60 ℃ of environment, promptly gets polacrilin resin/dextromethorphan hydrobromide composition I.
Embodiment 4:
Get 100g polacrilin resin, join in the sodium hydroxide solution of 1L 1.0mol/L, stirred 2 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with the 2L deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 2L 1.0mol/L again, stirs sucking filtration 1 hour, drain the back and slowly wash filter bed, drain standby with the 4L deionized water.
Other gets the 100g dextromethorphan hydrobromide, add the 1L deionized water, add the above-mentioned polacrilin resin of draining again, 80 ℃ of insulations were stirred 8 hours, sucking filtration, wait to drain the back and slowly wash filter bed, drain back reuse 1L ethanol and slowly wash filter bed, continue to drain with the 4L deionized water, the gained solid is put vacuum drying under 50 ℃ of environment, promptly gets polacrilin resin/dextromethorphan hydrobromide composition I I.
Embodiment 5:
Get 100g polacrilin resin, join in the sodium hydroxide solution of 1L 1.0mol/L, stirred 2 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with the 2L deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 2L 1.0mol/L again, stirs sucking filtration 1 hour, drain the back and slowly wash filter bed, drain standby with the 4L deionized water.
Other gets the 60g dextromethorphan hydrobromide, add the 1L deionized water, add the above-mentioned polacrilin resin of draining again, 80 ℃ of insulations were stirred 6 hours, sucking filtration, wait to drain the back and slowly wash filter bed, drain back reuse 1L ethanol and slowly wash filter bed, continue to drain with the 4L deionized water, the gained solid is put vacuum drying under 50 ℃ of environment, promptly gets polacrilin resin/dextromethorphan hydrobromide composition I II.
Embodiment 6:
Get 100g polacrilin resin, join in the sodium hydroxide solution of 1L 1.0mol/L, stirred 2 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with the 2L deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 2L 1.0mol/L again, stirs sucking filtration 2 hours, drain the back and slowly wash filter bed, drain standby with the 4L deionized water.
Other gets the 50g ambroxol hydrochloride, add the 1L deionized water, add the above-mentioned polacrilin resin of draining again, 50 ℃ of insulations were stirred 6 hours, sucking filtration, wait to drain the back and slowly wash filter bed, drain back reuse 1L ethanol and slowly wash filter bed, continue to drain with the 4L deionized water, the gained solid is put vacuum drying under 40 ℃ of environment, promptly gets polacrilin resin/ambroxol hydrochloride composition.
Embodiment 7:
Polacrilin resin combination mouth paster dissolves the time limit algoscopy:
Appoint and to get 10 of mouth pasters, get 1 at every turn, shut up one side of chamber paster of the clip that is about 2cm with a folder mouth connects in the water-bath that clip immerses 37 ℃ together, uses manual time-keeping, mouth paster from immersion water to dissolving and the time of dialysis clip is and dissolves the time limit.
Embodiment 8:
Dextromethorphan hydrobromide 55g
Hydroxypropyl emthylcellulose (4000 centipoise) 150g
Purified water 1000g
Hydroxypropyl emthylcellulose (4000 centipoise) with above-mentioned amount joins in the aqueous solution under stirring earlier, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add dextromethorphan hydrobromide again and stir and obtain dextromethorphan hydrobromide/hydroxypropyl emthylcellulose gel, the degassing, with dextromethorphan hydrobromide/hydroxypropyl emthylcellulose gel coating on flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing, the dextromethorphan hydrobromide mouth paster that obtains, this mouth paster is white in color, pliable and tough, it is extremely slow that inlet dissolves dispersion, and flavor is extremely bitter, and mouthfeel is poor, thickness is difficult to accept.
Embodiment 9:
Polacrilin resin/dextromethorphan hydrobromide composition I 82.5g
Hydroxypropyl emthylcellulose (15000 centipoise) 20g
Purified water 1000g
Hydroxypropyl emthylcellulose (15000 centipoise) with above-mentioned amount joins in the aqueous solution under stirring earlier, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/dextromethorphan hydrobromide composition I that embodiment 3 makes again and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and toughness is general, and is frangible, and inlet dissolves and disperses slowly, mildly bitter flavor, and mouthfeel is poor, and the thickness sense is arranged.
