CN103318551A - System for packaging and delivering freeze-dried excipient and preparation method of freeze-dried excipient - Google Patents

System for packaging and delivering freeze-dried excipient and preparation method of freeze-dried excipient Download PDF

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CN103318551A
CN103318551A CN2013102510593A CN201310251059A CN103318551A CN 103318551 A CN103318551 A CN 103318551A CN 2013102510593 A CN2013102510593 A CN 2013102510593A CN 201310251059 A CN201310251059 A CN 201310251059A CN 103318551 A CN103318551 A CN 103318551A
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freeze
preparation
packing
drying excipient
chamber
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李和伟
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Priority to PCT/CN2014/075364 priority patent/WO2014206137A1/en
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3255Containers provided with a piston or a movable bottom, and permitting admixture within the container

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Abstract

The invention provides a system for packaging and delivering a freeze-dried excipient. The system comprises the freeze-dried excipient, a solvent and a device for packaging and delivering the freeze-dried excipient and the solvent and is characterized in that the packaging and delivering device is a double-cavity blender, and the solvent and the freeze-dried excipient are stored in different cavities of the double-cavity blender respectively and can be blended and guided out instantly when in use through mutual action of parts of the double-cavity blender. The system for packaging and delivering the freeze-dried excipient has the advantages that stability of active ingredients is protected, using effect is improved, potential side effect is reduced, shelf life is prolonged, and single dose packaging, portability, pollution avoiding, convenience in use, cost reduction and the like are realized.

Description

A kind of packing of freeze-drying excipient preparation and delivery system and preparation method thereof
Technical field
The present invention relates to a kind of packing of freeze-drying excipient preparation and delivery system and preparation method thereof, a kind of freeze-drying excipient preparation that is applied to food, health food, oral drug, topical drug and cosmetics particularly, itself and solvent are preserved respectively, are joined when using the two-chamber blender of usefulness and pack and delivery system in same packing, with and corresponding preparation method.
Background technology
Freeze-drying excipient preparation is a kind of preparation form of utilizing freeze-drying excipient technology preparation, and it is by being filled in the forming mould and cryodesiccated technological process moulding forms.Because such preparation adopts freeze drying process; can protect thermally sensitive composition not to be destroyed; preparation itself produces a large amount of micropores and duct simultaneously; make disintegration and dissolving that it can be very fast; therefore be subject to being widely used, be applied in medicine, food, health food and the cosmetic fields such as oral disnitegration tablet, fast-release tablet, chewable tablets, special cosmetics.
Because the technological process of freeze-drying excipient preparation produces the characteristic in a large amount of micropores and duct, make freeze-drying excipient preparation all have not high, the easy friability of preparation intensity and the defective such as the moisture absorption very easily.Therefore the selected packing device of preparation of freeze-drying excipient technology preparation mostly is greatly two aluminium packings, to guarantee its damp proof insulation, oxygen barrier etc.But two aluminium packings often itself do not have good supportive, need to have the auxiliary package enhancing of certain degree of hardness to the protectiveness of preparation by other; It is all comparatively loaded down with trivial details when opening with use, for the experience sense that its product uses is brought certain influence.And two aluminium packings need to open its packing in use, with can use after its solvent mixes, in mixed process, the process more complicated of opening packing, mixing and mixed liquor is derived, and easily sneak into bacterium etc. and cause secondary pollution after packing is opened.
Traditional pre-fill type dual chamber syringe is mainly used in injecting use, for fear of produce and use procedure in germ and other pollution, in hundred grades of clean areas, finish packaging process after must in syringe, finishing the original position freeze-drying, greatly improved productive costs; Simultaneously; because it is main freeze drying protectant system that traditional lyophilisation is based on small molecular sugar class, sugar alcohol and amino acid; its freeze-dried powder form is very responsive to physical mechanical power; if do not use the original position freeze-drying; be very easy to broken; cause the inaccurate of dosage, freeze-dried powder fragment broken or that come off also can bring very large problem to assembling and the use of pre-fill type dual chamber syringe simultaneously.
