CN204078456U

CN204078456U - A kind of packing device of the freeze-drying excipient preparation containing adhesive agent and townhouse packing device thereof

Info

Publication number: CN204078456U
Application number: CN201320834988.2U
Authority: CN
Inventors: 李和伟
Original assignee: Individual
Current assignee: Beijing Weibo Haitai Biotechnology Co ltd
Priority date: 2013-08-30
Filing date: 2013-12-18
Publication date: 2015-01-07
Anticipated expiration: 2023-12-18

Abstract

The utility model relates to a kind of packing device and townhouse packing device thereof of the freeze-drying excipient preparation containing adhesive agent, this packing device and structure are applicable to the packaging of the freeze-drying excipient preparation containing adhesive agent, the classification of freeze-drying excipient preparation containing adhesive agent should comprise and be not limited to cosmetics, food, health food and medicine etc.The packaging of the freeze-drying excipient preparation containing adhesive agent of the present utility model have prolection composition stability, protection freeze-drying excipient dosage form, unit dose package, be easy to carry, avoid polluting, easy to use, the plurality of advantages such as to reduce costs.

Description

A kind of packing device of the freeze-drying excipient preparation containing adhesive agent and townhouse packing device thereof

Technical field

The utility model relates to a kind of packing device and townhouse packing device thereof of the freeze-drying excipient preparation containing adhesive agent, this packing device and structure are applicable to the packaging of the freeze-drying excipient preparation containing adhesive agent, the classification of freeze-drying excipient preparation containing adhesive agent should comprise and be not limited to cosmetics, food, health food and medicine etc.

background technology

Freeze-drying excipient preparation is a kind of dosage form utilizing freeze-drying excipient technology to prepare, and forms through cryodesiccated technological process is shaping by be filled into by preparation supplementary material in forming mould again.Because such preparation adopts freeze drying process; thermally sensitive composition can be protected not to be destroyed; simultaneously because preparation itself has a large amount of micropore and duct; make it can disintegration and dissolving soon, therefore freeze-drying excipient preparation be widely applied in medicine, food, health food and the cosmetic fields such as oral disnitegration tablet, fast-release tablet, chewable tablets, special cosmetics.

Traditional freeze-drying excipient preparation comprises skeleton supporting agent and adhesive agent, skeleton supporting agent content is larger, mostly be selected from (see Chinese patent CN200580013010.8) such as the amino acid of sugar, a sugar alcohol and 2-12 carbon atom and inorganic salts (as sodium phosphate, aluminium silicate etc.), there is the shortcomings such as the strong but hardness of complex manufacturing, high, the easy moisture absorption of cost, toughness is low.Although the plastic wrapping that most of medicine, cosmetics, food use can protect the product of easy friability, leak tightness is poor, therefore freeze-drying excipient preparation in the market there is no the inner packing adopting plastic material in packing.To contact the stability of functional component in the destroyed such as rear oxidation, moisture absorption preparation with air in order to stop freeze-drying excipient preparation; the packaged configuration of most of freeze-drying excipient preparation takes two aluminium packaging in the market; sealing property preferably two aluminium packaging can make the composition oxygen barrier damp proof insulation in freeze-drying excipient preparation; but due to the characteristic of aluminum itself; it is lower that two aluminium packs general hardness, can not play well support and protective effect the preparation in packaging.

Contriver is in the patent application declared on December 26th, 2012; remove skeleton supporting agent and also can make freeze-drying excipient preparation; on this basis; the feature of comprehensive freeze-drying excipient preparation; inventors performed in-depth study and a large amount of practice and test; find that a kind of aluminum-plastic composite membrane meets freeze-drying excipient preparation package encapsulation simultaneously and supports the large requirement of protectiveness two, thus complete the utility model.

summary of the invention

The purpose of this utility model; be to provide a kind of packing device of the freeze-drying excipient preparation containing adhesive agent, particularly provide a kind of there is enough hardness, can support and protect the freeze-drying excipient preparation containing adhesive agent and meet the good packing device of oxygen barrier damp proof insulation, leak tightness simultaneously.

For achieving the above object, packing device of the present utility model comprises with lower component: a container and a seal cover cap.