Embodiment 10:
Polacrilin resin/dextromethorphan hydrobromide composition I 82.5g
Hydroxypropyl emthylcellulose (100 centipoise) 200g
Purified water 1000g
Hydroxypropyl emthylcellulose (100 centipoise) with above-mentioned amount joins in the aqueous solution under stirring earlier, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/dextromethorphan hydrobromide composition I that embodiment 3 makes again and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and it is slower that inlet dissolves dispersion, mildly bitter flavor, and mouthfeel is poor, and the thickness sense is arranged.
Embodiment 11:
Polacrilin resin/dextromethorphan hydrobromide composition I I 110g
Hydroxypropyl emthylcellulose (60 centipoise) 150g
Purified water 1000g
Hydroxypropyl emthylcellulose (60 centipoise) with above-mentioned amount joins in the aqueous solution under stirring earlier, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/dextromethorphan hydrobromide composition I I that embodiment 4 makes again and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, does not have obvious bitterness, and mouthfeel is general, is limited to 46s when dissolving.
Embodiment 12:
Polacrilin resin/dextromethorphan hydrobromide composition I II 150g
Hydroxypropyl cellulose 200g
Aspartame 5g
Purified water 1000g
First aspartame with above-mentioned amount is dissolved in purified water and obtains aqueous solution, hydroxypropyl cellulose with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains hydroxypropyl cellulose gel, add polacrilin resin/dextromethorphan hydrobromide composition I II that embodiment 5 makes again and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and mouthfeel is general, is limited to 57s when dissolving.
Embodiment 13:
Diphhydramine hydrochloride 125g
Hydroxypropyl cellulose 200g
Aspartame 5g
Purified water 1000g
First aspartame with above-mentioned amount is dissolved in purified water and obtains aqueous solution, hydroxypropyl cellulose with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains hydroxypropyl cellulose gel, add diphhydramine hydrochloride again and stir and obtain diphhydramine hydrochloride/hydroxypropyl cellulose gel, the degassing, uniformly diphhydramine hydrochloride/hydroxypropyl cellulose gel is coated on the flat board, 70 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains the diphhydramine hydrochloride mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, and flavor is extremely bitter, and mouthfeel is poor, is limited to 61s when dissolving.
Embodiment 14:
Polacrilin resin/diphhydramine hydrochloride composition I 250g
Maltodextrin 1500g
Purified water 1000g
Maltodextrin with above-mentioned amount joins in the aqueous solution under stirring earlier, fully dispersed with stirring obtains the maltodextrin gel, add polacrilin resin/diphhydramine hydrochloride composition I that embodiment 1 makes again and stir and obtain polacrilin resin/diphhydramine hydrochloride composition gels, the degassing, uniformly polacrilin resin/diphhydramine hydrochloride composition gels is coated on the flat board, 70 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/diphhydramine hydrochloride compositions mouth paster.This mouth paster is white in color, and toughness is general, and is frangible, and hygroscopicity is strong, and inlet dissolves dispersion rapidly, and mildly bitter flavor has the fragrance of corn, and mouthfeel is general, is limited to 22s when dissolving.
Embodiment 15:
Polacrilin resin/diphhydramine hydrochloride composition I I 375g
Hydroxypropyl emthylcellulose (15 centipoise) 200g
Maltodextrin 150g
Purified water 1000g
Earlier that the maltodextrin of above-mentioned amount is soluble in water, obtain maltodextrin aqueous solution, hydroxypropyl emthylcellulose (15 centipoise) with above-mentioned amount joins in the maltodextrin aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/diphhydramine hydrochloride composition I I that embodiment 2 makes again and stir and obtain polacrilin resin/diphhydramine hydrochloride composition gels, the degassing, uniformly polacrilin resin/diphhydramine hydrochloride composition gels is coated on the flat board, 70 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/diphhydramine hydrochloride compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, does not have obvious bitterness, and mouthfeel is better, is limited to 36s when dissolving.
