CN108078962A - A kind of instant film of donepezil hydrochloride orally and preparation method thereof - Google Patents
A kind of instant film of donepezil hydrochloride orally and preparation method thereof Download PDFInfo
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- CN108078962A CN108078962A CN201810104327.1A CN201810104327A CN108078962A CN 108078962 A CN108078962 A CN 108078962A CN 201810104327 A CN201810104327 A CN 201810104327A CN 108078962 A CN108078962 A CN 108078962A
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- instant film
- donepezil hydrochloride
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The invention belongs to field of pharmaceutical preparations, are related to instant film of the simple donepezil hydrochloride orally of a kind of technical matters and preparation method thereof.The good oral quick-dissolving film preparation of a kind of taste provided by the invention, its each component in percentage by weight, includes Doneppezil Hydrochloride 1 40%, filmogen 20 80%, plasticizer 1 20%, odor mask 1 20%, filler 10 30%, other auxiliary materials 0 5%.Preparation method is simple, can by dissolved directly by various composition in appropriate solvent be uniformly dispersed after be coated on back lining materials, drying be made.Obtained film appearance uniform is smooth, physical mechanical property is good, dissolving is rapid, taste is good and easy to carry, can improve the compliance of alzheimer disease patient medication.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of instant film of donepezil hydrochloride orally and its preparation side
Method.
Background technology
Alzheimer disease is a kind of nervous system degenerative disease of the progress sexual development of onset concealment, is commonly called as old silly
It is slow-witted.Alzheimer disease is found in last century, and normal onset is gradually in progress, clinic is main in old or presenium, more slowly morbidities
Show as memory disorders, aphasia, appraxia, agnosia, the damage of visual space technical ability, perform function obstacle and personality and behavior change
Generalized dementias are waited, the cause of disease is unknown so far, and clinical treatment still faces big challenge at present.It is generally believed that the age often increases by 5
Year, illness rate will increase by 1 times.Under nowadays aging increasingly serious situation, alzheimer disease has become serious society
Public health problem becomes the great illness for influencing human health, and white elephant is brought for society and family.
Doneppezil Hydrochloride is the choice drug currently used for treating alzheimer disease, can reversibly inhibit choline
In nerve in nerve synapse gap acetylcholine hydrolysis, increase receptor to the usage amount of acetylcholine, improve A Erzi
The cholinergic nerve function of the silent patient's brain in sea, has higher selectivity, without apparent liver to maincenter acetylcholinesterase
Toxicity.Compared with similar drugs, have the characteristics that long action time, drug effect are high, safe, adverse drug reaction is small.
Pelliculae pro cavo oris is a kind of emerging drug delivery system, can be dissolved rapidly in the oral cavity, drug is discharged, suitable for not
It is convenient that the old man and children of same crowd, in particular dysphagia provide.Pelliculae pro cavo oris is using water-soluble polymer as film forming
Material after meeting saliva in the oral cavity dissolves and discharges drug quickly.Commercial oral quickly disintegrating tablet phase with needing extra package
Than, pelliculae pro cavo oris is non-friable and is easy to carry about with one, so clinically it is subject to doctor and patients favor.The agent of oral quick-dissolving film preparation
Type feature determines its rapid dissolving in the oral cavity, so also needing concern taste masking for more bitter drug.
The content of the invention
An object of the present invention is to provide that a kind of preparation method is simple, taste is good, drug release rate is fast, can rapid-onset
The instant film of donepezil hydrochloride orally, improve alzheimer disease patient medication compliance.
It is characteristic of the invention that preparing the instant film of donepezil hydrochloride orally in a simple way, pass through glycyrrhizin, three
Chlorine sucrose, menthol etc. carry out taste masking, solve the Doneppezil Hydrochloride bad mouthfeel of bitter taste and paralysis in the oral cavity；Into membrane material
Material selects the high molecular material of good water solubility, ensure that medicine film can quickly dissolve and discharge drug in the oral cavity.
