CN106821961B - A kind of method that hot melt extruded prepares Oxiracetam pelliculae pro cavo oris - Google Patents
A kind of method that hot melt extruded prepares Oxiracetam pelliculae pro cavo oris Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Abstract
The invention discloses a kind of methods preparing Oxiracetam pelliculae pro cavo oris, and Oxiracetam, filmogen, plasticizer, saliva stimulant and corrigent are fully ground, are uniformly mixed, is formed a film by hot melt extruded；To which effective solution film is easily broken off, intensity and toughness is bad and prolonged disintegration, solution time are longer, it is unfavorable for the technical problems such as the absorption of drug, realizing keeps Oxiracetam pelliculae pro cavo oris demolding performace obtained good, and medicine film is soft, not with fracture, the short excellent results of solution time.
Description
Technical field
The present invention relates to Oxiracetams, and in particular to a kind of method that hot melt extruded prepares Oxiracetam pelliculae pro cavo oris.
Background technology
Oxiracetam (Oxiracetam), the entitled Esomeprazole of chemistry, is by Italy
The cereboactive drug that SmithKline ratio Qie Mu companies synthesized for the first time in 1974 is a kind of hydroxy-amino-butyric acid (GABOB) derivative, can promote
Study enhances memory, protects the medicine for central nervous system of damaged nerve cell.Its structure is as follows：
Since its launch, since it works well, safe, indication range is wide, drug interaction is few
And toxicity it is low the features such as, be always treat anti-dementia agent in leading products, injection, capsule, tablets and other formulations are successive
Exploitation listing.
CN104069074A discloses a kind of Oxiracetam injection lyophilized preparation, and said preparation is that Oxiracetam is first formed one
Determine the aqueous solution of concentration, ethyl alcohol freeze-drying is then added and is made；The lyophilized preparation is substantially free of auxiliary material, redissolves rapid, high-quality, storage
Deposit stabilization.Such preparation is directly injected into tissue or blood vessel, and no absorption process or absorption process are very short, thus haemoconcentration can be rapid
Peak is reached to play a role；But it is developed and production process is complicated, since injection requires sterile apyrogeneity, production process tight
Lattice, step is more to need higher appointed condition, and drug is generally small with the micron-sized solid of molecular state in injection
Particle is dispersed in water, and dispersion degree is very big, and drug hydrolysis, oxidation, solids coalescence are often generated by high-temperature sterilization
The equistability that becomes larger problem.Simultaneously because injection directly quickly enters human body, the protection of no human body normal physiological barrier, therefore
If dosage it is improper or inject too fast or drug quality there are problems, be possible to bring harm to patient, or even cause not drawing
The consequence returned.In addition injection pain, cannot by patient's self-administer, injection site generate scleroma and intravenous injection cause blood vessel
When inflammation is all clinical application there are the problem of.
CN101732251A discloses a kind of oxiracetam liposome, by Oxiracetam, phosphatide, cholesterol, Tween 80 with
And suitable osmotic pressure regulator and buffer solution are made；The liposome stability is good, encapsulation rate is high, toxic 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 to be used for clinic.
CN103494790A discloses a kind of oxiracetam capsule, by the Aura west of xylitol, lubricant and crystal form
It is smooth to be made；Oxiracetam capsule quality stability obtained significantly improves, preparation process is simple, production cost reduces.
CN104739796A discloses a kind of Oxiracetam tablet, by a certain amount of Oxiracetam, filler, disintegrant, binder and
Lubricant is made；The tablets carry, and transport and storage are all more convenient.However in actual clinical, when capsule, tablet
Normal cough event of choking, and the patient of feeblemindedness is in the majority with the elderly, and this kind of patient is usually for drug 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 made, and can promptly be disintegrated into evenly dispersed fine particle after the medicine is oral, is conducive to drug-eluting absorption；It takes
It is convenient, can add it is water-dispersed after it is oral, also can be by it contained in sucking clothes in mouth or swallow.Oral dispersable tablet equally exists asking for cough of choking
Topic, and suck and take dispersible tablet, it works very slow, and there are sand type and bitter taste, be unfavorable for taking.
