CN106581049A - Calcium oral cavity rapid-dissolving membrane agent and preparation method thereof - Google Patents

Calcium oral cavity rapid-dissolving membrane agent and preparation method thereof Download PDF

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Publication number
CN106581049A
CN106581049A CN201610974940.XA CN201610974940A CN106581049A CN 106581049 A CN106581049 A CN 106581049A CN 201610974940 A CN201610974940 A CN 201610974940A CN 106581049 A CN106581049 A CN 106581049A
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calcium
film preparation
dissolving film
oral quick
cellulose
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Inventor
曾银杰
钟文锋
何燕
陈炽豪
钟振鹏
陈泽丰
武文敬
程书朋
江森
龙威
张焜
郑希
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Guangdong University of Technology
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Guangdong University of Technology
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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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to the technical field of medicine, health care, and food, particularly to a calcium oral cavity rapid-dissolving membrane agent and a preparation method thereof. According to the present invention, the calcium oral cavity rapid-dissolving membrane agent comprises a calcium source, vitamin D, a membrane material, a disintegrating agent, a filler, a plasticizer a flavoring agent, has characteristics of a certain flexibility and easy taking, does not produce discomfort during the taking, can be simply dissolved or disintegrated in the oral cavity, enters the digestive tract along with the swallowing action so as to be absorbed, has high solubility, and rapidly provide the effect, wherein the dissolving time of the calcium oral cavity rapid-dissolving membrane agent in 37 DEG C water is within 30 s; and the calcium oral cavity rapid-dissolving membrane agent further has pleasant taste and good palatability, can be taken without water, and is especially for children, elderly, and patients having swallowing difficulty.

Description

Calcium oral quick-dissolving film preparation and preparation method thereof
Technical field
The present invention relates to medicine, health care, food technology field, more particularly to calcium oral quick-dissolving film preparation and preparation method thereof.
Background technology
Oral instant film preparation early in 2003 in North America listing, preparation have small volume, dissolubility high, rapid-action and And be easily mastered user especially child's accurate medication dose the features such as, extensively applied by International Pharmaceutical market.Such as The instant membrane of the ondansetron (Zuplenz) of Strative drugmakers exploitation, the diphenhydramine film of Novartis Co., Ltd's listing (Triaminic Strips Cough＆Runny Nose), dextromethorphan membrane (Theraflu Thin Strip).The present invention Described oral quick-dissolving film preparation refers to the effective ingredient of doses and is dispersed in the thin film processed in filmogen Preparation.The medicine film is rich in pliability, when using, directly medicine film is placed on tongue, and medicine film is once contacted with saliva of buccal cavity, can be rapid Ground dissolving or disintegrate, after swallowing in gastrointestinal tract Fast Stripping.
With the continuous improvement of people's living standard, the health care consciousness of people also gradually strengthens, and how starts to focus more on The generation of prevention some diseases；And calcium is present in human body among 60,000,000 cells, the important battalion of all functions of body is to provide Support element.Once, that is, calcareous not enough, body just cannot normal operation for that.Calcium deficiency has for tooth, bone, immunity etc. Detrimental effect；It is also to produce different problems in different age brackets, to children：Anorexia, dental caries, easily wake up with a start, easily Flu, hair growth promoting late, occipitalia alopecia, look pale, mental retardation, learn to walk late, teething evening or teething irregular, X or O-shaped lower limbs Deng.To teenager：Energy do not concentrate, easily fatigue, sore waist and aching in the waist and the back, tooth development deformity, significantly growth pain, lower limb be soft, cramp, Powerless easy allergy of flaccid muscles etc..To adult：Osteoporosises, height shortening, hunchback, hyperosteogeny, the easy bleeding of having a toothache, fall tooth Alopecia, ache all over.To women：Knot weak, arthritis, dizzy insomnia, short-tempered, irritability, anemia and antenatal high blood Pressure syndrome, the normal dysmenorrheas of Jing, edema and galactopoiesiss are not enough, knot etc..To old people：Geroderma prurituss, heel pain, Lumbar vertebra cervical vertebra ache, odontoseisiies, come off, loss of appetite, digestive tract ulcer, constipation, insomnia, dreaminess, agitation etc..Appropriate benefit Calcium can prevent the problem of the above.
