CN105982860A - Gualfenesin water-free deglutible odor masking granule - Google Patents
Gualfenesin water-free deglutible odor masking granule Download PDFInfo
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Abstract
The invention provides a gualfenesin water-free deglutible odor masking granule, which is prepared by mixing guaifenesin coated pellets and flavoring materials, wherein the guaifenesin coated pellets are prepared by sequentially coating a specific odor masking layer and a specific smooth layer on medicine carrying pellets. The gualfenesin water-free deglutible odor masking granule has the advantages that on one hand, the bitter taste and the foreign odor of medicine are covered and masked; on the other hand, unexpectedly, a patient can swallow the gualfenesin water-free deglutible odor masking granule without drinking water in the taking process, so that the medicine use compliance is effectively improved; the applicable user groups of the patients are increased; the medicine taking by children is particularly facilitated; test results prove that the granule is coated by the odor masking layer and the smooth layer, but the main medicine of gualfenesin can be fast released and absorbed in the body; the medicine can be fast released after being orally taken into the gastrointestinal system; and the coated odor masking layer and the coated smooth layer cannot influence medicine release or absorption.
Description
Technical field
The present invention relates to a kind of guaifenesin pharmaceutical preparation, specifically, it is provided that a kind of guaifenesin is anhydrous swallows
Taste masked particle, patient is administered orally described granule without carrying out assisting along pharynx with water, uses the mode without water swallow to take medicine, belong to medicine
Formulation art.
Background technology
Guaifenesin is 3-(2-methoxyphenoxy) propane-1,2-glycol, white or off-white color crystalline powder, is slightly soluble in
Water, is dissolved in ethanol.
Stimulating gastric mucosa after Kou Fu, reflexive causes bronchial secretion to increase, and makes sputum dilute.And have sterilization anticorrosion to make
With, this product also has antitussive, spasmolytic, anticonvulsant action, for the excessive phlegm cough of chronic bronchitis, pulmonary abscess, bronchus
Expansion and Secondary cases asthma.How to share with other antitussive and antiasthmatic medicines.The situation of expectoration it is difficult to for mucus.
This medicine untoward reaction is mainly nauseating, dizzy, drowsiness and allergy.This product has to stimulate and the work of expansion vascular smooth muscle
With, therefore disable in pneumorrhagia, acute gastroenteritis and nephritis patient.
In prior art, guaifenesin pharmaceutical preparation is mainly syrup, granule and tablet, there is bitterness after on the one hand taking
And abnormal flavour, affect the compliance after medicine is taken medicine, on the other hand, when existing guaifenesin oral solid formulation is taken medicine, all
Needs drink water and carry out, along pharynx, for some patients of inconvenience that drinks water, limiting the application of medicine.
At present, oral solid formulation in prior art, particularly granule, still there is no anhydrous swallowing or without water swallow
Granule research and report.Research and develop the oral solid formulation without water swallow, particularly without the oral granular formulation of water swallow, no
Only expand and be suitable for patients, and greatly facilitate patient and take medicine, there is important invention meaning.
Summary of the invention
Present invention aim at providing a kind of new guaifenesin pharmaceutical preparation, specifically, it is provided that one is more created sweet
Ether is anhydrous swallows taste masked particle for oil, and it the most effectively eliminates or cover bitterness and the abnormal flavour of medicine itself, unexpected
It is that patient is administered orally described granule and carries out without drinking water, along pharynx, the mode without water swallow to be used to take medicine.
Technical solution of the present invention is as follows:
The invention provides that a kind of guaifenesin is anhydrous swallows taste masked particle, guaifenesin coated micropill and taste masking material mix and
Become, it is characterised in that described guaifenesin coated micropill is to be sequentially passed through by medicine carrying ball to pack taste mask layer and smooth layer and make
Become, wherein: described taste mask layer is made up of especially strange E range of models and plasticizer and/or the antiplastering aid being optionally present, institute
The especially strange E range of models stated is for especially strange E100 or especially strange E PO, described plasticizer and/or antiplastering aid are selected from acetyl
Tributyl citrate, acetyl tributyl citrate diethylester, citric acid diethylester, triethyl citrate, oleic acid, dibutyl sebacate,
Glycerol, propylene glycol, tween 80, Polyethylene Glycol, Pulvis Talci, glyceryl monostearate, magnesium stearate, titanium dioxide, carbon
Acid calcium, magnesium oxide in one or more；Described smooth layer is by especially strange E range of models, sodium bicarbonate, carbomer
971PNF and be optionally present other adjuvants composition, wherein said especially strange E range of models be especially very E100 or especially
Strange E PO, other described adjuvants selected from glyceryl monostearate, magnesium stearate, stearic acid, titanium dioxide, Pulvis Talci,
In calcium carbonate, magnesium oxide one or more.
