CN102309468A - Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof - Google Patents
Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof Download PDFInfo
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- CN102309468A CN102309468A CN201110285809A CN201110285809A CN102309468A CN 102309468 A CN102309468 A CN 102309468A CN 201110285809 A CN201110285809 A CN 201110285809A CN 201110285809 A CN201110285809 A CN 201110285809A CN 102309468 A CN102309468 A CN 102309468A
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Abstract
The present invention discloses levalbuterol hydrochloride oral controlled release tablet capsule and a preparation method thereof. The tablet capsule has a characteristic of drug controlled release according to the human circadian rhythm. The levalbuterol hydrochloride oral controlled release tablet capsule comprises a capsule and tablets inside the capsule. The tablets respectively comprise the levalbuterol hydrochloride pulsed tablet and the levalbuterol hydrochloride controlled release tablet. In the levalbuterol hydrochloride pulsed tablet and the levalbuterol hydrochloride controlled release tablet, the drug release rate are controlled according to adjustments of the drug carrier, the ratio of the drug carrier to the drug, the material and the thickness of the coating film, such that the levalbuterol hydrochloride is controlledly released on the attack nodes of the asthma patient. The preparation method provided by the present invention has advantages of short preparation period, easy operation, green environmental protection and low preparation cost, and is applicable for the industrial production.
Description
Technical field
The present invention relates to field of medicaments, relate in particular to a kind of albuterol hydrochloride oral controlled-release tablet capsule and preparation method thereof.
Background technology
Husky amine butanols is β
2Selective receptor agonists, the β on the alternative exciting bronchial smooth muscle
2Receptor makes bronchial smooth muscle lax, thereby removes bronchial muscular spasm, is the choice drug of treating asthma attack clinically.In recent years, along with the development of chronobiology and chronopharmacology, finder's multiple physical signs and some disease demonstrate the characteristics of rhythmicity.The dyspnea outbreak of asthmatic patient presents white-variation in daytime, and be the high-incidence season of asthma morning, thereby the desirable mode of administration of bronchial antispasmodic should be 12 administrations in morning and is maintained to point in early mornings 8.In the prior art; Though the existing controlled release drug (referring to number of patent application CN200410016125.X) that is directed against the rhythmicity characteristics of asthmatic patient outbreak, its preparation method exists manufacturing cycle long, and process is complicated; Paraffin for example with an organic solvent in a large number; Environment is caused potentially contaminated, and preparation cost is high, is unfavorable for the shortcoming of suitability for industrialized production.
Therefore, existing albuterol controlled release technology of preparing awaits to improve and improve.
Summary of the invention
Deficiency in view of above-mentioned prior art; The object of the present invention is to provide a kind of method for preparing of albuterol hydrochloride oral controlled-release tablet capsule of rhythmicity characteristics of suitable asthmatic patient outbreak; Be intended to solve organic solvent that long, a large amount of uses of complex process, manufacturing cycle that exist in the pharmaceutical dosage forms for controlled release method for preparing of existing treatment asthma can not harmless treatment for example paraffin, defect of high cost, so that suitability for industrialized production.
Technical scheme of the present invention is following:
A kind of method for preparing of albuterol hydrochloride oral controlled-release tablet capsule; Wherein, Be filled with a grain of salt acid Levalbuterol pulse sheet and the sour Levalbuterol slow-release tablet of a grain of salt in the said albuterol hydrochloride oral controlled-release tablet capsule, said albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released are for recharging in the capsule after the film-making respectively; Said albuterol hydrochloride oral controlled-release tablet capsule is in the release of asthmatic patient outbreak node;
Said albuterol hydrochloride oral controlled-release tablet capsule its preparation method is:
S1, with albuterol hydrochloride, filler, dilatancy excipient, mix lubricant; Adopt direct compression process to process sheet; Obtain label; Then the insoluble low permeability material of label water successively, water solublity height are oozed material or enteric material coating, obtain albuterol hydrochloride pulse sheet;
S2, albuterol hydrochloride, filler are mixed; Add the alcoholic solution that contains binding agent and granulate, oven dry is sieved; Add the lubricant tabletting; Obtain label, insoluble and low permeability material, water solublity height ooze material or enteric material coating with label water successively then, obtain albuterol hydrochloride sustained-released;
S3, the albuterol hydrochloride pulse sheet of step S1 and albuterol hydrochloride sustained-released of step S2 are filled into respectively in the gelatine capsule, contain a grain of salt acid Levalbuterol pulse sheet and the sour Levalbuterol slow-release tablet of a grain of salt in every capsules.
