CN105963280A - Voglibose oral instant film and preparation method thereof - Google Patents
Voglibose oral instant film and preparation method thereof Download PDFInfo
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- CN105963280A CN105963280A CN201610516869.0A CN201610516869A CN105963280A CN 105963280 A CN105963280 A CN 105963280A CN 201610516869 A CN201610516869 A CN 201610516869A CN 105963280 A CN105963280 A CN 105963280A
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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
- A61K31/13—Amines
- A61K31/133—Amines having hydroxy groups, e.g. sphingosine
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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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- 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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Abstract
The invention discloses a voglibose oral instant film and a preparation method thereof and belongs to the field of pharmaceutical preparations. The voglibose oral instant film is prepared from voglibose, a macromolecule film-forming material, a plasticizer, a penetration enhancer, a taste modifying agent and other auxiliary materials. The penetration enhancer is added into the voglibose oral instant film, the speed of a main medicine penetrating through animal oral mucosa is obviously increased; the voglibose oral instant film is quick to disintegrate, can be taken without water, is high in administration compliance, is superior to a major of oral solid preparations, and is especially suitable for crowds including the old and children with dysphagia.
Description
Technical field
The present invention relates to pharmaceutical formulations field, disclose a kind of voglibose oral instant membrane
And preparation method thereof, this voglibose oral instant membrane is by voglibose, macromolecule filming
Material, plasticizer, penetrating agent, correctives and other adjuvants composition；After adding penetrating agent, main
Medicine substantially increases through the speed of animal oral cavity mucosa.The feature of this dosage form is that disintegrate is rapid, no
Need to take with water and Compliance is good, be better than major part oral solid formulation, especially suitable
In crowds such as dysphagia, old man and children.
Background technology
Diabetes be a kind of because of internal insulin definitely or a series of clinics of causing of relative deficiency
Syndrome.The main clinical manifestation of diabetes is that polydipsia, polyuria, polyphagia and body constitution decline, with
And blood glucose is high, glucose in urine is high, also can cause the most serious complication such as malpractice, such as the heart
Angiopathy, retinopathy, chronic renal failure etc..World Health Organization's report of 2011
Announcement points out that the whole world has 3.46 hundred million people to suffer from diabetes, and within 2004, estimated 3,400,000 people die from
The consequence that hyperglycemia causes.[1]If current speed increment, estimate that the year two thousand thirty whole world will have
Nearly 500,000,000 people suffer from diabetes.China is the country that world population is most, the investigation knot of 2008
Fruit display, in the adult more than 20 years old, age-standardized diabetes prevalence is 9.7%, and
The ratio of prediabetes is more up to 15.5%.The treatment situation of diabetes is the severeest.
After diabetes come cardiovascular and cerebrovascular disease and cancer to the harm that the mankind bring, occupy
Three.Research show diabetes fatality rate and the higher main inducing of disability rate be its produce slow
Property complication.Show according to WHO statistical data, the complication of diabetes up to kind more than 100,
And diabetes are a kind of multigenic diseases with obvious genetic predisposition.
The drug main being used for treating diabetes in the market wants sulphanylureas, biguanides and α-sugar
Glycosides enzyme inhibitor.But sulfonylurea drugs easily causes persistent hypoglycemia, biguanides is then
Serious gastrointestinal reaction and lesions of liver and kidney can be produced, and alpha-glucosidase inhibitor is except gas in abdomen
Outside body increases, other untoward reaction are less, have been widely used for reducing postprandial hyperglycemia,
It it is considered as the adjuvant of the insulin treatment of the drug of first choice of type 2 diabetes mellitus and type 1 diabetes
Thing, has broad application prospects.
The alpha-glucosidase inhibitor medicine being used for treating diabetes the most clinically has glucobay (acarbose),
Cortex Mori in Voglibose and home made article Chinese medicine and relevant medicine.Voglibose is that effect is clear and definite
The inhibitory activity material of alpha-glucosidase, can effective blood sugar lowering.Existing voigelibo on market
Sugar dosage form has conventional tablet, dispersible tablet, chewable tablet, capsule formulation etc..
Patent documentation CN101732286A discloses voglibose film and preparation method thereof.
The present invention compared with above-mentioned patent voglibose film and preparation method thereof, its superiority
It is creatively rationally to add appropriate penetrating agent, improves its principal agent speed through hypoglossis mucous membrane
Rate and transmitance, substantially increase the advantage of this dosage form.
Summary of the invention
The technical problem to be solved is to provide a kind of voglibose oral instant membrane
Preparation method.
For solving above-mentioned technical problem, the technical solution used in the present invention is:
First the present invention discloses a kind of voglibose oral instant membrane, it is characterised in that bag
Include following component: voglibose, macromolecule filming material, mould agent, penetrating agent, rectify
Taste agent and other adjuvant.
Voglibose oral instant membrane of the present invention, it is characterised in that the hundred of each component
Proportion by subtraction is:
The percentage ratio sum of above-mentioned component is 100%.
