CN106822063A - A kind of method for preparing Oxiracetam pelliculae pro cavo oris - Google Patents

A kind of method for preparing Oxiracetam pelliculae pro cavo oris Download PDF

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CN106822063A
CN106822063A CN201510906744.4A CN201510906744A CN106822063A CN 106822063 A CN106822063 A CN 106822063A CN 201510906744 A CN201510906744 A CN 201510906744A CN 106822063 A CN106822063 A CN 106822063A
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oxiracetam
viscous fluid
bubble
filmogen
consumption
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叶雷
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Chongqing Runze Pharmaceutical Co Ltd
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Chongqing Runze Pharmaceutical Co Ltd
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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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
    • 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
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)

Abstract

A kind of method for preparing Oxiracetam pelliculae pro cavo oris, is obtained using composite membrane-forming material, plasticizer, filler and flavouring；The present invention prepares Oxiracetam pelliculae pro cavo oris using medicine film film applicator, and strictly control thickness, coating speed and the drying temperature of film, so as to stabilize technique, it is ensured that the quality of product so that the aspect such as fragility of the invention, disintegration time limited and solution time is more conducive to clinical practice；And preparation method of the present invention is simple, it is not necessary to large industry equipment, it is adapted to industrialized production.

Description

A kind of method for preparing Oxiracetam pelliculae pro cavo oris
Technical field
The present invention relates to Oxiracetam, and in particular to a kind of side for preparing Oxiracetam pelliculae pro cavo oris Method.
Background technology
Oxiracetam (Oxiracetam), chemical entitled 4- hydroxyls -2- OXo-1-pyrrolidines Acetamide, be by Italian SmithKline than the cereboactive drug that Qie Mu company synthesized first in 1974, It is a kind of hydroxy-amino-butyric acid (GABOB) derivative, study can be promoted, strengthen memory, protects Protect the medicine for central nervous system of damaged nerve cell.Its structure is as follows：
Since being put on market from it, worked well due to it, safe, indication scope is wide, Drug interaction is few and the low feature of toxicity, is always to treat the leading product in anti-dementia agent Product, injection, capsule, tablets and other formulations develop listing in succession.
CN104069074A discloses a kind of Oxiracetam injection lyophilized formulations, and said preparation is for first Oxiracetam is formed into the certain density aqueous solution, methyl alcohol is subsequently adding lyophilized prepared；This is freezed Preparation is substantially free of auxiliary material, and redissolution is rapid, quality is good, storage is stable.Such preparation is directly noted Enter tissue or blood vessel, it is very short without absorption process or absorption process, thus haemoconcentration can arrive rapidly Played a role up to peak；But it is developed and production process is complicated, because injection requirement is aseptic Apyrogeneity, production process is strict, and step is more to need appointed condition higher, and injection Middle medicine is generally dispersed in water with the micron-sized solid small particles of molecular state, and decentralization is very Greatly, and drug hydrolysis, oxidation, solids coalescence is often produced to become big by high-temperature sterilization Equistability problem.Simultaneously because injection directly quickly enters human body, without human body normal physiological The protection of barrier, if therefore dosage is improper or inject too fast, or there is problem in drug quality, It is possible to bring harm to patient, or even causes the consequence that cannot be retrieved.In addition injection pain, Scleroma and intravenous injection can not be produced to cause vascular inflammation by patient's self-administer, injection site The problem existed when being all clinical practice.
CN101732251A discloses a kind of oxiracetam liposome, by Oxiracetam, phosphatide, Cholesterol, Tween 80 and appropriate osmotic pressure regulator and cushioning liquid are obtained；The lipid Body good stability, envelop rate are high, toxic and side effect is small；But liposome preparation complex process, no It is adapted to large-scale production；Curative effect of the what is more important liposome in human body need further Study, the current country rarely has Liposomal formulation for clinic.
CN103494790A discloses a kind of oxiracetam capsule, by xylitol, lubricant and The Oxiracetam of crystal form is obtained；Obtained oxiracetam capsule quality stability is significantly carried Height, preparation process is simple, production cost reduction.CN104739796A discloses a kind of Aura Western smooth tablet, by a certain amount of Oxiracetam, filler, disintegrant, binder and lubricant It is obtained；The tablets, carry, and transport and storage are all more convenient.But in actual clinical, Capsule, tablet are choked and cough event often, and the patient of feeblemindedness is in the majority with the elderly, This kind of patient takes oxiracetam capsule agent, tablet very not usually for medicine dysphagia Just.
