CN108743567A - Molten film of galanthamine hydrobromide mouth and preparation method thereof - Google Patents
Molten film of galanthamine hydrobromide mouth and preparation method thereof Download PDFInfo
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- CN108743567A CN108743567A CN201810971699.4A CN201810971699A CN108743567A CN 108743567 A CN108743567 A CN 108743567A CN 201810971699 A CN201810971699 A CN 201810971699A CN 108743567 A CN108743567 A CN 108743567A
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- mouth
- film
- molten film
- molten
- galanthamine hydrobromide
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Classifications
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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
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Abstract
An embodiment of the present invention provides a kind of molten films of galanthamine hydrobromide mouth and preparation method thereof, belong to field of pharmaceutical preparations, can solve the problems, such as that existing galanthamine hydrobromide pharmaceutical dosage form takes inconvenience.The molten film of galanthamine hydrobromide mouth includes：The corrigent of the galanthamine hydrobromide of 5-30wt%, the water-soluble film forming agent of 20-70wt%, the plasticizer of 1-10wt%, the disintegrant of 10-30wt% and 1-15wt%.The molten film of galanthamine hydrobromide mouth can be used for treating Alzheimer disease.
Description
Technical field
The present invention relates to field of pharmaceutical preparations more particularly to a kind of molten film of galanthamine hydrobromide mouth and its preparation sides
Method.
Background technology
Galanthamine hydrobromide is a kind of cholinesterase inhibitor, can be extracted from amrallid short-tube lycoris.Britain 1998
The III clinical trial phases that year carries out show that the medical instrument has the double action of acetylcholine esterase inhibition and adjustment nicotine receptor
Mechanism.Therefore, galanthamine hydrobromide can improve the cognitive ability of early patients with Alzheimer disease, and be used as treatment slight extremely
The non-drug of moderate Alzheimer's disease is listed in the European Community.
Galanthamine hydrobromide has now been developed a variety of dosage forms, such as tablet, capsule, oral administration solution, injection etc., still
These dosage forms all have inconvenience on taking.Such as tablet and taking for capsule need water, and for old man, neck by
The people of wound and with very inconvenient for the patient for gulping down medicine obstacle.Although oral administration solution is without considering the problems of to swallow, mouth
Take solution be often stored in vial also need to cooperation suction pipe, be unfavorable for carrying.Injection for the patient that has a fainting spell during acupuncture treatment be also
Inconvenient.
Invention content
A kind of molten film of galanthamine hydrobromide mouth of offer of the embodiment of the present invention and preparation method thereof, provides a kind of hydrogen bromine
The novel form of sour galanthamine improves the convenience of medication.
The embodiment of the present invention provides a kind of molten film of galanthamine hydrobromide mouth, and the molten film of mouth includes 5-30wt%'s
The disintegrant and 1- of galanthamine hydrobromide, the water-soluble film forming agent of 20-70wt%, the plasticizer of 1-10wt%, 10-30wt%
The corrigent of 15wt%.
Optionally, the molten film of the mouth include the galanthamine hydrobromide of 15-25wt%, 30-50wt% it is water-soluble at
Film, 2-5wt% plasticizer 15-25wt% disintegrant and 3-7wt% corrigent.
Optionally, the water-soluble film forming agent be selected from polyvinyl alcohol, hydroxypropyl methyl cellulose, sodium cellulose glycolate,
One or more of hydroxypropyl cellulose, xanthans, pectin, polyoxyethylene, cornstarch.
Preferably, the water-soluble film forming agent is polyvinyl alcohol Mowiol4-88.
Optionally, the plasticizer is selected from polyethylene glycol, sorbierite, repefral, phthalic acid diethyl
One or more of ester, glycerine, glyceryl triacetate, propylene glycol Chinese holly edge acid esters, castor oil or Tween 80.
Preferably, the plasticizer is to account for the PEG4000 of the molten film 2-4wt% of mouth and account for the molten film 1-2wt% of mouth
The polyethylene glycol mixture of PEG400.