Embodiment 16:
Polacrilin resin/ambroxol hydrochloride composition 450g
Hydroxypropyl emthylcellulose (3 centipoise) 200g
Maltodextrin 100g
Sucralose 10g
Purified water 1000g
Earlier that the maltodextrin and the sucralose of above-mentioned amount is soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (3 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/ambroxol hydrochloride composition that embodiment 6 makes again and stir and obtain polacrilin resin/ambroxol hydrochloride composition gel, the degassing, uniformly with polacrilin resin/ambroxol hydrochloride composition gel coating on flat board, 65 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/ambroxol hydrochloride composition mouth paster.This mouth paster is white in color, and toughness is general, and inlet dissolves dispersion rapidly, good mouthfeel, and it is sweet to distinguish the flavor of, and is limited to 27s when dissolving.
Embodiment 17:
Polacrilin resin/ambroxol hydrochloride composition 450g
Hydroxypropyl emthylcellulose (60 centipoise) 100g
Maltodextrin 300g
Aspartame 10g
Purified water 1000g
Earlier that the maltodextrin and the aspartame of above-mentioned amount is soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (60 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/ambroxol hydrochloride composition that embodiment .6 makes again and stir and obtain polacrilin resin/ambroxol hydrochloride composition gel, the degassing, uniformly with polacrilin resin/ambroxol hydrochloride composition gel coating on flat board, 65 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/ambroxol hydrochloride composition mouth paster.This mouth paster is white in color, and toughness is general, and inlet dissolves dispersion rapidly, good mouthfeel, and it is sweet to distinguish the flavor of, and is limited to 26s when dissolving.
Embodiment 18:
Polacrilin resin/dextromethorphan hydrobromide composition I II 150g
Amylopectin 350g
Maltodextrin 150g
Stevioside 10g
Polyethylene Glycol-200 5g
Purified water 1000g
Earlier that the maltodextrin and the stevioside of above-mentioned amount is soluble in water, obtain aqueous solution, amylopectin with above-mentioned amount joins in the maltodextrin aqueous solution under stirring again, fully dispersed with stirring obtains the amylopectin gel, add Polyethylene Glycol-200 again and stir, add polacrilin resin/dextromethorphan hydrobromide composition I II that embodiment 5 makes at last and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, good mouthfeel, and it is sweet to distinguish the flavor of, and is limited to 41s when dissolving.
Embodiment 19:
Polacrilin resin/dextromethorphan hydrobromide composition I II 150g
Hydroxypropyl emthylcellulose (3 centipoise) 250g
Maltodextrin 100g
Aspartame 10g
Flavoring orange essence 20g
Glycerol 5g
Purified water 1000g
Earlier that the maltodextrin and the aspartame of above-mentioned amount is soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (3 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add glycerol again and stir, add polacrilin resin/dextromethorphan hydrobromide composition I II and the flavoring orange essence that embodiment 5 makes at last and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and strong Fructus Citri tangerinae fragrance is arranged, and good mouthfeel is limited to 24s when dissolving.
Embodiment 20:
Polacrilin resin/dextromethorphan hydrobromide composition I II 150g
Hydroxypropyl emthylcellulose (3 centipoise) 200g
Maltodextrin 50g
Sucralose 10g
Fructus Citri Limoniae essence 10g
Glycerol 5g
Ethyl hydroxybenzoate 2g
Citric acid 5g
Purified water 1000g
Elder generation is with the maltodextrin of above-mentioned amount, citric acid and sucralose are soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (3 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, get the ethyl hydroxybenzoate of above-mentioned amount, stir with joining again in the hydroxypropyl emthylcellulose gel after the glycerol heating for dissolving, add polacrilin resin/dextromethorphan hydrobromide composition I II and the Fructus Citri Limoniae essence that embodiment 5 makes at last and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and tart flavour is moderate, and joyful citrus scented is arranged, and mouthfeel is joyful, is limited to 41s when dissolving.