CN1555794A discloses a kind of Orazitan dispersion tablet, by Oxiracetam, disintegrant, Lubricant and glidant and adhesive are obtained, and can be promptly disintegrated into after the medicine is oral dispersed Fine particle, be conducive to drug-eluting to absorb；It is convenient to take, it is oral after the dispersion that can add water, Can be contained in mouth and suck clothes or swallow.Oral dispersable tablet equally exists the problem choked and cough, and suckes Dispersible tablet is taken, it works very slowly, and there is sand type and bitter taste, is unfavorable for taking.
The content of the invention
In order to overcome the shortcoming of prior art, according to the first aspect of the invention, the present invention is provided A kind of method for preparing Oxiracetam pelliculae pro cavo oris, the method is simple to operate, is adapted to industry metaplasia Produce.
Unless otherwise specified, percentage of the present invention is weight percentage.
The object of the present invention is achieved like this：
A kind of method for preparing Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen deionized water dissolving of 42-76%, slough bubble and be obtained uniformly Viscous fluid；
2) by the flavouring of the plasticizer of 8-36%, the filler of 10-38% and 1-5% spend from Sub- moisture dissipates non-uniform components dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 4-22% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) the medicine film coating dryer of the viscous fluid after bubble will be removed to be coated with, dry, peel off Obtain final product.
In order to strengthen patient adaptability, and disintegration time limited of the invention is rationally controlled, the present invention is difficult to understand The thickness of La Xitan pelliculae pro cavo orises is 80~120 μm.
In order to further improve the quality of Oxiracetam pelliculae pro cavo oris of the present invention, above-mentioned medicine film is dried The coating speed of machine is 60-85cm/min, and drying temperature is 70-90 DEG C.
The above-mentioned method for preparing Oxiracetam pelliculae pro cavo oris, Oxiracetam is 4-22%, into membrane material Expect for 42-76%, filler be 10-38%, plasticizer be 8-36%, flavouring be 1-5%； Wherein filmogen is comprising maltodextrin and at least another macromolecule filming material；It is described another A kind of macromolecule filming material is selected from hydroxypropyl cellulose, amylopectin, sodium alginate, Pu Lu Blue polysaccharide, PVP-vinyl acetate or sodium carboxymethylcellulose；The plasticizer be selected from glycerine, Propane diols, glyceryl triacetate, triethyl citrate, dibutyl phthalate, PEG400 With the one or more combination in PEG600；The filler is selected from microcrystalline cellulose, low takes For one or more in hydroxypropyl cellulose, pregelatinized starch, Ac-Di-Sol Combination；The flavouring is in acesulfame potassium, sweet Abbas, Sucralose, essence, xylitol One or more mixing.
Inventor has found that the Oxiracetam pelliculae pro cavo oris quality of preparation is unstable in R＆D process It is fixed, the problems such as easily occurring that matter is soft, filming performance is poor, be difficult to the demoulding.
An embodiment of the invention,
The above-mentioned method for preparing Oxiracetam pelliculae pro cavo oris, by the Oxiracetam of 8-20%, The filmogen of 45-70%, the filler of 10-32%, the plasticizer of 10-33% and 1-5%'s rectifys Taste agent is obtained；The filmogen is comprising maltodextrin and at least another macromolecule filming material Material；Another macromolecule filming material is selected from hydroxypropyl cellulose, amylopectin, marine alga Sour sodium, pulullan polysaccharide, PVP-vinyl acetate or sodium carboxymethylcellulose, wherein hydroxypropyl Base cellulose, amylopectin, sodium alginate, pulullan polysaccharide, PVP-vinyl acetate or The consumption of sodium carboxymethylcellulose is respectively：5%~40%, 10~15%, 3~15%, 1~5%, 12~18%, 5~18%.
An embodiment of the invention,
A kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 45-65%, (maltodextrin and hydroxypropyl cellulose are constituted, wherein hydroxyl Propyl cellulose consumption is 10%~30%) use deionized water dissolving, slough bubble be obtained it is uniform Viscous fluid；
2) by plasticizer (glycerine, propane diols or triethyl citrate), the 15-30% of 10-25% Filler (microcrystalline cellulose or low-substituted hydroxypropyl cellulose) and 1-5% flavouring (peace Match honey, sweet Abbas, Sucralose, essence or xylitol) it is uniformly dispersed into deionized water Dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8-20% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-85cm/min, then with 70-90 DEG C of drying, stripping is obtained final product.
An embodiment of the invention,
A kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 45-60%, (maltodextrin and amylopectin are constituted, and wherein side chain forms sediment Powder consumption be 11%~15%) use deionized water dissolving, slough bubble and uniform viscous fluid be obtained；
2) by plasticizer (propane diols or dibutyl phthalate), the 15-25% of 10-25% Filler (low-substituted hydroxypropyl cellulose or pregelatinized starch) and 1-5% flavouring (peace Match honey, sweet Abbas, Sucralose, essence or xylitol) it is uniformly dispersed into deionized water Dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8-18% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-80cm/min, then with 70-85 DEG C of drying, stripping is obtained final product.