Described voglibose oral instant membrane, it is characterised in that the percentage ratio of each component is:
The percentage ratio sum of above-mentioned component is 100%.
Voglibose oral instant membrane of the present invention, optimum prescription is voglibose
10%, macromolecule filming material 50%, plasticizer 20%, penetrating agent 10%, correctives 5%～10%,
Other adjuvant 0%～5%.
Described macromolecule filming material is arabic gum, polyvinylpyrrolidone, polyvinyl alcohol
(PVA), hydroxypropyl methyl cellulose (HPMC), pulullan polysaccharide (Pullulan), Huang
One or more in virgin rubber, sodium alginate, starch and maltodextrin；It is preferably HPMC-E15；
Described plasticizer is in benzoate, glycerol, Tween 80, Polyethylene Glycol, sorbitol
One or more；It is preferably PEG400；
Described penetrating agent be edetate, NaTDC, oleic acid, octanoic acid, sodium salicylate,
One or more in sodium lauryl sulphate, polyoxyethylene lauryl base ester, laurocapram；
It is preferably sodium salicylate；
Described correctives selected from sweeting agent and or aromatic；
Described sweeting agent has saccharin or saccharin sodium, sucralose, Aspartame, sucrose, sweet
In oxamidic acid., steviosin, erythritol one or more, preferably sucralose.
Other adjuvants described include filler, pigment, antioxidant or preservative；
Also include selected from by tree oil, oleum Citri sinensis, Oleum menthae, Oleum menthae or the fragrance of menthol
Agent.
The preparation method of described voglibose oral instant membrane, it is characterised in that step is as follows:
Voglibose is dissolved in the water of 2～12 times amount the solution obtaining homogeneous transparent, adds
Macromolecule filming material, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniformly
Serosity, deaeration, film, 40～80 DEG C be dried, thickness 80um ± 5, cut.
In described technique, the weight ratio of voglibose and water be 1:9 be optimum；
Described voglibose oral instant membrane, it is characterised in that the product that the method prepares exists
37 DEG C of water can dissolve in 59 seconds completely, principal agent voglibose is spread out；
Described voglibose oral instant membrane, it is characterised in that finished product membrane can have certain tough
Property and tensile strength, its tensile strength be more than 6.5PMa.
The index evaluating oral instant membrane mainly has outward appearance, dissolves time limit, tensile strength and mouth
Sense.Domestic at present to dissolving time limit the most unified requirement, generally less than 60 seconds, and high score
Sub-filmogen consumption is the fewest, and water-soluble plasticizer consumption is the most, and its disintegrate is the fastest, and premise is
Film forming can i.e. there is certain tensile strength；Correctives is the most then crossed sweet or slightly bitter, crosses taste masking at least
Inconspicuous.So filmogen, plasticizer and correctives and medicinal active ingredient are maintained at necessarily
In the range of then taste masking is good, tensile strength is moderate, disintegrate is fast.
Accompanying drawing illustrates:
Fig. 1, external pig oral mucosa are tested
Detailed description of the invention
The present invention, advantages of the present invention and feature is further described below in conjunction with specific embodiment
Will be with describe and apparent.It should be understood that described embodiment is only exemplary, no
The scope of the present invention is constituted any restriction.It will be understood by those skilled in the art that not
The details of technical solution of the present invention and form can be entered under deviation the spirit and scope of the present invention
Row amendment or replacement, but these amendments or replacement each fall within protection scope of the present invention.
The preparation of embodiment 1 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, and tension is strong
Degree 12.5 ± 2MPa, mouthfeel is micro-sweet, dissolves time limit 25s.
The preparation of embodiment 2 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, and tension is strong
Degree 10.9 ± 2MPa, mouthfeel is micro-sweet, dissolves time limit 28s.
The preparation of embodiment 3 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, tensile strength
11.6 ± 2MPa, mouthfeel is micro-sweet, dissolves time limit 30s.
The preparation of embodiment 4 voglibose oral instant membrane
Totally 1000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, and tension is strong
Degree 11.5MPa ± 2, mouthfeel is micro-sweet, dissolves time limit 27s.
The preparation of embodiment 5 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, and tension is strong
Degree 11.4MPa ± 2, mouthfeel is light and sweetless, dissolves time limit 29s.
The preparation of embodiment 6 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, and tension is strong
Degree 32.5MPa ± 2, mouthfeel is micro-sweet, dissolves time limit 59s.
The preparation of embodiment 7 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 240g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
The coating liquid that this technique prepares is diluter, and film former outward appearance is preferable, and milky, hands touches light
Sliding, thickness 80um ± 5, tensile strength 12.8MPa ± 2, mouthfeel is micro-sweet, dissolves time limit 25s.
The preparation of embodiment 8 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is preferable, and milky, hands is touched smooth, thickness 80um ± 5, tensile strength 14.5
MPa ± 2, mouthfeel is micro-sweet, dissolves time limit 24s.