Optionally, the disintegrant includes sodium carboxymethyl starch, low-substituted hydroxypropyl methylcellulose, crosslinked polyethylene pyrrolidines
One or more of ketone, croscarmellose sodium, sodium alginate, crospovidone and microcrystalline cellulose.
Optionally, the corrigent includes the aromatic of the sweetener and 0.1-2wt% that account for oral instant membrane 4-6wt%.
The embodiment of the present invention provides a kind of preparation method of the above-mentioned molten film of galanthamine hydrobromide mouth, the preparation method
Including：
It is under stirring that water-soluble film forming agent is soluble in water in 60-80 DEG C at a temperature of, obtain polymer gel；
Disintegrant, plasticizer, corrigent is added into polymer gel under stirring, and stirs evenly；
Galanthamine hydrobromide is added under stirring, and stirs evenly, obtains containing drug solns；
It is de-gassed, is film-made to containing drug solns, and the heat drying at 40-50 DEG C, cut, obtain galanthamine hydrobromide
Oral instant membrane.
Optionally, the film step includes：
Contain drug solns after even spread degassing on stainless steel.
Galanthamine hydrobromide oral instant membrane provided in an embodiment of the present invention and preparation method thereof, including corresponding percentage contain
Galanthamine hydrobromide, film forming agent, plasticizer, disintegrant, corrigent of amount etc..The molten film of galanthamine hydrobromide mouth, at
Film works well, and is not required to use water delivery service, can dissolve rapidly in the oral cavity, help to improve patient medication compliance.It was producing
Without dust in journey, labour protection and problem of environmental pollution can be solved, does not use organic solvent, production security high.
Specific implementation mode
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention
Technical solution be clearly and completely described, it is clear that described embodiments are some of the embodiments of the present invention, rather than
Whole embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not making creative work premise
Lower obtained every other embodiment, shall fall within the protection scope of the present invention.
Herein, unless otherwise specified, then wt% refers to weight accounting of each ingredient in the molten film of finished product mouth.
An embodiment of the present invention provides a kind of molten films of galanthamine hydrobromide mouth.The molten film of mouth is to refer to be put in oral cavity
The film type of middle dissolving.The main ingredient of the molten film of mouth provided in this embodiment is galanthamine hydrobromide.Galanthamine hydrobromide is
A kind of white crystalline powder, odorless, bitter are dissolved in water.Accounting of the galanthamine hydrobromide in the molten film of mouth can be 5-
30wt%, it is preferred that accounting can be 15-25wt%.Such as accounting be 5wt%, 10wt%, 15wt%, 20wt%,
25wt%, 30wt% etc..
The reagent of furtherance film supplemented by film forming agent, i.e., by the evaporation of solvent or carrier to the mixture containing film forming agent or
Solidification to the mixture for being mixed with film forming agent, can form continuous film.Water-soluble film forming agent can be dissolved in the film forming of water
Agent, to dissolve in the oral cavity.Water-soluble film forming agent for example selected from polyvinyl alcohol (PVA), hydroxypropyl methyl cellulose (HPMC),
In sodium cellulose glycolate (CMC-Na), hydroxypropyl cellulose (HPC), xanthans, pectin, polyoxyethylene (PEO), cornstarch
One or more.Preferably, water-soluble film forming agent is polyvinyl alcohol (PVA).
Accounting of the water-soluble film forming agent in the molten film of mouth can be 20-70wt%, it is preferred that accounting can be 30-
50wt%.Specifically, such as accounting 20wt%, 25wt%, 30wt%, 35wt%, 40wt%, 45wt%, 50wt%,
55wt%, 60wt%, 65wt%, 70wt% etc..
Plasticizer is used for increasing the plasticity of film.Plasticizer is for example selected from polyethylene glycol (PEG), sorbierite, O-phthalic
In dimethyl phthalate, diethyl phthalate, glycerine, glyceryl triacetate, propylene glycol Chinese holly edge acid esters, castor oil or Tween 80
It is one or more of.Preferably, plasticizer is selected from polyethylene glycol (PEG), glycerine.
