Summary of the invention
This utility model provides a kind of solid-liquid separation and namely joins packing device namely, and described packing device is made up of solid cabin (1), tank (2) two parts.
Solid cabin (1) is the nacelle being contained within solid formulation, and tank (2) is for be contained within can with the solvent of inclusions phased soln in solid cabin (1). Wherein solid cabin (1) and tank (2) can be designed to special shape further as required, make solid cabin nacelle (11) and tank nacelle (21) that special combination outward appearance can be presented upon connection, such as calabash, life shape, rocket etc.
The material of solid cabin (1) and tank (2) can be selected from has certain elastic material, such as one of which such as rubber, plastics, macromolecular materials, also selected from there is no elastic rigid material, such as one of which such as glass, wooden, metals.
The shape of solid cabin (1) and tank (2) includes but not limited to that spherical, cylindrical, taper, cylindricality, abnormity etc. are any; Solid cabin (1) and tank (2) can differentiate 1 further to multiple material mouths in any site, and the material mouth on solid cabin (1) can corresponding to tank (2) material mouth suitable, connected mode includes but not limited to that the material mouth of the one therein such as plug-in type, screw-type, clamping hoop type, form and dimension size and tank (2) adapts.
The material mouth in solid cabin (1) needs when not carrying out docking use to seal with the material mouth of tank (2), make in nacelle as closed environment, its sealing means includes but not limited to the one of which in the modes such as heat-sealing, gland, plug, ultrasonic sealing, high frequency sealing, and sealer material can be the one of which in the materials such as plastics, aluminum, aluminum-plastic composite membrane, rubber, latex, macromolecular material, glass, metal.
Solid preparation contained in solid cabin (1), for quickly dissolving, comparatively loose, breathable solid preparation; Solvent contained in tank (2), it is possible to be pure water or all liq solvent mixed with solid preparation, such as water preparation, oil, Emulsion etc.
Solid preparation in solid cabin (1), it is possible to use there is the powder of loose structure, press-powder, block powder or tabletting, effervescent tablet etc., it is possible to use lyophilizing excipient preparation (3) further.
Described lyophilizing excipient preparation (3) is mainly made up of active component and binding agent.
The volume ratio of described binding agent binder content after this lyophilizing excipient preparation lyophilizing and lyophilized excipient is 0.1mg/ml to 600mg/ml (weight/volume); Wherein more preferably 1mg/ml to 200mg/ml.
Described binding agent is edible or pharmaceutically useful a kind of water-soluble high-molecular material, it is possible to is polysaccharide, polypeptide, protein, is also likely to be synthetic polymeric's macromolecule, or through the natural macromolecular material retrofited or its mixture. conventional binding agent includes but not limited to glue class (collagen, gelatin, gelatin hydrolysate, arabic gum, xanthan gum, carrageenan, pectin, Konjac glucomannan, carrageenin, locust bean gum, natural gum, locust bean gum etc.), cellulose ethers (carboxymethyl cellulose, carboxyethyl cellulose, hydroxyethylmethyl-cellulose, hydroxypropyl methyl cellulose etc.), modified starch series (pulullan, hydroxypropyl starch etc., referring to R.P.SchererUS4305502A), PVP, PVA, hyalomitome acids, albumin, chitosan, dextran, agar, polyamino acid, glucosan and their combination etc. thereof, polyamino acid (polyglutamic acid, polyalanine, polylysine etc.), polysaccharide (fucoidin, inulin, glucosan) etc.
Described active component can be dissolved in water can also be insoluble in the material of water, and described active component can be selected from one or more the combination in chemicals composition, Chinese medicine ingredients, natural extract, bioactive ingredients, skin nursing beneficiating ingredient.
There is no particular limitation for active component involved by this utility model, it is possible to selected from but be not limited to the thin compound of one or more compositions following.