An embodiment of the invention,
A kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50-70%, (maltodextrin and sodium alginate are constituted, wherein alginic acid Sodium consumption be 8%~15%) use deionized water dissolving, slough bubble and uniform viscous fluid be obtained；
2) by the plasticizer (glycerine or dibutyl phthalate) of 10-25%, 10-25% Filler (low-substituted hydroxypropyl cellulose or Ac-Di-Sol) and 1-5%'s rectifys Taste agent (acesulfame potassium, sweet Abbas, Sucralose, essence or xylitol) deionized water point Dissipate non-uniform components dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8-20% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-78cm/min, then with 70-85 DEG C of drying, stripping is obtained final product.
An embodiment of the invention,
A kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, hydroxypropyl cellulose and the carboxymethyl cellulose of 50-65% Plain sodium composition, wherein hydroxypropyl cellulose consumption are 5%~20%, sodium carboxymethylcellulose consumption For 5~and deionized water dissolving 15%) is used, slough bubble and uniform viscous fluid is obtained；
2) plasticizer (propane diols or triethyl citrate) of 15-20%, 10-25% are filled out Fill agent (microcrystalline cellulose or Ac-Di-Sol) and flavouring (the peace match of 1-5% Honey, sweet Abbas, Sucralose, essence or xylitol) it is uniformly dispersed into point with deionized water Dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8-15% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-75cm/min, then with 70-85 DEG C of drying, stripping is obtained final product.
An embodiment of the invention,
A kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, sodium alginate and PVP-the acetic acid second of 45-55% Alkene constitute, wherein sodium alginate consumption be 3%~10%, PVP-vinyl acetate consumption be 15~ 18%) deionized water dissolving is used, bubble is sloughed and uniform viscous fluid is obtained；
2) by the plasticizer (glyceryl triacetate or dibutyl phthalate) of 15-25%, The filler (microcrystalline cellulose or pregelatinized starch) of 15-28% and the flavouring (peace of 1-5% Match honey, sweet Abbas, Sucralose, essence or xylitol) it is uniformly dispersed into deionized water Dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 9-15% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-80cm/min, then with 70-90 DEG C of drying, stripping is obtained final product.
An embodiment of the invention,
A kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 45-60% (maltodextrin, amylopectin and sodium alginate composition, Wherein amylopectin consumption be 12%~15%, sodium alginate consumption be 3%~10%) use deionization Water dissolves, slough bubble and uniform viscous fluid are obtained；
2) by the plasticizer (glycerine or glyceryl triacetate) of 10-25%, the filling of 10-30% Agent (pregelatinized starch or Ac-Di-Sol) and 1-5% flavouring (acesulfame potassium, Abbas is sweet, Sucralose, essence or xylitol) be uniformly dispersed into dispersion liquid with deionized water；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 10-20% Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-80cm/min, then with 70-85 DEG C of drying, stripping is obtained final product.
The invention has the advantages that：
Oxiracetam pelliculae pro cavo oris prepared by the present invention, it is solvable with a small amount of saliva in oral cavity Solution, medication by being not required to water delivery service, medication is convenient；And be difficult to spue after being adhered on tongue, It is adapted to the patient of dysphagia, and by mucosal absorption, it is to avoid first to cross elimination effect, carries Bioavilability high, reduces pharmaceutical dosage, so as to reduce drug side-effect.The present invention Oxiracetam, filmogen, filler and the plasticizer of specified quantitative is selected to be combined, and essence The heart select maltodextrin and at least another kind macromolecular material (hydroxypropyl cellulose, amylopectin, Sodium alginate, pulullan polysaccharide, PVP-vinyl acetate or sodium carboxymethylcellulose) formed Compound film material, easily occur that matter is soft, filming performance is poor so as to solve Oxiracetam pelliculae pro cavo oris, The technical problems such as the demoulding are difficult to, so as to improve product quality.The present invention is by specific compound The combination of membrane material, plasticizer and filler, so as to solve the Oxiracetam pelliculae pro cavo oris of preparation Mechanical performance is bad, disintegration time is long, film has fragility, the technical problem such as is easily broken off, from And ensure that product quality.The present invention prepares Oxiracetam pelliculae pro cavo oris using medicine film film applicator, And strictly the control thickness of film, coating speed and drying temperature, so as to stabilize technique, Ensure that the quality of product so that the side such as fragility of the invention, disintegration time limited and solution time Face is more conducive to clinical practice；And preparation method of the present invention is simple, it is not necessary to large industry equipment, It is adapted to industrialized production.
