CN102579398A - Enteric microcapsule with function of balancing bad taste of medicament and preparation method of enteric microcapsule - Google Patents
Enteric microcapsule with function of balancing bad taste of medicament and preparation method of enteric microcapsule Download PDFInfo
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- CN102579398A CN102579398A CN2011104566876A CN201110456687A CN102579398A CN 102579398 A CN102579398 A CN 102579398A CN 2011104566876 A CN2011104566876 A CN 2011104566876A CN 201110456687 A CN201110456687 A CN 201110456687A CN 102579398 A CN102579398 A CN 102579398A
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Abstract
The invention discloses an enteric microcapsule with a function of balancing bad taste of a medicament and a preparation method of the enteric microcapsule. A microcapsule initial core is externally enveloped with an active ingredient to form a spherical or spherical-similar capsule core, and the capsule core is externally enveloped with a microcapsule envelop to serve as an enteric-solubility high molecular material. The preparation method comprises the steps of preparing the capsule core, placing a pharmaceutical food-grade particle matter in Uster type fluidized bed granulating-enveloping equipment to serve as a core particle for granulation; stirring the active ingredient with a solvent to prepare a solution or suspension, adding an appropriate amount of adhesive, pumping the prepared solution into a fluid bed and atomizing the solution onto the core particle so as to prepare the capsule core with smooth surface, and conducting fluidized enveloping after preparing the envelop of the microcapsule core and a lower capsule envelop; and keeping on aging the prepared microcapsule and adding an appropriate amount of antisticking agent. According to the enteric microcapsule, a spherical or spherical-similar medicament-containing micro-particle prepared by adopting the fluidized bed is further enveloped with an enteric coating, thus the homogeneity of the enteric coating envelop is improved and the usage amount of the enveloping material is reduced; and the medicament is prevented from releasing in the oral cavity and the stomach, the instable medicament is protected in the stomach or the side effects of the medicament with irritation to the stomach are eliminated.
Description
Technical field
The present invention relates to a kind ofly in the medical technical field have enteric-coated microcapsule and a method for preparing of covering the effect of adverse drug taste.
Background technology
Oral solid formulation such as tablet, capsule etc. are easy to carry about with one, easy storing.But for the old man, child or the relatively poor patient of other function of deglutition, conventional tablet that volume is bigger and conventional capsule agent are not easy to be accepted.Powder, dry suspension, (carefully) granule, solid preparations such as oral cavity quick disintegrating slice because unit volume is less or can be in the oral cavity disintegrate rapidly, only with low amounts of water not even water just can let the patient smoothly under the clothes, so the exploitation of this type of preparation is more and more paid attention to.
Most drug is bitter, except bitterness, also has bad mouthfeels such as sour, puckery, fiber crops, and the medicine of odorless, tasteless seldom.Bad mouthfeel such as bitterness not only lets the patient be difficult to take medicine (especially for the child) smoothly but also the curative effect that can cause medicine reduces.Therefore the medicine that has poor taste should not directly be made preparations such as powder, granule, oral cavity quick disintegrating slice, need take suitable means to cover the poor taste of medicine.Unstable or to stomach medicine excitatory, finished product preparation not only should not discharge in the oral cavity under one's belt, can not discharge under one's belt, and only in intestinal, discharge.Therefore, develop that a kind of to have enteric-coated microcapsule and the method for preparing of covering the effect of adverse drug taste be the new problem that needs to be resolved hurrily always.
Summary of the invention
The object of the invention is to provide a kind of enteric-coated microcapsule and method for preparing of covering the effect of adverse drug taste that have; Adopt fluid bed to carry out enteric coated to drug microparticles or pastille microgranule; Can the release of blocking drugs in the stomach function regulating of oral cavity; And labile drug or eliminate the enteric solubility microcapsule of stomach irritation drug side effect in the protection stomach, microcapsule or its converted products be in the process of taking, the poor tastes such as bitterness of imperceptible active component in the oral cavity; Microcapsule release of active ingredients hardly in simulated gastric fluid can be protected unsettled under one's belt medicine to exempt to destroy and avoid stomach medicine excitatory is caused the stimulation to stomach, and in simulated intestinal fluid, discharge rapidly.
