CN108926547A - A kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect - Google Patents
A kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect Download PDFInfo
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- CN108926547A CN108926547A CN201810706401.7A CN201810706401A CN108926547A CN 108926547 A CN108926547 A CN 108926547A CN 201810706401 A CN201810706401 A CN 201810706401A CN 108926547 A CN108926547 A CN 108926547A
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- Prior art keywords
- boron sieve
- vertical boron
- gram vertical
- sticking effect
- binder
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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
-
- 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
- A61K31/69—Boron compounds
-
- 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
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/30—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
-
- 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
- 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
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
Abstract
The invention discloses a kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect, are prepared from the following raw materials: active constituent, plasticizer, filler, sorbefacient, suspending agent, binder.The frequency that present invention solution drug uses is excessively high and provides the longer skin residence time and reduces administration number of times, film is prepared using a variety of film forming supplementary product compatibilities, it complements each other, it is indispensable, plasticizer and filler enhance film forming, sorbefacient enhances Medicated Permeation ability, and suspending agent guarantees the dispersibility of raw material in a liquid state, and binder enhances the laminating degree of film and skin.
Description
Technical field
The present invention relates to a kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect, belong to biomedical material
Field.
Background technique
Gram vertical boron sieve (Crisaborole) is a kind of phosphodiesterase 4 (PDE4) inhibitor, and this inhibition causes intracellular
Cyclic adenosine monophosphate (cAMP) level increases, for treating fungal infection, in particular for treating onychomycosis and/or dermatophyte
Infection.The drug obtains U.S. Food and Drug Administration (FDA) approval listing in December, 2016, public by Anacor pharmacy
Department researches and develops and is responsible in U.S.'s list marketing, and the chemical name of trade name Crisaborole is 5- (4- cyano-benzene oxygen) -1,
3- dihydro -1- hydroxyl -2,1- benzoxaborole heterocyclic pentylene, English name are 4- ((1-hydroxy-1,3-
Dihydrobenzo [c] [1,2] oxaborol-5-yl) oxy) benzonitrile, shown in chemical structural formula such as formula (I):
The characteristics of medicament slow release is to reach reduction poisonous side effect of medicine by effective control to drug medical dosage, subtract
Few human body drug resistance, improves the stability of drug and the purpose of effective rate of utilization.Since the high molecular material of selection is different, drug
The control releasing mechanism of molecule is not also identical, therefore the research of Polymer Drug Delayed Release Materials has a very important significance.Mesh
Before, gram vertical boron sieve preparation is largely plaster, without reference to sustained release aspect, needs to pinpoint administration, and be easier to be wiped, cannot
Retain for a long time.
Summary of the invention
In view of above-mentioned deficiency, the good gram vertical boron sieve release membranes and preparation method thereof of sticking effect provided by the invention are solved
The frequency that drug uses is excessively high and provides the longer skin residence time and reduces administration number of times.
In order to solve the above-mentioned technical problem, technical scheme is as follows:
A kind of good gram vertical boron sieve release membranes of sticking effect, are prepared from the following raw materials: active constituent, plasticizer, filler,
Sorbefacient, suspending agent, binder.
Preferably, each raw material proportioning is as follows: active constituent 15-25%, plasticizer 20-30%, filler 20-30%, inhales
Receive promotor 5-10%, suspending agent 5-10%, binder 6-15%.
Preferably, active constituent includes gram vertical boron sieve and/or gram vertical boron sieve analog derivative.
Preferably, plasticizer is selected from one of glycerol, propenyl, polyethylene glycol and/or glyceryl triacetate or several
Kind.
Preferably, filler is selected from one of microcrystalline cellulose, D-sorbite, converted starch and/or dextrin or several
Kind.
Preferably, sorbefacient is selected from one or more of propylene glycol, polysorbate and/or menthol.
Preferably, suspending agent is selected from one or more of carrageenan, guar gum and/or sodium carboxymethylcellulose.
Preferably, binder is made of polyvinylpyrrolidone, polycarbophil, rosin, polyvinyl alcohol and cornstarch.
Preferably, binder is by polyvinylpyrrolidone 60%, polycarbophil 10%, rosin 10%, polyvinyl alcohol
10% and cornstarch 10% form.
The present invention also provides a kind of preparation methods of the good gram vertical boron sieve release membranes of sticking effect, the specific steps are as follows:
A, first layer is sustained film preparation: by active constituent, plasticizer, filler, sorbefacient, suspending agent, binder
Sufficiently, melting is extruded into film with extruder for mixing；
B, second layer extended release film preparation: by active constituent, plasticizer, filler, sorbefacient, suspending agent, binder
Mixing sufficiently, adds suitable quantity of water to dissolve, stirs evenly, it is uniformly applied in above-mentioned release membranes, and drying machine drying is not to bright
Aobvious moisture；
C, it cuts to obtain the final product.
Preferably, in step B, dryer temperature is 60-80 DEG C.