Pelliculae pro cavo oris is a kind of in recent years in the oral administration solid quick-release novel form of external increasingly extensive application, since it has
Without drinking-water, it can be made to have a variety of advantages, be particularly suitable for gerontal patient in the unique distinction that oral cavity is dissolved rapidly.
Although pelliculae pro cavo oris has many advantages, filmogen and the limitation of preparation technique and cause drugloading rate low, disintegration time
The problems such as founding intensity with anti-tensile to be difficult to control, and needing taste masking when majority, constrains the development and application of pelliculae pro cavo oris.
Invention content
The purpose of the present invention is to provide a kind of methods preparing Oxiracetam pelliculae pro cavo oris, and this method is easy to operate, can
Control property is high, is suitble to industrialized production.
Percentage of the present invention is mass percent unless otherwise specified.
The object of the present invention is achieved like this：
A method of preparing Oxiracetam pelliculae pro cavo oris, which is characterized in that use following steps：
By the Oxiracetam of 2-12%, the saliva stimulant of the filmogen of 84-94%, the plasticizer of 2-12%, 1-5%
It is fully ground, is uniformly mixed with the corrigent of 1-3%, the feed zone by heating film laminator is sent to hot melt area, in 70-95 DEG C of heat
Molten, the mixture of fusing continues through the output of dosage area, pours into mold, film is formed after cooling；The filmogen is selected from second
One or more of base cellulose, hyaluronic acid, chitosan, pectin, sodium carboxymethylcellulose or amylopectin combine；It is described
Saliva stimulant is one kind in malic acid, citric acid, lactic acid, ascorbic acid.
An embodiment according to the present invention, above-mentioned plasticizer are selected from propenyl, glyceryl triacetate, citron triethylenetetraminehexaacetic acid
One or more of ester, glycerine and PEG600 are combined.
An embodiment according to the present invention, above-mentioned corrigent are selected from smooth xylitol, Abbas, sucrose, glucose, fruit
One or more of sugar combines.
Inventor has found in R&D process, and the intensity and/or toughness that the Oxiracetam pelliculae pro cavo oris of preparation has are bad, hold
Easy fracture, some prolonged disintegrations, solution time is longer, is unfavorable for the absorption of drug.
An embodiment according to the present invention, a method of preparing Oxiracetam pelliculae pro cavo oris, which is characterized in that adopt
Use following steps：
By the Oxiracetam of 3-10%, the saliva stimulant of the filmogen of 84-91%, the plasticizer of 3-10%, 2-4%
It is fully ground, is uniformly mixed with the corrigent of 1-3%, the feed zone by heating film laminator is sent to hot melt area, in 70-95 DEG C of heat
Molten, the mixture of fusing continues through the output of dosage area, pours into mold, film is formed after cooling；Above-mentioned filmogen is selected from saturating
Bright matter acid or chitosan；Above-mentioned plasticizer is selected from propenyl or triethyl citrate.
An embodiment according to the present invention, a method of preparing Oxiracetam pelliculae pro cavo oris, which is characterized in that adopt
Use following steps：
By the Oxiracetam of 5-10%, the saliva stimulant of the chitosan of 84-89%, the propenyl of 3-8%, 2-4%, 1-
3% corrigent is fully ground, after mixing, and the feed zone by heating film laminator is sent to hot melt area, in 70-95 DEG C of heat
Molten, the mixture of fusing continues through the output of dosage area, pours into mold, film is formed after cooling.
An embodiment according to the present invention, a method of preparing Oxiracetam pelliculae pro cavo oris, which is characterized in that adopt
Use following steps：
By the saliva of the Oxiracetam of 3-6%, the hyaluronic acid of 88-91%, the triethyl citrate of 3-10%, 2-4%
The corrigent of stimulant, 1-3% is fully ground, after mixing, is added in hot melt film laminator, in 80-90 DEG C of hot melt extruded
Film forming.
