CN109106690A - A kind of freeze-drying excipient preparation protective device and preparation method thereof containing skeleton supporting agent and binder - Google Patents
A kind of freeze-drying excipient preparation protective device and preparation method thereof containing skeleton supporting agent and binder Download PDFInfo
- Publication number
- CN109106690A CN109106690A CN201710490058.2A CN201710490058A CN109106690A CN 109106690 A CN109106690 A CN 109106690A CN 201710490058 A CN201710490058 A CN 201710490058A CN 109106690 A CN109106690 A CN 109106690A
- Authority
- CN
- China
- Prior art keywords
- freeze
- preparation
- protective device
- drying excipient
- excipient preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of freeze-drying excipient preparation protective devices and preparation method thereof; especially a kind of freeze-drying excipient preparation formed containing skeleton supporting agent and binder and the protective device that excipient preparation is lyophilized; inherently solve it is above-mentioned tradition freeze-drying excipient preparation hardness it is low, it is easily broken, need manpower taking-up cause the preparations defect such as secondary pollution; both preparation cost can be reduced; improve yield rate; packing cost can also be reduced, realizes automated production.
Description
Technical field
The present invention relates to a kind of freeze-drying excipient preparation protective devices and preparation method thereof, especially a kind of to support containing skeleton
The protective device and its corresponding preparation method of the freeze-drying excipient preparation of agent and binder composition.
Background technique
Freeze-drying excipient technology refers to the addition skeleton supporting agent in the active constituent of flowable liquid, semisolid or solid
And itself contains binder and skeleton supporting agent in binder or the flowable liquid, semisolid or solid, then will
It is filled into molding die, is able to molding technology by freeze drying process, passes through the preparation of freeze-drying excipient technology preparation
Excipient preparation is referred to as lyophilized.
Since such preparation uses freeze drying process, it can protect thermally sensitive composition and be not destroyed, while passing through moisture
Distillation generates a large amount of micropores and duct, can have cracking disintegration and solution rate, therefore receive extensive use, Ke Yiying
For multiple fields such as oral disnitegration tablet, fast-release tablet, chewable tablets, special cosmetics.
Traditional freeze-drying excipient preparation (referring to Chinese patent CN200580013010.8), that there are production technologies is complicated, at
This height, easy to moisture absorption, toughness is strong but the disadvantages such as hardness is low.
Inventor dedicates itself to innovation, and provides a kind of freeze-drying excipient preparation containing skeleton supporting agent and binder and freeze-drying is assigned
The protective device of type preparation, inherently solve it is above-mentioned tradition freeze-drying excipient preparation hardness it is low, it is easily broken, need manpower taking-up cause
The preparations defect such as secondary pollution can both reduce preparation cost, improve yield rate, can also reduce packing cost, realize automatic
Metaplasia produces.
Summary of the invention
The present invention provides the protective device and system of a kind of freeze-drying excipient preparation formed containing skeleton supporting agent and binder
Preparation Method.
The protective device of the freeze-drying excipient preparation is the cavity of a both ends open, including feed end (1), freeze-drying excipient
Preparation (2), discharge end (3) three parts.
The feed end (1) of the protective device, can be connected with the port of various adapters, and connection type includes but unlimited
In the various fixed forms that can be dismantled after use such as plug-in type, screw-type, clamping hoop type, form and dimension size and adapter
Port is adapted；
The discharge end (3) of the protective device can be the discharge port of any form, including but not limited to straight pipe type, suction
Tubulose, dropper shape, ball shape, fog-spray nozzle etc.；
Freeze-drying excipient preparation (2) in the protective device, is mainly made of active constituent and matrix.
The main component of the matrix is binder and skeleton supporting agent.
The weight proportion of the matrix is binder: skeleton supporting agent=1:100 to 100:1.Can be more preferably 1:
50 to 50:1,1:30 are to 30:1,1:25 to 25:1,1:20 to 20:1,1:15 to 15:1,1:10 to 10:1,1:5 to 5:1,1:3
To 3:1, wherein most preferably 1:25 to 25:1,1:5 are to 5:1,1:3 to 3:1.
