CN104443822A - Freeze-dried excipient and matched solvent packaging double-cavity bag - Google Patents
Freeze-dried excipient and matched solvent packaging double-cavity bag Download PDFInfo
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- CN104443822A CN104443822A CN201310432717.9A CN201310432717A CN104443822A CN 104443822 A CN104443822 A CN 104443822A CN 201310432717 A CN201310432717 A CN 201310432717A CN 104443822 A CN104443822 A CN 104443822A
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Abstract
The invention relates to a freeze-dried excipient and a matched solvent packaging double-cavity bag, in particular to a double-cavity bag which enables a freeze-dried excipient applied to foods or health foods or oral drugs or topical drugs or cosmetics and a solvent to be independently stored and used in the same package and prepared to be readily available. The packaging double-cavity bag for the freeze-dried excipient has the advantages of protecting the stability of active ingredients, achieving single-dose packaging, being convenient to carry and use, avoiding contamination, lowering the cost and the like.
Description
Technical field
The Double-cavity bag that the present invention relates to a kind of freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag, be particularly a kind ofly applied to itself and solvent being preserved respectively in same packaging of the freeze-drying excipient preparation of food, health food, oral drug, topical drug and cosmetics, join when using.
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, effectively nutritional labeling, readily oxidizable substance can be protected not to be destroyed; can save and not degenerate for a long time; add water or can dissolve rapidly after solvent and recover original proterties; therefore receive and widely use, be widely applied in medicine, food, health food and the cosmetic fields such as oral disnitegration tablet, fast-release tablet, chewable tablets, special cosmetics.
Packing device selected by preparation prepared by current freeze-drying excipient technology is mostly two aluminium packaging, moisture barrier to ensure its oxygen barrier, but can use after also needing when using mix with water or solvent, and operation is very inconvenient and easily cause secondary pollution in mixed process.
Traditional pre-fill type dual chamber syringe is mainly used in injecting use, and design complicated production cost is high; Simultaneously; be main freeze drying protectant system based on Small molecular carbohydrate, sugar alcohol and amino acid due to traditional lyophilisation; its freeze-dried powder form is very responsive to physical mechanical power; if do not use original position freeze-drying; be very easy to broken; cause the inaccurate of dosage, freeze-dried powder fragment that is broken or that come off also can bring very large problem to the assembling of pre-fill type dual chamber syringe and use simultaneously.The co-extrusion infusion also having a class medical packaging field conventional two rooms bag, adopt the two rooms design of bag altogether, two interventricular septum often adopts " can break a seal bar ", " in thinner every ", " segmentation weld seam can be pulled open ", the technology such as " rosin joint ", these technology or design complicated production cost is high, weld seam very easily ftractures not resistance to certain pressure, and situation about opening two Room easily occurs in transport and lay up period.
Therefore, contriver dedicates itself to innovation, in order to simplify packaging and the occupation mode of freeze-drying excipient preparation and matching dissolvent thereof, a large amount of deep research and experimental work are carried out, thus complete the present invention, provide one namely to join in use namely to separate in same packaging with its solvent with, freeze-drying excipient preparation and preserve, directly mix the Double-cavity bag of derivation during use, this completes the present invention.
Summary of the invention
The invention provides a kind of freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag.
The freeze-drying excipient preparation used in freeze-drying excipient preparation provided by the present invention and matching dissolvent packaging Double-cavity bag, it is primarily of functional component and adhesive agent composition, 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 synthetic polymeric's Polymer, or through the natural macromolecular material of modification or its compound.Conventional adhesive agent 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 thereof or their combination etc.
Described functional component can be water-soluble also can be water-fast material, can be chemicals, bio-pharmaceutical, Chinese medical extract, vitamin, mineral matter, cosmetic beneficiating ingredient and other is to one or more in the useful active component of human body; The composite of one or more compositions following can be selected from:
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 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: 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, placenta hydrolyzate, milk extract, various surfactants, algae extract, various vitamin, 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 primarily of functional component, adhesive agent composition, and needs to add or not add skeleton supporting agent and other auxiliary material (as thickening supensoid 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.