Embodiment
In order that the purpose of the present invention and technical scheme are clearer, below to of the invention preferred Embodiment is described in detail.To illustrate that：Following examples are served only for entering the present invention Row further instruction, and it is not intended that limiting the scope of the invention.This area Some nonessential modifications and adaptations that technical staff's the above of the invention is made are equal Belong to protection scope of the present invention.
The present invention is raw materials used to be commercially available prod with reagent.Wherein Oxiracetam raw material (content 99.8%, Chongqing Dongze Pharmaceutical Technology Development Co., Ltd. provides, and lot number is：20150210)； Hydroxypropyl methylcellulose (HPMC, Dow Chemical company, specification E50)；Hydroxypropylcellulose (HPC, Ashland companies of the U.S., specification LF)；(Shandong Fu Ruida is biological for sodium alginate Science and Technology Ltd.)；Polyethylene glycol (PEG) 400 (Hunan Hua pharmaceutical Co. Ltds)； Glycerine (Hu'nan Erkang Pharmaceutical Co., Ltd.)；Triethyl citrate (TEC, Bang Bufeng Former medical sci-tech Development Co., Ltd)；Low-substituted hydroxypropyl cellulose (L-HPC), pre- glue Change starch (Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.)；Microcrystalline cellulose (MCC, moral JRS companies of state, specification VIVAPUR 101)；Acetonitrile, methyl alcohol are chromatographically pure, other reagents It is pure to analyze.
Medicine film coating dryer used of the invention is commercially available prod, it is also possible to reference to CN 201668734 U make by oneself, and medicine film coating dryer is by main box, auxiliary box body, peristaltic pump, flat Plate scraper, master roller, deputy roller cylinder, conveyer belt, heating electroplax, induced-draught fan and rolling-up mechanism group Into.Its action principle is added on a moving belt for drug slurry by peristaltic pump, and conveyer belt is in motor Under drive, around main box operating, the liquid on conveyer belt is hung into film by flat scraper, plus Thermoelectric plate air is heated, and induced-draught fan takes the air in main box away, makes air in main box Interior flowing, the solvent of liquid is flung to, drying and moulding, and rolling-up mechanism collects the medicine film of shaping.
Embodiment 1
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by 60g filmogens, (maltodextrin and hydroxypropyl cellulose are constituted, wherein hydroxypropyl Cellulose consumption is 30g) 80mL deionized water dissolvings are used, slough bubble prepared uniform sticky Liquid；
2) by 15g glycerine, 15g microcrystalline celluloses and 2g xylitols 50mL deionized waters It is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8g Oxiracetam is uniformly dispersed, and then stands and sloughs bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60cm/min, then with 75-77 DEG C of drying, stripping is obtained final product.
Embodiment 2
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 45g, (maltodextrin and hydroxypropyl cellulose are constituted, wherein hydroxypropyl Base cellulose consumption is 10g) 50mL deionized water dissolvings are used, slough bubble and uniform gluing is obtained Magma；
2) by 15g propane diols, 20g low-substituted hydroxypropyl celluloses and 2g acesulfame potassiums 60mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 18g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 80cm/min, then with 70-72 DEG C of drying, stripping is obtained final product.
Embodiment 3
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g, (maltodextrin and hydroxypropyl cellulose are constituted, wherein hydroxypropyl Base cellulose consumption is 20g) 50mL deionized water dissolvings are used, slough bubble and uniform gluing is obtained Magma；
2) by 15g triethyl citrates, 19g microcrystalline celluloses and 1g Abbas is sweet uses 40mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 15g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 83-85 DEG C of drying, stripping is obtained final product.
Embodiment 4
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 60g, (maltodextrin and amylopectin are constituted, wherein amylopectin Consumption is 15g) 80mL deionized water dissolvings are used, slough bubble and uniform viscous fluid is obtained；
2) by 10g propane diols, 15g low-substituted hydroxypropyl celluloses and 3g Sucraloses 30mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 10g Oxiracetam is uniformly dispersed, and then stands and sloughs bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 65cm/min, then with 70-72 DEG C of drying, stripping is obtained final product.
Embodiment 5
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 45g, (maltodextrin and amylopectin are constituted, wherein amylopectin Consumption is 11g) deionized water dissolving is used, slough bubble and uniform viscous fluid is obtained；
2) by 25g dibutyl phthalates, 21g pregelatinized starch and 1g xylitols 60mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 18g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 75-78 DEG C of drying, stripping is obtained final product.
Embodiment 6
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g, (maltodextrin and amylopectin are constituted, wherein amylopectin Consumption is 12g) 55mL deionized water dissolvings are used, slough bubble and uniform viscous fluid is obtained；
2) by 18g dibutyl phthalates, 17g pregelatinized starch and 3g acesulfame potassiums 45mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 12g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 80cm/min, then with 80-82 DEG C of drying, stripping is obtained final product.