On the market conventional oral formulations mostly are tablet, capsule, pill, are both needed to chew or swallow into digestive tract absorbed After could work, and because the drug effect utilization rate of calcium tablet is relatively low, our absorbances of human body are undesirable, and deposit during swallowing In first pass effect, many troubles can be brought to the patient of dysphagia.Especially children, because its mouthfeel is bad, gulps down Pharynx is difficult, and old people, child and some patients are inconvenient to take conventional oral administration solid system because of dysphagia Agent, so oral quick-dissolving film preparation provides a kind of oral formulations of new, non-deglutition type for this part special population.
Therefore, develop agreeable to the taste degree good, saliva is met in the oral cavity and collapses molten, rapid-action oral instant calcium membrane rapidly, it is right In child, old age, be unable to leave the bed it is extremely important with for severe disability patient.
The content of the invention
In view of this, the technical problem to be solved in the present invention is to provide calcium oral quick-dissolving film preparation and preparation method thereof.This The calcium oral quick-dissolving film preparation that invention is provided is enough dry good, and the thawing time is shorter.
The calcium oral quick-dissolving film preparation that the present invention is provided, including：
In the present invention, calcium source is selected from calcium citrate, calcium lactate, chelating calcium, Calcium Carbonate, calcium gluconate, calcium acetate or day Winter propylhomoserin calcium.
In some embodiments, calcium source is selected from calcium citrate, calcium lactate or chelating calcium.
In the present invention, membrane material is selected from polyvinyl alcohol, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, xanthan gum, Sargassum Sour sodium, polyvidone, methylcellulose, hydroxypropyl cellulose, high replacement hypromellose, maltodextrin, gelatin, hyalomitome Acid, shitosan, ethyl cellulose, cellulose acetate, polyvinylpyrrolidone, Polyethylene oxide, corn starch, pre-paying starch, Carboxymethyl starch sodium, polyvinylpolypyrrolidone or Microcrystalline Cellulose.
In some embodiments, membrane material selected from hydroxypropyl methyl cellulose (HPMC), polyvinyl alcohol, sodium carboxymethyl cellulose or Sodium alginate.
Wherein, the hydroxypropyl methyl cellulose (HPMC) is preferably HPMC-AN5.
In the present invention, disintegrating agent is selected from Croscarmellose Sodium, low-substituted hydroxypropyl cellulose, crosslinked polyethylene pyrrole Pyrrolidone, carboxymethyl starch sodium, sodium alginate, Microcrystalline Cellulose, pregelatinized Starch, polyvinylpolypyrrolidone, crosslinked carboxymethyl fecula Sodium, starch or carboxymethyl starch sodium.
In some embodiments, disintegrating agent is selected from Croscarmellose Sodium, low-substituted hydroxypropyl cellulose, the poly- second of crosslinking Alkene pyrrolidone (PVPP), polyvinylpolypyrrolidone.
In the present invention, filler selected from Sorbitol, Mannitol, Lactose, Microcrystalline Cellulose, sucrose, glucose, maltose, Xylitol, maltose alcohol, galactitol, erythritol, dextrin or trehalose.
In some embodiments, filler is selected from Mannitol, dextrin, Lactose, Sorbitol.
In the present invention, plasticizer selected from Propylene Glycol, Polyethylene Glycol, glycerol, silicone oil, diethyl phthalate, dibutyl ester, Triethyl citrate, glycerol, Tween 80 or butanediol.
In some embodiments, plasticizer is selected from Polyethylene Glycol, glycerol, butanediol.
Wherein, the Polyethylene Glycol is preferably PEG-400.
In the present invention, correctivess are selected from acidic flavoring agent, sweeting agent and spice.
The acidic flavoring agent is selected from citric acid, malic acid, lactic acid, glutamic acid, tartaric acid, ascorbic acid, gluconic acid, acetic acid Or succinic acid.Preferably, acidic flavoring agent is citric acid.
The sweeting agent is selected from aspartame, sucralose, Fructose, sucrose, stevioside, glycyrrhizin, saccharin and saccharin Sodium, Mannitol, glucosan, Sorbitol, xylitol, maltose alcohol, maltose, galactitol, erythritol, trehalose.It is preferred that , sweeting agent is aspartame, sucralose or maltose alcohol.