What one container comprised an opening upwards is installed in space; The outside horizontal-extending in the perisporium top of this container forms roof simultaneously, for seal cover cap pressing; The shape of described container is circular, oval or N limit shape, wherein N=3-100.

One seal cover cap, for covering on said vesse and seal cover cap edge and vessel top wall pressing seals, forms the pack environment of an airtight oxygen barrier damp proof insulation; Can leave the unsealing edge being convenient to open during sealing, and its unsealing edge does not affect sealing effectiveness.

The material of a described container is a kind of aluminium plastic composite material, for a kind of high hardness composite material of oxygen barrier damp proof insulation, wherein aluminium lamination (forming the internal layer of said vesse) thickness is 15-1000 micron, preferred 30-900 micron, 30-800 micron, 30-700 micron, 30-600 micron, 30-500 micron, 30-400 micron, 30-300 micron, 30-200 micron, 30-100 micron, 40-900 micron, 40-800 micron, 40-700 micron, 40-600 micron, 40-500 micron, 40-400 micron, 40-300 micron, 40-200 micron, 40-100 micron, most preferably 30-200 micron.Plastic layer (forming the skin of the said vesse) thickness of this aluminium plastic composite material is 20 microns-5000 microns, preferably 20 microns-4000 microns, 20 microns-3000 microns, 20 microns-2000 microns, 20 microns-1000 microns, 25 microns-5000 microns, 25 microns-4000 microns, 25 microns-3000 microns, 25 microns-2000 microns, 25 microns-1000 microns, 30 microns-5000 microns, 30 microns-4000 microns, 30 microns-3000 microns, 30 microns-2000 microns, 30 microns-1000 microns, most preferably 20-2000 micron.

The hardness of this aluminium plastic composite material is about allowable stress 300-500 ox.

For making the hardness of this aluminium plastic composite material be about allowable stress 300-500 ox, the aluminum layer thickness of this material and plastic layer are very important, as long as appropriate adjustment aluminum layer thickness and plastic layer, namely can reach the hardness of needs.But however, the aluminium used in the utility model can be the aluminium with Types Below, such as, 1050,1060,1070,1000 serial fine aluminiums, aircraft aluminum, aluminum alloy etc.The plastics used in the utility model can be, such as, and polyvinylchloride, nylon, polyethylene, polypropylene, cast polypropylene etc.

This aluminium plastic composite material preferably can be uploaded aluminium lamination (forming the internal layer of said vesse) increases one deck plastic layer, the thickness of this plastic layer can be 20 microns-5000 microns, preferably 20 microns-4000 microns, 20 microns-3000 microns, 20 microns-2000 microns, 20 microns-1000 microns, 25 microns-5000 microns, 25 microns-4000 microns, 25 microns-3000 microns, 25 microns-2000 microns, 25 microns-1000 microns, 30 microns-5000 microns, 30 microns-4000 microns, 30 microns-3000 microns, 30 microns-2000 microns, 30 microns-1000 microns, most preferably 20-2000 micron.The object increasing this layer is to improve hardness and mechanical strength.Select to make the hardness of this aluminium plastic composite material be about allowable stress 300-500 ox by the thickness of 3 layer materials.

This aluminium plastic composite material business can be buied or manufacture voluntarily, the material such as aluminium, polyvinylchloride, nylon, polyethylene, polypropylene, cast polypropylene during manufacture, each material of different-thickness is selected to carry out various combination, obtain structure can be but be not limited to polyvinylchloride/aluminium/nylon, polyethylene/aluminium/polypropylene, nylon/aluminium/cast polypropylene, polypropylene/aluminium/polyacrylic aluminium plastic composite material, the method manufacturing aluminium plastic composite material can be carry out cold stamping shaped making or additive method.

The material of a described seal cover cap includes but not limited to that aluminium foil, paper plastic-aluminum, aluminum-plastic composite membrane, heat-sealing aluminium compressing tablet etc. can carry out with said vesse the supplementary material that seals.

In seal cover cap and seal of vessel process, the unlatching limit of unsealing pressing or stingy hand can be retained in side, seal cover cap can be upwardly opened thus.

