CN106822061A - A kind of method for preparing Oxiracetam orodispersible film - Google Patents
A kind of method for preparing Oxiracetam orodispersible film Download PDFInfo
- Publication number
- CN106822061A CN106822061A CN201510904235.8A CN201510904235A CN106822061A CN 106822061 A CN106822061 A CN 106822061A CN 201510904235 A CN201510904235 A CN 201510904235A CN 106822061 A CN106822061 A CN 106822061A
- Authority
- CN
- China
- Prior art keywords
- parts
- film
- oxiracetam
- hot melt
- filmogen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- 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
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Zoology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
A kind of method for preparing Oxiracetam orodispersible film, 1-15 parts of Oxiracetam, 80-95 parts of filmogen, 5-10 parts of plasticizer, 2-5 parts of saliva stimulant and 1-3 parts of sweetener are fully ground, are well mixed, hot melt area is sent to by the feed zone for heating film laminator, in 70-95 DEG C of hot melt, the mixture of fusing continues through the output of dosage area, mould is poured into, film is formed after cooling.Present invention selection particular types are combined with the filmogen of consumption with plasticizer, it is easily broken off so as to effectively solve film, intensity and toughness is bad and prolonged disintegration, solution time is more long, it is unfavorable for the technical problems such as the absorption of medicine, makes obtained Oxiracetam orodispersible film demolding performace good, medicine film is soft, not to be broken, solution time is short.
Description
Technical field
The present invention relates to Oxiracetam, and in particular to a kind of method for preparing Oxiracetam orodispersible film.
Background technology
Oxiracetam (Oxiracetam), chemical entitled Esomeprazole, is by Italy
SmithKline, than the cereboactive drug that Qie Mu company synthesized first in 1974, is a kind of hydroxy-amino-butyric acid (GABOB) derivative, can be promoted
Study, strengthens memory, protects 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, it is always to treat the leading products in anti-dementia agent, injection, capsule, tablets and other formulations are successive
Exploitation listing.
CN104069074A discloses a kind of Oxiracetam injection lyophilized formulations, and said preparation is for first by Oxiracetam formation one
Determine the aqueous solution of concentration, be subsequently adding ethanol lyophilized prepared;The lyophilized formulations are substantially free of auxiliary material, and redissolution is rapid, quality is good, storage
Deposit stabilization.Such preparation is directly injected into tissue or blood vessel, very short without absorption process or absorption process, thus haemoconcentration can be rapid
Peak is reached to play a role;But it is developed and production process is complicated, due to the injection aseptic apyrogeneity of requirement, production process is tight
Lattice, step is more to need appointed condition higher, and medicine is generally small with the micron-sized solid of molecular state in injection
Particle is dispersed in water, and decentralization is very big, and often to produce drug hydrolysis, oxidation, solids to coalesce by high-temperature sterilization
Become big equistability problem.Simultaneously because injection directly quickly enters human body, the protection without human body normal physiological barrier, therefore
If dosage is improper or injects too fast, or there is problem in drug quality, be possible to bring harm to patient, or even cause to draw
The consequence returned.In addition injection pain, can not by patient's self-administer, injection site produce scleroma and intravenous injection cause blood vessel
The problem that inflammation exists when being all clinical practice.
CN101732251A discloses a kind of oxiracetam liposome, by Oxiracetam, phosphatide, cholesterol, Tween 80 with
And appropriate osmotic pressure regulator and cushioning liquid are obtained;The liposome stability is good, envelop rate is high, toxic and side effect is small;But
Liposome preparation complex process, is not suitable for large-scale production;Curative effect of the what is more important liposome in human body need into
One step research, the current country rarely have Liposomal formulation for clinic.
CN103494790A discloses a kind of oxiracetam capsule, by the Aura west of xylitol, lubricant and crystal form
It is smooth to be obtained;Obtained oxiracetam capsule quality stability is significantly improved, the reduction of preparation process is simple, production cost.
CN104739796A discloses a kind of Oxiracetam tablet, by a certain amount of Oxiracetam, filler, disintegrant, binder and
Lubricant is obtained;The tablets, carry, and transport and storage are all more convenient.But in actual clinical, when capsule, tablet
Often choke and cough event, and the patient of feeblemindedness is in the majority with the elderly, and this kind of patient is usually for medicine dysphagia, clothes
It is inconvenient with oxiracetam capsule agent, tablet.