The spice also known as essence, selected from strawberry essence, milk flavour, cocoanut flavour, orange flavor, Fructus Citri Limoniae essence, Portugal Grape essence, apple essence, flavoring banana essence, lychee flavor, peach flavor, chocolate essence, coffee aroma, Mint Essence, osmanthus Extrait, rose essence or jasmin essence.
Also include coloring agent in the calcium oral quick-dissolving film preparation that the present invention is provided.The coloring agent is selected from：Beet red, Rhizoma Curcumae Longae, Safflower yellow, lac are red, get over Exocarpium Citri Rubrum, capsanthin, chilli orange, burnt sugar coloring, red red rice, coreopsis yellow extract, red Semen sojae atricolor, Kaoliang red, jade Cream colour, radish red, cacao pigment, Monas cuspurpureus Went, red yeast rice, Herba basellae rubrae are red, Hei Jialun is red, gardenia yellow, Fructus Gardeniae blue, Hippophac Rhamnoides Yellow, Calyx Hibisci Sabdariffae Red, acorn cup is brown, NP is red, many favour Ke palm fibre, and Fructus Mori is red, natural Caulis et Folium Brassicae junceae is red, Fructus Rosae Laevigatae is brown, curcumin, Semen arachidis hypogaeae agriculture are red, Pericarpium Vitis viniferae Red, blue ingot arnotto, algae are blue, plant white carbon black, Mi Menghuang, and Radix Arnebiae (Radix Lithospermi) is red, tea flavochrome, Tea Green Pigment, Citrus yellow, relation by marriage fat tree orange is (red Lignin/drop bixin), alkermes, ferrum oxide, capsanthin, beet red, red yeast rice, alkermes, chrysanthemum, copper chlorophyll Sodium, Rhizoma Curcumae Longae, Gardenia Yellow, carotene, phycocyanobilin, cacao color or caramel color.
In the present invention, correctivess include acidic flavoring agent and sweeting agent, wherein the mass ratio of the acidic flavoring agent and the sweeting agent For (0.5～1.7)：(0.5～1.7).
In the present invention, the ratio of calcium source and vitamin D is (1g：30iu)～(3g：100iu).
In certain embodiments, calcium oral quick-dissolving film preparation includes：
In a specific embodiment, calcium oral quick-dissolving film preparation includes：
In this embodiment, calcium source is calcium citrate；Membrane material is HPMC-AN5；Disintegrating agent is cross-linked carboxymethyl cellulose Sodium；Filler is Sorbitol；Plasticizer is PEG 400；Correctivess are citric acid and aspartame；The citric acid and A Sipa Smooth mass ratio is 1：1.
In a specific embodiment, calcium oral quick-dissolving film preparation includes：
In this embodiment, calcium source is calcium lactate；Membrane material is polyvinyl alcohol；Disintegrating agent is low-substituted hydroxypropyl cellulose； Filler is Mannitol；Plasticizer is PEG 400；Correctivess are citric acid and sucralose；The citric acid and sucralose Mass ratio be 1：1.
In a specific embodiment, calcium oral quick-dissolving film preparation includes：
In this embodiment, calcium source is chelating calcium；Membrane material is sodium carboxymethyl cellulose；Disintegrating agent is PVPP；Filler is Lactose；Plasticizer is glycerol；Correctivess are citric acid and aspartame；The citric acid is 0.8 with the mass ratio of aspartame： 1。
In a specific embodiment, calcium oral quick-dissolving film preparation includes：
In this embodiment, calcium source is calcium citrate；Membrane material is sodium alginate；Disintegrating agent is polyvinylpolypyrrolidone；Filler For dextrin；Plasticizer is butanediol；Correctivess are citric acid and maltose alcohol；The citric acid is with the mass ratio of maltose alcohol 1.5：1.5.
In a specific embodiment, calcium oral quick-dissolving film preparation includes：
In this embodiment, calcium source is calcium acetate；Membrane material is HPMC-AN5；Disintegrating agent is Croscarmellose Sodium； Plasticizer is glycerol；Correctivess are citric acid and aspartame；The citric acid is 0.5 with the mass ratio of aspartame：1.5.