Accounting of the plasticizer in the molten film of mouth can be 1-10wt%, it is preferred that accounting can be 2-5wt%.Such as
1wt%, 2wt%, 5wt%, 10wt% etc..
Disintegrant can make the molten film of mouth accelerate to split the substance for being broken into fine particle in the oral cavity.The disintegrant for example selects
From sodium carboxymethyl starch, low-substituted hydroxypropyl methylcellulose, crosslinked polyvinylpyrrolidone, croscarmellose sodium, seaweed
One or more of sour sodium, crospovidone and microcrystalline cellulose.
Accounting of the disintegrant in the molten film of mouth can be 10-30wt%, it is preferred that accounting can be 15-25wt%.Tool
Body, such as accounting 10wt%, 15wt%, 20wt%, 25wt%, 30wt% etc..
Corrigent includes sweetener and/or aromatic etc..Galanthamine hydrobromide has certain bitter taste, and corrigent is added
It can improve and take mouthfeel.Sweetening agents are as selected from saccharin, Sucralose, neotame, A Litian, honey element, acesulfame potassium, A Siba
One or more of sweet tea and ammonium glycyrrhizinate.Sweetener is preferably Sucralose.Aromatic is for example fragrant selected from petit grain oil, strawberry
One kind in essence, vanilla flavour concentrate, oil of grapefruit, Mint Essence, cinnamyl acetate, citral, citronella oil, Levomenthol and menthol
Or it is several.Aromatic is preferably Mint Essence.
Accounting of the corrigent in the molten film of mouth can be 1-15wt%, can be preferably 3-7wt%.Specifically, example
Such as accounting 1wt%, 3wt%, 5wt%, 7wt%, 10wt%, 15wt%.
It is preferred that the aromatic of the sweetener of accounting 4-6wt% and accounting 0.1-2wt% are collectively as strong in the molten film of mouth
Taste agent.
Can also include colorant in the molten film of mouth to make film that certain appearance be presented.Colorant is for example selected from water
Dissolubility pigment etc..Accounting of the colorant in the molten film of mouth is 0-2wt%, it is preferred that 0-0.5wt%.
Finally, it will be appreciated that usually also containing the acceptable excess water for not influencing medicine film storage, surplus in film
Accounting of the water in the molten film of mouth is 0.5-7wt%.Moisture is excessive, and film is not easily molded；The too low film of moisture is easy drying
It splits, it is not easy to maintain.Specifically, such as accounting 0.5wt%, 1wt%, 2wt%, 3wt%, 4wt%, 5wt%, 6wt%,
7wt% etc..It is further preferred that water content is preferably between 0.5-5wt%.It is furthermore preferred that water content preferably between
Between 1-3wt%.The toughness of the molten film of mouth within the scope of this is preferable.
The molten film of galanthamine hydrobromide mouth provided in an embodiment of the present invention, includes the galantamine hydrobromide of corresponding percentage composition
His quick, film forming agent, plasticizer, disintegrant, corrigent etc..The molten film of galanthamine hydrobromide mouth, film-formation result is good, is not required to
With water delivery service, it can dissolve rapidly in the oral cavity, help to improve patient medication compliance.In process of production without dust, can solve
Certainly labour protection and problem of environmental pollution do not use organic solvent, production security high.
In another embodiment of the invention, it is 20-400KDa as the molecular weight of the polyvinyl alcohol of water-soluble film forming agent,
Degree of hydrolysis is 85-90%.In certain embodiments of the present invention, it is preferred to use molecular weight 31KDa, degree of hydrolysis 68.7-
88.8% polyvinyl alcohol namely trade name is the polyvinyl alcohol product of Mowiol4-88.The polyethylene product is formed by
Medicine film uniform ground.