Embodiment 21:
Polacrilin resin/dextromethorphan hydrobromide composition I II 150g
Hydroxypropyl emthylcellulose (3 centipoise) 200g
Maltodextrin 100g
Sucralose 10g
Fructus Citri Limoniae essence 10g
Glycerol 5g
Ethyl hydroxybenzoate 2g
Citric acid 5g
Lemon yellow 2g
Purified water 1000g
Elder generation is with the maltodextrin of above-mentioned amount, citric acid and sucralose are soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (3 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, get the ethyl hydroxybenzoate of above-mentioned amount, stir with joining again in the hydroxypropyl emthylcellulose gel after the glycerol heating for dissolving, add polacrilin resin/dextromethorphan hydrobromide composition I II that embodiment 5 makes at last, Fructus Citri Limoniae essence and lemon yellow also stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is light yellow, and is pliable and tough, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and tart flavour is moderate, and joyful citrus scented is arranged, and mouthfeel is joyful, is limited to 26s when dissolving.
Embodiment 22:
Polacrilin resin/dextromethorphan hydrobromide composition I II 150g
Hydroxypropyl emthylcellulose (3 centipoise) 150g
Maltodextrin 50g
Sorbitol 150g
Sucralose 10g
Strawberry essence 10g
Glycerol 5g
Ethyl hydroxybenzoate 2g
Citric acid 5g
The red 5g of the certain kind of berries
Purified water 1000g
Elder generation is with the maltodextrin of above-mentioned amount, sorbitol, citric acid and sucralose are soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (3 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, get the ethyl hydroxybenzoate of above-mentioned amount, stir with joining again in the hydroxypropyl emthylcellulose gel after the glycerol heating for dissolving, add polacrilin resin/dextromethorphan hydrobromide composition I II that embodiment 5 makes at last, the strawberry essence and the certain kind of berries are red and stir and obtain polacrilin resin/dextromethorphan hydrobromide composition gels, the degassing, uniformly polacrilin resin/dextromethorphan hydrobromide composition gels is coated on the flat board, 80 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster.This mouth paster is certain kind of berries redness, and is pliable and tough, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and tart flavour is moderate, and with the fragrance of strong Fructus Fragariae Ananssae, mouthfeel is joyful, is limited to 21s when dissolving.
Embodiment 23:
Polacrilin resin/diphhydramine hydrochloride composition I I 375g
Hydroxypropyl emthylcellulose (3 centipoise) 200g
Maltodextrin 100g
Mannitol 100g
Pregelatinized Starch 100g
Sucralose 10g
Strawberry essence 10g
Polyethylene Glycol-400 5g
Sodium benzoate 5g
Tartaric acid 5g
Purified water 1000g
Elder generation is with the maltodextrin of above-mentioned amount, mannitol, sucralose, sodium benzoate and tartaric acid are soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (3 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/diphhydramine hydrochloride composition I I that embodiment 2 makes at last, pregelatinized Starch and strawberry essence also stir and obtain polacrilin resin/diphhydramine hydrochloride composition gels, the degassing, uniformly polacrilin resin/diphhydramine hydrochloride composition gels is coated on the flat board, 70 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/diphhydramine hydrochloride compositions mouth paster.This mouth paster is white in color, and is pliable and tough, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and tart flavour is moderate, and with the fragrance of strong Fructus Fragariae Ananssae, mouthfeel is joyful, is limited to 25s when dissolving.