In a specific embodiment, calcium oral quick-dissolving film preparation includes：
In this embodiment, calcium source is chelating calcium；Membrane material is polyvinyl alcohol；Disintegrating agent is low-substituted hydroxypropyl cellulose； Filler is Mannitol；Plasticizer is Polyethylene Glycol；Correctivess are citric acid and sucralose；The citric acid and sucralose Mass ratio be 1.5：0.5.
The preparation method of the oral quick-dissolving film preparation that the present invention is provided can be freeze-drying, solvent casting method, hot melt Extrusion molding, semi-solid casting method, rolled-on method, solid dispersion squeezing and pressing method, specifically：
The preparation method of the calcium oral quick-dissolving film preparation that the present invention is provided, including：By calcium source, vitamin D, membrane material, disintegrating agent, After filler, plasticizer, correctivess mixing, Jing moldings, cut, calcium oral quick-dissolving film preparation is obtained.
The preparation method includes freeze-drying, solution casting method, hot-melt extruded method, semi-solid casting method, rolled-on method Or solid dispersion squeezing and pressing method.
In a specific embodiment, the preparation method of calcium oral quick-dissolving film preparation adopts freeze-drying, including：By each group Divide so that after water dissolution, stirring, degassing, coating, the dry, demoulding cut, prepared calcium oral quick-dissolving film preparation.
In a specific embodiment, the preparation method of calcium oral quick-dissolving film preparation adopts solvent casting method, including：By each group Divide so that after water dissolution, stirring, evacuation forms solution and is wrapped in cast membrane, is dried, cutting.
In a specific embodiment, the preparation method of calcium oral quick-dissolving film preparation adopts hot-melt extruded method, including：By each group After dividing hot melt, pour on film tool, cool drying, cutting.
In a specific embodiment, the preparation method of calcium oral quick-dissolving film preparation adopts semi-solid casting method, including：Will be each Component is dissolved in after water, then adds plasticizer formation spawn, and then founding film forming, is dried, cutting.
In a specific embodiment, the preparation method of calcium oral quick-dissolving film preparation adopts rolled-on method, including：Each component is molten After Xie Yushui, it is dropped on the carrier of roller, is dried and cuts.
In a specific embodiment, the preparation method of calcium oral quick-dissolving film preparation disperses squeezing and pressing method using solid：Including：Will Each component is prepared into solid dispersion, and by mould film former is prepared, cutting.
Obtained every 1cm2Contain 1mg～50mg Ca in calcium oral instant film preparation2+。
Obtained every 1cm2Contain 5mg～20mg Ca in calcium oral instant film preparation2+。
The present invention provide calcium oral quick-dissolving film preparation include calcium source, vitamin D, membrane material, disintegrating agent, filler, plasticizer, Correctivess.The oral quick-dissolving film preparation has certain pliability, is easy to take, and does not have sense of discomfort when taking, can be simply molten in mouth Solution or disintegrate, medicine absorbs with swallowing act into digestive tract, and dissolubility is high, and disintegration time works in 30s in 37 DEG C of water Hurry up.And the mouthfeel of the oral quick-dissolving film preparation pleases, agreeable to the taste degree is good, is not required to use water delivery service, it is adaptable to which child, old age, bed are not Rise and severe disability patient, it is easy to use.
Specific embodiment
The invention provides calcium oral quick-dissolving film preparation and preparation method thereof, those skilled in the art can use for reference interior herein Hold, be suitably modified technological parameter realization.Specifically, all similar replacements and change are to those skilled in the art For be it will be apparent that they are considered as being included in the present invention.The method of the present invention and application have passed through preferably enforcement Example is described, and related personnel substantially can be in without departing from present invention, spirit and scope to methods herein and application It is modified or suitably the technology of the present invention is realized and applied to change with combining.
The material and instrument that the present invention is adopted is all common commercially available product, all can buy in market.
With reference to embodiment, the present invention is expanded on further：
Embodiment 1
Recipe quantity is 1000 (every calcium citrate content is 10mg)
Freeze-drying：Each component, plus 500g water dissolutioies are weighed according to prescription, it is stirring while adding, after stirring, take off Gas, above-mentioned calcium citrate suspension glue is uniformly coated on flat board, places 30min in freezer dryer, cut (2cm × 2cm), calcium oral instant membrane is obtained final product.