In another embodiment of the present invention, the mixture of two kinds of polyethylene glycol can be selected as plasticizer application.Such as
Select molecular weight 3000-6000Da PEG and molecular weight the PEG of 250-1000Da mixture, more specifically,
The mixture of PEG4000 and PEG400.Preferably, plasticizer is to account for the PEG4000 of the molten film 2-4wt% of mouth and account for the molten film of mouth
The mixture of the PEG400 of 1-2wt%, such as account for the PEG4000 of the molten film 3wt% of mouth and account for the molten film 1.5wt%PEG400 of mouth
Mixture.When the mixture of PEG4000 and PEG400 is as plasticizer, the toughness of film is higher.
In another embodiment of the present invention, the preferred croscarmellose sodium of disintegrant and sodium carboxymethyl starch are total to
Mixed object.The blend is as disintegrant in application, the molten membrane surface of mouth formed is smooth, without particulate matter.In the another of the present invention
In one embodiment, the preferred sodium alginate of disintegrant.Sodium alginate is as disintegrant in application, the molten membrane surface light of mouth formed
It is sliding, without particulate matter.
Corresponding with the molten film of galanthamine hydrobromide mouth provided in an embodiment of the present invention, the embodiment of the present invention additionally provides
The preparation method of the molten film of galanthamine hydrobromide mouth.This method comprises the following steps.
Step 1：It is under stirring that water-soluble film forming agent is soluble in water in 60-80 DEG C at a temperature of, obtain polymer
Gel.
Preferably, water-soluble film forming agent is dissolved in water at a temperature of 70-75 DEG C.
Step 2：Disintegrant, plasticizer, corrigent is added into polymer gel under stirring, and stirs evenly.
It is understood that the order of addition of disintegrant, plasticizer, corrigent can be according to the specific feelings of the material of selection
Condition is configured.It is preferred that being added according to the sequence for being firstly added disintegrant and then the last corrigent of plasticizer.Disintegrant content is logical
Often it is higher than plasticizer and corrigent, disintegrant is first added and is more advantageous to the uniform of solution.
Step 3：Galanthamine hydrobromide is added under stirring, and stirs evenly, obtains containing drug solns.
It is eventually adding main ingredient ingredient galanthamine hydrobromide so that drug can be evenly distributed in containing in drug solns.
Step 4：It is de-gassed, is film-made to containing drug solns, and the heat drying at 40-50 DEG C, cut, obtain hydrobromic acid and add
Lan Tamin oral instant membranes.
Preferably, the heat drying at 40-45 DEG C.Preferably, it is filmed on stainless steel.
The preparation method of the molten film of galanthamine hydrobromide mouth provided in an embodiment of the present invention, in process of production without powder
Dirt can solve labour protection and problem of environmental pollution, not use organic solvent, production security high.The molten film of made mouth
Agent includes galanthamine hydrobromide, film forming agent, plasticizer, disintegrant, corrigent of corresponding percentage composition etc., and film-formation result is good
It is good, it is not required to use water delivery service, can dissolve rapidly in the oral cavity, help to improve patient medication compliance.
In order to more preferably illustrate molten film of galanthamine hydrobromide mouth provided in an embodiment of the present invention and preparation method thereof, below
It is described in conjunction with specific embodiments.
Embodiment 1
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
| Ingredient | Content |
| Galanthamine hydrobromide | 4.0g |
| Polyvinyl alcohol Mowiol4-88 | 9.8g |
| Polyethylene glycol 400 | 1.0g |
| Sodium alginate | 4.0g |
| Sucralose | 0.8g |
| Purified water | 30mL |
Under stirring, polyvinyl alcohol Mowiol4-88 is dissolved in the purified water of the 30mL under 75 DEG C of water bath conditions
In, obtain polymer gel.Polyethylene glycol 400, sodium alginate, Sucralose are added into gel to stir evenly.In stirring shape
Galanthamine hydrobromide is added under state, stirs evenly, obtains containing drug solns.It is coated on stainless steel after drug containing solution left standstill is deaerated
On plate, and it is dry at 45 DEG C.Finally cut into 1000 medicine films.Weighed, the average weight of every medicine film is 20mg.