Therefore, the contriver dedicates itself to innovation, in order to solve packing and the occupation mode of freeze-drying excipient preparation, packing and the occupation mode of while in order to open up non-injecting type lyophilized formulations, a large amount of deep researchs and experimental work have been carried out, thereby finished the present invention, provide that a kind of non-injection is used, can namely join in use namely with, freeze-drying excipient preparation and in same the packing, separate preservation with its solvent, directly mix the packing of the freeze-drying excipient preparation of deriving and preparation, the assembly method of delivery system and corresponding freeze-drying excipient preparation thereof during use, finished thus the present invention.
Summary of the invention
Packing and the delivery system of a kind of freeze-drying excipient preparation provided by the present invention, comprise freeze-drying excipient preparation, solvent and packing and send packing and the delivery apparatus of described freeze-drying excipient preparation and solvent, it is characterized in that described packing and delivery apparatus are the two-chamber blender, wherein solvent and freeze-drying excipient preparation are stored in respectively in the different cavitys of two-chamber blender, and the interaction by each parts of two-chamber blender can mix and derive solvent and freeze-drying excipient preparation in use immediately.
Employed freeze-drying excipient preparation in the packing of freeze-drying excipient preparation provided by the present invention and the delivery system, it mainly is comprised of functional component and adhesive agent, and adhesive agent: functional component=1: 10 to 10: 1.
Described adhesive agent is edible, can does used for cosmetic or pharmaceutically useful a kind of water-soluble high-molecular material, can be polysaccharide, polypeptide, protein, also may be artificial polymerization macromolecule, or through natural macromolecular material or its compound of modification.Adhesive agent commonly used includes but not limited to, gelatin class (gelatin, gelatin hydrolysate etc.), cellulose ethers (carboxymethyl cellulose, HEMC etc.), modified starch series (pulullan, hydroxypropul starch etc.), PVP, PVA, hyalomitome acids, albumin, shitosan and different molecular weight product or their combination etc.
Described functional component can be water-soluble also can be water-fast material, can for chemicals, bio-pharmaceutical, Chinese medical extract, vitamin, mineral matter, cosmetic beneficiating ingredient and other in human body beneficial's the active component one or more; Can be selected from the composite of following one or more compositions:
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, for example Sumatriptan succinate;
Antalgesic, such as rotundin, buprenorphine, pentazocine, naloxone etc.;
Anti-parkinson and treatment senile dementia medicine, for example 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.;
Anti-epileptic disease and anticonvulsive drug, such as dilantin sodium, carbamazepine, Primidone, Gabapentin, Lamotrigine, sodium vedproate, Clonazepam etc.Hypnotic sedative agent, such as ground two dissolve, nitrazepam, difficult to understand husky two dissolves, Lorazepam, phenobarbital etc.;
Cholinesterase inhibitor is such as hyoscine etc.;
Antiarrhymic, such as the third pyridine, tocainide, U.S. two rules, 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.;
The adrenoreceptor blocking agent, such as acebutolol, alprenolol etc.;
The corticosteroid medicine, such as betamethasone, cortisone acetate etc.;
Antidiabetic is such as Repaglinide etc.;
Antithyroid drug, such as propylthiouracil (PTU), Carbimazole, methimazole etc.;
Antithistamine, such as Cetirizine Hydrochloride, Loratadine etc.;
From the body active substance, such as dinoprostone, Alprostadil, Betahistine etc.;
The digestive system medication, such as scopolamine butylbromide, Granisetron Hydrochloride etc.;
The hematological system medicine, such as EPO, cobamamide etc.;
The urinary system medicine, such as azosemide, frusemide etc.;
The 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:
The Effective Component of Chinese Medicine monomer, as: Breviscapinun, qinghaosu 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, Breviscapinun, notoginseng triol-saponin, Glabrous Sarcandra Herb medicinal extract, arasaponin, capillary extract, extractum rhei, andrographolide, hawthorne leaf P.E, asiaticoside etc.;
Natural plant extracts: such as aloe extract, yam extract, Bilberry fruit P.E, Bitter Melon P.E, green-tea extract, fucoidin, glabridin, Paeoniflorin etc.;
Bioactive ingredients: EGF, bFGF, aFGF, KGF, IGF, PDGF, VEGF, placenta hydrolyzate, milk extract etc.