In the present invention, film is prepared using a variety of film forming supplementary product compatibilities, complemented each other, it is indispensable, it plasticizer and fills out
Agent enhancing film forming is filled, sorbefacient enhances Medicated Permeation ability, and suspending agent guarantees the dispersibility of raw material in a liquid state,
The laminating degree of binder enhancing film and skin.
Binder provided by the invention is sticked by a variety of natural glues and non-natural binder, moist binder and stemness
Mixture compounds, and can make up for it the disadvantage of bonding effect difference brought by single binder, is compounded by said components
Binder, it is strong with human skin binding force, and drug molecule will not be stopped to penetrate into skin.
Bilayer film provided by the invention, first layer release membranes are prepared using the raw material of molten condition, second layer extended release film
Using aqueous solution of raw material brushing, when in use, second layer extended release film is labelled on skin, is slowly absorbed into disease to water composition
In stove, the fused raw material of first layer will continue to discharge drug, and due to diluting without solvent, concentration is higher, can be constant
Carry out treat, reach extraordinary slow release treatment effect.
Detailed description of the invention
Fig. 1 is the film dropping situations of embodiment 1, embodiment 2, comparative example 1 and comparative example 2.
Specific embodiment
Above scheme is described further below in conjunction with specific embodiment；It should be understood that these embodiments are for illustrating
The basic principles, principal features and advantages of the present invention, and the present invention is not by the scope limitation of following embodiment；It is used in embodiment
Implementation condition further adjustment can be done according to specific requirement, the implementation condition being not specified is usually the item in routine experiment
Part.
Embodiment 1
A, first layer be sustained film preparation: by gram vertical boron sieve 20%, glycerol 25%, microcrystalline cellulose 25%, propylene glycol 7%,
Carragheen 8%, binder 15% are (by polyvinylpyrrolidone 60%, polycarbophil 10%, rosin 10%, polyvinyl alcohol 10%
Formed with cornstarch 10%) it mixes sufficiently, melting is extruded into film with extruder；
B, second layer extended release film preparation: by gram vertical boron sieve 20%, propenyl 25%, D-sorbite 25%, polysorbate
7%, guar gum 8%, binder 15% are (by polyvinylpyrrolidone 60%, polycarbophil 10%, rosin 10%, polyvinyl alcohol
10% and cornstarch 10% form) mixing sufficiently, add suitable quantity of water to dissolve, stir evenly, it is uniformly applied to above-mentioned sustained release
On film, drying machine drying to unobvious moisture, drying temperature is 60 DEG C；
C, it cuts to obtain the final product.
Embodiment 2
A, first layer is sustained film preparation: by gram vertical boron sieve 25%, polyethylene glycol 23%, converted starch 22%, menthol
8%, sodium carboxymethylcellulose 7%, binder 15% (by polyvinylpyrrolidone 60%, polycarbophil 10%, rosin 10%,
Polyvinyl alcohol 10% and cornstarch 10% form) it mixes sufficiently, melting is extruded into film with extruder；
B, second layer extended release film preparation: by gram vertical boron sieve 25%, glyceryl triacetate 23%, dextrin 22%, menthol
8%, sodium carboxymethylcellulose 7%, binder 15% (by polyvinylpyrrolidone 60%, polycarbophil 10%, rosin 10%,
Polyvinyl alcohol 10% and cornstarch 10% form) it mixes sufficiently, add suitable quantity of water to dissolve, stir evenly, it is uniformly applied to
In above-mentioned release membranes, drying machine drying to unobvious moisture, drying temperature is 60 DEG C；
C, it cuts to obtain the final product.
Comparative example 1
A, first layer be sustained film preparation: by gram vertical boron sieve 20%, glycerol 25%, microcrystalline cellulose 25%, propylene glycol 7%,
Carragheen 8%, binder 15% are (by polyvinylpyrrolidone 70%, polycarbophil 5%, rosin 5%, 10% and of polyvinyl alcohol
Cornstarch 10% forms) it mixes sufficiently, melting is extruded into film with extruder；
B, second layer extended release film preparation: by gram vertical boron sieve 20%, propenyl 25%, D-sorbite 25%, polysorbate
7%, guar gum 8%, binder 15% are (by polyvinylpyrrolidone 70%, polycarbophil 5%, rosin 5%, polyvinyl alcohol
10% and cornstarch 10% form) mixing sufficiently, add suitable quantity of water to dissolve, stir evenly, it is uniformly applied to above-mentioned sustained release
On film, drying machine drying to unobvious moisture, drying temperature is 60 DEG C；
C, it cuts to obtain the final product.
Comparative example 2
A, first layer is sustained film preparation: by gram vertical boron sieve 25%, polyethylene glycol 23%, converted starch 22%, menthol
8%, sodium carboxymethylcellulose 7%, binder 15% are (by polyvinylpyrrolidone 70%, rosin 10%, 10% and of polyvinyl alcohol
Cornstarch 10% forms) it mixes sufficiently, melting is extruded into film with extruder；
B, second layer extended release film preparation: by gram vertical boron sieve 25%, glyceryl triacetate 23%, dextrin 22%, menthol
8%, sodium carboxymethylcellulose 7%, binder 15% are (by polyvinylpyrrolidone 70%, rosin 10%, 10% and of polyvinyl alcohol
Cornstarch 10% forms) it mixes sufficiently, add suitable quantity of water to dissolve, stir evenly, it is uniformly applied in above-mentioned release membranes, dries
Dry machine is dried to no obvious moisture, and drying temperature is 60 DEG C；
C, it cuts to obtain the final product.