Embodiment 7
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 65g, (maltodextrin and sodium alginate are constituted, wherein sodium alginate Consumption is 15g) 80mL deionized water dissolvings are used, slough bubble and uniform viscous fluid is obtained；
2) by 10g glycerine, 15g low-substituted hydroxypropyl celluloses and 2g Abbas is sweet uses 30mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 65cm/min, then with 76-78 DEG C of drying, stripping is obtained final product.
Embodiment 8
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g, (maltodextrin and sodium alginate are constituted, wherein sodium alginate Consumption is 8g) 65mL deionized water dissolvings are used, slough bubble and uniform viscous fluid is obtained；
2) by 16g dibutyl phthalates, 15g Ac-Di-Sols and 1g wood Sugar alcohol is uniformly dispersed into dispersion liquid with 50mL deionized waters；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 18g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 70-72 DEG C of drying, stripping is obtained final product.
Embodiment 9
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 60g, (maltodextrin and sodium alginate are constituted, wherein sodium alginate Consumption is 12g) 65mL deionized water dissolvings are used, slough bubble and uniform viscous fluid is obtained；
2) by 10g glycerine, 15g low-substituted hydroxypropyl celluloses and 3g Abbas is sweet uses 35mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 12g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 78cm/min, then with 83-85 DEG C of drying, stripping is obtained final product.
Embodiment 10
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, hydroxypropyl cellulose and the carboxymethylcellulose calcium of 50g Sodium is constituted, and wherein hydroxypropyl cellulose consumption is 5g, and sodium carboxymethylcellulose consumption is 5g) 50mL deionized water dissolvings are used, bubble is sloughed and uniform viscous fluid is obtained；
2) by 15g propane diols, 20g microcrystalline celluloses and 5g acesulfame potassiums 50mL deionizations Moisture dissipates non-uniform components dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 10g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60cm/min, then with 80-82 DEG C of drying, stripping is obtained final product.
Embodiment 11
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, hydroxypropyl cellulose and the carboxymethylcellulose calcium of 50g Sodium is constituted, and wherein hydroxypropyl cellulose consumption is 20g, and sodium carboxymethylcellulose consumption is 15g) 80mL deionized water dissolvings are used, bubble is sloughed and uniform viscous fluid is obtained；
2) by 16g triethyl citrates, 20g Ac-Di-Sols and 4g Abbas Sweet 50mL deionized waters are uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 10g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 75cm/min, then with 70-72 DEG C of drying, stripping is obtained final product.
Embodiment 12
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, hydroxypropyl cellulose and the carboxymethylcellulose calcium of 60g Sodium is constituted, and wherein hydroxypropyl cellulose consumption is 10g, and sodium carboxymethylcellulose consumption is 10g) 65mL deionized water dissolvings are used, bubble is sloughed and uniform viscous fluid is obtained；
2) by 15g propane diols, 15g microcrystalline celluloses and 2g Sucraloses 40mL go from Sub- moisture dissipates non-uniform components dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 8g Oxiracetam is uniformly dispersed, and then stands and sloughs bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 75-78 DEG C of drying, stripping is obtained final product.
Embodiment 13
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, sodium alginate and PVP-the vinyl acetate group of 45g Into wherein sodium alginate consumption is 3g, and PVP-vinyl acetate consumption is 15g) use 50mL Deionized water dissolving, sloughs bubble and uniform viscous fluid is obtained；
2) by 15g glyceryl triacetates, 25g microcrystalline celluloses and 3g xylitols 50mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 12g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 80cm/min, then with 85-90 DEG C of drying, stripping is obtained final product.
Embodiment 14
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, sodium alginate and PVP-the vinyl acetate group of 63g Into wherein sodium alginate consumption is 10g, and PVP-vinyl acetate consumption is 18g) use 70mL Deionized water dissolving, sloughs bubble and uniform viscous fluid is obtained；
2) 10g dibutyl phthalates, 15g pregelatinized starch are used and 2g xylitols 30mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 10g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 85-88 DEG C of drying, stripping is obtained final product.
Embodiment 15
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by filmogen (maltodextrin, sodium alginate and PVP-the vinyl acetate group of 50g Into wherein sodium alginate consumption is 8g, and PVP-vinyl acetate consumption is 16g) use 50mL Deionized water dissolving, sloughs bubble and uniform viscous fluid is obtained；
2) by 16g glyceryl triacetates, 21g pregelatinized starch and 1g Abbas is sweet uses 50mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 12g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 83-85 DEG C of drying, stripping is obtained final product.