The binder is a kind of edible or pharmaceutical water-soluble high-molecular material, can be polysaccharide, polypeptide, egg
White matter is also likely to be synthetic polymeric's macromolecule, or by or mixtures thereof the natural macromolecular material of remodeling.It is common viscous
Tying agent includes but is not limited to glue class (collagen, gelatin, gelatin hydrolysate, Arabic gum, xanthan gum, carragheen, pectin, konjac glucomannan, angle
Pitch dish glue, locust bean gum, natural gum, locust bean gum etc.), cellulose ethers (carboxymethyl cellulose, carboxyethyl cellulose, ethoxy first
Base cellulose, hydroxypropyl methyl cellulose etc.), modified starch series (pulullan, hydroxypropul starch etc., referring to R.P.Scherer
US4305502A), PVP, PVA, hyalomitome acids, albumin, chitosan, dextran, agar, polyaminoacid, glucan and
(fucoidin, synanthrin, Portugal are poly- for its their combination etc., polyaminoacid (polyglutamic acid, polyalanine, polylysine etc.), glycan
Sugar) etc..
The skeleton supporting agent includes to be not limited to sugared (such as maltose, trehalose), sugar alcohol (such as mannitol, sorb
Alcohol), the amino acid (such as glycine, alanine, glutamic acid) and inorganic salts (such as sodium phosphate, alumina silicate) of 2-12 carbon atom
Equal substances.
The active constituent can be dissolved in water and be also possible to substance not soluble in water, and the active constituent can be selected from
One of chemicals ingredient, traditional Chinese medicine ingredients, natural extract, bioactive ingredients, skin nursing beneficiating ingredient are a kind of
Above combination.
There is no particular limitation for active constituent according to the present invention, can selected from but not limited to it is following it is one or more of at
The composition divided.
Chemicals (active pharmaceutical ingredient):
Antipyretic-antalgic anti-inflammatory agent, for example, aspirin, Diflunisal, salsalate, paracetamol, Indomethacin,
Brufen, naproxen, Ketoprofen, pirprofen, suprofen, Flurbiprofen, piroxicam, Meloxicam, aulin, benzene bromine horse
It is grand etc.；
Central stimulant, such as pemoline, adrafinil, Piracetam etc.；
Treat migraine agent, such as Sumatriptan succinate；
Antalgesic, such as rotundin, buprenorphine, pentazocine, naloxone etc.；
Anti-Parkinson's disease and treatment senile dementia medicine, such as levodopa, compound carbidopa, compound benserazide, hydrochloric acid
Amantadine, piribedil, phenolicamine, donepezil, huperzine are first-class；
Psychotolytic, such as chlorpromazine, fenazil, pethidine, thioridazine, Chlorprothixene, Clozapine, Shu Bi
Benefit, Tai Bili, penfluridol, Risperidone etc.；
Antiepileptic and anticonvulsive drug, such as dilantin sodium, carbamazepine, Primidone, Gabapentin, Lamotrigine, third
Natrium valericum, Clonazepam etc..Hypnotic sedative agent, such as diazepam, nitrazepam, Oxazepam, Lorazepam, phenobarbital etc.；
Cholinesterase inhibitor, such as hyoscine etc.；
Antiarrhymic, such as third pyridine, tocainide, mexiletine, aetmozine, dilantin sodium, Propafenone, amine iodine
Ketone etc.；
Antianginal and antiatherosclerotic, such as Propranolol, nifedipine, Gemfibrozil, Bezafibrate, Lip river
Cut down statin, 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 sodium etc.；
Tri-Biocin, such as Amoxicillin, cefalexin, Cefprozil, CEFUROXIME AXETIL, roxithromycin, amber second are red
Mycin, josamycin etc..