Chemicals (active constituents of medicine);
Antipyretic-antalgic anti-inflammatory agent, for instance aspirin, diflunisal, salsalate, acetaminophen, indomethacin, ibuprofen, naproxen, ketoprofen, pirprofen, suprofen, flurbiprofen, piroxicam, meloxicam, nimesulide, benzbromarone etc.;
Central stimulants, for instance pemoline, adrafinil, piracetam etc.;
Treatment migraine agent, for instance Sumatriptan Succinate;
Analgesic, for instance rotundine, buprenorphine, pentazocine, naloxone etc.;
Anti-parkinson and treatment senile dementia medicine, for instance levodopa, compound recipe carbidopa, compound recipe benserazide, amantadine hydrochloride, piribedil, general sieve phenol amine, donepezil, huperzine are first-class;
Psychotolytic, for instance chlorpromazine, promethazine, Pethidine, thioridazine, chlorprothixene, clozapine, sulpiride, Tai Bili, penfluridol, risperidone etc.;
Antiepileptic and anticonvulsant, for instance phenytoin Sodium, carbamazepine, primidone, gabapentin, lamotrigine, sodium valproate, clonazepam etc.
Sedative hypnotic, for instance diazepam, nitrazepam, oxazepam, lorazepam, phenobarbital etc.;
Cholinesterase inhibitor, for instance scopolamine etc.;
Anti-arrhythmic, for instance the third pyridine, tocainide, mexiletine, aetmozine, phenytoin Sodium, Propafenone, amiodarone etc.;
Antianginal and antiatherosclerotic, for instance Propranolol, nifedipine, gemfibrozil, bezafibrate, lovastatin, simvastatin, pravastatin etc.;
Antihypertensive, for instance Enalapril, captopril, hydrochlorothiazide, amlodipine etc.;
Adrenoceptor blocking agents, for instance acebutolol, alprenolol etc.;
Corticosteroid medicine, for instance betamethasone, cortisone acetate etc.;
Antidiabetic drug, for instance repaglinide etc.;
Antithyroid drug, for instance propylthiouracil, carbimazole, thiamazole etc.;
Antihistaminic, for instance cetirizine hydrochloride, loratadine etc.;
Autacoid, for instance dinoprostone, Alprostadil, betahistine etc.;
Digestive system surgical procedures, for instance scopolamine butylbromide, Granisetron Hydrochloride etc.;
Blood system medicine, for instance EPO, cobamamide etc.;
Urinary system medicine, for instance azosemide, furosemide etc.;
Reproductive system medicine, for instance estrogen, nandrolone phenylpropionate etc.;
Antiparasitic, for instance albendazole, cambendazole etc.;
Antineoplastic agent, for instance aminoglutethimide, amsacrine etc.;
Antimicrobial drug, for instance ampicillin, sulbenicillin disodium etc.;
Tri-Biocin, for instance amoxicillin, cefalexin, cefprozil, CEFUROXIME AXETIL, Roxithromycin, erythromycin ethylsuccinate, josamycin etc.
Chinese medicine ingredients:
Effective Component of Chinese Medicine monomer, as: breviscapine, arteannuin, huperzine A, tetrahydropalmatine etc.;
Single medicinal material material extract and compound Chinese medicine extract, as: tanshinone extract, Radix Salviae Miltiorrhizae total phenolic acids extract, composite salvia dropping extract of bolus, cow-bezoar bolus for clearing away heat of the upper part of the body compound extract, stem and leaf of Radix Ginseng total saponins, Rhizoma Menispermi extract, Radix Ginseng total saponins, American ginseng total saponins, breviscapine, Herba Sarcandrae extractum, Radix Notoginseng total arasaponins, Herba Artemisiae Scopariae extract, extractum rhei, andrographolide, Folium Crataegi extract, Herba Centellae total glycosides, Folium Ginkgo extract etc.
Natural plant extracts: such as Aloe extract, Rhizoma Dioscoreae extract, Pericarpium Citri tangerinae extract, Fructus Momordicae charantiae extract, Echinacea extract, Feverfew P.E, mangosteen extract, Folium Pini and Cortex Pini Massonianae extract, Brazil's blackberry extract, Fructus Mori extract, fruit of Ramulus Sambuci Williamsii extract, Cranberry extract, astaxanthin, lycopene, green tea extract, Semen Vitis viniferae and Pericarpium Vitis viniferae extract, glabridin, peoniflorin, licoflavone, Cortex Moutan extract etc.
Bioactive ingredients: EGF, bFGF, aFGF, KGF, IGF, NGF, TGF, HGH etc.
Supplementary, 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, protease, metallothionein, Margarita and hydrolysate, Lac Bovis seu Bubali and extract, pollen and extract, Lac regis apis, propolis etc.