The objective of the invention is to realize like this: a kind of have an enteric-coated microcapsule of covering the effect of adverse drug taste, and the initial core expoeridium of microcapsule active component constitutes sphere or almost spherical capsule core material, and capsule core material expoeridium microcapsule cyst membrane is the enteric solubility macromolecular material; Described a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has, its preparation method comprise the steps,
(1) preparation of microcapsule capsule core material is put into Wu Siteshi (Wurster) fluidized bed granulation coating equipment as the core particle of granulating with a kind of medicinal or food-grade particles material; Active component and stirring solvent are processed solution or the suspension (add proper amount of surfactant in case of necessity and increase drug solubility) that concentration is 0.5-50%; And adding an amount of binding agent, the solution pump that makes is gone into thermopnore and is sprayed to the capsule core material of preparation smooth surface rounding on the core particle;
(2) coating of the microcapsule capsule heart; After the capsule core material preparation is accomplished down according to above-mentioned (1) item; Continue to pump into aqueous dispersion or the organic solution that fluid bed contains the enteric solubility macromolecule coating material of an amount of plasticizer; Carry out fluidized coating, the intake air temperature of thermopnore is chosen between 30-100 ℃, and the weight ratio of microcapsule cyst membrane and capsule core material is 0.03:1-1:1;
(3) microcapsule that makes continues aging 1-120 hour in 30-100 ℃ of temperature range, and adds an amount of antitack agent;
Described active component is meant under one's belt unstable or stomach is had irritating medicine or not only instability but also have irritating medicine or extract under one's belt; Perhaps have the medicine of bad mouthfeels such as bitterness in the oral cavity, unsettled under one's belt medicine (medicine that has has stomach irritation simultaneously) includes but not limited to: erythromycin, Roxithromycin, omeprazole, clarithromycin; Stomach material excitatory is included but not limited to: like aspirin, ibuprofen, ketoprofen, diclofenac and its esters, naproxen, indomethacin, Rhizoma Chuanxiong extract, Flos Carthami extract, Bulbus Allii extract; Active component accounts for the 0.01-90% of microcapsule capsule heart weight, and the medicine with bad mouthfeels such as bitterness includes but not limited to: azithromycin, PCs, cephalo-type, berberine hydrochloride etc.; Described core particle particle diameter 20-1000 micron, more excellent 50-800 micron, optimum 50-250 micron can be but be not limited to graininess sucrose, maltose, fructose, lactose; Xylose ， Chi ?sugar, mannitol, sorbitol, starch; Microcrystalline Cellulose, sodium chloride, calcium carbonate, magnesium oxide, Pulvis Talci; Silicon dioxide, and commercially available initial core such as the cellulose microsphere that is used for fluidized bed coating, Icing Sugar microsphere, spherex; Described binding agent can but be not limited to sodium carboxymethyl cellulose (CMC-Na), hydroxypropyl emthylcellulose (HPMC), hydroxypropyl cellulose (HPC); Methylcellulose (MC), ethyl cellulose (EC), Polyethylene Glycol (PEG); Polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), acrylic resin (Eudragit) E; L30D-55, or their mixture, the concentration of binding agent is 0.1-40%; Described surface activity can be but be not limited to soil temperature 80, ovum (bean) phospholipid, and sodium cholate, sodium lauryl sulphate, poloxamer or their mixture, consumption are 0.1-20%; Described solvent is water, ethanol, propylene glycol, glycerol, isopropyl alcohol, n-butyl alcohol, ethyl acetate, dichloromethane or their mixture; The constituent of described microcapsule cyst membrane is dissolved macromolecular material and suitable plasticizer in the intestinal; The enteric solubility macromolecular material can be acrylic resin (Eudragit) S; L; L100-55, L30D-55 or cellulose acetate phthalate ester (cellulose acetate phthalate) or hydroxypropyl methyl cellulose phthalate (hydroxypropylmethyl cellulose phthalate); Plasticizer can be soil temperature 80, triethyl citrate, and triacetyl glycerine, glycerol, polyethylene glycol 6000,4000,400 or its mixture, consumption is the 0.2-35% of enteric solubility macromolecular material dry weight; Said microcapsule can further be prepared into powder; Said microcapsule can further be prepared into dry suspension; Said microcapsule can further be prepared into (carefully) granule; Said microcapsule can further be prepared into tablet (oral cavity quick disintegrating slice); Said microcapsule can further be prepared into capsule.