Other described auxiliary material is including but not limited to thickening supensoid agent, antioxidant, flavouring and essence, skin penetration enhancer, pH adjusting agent etc.; Wherein thickening supensoid agent can be selected from the combination etc. of any one 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 polysaccharide; 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 vanilla flavored, caf, tea flavour, corn taste, lemon, milk flavor or more one or more fragrance; Described skin penetration enhancer include but not limited to lecithin, saponin(e, bay alkyd, the compound of any one or several in 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.
Freeze-drying excipient preparation provided by the present invention and matching dissolvent packaging Double-cavity bag are formed by specific aluminum-plastic composite membrane hot pressing, and it is higher that this specific aluminum-plastic composite membrane has heat-seal temperature, the characteristic that sealing strength is higher.Described material basic structure is internal layer and skin is two plastic layers, and middle one deck is aluminium lamination.
Wherein aluminium lamination (forming the interlayer of said vesse) thickness is 5-500 micron, preferred 5-100 micron, 10-100 micron, 12-200 micron, 30-150 micron, 50-200 micron, 80-300 micron, 100-500 micron, most preferably 10-60 micron.The aluminium used in the present invention can be fine aluminium film or metallized film etc.
Plastic layer (forming internal layer and the skin of the said vesse) thickness of this aluminium plastic composite material is 5-500 micron, preferred 5-100 micron, 10-100 micron, 15-100 micron, 15-200 micron, 20-200 micron, 30-150 micron, 50-200 micron, 80-300 micron, 100-500 micron, most preferably 15-200 micron.The plastics used in the present invention can be polyvinylchloride, polyethylene, polyethylene terephthalate, polypropylene, or based on the coextrusion plastic material etc. of polyethylene, polypropylene.
Described specific material can manufacture acquisition voluntarily.During manufacture, structure is the basic structure of plastic layer-aluminium lamination-plastic layer, and wherein the plastic layer of both sides can be certain plastic sheeting or the multilayer composite plastic Film laminated of selecting individual layer.Manufacture the mode of aluminium plastic composite material be on aluminium lamination coat plastics coextrusion material or be coated with glue on aluminium lamination after bond plastic material form.
Described freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag by bag open end (10), bag tail end (7) and in three road heat seal sealing lips every (11) form two cavitys: solid pharmaceutical preparation chamber and liquid preparation chamber; Wherein any one cavity can as solid pharmaceutical preparation chamber, and another one cavity can as liquid preparation chamber.Encapsulate freeze-drying excipient preparation in described solid pharmaceutical preparation chamber, in described liquid preparation chamber, encapsulate the matching dissolvent of freeze-drying excipient preparation.
Described freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag, freeze-drying excipient preparation (14) in its solid pharmaceutical preparation chamber can be the freeze-drying excipient preparation of various formula, form, for being distributed into the preparation in solid pharmaceutical preparation chamber after carry out freeze-drying in forming mould; Solvent (13) in its liquid preparation chamber can for water, the nutrient solution with certain functional component, Essence and can with freeze-drying excipient directly with the use of various solvents.
Described freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag, its open end (10), bag tail end (7) and in three road heat seal process every (11) only temperature and pressure is slightly distinguished, but all reach the minimum temperature 80-200 DEG C ensureing its leak tightness; Therefore Double-cavity bag provided by the present invention can ensure transport in storage process be subject to certain external force time in can not the damaged and situation that causes two room through every (11); Utilize the characteristic of particular plastic or aluminum-plastic composite membrane simultaneously, every the temperature 20-50 DEG C of the temperature of (11) heat seal lower than open end (10) and tail end (7) heat seal in during heat seal, therefore in every the sealing strength of (11) a little less than open end (10) and tail end (7), when applying larger pressure in liquid preparation chamber, due to tail end (7) sealing-strength be greater than in every the sealing-strength of (11), the freeze-drying excipient preparation during solvent is forced to break through in (11) with solid pharmaceutical preparation chamber is mixed to form mixed solution (15).
Described freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag, have otch (8) in the both sides near open end (10), tears open end sealing, thus extruded from bag by mixed solution (15) to facilitate.