CN1555794A discloses a kind of Orazitan dispersion tablet, by Oxiracetam, disintegrant, lubricant and glidant and
Adhesive is obtained, and dispersed fine particle can be promptly disintegrated into after the medicine is oral, is conducive to drug-eluting to absorb;Take
It is convenient, it is oral after the dispersion that can add water, can be also contained in mouth and suck clothes or swallow.Oral dispersable tablet equally exists the asking of coughing of choking
Topic, and suck and take dispersible tablet, it works very slowly, and there is sand type and bitter taste, is unfavorable for taking.
Orodispersible film is a kind of oral administration solid quick-release novel form of increasingly extensive application abroad in recent years, due to it
With without drinking-water, the unique distinction that can be rapidly dissolved in oral cavity makes it possess various advantages, is particularly suited for old trouble
Person.Although orodispersible film has many advantages, its filmogen causes drugloading rate low with the limitation of preparation technique, collapses
The vertical intensity of solution time and anti-tensile is difficult to control, and the problems such as need taste masking when most, constrains the development of orodispersible film
With application.
The content of the invention
It is an object of the invention to provide a kind of method for preparing Oxiracetam orodispersible film, the method operation letter
Just, controllability is high, is adapted to industrialized production.
Number of the present invention unless otherwise specified, is weight portion.
The object of the present invention is achieved like this:
A kind of method for preparing Oxiracetam orodispersible film, it is characterised in that use following steps:
By 1-15 parts of Oxiracetam, 80-95 parts of filmogen, 5-10 parts of plasticizer, 2-5 parts of saliva stimulant and 1-3 parts
Sweetener is fully ground, is well mixed, and hot melt area is sent to by the feed zone for heating film laminator, in 70-95 DEG C of hot melt, fusing
Mixture continues through the output of dosage area, pours into mould, and film is formed after cooling.
An embodiment of the invention, above-mentioned filmogen is selected from ethyl cellulose, HPMC, gathers
One or more combination in oxygen ethene, pectin, sodium carboxymethylcellulose or amylopectin.
An embodiment of the invention, above-mentioned plasticizer be selected from propane diols, glycerine, triethyl citrate,
One or more combination in PEG400 and PEG600.
An embodiment of the invention, above-mentioned saliva stimulant is citric acid, malic acid, lactic acid, ascorbic acid
In one kind.
An embodiment of the invention, above-mentioned sweetener is selected from saccharin, smooth Abbas, sucrose, glucose, fructose
In one or more combination.
Inventor has found in R&D process, and intensity that the Oxiracetam orodispersible film of preparation has and/or toughness are not
It is good, it is easily broken off, some prolonged disintegrations, solution time is more long, is unfavorable for the absorption of medicine.
An a kind of embodiment of the invention, method for preparing Oxiracetam orodispersible film, its feature exists
In using following steps:
Will be including including 5-12 parts of Oxiracetam, 90-95 parts of filmogen, 5-8 parts of plasticizer, 2-5 parts of saliva stimulant
Raw material be fully ground, be well mixed, by the feed zone for heating film laminator be sent to hot melt area, 70-95 DEG C hot melt, fusing
Mixture continues through the output of dosage area, pours into mould, and film is formed after cooling;Above-mentioned filmogen is selected from hydroxypropyl methylcellulose
Element or polyoxyethylene;Above-mentioned plasticizer is selected from propane diols or triethyl citrate.
An a kind of embodiment of the invention, method for preparing Oxiracetam orodispersible film, its feature exists
In using following steps:
Will be including 5-10 parts of Oxiracetam, 90-94 parts of polyoxyethylene, 5-8 parts of propane diols, 3-5 parts of saliva stimulant, 2-3
Part sweetener is sent to hot melt area, in 70- after interior raw material is fully ground, is well mixed by the feed zone for heating film laminator
95 DEG C of hot melts, the mixture of fusing continues through the output of dosage area, pours into mould, and film is formed after cooling.