Traditional Chinese medicine ingredients:
Effective component of chinese medicine monomer, such as: Breviscapinun, qinghaosu, huperzine, tetrahydropalmatine；
Single medicinal material material extract and compound Chinese medicine extract, such as: tanshinone extract, is answered at salvianolic acid extract
Square Danshen Root dropping ball extract, 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, mountain
Short, bristly hair or beard leaf extract, asiaticoside, ginkgo biloba p.e etc..
Natural plant extracts: as aloe extract, yam extract, Bilberry fruit P.E, Bitter Melon P.E, Echinacea mention
It takes object, Feverfew P.E, mangosteen extract, pine needle and Pine Bark, Brazilian blackberry extract, mulberries extract, connect
Bone wood berry extract, Cranberry extract, astaxanthin, lycopene, green-tea extract, grape pip and grape skin extract, light
Licoricidin, Paeoniflorin, licoflavone, Cortex Moutan extract etc..
Bioactive ingredients: EGF, bFGF, aFGF, KGF, IGF, NGF, TGF, HGH etc..
Nutritional supplement, 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, pearl and
Its hydrolysate, cow's milk and its extract, pollen and its extract, royal jelly, propolis etc..
The freeze-drying excipient preparation can add antioxidant, corrigent and essence, Transdermal absorption according to preparation process needs
Promotor, pH adjusting agent etc..
The antioxidant includes but is not limited to vitamin C and its derivative, anthocyanidin, resveratrol, plant origin
One of polyhydric phenols or several mixtures；
The corrigent and essence include but is not limited to mint flavored, chocolate flavoured, fruity, vanilla flavored, caf, tea flavour,
The mixture of the essence such as corn taste, lemon, milk flavor or one of the above or several fragrance；
The skin penetration enhancer include but is not limited to lecithin, saponin(e, laurel alkyd sodium, azone, tween, in sapn
Any or several mixture；
The pH adjusting agent includes but is not limited to citric acid, tartaric acid, carbonate, sodium carbonate, any one in phosphate
Kind or several mixtures.
The freeze-drying excipient that freeze-drying excipient preparation (2) can be arbitrary shape and size and protective device cavity is adapted
Preparation, protective device cavity can be further in devices such as inner surface setting protrusion, screw thread or sieve plates, to guarantee that excipient preparation is lyophilized
It will not fall off or skid off from protective device in preparation and course of normal operation.
The protective device can according to need and is made of any material, including but not limited to plastics, rubber, metal,
Glass, composite material etc..
The invention further relates to the method for preparing above-mentioned freeze-drying excipient preparation, this method includes in-suit desivac and fills after being lyophilized
With method.
I. in-suit desivac:
(a) including but not limited to active constituent, water, binder, skeleton supporting agent and other auxiliaries are formed molten
Liquid or suspension inject protective device cavity；Or solid component (may include active constituent, binder and other auxiliary materials) is injected
Protective device cavity adds water and is made into suspension；
(b) (a) obtained solution or suspension are de-gassed in protective device；
(c) not degassed direct (a) is freezed the suspension after degassing that (b) is obtained or at low temperature；
(d) preparation for obtaining (c) is freeze-dried in protective device, obtains freeze-drying excipient preparation.
II. assembling method after being lyophilized:
(a) including but not limited to active constituent, water, binder, skeleton supporting agent and other auxiliaries are formed molten
Liquid or suspension injection moulding mold；Or by solid component (may include active constituent, binder and other auxiliary materials) injection moulding
Mold adds water and is made into suspension；
(b) (a) obtained solution or suspension are de-gassed in molding die；
(c) not degassed direct (a) is freezed the suspension after degassing that (b) is obtained or at low temperature；
(d) preparation for obtaining (c) is freeze-dried in molding die, obtains freeze-drying excipient preparation；
(e) the freeze-drying excipient preparation for obtaining (d) is detached from molding die, is fitted into protective device cavity.
In above-mentioned preparation method, wherein Liquid Injection can be using accurate quantification pipette, liquid-transfering gun, electronic liquor-transferring rifle etc.