The good oral quick-dissolving film preparation of a kind of taste provided by the invention, each component in percentage by weight, comprising
Doneppezil Hydrochloride 1-40%, filmogen 20-80%, plasticizer 1-20%, odor mask 1-20%, filler 10-30%, screening
Photo etching and other auxiliary materials 0-5%.
Filmogen should have the characteristics that fast, the good film forming of dissolving and release property, should additionally have nontoxic, stingless
Swash, property is stable, the features such as not having an effect with drug.Used film forming material is selected from Kollicoat, polyoxy second in the present invention
Alkene, polyvinyl alcohol, hypromellose, pulullan, sodium alginate, gelatin, xanthans, hydroxyethyl cellulose, carboxymethyl
One or more in fiber.Plasticizer improves film performance, increases toughness, reduces brittleness.Plasticizer is selected from polyethylene glycol, second
Glycol, propylene glycol, phthalate, glycerine, castor oil, acetyl list monoglyceride, one kind in triacetin or
It is a variety of.Filler can increase film weight and volume, reduce molding shrinkage, adjust resin viscosity, reduce surface roughness.This
Invention improves film performance and appearance using appropriate filler, is smoothed out preparation process.Filler is selected from mannitol, mountain
One or more in pears alcohol, antierythrite, xylitol, maltitol, dextrin, trehalose.Odor mask is selected from Sucralose, sweet
Reveal alcohol, Aspartame, stevioside, glycyrrhizin, saccharin sodium, menthol, the one or more in essence, preferably Sucralose and
Glycyrrhizin is applied in combination.Sucralose is more perfect, the sweet tea of new generation that competitiveness is very strong that human development so far comes out
Taste agent, sugariness are 600 times of sucrose, are a kind of faster sweeteners of sweet taste explosive ratio.But individually using Sucralose as covering
Taste means, it is difficult to cover the bitter taste in later stage.Glycyrrhizin sugariness is 200 times of sucrose, and sweet taste is different from sucrose, after entrance slightly
Through just pleasantly sweet sense for a moment, the retention time is long, there is flavour and flavouring effect.Both is used in combination and can preferably be covered
The bitter taste and paralysis of Doneppezil Hydrochloride are felt.Other compositions such as colorant is selected from iron oxide red, iron oxide yellow, and opacifier is dioxy
Change titanium.
The present invention also provides the preparation methods of the instant film of donepezil hydrochloride orally, include the following steps：
Weigh filmogen, plasticizer is dissolved in 30-80 DEG C of stirred in water bath, add in Doneppezil Hydrochloride, odor mask, fill out
It fills agent and opacifier etc. to continue to stir under the same conditions, makes it scattered, uniformly rear ultrasound degassing to be mixed, by its even spread
On back lining materials, 30-60 DEG C of heat drying cuts into a certain size diaphragm to get the instant film of donepezil hydrochloride orally.
The instant film of the donepezil hydrochloride orally, it is characterized in that, appearance uniform is smooth；Toughness is high, folding number
It is more；Good mechanical property has preferable tensile strength and percent elongation；Solution rate is fast, and the disintegration time in 37 DEG C of water is small
In 30s, it is generally less than 20s, scattered, release drug can be dissolved rapidly in the oral cavity.
Specific embodiment
The present invention will be further elaborated below.
Embodiment 1
Specific preparation process：Weigh Kollicoat IR, glycerine is dissolved in 60 DEG C of stirred in water bath, add in hydrochloric acid mostly how piperazine
Together, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, ultrasonic after being uniformly dispersed
30min deaerates, and is spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Size diaphragm, obtains Doneppezil Hydrochloride
Oral quick-dissolving film preparation.
Embodiment 2
Specific preparation process：Weigh Kollicoat IR, glycerine is dissolved in 60 DEG C of stirred in water bath, add in hydrochloric acid mostly how piperazine
Together, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, ultrasonic after being uniformly dispersed
30min deaerates, and is spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2 size diaphragms, obtain Doneppezil Hydrochloride
Oral quick-dissolving film preparation.