The preparation of embodiment 9 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 40g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
The coating liquid relatively thickness that this technique prepares, film former outward appearance is preferable, and milky, hands is touched
Smooth, thickness 80um ± 5, tensile strength 12.8MPa ± 2, mouthfeel is micro-sweet, dissolves the time limit
24s。
The preparation of embodiment 10 voglibose oral instant membrane
Totally 10000, specification 0.2mg, prescription is as follows:
Voglibose is dissolved in 180g water the solution obtaining homogeneous transparent, adds macromolecule
Filmogen, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniform serosity,
Deaeration, film, 40～80 DEG C are dried, cut.
This membrane outward appearance is general, and milky, hands touches with granular sensation, thickness 80um ± 5, tension
Intensity 6.5MPa ± 2, mouthfeel is micro-sweet, dissolves time limit 20s.
Embodiment 11 external pig oral mucosa test (embodiment 1, embodiment 2 and embodiment 8)
Its hypoglossis mucous membrane is taken immediately from the pig's head just slaughtered, with normal saline flushing 2～3 times,
37 DEG C ± 2 constant temperature are standby.
Franz solid diffusion cell is used to carry out external hypoglossis mucous membrane permeability test.By expansion reservoir by pig tongue
Lower mucosa state is fixed, and the outer layer of smooth mucosal is towards supply pool, and the internal layer of fold is towards water-accepting tank.
37 DEG C ± 2 water-baths, mixing speed 600rpm, saturating mucosa area 0.556 square centimeter, receive
Cell body amasss 1.5mL, receives the physiological salt liquid that liquid is 0.1mol/L hydrochloric acid.
Prepared embodiment 1, the molten film of embodiment 2 and embodiment 8 Sublingual are respectively placed in pig oral cavity
On mucosa, timing sampling 1mL, and supplement the blank reception liquid of 37 DEG C ± 2.Sample is with efficiently
Chromatograph of liquid is analyzed with suitable detection method, result Figure of description.
Claims (8)
1. a voglibose oral instant membrane, it is characterised in that include following component: volt
Lattice array wave sugar, macromolecule filming material, mould agent, penetrating agent, correctives and other adjuvant.
2. according to the voglibose oral instant membrane described in claim 1, it is characterised in that each group
The percentage ratio divided is:
The percentage ratio sum of above-mentioned component is 100%.
3. according to the voglibose oral instant membrane described in claim 2, it is characterised in that each group
The percentage ratio divided is:
The percentage ratio sum of above-mentioned component is 100%.
4., according to the voglibose oral instant membrane described in claims 1 to 3, optimum prescription is
Voglibose 10%, macromolecule filming material 50%, plasticizer 20%, penetrating agent 10%,
Correctives 5%～10%, other adjuvant 0%～5%；Described macromolecule filming material is Arabic
Glue, polyvinylpyrrolidone, polyvinyl alcohol (PVA), hydroxypropyl methyl cellulose (HPMC),
In pulullan polysaccharide (Pullulan), xanthan gum, sodium alginate, starch and maltodextrin one
Plant or multiple；It is preferably HPMC-E15；Described plasticizer is benzoate, glycerol, tween
80, one or more in Polyethylene Glycol, sorbitol；It is preferably PEG400；Described
Penetrating agent is edetate, NaTDC, oleic acid, octanoic acid, sodium salicylate, dodecyl
One or more in sodium sulfate, polyoxyethylene lauryl base ester, laurocapram；It is preferably water
Poplar acid sodium；Described correctives selected from sweeting agent and or aromatic；Described sweeting agent has saccharin
Or saccharin sodium, sucralose, Aspartame, sucrose, Radix Glycyrrhizae propylhomoserin, steviosin, erythrose
In alcohol one or more, preferably sucralose；Other adjuvants described include filler, pigment,
Antioxidant or preservative；Also include selected from by tree oil, oleum Citri sinensis, Oleum menthae, Oleum menthae
Or the aromatic of menthol.
5. according to the preparation of voglibose oral instant membrane described in Claims 1-4 any one
Method, it is characterised in that step is as follows:
Voglibose is dissolved in the water of 2～12 times amount the solution obtaining homogeneous transparent, adds
Macromolecule filming material, plasticizer, penetrating agent, correctives and other adjuvants, stir into uniformly
Serosity, deaeration, film, 40～80 DEG C be dried, thickness 80um ± 5, cut.
The most according to claim 5, in technique, voglibose is that 1:9 is with the weight ratio of water
Optimum.
Voglibose oral instant membrane the most according to claims 1 to 6, it is characterised in that
The product that the method prepares can dissolve in 59 seconds, by principal agent voigelibo in 37 DEG C of water completely
Sugar spreads out.
Voglibose oral instant membrane the most according to claims 1 to 7, it is characterised in that
Finished product membrane can have certain toughness and tensile strength, and its tensile strength is more than 6.5PMa.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106509652A (en) * | 2016-11-08 | 2017-03-22 | 雅安职业技术学院 | Method for preparing diced pork in pot by use of microwave heating sterilization |
| CN107468672A (en) * | 2017-07-28 | 2017-12-15 | 合肥华方医药科技有限公司 | A kind of silaenafil oral quick-dissolving film preparation and preparation method thereof |
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