Plunger pump, gear pump, peristaltic pump etc. can also be used in liquid-transfering device, and it is fixed that configured solution, suspension or suspension are injected
Molding die is measured, solid injection molding can be using accurate solid measurer, vibration capillary flow of powder controller；
Wherein degassing method can be using centrifugal degassing method, vacuum outgas method and ultrasonic degassing method etc.；
Wherein freezing can be using liquid nitrogen or liquid, drikold spray refrigeration or casing cooling back installation
Mode, turbine expander refrigeration mode or cascade refrigeration mode, at -20 DEG C -- at a temperature of 196 DEG C, rapidly by solution, suspension
Or suspension freezing becomes solid；
Wherein freeze-drying uses 0.01-20 millibars of vacuum degree, and temperature is lyophilized between -70 DEG C to 50 DEG C ranges；
When in use, after the feed end (1) in protective device being connect with the adapter port containing liquid, liquid can
Entered in protective device cavity by feed end (1) and mixed with freeze-drying excipient preparation (2), then flowed out from discharge end (3).
Detailed description of the invention
Fig. 1 is the structural schematic diagram that excipient preparation protective device is lyophilized；
Specific embodiment
The present invention is further illustrated by the following examples, but the present invention is not restricted to this.
Embodiment 1:
Pearl powder: mannitol: hyaluronic acid=1:2:100, hyaluronic acid 100mg, wherein 90mg hyaluronic acid and 1mg are precious
After pearl fine powder and the mixing of 2mg mannitol, it is accurate it is filling enter in 0.5ml mold, 10mg hyaluronic acid after the dissolution of 0.3ml water,
It is poured into the mold containing 90mg hyaluronic acid and 1mg pearl powder, stirring makes water dispersion in powder, and quick-frozen extremely -20 is Celsius
Degree, freeze-drying become skin care solid essence, are fitted into protective device.
In use, taking out freeze-drying excipient preparation protective device, connecting pin is inserted on hair conditioner extrusion, pushes extruder pump
Head, hair conditioner enter protective device by feed end, squeeze out after being sufficiently mixed with freeze-drying excipient preparation from discharge end, become novel
Hair products.
Embodiment 2:
Gelatin, gelatin hydrolysate and mannitol is added in EGF stoste after defrosting, be configured to the EGF (weight containing 5/100000ths
Than), containing 5% gelatin+gelatin hydrolysate solution, it is filling enter 0.1 milliliter of molding die, freeze-drying molding after be packed into protective device chamber
In body.
In use, taking out freeze-drying excipient preparation protective device, feed end is accessed into the Essence bottle mouth position with Pressing pump, is pressed
Press pump head enters Essence in freeze-drying excipient preparation protective device cavity from feed end, sufficiently mixed to water and freeze-drying excipient preparation
After conjunction, then mixed liquor is squeezed out from discharge end and is used, becomes modern biotechnology cosmetics.
Embodiment 3:
Royal jelly: trehalose: PVP=2:1:1 is configured to solution, is fed into the protective device cavity with fog-spray nozzle,
In cavity after quick-frozen to -100 degrees Celsius, it is lyophilized in situ.Suck drinking water when use in syringe in advance, it later will freeze-drying
Excipient preparation protective device is connected on syringe outlet position, when the drinking water in syringe from outlet squeeze out when, by into
Material end enters freeze-drying excipient preparation protective device cavity, is thoroughly mixed to form with freeze-drying excipient preparation containing drug solns, passes through later
The fog-spray nozzle of discharge end sprays into oral cavity, forms mouth spray type drug.
Protective device structure of the invention is not limited in embodiment cited form, embodiment be only it is of the invention compared with
Good embodiment cannot limit protection scope with this.It is all with simple or equivalent described in scope of the presently claimed invention
Variation and modification, come under protection scope of the present invention.
Claims (10)
1. a kind of freeze-drying excipient preparation protective device containing skeleton supporting agent and binder is the cavity of a both ends open,
Including feed end (1), freeze-drying excipient preparation (2), discharge end (3) three parts.