Preferably, the anhydrous taste masked particle of swallowing of guaifenesin described above, wherein said taste mask layer is by the strangest
E100, Pulvis Talci, triethyl citrate and magnesium stearate composition.
Preferably, the anhydrous taste masked particle of swallowing of guaifenesin described above, wherein said smooth layer is by the strangest
E100, sodium bicarbonate, Carbopol 971PNF, Pulvis Talci and stearic acid composition.
The anhydrous taste masked particle of swallowing of guaifenesin that the present invention is described above, wherein said medicine carrying ball be by guaifenesin and
The filler being optionally present or binding agent composition, preferably described filler or binding agent are selected from microcrystalline Cellulose, lactose, shallow lake
Powder, pregelatinized Starch, dextrin, glucose, mannitol, polyvidone, hypromellose, hydroxypropylcellulose, carbomer
In one or more.
Preferably, the anhydrous taste masked particle of swallowing of guaifenesin described above, wherein said taste mask layer is for more creating glycerol
The 1.0%～33.6% of ether coated micropill percentage by weight, more preferably 5.0%～23.6%.
Preferably, the anhydrous taste masked particle of swallowing of guaifenesin described above, wherein said smooth layer is for more creating glycerol
The 0.5%～40.7% of ether coated micropill percentage by weight, more preferably 3.7%～35.7%.
The anhydrous taste masked particle of swallowing of guaifenesin that the present invention is described above, wherein said taste masking material by sorbitol and
The adjuvant composition being optionally present, described adjuvant is selected from smooth dose, essence, sweeting agent or fluidizer, preferably described adjuvant choosing
From sodium carboxymethyl cellulose, hypromellose, hydroxypropylcellulose, carbomer, xanthan gum, fruit essence, fresh milk essence,
Aspa is sweet, in sucralose, cyclamate, acesulfame-K, magnesium stearate or Pulvis Talci one or more.
Preferably, guaifenesin described above is anhydrous swallows taste masked particle, calculates the most by weight, and described heals
The anhydrous taste masked particle of swallowing of wound glycerin ether is by 0.5～10 part of guaifenesin coated micropill and 0.5～10 part of taste masking material mixing
Become.
Present invention guaifenesin described above is anhydrous swallows taste masked particle, wherein guaifenesin content be 0.5%～
31.8%, more preferably 2.0%～21.8%.
As the embodiment of the invention, guaifenesin described above is anhydrous swallows taste masked particle, wherein unit
In preparation, containing following component:
Medicine carrying ball: guaifenesin 100mg, microcrystalline Cellulose 10596.15mg, 30 POVIDONE K 30 BP/USP 258.0mg；
Taste mask layer: especially strange E10012.10mg, Pulvis Talci 22.10mg, triethyl citrate 1.0mg, magnesium stearate 1.4mg；
Smooth layer: especially strange E1009.0mg, Carbopol 971PNF 7.2mg, sodium bicarbonate 7.2mg, Pulvis Talci 3.7mg, firmly
Fat acid 501.8mg；
Taste masking material: sorbitol 549mg, sodium carboxymethyl cellulose 10.0mg, Fructus Citri tangerinae essence 10.0mg, strawberry essence 8.0mg,
Aspartane 2.0mg, magnesium stearate 3.0mg.
The especially strange E100 that the present invention is described above, is methacrylic acid aminoalkyl ester copolymer E type (methacrylic acid
Butyl ester, Dimethylaminoethyl Methacrylate and methyl methacrylate (1:2:1) copolymer), for water white transparency or faint yellow
Grain, has faint ammonia smelly, and merchandise resources is for winning wound Degussa.
The Carbopol 971PNF that the present invention is described above, refers to acrylic acid bonding allyl sucrose or tetramethylolmethane allyl ether
High molecular polymer, white loose sprills；Having acescency, have and draw moist, merchandise resources is Lubrizol.