Having a concealed adverse taste effects enteric microcapsules design principle is in oral drugs, agents in the oral cavity residence time in the 20-30s or less (Society of Powder Technology Built AGENT と particle design department will, す strongly ni labor legislation つParticle design? processing technology [M], Tokyo: Mizuho Corporation じ u ,2003,239 -272.), enteric-coated microcapsule can the implosion dissolving in the oral cavity in the so short time, thereby can prevent that medicine from discharging cause bad mouthfeel in the oral cavity.The microcapsule that has encapsulated the enteric solubility material simultaneously can be in the stomach under the sour environment yet disintegrate stripping medicine, thereby can protect in the stomach labile drug or eliminate the stomach irritation drug side effect.
A kind of have the enteric-coated microcapsule of covering the effect of adverse drug taste and method for preparing compared with prior art; Has the spherical or subsphaeroidal drug microgranule and further enteric coated of the fluid bed of employing preparation; Can improve the homogeneity of microcapsule enteric coating film; Reduce the coating material consumption, and the release of blocking drugs in the stomach function regulating of oral cavity, and labile drug or eliminate the enteric solubility microcapsule of stomach irritation drug side effect in the protection stomach; Microcapsule or its converted products in the process of taking, the poor tastes such as bitterness of imperceptible active component in the oral cavity; Microcapsule release of active ingredients hardly in simulated gastric fluid; Can protect unsettled under one's belt medicine to exempt to destroy and avoid stomach medicine excitatory is caused the stimulation to stomach; And in simulated intestinal fluid rapid advantage such as release, will be widely used in the medical technical field.
Description of drawings
Below in conjunction with accompanying drawing and embodiment the present invention is elaborated.
Aspect graph under the optical microscope of Fig. 1 capsule core material.
Aspect graph under the optical microscope of Fig. 2 microcapsule.
The particle size distribution figure of Fig. 3 capsule core material and microcapsule.
The drug release determination figure of the Roxithromycin enteric-coated microcapsule of Fig. 4 different batches.
Fig. 5 simulates little liquid stripping lab diagram through the pH1.2 of 2h.
Microcapsule figure after Fig. 6 tests through the simulated intestinal fluid stripping of the pH6.8 of 1h.
The specific embodiment
Following embodiment will further explain the present invention, but therefore not limit the present invention.
Embodiment one
Preparation Roxithromycin enteric-coated microcapsule.The preparation of capsule core material: the Roxithromycin of recipe quantity and binding agent PVP K-30 be dissolved in 80% an amount of ethanol for use.The CaCO of 30g
3(53-63 μ m) places thermopnore as core particle, and intake air temperature is 40 ℃, and liquor charging speed is 2.0 ml/min, and intake is 0.10 m
3/ min, atomisation pressure 2.3 atm, nozzle air flow velocity 51 l/min.The preparation of microcapsule: get the dilution of an amount of Eudragit L30D-55 aqueous dispersion adding distil water, make that to contain solid constituent be 10%, under magnetic agitation, drip an amount of plasticizer triethyl citrate as the coating solution for later use.Get capsule core material 30g and place the spray pattern thermopnore, intake air temperature is 60 ℃, and coating solution liquor charging speed is 1.5 ml/min, and delivery temperature is 31-32 ℃, and intake is 0.18 m
3/ min, atomisation pressure 2.3 atm, nozzle air flow velocity 50-51 l/min.