Embodiment 2
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
| Ingredient | Content |
| Galanthamine hydrobromide | 4.0g |
| Polyvinyl alcohol 1788 | 7.2g |
| Glycerine | 0.6g |
| The blend of croscarmellose sodium and sodium carboxymethyl starch | 3.2g |
| Abbas's sweet tea | 0.3g |
| Purified water | 30mL |
Under stirring, in the purified water for the 30mL that polyvinyl alcohol 1788 is dissolved under 70 DEG C of water bath conditions, obtain
Polymer gel.Blend, the Abbas's sweet tea of glycerine, croscarmellose sodium and sodium carboxymethyl starch are added into gel
It stirs evenly.Galanthamine hydrobromide is added under stirring, stirs evenly, obtains containing drug solns.By drug containing solution left standstill
It is coated on stainless steel plate after degassing, and dry at 45 DEG C.Finally cut into 1000 medicine films.It is weighed, every medicine film
Average weight is 16mg.
Embodiment 3
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
| Ingredient | Content |
| Galanthamine hydrobromide | 4.0g |
| Hydroxypropyl methyl cellulose | 11.5g |
| Glycerine | 1.3g |
| Sodium carboxymethyl starch | 6.7g |
| Abbas's sweet tea | 1.3g |
| Mint Essence | 0.5g |
| Purified water | 30mL |
Under stirring, in the purified water for the 30mL that hydroxypropyl methyl cellulose is dissolved under 65 DEG C of water bath conditions,
Obtain polymer gel.Glycerine, sodium carboxymethyl starch, Abbas's sweet tea and Mint Essence are added into gel to stir evenly.It is stirring
It mixes and galanthamine hydrobromide is added under state, stir evenly, obtain containing drug solns.It is coated on not after drug containing solution left standstill is deaerated
It becomes rusty on steel plate, and dry at 50 DEG C.Finally cut into 1000 medicine films.Weighed, the average weight of every medicine film is
26.7mg。
Embodiment 4
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
Under stirring, polyvinyl alcohol Mowiol4-88 is dissolved in the purified water of the 30mL under 65 DEG C of water bath conditions
In, obtain polymer gel.Glycerine, sodium alginate, Sucralose and Mint Essence are added into gel to stir evenly.It is stirring
Galanthamine hydrobromide is added under state, stirs evenly, obtains containing drug solns.To contain be coated on after drug solns vacuum outgas it is stainless
On steel plate, and it is dry at 50 DEG C.Finally cut into 1000 medicine films.Weighed, the average weight of every medicine film is 23.5mg.
Embodiment 5
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
| Ingredient | Content |
| Galanthamine hydrobromide | 4.0g |
| Polyvinyl alcohol Mowiol4-88 | 8.0g |
| Polyethylene glycol 400 | 0.8g |
| Sodium alginate | 2.7g |
| Sucralose | 0.7g |
| Purified water | 30mL |
Under stirring, polyvinyl alcohol Mowiol4-88 is dissolved in the purified water of the 30mL under 60 DEG C of water bath conditions
In, obtain polymer gel.Polyethylene glycol 400, sodium alginate, Sucralose are added into gel to stir evenly.In stirring shape
Galanthamine hydrobromide is added under state, stirs evenly, obtains containing drug solns.It is coated on stainless steel after drug containing solution left standstill is deaerated
On plate, and it is dry at 40 DEG C.Finally cut into 1000 medicine films.Weighed, the average weight of every medicine film is 16.7mg.
Embodiment 6
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
| Ingredient | Content |
| Galanthamine hydrobromide | 4.0g |
| Polyvinyl alcohol Mowiol4-88 | 7.5g |
| Macrogol 4000 | 0.5g |
| Glycerine | 0.3g |
| Sodium alginate | 3.1g |
| Sucralose | 0.7g |
| Mint Essence | 0.1g |
| Purified water | 30mL |
Under stirring, polyvinyl alcohol Mowiol4-88 is dissolved in the purified water of the 30mL under 65 DEG C of water bath conditions
In, obtain polymer gel.Macrogol 4000, glycerine, sodium alginate, Sucralose and Mint Essence are added into gel to stir
It mixes uniformly.Galanthamine hydrobromide is added under stirring, stirs evenly, obtains containing drug solns.Drug containing solution left standstill is taken off
It is coated on stainless steel plate after gas, and dry at 50 DEG C.Finally cut into 1000 medicine films.It is weighed, every medicine film it is flat
Equal weight is 16.7mg.