Cosmetic beneficiating ingredient: collagen, hyaluronic acid, sodium alginate, aloe extract, general ginsenoside, arasaponin, Chinese rhubarb extract, bamboo lotus water Bulbus Lilii extract, peony extract, EGF, bFGF, aFGF, KGF, IGF, PDGF, VEGF, the placenta hydrolyzate, the milk extract, various surfactants, algae extract, various vitamins, various beneficial mineral matter, SOD, metallothionein, other raw materials see " international cosmetic raw material standard Chinese catalogue (version in 2010) "
Described freeze-drying excipient preparation, it mainly is comprised of functional component, adhesive agent, and can add or not add skeleton supporting agent and other auxiliary material (such as thickening supensoid agent, antioxidant, flavouring and essence, skin penetration enhancer, pH adjusting agent etc.) according to the preparation process needs.
Described skeleton supporting agent comprises the materials such as the amino acid (such as amino acetic acid, alanine, glutamic acid etc.) that is not limited to sugar (such as maltose, trehalose etc.), sugar alcohol (such as sweet mellow wine, sorbierite), 2-12 carbon atom and inorganic salts (such as sodium phosphate, aluminium silicate etc.).
Described other auxiliary material is including but not limited to thickening supensoid agent, antioxidant, flavouring and essence, skin penetration enhancer, pH adjusting agent etc.; Wherein the thickening supensoid agent can be selected from combination of any or they in the natural origin glue classes such as dextran, Arabic gum, xanthans, carragheen, pectin, konjac glucomannan, agar, carbomer, carrageenan and synthetic macromolecular compound and other polypeptide or the polysaccharide etc.; Described antioxidant includes but not limited to one or several the compound 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 the essence such as mint flavored, chocolate flavoured, vanilla flavored, caf, tea flavour, corn flavor, lemon, milk flavor or above one or more fragrance; Described skin penetration enhancer include but not limited to lecithin, saponin(e, bay alkyd, any or several the compound in the azone, tween, sapn; Described pH adjusting agent includes but not limited to any in citric acid, tartaric acid, carbonate, natrium carbonate, the phosphate or several compound.
Employed packing and delivery apparatus for packing and send described freeze-drying excipient preparation and solvent is any device that can realize the object of the invention in the packing of freeze-drying excipient preparation provided by the present invention and the delivery system, is preferably a kind of two-chamber blender.
Described two-chamber blender comprises that two cavitys (3,6), two pistons (5,7), a bypass (4), a push rod press hand (10), a discharger (2), discharging lid (1) six part.
Described two cavitys are solid pharmaceutical preparation chamber 3 and liquid preparation chamber 6; Solid pharmaceutical preparation chamber 3 is the cavity near the discharger part, and liquid preparation chamber 6 is the cavity away from the discharger part; Two parts that it can be separated into by piston for single whole cavity, also can be linked together by two individual cavity and form, its connection mode comprises the modes such as bonding (welding), non-shape sealed (bonding) or shape sealed (inserting sealed), and its connection mode depends on global shape, material and function needs.
Freeze-drying excipient preparation 9 in the solid pharmaceutical preparation chamber 3 can be the freeze-drying excipient preparation of various prescriptions, form, for carry out being distributed into after the freeze-drying preparation in the solid pharmaceutical preparation chamber 3 in forming mould; Solvent 8 in the liquid preparation chamber 6 can be water, the nutrient solution with certain functional component, Essence and the various solvents that can directly be used in conjunction with the freeze-drying excipient.
A described bypass 4 is positioned at side, solid pharmaceutical preparation chamber, and its width is slightly larger than the thickness of piston 5, mixes with freeze-drying excipient preparation 9 in the solid pharmaceutical preparation chamber 3 thereby can make solvent in the cavity 6 form opening during to bypass 4 place by piston movement.
A described push rod is pressed hand 10, for exerting pressure to cavity so that the device of piston movement.
A described discharger 2 is any form discharging opening of non-injection needle form, such as suction pipe shape, dropper shape, ball shape, the first-class form of spraying.
Described discharging lid 1 is the device of salable discharger mouth, makes material and external environment isolation in the cavity.
The invention still further relates to the preparation method of above-mentioned freeze-drying excipient preparation.