With the resulting albuterol hydrochloride oral controlled-release of above-mentioned method for preparing tablet capsule; Wherein, Said albuterol hydrochloride oral controlled-release tablet capsule is made up of two tablets in capsule and the capsule, and said tablet is respectively a grain of salt acid Levalbuterol pulse sheet and a grain of salt acid Levalbuterol slow-release tablet;
In said albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released; Through regulating pharmaceutical carrier composition and the material of ratio and coating membrane and the thickness of coating membrane wherein; Control the rate of release of medicine, make albuterol hydrochloride in the release of asthmatic patient outbreak node.
Described albuterol hydrochloride oral controlled-release tablet capsule, wherein, said albuterol hydrochloride pulse sheet is made up of label and coating membrane, and said label is made up of the principal agent of pulsed dosage, pharmaceutically acceptable pharmaceutical carrier; The weight ratio of principal agent and pharmaceutical carrier is 1:1～3 in the said albuterol hydrochloride pulse sheet;
Said principal agent is an albuterol hydrochloride;
Said pharmaceutical carrier is one or more the mixture in filler, binding agent, surfactant, dilatancy excipient and the lubricant;
Said coating membrane is one or more the mixture in water-insoluble and low permeability material, water solublity hypertonicity material, enteric material, plasticizer and the lubricant.
Described albuterol hydrochloride oral controlled-release tablet capsule; Wherein, Form by label and coatings for said albuterol hydrochloride sustained-released; Said label is made up of principal agent, pharmaceutically acceptable pharmaceutical carrier, and the weight ratio of principal agent and pharmaceutical carrier is 1:1～3 in the said albuterol hydrochloride controlled release tablet;
Said principal agent is an albuterol hydrochloride;
Said pharmaceutical carrier is one or more the mixture in filler, binding agent, surfactant, dilatancy excipient and the lubricant;
Said coating membrane is one or more the mixture in water-insoluble and low permeability material, water solublity hypertonicity material, enteric material, plasticizer and the lubricant.
Described albuterol hydrochloride oral controlled-release tablet capsule; Wherein, Said albuterol hydrochloride pulse sheet is by the gross weight of label, and the percentage by weight of albuterol hydrochloride, filler, dilatancy excipient, surfactant and binding agent is:
Albuterol hydrochloride 30-50%
Filler 10-40%
Dilatancy excipient 10-30%
Described albuterol hydrochloride oral controlled-release tablet capsule, wherein, the coating component and the weight percent content of said albuterol hydrochloride pulse sheet, by the gross weight of albuterol hydrochloride pulse sheet, for:
Water-insoluble and low permeability material 10-30%
The water solublity height oozes material or enteric material 10-30%
Plasticizer 3-6%
Lubricant 3-8%.
Described albuterol hydrochloride oral controlled-release tablet capsule, wherein, said albuterol hydrochloride sustained-released gross weight by label, the percentage by weight of albuterol hydrochloride, filler, binding agent and lubricant is:
Albuterol hydrochloride 30-50%
Filler 30-50%
Binding agent 4-10%
Lubricant 3-6%.
Described albuterol hydrochloride oral controlled-release tablet capsule, wherein, said albuterol hydrochloride sustained-released coating component and weight percent content, by albuterol hydrochloride sustained-released gross weight, for:
Water-insoluble and low permeability material 30-50%
The water solublity height oozes material or enteric material 30-50%
Plasticizer 4-8%
Lubricant 3-10%.