Preferably, entrance dissolves rapidly dispersion to the membrane pliability, and good mouthfeel, taste is sweet, and solution time is in 37 DEG C of water 30s。
Embodiment 2
Recipe quantity is 1000 (every lactic acid calcium content is 6mg)
Solvent casting method：Filmogen polyvinyl alcohol being weighed according to prescription and being dissolved in 500g water make uniform thick liquid. Other compositions are uniformly dispersed in a small amount of water under homogenizer effect, are then added to form uniform sticky in above-mentioned thick liquid Liquid, evacuation.Form solution to be wrapped in cast membrane, be dried, cutting.
Preferably, entrance dissolves rapidly dispersion to the membrane pliability, and good mouthfeel, taste is sweet, and solution time is 15s in 37 DEG C of water ～20s.
Embodiment 3
Recipe quantity is 1000 (it is 20mg that calcium content is chelated per piece)
Hot-melt extruded method：The feed zone that each component adds single screw rod or double screw extruder from funnel is weighed according to prescription, Send into fusing behind hot melt area to mix, the mixture of fusing continues through the output of dispensing area, pour on film tool, cooling, cutting.
Preferably, entrance dissolves rapidly dispersion to the membrane pliability, and good mouthfeel, taste is sweet, and solution time is 15s in 37 DEG C of water ～20s.
Embodiment 4
Recipe quantity is 1000 (it is 10mg that calcium content is chelated per piece)
Semi-solid casting method：Each component is weighed according to prescription and be dissolved in 500g water and form thick liquid, then the liquid is added In entering the acid solution of insoluble high polymer, plasticizer is added, form spawn, then by its founding film forming, be dried, cutting.
Preferably, entrance dissolves rapidly dispersion to the membrane pliability, and good mouthfeel, taste is sweet, and solution time is 15s in 37 DEG C of water ～20s.
Embodiment 5
Recipe quantity is 1000 (every acetic acid calcium content is 5mg)
Rolled-on method：Each component is weighed according to prescription and be dissolved in formation mixed solution or suspension in 500g water, be dropped in On the carrier of roller, membrane is dried and is cut on cylinder.
Preferably, entrance dissolves rapidly dispersion to the membrane pliability, and good mouthfeel, taste is sweet, and solution time is 15s in 37 DEG C of water ～20s.
Embodiment 6
Recipe quantity is 1000 (every calcium citrate content is 6mg)
Solid disperses squeezing and pressing method：Each component is weighed according to prescription enduringly to grind, prepare solid dispersion, by mould Film former is prepared, is cut.Preferably, entrance dissolves rapidly dispersion to the membrane pliability, and good mouthfeel, taste is sweet, dissolves in 37 DEG C of water Time is 30s～60s.
The above is only the preferred embodiment of the present invention, it is noted that for those skilled in the art come Say, under the premise without departing from the principles of the invention, can also make some improvements and modifications, these improvements and modifications also should be regarded as Protection scope of the present invention.

Claims (9)

1. calcium oral quick-dissolving film preparation, it is characterised in that include：
2. calcium oral quick-dissolving film preparation according to claim 1, the calcium source is selected from calcium citrate, calcium lactate, chelating calcium, carbon Sour calcium, calcium gluconate, l threonic acid, calcium acetate or calcium aspartate, particle diameter below 100 μm in one kind or arbitrarily several The combination planted.
3. calcium oral quick-dissolving film preparation according to claim 1, the membrane material is selected from polyvinyl alcohol (PVA), Polyethylene oxide (PEO), hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), the poly- dimension of crosslinking Ketone, sodium alginate, polyvinyl alcohol/polyethyleneglycol-graft copolymer, sodium carboxymethyl cellulose, xanthan gum, methylcellulose, height take Form sediment for hypromellose, maltodextrin, gelatin, hyaluronic acid, shitosan, ethyl cellulose, cellulose acetate, Semen Maydiss One kind or arbitrarily several combinations in powder, pre-paying starch, carboxymethyl starch sodium or Microcrystalline Cellulose.