Embodiment 16
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 45g (maltodextrin, amylopectin and sodium alginate composition, its Middle amylopectin consumption is 12g, and sodium alginate consumption is 3g) 50mL deionized water dissolvings are used, Slough bubble and uniform viscous fluid is obtained；
2) by 15g glyceryl triacetates, 20g Ac-Di-Sols and 5g xylitols Dispersion liquid is uniformly dispersed into 30mL deionized waters；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 15g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 65cm/min, then with 75-77 DEG C of drying, stripping is obtained final product.
Embodiment 17
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 60g (maltodextrin, amylopectin and sodium alginate composition, its Middle amylopectin consumption is 15g, and sodium alginate consumption is 10g) 70mL deionized water dissolvings are used, Slough bubble and uniform viscous fluid is obtained；
2) by 10g glycerine, 17g pregelatinized starch and 3g acesulfame potassiums 30mL deionized waters It is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 10g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 80cm/min, then with 83-85 DEG C of drying, stripping is obtained final product.
Embodiment 18
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g (maltodextrin, amylopectin and sodium alginate composition, its Middle amylopectin consumption is 13g, and sodium alginate consumption is 7g) 55mL deionized water dissolvings are used, Slough bubble and uniform viscous fluid is obtained；
2) by 15g glycerine, 20g Ac-Di-Sols and 2g Abbas is sweet uses 45mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 13g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 75-78 DEG C of drying, stripping is obtained final product.
Embodiment 19
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the maltodextrin of 50g 55mL deionized water dissolvings, slough bubble and be obtained Even viscous fluid；
2) by 15g glycerine, 20g Ac-Di-Sols and 2g Abbas is sweet uses 45mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 13g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 75-78 DEG C of drying, stripping is obtained final product.
Embodiment 20
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g (hydroxypropyl cellulose, amylopectin and sodium alginate composition, Wherein hydroxypropyl cellulose 30g, amylopectin consumption is 13g, and sodium alginate consumption is 7g) 55mL deionized water dissolvings are used, bubble is sloughed and uniform viscous fluid is obtained；
2) by 15g glycerine, 20g Ac-Di-Sols and 2g Abbas is sweet uses 45mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 13g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 75-78 DEG C of drying, stripping is obtained final product.
Embodiment 21
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g (maltodextrin, amylopectin and sodium alginate composition, its Middle amylopectin consumption is 13g, and sodium alginate consumption is 7g) 55mL deionized water dissolvings are used, Slough bubble and uniform viscous fluid is obtained；
2) by 15g glycerine, 20g Ac-Di-Sols and 2g Abbas is sweet uses 45mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 13g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 20cm/min, then with 75-78 DEG C of drying, stripping is obtained final product.
Embodiment 22
The preparation of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen of 50g (hydroxypropyl cellulose, amylopectin and sodium alginate composition, Wherein hydroxypropyl cellulose 30g, amylopectin consumption is 13g, and sodium alginate consumption is 7g) 55mL deionized water dissolvings are used, bubble is sloughed and uniform viscous fluid is obtained；
2) by 15g glycerine, 20g Ac-Di-Sols and 2g Abbas is sweet uses 45mL Deionized water is uniformly dispersed into dispersion liquid；
3) by step 2) dispersion liquid be added to step 1) viscous fluid in, and add 13g Oxiracetam be uniformly dispersed, then stand slough bubble；
4) viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 70cm/min, then with 50 DEG C of dryings, stripping is obtained final product.
Embodiment 23
Oxiracetam pelliculae pro cavo oris obtained in embodiment 1-22 is evaluated, including outward appearance, Thickness, ifs vitro disintegration, the evaluation of mechanical properties.
Evaluation method
Ocular estimate：Whether observation membrane surface is complete bright and clean, and whether thickness is consistent, and color and luster is It is no it is uniform, whether there is obvious bubble.
Thickness measurement：Use resolution ratio carries out thickness for the digimatic micrometer of 0.001mm to film Degree measurement, is determined 3 times respectively in every piece of the 3 of film different parts, and record data is obtained Average thickness.
Ifs vitro disintegration time study：The disintegrating property of film is investigated by the disintegration time for determining film And solvability.Magnetic stirring apparatus is placed in the beaker that 50mL distilled water is added 100mL On, be clipped in for test film water-bath be put on clip by 37 DEG C of waters bath with thermostatic control, rotating speed 100r/min Middle beginning timing, the time of record film dissolving.In this experiment, every piece of film is cut out at random 3 block sizes are cut for 1 × 1cm2Membranelle determine, using three average values of measurement result as survey Amount result.
Mechanical performance is evaluated：
This experiment has used the universal testing machine of model 3365 to carry out the mechanical performance of film Evaluate.It is 2 × 0.5cm by size2Film be put between two clips at a distance of 5cm. Draw vice is with the speed membrane of 10mm/min.The elastic modelling quantity (EM) of film, refers to become in elasticity In the shape stage, the ratio of applied stress and adaptability to changes, it is possible to use formula below is calculated：
Elastic modelling quantity=applied stress/adaptability to changes/area of section.