Above-mentioned hot melt extruded film forming is substantially drug and is pressed with high molecular polymer filmogen and other auxiliary materials by heating
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
It is exported by dosage area, pours into the mold of selected character, film is formed after cooling.
Disintegration time and patient adaptability in order to balance, the thickness of Oxiracetam oral quick-dissolving film preparation prepared by the present invention with
100~110 μm are advisable.
Raw material mixed charging rate when hot melt extruded of the present invention, mold, output speed is by those skilled in the art's root
According to actual needs selection or adjustment；The thickness of film is set and is cut according to the actual needs with size.
The invention has the advantages that：
1, the Oxiracetam pelliculae pro cavo oris appearance uniform that prepared by the present invention is complete, and uniform color, thickness is consistent, physics and change
Learn property stablize, in oral cavity with a small amount of saliva i.e. can dissolve, be not required to water delivery service can medication, medication conveniently.
2, Oxiracetam pelliculae pro cavo oris prepared by the present invention is not easy to spue after adhering on tongue, is suitble to the old of dysphagia
People, and by mucosal absorption, avoid head and cross elimination effect, improve bioavilability, reduce pharmaceutical dosage, to drop
Low drug side-effect.
3, preparation method of the present invention is simple, does not have the participation of water or organic solvent in preparation process, avoids due to solvent
Moisture is high in air bubble problem and film caused by there is a problem of, is effectively guaranteed the equal of Oxiracetam pelliculae pro cavo oris
One property.
4, the present invention selects the saturating of specific dosage meticulously to take into account filming performance, appearance and the disintegration time of pelliculae pro cavo oris
Bright matter acid or chitosan make moderate Oxiracetam pelliculae pro cavo oris thickness obtained, satisfactory mechanical property and collapse as filmogen
It is shorter to solve the time.
5, the present invention is combined with specific filmogen with the plasticizer of particular types and dosage, to effective solution
Film is easily broken off, intensity and toughness is bad and prolonged disintegration, and solution time is longer, is unfavorable for the technologies such as the absorption of drug and asks
Topic, realizing keeps Oxiracetam pelliculae pro cavo oris demolding performace obtained good, and medicine film is soft, not with fracture, short excellent of solution time
Good effect.
6, saliva stimulant and flavoring agent in raw material of the present invention, effectively raise Oxiracetam pelliculae pro cavo oris in oral cavity
In melting speed, and solve sand type existing for film the technical issues of, effectively raise the compliance of film.
Embodiment
In order to keep the purpose of the present invention and technical solution clearer, the preferred embodiment of the present invention is carried out below detailed
Description.To illustrate that：Following embodiment is served only for that the present invention is further detailed, and should not be understood as to this hair
The limitation of bright protection domain.Those skilled in the art's the above according to the present invention make some it is nonessential improvement and
Adjustment all belongs to the scope of protection of the present invention.
The raw materials used in the present invention and reagent are commercial product.Wherein Oxiracetam raw material (content 99.8%, Chongqing East pool
Medical sci-tech Development Co., Ltd provides, and lot number is：20141110)；Hydroxypropyl methylcellulose (HPMC, Dow Chemical company,
Specification E5)；Chitosan (deacetylation 85%, viscosity 100, Shandong Apollo Group Co., Ltd)；(Shaanxi is gloomy not for hyaluronic acid
Bioisystech Co., Ltd)；Polyethylene glycol (PEG) 400 (Hunan Hua pharmaceutical Co. Ltds)；Triethyl citrate (TEC, freshwater mussel
Bu Fengyuan medical sci-teches Development Co., Ltd)；Acetonitrile, methanol are chromatographically pure, other reagents are that analysis is pure.N is to survey in embodiment
Fixed Oxiracetam pelliculae pro cavo oris piece number.
Embodiment 1
By 6g Oxiracetams, 87g chitosans, 4g propenyls, 2g malic acid, the mixing of 1g fructose is fully ground, is uniformly mixed
Afterwards, it is sent to hot melt area by heating the feed zone of film laminator, is heated at 80-85 DEG C, the mixture of fusing continues through dosage area
Output pours into mold, film is formed after cooling.