Beneficial effect of the present invention is:
1, the stability of prolection composition: by this Double-cavity bag package design, achieve solid and liquid separately, high active substance 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: compared with many measuring productses of routine, this Double-cavity bag packaging is unit dose package, and its amount of liquid meets aircraft and carries with requirement, is easy to carry;
3, avoid polluting: pack compared with matching dissolvent uses with traditional two aluminium, this Double-cavity bag package production completes in clear production district, and mixed preparing process is carried out in bag, can not cause secondary pollution during use;
4, easy to use: compared with packing with traditional two aluminium, this Double-cavity bag packaging, without the need to opening packaging, puts into the palm, add liquid again, the complicated occupation mode coordinated with the both hands pointing mixing, only needs squeezed fluid body preparation chamber, wait for several seconds, tearing open end can directly use, very convenient;
5, reduce costs: compare with co-extrusion infusion two rooms bag with traditional pre-fill type dual chamber syringe, there is no complicated design, full automation packaging can be realized, significantly reduce productive costs.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag;
Detailed description of the invention
Further illustrate the present invention by the following examples, but the present invention is not restricted to this.
(internal layer is the PP of 50um to adopt specific aluminum-plastic composite membrane, interlayer is the aluminium lamination of 20um, skin is the PP of 40um) as freeze-drying excipient preparation of the present invention and matching dissolvent packaging Double-cavity bag bag, the feature of this specific composite plastic film be nontoxic, high resistant wet, high resistant oxygen, elasticity are good, heat sealing strength raises and increasing etc. with temperature.Every (11) heat seal (heat-seal temperature 100 DEG C) during manufacturing process comprises, liquid flux is filling, bag tail end (7) heat seal (heat-seal temperature 160 DEG C), the packing of solid freeze-drying excipient preparation, open end (10) heat seal (heat-seal temperature 160 DEG C), the sequence of operations such as otch (8); Wherein every (11) heat-seal temperature lower than bag tail end (7) and open end (10) heat-seal temperature; Aforesaid operations all uses automatic equipment to complete in dust proof workshop, effectively prevents the pollution that manual operation causes, time saving and energy saving, cuts the waste.Pressure is applied in liquid preparation chamber during use, every (11) during solvent breaks through, after being mixed to form mixed solution (15) with the freeze-drying excipient preparation in solid pharmaceutical preparation chamber, tear open end from the otch (8) near open end (10), mixed solution (15) is extruded and can be used from bag.
Heat insulation conjunction intensity detection in above-mentioned freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag: get 10 bags, Double-cavity bag sample and place 48 hours under the condition of-30 DEG C ± 2 DEG C, and then place 48 hours under the condition of 50 DEG C ± 2 DEG C, place under 23 DEG C ± 2 DEG C conditions again after 24 hours, sample is lain between two flat boards, the pressure of 60Kpa can be born, remain intact without cracking every still in 10 minutes, when continuation increase external pressure reaches about 75Kpa, in heat insulation conjunction district cracking, two chambers are through, realize the mixed dissolution of freeze-drying excipient preparation and solvent, now Double-cavity bag two ends still stand intact.
Packaging structure of the present invention is not limited to form cited in embodiment, and embodiment is only preferred embodiment of the present invention, can not limit protection domain with this.All with the simple or equivalent change described in right of the present invention and modification, all belong to protection scope of the present invention.
Claims (15)
1. a freeze-drying excipient preparation and matching dissolvent packaging Double-cavity bag, it is characterized in that, described packaging Double-cavity bag by bag open end (10), bag tail end (7) and in three road heat seal sealing lips every (11) form two cavitys: solid pharmaceutical preparation chamber and liquid preparation chamber; Wherein any one cavity can as solid pharmaceutical preparation chamber, and another one cavity can as liquid preparation chamber.Encapsulate freeze-drying excipient preparation in described solid pharmaceutical preparation chamber, in described liquid preparation chamber, encapsulate the matching dissolvent of freeze-drying excipient preparation.
2. packaging Double-cavity bag according to claim 1, it is characterized in that, described packaging Double-cavity bag is formed by specific plastics or aluminum-plastic composite membrane hot pressing, and these special plastics or aluminum-plastic composite membrane have the change along with sealing temperatures and pressure, the characteristic that sealing strength can change.
3. packaging Double-cavity bag according to claim 2, is characterized in that, described packaging Double-cavity bag is formed by specific plastics or aluminum-plastic composite membrane hot pressing, and it is higher that these special plastics or aluminum-plastic composite membrane have heat-seal temperature, the characteristic that sealing strength is higher.