The above embodiments merely illustrate the technical concept and features of the present invention, and its object is to allow person skilled in the art
Scholar cans understand the content of the present invention and implement it accordingly, and it is not intended to limit the scope of the present invention, it is all according to the present invention
Equivalent change or modification made by Spirit Essence, should be covered by the protection scope of the present invention.
Claims (10)
1. a kind of good gram vertical boron sieve release membranes of sticking effect, which is characterized in that be prepared from the following raw materials: active constituent, plasticising
Agent, filler, sorbefacient, suspending agent, binder, binder is by polyvinylpyrrolidone, polycarbophil, rosin, poly-
Vinyl alcohol and cornstarch composition.
2. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that each raw material proportioning
It is as follows: active constituent 15-25%, plasticizer 20-30%, filler 20-30%, sorbefacient 5-10%, suspending agent 5-
10%, binder 6-15%.
3. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that its active constituent
Including gram vertical boron sieve and/or gram vertical boron sieve analog derivative.
4. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that the choosing of its plasticizer
From one or more of glycerol, propenyl, polyethylene glycol and/or glyceryl triacetate.
5. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that the choosing of its filler
From one or more of microcrystalline cellulose, D-sorbite, converted starch and/or dextrin.
6. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that its absorption enhancement
Agent is selected from one or more of propylene glycol, polysorbate and/or menthol.
7. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that the choosing of its suspending agent
From one or more of carrageenan, guar gum and/or sodium carboxymethylcellulose.
8. a kind of good gram vertical boron sieve release membranes of sticking effect according to claim 1, which is characterized in that its binder by
Polyvinylpyrrolidone 60%, polycarbophil 10%, rosin 10%, polyvinyl alcohol 10% and cornstarch 10% form.
9. a kind of preparation method of the good gram vertical boron sieve release membranes of sticking effect described in -8, feature exist according to claim 1
In, the specific steps are as follows:
A, first layer is sustained film preparation: active constituent, plasticizer, filler, sorbefacient, suspending agent, binder are mixed
Sufficiently, it melts, is extruded into film with extruder；
B, second layer extended release film preparation: active constituent, plasticizer, filler, sorbefacient, suspending agent, binder are mixed
Sufficiently, add suitable quantity of water to dissolve, stir evenly, it is uniformly applied in above-mentioned release membranes, drying machine drying to unobvious water
Point；
C, it cuts to obtain the final product.
10. a kind of preparation method of the good gram vertical boron sieve release membranes of sticking effect as claimed in claim 9, which is characterized in that B
In step, dryer temperature is 60-80 DEG C.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810706401.7A CN108926547A (en) | 2018-07-02 | 2018-07-02 | A kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201810706401.7A CN108926547A (en) | 2018-07-02 | 2018-07-02 | A kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect |
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| CN108926547A true CN108926547A (en) | 2018-12-04 |
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| CN201810706401.7A Pending CN108926547A (en) | 2018-07-02 | 2018-07-02 | A kind of good gram vertical boron sieve release membranes and preparation method thereof of sticking effect |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11648197B2 (en) | 2018-06-28 | 2023-05-16 | Arx, Llc | Dispensing method for producing dissolvable unit dose film constructs |
Citations (3)
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|---|---|---|---|---|
| CN101568327A (en) * | 2006-12-29 | 2009-10-28 | 巴斯夫欧洲公司 | Rapidly dispersable, particulate film coating agent based on polyvinyl alcohol-polyether graft copolymers |
| CN102504350A (en) * | 2011-10-11 | 2012-06-20 | 福建农林大学 | Degradable food packaging paper and preparation method thereof |
| US20170152273A1 (en) * | 2015-11-30 | 2017-06-01 | Anacor Pharmaceuticals Inc. | Topical Pharmaceutical Formulations For Treating Inflammatory-Related Conditions |
-
2018
- 2018-07-02 CN CN201810706401.7A patent/CN108926547A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101568327A (en) * | 2006-12-29 | 2009-10-28 | 巴斯夫欧洲公司 | Rapidly dispersable, particulate film coating agent based on polyvinyl alcohol-polyether graft copolymers |
| CN102504350A (en) * | 2011-10-11 | 2012-06-20 | 福建农林大学 | Degradable food packaging paper and preparation method thereof |
| US20170152273A1 (en) * | 2015-11-30 | 2017-06-01 | Anacor Pharmaceuticals Inc. | Topical Pharmaceutical Formulations For Treating Inflammatory-Related Conditions |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11648197B2 (en) | 2018-06-28 | 2023-05-16 | Arx, Llc | Dispensing method for producing dissolvable unit dose film constructs |
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