Embodiment 24:
Polacrilin resin/ambroxol hydrochloride composition 450g
Hydroxypropyl emthylcellulose (15 centipoise) 200g
Maltodextrin 100g
Pyrusussuriensis 100g
Aspartame 10g
Blue berry essence 10g
Pregelatinized Starch 50g
Color lake (light blue) 5g
Purified water 1000g
Elder generation is with the maltodextrin of above-mentioned amount, sorbitol and aspartame are soluble in water, obtain aqueous solution, hydroxypropyl emthylcellulose (15 centipoise) with above-mentioned amount joins in the aqueous solution under stirring again, fully dispersed with stirring obtains the hydroxypropyl emthylcellulose gel, add polacrilin resin/ambroxol hydrochloride composition at last, blue berry essence, pregelatinized Starch and color lake (light blue) also stir and obtain polacrilin resin/ambroxol hydrochloride composition gel, the degassing, uniformly with polacrilin resin/ambroxol hydrochloride composition gel coating on flat board, 65 ℃ of air blast heat dryings, intermediate detects, cut, packing obtains described polacrilin resin/ambroxol hydrochloride composition mouth paster.It is blue, pliable and tough that this mouth paster is, and inlet dissolves dispersion rapidly, and it is sweet to distinguish the flavor of, and with the fragrance of blue berry, mouthfeel is joyful, is limited to 28s when dissolving.
Embodiment 25:
Described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster content is measured according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; So that acetonitrile (containing 0.007mol/L docusate sodium and 0.007mol/L ammonium nitrate)-water (65: 35) is mobile phase; The detection wavelength is 280nm.Number of theoretical plate calculates by the dextromethorphan hydrobromide peak and is not less than 2000, and the holder tail factor must not be greater than 2.5.
Algoscopy is got 20 of described polacrilin resins/dextromethorphan hydrobromide compositions mouth paster, the accurate title, decide, shred, precision takes by weighing in right amount (being equivalent to dextromethorphan hydrobromide 25mg approximately), put in the 25ml measuring bottle, add 1mol/L hydrochloric acid solution 2ml, the ultrasonic suspension that makes into, add 1mol/L sodium hydroxide solution 2ml neutralization, add mobile phase again and be diluted to scale, shake up, filter, precision is measured subsequent filtrate 5ml, put in the 25ml measuring bottle, add mobile phase and be diluted to scale, shake up, precision is measured 20 μ l and is injected chromatograph of liquid, the record chromatogram; It is an amount of that other gets the dextromethorphan hydrobromide reference substance, makes the solution that contains 0.2mg among every 1ml approximately with mobile phase dissolving and dilution, measures with method.Press external standard method with calculated by peak area, and result of calculation be multiply by 1.051, promptly.
Embodiment 26:
Described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster related substance is measured according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; So that acetonitrile (containing 0.007mol/L docusate sodium and 0.007mol/L ammonium nitrate)-water (65: 35) is mobile phase; The detection wavelength is 280nm. Number of theoretical plate calculates by the dextromethorphan hydrobromide peak and is not less than 2000, and the holder tail factor must not be greater than 2.5.
Get described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster and be cut into fragment, take by weighing an amount of (being equivalent to dextromethorphan hydrobromide 25mg approximately), put in the 25ml measuring bottle, add 1mol/L hydrochloric acid solution 2ml, the ultrasonic suspension that makes into adds 1mol/L sodium hydroxide solution 2ml neutralization, add mobile phase again and be diluted to scale, shake up, filter, get subsequent filtrate as need testing solution; Precision is measured need testing solution 1ml and is put in the 100ml measuring bottle, adds mobile phase and is diluted to scale, shakes up, in contrast solution.Get contrast solution 20 μ l, inject chromatograph of liquid, regulate detection sensitivity, make the peak height of main constituent chromatographic peak be about 20%～30% of full scale; Precision is measured need testing solution and each 20 μ l of contrast solution again, inject chromatograph of liquid respectively, the record chromatogram is to 2 times of main constituent peak retention time, in the need testing solution chromatogram if any impurity peaks, remove outside the adjuvant peak, impurity peak area and and single impurity peak area respectively with contrast solution main peak area relatively, it is an amount of to get the dextromethorphan hydrobromide reference substance, add the also quantitative dilution of mobile phase dissolving and make the solution that contains 1mg among every 1ml approximately, precision is measured 20 μ l and is injected chromatograph of liquid, and the record chromatogram is to 2 times of main constituent peak retention time.Calculate impurity peak area.