Above-mentioned packing device is connected to form the packing device of one group of freeze-drying excipient preparation by any-mode, and the number of packing device is 2-100;

During packaging, each container is installed in the freeze-drying excipient preparation containing adhesive agent of an once used amount respectively, primarily of active component and adhesive agent composition.

The volume ratio of the binder content of described adhesive agent after this freeze-drying excipient preparation freeze-drying and lyophilized excipient is 0.1mg/ml to 600mg/ml (weight/volume); Wherein more preferably 1mg/ml to 200mg/ml.

Described adhesive agent is edible or pharmaceutically useful a kind of water-soluble high-molecular material, can be polysaccharide, polypeptide, protein, also may be synthetic polymeric's Polymer, or through the natural macromolecular material of remodeling or its compound.Conventional adhesive agent includes but not limited to glue class (collagen, gelatin, gelatin hydrolysate, Arabic gum, xanthans, carragheen, pectin, konjac glucomannan, carrageenan, locust bean gum, natural gum, locust bean gum etc.), cellulose ethers (carboxymethyl cellulose, carboxyethyl cellulose, HEMC, hydroxypropyl methylcellulose etc.), modified starch series (pulullan, hydroxypropul starch etc., see R.P.Scherer US4305502A), PVP, PVA, hyalomitome acids, albumin, shitosan, dextran, agar, polyaminoacid, glucan and their combination etc. thereof, polyaminoacid (polyglutamic acid, polyalanine, polylysine etc.), glycan (fucoidin, synanthrin, glucan) etc.

Described active component can be water-soluble also can be water-fast material, and described active component can be selected from one or more the combination in chemicals composition, traditional Chinese medicine ingredients, natural extract, bioactive ingredients, skin nursing beneficiating ingredient.

There is no particular limitation for active component involved in the present invention, can be selected from but be not limited to the composite of one or more compositions following.

Chemicals (active constituents of medicine):

Antipyretic-antalgic anti-inflammatory agent, such as aspirin, Diflunisal, salsalate, paracetamol, Indomethacin, brufen, naproxen, Ketoprofen, pirprofen, suprofen, Flurbiprofen, piroxicam, Meloxicam, aulin, Benzbromarone etc.;

Central stimulant, such as pemoline, adrafinil, Piracetam etc.;

Treatment migraine agent, such as Sumatriptan succinate;

Antalgesic, such as rotundin, buprenorphine, pentazocine, naloxone etc.;

Anti-parkinson and treatment senile dementia medicine, such as levodopa, compound carbidopa, compound benserazide, amantadine hydrochloride, piribedil, general sieve phenol amine, donepezil, huperzine are first-class;

Psychotolytic, such as chlorpromazine, fenazil, pethidine, thioridazine, Chlorprothixene, Clozapine, Sulpiride, Tai Bili, penfluridol, Risperidone etc.;

Antiepileptic and anticonvulsive drug, such as dilantin sodium, carbamazepine, Primidone, Gabapentin, Lamotrigine, sodium vedproate, Clonazepam etc.Hypnotic sedative agent, such as diazepam, nitrazepam, Oxazepam, Lorazepam, phenobarbital etc.;

Cholinesterase inhibitor, such as hyoscine etc.;

Antiarrhymic, such as the third pyridine, tocainide, mexiletine, aetmozine, dilantin sodium, Propafenone, amiodarone etc.;

Antianginal and antiatherosclerotic, such as Propranolol, nifedipine, Gemfibrozil, Bezafibrate, Lovastatin, Simvastatin, Pravastatin etc.;

Antihypertensive, such as Enalapril, captopril, Hydrochioro, Amlodipine etc.;

Adrenoceptor blocking agents, such as acebutolol, alprenolol etc.;

Corticosteroid medicine, such as betamethasone, cortisone acetate etc.;

Antidiabetic, such as Repaglinide etc.;

Antithyroid drug, such as propylthiouracil (PTU), Carbimazole, methimazole etc.;

Antithistamine, such as Cetirizine Hydrochloride, Loratadine etc.;

Autacoid, such as dinoprostone, Alprostadil, Betahistine etc.;

Digestive system surgical procedures, such as scopolamine butylbromide, Granisetron Hydrochloride etc.;