An a kind of embodiment of the invention, method for preparing Oxiracetam orodispersible film, its feature exists
In using following steps:
Will be including 8-12 parts of Oxiracetam, 92-95 parts of HPMC, 5-8 parts of triethyl citrate, 2-4 parts of saliva
Liquid stimulant, 1-3 parts of sweetener is added in hot melt film laminator, in 80-90 after interior raw material is fully ground, is well mixed
DEG C hot melt extruded film forming.
Above-mentioned hot melt extruded film forming is substantially medicine and is pressed by heating with high molecular polymer filmogen and other auxiliary materials
The feed zone of film machine is sent to hot melt area, and under the control of specific temperature, raw material gradually melts mixing, and the mixture of fusing continues
Exported by dosage area, pour into the mould of selected proterties, film is formed after cooling.
In order to take into account disintegration time and patient adaptability, the thickness of Oxiracetam orodispersible film prepared by the present invention is excellent
Select 100~110 μm.
Raw material mixed charging rate during hot melt extruded of the present invention, mould, output speed is by those skilled in the art's root
Select or adjust according to being actually needed;The thickness of film is set and is cut according to the actual needs with size.
The invention has the advantages that:
Oxiracetam orodispersible film appearance uniform prepared by the present invention is complete, uniform color, and thickness is consistent, physics and
Stable chemical nature, with a small amount of saliva is that can dissolve in oral cavity, be not required to water delivery service can medication, medication facilitates;On tongue
It is difficult to spue after adhesion, is adapted to the old man of dysphagia, and by mucosal absorption, it is to avoid be first to cross elimination effect, improves
Bioavilability, reduces pharmaceutical dosage, so as to reduce drug side-effect.Preparation method of the present invention is simple, in preparation process
There is no a participation of water or organic solvent, it is to avoid moisture is high in air bubble problem and film caused by existing due to solvent
Problem, is effectively guaranteed the homogeneity of Oxiracetam orodispersible film.Film forming to take into account orodispersible film of the invention
Performance, outward appearance and disintegration time, select the HPMC or polyoxyethylene of specific consumption as filmogen meticulously, make
Obtained Oxiracetam orodispersible film thickness is moderate, satisfactory mechanical property and disintegration time is shorter.The present invention is with specific
Filmogen is combined with the plasticizer of particular types and consumption, so as to effectively solve film be easily broken off, intensity and toughness
Bad and prolonged disintegration, solution time is more long, is unfavorable for the technical problems such as the absorption of medicine, and realizing makes obtained Oxiracetam
Orodispersible film demolding performace is good, and medicine film is soft, not to be broken, the short excellent results of solution time.Saliva in raw material of the present invention
Liquid stimulant and flavor enhancement, effectively raise Oxiracetam pelliculae pro cavo oris melting speed in the oral cavity, and solve film
The technical problem of the sand type that agent is present, effectively raises the compliance of film.
Embodiment
In order that the purpose of the present invention and technical scheme are clearer, the preferred embodiments of the present invention are carried out in detail below
Description.To illustrate that:Following examples are served only for being further detailed the present invention, and it is not intended that to this hair
The limitation of bright protection domain.Those skilled in the art's the above of the invention make some it is nonessential improvement and
Adjustment belongs to protection scope of the present invention.
The present invention is raw materials used to be commercially available prod with reagent.Wherein (content 99.8%, Chongqing East is damp for Oxiracetam raw material
Medical sci-tech Development Co., Ltd provides, and lot number is:20140917);Hydroxypropyl methylcellulose (HPMC, Dow Chemical company,
Specification E5);Polyoxyethylene (PEO, Dow Chemical company, specification N10);(the Hunan China day pharmacy of polyethylene glycol (PEG) 400
Co., Ltd);Glycerine, absolute ethyl alcohol (Hu'nan Erkang Pharmaceutical Co., Ltd.);Triethyl citrate (TEC, the rich former doctor in Bangbu
Medicine development in science and technology Co., Ltd);Acetonitrile, methyl alcohol are chromatographically pure, and other reagents are pure for analysis.N is the Aura for determining in embodiment
Western smooth orodispersible film piece number.
Embodiment 1
8 parts of Oxiracetams, 93 parts of polyoxyethylene, 8 parts of propane diols, 5 parts of citric acids, 2 parts of fructose are mixed, be fully ground,
After well mixed, hot melt area is sent to by the feed zone for heating film laminator, in 80-85 DEG C of hot melt, the mixture of fusing persistently leads to
The output of dosage area is crossed, mould is poured into, film is formed after cooling.