2. freeze-drying excipient preparation protective device as described in claim 1, it is characterised in that feed end (1) can be with various adapters
Port be connected, connection type include but is not limited to plug-in type, screw-type, clamping hoop type etc. it is various can dismantle after use consolidate
Determine mode, the port of form and dimension size and adapter is adapted；Discharge end (3) can be the discharge port of any form, packet
Include but be not limited to straight pipe type, pipe shape, dropper shape, ball shape, fog-spray nozzle etc..
3. freeze-drying excipient preparation protective device as described in claim 1, it is characterised in that the cavity inner surface of protective device can
The further devices such as setting protrusion, screw thread or sieve plate, to guarantee freeze-drying excipient preparation in manufacture, packaging, transport and use process
In will not fall off or skid off from protective device.
4. freeze-drying excipient preparation as described in claim 1, it is characterised in that the freeze-drying excipient preparation mainly by active constituent and
Matrix composition, the main component of mesostroma are binder and skeleton supporting agent, and the weight proportion of matrix is binder: skeleton branch
Hold agent=1:100 to 100:1.
5. as claimed in claim 4 freeze-drying excipient preparation, it is characterised in that the active constituent be selected from chemicals ingredient,
One of traditional Chinese medicine ingredients, natural extract, bioactive ingredients, nutrition fortifier, skin nursing beneficiating ingredient or it is a kind of with
On combination.
6. as claimed in claim 4 freeze-drying excipient preparation, it is characterised in that the binder be glue class, cellulose ethers,
Modified starch series, carbomer, PVA, hyalomitome acids, albumin, chitosan, dextran, agar, polyaminoacid, gather PVP
Sugar or their combination.
7. freeze-drying excipient preparation as claimed in claim 4, it is characterised in that the skeleton contained by the freeze-drying excipient preparation is supported
Agent includes the amino acid for being not limited to sugared (such as maltose, trehalose), sugar alcohol (such as mannitol, sorbierite), 2-12 carbon atom
The substances such as (such as glycine, alanine, glutamic acid) and inorganic salts (such as sodium phosphate, alumina silicate).
8. freeze-drying excipient preparation as claimed in claim 4, it is characterised in that wherein also contain other auxiliary materials, other auxiliary materials
For one of antioxidant, corrigent and essence, skin penetration enhancer, PH regulator or more than one.
9. the preparation method of freeze-drying excipient preparation as claimed in claim 4, it is characterised in that the preparation method is divided into jelly in situ
Two methods of assembling method after dry method and freeze-drying:
I. in-suit desivac:
(a) by including but not limited to active constituent, water, binder, skeleton supporting agent and other auxiliaries formed solution or
Suspension injects protective device cavity；Or solid component (may include active constituent, binder and other auxiliary materials) is injected and is protected
Device cavity adds water and is made into suspension；
(b) (a) obtained solution or suspension are de-gassed in protective device；
(c) not degassed direct (a) is freezed the suspension after degassing that (b) is obtained or at low temperature；
(d) preparation for obtaining (c) is freeze-dried in protective device, obtains freeze-drying excipient preparation.
II. assembling method after being lyophilized:
(a) by including but not limited to active constituent, water, binder, skeleton supporting agent and other auxiliaries formed solution or
Suspension injection moulding mold；Or by solid component (may include active constituent, binder and other auxiliary materials) injection moulding mold,
It adds water and is made into suspension；
(b) (a) obtained solution or suspension are de-gassed in molding die；
(c) not degassed direct (a) is freezed the suspension after degassing that (b) is obtained or at low temperature；
(d) preparation for obtaining (c) is freeze-dried in molding die, obtains freeze-drying excipient preparation；
(e) the freeze-drying excipient preparation for obtaining (d) is detached from molding die, is fitted into protective device cavity.