The stearic acid 50 that the present invention is described above, the solid fatty acid referring to that this strain is driven, obtaining in Vegetable oil lipoprotein, main
Wanting composition is stearic acid (C18H36O2) and Palmic acid (C16H32O2), this product is white or off-white color have soapy feeling powder or
Crystallinity lump, its section has the fine needle crystal of micro-strip gloss；There is the micro-smelly of similar oils and fats, tasteless.This product is in chloroform or second
In ether readily soluble, dissolve in ethanol, the most insoluble in water.Merchandise resources is BASF.
The 30 POVIDONE K 30 BP/USP 25 that the present invention is described above, is non-ionic macromolecule compound, refers to polyvinylpyrrolidone, 1-
The linear homopolymer of ethylene-2-Pyrrolidone synthesis, merchandise resources is ISP.
The microcrystalline Cellulose 105 that the present invention is described above, refers to by D-glucopyranosyl each other with Isosorbide-5-Nitrae-β-glycosidic bond even
A kind of homogeneous macromolecule connect, this product is widely used in oral drug preparation and food, is relative nontoxic and non-stimulated
The material of property.Do not absorb, almost without potential toxicity after this product is oral.Merchandise resources is Taiwan Ming Tai.
The anhydrous taste masked particle of swallowing of guaifenesin of the present invention, uses and prepared by principal agent and specific adjuvant medicine carrying granule
Or the dosage form of micropill, then use specific macromolecular material to carry out packing and smooth layer coating bag of taste masking merit film clothing successively
System, the specific taste masking material of a mixing part outside obtained coated micropill, obtained guaifenesin is anhydrous swallows taste masked particle
On the one hand bitterness and the abnormal flavour of medicine are masked, on the other hand, surprisingly, make patient take process without drinking water
Can swallow, process of taking, without bad mouthfeel and bitterness, effectively improves compliance；Improve the applicable crowd of patient,
Particularly it is beneficial to child be administered.And result of the test also confirms that, although the granule of the present invention packs through taste mask layer and smooth layer,
But quickly release and the absorption in vivo of principal agent guaifenesin, energy quickly release, the taste masking that packed are administered orally to gastronintestinal system
Layer and smooth layer do not affect release and the absorption of medicine.
Accompanying drawing explanation
Fig. 1: embodiment 1 guaifenesin is anhydrous swallows taste masked particle release in the HCl solvent of 0.01mol/L
Release impact is investigated test by the weightening finish of Fig. 2: taste mask layer
Release impact is investigated test by the weightening finish of Fig. 3: smooth layer
Detailed description of the invention
Following example are to explain or technical solution of the present invention being described, it does not constitute limit to the protection domain of this patent
System.
Embodiment 1: guaifenesin is anhydrous swallows taste masked particle
Guaifenesin is anhydrous, and to swallow the composition of taste masked particle unit formulation as follows:
Composition list:
Preparation process:
The preparation of medicine carrying ball uses the mode of extrusion spheronization to be prepared, and is surrounded by taste mask layer and smooth layer respectively outside medicine carrying ball, and each layer is equal
Using fluid bed to pack, coated micropill and taste masking material are mixed to prepare semi-finished product.Concrete preparation process is as follows:
1, the preparation of medicine carrying ball:
Medicine carrying ball is prepared by the mode using extrusion spheronization.
The preparation of 1.1 binding agents: recipe quantity 30 POVIDONE K 30 BP/USP 25 is configured to the aqueous solution that concentration is 15% (w/w), standby
With.
The preparation of 1.2 soft materials: the microcrystalline Cellulose 105 of recipe quantity, guaifenesin are put in wet granulation granulator, opens
Opening granulator to stir, material, when stirring, uses the mode toppled over to add binder solution, makes after having added
Grain machine, when running, adds appropriate purified water, continues stirring certain time, prepares soft material.
The extrusion of 1.3 soft materials: use 0.5mm extrusion screen cloth that material is extruded, obtain the extrudate of appropriate length.
1.4 ball blasts: shot-blasting machine, when running, adds extrudate, the rotating speed of shot-blasting machine follows the slowest rear fast principle
Carry out throwing of micropill, run certain time prepared required micropill.
1.5 are dried: using ebullated bed to carry out being dried of micropill, controlling temperature of charge is 40 DEG C, control micropill moisture and are
2～4%, collect the micropill between 35～50 mesh.