Embodiment 27:
Get described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster, carry out influence factor, accelerated test (40 ℃ ± 2 ℃, RH75% ± 5%) stability and long term test (25 ℃ ± 2 ℃, RH60% ± 10%) study on the stability by embodiment 1, embodiment 24 and embodiment 25, the results are shown in Table 1, table 2 and table 3.
Influence factor's result of the test shows: described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster illumination (placed 10 days under 4500Lx ± 500Lx), high temperature (40 ℃, 60 ℃), the high humidity conditions such as (25 ℃ of RH75%, 25 ℃ of RH92.5%), every investigation index such as character under each condition, dissolve time limit, content, related substance etc. and place before relatively there is no significant change.
Accelerated test result shows: described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster was placed 6 months under 40 ℃ ± 2 ℃, the condition of RH75% ± 5%, every investigation index such as character, dissolve time limit, content, related substance etc. and place before relatively there is no significant change.
Long-term test results shows: described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster kept sample 12 months under 25 ℃ ± 2 ℃, RH60% ± 10% condition, every investigation index such as character, dissolve time limit, content, related substance etc. and place before relatively there is no significant change.
This shows that described polacrilin resin/dextromethorphan hydrobromide compositions mouth paster has stability preferably, but safe storage.
Table 1 polacrilin resin/dextromethorphan hydrobromide compositions mouth paster influence factor tests the investigation result
Table 2 polacrilin resin/dextromethorphan hydrobromide compositions mouth paster accelerated test study on the stability result
Table 3 polacrilin resin/dextromethorphan hydrobromide compositions mouth paster long term test study on the stability result
Claims (9)
1, a kind of mouth paster of polacrilin resin combination, it is characterized in that containing the polacrilin resin combination, and the acceptable water-soluble polymer of at least a biology, wherein the polacrilin resin combination is meant polacrilin resin and active constituents of medicine dextromethorphan hydrobromide, diphhydramine hydrochloride, a kind of or mixture in the ambroxol hydrochloride is in conjunction with the material of gained, its content is 0.1～80% of described mouth paster weight, the substance weight proportioning of polacrilin resin and active constituents of medicine is 1: 0.1～1, and the content of biological acceptable water-soluble polymer is 20～99.9% of described mouth paster weight;
The preparation method of the mouth paster of described polacrilin resin combination is:
Get the polacrilin resin, join in the sodium hydroxide solution of 1.0mol/L, stirred 1～3 hour, sucking filtration is waited to drain the back and is slowly washed filter bed with deionized water, continue to drain, the polacrilin resin of gained joins in the sodium hydroxide solution of 1.0mol/L again, stirs sucking filtration 1～3 hour, drain the back and slowly wash filter bed, drain standby with deionized water;
Other thing active component of getting it filled, wherein the substance weight proportioning of polacrilin resin and active constituents of medicine is 1: 0.1～1, adds deionized water, adds the above-mentioned polacrilin resin of draining again, 50～80 ℃ of insulations, stirred 6～10 hours, sucking filtration is waited to drain the back and is slowly washed filter bed with deionized water, drain back reuse ethanol and slowly wash filter bed, continue to drain, the gained solid is put vacuum drying under 40～60 ℃ of environment, promptly gets the polacrilin resin combination;
Water soluble ingredient that will be except that water-soluble polymer is soluble in water, obtains aqueous solution;
The acceptable water-soluble polymer of at least a biology is joined in the aqueous solution under stirring, and fully dispersed with stirring obtains polymer gel;
In above-mentioned polymer gel, add plasticizer and stir;
Add polacrilin resin combination and other components and stir and obtain polacrilin resin combination gel;
The degassing, uniformly with polacrilin resin combination gel coating on flat board;
Air blast heat drying, heat drying temperature are 40～90 ℃, and intermediate detects, and cut, and pack, and promptly obtain the mouth paster of described polacrilin resin combination.