Hematological system medicine, such as EPO, cobamamide etc.;

Urinary system medicine, such as azosemide, frusemide etc.;

Reproductive system medicine, such as estrogen, Nandrolone Phenylpropionate etc.;

Antiparasitic agent, such as albendazole, cambendazole etc.;

Antineoplastic, such as aminoglutethimide, amsacrine etc.;

Antimicrobial, such as ampicillin, sulbenicillin disodium etc.;

Tri-Biocin, such as Amoxicillin, cefalexin, Cefprozil, CEFUROXIME AXETIL, Roxithromycin, Erythromycin Ethylsuccinate, josamycin etc.

Traditional Chinese medicine ingredients:

Effective Component of Chinese Medicine monomer, as: Breviscapinun, qinghaosu, huperzine, tetrahydropalmatine etc.;

Single medicinal material material extract and compound Chinese medicine extract, as: tanshinone extract, salvianolic acid extract, composite salvia dropping extract of bolus, cow-bezoar bolus compound extract, ginseng stem and leave general saponin, asiatic moonseed extract, general ginsenoside, American ginseng total saponins, Breviscapinun, Glabrous Sarcandra Herb medicinal extract, arasaponin, capillary extract, extractum rhei, andrographolide, hawthorne leaf P.E, asiaticoside, ginkgo biloba p.e etc.

Natural plant extracts: as aloe extract, yam extract, Bilberry fruit P.E, Bitter Melon P.E, Echinacea Purpurea Herb P.E, Feverfew P.E, mangosteen extract, pine needle and Pine Bark, Brazilian blackberry extract, mulberries extract, elder berry extract, Cranberry extract, astaxanthin, lycopene, green-tea extract, grape pip and grape skin extract, glabridin, Paeoniflorin, licoflavone, Cortex Moutan extract etc.

Bioactive ingredients: EGF, bFGF, aFGF, KGF, IGF, NGF, TGF, HGH etc.

Nutritious supplementary pharmaceutical, skin nursing beneficiating ingredient: vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, coenzyme class, proteinase, metallothionein, pearl and hydrolyzate, cow's milk and extract thereof, pollen and extract, royal jelly, propolis etc.

Described freeze-drying excipient preparation, it primarily of active component, adhesive agent composition, and needs to add skeleton supporting agent, antioxidant, flavouring and essence, skin penetration enhancer, pH adjusting agent etc. according to preparation process.

Described skeleton supporting agent comprises the material such as amino acid (as amino acetic acid, alanine, glutamic acid etc.) and inorganic salts (as sodium phosphate, aluminium silicate etc.) being not limited to sugar (as maltose, trehalose etc.), sugar alcohol (as sweet mellow wine, sorbierite), 2-12 carbon atom;

Described antioxidant includes but not limited to the compound of one or several in the polyhydric phenols of vitamin C and derivant thereof, anthocyanidin, resveratrol, plant origin;

Described flavouring and essence include but not limited to the compound of mint flavored, chocolate flavoured, the essence such as fruity, vanilla flavored, caf, tea flavour, corn taste, lemon, milk flavor or more one or more fragrance;

Described skin penetration enhancer includes but not limited to the compound of any one or several in lecithin, saponin(e, bay alkyd sodium, azone, tween, sapn;

Described pH adjusting agent includes but not limited to any one in citric acid, tartaric acid, carbonate, sodium carbonate, phosphate or several compound.

The invention still further relates to the method for the above-mentioned freeze-drying excipient preparation containing adhesive agent of preparation, the method comprises assembling method after original position desivac and freeze-drying.

I. original position desivac:

A () will include but not limited to that the solution that active component, water, adhesive agent and other auxiliaries are formed or suspension inject packing device; Or solid constituent (can comprise active component, adhesive agent and other auxiliary materials) is injected packing device, then add water and be made into suspension;

B solution that (a) obtains by () or suspension carry out degassed in packing device;

(c) (b) is obtained degassed after suspension or without degassed direct that (a) is freezing at low temperatures;

D preparation that (c) obtains by () carries out lyophilisation in packing device, obtains freeze-drying excipient preparation.