Described albuterol hydrochloride oral controlled-release tablet capsule, wherein, said filler includes but not limited to a kind of or its mixture in starch, dextrin and the Icing Sugar; Said binding agent includes but not limited to one or more the mixture in polyvinylpyrrolidone, hypromellose and the hydroxypropyl cellulose; Said surfactant comprise but be not limited in sodium lauryl sulphate, the tween one or more mixture; Said dilatancy excipient includes but not limited to one or more the mixture in microcrystalline Cellulose, crospolyvinylpyrrolidone, Sodium Hydroxymethyl Stalcs and the hydroxypropyl cellulose; Said lubricant comprises a kind of in Pulvis Talci, magnesium stearate and the micropowder silica gel; Said water-insoluble and low permeability material are one or more the mixture in acrylic resin, ethyl cellulose and the polyvinyl acetate; Said water solublity hypertonicity material is one or more the mixture in Polyethylene Glycol and the hypromellose; Said enteric material is one or more the mixture in acrylic resin, hydroxypropyl emthylcellulose, phthalic acid ester cellulose acetate and the phthalic acid ester; Said plasticizer is one or more the mixture in triethyl citrate, hypromellose and the Polyethylene Glycol.
Described albuterol hydrochloride oral controlled-release tablet capsule, wherein, said capsule is 0 or No. 1 hollow gelatine capsule.
Beneficial effect: the present invention also provides said albuterol hydrochloride controlled release oral tablet capsular method for preparing; This method for preparing has that step is few, manufacturing cycle is short; Easy to operate, need not to use other organic solvent except that ethanol, environmentally safe; Preparation cost is low, is suitable for the advantage that large-scale industrialization is produced.In addition; The present invention is provided at the albuterol hydrochloride controlled release oral tablet capsule of asthmatic patient outbreak node release; To the rhythmicity characteristics of asthmatic patient outbreak,, be convenient to rationally use clinically albuterol treatment asthma in the time point release of patient's asthma attack.
Description of drawings
Fig. 1 is the axonometric chart of tablet capsule combination of the present invention.1 is following utricule, and 2 be last utricule, and 3 be albuterol hydrochloride pulse sheet, and 4 is albuterol hydrochloride sustained-released (prerequisite is that then 4 is slow releasing tablet if 3 be the pulse sheet, and vice versa).
Fig. 2 is the A-A cutaway view of tablet capsule combination of the present invention.
Fig. 3 is the external release curve chart of albuterol tablet capsule of the present invention.
The specific embodiment
The present invention provides a kind of albuterol hydrochloride oral controlled-release tablet capsule and preparation method thereof, and is clearer, clear and definite for making the object of the invention, technical scheme and effect, below to further explain of the present invention.Should be appreciated that specific embodiment described herein only in order to explanation the present invention, and be not used in qualification the present invention.
A kind of albuterol hydrochloride oral controlled-release tablet capsule provided by the invention, said tablet capsule has by body ' s physiological rhythm controlled release drug release feature.
Shown in accompanying drawing 1 and accompanying drawing 2; Said albuterol hydrochloride oral controlled-release tablet capsule is made up of two tablets in capsule and the capsule; (prerequisite is if 3 be the pulse sheet to be filled with a grain of salt acid Levalbuterol pulse sheet 3 and a grain of salt acid Levalbuterol slow-release tablet 4 in the capsule; Then 4 is slow releasing tablet, and vice versa).Said capsule is made up of with following utricule 1 the separable utricule 2 of going up.Said capsule can be 0 or No. 1 hollow gelatine capsule.But, also can select the capsule of other model in order to adapt to the tablet of different content active component.
Said tablet capsule is to the rhythmicity characteristics of asthmatic patient outbreak; Through regulate albuterol hydrochloride pulse sheet 3 with albuterol hydrochloride sustained-released 4 in the pharmaceutical carrier composition with and the material of proportional quantities and coating membrane and the thickness of coating membrane; Control the rate of release of medicine; Make albuterol hydrochloride in the release of asthmatic patient outbreak node, be convenient to rationally use clinically albuterol hydrochloride treatment asthma.