4. calcium oral quick-dissolving film preparation according to claim 1, the plasticizer selected from Polyethylene Glycol, glycerol, Propylene Glycol, One kind or arbitrarily several in Tween 80, glycerol, silicone oil, diethyl phthalate, dibutyl ester, triethyl citrate or butanediol The combination planted.
5. calcium oral quick-dissolving film preparation according to claim 1, the disintegrating agent is selected from Croscarmellose Sodium, crosslinking Carboxymethyl starch sodium, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, pregelatinized Starch, carboxylic first In base Starch Sodium, sodium alginate, carboxymethyl cellulose, hydroxypropylcellulose, carboxymethylcellulose calcium, starch or carboxymethyl starch sodium One kind or arbitrarily several combinations.
6. calcium oral quick-dissolving film preparation according to claim 1, the filler includes starch, Mannitol, hydroxypropyl methyl Cellulose, low-substituted hydroxypropyl cellulose, Microcrystalline Cellulose, Lactose mannitol, sucrose, glucose, Lactose, Sorbitol, wood In one or more in sugar alcohol, Borneolum Syntheticum, Mentholum, maltose alcohol, galactitol, erythritol, dextrin, trehalose one Plant or arbitrarily several combinations.
7. calcium oral quick-dissolving film preparation according to claim 1, correctivess include xylitol, maltose alcohol, acesulfame potassium, A Si Ba Tian, sucralose, steviosin, Mannitol, Fructose, sucrose, glucosan, glycyrrhizin, essence, spice, saccharin, saccharin sodium, One kind or arbitrarily several combinations in bitterness odor mask and protein sugar, aromatic；Aromatic refers to Eucalyptus oil, oleum Citri sinensis, thin Lotus oil, peppermint, menthol.
8. calcium oral quick-dissolving film preparation according to claim 1, it is characterised in that the ratio of the calcium source and vitamin D is (1g：30iu)～(3g：100iu).
9. the preparation method of calcium oral quick-dissolving film preparation described in claim 1～8, it is characterised in that include：By calcium source, vitamin After D, membrane material, disintegrating agent, filler, plasticizer, correctivess mixing, Jing moldings, cut, calcium oral quick-dissolving film preparation is obtained.
CN201610974940.XA 2016-10-27 2016-10-27 Calcium oral cavity rapid-dissolving membrane agent and preparation method thereof Pending CN106581049A (en)

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CN108451935A (en) * 2018-04-12 2018-08-28 天津双硕医药科技有限公司 A kind of solid composite medicament containing Mitiglinide Calcium
CN108813630A (en) * 2018-07-04 2018-11-16 上海海洋大学 It is a kind of directly to take orally and instant self-emulsifying film and preparation method thereof
CN114073683A (en) * 2021-09-27 2022-02-22 广州汇元医药科技有限公司 Vitamin orally-dissolving film agent and preparation method thereof
CN114831983A (en) * 2022-05-27 2022-08-02 北京振东健康科技有限公司 Melatonin sublingual oral cavity instant composition and preparation method thereof
BE1029685B1 (en) * 2021-08-13 2023-03-13 Wooshin Labottach Co Ltd FILM FORMULATION INCLUDING VITAMIN D3

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Publication number Priority date Publication date Assignee Title
CN108451935A (en) * 2018-04-12 2018-08-28 天津双硕医药科技有限公司 A kind of solid composite medicament containing Mitiglinide Calcium
CN108813630A (en) * 2018-07-04 2018-11-16 上海海洋大学 It is a kind of directly to take orally and instant self-emulsifying film and preparation method thereof
CN108813630B (en) * 2018-07-04 2021-09-17 上海海洋大学 Self-emulsifying film agent capable of being directly taken orally and rapidly dissolved and preparation method thereof
BE1029685B1 (en) * 2021-08-13 2023-03-13 Wooshin Labottach Co Ltd FILM FORMULATION INCLUDING VITAMIN D3
CN114073683A (en) * 2021-09-27 2022-02-22 广州汇元医药科技有限公司 Vitamin orally-dissolving film agent and preparation method thereof
CN114831983A (en) * 2022-05-27 2022-08-02 北京振东健康科技有限公司 Melatonin sublingual oral cavity instant composition and preparation method thereof

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Application publication date: 20170426