II. assembling method after freeze-drying:

A () will include but not limited to the solution that active component, water, adhesive agent and other auxiliaries are formed or suspension injection moulding mould; Or by solid constituent (active component, adhesive agent and other auxiliary materials can be comprised) injection moulding mould, then add water and be made into suspension;

B solution that (a) obtains by () or suspension carry out degassed in forming mould;

D preparation that (c) obtains by () carries out lyophilisation in forming mould, obtains freeze-drying excipient preparation;

E freeze-drying excipient preparation that (d) obtains by () is detached into mould, is fitted in packing device.

In above-mentioned preparation method, wherein Liquid Injection can adopt the liquid-transfering devices such as accurate quantification pipet, liquid-transfering gun, electronic liquor-transferring rifle, also plunger pump, gear type pump, peristaltic pump etc. can be adopted, the solution configured, suspension or suspending fluid are injected quantitative forming mould, and solid injection molding can adopt accurate solid measurer, vibrations capillary tub flow of powder controller;

Wherein degas method can adopt centrifugal degassing method, vacuum degasification method and ultrasonic degas method etc.;

The wherein freezing mode that can adopt liquid nitrogen or liquid, dry ice spray refrigeration or sleeve pipe cooling back installation, turbine expander refrigeration mode or cascade refrigeration mode, at-20 DEG C--at 196 DEG C of temperature, become solid by freezing to solution, suspension or suspending fluid rapidly;

Wherein freeze-drying adopts the degree of vacuum of 0.01-20 millibar, temperature freeze-drying between-70 DEG C to 50 DEG C scopes;

The purposes of the above-mentioned freeze-drying excipient preparation containing adhesive agent comprises and is not limited to food, health food, cosmetics and medicine, and user in use, opens seal cover cap and can take out freeze-drying excipient preparation and use.

Accompanying drawing explanation

Fig. 1 is the schematic diagram of the utility model freeze-drying excipient preparation packing device.

Fig. 2 is the schematic diagram after the utility model freeze-drying excipient preparation packing device is opened.

Detailed description of the invention

Relevant aforementioned and technology contents, feature of the present utility model, in following examples and in describing in detail, can clearly present.

Embodiment 1

Use the polyvinylchloride of outer layer thickness 100 microns, container made by the composite material of the aluminium that internal layer thickness is 40 microns, uses aluminum foil material to make seal cover cap.

Pearl powder: hyaluronic acid=1: 100, hyaluronic acid 100mg, after wherein 90mg hyaluronic acid mixes with 1mg pearl fine powder, accurately fillingly enter in 0.5ml mould, 10mg hyaluronic acid is after the water-soluble solution of 0.3ml, pour into in the mould containing 90mg hyaluronic acid and 1mg pearl powder, stirring makes aqueous dispersion in powder, quick-frozen is to-20 degrees Celsius, freeze-drying becomes skin care solid elite, the freeze-drying excipient preparation of once used amount is put into container, and seal cover cap is covered on container, again with pressing machine seal cover cap and vessel top wall carried out sealing install time, said process all can utilize automated machine always to change automatic production.

During use, after directly opening seal cover cap, use the freeze-drying excipient preparation of single dose.

The container using above-mentioned composite material to make after measured its hardness is about and can bears 350 Ns of pressure, is better than the hardness (on the market multiple common double aluminium packaging hardness be about can bear 50-200 ox pressure) of common double aluminium packaging on the market.

Use above-mentioned composite material to make and make identical container with common plastics, be respectively charged into the freeze-drying excipient preparation of equivalent, seal with seal cover cap, together put into constant temperature and humidity accelerating chamber (temperature 40 DEG C, humidity 70%), whether intactly monthly observe freeze-drying excipient formulation aesthetics in a container, with or without the moisture absorption, result is as follows:

Accelerated test

January

February

March

April

May

June

Composite material

Intact

Common plastics

Intact

The moisture absorption

——

Embodiment 2

Use the composite material of the polyvinylchloride of the polyvinylchloride of outer layer thickness 120 microns, the aluminium of intermediate layer thickness 50 microns and innermost layer thickness 100 microns to make container, use plastic-aluminum combined membrane material to make seal cover cap.