10. freeze-drying excipient preparation protective device as described in claim 1, it is characterised in that the protective device when in use, will
After feed end (1) in protective device is connect with the adapter port containing liquid, liquid can be entered by feed end (1) to be protected
It mixes in protection unit cavity with freeze-drying excipient preparation (2), then is flowed out from discharge end (3).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710490058.2A CN109106690A (en) | 2017-06-25 | 2017-06-25 | A kind of freeze-drying excipient preparation protective device and preparation method thereof containing skeleton supporting agent and binder |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710490058.2A CN109106690A (en) | 2017-06-25 | 2017-06-25 | A kind of freeze-drying excipient preparation protective device and preparation method thereof containing skeleton supporting agent and binder |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109106690A true CN109106690A (en) | 2019-01-01 |
Family
ID=64733546
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710490058.2A Pending CN109106690A (en) | 2017-06-25 | 2017-06-25 | A kind of freeze-drying excipient preparation protective device and preparation method thereof containing skeleton supporting agent and binder |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109106690A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112237949A (en) * | 2020-12-14 | 2021-01-19 | 上海简逸生物科技有限公司 | Freeze-dried preparation production process, freeze-dried preparation and freeze-dried reagent preparation box |
-
2017
- 2017-06-25 CN CN201710490058.2A patent/CN109106690A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112237949A (en) * | 2020-12-14 | 2021-01-19 | 上海简逸生物科技有限公司 | Freeze-dried preparation production process, freeze-dried preparation and freeze-dried reagent preparation box |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103893770B (en) | A kind of freeze-drying excipient preparation and preparation method thereof | |
| CN104644571B (en) | Freeze-drying excipient protection device and preparation method thereof | |
| CN103893133B (en) | A kind of formula of lyophilized excipient preparation and preparation method thereof | |
| CN104644568A (en) | Protective apparatus and preparation method of freeze-dried excipient preparation containing active components and binding agent | |
| WO2015032319A1 (en) | Lyophilized excipient formulation packaging and delivery system and preparation method | |
| CN103318551A (en) | System for packaging and delivering freeze-dried excipient and preparation method of freeze-dried excipient | |
| EP3357478A1 (en) | Method using rolling mold to prepare freeze-dried excipient, and product thereof | |
| WO2018028531A1 (en) | Lyophilized preparation and preparation method therefor | |
| CN106963737A (en) | A kind of any form of easy disintegrating freezes shaped preparation and preparation method thereof | |
| CN108066152A (en) | A kind of preparation method of lyophilized excipient | |
| CN106821770A (en) | It is a kind of to prepare method of lyophilized formulations of arbitrary shape and products thereof | |
| CN107468528A (en) | A kind of lyophilized formulations and preparation method thereof | |
| CN107714654A (en) | A kind of lyophilized formulations and preparation method thereof | |
| CN106466228A (en) | A kind of multi-mould prepares method of lyophilized excipient of arbitrary shape and products thereof | |
| CN104648834A (en) | Protecting device of freeze-drying excipient containing skeleton support agent and binder and preparation method thereof | |
| CN104760767A (en) | Packaging device of freeze-drying excipient preparation with barrier property and manufacturing method of packaging device | |
| CN205274216U (en) | Solid -liquid separation joins in marriage packing plant of usefulness promptly | |
| CN109106690A (en) | A kind of freeze-drying excipient preparation protective device and preparation method thereof containing skeleton supporting agent and binder | |
| CN107280979A (en) | It is a kind of to prepare method of lyophilized formulations of arbitrary shape and products thereof | |
| WO2017016506A1 (en) | Freeze-drying excipient preparation of arbitrary shape and preparation method therefor | |
| CN106619539A (en) | Method for preparing freeze-dried excipient preparation in any shape and product of method | |
| CN203473563U (en) | Freeze-drying excipient packaging and delivering system | |
| CN107260557A (en) | A kind of rolling modulus method prepares method of lyophilized formulations and products thereof | |
| CN107303288A (en) | A kind of production method of film and products thereof | |
| CN107334656A (en) | A kind of packing device of Modified Membrane cloth and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20190101 |
|
| WD01 | Invention patent application deemed withdrawn after publication |