2, the packing of taste mask layer
The preparation of 2.1 taste mask layer solution:
By appropriate second alcohol and water mixing, being configured to alcohol aqueous solvent, the solvent taking above-mentioned 50% dissolves especially strange E100, remains 50%
Solvent dispersion prescription in remainder, during dispersion liquid adds the especially strange solution of stirring the most at last, stirring 20min is formed
Final solution.
Packing of 2.2 taste mask layer:
Using fluid bed to carry out packing of taste mask layer, it is 30 ± 5 DEG C that coating process controls material.
3, the packing of smooth layer:
The preparation of 3.1 smooth layers of solution:
Especially strange E100 is dissolved in the ethanol of 50%, other components in prescription is added in residue 50% ethanol and form colloid suspendible
Liquid, adds colloidal suspension in the especially strange E100 solution of stirring, and final employing refiner homogenizes 45min, is formed
Final solution.
Packing of 3.2 smooth layers:
Use fluid bed to carry out packing of taste mask layer, be 30 ± 5 DEG C according to the character coating process of material controls temperature of charge.
4, the mixing of taste masking material:
Above-mentioned prepared coated micropill is mixed with taste masking material, i.e. prepares that guaifenesin is anhydrous swallows taste masked particle.
Preparation effect assessment: dissolution, mouthfeel, anhydrous swallow effect.Result see table.
Release such as following table in table 1 water
For the drug release rate of Mouthsimulator Chinese medicine, the release in detection water is evaluated medicine taste masking effect in the oral cavity, passes through
Result draws, medicine 5min release in water is 2.7%, almost without carrying out release, and finds 10 health status
Good volunteer carries out test to medicine and draws, medicine 5min in oral cavity does not the most get one's bitters or abnormal flavour, after taking medicine all
Having nice and cool brisk sensation in reaction oral cavity, thus explanation has reached to cover effect of adverse drug taste.
Anhydrous effect of swallowing: blank coated micropill is mixed final preparation, after volunteer's oral administration, anhydrous
Under state along pharynx, 90% volunteer can swallow within 1min smoothly, and other 10% volunteer is complete at 1.5min
Becoming to swallow administration, the sorbitol formed in smooth layer, and taste masking material after contact saliva due to coated micropill contributes to saliva
Secretion, reached certain smooth effect, swallowed effect and meet drug quality requirement.
Table 2 release in the HCl of 0.01mol/L
Result illustrates: medicine is rapidly performed by release in acid, meets the requirement of quick acting after oral administration.
Embodiment 2: guaifenesin is anhydrous swallows taste masked particle
1, the prescription of medicine carrying ball forms and preparation technology parameter:
2, the preparation of taste mask layer solution and pack process
3, the preparation of smooth layer solution and pack process
4, release impact is investigated and is tested by the weightening finish of each layer:
(1) release impact is investigated and is tested by taste mask layer weightening finish: result such as following table 3-4 and Fig. 2
Release in 1.1 water: the results are shown in Table 3.
Release in table 3 water
Result illustrates: the sample of taste mask layer weightening finish 7.3%, the release overrun requirement caused in water owing to clothing is lepthymenia, other
The samples met bound requirements of weightening finish.
1.2 in acid release: the results are shown in Table 4 and Fig. 2.
The table 4 release in acid
Interpretation of result: taste mask layer in the range of being investigated on release without impact.
(2) release impact is investigated and is tested by the weightening finish of smooth layer: result such as table 5 below and Fig. 3
1.3 smooth layers of micropill release in acid: the results are shown in Table 5 and Fig. 3.
Release is affected by the weightening finish of table 5 smooth layer
Result illustrates: in the range of being investigated, and smooth layer increases weight to the release in acid without significant impact.