EGF stoste, gelatin, gelatin hydrolysate and sweet mellow wine is added after thawing, be mixed with containing the EGF (weight ratio) of 5/100000ths, the gelatin+gelatin hydrolysate solution containing 5%, fillingly enter 0.1 milliliter of forming mould, packing container is put into after freeze-drying is shaping, and seal cover cap is covered on container, then with pressing machine seal cover cap and vessel top wall carried out sealing install time, said process all can utilize automated machine always to change automatic production.

The container using above-mentioned composite material to make after measured its hardness is about allowable stress 500 Ns, is better than the hardness (multiple common double aluminium packaging hardness is about allowable stress 50-200 ox on the market) of common double aluminium packaging on the market.

Accelerated test

January

February

March

April

May

June

Composite material

Intact

Common plastics

Intact

The moisture absorption

——

Embodiment 3

Use the composite material of the cast polypropylene of the nylon of outer layer thickness 25 microns, the aluminium of intermediate layer thickness 80 microns and innermost layer thickness 150 microns to make container, make paper using aluminium plastic material make seal cover cap.

Arasaponin: PVP=2: 1; be mixed with solution; be fed in the fender guard cavity with fog-spray nozzle; in cavity, quick-frozen is to after-100 degrees Celsius; freeze-drying in position; and seal cover cap is covered on container, then with pressing machine seal cover cap and vessel top wall carried out sealing install time, said process all can utilize automated machine always to change automatic production.

Accelerated test

January

February

March

April

May

June

Composite material

Intact

Common plastics

Intact

The moisture absorption

——

Embodiment 4

Use the polyacrylic composite material of the cast polypropylene of outer layer thickness 30 microns, the aluminium of intermediate layer thickness 120 microns and innermost layer thickness 300 microns to make container, use aluminum-plastic composite membrane to make seal cover cap.

Vitamin C: collagen=100: 1, vitamin C 100mg, accurately fillingly enters 0.3ml mould, collagen 1mg, add after dissolving in 0.2ml water, pour into into containing in the ascorbic mould of 100mg, stir and make aqueous dispersion in powder, quick-frozen is to-100 degrees Celsius, packing container is put into after freeze-drying is shaping, and seal cover cap is covered on container, then with pressing machine seal cover cap and vessel top wall carried out sealing install time, said process all can utilize automated machine always to change automatic production.

Accelerated test

January

February

March

April

May

June

Composite material

Intact

Common plastics

Intact

The moisture absorption

——

As shown in the above description, the freeze-drying excipient preparation containing adhesive agent that the utility model utilizes oxygen barrier damp proof insulation high hardness material fitted seal lid to make once used amount is packed, and has health, safe, easy, actv. feature.

Packaging structure of the present utility model is not limited to form cited in embodiment, and embodiment is only preferred embodiment of the present utility model, can not limit protection domain with this.All with the simple or equivalent change described in right of the present utility model and modification, all belong to protection domain of the present utility model.

Claims

1. a packing device for the freeze-drying excipient preparation containing adhesive agent, comprises with lower component:

One container, comprise perisporium and the opening upwards that formed by perisporium be installed in space;

One seal cover cap, for covering on the container and sealing described opening;

It is characterized in that, the material of container is a kind of aluminium plastic composite material, and its aluminum layer thickness is 15 microns-1000 microns and plastic layer is 20 microns-5000 microns; The pack environment of container coordinates formation one airtight oxygen barrier damp proof insulation with seal cover cap.

2. packing device as claimed in claim 1, is characterized in that, the outside horizontal-extending in perisporium top of container forms roof, and described roof is used for and seal cover cap pressing, thus forms closed structure.

3. the packing device as described in claim 1-2 any one, is characterized in that, described seal cover cap is can carry out with container the supplementary material that seals, is selected from aluminium foil, paper plastic-aluminum, aluminum-plastic composite membrane or heat-sealing aluminium compressing tablet.

4. packing device as claimed in claim 2, is characterized in that, the shape of described container is circular, oval or N limit shape, wherein N=3-100.

5. a townhouse packing device, is formed by connecting by the packing device described in claim 1-4, and the number of connection is 2-100.