The preparation of described freeze-drying excipient preparation be in forming mould after the freeze-drying demoulding and being fitted in the solid pharmaceutical preparation cavity in the two-chamber blender pack.The preparation method comprises
(a) functional component, adhesive agent and other auxiliary material are mixed with solution, emulsion or suspending fluid injection molding; Or with solid functional component injection molding, add again adhesive agent and other auxiliary material wiring solution-forming, emulsion or suspending fluid;
(b) solution that (a) is obtained or suspending fluid carry out degassed in quantitative forming mould;
(c) (b) obtained degassed after solution, emulsion or suspending fluid or solution emulsion or the suspending fluid, freezing at low temperatures that directly (a) is obtained;
(d) preparation that (c) is obtained lyophilisation in quantitative forming mould, desolventizing obtain freeze-drying excipient preparation;
(e) the freeze-drying excipient preparation that (d) is obtained is detached into mould and pack into packing device or its forming mould are exactly one of them cavity, directly assembles with this.
Wherein the described injection molding volume of step (a) is 0.01-5.0ml; Wherein injection molding can adopt the liquid-transfering devices such as accurate quantification pipet, liquid-transfering gun, electronic liquor-transferring rifle, also can adopt plunger pump, gear type pump, peristaltic pump etc., and solution or the suspending fluid that configures injected quantitative forming mould; Wherein degas method can adopt centrifugal degassing method, vacuum degasification method and ultrasonic degas method etc.; The freezing mode that can adopt liquid nitrogen or liquid, dry ice spray refrigeration wherein, turbine expander refrigeration mode or cascade refrigeration mode, at-20 ℃--under 196 ℃ of temperature, rapidly with solution or the freezing solid that becomes of suspending fluid; Wherein the degree of vacuum of 0.01-20 millibar, temperature freeze-drying between-70 ℃ of-50 ℃ of scopes are adopted in freeze-drying.
Beneficial effect of the present invention is:
1. the stability of prolection composition: by this packing and delivery system, realized solid and liquid separately, high activity material stability is often bad, preserves with solid forms, its stability improves greatly, can improve result of use, reduce potential side reaction, Shelf-life;
2. unit dose package: compare with many measuring productses of routine, this packing and delivery system are unit dose packages,, its amount of liquid meets aircraft and carries requirement, is easy to carry;
3. avoid polluting: compare with the bottled freeze-dried powder form of traditional double with the two aluminium packings of traditional freeze-drying figuration, all assembling process of this packing and delivery system are finished in clean producing tract, do not have exposed component only to extrude from discharging opening, can not cause the microbial contamination in the process for preparation;
4. easy to use: compare with the two aluminium packings of traditional freeze-drying figuration, this packing and delivery system need not to open packing, put into the palm, add again liquid, the complicated occupation mode that cooperates with the both hands of finger mixing, only need one to push away, open two actions of discharging opening and can use, very convenient;
5. reduction cost: compare with freeze-dried powder, do not have complicated two Bottle and bottle cap system; Compare with the two aluminium packings of traditional freeze-drying figuration, do not have complicated support and structure design, the full automation packing significantly reduces production costs;
Description of drawings
Fig. 1 is packing and each exploded view of delivery apparatus (two-chamber blender) in the packing of freeze-drying excipient preparation and the delivery system;
Fig. 2-Fig. 4 is the packing of freeze-drying excipient preparation and the use step diagram of delivery system.
The specific embodiment
Further specify by the following examples the present invention, but the present invention is not restricted to this.
The bottom of the cavity of following examples indication refers to that cavity is away from the far-end of discharging opening; The top of bypass 4 refers to the end near discharging opening, and the below of bypass 4 refers to the other end away from discharging opening; The top of piston refers to piston near an end of discharging opening, and the bottom of piston refers to that piston is away from the other end of discharging opening.
Embodiment 1:
EGF stoste, rear adding gelatin, gelatin hydrolysate thaw, be mixed with and contain 5/100000ths EGF (weight ratio), contain 5% gelatin+gelatin hydrolysate solution, can enters 0.1 milliliter of forming mould, pack into after the freeze-drying moulding solid pharmaceutical preparation chamber 3 of two-chamber blender of glass material, then the piston 5 with quality of rubber materials is fitted into 3 bottoms, solid pharmaceutical preparation chamber, bypass 4 belows; Again 2 milliliters of 3% hyaluronic acid solutions are filled into the liquid preparation chamber 6 that the piston 5 of quality of rubber materials isolates; The piston 7 that adds afterwards quality of rubber materials makes that liquid is complete to be stored in the liquid preparation chamber 6, can not ooze out between the piston 7 of the piston 5 of quality of rubber materials and quality of rubber materials, namely obtains comprising the two-chamber blender packing device of lyophilized excipient and solvent.