Described lyophilizing excipient preparation, it is mainly made up of active component, binding agent, and needs to add skeleton proppant, antioxidant, correctives and essence, Percutaneous absorption enhancer, pH adjusting agent etc. according to preparation process.
Described skeleton proppant comprises the material such as aminoacid (such as glycine, alanine, glutamic acid etc.) and inorganic salt (such as sodium phosphate, aluminium silicate etc.) being not limited to sugar (such as maltose, trehalose etc.), sugar alcohol (such as mannitol, sorbitol), 2-12 carbon atom;
Described antioxidant includes but not limited to the mixture of one or several in the polyhydric phenols of vitamin C and derivant thereof, anthocyanidin, resveratrol, plant origin;
Described correctives and essence include but not limited to the mixture of the essence such as mint flavored, chocolate flavoured, fruity, vanilla flavored, caf, tea flavour, Semen Maydis taste, lemon, milk flavor or one of the above or several fragrance;
Described Percutaneous absorption enhancer includes but not limited to any one in lecithin, saponin, Laurel alkyd sodium, azone, tween, span or several mixture;
Described pH adjusting agent includes but not limited to any in citric acid, tartaric acid, carbonate, sodium carbonate, phosphate or several mixture.
This utility model further relates to based on above-mentioned lyophilized excipient packaging and the delivery system method of preparing above-mentioned lyophilizing excipient preparation, and the method includes assembling method after original position lyophilization and lyophilizing.
I. original position lyophilization:
A the solution or suspension that include but not limited to active component, water, binding agent and the formation of other auxiliaries are injected in the nacelle of described solid cabin by (); Or solid constituent is injected (can include active component, binding agent and other adjuvants) in the nacelle of described solid cabin (1), add water and be made into suspension;
B solution or suspension that (a) is obtained by () carry out degassed in the nacelle of described solid cabin (1);
(c) (b) is obtained degassed after suspension or not degassed direct that (a) is freezing at low temperatures;
D preparation that (c) is obtained by () carries out lyophilization in the nacelle of described solid cabin (1), obtains lyophilizing excipient preparation.
II. assembling method after lyophilizing:
A the solution or the suspension that include but not limited to active component, water, binding agent and the formation of other auxiliaries are injected into mould by (); Or solid constituent (can include active component, binding agent and other adjuvants) is injected into mould, add water and be made into suspension;
B solution or suspension that (a) is obtained by () carry out degassed in mould;
(c) (b) is obtained degassed after suspension or not degassed direct that (a) is freezing at low temperatures;
D preparation that (c) is obtained by () carries out lyophilization in mould, obtains lyophilizing excipient preparation;
E lyophilizing excipient preparation that (d) is obtained by () is detached into mould, is fitted in the nacelle of described solid cabin (1).
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, may be used without plunger displacement pump, gear pump, peristaltic pump etc., the solution configured, suspension or suspension are injected quantitative mould, and solid injection molding can adopt accurate solid measurer, vibrations capillary tube flow of powder controller.
Wherein degassed method can adopt centrifugal degassing method, vacuum outgas method and ultrasonic degassing method etc.
The wherein freezing mode that can adopt liquid nitrogen or liquid, drikold 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, rapidly solution, suspension or suspension freezing are become solid.
Wherein lyophilizing adopts the vacuum of 0.01-20 millibar, temperature lyophilizing between-70 DEG C to 50 DEG C scopes.
In use, solid cabin (1) and tank (2) are connected by material mouth, by extruding or the mode such as ventilation, solvent in tank (2) is pressed in the solid preparation in solid cabin (1) and is mutually dissolved, after fully dissolving, lysate uses same way release from solid cabin (1) or extrude nacelle, can use.
The preparation method that this utility model provides packing device and the inclusions lyophilizing excipient preparation thereof joined when the preservation of a kind of solid-liquid separation, use, solves the problem of secondary pollution in the product redissolution use procedures such as food, medicine, cosmetics on the one hand; Inherently solve above-mentioned tradition lyophilizing excipient preparation hardness defect low, breakable on the other hand, and reduce preparation cost further, improve yield rate, it is also possible to reduce packing cost, it is achieved automated production.