The tensile strength (TS) of film is also strength degree, refers to that material bears maximum before breaking Stress value, computing formula is：
Tensile strength=applied stress/cross-sectional area.
The percent elongation (E%) of film is calculated by following formula：
Percent elongation=length incrementss/the original length × 100.
The Oxiracetam pelliculae pro cavo oris the performance test results such as following table of embodiment 1-7：
Note：1)The n=10 of the n=6 of thickness, quality and mechanical performance, content and uniformity of dosage units
Experiment display, the Oxiracetam pelliculae pro cavo oris surface light prepared by embodiment 1-7 above Sliding, thickness evenness preferably, possesses suitable suppleness and tensile property, conveniently stripped, collapses The solution time in 20s or so, no more than 24s.
The test result of the Oxiracetam pelliculae pro cavo oris of embodiment 8-15 is as follows：
Note：1)The n=10 of the n=6 of thickness, quality and mechanical performance, content and uniformity of dosage units
Experiment display, the Oxiracetam pelliculae pro cavo oris surface light prepared by embodiment 8-15 above Sliding, thickness evenness preferably, possesses suitable suppleness and tensile property, conveniently stripped, collapses The solution time in 20s or so, no more than 24s.
The test result of the Oxiracetam pelliculae pro cavo oris of embodiment 16-22 is as follows：
Note：1)The n=10 of the n=6 of thickness, quality and mechanical performance, content and uniformity of dosage units
Experiment display, the Oxiracetam pelliculae pro cavo oris surface light prepared by embodiment 16-18 above Sliding, thickness evenness preferably, possesses suitable suppleness and tensile property, conveniently stripped, collapses The solution time in 20s or so, no more than 24s；The membrane surface of embodiment 19 has projection, takes off Mould is also more difficult, and disintegration time limited also relative extension；The surface of embodiment 20 is smooth, Toughness is preferable, the also easy demoulding, but disintegration time is slightly long；The membrane surface of embodiment 21 There is projection, the demoulding is also more difficult, and disintegration time limited also relative extension；Embodiment 22 Film is partially wet, there is adhesion phenomenon, and disintegration time is slightly long.
Oxiracetam pelliculae pro cavo oris obtained in embodiment 1-22 is carried out into dissolution in vitro experiment, Result shows：The Oxiracetam pelliculae pro cavo oris of embodiment 1-18 starts disintegration in 10s, Drug release is rapid, and dissolution is complete more than the basic dissolutions of 90%, 10min in 5min；Embodiment 19-22 Start disintegration in obtained Oxiracetam pelliculae pro cavo oris 10s, drug release is more rapid, 5min Interior dissolution is complete more than the basic dissolutions of 90%, 20min more than dissolution in 70%, 10min；
Embodiment 19 and embodiment 20 have investigated filmogen to influence of the invention, alone Maltodextrin is used as filmogen, and disintegration time is slightly long, there is the slightly poor situation of film forming, Demoulding difficulty (embodiment 19) can be caused；Prepared by without maltodextrin film, film forming Better performances, the easy demoulding, but disintegration time is (embodiment 20) more long.Embodiment 21 The influence of coating speed and drying temperature to film in film-forming process has been investigated with embodiment 22, Wherein coating speed is too fast can cause partially wet, there is adhesion phenomenon；Coating speed can cause film slowly excessively Agent overdrying, so that film is more crisp.Drying temperature can equally influence the brittleness and humidity of film.
To sum up, Oxiracetam pelliculae pro cavo oris appearance uniform of the present invention is complete, uniform color, thickness Unanimously, physics and stable chemical nature, disintegration time are short, and dissolution rate is fast, work rapid.

Claims (8)

1. a kind of method for preparing Oxiracetam pelliculae pro cavo oris, using following steps：
1）By the filmogen deionized water dissolving of 42-76%, slough bubble and uniform viscous fluid is obtained；
2）The flavouring deionized water of the plasticizer of 8-36%, the filler of 10-38% and 1-5% is uniformly dispersed into dispersion liquid；
3）By step 2）Dispersion liquid be added to step 1）Viscous fluid in, and add the Oxiracetam of 4-22% to be uniformly dispersed, then stand and slough bubble；
4）The viscous fluid medicine film coating dryer coating after bubble, dry, stripping will be removed to obtain final product.
2. the method for claim 1, it is characterised in that：The thickness of the Oxiracetam pelliculae pro cavo oris is 80~120 μm.
3. the method for claim 1, it is characterised in that：The coating speed of the medicine film drying machine is 60-85cm/min, and drying temperature is 70-90 DEG C.