Said albuterol hydrochloride pulse sheet 3 is made up of the principal agent of pulsed dosage, pharmaceutically acceptable pharmaceutical carrier and coating membrane.Said albuterol hydrochloride pulse sheet 3 is made up of coating membrane and label, and said label is made up of the principal agent of pulsed dosage, pharmaceutically acceptable pharmaceutical carrier.Said principal agent is an albuterol hydrochloride.The principal agent in the said pulse sheet and the weight ratio of pharmaceutical carrier are 1:1～3.
Form by principal agent, pharmaceutically acceptable pharmaceutical carrier and coating for said albuterol hydrochloride sustained-released 4.Said albuterol hydrochloride sustained-released 4 coats label by coating and forms, and said label is made up of principal agent, pharmaceutically acceptable pharmaceutical carrier.Said principal agent is an albuterol hydrochloride.The principal agent in the said slow releasing tablet and the weight ratio of pharmaceutical carrier are 1:1～3.
Wherein, said albuterol hydrochloride pulse sheet 3 and pharmaceutical carrier in albuterol hydrochloride sustained-released 4 all are to be one or more the mixture in the materials such as filler, binding agent, surfactant, dilatancy excipient and lubricant.
Said filler includes but not limited to one or more the mixture in starch, dextrin and the Icing Sugar.Said binding agent includes but not limited to one or more the mixture in polyvinylpyrrolidone, hypromellose and the hydroxypropyl cellulose.Said surfactant comprises but is not limited to one or more the mixture in sodium lauryl sulphate and the tween.Said dilatancy excipient includes but not limited to one or more the mixture in microcrystalline Cellulose, crospolyvinylpyrrolidone, Sodium Hydroxymethyl Stalcs and the hydroxypropyl cellulose.Said lubricant includes but not limited to a kind of in Pulvis Talci, magnesium stearate and the micropowder silica gel.
Said albuterol hydrochloride pulse sheet 3 includes but not limited to water-insoluble and low permeability material with coating material in albuterol hydrochloride sustained-released 4; The water solublity height oozes material or enteric material, the mixture of one or more in plasticizer and the lubricant.
Said water-insoluble and low permeability material include but not limited to one or more the mixture in acrylic resin, ethyl cellulose and the polyvinyl acetate.Water solublity hypertonicity material is one or more the mixture in Polyethylene Glycol and the hypromellose.Enteric material is one or more the mixture in acrylic resin (L), hydroxypropyl emthylcellulose, phthalic acid ester cellulose acetate and the phthalic acid ester.Plasticizer includes but not limited to one or more the mixture in triethyl citrate, hypromellose and the Polyethylene Glycol.Lubricant can be Pulvis Talci.
In said albuterol hydrochloride pulse sheet 3, by the gross weight of label, the percentage by weight of albuterol hydrochloride, filler, dilatancy excipient, surfactant and binding agent is:
Albuterol hydrochloride 30-50%
Filler 40-60%
Dilatancy excipient 10-50%
The coating component and the weight percent content of said albuterol hydrochloride pulse sheet 3, the punching tablet total weight of feeling the pulse amount meter, for:
Water-insoluble and low permeability material 5-50%
The water solublity height oozes material or enteric material 5-50%
Plasticizer 3-6%
Lubricant 3-8%.
In albuterol hydrochloride sustained-released 4, by the gross weight of label, the percentage by weight of albuterol hydrochloride, filler, binding agent and lubricant is:
Albuterol hydrochloride 3-30%
Filler 30-60%
Binding agent 30-50%
Lubricant 3-6%.
Said albuterol hydrochloride sustained-released 4 coating component and weight percent content, by the tablet total weight amount, for:
Water-insoluble and low permeability material 50-90%
The water solublity height oozes material or enteric material 50-90%
Plasticizer 4-8%
Lubricant 3-10%.
The present invention also provides the method for the said albuterol oral controlled-release tablet capsule of preparation, and its concrete steps are following:
Prepare albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released respectively; Then the albuterol hydrochloride pulse sheet that makes and albuterol hydrochloride sustained-released are filled into respectively in the gelatine capsule, make to contain a grain of salt acid Levalbuterol pulse sheet and the sour Levalbuterol slow-release tablet of a grain of salt in every capsules.