Embodiment 2
10 parts of Oxiracetams, 94 parts of polyoxyethylene, 8 parts of propane diols, 5 parts of malic acid, 3 parts of glucose mixing are fully ground
Mill, it is well mixed after, hot melt area is sent to by the feed zone for heating film laminator, in 85-90 DEG C of hot melt, the mixture of fusing continues
Exported by dosage area, pour into mould, film is formed after cooling.
Hot melt press mold technique is referred to documents below to be carried out:Repka MA,Battu SK,Upadhye SB,et
al.Pharmaceutical applications ofhot-melt extrusion:part II[J].Drug Dev Ind
Pharm,2007,33(10):1043-1057.
Embodiment 3
By 12 parts of Oxiracetams, 95 parts of HPMCs, 8 parts of triethyl citrates, 4 parts of saliva stimulants, 3 parts of wood
Sugar alcohol mixes, be fully ground, it is well mixed after, hot melt area is sent to by the feed zone for heating film laminator, heated at 85-90 DEG C,
The mixture of fusing continues through the output of dosage area, pours into mould, and film is formed after cooling.
With reference to embodiment 1-3, following examples are prepared:(consumption is weight portion in following table)
Embodiment 13
Orodispersible film property is determined
Assay method
Thickness and quality
With calibrator thickness measurement (4 Ge Jiaohe centers), and accurately weighed every piece of film are carried out in the different position of film
Quality, calculates average and standard deviation.
Mechanical performance
Weighing film mechanical performance mainly has 3 indexs:Tensile strength, elongation and folding strength.Film is cut into
2.0cm × 3.0cm sizes, every piece of film uses tensile testing machine (draw speed is 25mm/min) longitudinal stretching, until film
Untill fracture, reading is recorded, calculate tensile strength and elongation.The same position of film it is folding to its fracture determining film
The folding strength of agent, folding strength is represented with the logarithm of twofold number of times before fracture.
Content
The content of Oxiracetam orodispersible film is determined using HPLC methods.Chromatographic condition:Chromatographic column InertSustain
C18 posts (4.6mm × 250mm, 5 μm);0.02mol/L sodium dihydrogen phosphates are mobile phase, Detection wavelength 210nm;Column temperature 30
℃;Flow velocity 0.6ml/min;The μ l of sample size 20.Oxiracetam concentration c is linearly closed in the range of 0.5~100 μ g/ml with peak area A
System is good, and linear equation is A=3.7381 × 104c+3.7513×103, R2=0.9998.In a few days RSD is 0.60% (n to this law
=6), average recovery rate is 100.4% (n=9), and the analysis that can be directly used for Oxiracetam orodispersible film is determined.
Embodiment 1-7 test results table specific as follows:
Note:1)The n=10 of the n=6 of thickness, quality and mechanical performance, content and uniformity of dosage units
Prepared Oxiracetam film thickness evenness preferably, possesses suitable suppleness and tensile property, weight difference
Different and uniformity of dosage units meets the Chinese Pharmacopoeia regulation of version two in 2010.Film A+1.80 × S is small obtained in embodiment 1-7
In 5.
Disintegration time
Film is put into equipped with 37 DEG C of beakers of purified water 50ml, is vortexed.Visually observe, when recording the disintegration of film
Between, each embodiment takes 3 pieces of films and is measured.
The Mean disintegration time of acetonideexample 1-7 is:
Oxiracetam orodispersible film disintegration time is in below 40s obtained in embodiment 1-7.
Dissolution in vitro is tested
Dissolution determination uses slurry processes, determines the dissolution rate of the Oxiracetam orodispersible film of embodiment 1-7, and dissolution is situated between
Matter is water, and dissolution volume is 1000mL, and temperature is 37 DEG C, rotating speed 100rpm.Result specifically see the table below.
Experiment display:The Oxiracetam orodispersible film of embodiment 1-7 starts disintegration in 10s, and drug release is rapid,
Dissolution is complete more than the basic dissolutions of 85%, 10min in 5min.
The property of orodispersible film with reference to obtained in above method measurement embodiment 8-12.