4. method as claimed in claim 2, it is characterised in that：The coating speed of the medicine film drying machine is 60-85cm/min, and drying temperature is 70-90 DEG C.
5. the method as described in claim any one of 1-4, it is characterised in that：The Oxiracetam consumption is 4-22%, filmogen consumption is 42-76%, filler loading is 10-38%, plasticizer consumption is 8-36%, flavouring consumption is 1-5%；Wherein filmogen is comprising maltodextrin and at least another macromolecule filming material；Another macromolecule filming material is selected from hydroxypropyl cellulose, amylopectin, sodium alginate, pulullan polysaccharide, PVP-vinyl acetate or sodium carboxymethylcellulose；The plasticizer is selected from the one or more combination in glycerine, propane diols, glyceryl triacetate, triethyl citrate, dibutyl phthalate, PEG400 and PEG600；The filler is selected from the one or more combination in microcrystalline cellulose, low-substituted hydroxypropyl cellulose, pregelatinized starch, Ac-Di-Sol；The flavouring is one or more mixing in acesulfame potassium, sweet Abbas, Sucralose, essence, xylitol.
6. method as claimed in claim 5, it is characterised in that：It is obtained by the flavouring of the Oxiracetam of 8-20%, the filmogen of 45-70%, the filler of 10-32%, the plasticizer of 10-33% and 1-5%；The filmogen is comprising maltodextrin and at least another macromolecule filming material；Another macromolecule filming material is selected from hydroxypropyl cellulose, amylopectin, sodium alginate, pulullan polysaccharide, PVP-vinyl acetate or sodium carboxymethylcellulose, and the consumption of wherein hydroxypropyl cellulose, amylopectin, sodium alginate, pulullan polysaccharide, PVP-vinyl acetate or sodium carboxymethylcellulose is respectively：5%~40%, 10~15%, 3~15%, 1~5%, 12~18%, 5~18%.
7. a kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen deionized water dissolving of 50-70%, slough bubble and uniform viscous fluid is obtained, the filmogen is that maltodextrin and sodium alginate are constituted, and wherein sodium alginate consumption is 8%~15%；
2）The flavouring deionized water of the plasticizer of 10-25%, the filler of 10-25% and 1-5% is uniformly dispersed into dispersion liquid, the plasticizer is glycerine or dibutyl phthalate, the filler is low-substituted hydroxypropyl cellulose or Ac-Di-Sol, and the flavouring is the one kind in acesulfame potassium, sweet Abbas, Sucralose, essence or xylitol；
3）By step 2）Dispersion liquid be added to step 1）Viscous fluid in, and add the Oxiracetam of 8-20% to be uniformly dispersed, then stand and slough bubble；
4）The viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-78cm/min, and then with 70-85 DEG C of drying, stripping is obtained final product.
8. a kind of preparation method of Oxiracetam pelliculae pro cavo oris, using following steps：
1) by the filmogen deionized water dissolving of 50-65%, slough bubble and uniform viscous fluid is obtained, the filmogen is maltodextrin, hydroxypropyl cellulose and sodium carboxymethylcellulose composition, and wherein hydroxypropyl cellulose consumption is 5%~20%, and sodium carboxymethylcellulose consumption is 5~15%；
2）The flavouring deionized water of the plasticizer of 15-20%, the filler of 10-25% and 1-5% is uniformly dispersed into dispersion liquid, the plasticizer is propane diols or triethyl citrate, the filler is microcrystalline cellulose or Ac-Di-Sol, and the flavouring is acesulfame potassium, sweet Abbas, Sucralose, essence or xylitol；
3）By step 2）Dispersion liquid be added to step 1）Viscous fluid in, and add the Oxiracetam of 8-15% to be uniformly dispersed, then stand and slough bubble；
4）The viscous fluid after bubble will be removed to be coated with medicine film coating dryer, coating speed is 60-75cm/min, and then with 70-85 DEG C of drying, stripping is obtained final product.
CN201510906744.4A 2015-12-07 2015-12-07 A kind of method for preparing Oxiracetam pelliculae pro cavo oris Withdrawn CN106822063A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102600130A (en) * 2012-03-26 2012-07-25 北京阜康仁生物制药科技有限公司 New clinical use of oxiracetam and optical isomer of oxiracetam
CN104940174A (en) * 2015-07-23 2015-09-30 合肥华方医药科技有限公司 Preparation method of donepezil oral fast dissolving film

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102600130A (en) * 2012-03-26 2012-07-25 北京阜康仁生物制药科技有限公司 New clinical use of oxiracetam and optical isomer of oxiracetam
CN104940174A (en) * 2015-07-23 2015-09-30 合肥华方医药科技有限公司 Preparation method of donepezil oral fast dissolving film

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