Embodiment 7
Formula as below is the amount of 1000 molten films of galanthamine hydrobromide mouth, and made galanthamine hydrobromide mouth is molten
The medicament contg specification of film is 4mg.
Under stirring, polyvinyl alcohol Mowiol4-88 is dissolved in the purified water of the 30mL under 60 DEG C of water bath conditions
In, obtain polymer gel.Macrogol 4000, polyethylene glycol 400, sodium alginate, Sucralose and thin are added into gel
Lotus essence stirs evenly.Galanthamine hydrobromide is added under stirring, stirs evenly, obtains containing drug solns.Drug containing is molten
Liquid is coated on after standing degassing on stainless steel plate, and dry at 43 DEG C.Finally cut into 1000 medicine films.It is weighed, every
The average weight of medicine film is 16mg.
Performance test
1, basic performance is tested
The basic performance of each embodiment oral instant membrane is tested, it is as follows to obtain parameter area.
| Project | As a result |
| Film thickness | 30μm±1μm |
| Appearance | Membranous type is smooth, and bubble-free, surface is without particle |
2, sensory test and dissolution time are tested
Choose 30 subjects and take each molten film of embodiment galanthamine hydrobromide mouth, and according to mouthfeel give it is excellent, good,
Can, the scoring of poor four grades it is as follows, while recording the dissolution time of the molten film of mouth.Each embodiment test knot of what following table provided
The average value of fruit.
3, Mechanics Performance Testing
Mechanical property is carried out to the oral instant membrane of each embodiment using LabthinkXLW (EC) Intelligent electronic tensil testing machines
It can test, obtain 250~400kg/cm of elasticity modulus2, 400~200kg/cm of tensile strength2, 200~50kg/cm of tear edge prolongs
Stretch rate 150~220%.
The above performance test explanation, the molten film of mouth provided in an embodiment of the present invention meet using standard.
Finally it should be noted that：The above embodiments are only used to illustrate the technical solution of the present invention., rather than its limitations；To the greatest extent
Present invention has been described in detail with reference to the aforementioned embodiments for pipe, it will be understood by those of ordinary skill in the art that：Its according to
So can with technical scheme described in the above embodiments is modified, either to which part or all technical features into
Row equivalent replacement；And these modifications or replacements, various embodiments of the present invention technology that it does not separate the essence of the corresponding technical solution
The range of scheme.
Claims (10)
1. a kind of molten film of galanthamine hydrobromide mouth, which is characterized in that the molten film of mouth includes the hydrobromic acid of 5-30wt%
The disintegrant and 1-15wt% of galanthamine, the water-soluble film forming agent of 20-70wt%, the plasticizer of 1-10wt%, 10-30wt%
Corrigent.
2. the molten film of mouth according to claim 1, which is characterized in that the molten film of mouth includes the hydrogen bromine of 15-25wt%
Sour galanthamine, the water-soluble film forming agent of 30-50wt%, 2-5wt% plasticizer 15-25wt% disintegrant and 3-7wt%
Corrigent.
3. the molten film of mouth according to claim 1 or 2, which is characterized in that the water-soluble film forming agent be selected from polyvinyl alcohol,
In hydroxypropyl methyl cellulose, sodium cellulose glycolate, hydroxypropyl cellulose, xanthans, pectin, polyoxyethylene, cornstarch
One or more.