The piston 7 of during use one push rod 10 being packed into promotes push rod 10 to the motion of liquid preparation chamber 6 directions, and liquid preparation chamber 6 interior fluid pressures drive pistons 5 and move to solid pharmaceutical preparation chamber 3 directions; When the motion of piston 5 bottoms surpasses bypass 4 below, liquid preparation chamber 6 interior liquid are under piston 7 pressure, directly get around piston 5 by bypass 4, enter solid pharmaceutical preparation chamber 3, mix with lyophilized excipient wherein, continue to promote forward push rod to piston 7 tops and contact with piston 5 bottoms, all liquid preparation chamber 6 interior 2 milliliter 3% hyaluronic acid solutions mix with lyophilized excipient fully, form the EGF, 0.25% gelatin+gelatin hydrolysate, the 3% hyaluronic solution that contain 2.5ppm; Open discharging lid 1, continue to promote push rod 10, drive piston 7 and press piston 5, aforesaid mixed solution is extruded from discharger 2, discharger 2 nose shapes are the ball form, can be applied to face by Direct Uniform in extrusion, become modern biological cosmetics.
Embodiment 2:
Vitamin C: Propiram=5: 1, mixed powder 50mg enters 0.4 milliliter of forming mould with the solid form can, then after remaining 10mg being dissolved with 0.4 ml water, can advances to contain the forming mould of powder, after the freeze-drying lyophilized excipient that obtains packed in the solid pharmaceutical preparation chamber 3 with the two-chamber blender of the plastic material of bypass 4, then the piston 5 of silica gel material is fitted into 3 bottoms, solid pharmaceutical preparation chamber, bypass 4 belows of plastic material.
2 milliliters of deionized waters are filled into the liquid preparation chamber 6 of the plastic material that the piston 7 of silica gel material isolates; Afterwards the solid pharmaceutical preparation chamber 3 of plastic material is inserted the liquid preparation chamber 6 of plastic materials, and with super sonic with two cavity weldings together, namely obtain comprising the two-chamber blender packing device of the plastic material of lyophilized excipient.
The piston 7 of during use one push rod 10 being packed into promotes push rod 10 to the motion of liquid preparation chamber 6 directions, and liquid preparation chamber 6 interior fluid pressures drive pistons 5 and move to solid pharmaceutical preparation chamber 3 directions; When the motion of piston 5 bottoms surpasses bypass 4 below, liquid preparation chamber 6 interior liquid are under piston 7 pressure, directly get around piston 5 by bypass 4, enter solid pharmaceutical preparation chamber 3, mix with lyophilized excipient wherein, continue to promote forward push rod to piston 7 tops and contact with piston 5 bottoms, all 2 ml deionized water are mixed with lyophilized excipient fully in the liquid preparation chamber 6, form and contain 2.5% ascorbic solution; Open discharging lid 1, continue to promote push rod 10, drive piston 7 and press piston 5, aforesaid mixed solution is extruded from discharger 2, directly be applied to face, become modern cosmetics.
Embodiment 3:
Cordyceps: collagen=1 gram: 5 grams, be mixed with suspension solution, perfusion enters 5 milliliters of forming moulds, after the freeze-drying lyophilized excipient that obtains packed in the solid pharmaceutical preparation chamber 3 with the two-chamber blender of the clad aluminum material of bypass 4, then the piston 5 of butyl rubber material is fitted into the clad aluminum material 3 bottoms, solid pharmaceutical preparation chamber, bypass 4 belows.
10 milliliters of the deionized waters that will contain natural essence are filled into the liquid preparation chamber 6 of the clad aluminum material that the piston 7 of butyl rubber material isolates; Afterwards the solid pharmaceutical preparation chamber 3 of clad aluminum material is inserted the liquid preparation chamber 6 of clad aluminum materials, and with high temperature with two cavity weldings together, namely obtain comprising the two-chamber blender packing device of the clad aluminum material of lyophilized excipient.