Embodiment 2
By 7g Oxiracetams, 85g chitosans, 5g propenyls, 2g citric acids, the mixing of 1g glucose is fully ground, mixes
After even, the feed zone by heating film laminator is sent to hot melt area, is heated at 85-90 DEG C, the mixture of fusing continues through dosage
Area exports, and pours into mold, film is formed after cooling.
Hot melt press mold technique is referred to following documents progress:Repka MA,Battu SK,Upadhye SB,et
al.Pharmaceutical applications of hot-melt extrusion:part II[J].Drug Dev Ind
Pharm,2007,33(10):1043-1057.
Embodiment 3
By 8g Oxiracetams, 86g hyaluronic acids, 3g triethyl citrates, 2g saliva stimulants, the mixing of 1g xylitols is filled
Divide and grind, after mixing, the feed zone by heating film laminator is sent to hot melt area, is heated at 85-90 DEG C, the mixture of fusing
The output of dosage area is continued through, mold is poured into, film is formed after cooling.
With reference to embodiment 1-3, following embodiment is prepared：(dosage is weight g) in following table
Embodiment 13
Pelliculae pro cavo oris property measures
Assay method
Thickness and quality
With calibrator thickness measurement (4 angles and center), and accurately weighed every piece of film are carried out in the different position of film
Quality calculates mean value 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 use tensile testing machine (tensile speed 25mm/min) longitudinal stretching, until film
Until fracture, record reading calculates tensile strength and elongation.The same position of film it is folding to its fracture to measure film
The folding strength of agent indicates folding strength with the logarithm of twofold number before fracture.
Content
The content of Oxiracetam pelliculae pro cavo oris is measured using HPLC methods.Chromatographic condition：Chromatographic column InertSustain C18
Column (4.6mm × 250mm, 5 μm)；0.02mol/L sodium dihydrogen phosphates are mobile phase, Detection wavelength 210nm；30 DEG C of column temperature；
Flow velocity 0.6ml/min；20 μ l of sample size.Oxiracetam concentration c within the scope of 0.5~100 μ g/ml with peak area A linear relationships
Well, 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 pelliculae pro cavo oris measures.
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 is preferable, has suitable suppleness and tensile property, weight difference
Different and uniformity of dosage units meets the regulation of Chinese Pharmacopoeia version two in 2010.Film A+1.80 × S made from embodiment 1-7 is small
In 5.
Disintegration time
Film is put into the beaker equipped with 37 DEG C of purified water 50ml, is vortexed.It visually observes, when recording the disintegration of film
Between, each embodiment takes 3 pieces of films to be measured.
The Mean disintegration time of acetonideexample 1-7 is：
Oxiracetam pelliculae pro cavo oris disintegration time is in 32s or less made from embodiment 1-7.
Dissolution in vitro is tested
Dissolution determination uses slurry processes, measures the dissolution rate of the Oxiracetam pelliculae pro cavo oris of embodiment 1-7, and dissolution medium is
Water, dissolution volume are 1000mL, and temperature is 37 DEG C, rotating speed 100rpm.
As a result it specifically see the table below：
Experiment display：The Oxiracetam pelliculae pro cavo oris of embodiment 1-7 starts to be disintegrated in 10s, and drug release is rapid, in 5min
Dissolution dissolves out completely substantially more than 85%, 10min.
The property of pelliculae pro cavo oris made from embodiment 8-12 is measured with reference to the above method.
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, has suitable suppleness and tensile property, weight
Difference and uniformity of dosage units are preferable, and A+1.80 × S is not more than 3.5.Embodiment 10/11 is comparative example, and surface is smooth, power
The property learned is slightly worse, and A+1.80 × S is apparently higher than embodiment 8.12 weight differential of embodiment and uniformity of dosage units are preferable.
Disintegration time specifically see the table below：
The disintegration time longest of embodiment 10/11,12 disintegration time of embodiment is shorter than embodiment 10, and embodiment 8/9 is disintegrated
Time is not more than 30s.