The method for preparing of albuterol hydrochloride pulse sheet is with albuterol hydrochloride, filler, dilatancy excipient, mix lubricant; Adopt direct compression process to process sheet; Obtain label, adopt method well known in the art that the insoluble low permeability material of label water successively, water solublity height are oozed material or enteric material coating then.
Albuterol hydrochloride sustained-released method for preparing is that albuterol hydrochloride, filler are mixed; Adding the alcoholic solution that contains binding agent granulates; Oven dry; Add lubricant and process sheet, obtain label, insoluble and low permeability material, water solublity height ooze material or enteric material coating with label water successively to adopt method well known in the art then.
The method for preparing of albuterol oral controlled-release tablet capsule provided by the present invention; With albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released film-making respectively; And then be filled in the capsule; Method for preparing tablet thereof is a conventional method, the pharmaceutical carrier composition that only need control tablet during preparation with and the thickness of proportional quantities and coating material and coating membrane, just can reach the purpose of control drug release speed.This method is not only simple, and manufacturing cycle is short, preparation cost is low, and does not use the organic solvent that environment is polluted in the preparation process, compliance with environmental protection requirements.
Through implementing technique scheme, tablet capsule of the present invention is presented at the advantage of asthmatic patient outbreak time point release.
In following embodiment, said capsule is 0 or No. 1 hollow gelatine capsule.
Embodiment 1: the preparation of albuterol hydrochloride pulse sheet
(1) preparation of pulse label
Albuterol hydrochloride 100g
Microcrystalline Cellulose KG-801 40g
Microcrystalline cellulose PH-302 32 g
Oligomeric hydroxypropyl cellulose 40g
Amylum pregelatinisatum 80g
Magnesium stearate 8g
Take by weighing principal agent, microcrystalline Cellulose, oligomeric hydroxypropyl cellulose, amylum pregelatinisatum, magnesium stearate mix homogeneously by recipe quantity, tabletting obtains the label of 10mg/ sheet.
(2) preparation of packet of pulses garment piece
With coating pan with label with 160g acrylic resin RS, 100g acrylic resin L100,10g triethyl citrate, 30g Pulvis Talci, 1000ml dehydrated alcohol coating, promptly get.
Embodiment 2: albuterol hydrochloride sustained-released preparation
(1) preparation of slow release label
Albuterol hydrochloride 100g
Lactose 100g
Microcrystalline cellulose PH-302 30g
Oligomeric hydroxypropyl cellulose 45g
Polyvinylpyrrolidone (K30) 15g
Magnesium stearate 2g
Pulvis Talci 8g
75% ethanol is an amount of
Polyvinylpyrrolidone is dissolved in an amount of 75% ethanol; Add recipe quantity medicine, lactose, microcrystalline cellulose PH-302, oligomeric hydroxypropyl cellulose system soft material, cross 40 mesh sieves, 60 ℃ of oven dry of ventilating down; Cross 60 mesh sieve granulate; Add an amount of magnesium stearate, tabletting behind the mix homogeneously obtains the label of 10mg/ sheet.
(2) preparation of sustained release coating sheet
With coating pan with label with 330g acrylic resin RS, 230g acrylic resin L100,30g triethyl citrate, 110g Pulvis Talci, 2000ml dehydrated alcohol coating, promptly get.
Embodiment 3: capsule is filled
Get hollow gelatine capsule No. 0, place capsule filling machine, above-mentioned pulse sheet, slow releasing tablet are filled in each Capsules successively, the different Release Performance tablets of filling are each one in every capsules, and packing promptly gets tablet capsule of the present invention.
The following harmony in the exterior of vitro drug release degree result of the test is shown in Figure 3:
| Time (h) | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
| Release amount (%) | 0 | 0 | 0 | 46.8 | 63.1 | 75.3 | 88.5 | 92.1 | 94.7 |
Should be understood that application of the present invention is not limited to above-mentioned giving an example, concerning those of ordinary skills, can improve or conversion that all these improvement and conversion all should belong to the protection domain of accompanying claims of the present invention according to above-mentioned explanation.