2, the mouth paster of polacrilin resin combination according to claim 1 is characterized in that the acceptable water-soluble polymer of described biology is selected from a kind of or mixture in hydroxypropyl emthylcellulose, hydroxypropyl cellulose, maltodextrin, amylopectin, hydroxyethyl-cellulose, polyvinyl alcohol, pectin, chondrus ocellatus Holmes polysaccharide, sodium alginate, potassium alginate, carboxymethyl cellulose, polyvidone, elsinan, xanthan gum, agar, gelatin, chitosan, the chitin.
3, the mouth paster of polacrilin resin combination according to claim 2 is characterized in that the acceptable water-soluble polymer of described biology is a kind of or mixture of hydroxypropyl emthylcellulose, hydroxypropyl cellulose, maltodextrin.
4, the mouth paster of polacrilin resin combination according to claim 3 is characterized in that the acceptable water-soluble polymer of described biology is the mixture of hydroxypropyl emthylcellulose and maltodextrin.
5, the mouth paster of polacrilin resin combination according to claim 4 is characterized in that described hydroxypropyl emthylcellulose viscosity is 3～60 centipoises.
6, the mouth paster of polacrilin resin combination according to claim 4 is characterized in that described hydroxypropyl emthylcellulose and maltodextrin weight proportion are 1: 0.1～2.
7, the mouth paster of polacrilin resin combination according to claim 1 is characterized in that also containing a kind of or mixture of the sorbitol that accounts for described mouth paster weight 5～30%, mannitol, xylitol.
8, the mouth paster of polacrilin resin combination according to claim 1 is characterized in that also comprising the acceptable component of other biological: flavoring agent, coloring agent, plasticizer, antiseptic, saliva stimulant, disintegrating agent and water.
9, the mouth paster of polacrilin resin combination according to claim 8 is characterized in that described flavoring agent is selected from a kind of or mixture in aspartame, sucralose, stevioside, glycyrrhizin, saccharin sodium, glucide, fructose, sucrose, maltose, essence, the sodium glutamate; Coloring agent is selected from a kind of or mixture in color lake, the pigment; Plasticizer is selected from a kind of or mixture in Polyethylene Glycol, glycerol, mono glycerinate, diglyceride, the polyethylene glycol oxide sorbitol ester; Antiseptic is selected from a kind of or mixture in methyl hydroxybenzoate, ethyl hydroxybenzoate, sodium benzoate, the potassium sorbate; Saliva stimulant is selected from a kind of or mixture in citric acid, tartaric acid, lactic acid, the fumaric acid; Disintegrating agent is selected from a kind of or mixture in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, the pregelatinized Starch.
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| CNB2006101613605A CN100450548C (en) | 2006-12-22 | 2006-12-22 | Oral patches containing pdacrilin resin composition and its preparing method |
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| CNB2006101613605A CN100450548C (en) | 2006-12-22 | 2006-12-22 | Oral patches containing pdacrilin resin composition and its preparing method |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1027133C (en) * | 1988-05-11 | 1994-12-28 | 格拉克索公司 | Drug adsorbates |
| CN1095666C (en) * | 1994-09-14 | 2002-12-11 | 史密斯克莱·比奇曼公司 | Codeine contg. formulations |
| WO2005065640A1 (en) * | 2004-01-06 | 2005-07-21 | Panacea Biotec Ltd. | Compositions of buccal dosage forms for extended drug release and the process of preparing such compositions |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1027133C (en) * | 1988-05-11 | 1994-12-28 | 格拉克索公司 | Drug adsorbates |
| CN1095666C (en) * | 1994-09-14 | 2002-12-11 | 史密斯克莱·比奇曼公司 | Codeine contg. formulations |
| WO2005065640A1 (en) * | 2004-01-06 | 2005-07-21 | Panacea Biotec Ltd. | Compositions of buccal dosage forms for extended drug release and the process of preparing such compositions |
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