Embodiment 3
Specific preparation process：Weigh filmogen HPMC E5, glycerine is dissolved in 60 DEG C of stirred in water bath, add in hydrochloric acid it is more
Donepezil, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, after being uniformly dispersed
Ultrasonic 30min degassings, are spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Mostly how, size diaphragm obtains hydrochloric acid
The neat oral quick-dissolving film preparation of piperazine.
Embodiment 4
Specific preparation process：Weigh filmogen HPMC E5, glycerine is dissolved in 60 DEG C of stirred in water bath, add in hydrochloric acid it is more
Donepezil, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, after being uniformly dispersed
Ultrasonic 30min degassings, are spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Mostly how, size diaphragm obtains hydrochloric acid
The neat oral quick-dissolving film preparation of piperazine.
Embodiment 5
Specific preparation process：Weigh Kollicoat IR, 1,2-PD is dissolved in 60 DEG C of stirred in water bath, addition hydrochloric acid
Donepezil, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, are uniformly dispersed
Ultrasound 30min deaerates afterwards, is spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Size diaphragm, it is more to obtain hydrochloric acid
Donepezil oral quick-dissolving film preparation.
Embodiment 6
Specific preparation process：It weighs Kollicoat IR, PEG-400 to dissolve in 60 DEG C of stirred in water bath, it is more to add in hydrochloric acid
Donepezil, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, after being uniformly dispersed
Ultrasonic 30min degassings, are spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Mostly how, size diaphragm obtains hydrochloric acid
The neat oral quick-dissolving film preparation of piperazine.
Embodiment 7
Specific preparation process：Weigh Kollicoat IR, 1,2-PD is dissolved in 60 DEG C of stirred in water bath, addition hydrochloric acid
Donepezil, mannitol, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered, point
Ultrasound 30min degassings, are spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm after dissipating uniformly2Size diaphragm, obtains
The instant film of donepezil hydrochloride orally.
Embodiment 8
Specific preparation process：Weigh Kollicoat IR, 1,2-PD is dissolved in 60 DEG C of stirred in water bath, addition hydrochloric acid
Donepezil, antierythrite, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it are made fully to dissolve scattered,
Ultrasound 30min deaerates after being uniformly dispersed, and is spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Size diaphragm,
Obtain the instant film of donepezil hydrochloride orally.
Embodiment 9
Specific preparation process：Weigh Kollicoat IR, 1,2-PD is dissolved in 60 DEG C of stirred in water bath, addition hydrochloric acid
Donepezil, sorbierite P60, Sucralose, glycyrrhizin, menthol, titanium dioxide continue to stir, it is made fully to dissolve point
It dissipates, ultrasound 30min deaerates after being uniformly dispersed, and is spread evenly across on glass plate, 60 DEG C of dryings cut into 2 × 1.5cm2Sized membrane
Piece obtains the instant film of donepezil hydrochloride orally.
The instant film evaluation method of donepezil hydrochloride orally
The evaluation method of oral quick-dissolving film preparation is inspection target according to appearance and sensory evaluation, from the uniformity, film forming, is taken off
Three aspects of mould complexity are investigated；It is inspection target according to the physical property of film, from folding strength, tensile strength and hundred
Three aspects of elongation is divided to be investigated；In addition its disintegration time is investigated.
It is inspection target standards of grading according to appearance and sensory evaluation
Evaluation result is as follows
Claims (7)
1. a kind of instant film of donepezil hydrochloride orally and preparation method thereof, it is characterised in that the oral quick-dissolving film preparation is by salt
Sour donepezil, filmogen, plasticizer, filler, odor mask, opacifier and other auxiliary materials composition.
2. the instant film of donepezil hydrochloride orally according to claim 1, it is characterised in that the wherein weight of each component
Percentage composition is：Doneppezil Hydrochloride 1-40%, filmogen 20-80%, plasticizer 1-20%, filler 10-30%, taste masking
Agent 1-20%, opacifier and other auxiliary materials 0-5%.
3. the instant film of donepezil hydrochloride orally according to claim 1, it is characterised in that the filmogen is selected from
Kollicoat, polyoxyethylene, polyvinyl alcohol, hypromellose, pulullan, sodium alginate, gelatin, xanthans, hydroxyl second
One or more in base cellulose, carboxymethyl cellulose, preferably Kollicoat IR, HPMC.