Thickness, quality, mechanical performance, content and uniformity of dosage units detection such as following table:
Note:1)The n=10 of the n=6 of thickness, quality and mechanical performance, content and uniformity of dosage units
Experiment display, the thickness of embodiment 8,9 is uniform, and surface is smooth, possesses suitable suppleness and tensile property, weight
Preferably, A+1.80 × S is not more than 3.5 for difference and uniformity of dosage units.Embodiment 10/11 is comparative example, and its surface is smooth, power
The property learned is slightly worse, and A+1.80 × S is apparently higher than embodiment 8.The weight differential of embodiment 12 and uniformity of dosage units are preferable.
Disintegration time, specifically see the table below:
The disintegration time of embodiment 10/11 is most long, and the disintegration time of embodiment 12 is shorter than embodiment 10, and embodiment 8/9 is disintegrated
Time is not more than 30s.
Dissolution in vitro is tested, and specifically be see the table below
The experiment display favorable solubility of embodiment 8/9, embodiment 10-12 is poor.
In above-mentioned experiment, embodiment 10-12 is comparative example, and embodiment 10 has investigated plasticizer to preparing Oxiracetam
The influence of orodispersible film, when experiment display is with PEG400 as plasticizer, the Oxiracetam orodispersible film of preparation contains
The amount uniformity is poor, and disintegration time and accumulative dissolution all can be filmogen than polyoxyethylene, and propane diols is plasticizer system
The film for obtaining is poor.Embodiment 11 has investigated filmogen to influence of the invention, and experiment display is with amylopectin as filmogen
When, the uniformity of dosage units of the Oxiracetam orodispersible film of preparation is poor, and disintegration time and accumulative dissolution all can be than poly-
Oxygen ethene is filmogen, and propane diols is that plasticizer or HPMC are filmogen, and triethyl citrate is used as increasing
Film obtained in modeling agent is poor.Inventor has also investigated other plasticizer (propane diols, glycerine, triethyl citrate, PEG400 simultaneously
Or PEG600) with filmogen (ethyl cellulose, HPMC, polyoxyethylene, pectin, sodium carboxymethylcellulose or
Amylopectin) prepare Oxiracetam orodispersible film;When filmogen be polyoxyethylene when, plasticizer be propane diols most
Good, obtained Oxiracetam orodispersible film medicine film is soft, non-breakable;When HPMC is filmogen, Chinese holly
As plasticizer preferably, obtained Oxiracetam orodispersible film medicine film solution time is most short for rafter triethylenetetraminehexaacetic acid ester.
To sum up, Oxiracetam orodispersible film appearance uniform of the present invention is complete, uniform color, and thickness is consistent, physics and
Stable chemical nature, disintegration time is short, and dissolution rate is fast, works rapid.
Claims (7)
1. a kind of method for preparing Oxiracetam orodispersible film, it is characterised in that use following steps:
By 1-15 parts of Oxiracetam, 80-95 parts of filmogen, 5-10 parts of plasticizer, 2-5 parts of saliva stimulant and 1-3 parts of sweet taste
Agent is fully ground, is well mixed, and hot melt area is sent to by the feed zone for heating film laminator, in 70-95 DEG C of hot melt, the mixing of fusing
Thing continues through the output of dosage area, pours into mould, and film is formed after cooling.
2. the method for claim 1, it is characterised in that:It is fine that the filmogen is selected from ethyl cellulose, hydroxypropyl
One or more combination in dimension element, polyoxyethylene, pectin, sodium carboxymethylcellulose or amylopectin.
3. the method for claim 1, it is characterised in that:The plasticizer is selected from propane diols, glycerine, citron triethylenetetraminehexaacetic acid
One or more combination in ester, PEG400 and PEG600.
4. the method for claim 1, it is characterised in that:The saliva stimulant is citric acid, malic acid, lactic acid, anti-
One kind in bad hematic acid.
5. the method for claim 1, it is characterised in that:The sweetener is selected from saccharin, smooth Abbas, sucrose, grape
One or more combination in sugar, fructose.
6. a kind of method for preparing Oxiracetam orodispersible film, it is characterised in that use following steps:
Will be including 5-10 parts of Oxiracetam, 90-94 parts of polyoxyethylene, 5-8 parts of propane diols, 3-5 parts of saliva stimulant, 2-3 parts is sweet
Taste agent is sent to hot melt area, at 72-92 DEG C after interior raw material is fully ground, is well mixed by the feed zone for heating film laminator
Hot melt, the mixture of fusing continues through the output of dosage area, pours into mould, and film is formed after cooling.