The piston 7 of during use one push rod 10 being packed into promotes push rod 10 to the motion of liquid preparation chamber 6 directions, and liquid preparation chamber 6 interior fluid pressures drive pistons 5 and move to solid pharmaceutical preparation chamber 3 directions; When the motion of piston 5 bottoms surpasses bypass 4 below, liquid preparation chamber 6 interior liquid are under piston 7 pressure, directly get around piston 5 by bypass 4, enter solid pharmaceutical preparation chamber 3, mix with lyophilized excipient wherein, continue to promote forward push rod to piston 7 tops and contact with piston 5 bottoms, all 10 ml deionized water are mixed with lyophilized excipient fully in the liquid preparation chamber 6, form the solution that contains Cordyceps and collagen; Open discharging lid 1, continue to promote push rod 10, drive piston 7 and press piston 5, aforesaid mixed solution is extruded from discharger 2, directly oral, become health food.
Embodiment 4:
Arasaponin: PVP=30mg: 15mg, be mixed with solution, be filled into the 0.3ml forming mould, the solid pharmaceutical preparation chamber 3 of the two-chamber blender of the clad aluminum of packing into after freeze-drying material, then the piston 5 with the silica gel material is fitted into 3 bottoms, solid pharmaceutical preparation chamber, bypass 4 belows; Again 1 milliliter of the deionized water of natural essence is filled into the liquid preparation chamber 6 that the piston 5 of silica gel material isolates; The piston 7 that adds afterwards the silica gel material makes that liquid is complete to be stored in the liquid preparation chamber 6, can not ooze out between the piston 7 of the piston 5 of silica gel material and silica gel material, namely obtains comprising the two-chamber blender packing device of lyophilized excipient.
The piston 7 of during use one push rod 10 being packed into promotes push rod 10 to the motion of liquid preparation chamber 6 directions, and liquid preparation chamber 6 interior fluid pressures drive pistons 5 and move to solid pharmaceutical preparation chamber 3 directions; When the motion of piston 5 bottoms surpasses bypass 4 below, liquid preparation chamber 6 interior liquid are under piston 7 pressure, directly get around piston 5 by bypass 4, enter solid pharmaceutical preparation chamber 3, mix with lyophilized excipient wherein, continue to promote forward push rod to piston 7 tops and contact with piston 5 bottoms, all 1 ml deionized water is mixed with lyophilized excipient fully in the liquid preparation chamber 6, forms the solution that contains 3% arasaponin; Open discharging lid 1, continue to promote push rod 10, drive piston 7 and press piston 5, aforesaid mixed solution is oral by discharging gate 2, form health food.
Embodiment 5:
Bilberry fruit P.E: Propiram=100mg: 15mg, be mixed with solution, perfusion enters 0.5 milliliter of forming mould, the solid pharmaceutical preparation chamber 3 of the two-chamber blender of the plastic material of packing into after the freeze-drying, and then the piston 5 with the silica gel material is fitted into 3 bottoms, solid pharmaceutical preparation chamber, bypass 4 belows; 20 ml deionized water that will contain again natural colouring matter are filled into the liquid preparation chamber 6 that the piston 5 of silica gel material isolates; The piston 7 that adds afterwards the silica gel material be connected with push rod 10 makes that liquid is complete to be stored in the liquid preparation chamber 6, can not ooze out between the piston 7 of the piston 5 of silica gel material and silica gel material, namely obtains comprising the two-chamber blender packing device of lyophilized excipient.
Promote push rod 10 during use to the motion of liquid preparation chamber 6 directions, liquid preparation chamber 6 interior fluid pressures drive piston 5 and move to solid pharmaceutical preparation chamber 3 directions; When the motion of piston 5 bottoms surpasses bypass 4 below, liquid preparation chamber 6 interior liquid are under piston 7 pressure, directly get around piston 5 by bypass 4, enter solid pharmaceutical preparation chamber 3, mix with lyophilized excipient wherein, continue to promote forward push rod to piston 7 tops and contact with piston 5 bottoms, all liquid preparation chamber 6 interior 20 milliliters of deionized waters that contain natural colouring matter are mixed with lyophilized excipient fully, form the solution that contains 0.5% Bilberry fruit P.E; Open discharging lid 1, continue to promote push rod 10, drive piston 7 and press piston 5, aforesaid mixed solution is oral from discharging gate 2, form solid beverage food.
Packaging structure of the present invention is not limited to form cited among the embodiment, and embodiment only is preferred embodiment of the present invention, can not limit protection domain with this.All with the described simple or equivalent variation of claim scope of the present invention and modification, all belong to protection scope of the present invention.