4. the instant film of donepezil hydrochloride orally according to claim 1, it is characterised in that the plasticizer is selected from poly-
In ethylene glycol, ethylene glycol, propylene glycol, phthalate, glycerine, castor oil, acetyl list monoglyceride, triacetin
One or more, preferably glycerine, 1,2-PD.
5. the instant film of donepezil hydrochloride orally according to claim 1, it is characterised in that the filler is selected from sweet
Reveal the one or more in sugar alcohol, sorbierite, antierythrite, xylitol, maltitol, dextrin, trehalose, preferably mannose
Alcohol, antierythrite, sorbierite.
6. the instant film of donepezil hydrochloride orally according to claim 1, it is characterised in that the odor mask is selected from small
Molecule sweetener such as Sucralose, mannitol, Aspartame, stevioside, glycyrrhizin, saccharin sodium, menthol, essence, taste masking
Resinae such as polacrilin and its sylvite resin, crylic acid resin and one kind or more in taste masking inclusion compound such as cyclodextrin
Kind, preferably Sucralose, glycyrrhizin, menthol.
7. the instant film of donepezil hydrochloride orally according to claim 1, it is characterised in that preparation method includes as follows
Step：
Weigh filmogen, plasticizer is dissolved in 30-80 DEG C of stirred in water bath, addition Doneppezil Hydrochloride, odor mask, filler
Continue to stir with opacifier etc., make it scattered, it is to be mixed uniformly after ultrasound degassing, by its even spread back lining materials, 30-60
DEG C heat drying, cuts into a certain size diaphragm to get the instant film of donepezil hydrochloride orally.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810104327.1A CN108078962A (en) | 2018-01-29 | 2018-01-29 | A kind of instant film of donepezil hydrochloride orally and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810104327.1A CN108078962A (en) | 2018-01-29 | 2018-01-29 | A kind of instant film of donepezil hydrochloride orally and preparation method thereof |
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| CN201810104327.1A Pending CN108078962A (en) | 2018-01-29 | 2018-01-29 | A kind of instant film of donepezil hydrochloride orally and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693834A (en) * | 2019-10-24 | 2020-01-17 | 大连怡爽口腔医疗科技有限公司 | Oral moistening spray |
| CN113082005A (en) * | 2021-04-07 | 2021-07-09 | 青岛科技大学 | Preparation of nano cellulose base taste-masking oral instant membrane |
| CN115569122A (en) * | 2022-10-20 | 2023-01-06 | 深圳善康医药科技股份有限公司 | Donepezil sustained-release implant and preparation method and application thereof |
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| WO2012148225A2 (en) * | 2011-04-29 | 2012-11-01 | Bio Pharmartis Co., Ltd. | Sustained-release pharmaceutical composition comprising donepezil or pharmaceutically acceptable salt thereof having improved dissolution stability and method for manufacturing the same |
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| CN104586819A (en) * | 2015-01-05 | 2015-05-06 | 万特制药(海南)有限公司 | Medicine composition for treating senile dementia and preparation method thereof |
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| CN107375945A (en) * | 2017-08-29 | 2017-11-24 | 沈阳药科大学 | A kind of donepezil cyclodextrin inclusion compound and the oral instant film containing this inclusion compound |
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2018
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693834A (en) * | 2019-10-24 | 2020-01-17 | 大连怡爽口腔医疗科技有限公司 | Oral moistening spray |
| CN113082005A (en) * | 2021-04-07 | 2021-07-09 | 青岛科技大学 | Preparation of nano cellulose base taste-masking oral instant membrane |
| CN115569122A (en) * | 2022-10-20 | 2023-01-06 | 深圳善康医药科技股份有限公司 | Donepezil sustained-release implant and preparation method and application thereof |
| CN115569122B (en) * | 2022-10-20 | 2024-05-31 | 深圳善康医药科技股份有限公司 | Donepezil Ji Huanshi implant and preparation method and application thereof |
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