Claims (10)
1. a guaifenesin is anhydrous swallows taste masked particle, mixed by guaifenesin coated micropill and taste masking material, it is characterized in that described guaifenesin coated micropill is sequentially passed through by medicine carrying ball to pack taste mask layer and smooth layer and make, wherein: described taste mask layer is made up of especially strange E range of models and plasticizer and/or the antiplastering aid being optionally present, described especially strange E range of models is especially strange E100 or especially strange E PO, described plasticizer and/or antiplastering aid are selected from tributyl 2-acetylcitrate, acetyl tributyl citrate diethylester, citric acid diethylester, triethyl citrate, oleic acid, dibutyl sebacate, glycerol, propylene glycol, tween 80, Polyethylene Glycol, Pulvis Talci, glyceryl monostearate, magnesium stearate, titanium dioxide, calcium carbonate, in magnesium oxide one or more；Described smooth layer is by especially strange E range of models, sodium bicarbonate, Carbomer971
PNF forms with being optionally present other adjuvants, wherein said especially strange E range of models is especially strange E100 or especially strange E PO, and other described adjuvants are selected from glyceryl monostearate, magnesium stearate, stearic acid, titanium dioxide, Pulvis Talci, calcium carbonate, magnesium oxide one or more.
The anhydrous taste masked particle of swallowing of guaifenesin the most according to claim 1, wherein said taste mask layer is made up of especially strange E100, Pulvis Talci, triethyl citrate and magnesium stearate.
3., according to the anhydrous taste masked particle of swallowing of the guaifenesin described in claim 1-2, wherein said smooth layer is made up of especially strange E100, sodium bicarbonate, Carbomer971 PNF, Pulvis Talci and stearic acid.
4. swallow taste masked particle according to the guaifenesin described in claim 1-3 is anhydrous, wherein said medicine carrying ball is made up of guaifenesin and filler or the binding agent being optionally present, and preferably described filler or binding agent are selected from microcrystalline Cellulose, lactose, starch, pregelatinized Starch, dextrin, glucose, mannitol, polyvidone
, hypromellose, hydroxypropylcellulose, in carbomer one or more.
5., according to the anhydrous taste masked particle of swallowing of the guaifenesin described in claim 1-4, wherein said taste mask layer is the 1.0%～33.6% of guaifenesin coated micropill percentage by weight, more preferably 5.0%～23.6%.
6., according to the anhydrous taste masked particle of swallowing of the guaifenesin described in claim 1-5, wherein said smooth layer is the 0.5%～40.7% of guaifenesin coated micropill percentage by weight, more preferably 3.7%～35.7%.
7. swallow taste masked particle according to the guaifenesin described in claim 1-6 is anhydrous, wherein said taste masking material is made up of sorbitol and the adjuvant being optionally present, described adjuvant selected from smooth dose, essence, sweeting agent or fluidizer, preferably described adjuvant is sweet selected from sodium carboxymethyl cellulose, hypromellose, hydroxypropylcellulose, carbomer, xanthan gum, fruit essence, fresh milk essence, aspa, in sucralose, cyclamate, acesulfame-K, magnesium stearate or Pulvis Talci one or more.
8. swallowing taste masked particle according to the guaifenesin described in claim 1-7 is anhydrous, calculate the most by weight, the anhydrous taste masked particle of swallowing of described guaifenesin is mixed by 0.5～10 part of guaifenesin coated micropill and 0.5～10 part of taste masking material.
9. swallowing taste masked particle according to the guaifenesin described in claim 1-8 is anhydrous, wherein guaifenesin content is 0.5%～31.8%, more preferably 2.0%～21.8%.
10. swallow taste masked particle according to the guaifenesin described in claim 1-9 is anhydrous, wherein in unit formulation, containing following component:
(1) medicine carrying ball: guaifenesin 100mg, microcrystalline Cellulose 105 96.15mg, 30 POVIDONE K 30 BP/USP 25 8.0mg；
(2) taste mask layer: especially strange E100 12.10mg, Pulvis Talci 22.10mg, triethyl citrate 1.0mg, magnesium stearate 1.4mg；
(3) smooth layer: especially strange E100 9.0mg, Carbomer971 PNF 7.2mg, sodium bicarbonate 7.2mg, Pulvis Talci 3.7mg, stearic acid 50 1.8mg；
(4) taste masking material: sorbitol 549mg, sodium carboxymethyl cellulose 10.0mg, Fructus Citri tangerinae essence 10.0mg, strawberry essence 8.0mg, Aspartane 2.0mg, magnesium stearate 3.0mg.
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| CN201510073328.0A CN105982860B (en) | 2015-02-11 | 2015-02-11 | Guaifenesin water-free swallowable taste-masking granule |
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| CN1655766A (en) * | 2002-04-15 | 2005-08-17 | 亚当斯实验室有限公司 | Sustained release of guaifenesin combination drugs |
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