Claims (10)
1. the method for preparing of an albuterol hydrochloride oral controlled-release tablet capsule; It is characterized in that; Be filled with a grain of salt acid Levalbuterol pulse sheet and the sour Levalbuterol slow-release tablet of a grain of salt in the said albuterol hydrochloride oral controlled-release tablet capsule, said albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released are for recharging in the capsule after the film-making respectively; Said albuterol hydrochloride oral controlled-release tablet capsule is in the release of asthmatic patient outbreak node;
Said albuterol hydrochloride oral controlled-release tablet capsule its preparation method is:
S1, with albuterol hydrochloride, filler, dilatancy excipient, mix lubricant; Adopt direct compression process to process sheet; Obtain label; Then the insoluble low permeability material of label water successively, water solublity height are oozed material or enteric material coating, obtain albuterol hydrochloride pulse sheet;
S2, albuterol hydrochloride, filler are mixed; Add the alcoholic solution that contains binding agent and granulate, oven dry is sieved; Add the lubricant tabletting; Obtain label, insoluble and low permeability material, water solublity height ooze material or enteric material coating with label water successively then, obtain albuterol hydrochloride sustained-released;
S3, the albuterol hydrochloride pulse sheet of step S1 and albuterol hydrochloride sustained-released of step S2 are filled into respectively in the gelatine capsule, contain a grain of salt acid Levalbuterol pulse sheet and the sour Levalbuterol slow-release tablet of a grain of salt in every capsules.
2. one kind with the resulting albuterol hydrochloride oral controlled-release of the described method for preparing of claim 1 tablet capsule; It is characterized in that; Said albuterol hydrochloride oral controlled-release tablet capsule is made up of two tablets in capsule and the capsule, and said tablet is respectively albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released;
In said albuterol hydrochloride pulse sheet and albuterol hydrochloride sustained-released; Through regulating pharmaceutical carrier composition and the material of ratio and coating membrane and the thickness of coating membrane wherein; Control the rate of release of medicine, make albuterol hydrochloride in the release of asthmatic patient outbreak node.
3. albuterol hydrochloride oral controlled-release tablet capsule according to claim 2; It is characterized in that; Said albuterol hydrochloride pulse sheet is made up of label and coating membrane, and said label is made up of the principal agent of pulsed dosage, pharmaceutically acceptable pharmaceutical carrier; The weight ratio of principal agent and pharmaceutical carrier is 1:1～3 in the said albuterol hydrochloride pulse sheet;
Said principal agent is an albuterol hydrochloride;
Said pharmaceutical carrier is one or more the mixture in filler, binding agent, surfactant, dilatancy excipient and the lubricant;
Said coating membrane is one or more the mixture in water-insoluble and low permeability material, water solublity hypertonicity material, enteric material, plasticizer and the lubricant.
4. albuterol hydrochloride oral controlled-release tablet capsule according to claim 2; It is characterized in that; Form by label and coating membrane for said albuterol hydrochloride sustained-released; Said label is made up of principal agent, pharmaceutically acceptable pharmaceutical carrier, and the weight ratio of principal agent and pharmaceutical carrier is 1:1～3 in the said albuterol hydrochloride controlled release tablet;
Said principal agent is an albuterol hydrochloride;
Said pharmaceutical carrier is one or more the mixture in filler, binding agent, surfactant, dilatancy excipient and the lubricant;
Said coating membrane is one or more the mixture in water-insoluble and low permeability material, water solublity hypertonicity material, enteric material, plasticizer and the lubricant.
5. albuterol oral controlled-release tablet capsule according to claim 3; It is characterized in that; Said albuterol hydrochloride pulse sheet is by the gross weight of label, and the percentage by weight of albuterol hydrochloride, filler, dilatancy excipient, surfactant and binding agent is:
Albuterol hydrochloride 30-50%
Filler 10-40%
Dilatancy excipient 10-30%
Lubricant 3 – 5%.