Claims (10)

1. packing and the delivery system of a freeze-drying excipient preparation, comprise freeze-drying excipient preparation, solvent and packing and send packing and the delivery apparatus of described freeze-drying excipient preparation and solvent, it is characterized in that described packing and delivery apparatus are the two-chamber blender, wherein solvent and freeze-drying excipient preparation are stored in respectively in the different cavitys of two-chamber blender, and the interaction by each parts of two-chamber blender can mix and derive solvent and freeze-drying excipient preparation in use immediately.
2. packing and the delivery system of freeze-drying excipient preparation as claimed in claim 1 is characterized in that described freeze-drying excipient preparation contains functional component and adhesive agent, and adhesive agent: functional component=1: 10 to 10: 1.
3. packing and the delivery system of freeze-drying excipient preparation as claimed in claim 2 is characterized in that described adhesive agent is edible, can does used for cosmetic or pharmaceutically useful a kind of water-soluble high-molecular material.
4. packing and the delivery system of freeze-drying excipient preparation as claimed in claim 2 is characterized in that described functional component is chemicals, bio-pharmaceutical, Chinese medical extract, vitamin, mineral matter, cosmetic beneficiating ingredient and other in human body beneficial's the active component one or more.
5. such as packing and the delivery system of the described freeze-drying excipient of claim 2-4 any one preparation, it is characterized in that described freeze-drying excipient preparation also contains a kind of in skeleton supporting agent, thickening supensoid agent, antioxidant, flavouring and essence, skin penetration enhancer, the pH adjusting agent or more than one.
6. packing and the delivery system of freeze-drying excipient preparation as claimed in claim 1 is characterized in that described two-chamber blender comprises that two cavitys (3,6), two pistons (5,7), a bypass (4), a push rod press hand (10), a discharger (2), discharging lid (1) 6 part.
7. packing and the delivery system of freeze-drying excipient preparation as claimed in claim 6 is characterized in that described two cavitys are solid pharmaceutical preparation chamber (3) and liquid preparation chamber (6); Solid pharmaceutical preparation chamber (3) is the cavity near discharger (2) part, and liquid preparation chamber (6) are the cavity away from discharger (2) part; Two parts that solid pharmaceutical preparation chamber (3) and liquid preparation chamber (6) are separated into by piston for single whole cavity, or linked together by two individual cavity and to form.
8. packing and the delivery system of a kind of freeze-drying excipient preparation as claimed in claim 7 is characterized in that freeze-drying excipient preparation (9) is arranged in solid pharmaceutical preparation chamber (3); Solvent (8) is arranged in liquid preparation chamber (6); Other various solvents that solvent (8) is selected from water, have the nutrient solution of certain functional component or Essence and can directly be used in conjunction with the freeze-drying excipient.
9. such as packing and the delivery system of the described freeze-drying excipient of claim 6-8 any one preparation, it is characterized in that described bypass (4) is positioned at side, solid pharmaceutical preparation chamber, mix with freeze-drying excipient preparation thereby can make solvent in the cavity form opening by piston movement during to bypass place; Described push rod by hand (10) for to exert pressure so that the device of piston movement to cavity; Described discharger (2) is the discharging opening of any form of non-injection needle form; Described discharging lid (1) is the device of salable discharger (2) mouth, makes material and external environment isolation in the cavity.
10. such as the packing of the described freeze-drying excipient of claim 1-9 any one preparation and the preparation method of delivery system, it is characterized in that may further comprise the steps:
(a) functional component, adhesive agent and other auxiliary material are mixed with solution, emulsion or suspending fluid injection molding; Or with solid functional component injection molding, add again adhesive agent and other auxiliary material wiring solution-forming, emulsion or suspending fluid;
(b) solution that (a) is obtained or suspending fluid carry out degassed in quantitative forming mould;
(c) (b) obtained degassed after solution, emulsion or suspending fluid or solution emulsion or the suspending fluid, freezing at low temperatures that directly (a) is obtained;
(d) preparation that (c) is obtained lyophilisation in quantitative forming mould, desolventizing obtain freeze-drying excipient preparation;
(e) the freeze-drying excipient preparation that (d) is obtained is detached into mould and pack into packing device or its forming mould are exactly one of them cavity, directly assembles with this.