4. packaging Double-cavity bag according to claim 3, is characterized in that, described packaging Double-cavity bag is formed by specific aluminum-plastic composite membrane hot pressing, and it is higher that this special aluminum-plastic composite membrane has heat-seal temperature, the characteristic that sealing strength is higher.
5. packaging Double-cavity bag according to claim 3, is characterized in that, described packaging Double-cavity bag is formed by specific aluminum-plastic composite membrane hot pressing, this special its innermost layer of aluminum-plastic composite membrane for mutual involution, the material producing involution layer contains PP or PE.
6. the packaging Double-cavity bag according to claim 1-5, is characterized in that, encapsulates freeze-drying excipient preparation (13) in described solid pharmaceutical preparation chamber, encapsulates the matching dissolvent (14) of freeze-drying excipient preparation in described liquid preparation chamber.
7. the packaging Double-cavity bag according to claim 1-5, is characterized in that the freeze-drying excipient preparation in described solid pharmaceutical preparation chamber is the preparation be distributed into carry out freeze-drying in forming mould after in solid pharmaceutical preparation chamber.
8. packaging Double-cavity bag according to claim 6, it is characterized in that the matching dissolvent in described liquid preparation chamber is water, there is the nutrient solution of certain functional component, Essence or can with freeze-drying excipient preparation directly with the use of various solvents.
9. the packaging Double-cavity bag according to claim 1-8 any one, in described when it is characterized in that preparing described packaging Double-cavity bag every heat-seal temperature or heat seal pressure lower than the heat-seal temperature of open end and tail end or heat seal pressure, therefore this packaging Double-cavity bag reaches under the prerequisite ensureing the bag leak tightness before using, and can be reached through during external force extruding makes its pressure wash open the object being carried out by two lumenal contents every sealing layer mixing during use.
10. the packaging Double-cavity bag according to claim 1-9 any one, is characterized in that described freeze-drying excipient preparation is food, health food, medicine equipment, oral drug, topical drug or cosmetics.
11. packaging Double-cavity bags according to claim 1-10 any one, is characterized in that described packaging Double-cavity bag is provided with otch (8) in the one or both sides of (7) or (10) near two ends.
The packaging of 12. freeze-drying excipient preparations as claimed in claim 1 and delivery system, 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.
The packaging of 13. freeze-drying excipient preparations as claimed in claim 12 and delivery system, 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.
The packaging of 14. freeze-drying excipient preparations as claimed in claim 12 and delivery system, is characterized in that described functional component is chemicals, bio-pharmaceutical, Chinese medical extract, vitamin, mineral matter, cosmetic beneficiating ingredient and other is to one or more in the useful active component of human body.
The packaging of 15. freeze-drying excipient preparations as described in claim 12-14 any one and delivery system, is characterized in that described freeze-drying excipient preparation also containing the one or more than one in skeleton supporting agent, thickening supensoid agent, antioxidant, flavouring and essence, skin penetration enhancer, pH adjusting agent.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310432717.9A CN104443822A (en) | 2013-09-23 | 2013-09-23 | Freeze-dried excipient and matched solvent packaging double-cavity bag |
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| CN201310432717.9A CN104443822A (en) | 2013-09-23 | 2013-09-23 | Freeze-dried excipient and matched solvent packaging double-cavity bag |
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| CN104443822A true CN104443822A (en) | 2015-03-25 |
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| CN201310432717.9A Pending CN104443822A (en) | 2013-09-23 | 2013-09-23 | Freeze-dried excipient and matched solvent packaging double-cavity bag |
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| CN107303288A (en) * | 2016-04-15 | 2017-10-31 | 董玲 | A kind of production method of film and products thereof |
| US9931458B1 (en) | 2017-05-31 | 2018-04-03 | Adienne Pharma & Biotech Sa | Multi chamber flexible bag and methods of using same |
| US10507165B2 (en) | 2017-05-31 | 2019-12-17 | Adienne Pharma & Biotech Sa | Multi chamber flexible bag and methods of using same |
| CN115054574A (en) * | 2022-08-05 | 2022-09-16 | 北京中科利华医药研究院有限公司 | Paracetamol injection packed in double-chamber bag |
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Application publication date: 20150325 |