Dissolution in vitro is tested, and specifically see the table below
Experiment shows that 8/9 favorable solubility of embodiment, embodiment 10-12 are poor.
In above-mentioned experiment, embodiment 10-12 is comparative example, and embodiment 10 has investigated plasticizer to preparing Oxiracetam
The influence of pelliculae pro cavo oris, when experiment display is using PEG600 as plasticizer, the uniformity of dosage units of the Oxiracetam pelliculae pro cavo oris of preparation
Poor, disintegration time and accumulative dissolution all can be filmogen than chitosan, and propenyl is that film made from plasticizer is poor.
Embodiment 11 has investigated influence of the filmogen to the present invention, when experiment display is using amylopectin as filmogen, Austria of preparation
The uniformity of dosage units of La Xitan pelliculae pro cavo oris is poor, and disintegration time and accumulative dissolution all can be filmogen than chitosan,
Propenyl is plasticizer or hyaluronic acid is filmogen, and triethyl citrate is poor as film made from plasticizer.It sends out simultaneously
A person of good sense has also investigated other plasticizer (propenyl, glyceryl triacetate, triethyl citrate, glycerine or PEG600) and at membrane material
Material (ethyl cellulose, hyaluronic acid, chitosan, pectin, sodium carboxymethylcellulose or amylopectin) prepares Oxiracetam oral cavity
Film；When filmogen is chitosan, plasticizer is that propenyl is best, and Oxiracetam pelliculae pro cavo oris medicine film obtained is soft
It is soft, non-breakable；When hyaluronic acid is filmogen, triethyl citrate is best as plasticizer, Oxiracetam mouth obtained
Chamber film medicine film solution time is most short.
To sum up, Oxiracetam pelliculae pro cavo oris appearance uniform of the present invention is complete, and uniform color, thickness is consistent, physics and chemistry
Property is stablized, and disintegration time is short, and dissolution rate is fast, works rapid.
Claims (4)
1. a kind of method preparing Oxiracetam pelliculae pro cavo oris, which is characterized in that use following steps：By the Aura west of 3-10%
Smooth, 84-91% filmogen, the plasticizer of 3-10%, the saliva stimulant of 2-4% and 1-3% corrigent be fully ground, mix
Uniformly, it is sent to hot melt area by heating the feed zone of film laminator, is heated at 70-95 DEG C, the mixture of fusing continues through dosage
Area exports, and pours into mold, film is formed after cooling；The filmogen is selected from hyaluronic acid or chitosan；The plasticizer is selected
From propenyl or triethyl citrate；The saliva stimulant is one kind in malic acid, citric acid, lactic acid, ascorbic acid.
2. the method as described in claim 1, it is characterised in that：The corrigent is selected from smooth xylitol, Abbas, sucrose, Portugal
The combination of one or more of grape sugar, fructose.
3. the method as described in claim 1, which is characterized in that use following steps：By the Oxiracetam of 5-10%, 84-89%
Chitosan, the propenyl of 3-8%, 2-4% saliva stimulant, the corrigent of 1-3% is fully ground, after mixing, passes through heat
The feed zone of molten film laminator is sent to hot melt area, is heated at 70-95 DEG C, and the mixture of fusing continues through the output of dosage area, pours into
Mold forms film after cooling.
4. the method as described in claim 1, it is characterised in that：The thickness of the Oxiracetam pelliculae pro cavo oris of preparation is 100~110
μm。
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| CN103083283A (en) * | 2013-02-06 | 2013-05-08 | 上海现代药物制剂工程研究中心有限公司 | Loratadine film preparation |
| CN103432105A (en) * | 2013-09-02 | 2013-12-11 | 天津市聚星康华医药科技有限公司 | Meclozine oral film and preparation method thereof |
| 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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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103083283A (en) * | 2013-02-06 | 2013-05-08 | 上海现代药物制剂工程研究中心有限公司 | Loratadine film preparation |
| CN103432105A (en) * | 2013-09-02 | 2013-12-11 | 天津市聚星康华医药科技有限公司 | Meclozine oral film and preparation method thereof |
| 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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