6. albuterol oral controlled-release tablet capsule according to claim 3 is characterized in that, the coating component and the weight percent content of said albuterol hydrochloride pulse sheet, and by the gross weight of albuterol hydrochloride pulse sheet, for:
Water-insoluble and low permeability material 10-30%
The water solublity height oozes material or enteric material 10-30%
Plasticizer 3-6%
Lubricant 3-8%.
7. albuterol oral controlled-release tablet capsule according to claim 4 is characterized in that, said albuterol hydrochloride sustained-released gross weight by label, and the percentage by weight of albuterol hydrochloride, filler, binding agent and lubricant is:
Albuterol hydrochloride 30-50%
Filler 30-50%
Binding agent 4-10%
Lubricant 3-6%.
8. albuterol oral controlled-release tablet capsule according to claim 4 is characterized in that, said albuterol hydrochloride sustained-released coating component and weight percent content, and by albuterol hydrochloride sustained-released gross weight, for:
Water-insoluble and low permeability material 30-50%
The water solublity height oozes material or enteric material 30-50%
Plasticizer 4-8%
Lubricant 3-10%.
9. according to claim 3 or 4 described albuterol oral controlled-release tablet capsules, it is characterized in that said filler includes but not limited to a kind of or its mixture in starch, dextrin and the Icing Sugar; Said binding agent includes but not limited to one or more the mixture in polyvinylpyrrolidone, hypromellose and the hydroxypropyl cellulose; Said surfactant comprise but be not limited in sodium lauryl sulphate, the tween one or more mixture; Said dilatancy excipient includes but not limited to one or more the mixture in microcrystalline Cellulose, crospolyvinylpyrrolidone, Sodium Hydroxymethyl Stalcs and the hydroxypropyl cellulose; Said lubricant comprises a kind of in Pulvis Talci, magnesium stearate and the micropowder silica gel; Said water-insoluble and low permeability material are one or more the mixture in acrylic resin, ethyl cellulose and the polyvinyl acetate; Said water solublity hypertonicity material is one or more the mixture in Polyethylene Glycol and the hypromellose; Said enteric material is one or more the mixture in acrylic resin, hydroxypropyl emthylcellulose, phthalic acid ester cellulose acetate and the phthalic acid ester; Said plasticizer is one or more the mixture in triethyl citrate, hypromellose and the Polyethylene Glycol.
10. albuterol oral controlled-release tablet capsule according to claim 2 is characterized in that, said capsule is 0 or No. 1 hollow gelatine capsule.
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| CN 201110285809 CN102309468B (en) | 2011-09-23 | 2011-09-23 | Levalbuterol hydrochloride oral controlled release tablet capsule and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103271393A (en) * | 2013-04-09 | 2013-09-04 | 广东工业大学 | Health care curcumin-sea-buckthorn beverage and preparation method thereof |
| CN103520136A (en) * | 2013-10-15 | 2014-01-22 | 天垚医药科技发展（上海）有限公司 | Montelukast sodium pulse capsule and preparation method thereof |
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| CN1650847A (en) * | 2004-02-04 | 2005-08-10 | 上海医药工业研究院 | Albuterol time controlling pulse slow release oral preparation and its preparation method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1650847A (en) * | 2004-02-04 | 2005-08-10 | 上海医药工业研究院 | Albuterol time controlling pulse slow release oral preparation and its preparation method |
Non-Patent Citations (1)
| Title |
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| 张蜀等: "左旋盐酸沙丁胺醇凝胶骨架包衣缓释片的制备", 《中国新药杂志》, vol. 18, no. 13, 31 December 2009 (2009-12-31), pages 1257 - 1261 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103271393A (en) * | 2013-04-09 | 2013-09-04 | 广东工业大学 | Health care curcumin-sea-buckthorn beverage and preparation method thereof |
| CN103520136A (en) * | 2013-10-15 | 2014-01-22 | 天垚医药科技发展（上海）有限公司 | Montelukast sodium pulse capsule and preparation method thereof |
| CN103520136B (en) * | 2013-10-15 | 2020-07-31 | 天垚医药科技发展（上海）有限公司 | Montelukast sodium pulse capsule and preparation method thereof |
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