Embodiment two
Preparation indomethacin enteric-coated microcapsule.The preparation of capsule core material: with the indomethacin and the HPMC of recipe quantity, it is for use that soil temperature 80 homogenate make the Roxithromycin suspension.The CaCO of 30g
3(53-75 μ m) places thermopnore as core particle, and intake air temperature is 60 ℃, and liquor charging speed is 2.0 ml/min, and intake is 0.10 m
3/ min, atomisation pressure 2.5 atm, nozzle air flow velocity 51 l/min.The preparation of microcapsule: get the dilution of an amount of Eudragit L30D-55 aqueous dispersion adding distil water, make that to contain solid constituent be 10%, under magnetic agitation, drip an amount of plasticizer triethyl citrate as the coating solution for later use.Get capsule core material 30g and place the spray pattern thermopnore, intake air temperature is 60 ℃, and coating solution liquor charging speed is 1.5 ml/min, and delivery temperature is 31-32 ℃, and intake is 0.18 m
3/ min, atomisation pressure 2.3 atm, nozzle air flow velocity 50-51 l/min.
Embodiment three
Method with embodiment one prepares the enteric solubility microcapsule.Get 100 gram microcapsules, 100 gram erithritols, 4 gram carboxymethyl starch sodium, 5 gram magnesium stearate behind the 2 gram micropowder silica gel mixings, are processed tablet by known direct powder compression technology and equipment.
Embodiment four
Method with embodiment two prepares the enteric solubility microcapsule.Get 100 gram microcapsules, 50 gram mannitol are crossed 18 mesh sieves with the soft just back of 15% starch slurry modulation and are granulated; In 40 ℃ of baking ovens after the drying; Adopt 20 mesh sieve granulate to make granule,, make the microcapsule-type capsule packing in the hard capsule according to known method behind the micropowder silica gel mixing of the granule that makes and 1%.
Embodiment five
Method with embodiment one prepares the enteric solubility microcapsule.Get microcapsule 100 grams and insert in the fluidized bed granulation equipment, pump in the fluid bed after 50 gram mannitol and 2 gram HPMC are dissolved in 500 ml waters, transfusion speed is 5ml/min, and air inlet temperature is 40 ℃.Transfusion was accomplished continued low-intensity fluidisation 10 minutes, made the granule intensive drying.The granule that makes continues intensive drying in 40 ℃ of baking ovens after, granulate promptly gets granule.
Embodiment six
Method with embodiment one prepares the enteric solubility microcapsule, gets microcapsule 100 grams and 20 gram dextrin, 30 gram lactose, 2 gram HPMC mix homogeneously, 1 gram micropowder silica gel mix homogeneously, and packing promptly gets dry suspension.
Roxithromycin microcapsule with embodiment one preparation is the laboratory report that example is made.。
1, the morphological examination of microcapsule capsule core material and microcapsule.Accompanying drawing 1 shows that capsule core material is a simple grain basically all, explains that the granulation condition is fit to, and does not take place significantly to assemble.Capsule core material surface round and smooth, the consumption of reduction coating material reduces the operating time when helping preparing microcapsule, practices thrift cost.Accompanying drawing 2 microcapsule smooth surface roundings are simple grain basically all, explain not take place in the coating process significantly to assemble, and the microcapsule preparation condition is suitable.
2, particle size distribution.Adopt the sieve analysis of paddle type mill vibrosieve, sample thief 20g sneaks into about 1% differential silica gel as helping the sieve agent, and concussion is sieved behind the 10min, adopts the semilog graphing method to map in the mesh size magnitude relationship to sieving down percentage by weight.The particle size distribution figure of accompanying drawing 3 capsule core materials and microcapsule.■ representes capsule core material among the figure; Zero, △, ◇ are expressed as the microcapsule of different batches.Can find out that by Fig. 3 the microcapsule capsule core material mean diameter that makes is about 130 microns, the microcapsule mean diameter is about 160 microns.The microcapsule mean diameter that the present invention's preparation is described can reach below 200 microns.