4. the molten film of mouth according to claim 3, which is characterized in that the water-soluble film forming agent is polyvinyl alcohol
Mowiol4-88。
5. the molten film of mouth according to claim 1 or 2, which is characterized in that the plasticizer is selected from polyethylene glycol, sorb
Alcohol, repefral, diethyl phthalate, glycerine, glyceryl triacetate, propylene glycol Chinese holly edge acid esters, castor oil
Or one or more of Tween 80.
6. the molten film of mouth according to claim 5, which is characterized in that the plasticizer is to account for the molten film 2-4wt% of mouth
The polyethylene glycol mixture of PEG4000 and the PEG400 for accounting for the molten film 1-2wt% of mouth.
7. the molten film of mouth according to claim 1 or 2, which is characterized in that the disintegrant includes sodium carboxymethyl starch, low
Replace hydroxypropyl methylcellulose, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium alginate, crospovidone and
One or more of microcrystalline cellulose.
8. the molten film of mouth according to claim 1 or 2, which is characterized in that the disintegrant is selected from cross-linked carboxymethyl fiber
The blend or sodium alginate of plain sodium and sodium carboxymethyl starch.
9. the molten film of mouth according to claim 1 or 2, which is characterized in that the corrigent includes accounting for oral instant membrane 4-
The sweetener of 6wt% and the aromatic of 0.1-2wt%.
10. a kind of preparation method of such as molten film of claim 1-9 any one of them galanthamine hydrobromide mouths, feature exist
In the preparation method includes：
It is under stirring that water-soluble film forming agent is soluble in water in 60-80 DEG C at a temperature of, obtain polymer gel；
Disintegrant, plasticizer, corrigent is added into polymer gel under stirring, and stirs evenly；
Galanthamine hydrobromide is added under stirring, and stirs evenly, obtains containing drug solns；
It is de-gassed, is film-made to containing drug solns, and the heat drying at 40-50 DEG C, cut, obtain galanthamine hydrobromide oral cavity
Dissolving films.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810971699.4A CN108743567A (en) | 2018-08-24 | 2018-08-24 | Molten film of galanthamine hydrobromide mouth and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810971699.4A CN108743567A (en) | 2018-08-24 | 2018-08-24 | Molten film of galanthamine hydrobromide mouth and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111012762A (en) * | 2019-11-05 | 2020-04-17 | 浙江工业大学 | Galanthamine hydrobromide oral instant film agent and preparation method thereof |
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| EP2089006B1 (en) * | 2006-11-30 | 2011-11-30 | Ratiopharm GmbH | Medicament with controlled release containing galanthamine |
| CN102333526A (en) * | 2009-06-25 | 2012-01-25 | Cha生物&Diostech株式会社 | Fast-dissolving oral film for effectively concealing unpleasant tastes |
| CN105168186A (en) * | 2006-10-02 | 2015-12-23 | Apr应用制药研究股份公司 | Non-mucoadhesive film dosage forms |
| CN105343887A (en) * | 2015-10-30 | 2016-02-24 | 济南康和医药科技有限公司 | Dexzopiclone oral fast-dissolving film and preparation method thereof |
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| CN105168186A (en) * | 2006-10-02 | 2015-12-23 | Apr应用制药研究股份公司 | Non-mucoadhesive film dosage forms |
| EP2089006B1 (en) * | 2006-11-30 | 2011-11-30 | Ratiopharm GmbH | Medicament with controlled release containing galanthamine |
| CN102333526A (en) * | 2009-06-25 | 2012-01-25 | Cha生物&Diostech株式会社 | Fast-dissolving oral film for effectively concealing unpleasant tastes |
| CN105343887A (en) * | 2015-10-30 | 2016-02-24 | 济南康和医药科技有限公司 | Dexzopiclone oral fast-dissolving film and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111012762A (en) * | 2019-11-05 | 2020-04-17 | 浙江工业大学 | Galanthamine hydrobromide oral instant film agent and preparation method thereof |
| CN111012762B (en) * | 2019-11-05 | 2023-03-14 | 浙江工业大学 | Galanthamine hydrobromide oral instant film agent and preparation method thereof |
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