7. the method as described in claim 1-6, it is characterised in that:The thickness of prepared Oxiracetam orodispersible film is
100~110 μm.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510904235.8A CN106822061A (en) | 2015-12-07 | 2015-12-07 | A kind of method for preparing Oxiracetam orodispersible film |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510904235.8A CN106822061A (en) | 2015-12-07 | 2015-12-07 | A kind of method for preparing Oxiracetam orodispersible film |
Publications (1)
Publication Number | Publication Date |
---|---|
CN106822061A true CN106822061A (en) | 2017-06-13 |
Family
ID=59151668
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201510904235.8A Withdrawn CN106822061A (en) | 2015-12-07 | 2015-12-07 | A kind of method for preparing Oxiracetam orodispersible film |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN106822061A (en) |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101766595A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Solid preparation with levo-oxiracetam as active component |
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 |
-
2015
- 2015-12-07 CN CN201510904235.8A patent/CN106822061A/en not_active Withdrawn
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101766595A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Solid preparation with levo-oxiracetam as active component |
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 |
Non-Patent Citations (1)
Title |
---|
陈芳 等: "伏格列波糖口溶膜剂的制备及质量评价", 《中国医药工业杂志》 * |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
AU2016263338B2 (en) | SOMCL-9112 solid dispersion and preparation method thereof and SOMCL-9112 solid preparation containing SOMCL-9112 solid dispersion | |
TW201350137A (en) | An oral instant soluble film former of Olanzapine | |
CN100463674C (en) | Oral cavity quick dissolved film containing civeran, and method for preparing the same | |
CN103784426B (en) | Molten membrane of Aripiprazole mouth and preparation method thereof | |
CN109662949A (en) | A kind of fludrocortisone acetate oral disnitegration tablet and preparation method thereof | |
CN104546807A (en) | Olanzapine oral fast dissolving film preparation | |
CN109602728A (en) | A kind of fludrocortisone acetate oral quick-dissolving film preparation and preparation method thereof | |
CN105663096A (en) | Vonoprazan oral quick-dissolving film agent and method for preparing same | |
CN106821961B (en) | A kind of method that hot melt extruded prepares Oxiracetam pelliculae pro cavo oris | |
CN101455653B (en) | Arginine ibuprofen oral disintegrating tablets and preparation method thereof | |
CN113440499B (en) | Folic acid oral dissolving film agent and preparation method thereof | |
CN106852917A (en) | A kind of levo-oxiracetam orodispersible film and preparation method thereof | |
CN106822061A (en) | A kind of method for preparing Oxiracetam orodispersible film | |
CN102266309A (en) | Novel roxithromycin capsule and preparation method thereof | |
CN101716135B (en) | Soy isoflavone solid dispersion suppository and preparation method thereof | |
CN108785278A (en) | A kind of dextrorotation oxiracetam pharmaceutical composition and preparation method thereof | |
CN106821957A (en) | A kind of method for preparing levo-oxiracetam orodispersible film | |
CN106822051A (en) | A kind of Oxiracetam pelliculae pro cavo oris and preparation method thereof | |
CN106822050A (en) | A kind of method that hot melt extruded prepares levo-oxiracetam oral quick-dissolving film preparation | |
CN103006568A (en) | Felodipine solid dispersion (SD) and preparation method thereof | |
CN106822055A (en) | A kind of Oxiracetam pelliculae pro cavo oris and preparation method thereof | |
CN106821958A (en) | A kind of preparation method of levo-oxiracetam pelliculae pro cavo oris | |
CN117618399A (en) | Suvorexant oral dissolved film with high bioavailability and preparation method and application thereof | |
CN108785285A (en) | The method that hot-melt extruded prepares dextrorotation oxiracetam oral quick-dissolving film preparation | |
CN106822053A (en) | A kind of levo-oxiracetam oral quick-dissolving film preparation and preparation method thereof |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
WW01 | Invention patent application withdrawn after publication | ||
WW01 | Invention patent application withdrawn after publication |
Application publication date: 20170613 |