3, the dissolution of microcapsule test.Adopt 2000 editions dissolution laboratory methoies of Chinese Pharmacopoeia, the oar method.It is an amount of that precision takes by weighing the Roxithromycin enteric-coated microcapsule, puts 37 ℃, and in the 0.1mol/l HCl of 750ml (pH 1.2) simulated gastric fluid, rotating speed of agitator is 50rpm, adds 0.2 mol/l Na behind the 2h
3PO
4Solution 250ml, using 2 mol/l HCl or 2 mol/l NaOH to regulate pH value in case of necessity is 6.8.At predetermined sample point sampling 10ml, replenish the fresh dissolution medium 10ml of 37 ℃ of preheatings then immediately.Sampling solution is used high effective liquid chromatography for measuring content.Visible by accompanying drawing 4, the Roxithromycin microcapsule discharges medicine hardly in the 2h in simulated gastric fluid, and is adding Na
3PO
4Solution adjustment pH value is 6.8 o'clock, and medicine discharges rapidly.
4, the variation of microcapsule outward appearance in the stripping experiment.In the stripping experimentation, draw a small amount of microcapsule with dropper and under optical microscope, observe, can see that from accompanying drawing 5 the acidproof ability of microcapsule is good, form remains intact in 2 hours.And microcapsule discharges fully in simulated intestinal fluid, only remaining insoluble core particle.
5, the taste masking effect assessment of enteric solubility microcapsule.6 healthy volunteers sucked the Roxithromycin enteric-coated microcapsule 1 minute, if bitter is arranged then note the corresponding time in the sensation mouthful.The result is illustrated within 1 minute 6 people and does not all feel bitterness.General oral formulations is 5-30 second in the intraoral time of staying, therefore in normally taking this microcapsule process, can not feel bitterness, explains that this microcapsule taste masking is respond well.
Claims (13)
1. one kind has the enteric-coated microcapsule of covering the effect of adverse drug taste, it is characterized in that: the initial core expoeridium of microcapsule active component constitutes sphere or almost spherical capsule core material, and capsule core material expoeridium microcapsule cyst membrane is the enteric solubility macromolecular material.
2. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1 is characterized in that: its preparation method comprises the steps,
(1) preparation of microcapsule capsule core material is put into Wu Siteshi (Wurster) fluidized bed granulation coating equipment as the core particle of granulating with a kind of medicinal or food-grade particles material; Active component and stirring solvent are processed solution or the suspension (add proper amount of surfactant in case of necessity and increase drug solubility) that concentration is 0.5-50%; And adding an amount of binding agent, the solution pump that makes is gone into thermopnore and is sprayed to the capsule core material of preparation smooth surface rounding on the core particle;
(2) coating of the microcapsule capsule heart; After the capsule core material preparation is accomplished down according to above-mentioned (1) item; Continue to pump into aqueous dispersion or the organic solution that fluid bed contains the enteric solubility macromolecule coating material of an amount of plasticizer; Carry out fluidized coating, the intake air temperature of thermopnore is chosen between 30-100 ℃, and the weight ratio of microcapsule cyst membrane and capsule core material is 0.03:1-1:1;
(3) microcapsule that makes continues aging 1-120 hour in 30-100 ℃ of temperature range, and adds an amount of antitack agent.
3. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1; It is characterized in that: described active component is meant under one's belt unstable or stomach is had irritating medicine or not only instability but also have irritating medicine or extract under one's belt; Perhaps have the medicine of bad mouthfeels such as bitterness in the oral cavity, unsettled under one's belt medicine (medicine that has has stomach irritation simultaneously) includes but not limited to: erythromycin, Roxithromycin, omeprazole, clarithromycin; Stomach material excitatory is included but not limited to: like aspirin, ibuprofen, ketoprofen, diclofenac and its esters, naproxen, indomethacin, Rhizoma Chuanxiong extract, Flos Carthami extract, Bulbus Allii extract; Active component accounts for the 0.01-90% of microcapsule capsule heart weight, and the medicine with bad mouthfeels such as bitterness includes but not limited to: azithromycin, PCs, cephalo-type, berberine hydrochloride etc.
4. according to claim 1 and 2 described a kind of enteric-coated microcapsules of covering the effect of adverse drug taste that have, it is characterized in that: described core particle particle diameter 20-1000 micron, more excellent 50-800 micron, optimum 50-250 micron can be but be not limited to graininess sucrose, maltose; Fructose, lactose, xylose ， Chi ?sugar; Mannitol, sorbitol, starch, microcrystalline Cellulose; Sodium chloride, calcium carbonate, magnesium oxide, Pulvis Talci; Silicon dioxide, and commercially available initial core such as the cellulose microsphere that is used for fluidized bed coating, Icing Sugar microsphere, spherex.
5. according to claim 1 and 2 described a kind of enteric-coated microcapsules of covering the effect of adverse drug taste that have, it is characterized in that: described binding agent can but be not limited to sodium carboxymethyl cellulose (CMC-Na), hydroxypropyl emthylcellulose (HPMC); Hydroxypropyl cellulose (HPC), methylcellulose (MC), ethyl cellulose (EC); Polyethylene Glycol (PEG), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA); Acrylic resin (Eudragit) E; L30D-55, or their mixture, the concentration of binding agent is 0.1-40%.
6. according to claim 1 and 2 described a kind of enteric-coated microcapsules of covering the effect of adverse drug taste that have; It is characterized in that: described surface activity can be but be not limited to soil temperature 80; Ovum (bean) phospholipid, sodium cholate, sodium lauryl sulphate; Poloxamer or their mixture, consumption are 0.1-20%.
7. according to claim 1 and 2 described a kind of enteric-coated microcapsules of covering the effect of adverse drug taste that have, it is characterized in that: described solvent is water, ethanol, propylene glycol, glycerol, isopropyl alcohol, n-butyl alcohol, ethyl acetate, dichloromethane or their mixture.
8. according to claim 1 and 2 described a kind of enteric-coated microcapsules of covering the effect of adverse drug taste that have, it is characterized in that: the constituent of described microcapsule cyst membrane is dissolved macromolecular material and suitable plasticizer in the intestinal; The enteric solubility macromolecular material can be acrylic resin (Eudragit) S; L; L100-55, L30D-55 or cellulose acetate phthalate ester (cellulose acetate phthalate) or hydroxypropyl methyl cellulose phthalate (hydroxypropylmethyl cellulose phthalate); Plasticizer can be soil temperature 80, triethyl citrate, and triacetyl glycerine, glycerol, polyethylene glycol 6000,4000,400 or its mixture, consumption is the 0.2-35% of enteric solubility macromolecular material dry weight.
9. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1 is characterized in that: said microcapsule can further be prepared into powder.
10. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1 is characterized in that: said microcapsule can further be prepared into dry suspension.
11. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1, it is characterized in that: said microcapsule can further be prepared into (carefully) granule.
12. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1 is characterized in that: said microcapsule can further be prepared into tablet (oral cavity quick disintegrating slice).
13. a kind of enteric-coated microcapsule of covering the effect of adverse drug taste that has according to claim 1 is characterized in that: said microcapsule can further be prepared into capsule.
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| CN105816436B (en) * | 2016-03-22 | 2019-10-22 | 广州共禾医药科技有限公司 | A kind of Pantoprazole enteric-coated micro-pill, Pantoprazole enteric slow-release tablet agent and preparation method thereof |
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Application publication date: 20120718 |