CN2013102510593A 2013-06-24 2013-06-24 System for packaging and delivering freeze-dried excipient and preparation method of freeze-dried excipient Pending CN103318551A (en)

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WO2014206137A1 (en) * 2013-06-24 2014-12-31 Li Hewei Packing and delivery system for freeze-dried excipient and method of preparing freeze-dried excipient
WO2015032319A1 (en) * 2013-09-04 2015-03-12 Li Hewei Lyophilized excipient formulation packaging and delivery system and preparation method
CN104648834A (en) * 2013-11-21 2015-05-27 李和伟 Protecting device of freeze-drying excipient containing skeleton support agent and binder and preparation method thereof
CN104644571A (en) * 2013-11-21 2015-05-27 李和伟 Protecting device and preparation method of freeze-dried excipient
CN104644568A (en) * 2013-11-21 2015-05-27 李和伟 Protective apparatus and preparation method of freeze-dried excipient preparation containing active components and binding agent
CN104803082A (en) * 2014-01-24 2015-07-29 李和伟 Novel three-chamber facial mask packing bag including freeze-drying endowed preparation and preparation method thereof
CN105883218A (en) * 2014-10-29 2016-08-24 李和伟 Solid-liquid separation prepared-immediate-used packing device and preparation method thereof
CN105923413A (en) * 2016-05-31 2016-09-07 湖州华尔泰服饰制造有限公司 Raw material proportioning barrel device
CN108689011A (en) * 2017-04-07 2018-10-23 贺利氏医疗有限公司 Equipment and associated method for storing, mixing and distribute bone cement
CN108945827A (en) * 2017-05-17 2018-12-07 贺利氏医疗有限公司 There is the bone cement applicator of hollow cylinder beyond the Great Wall in transport column
CN109080990A (en) * 2017-06-14 2018-12-25 贺利氏医疗有限公司 Bone cement applicator with duct element and closure member bracket
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WO2014206137A1 (en) * 2013-06-24 2014-12-31 Li Hewei Packing and delivery system for freeze-dried excipient and method of preparing freeze-dried excipient
WO2015032319A1 (en) * 2013-09-04 2015-03-12 Li Hewei Lyophilized excipient formulation packaging and delivery system and preparation method
CN104417918A (en) * 2013-09-04 2015-03-18 李和伟 Freeze-drying excipient packing and transferring system and production method thereof
CN104648834A (en) * 2013-11-21 2015-05-27 李和伟 Protecting device of freeze-drying excipient containing skeleton support agent and binder and preparation method thereof
CN104644571A (en) * 2013-11-21 2015-05-27 李和伟 Protecting device and preparation method of freeze-dried excipient
CN104644568A (en) * 2013-11-21 2015-05-27 李和伟 Protective apparatus and preparation method of freeze-dried excipient preparation containing active components and binding agent
WO2015074587A1 (en) * 2013-11-21 2015-05-28 李和伟 Protective device for freeze-dried excipient preparation containing binder and preparation methods therefor
CN104803082A (en) * 2014-01-24 2015-07-29 李和伟 Novel three-chamber facial mask packing bag including freeze-drying endowed preparation and preparation method thereof
CN105883218A (en) * 2014-10-29 2016-08-24 李和伟 Solid-liquid separation prepared-immediate-used packing device and preparation method thereof
CN105923413A (en) * 2016-05-31 2016-09-07 湖州华尔泰服饰制造有限公司 Raw material proportioning barrel device
CN108689011A (en) * 2017-04-07 2018-10-23 贺利氏医疗有限公司 Equipment and associated method for storing, mixing and distribute bone cement
CN108689011B (en) * 2017-04-07 2020-04-03 贺利氏医疗有限公司 Apparatus for storing, mixing and dispensing bone cement and related methods
CN108945827A (en) * 2017-05-17 2018-12-07 贺利氏医疗有限公司 There is the bone cement applicator of hollow cylinder beyond the Great Wall in transport column
US10987147B2 (en) 2017-05-17 2021-04-27 Heraeus Medical Gmbh Bone cement applicator with hollow cylinder on delivery plunger
CN109080990A (en) * 2017-06-14 2018-12-25 贺利氏医疗有限公司 Bone cement applicator with duct element and closure member bracket
US10765463B2 (en) 2017-06-14 2020-09-08 Heraeus Medical Gmbh Bone cement applicator with pipe line element and closure receptacle
CN112770982A (en) * 2018-06-08 2021-05-07 德克索斯饮料有限公司 Dispenser

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