CN106963737A - A kind of any form of easy disintegrating freezes shaped preparation and preparation method thereof - Google Patents
A kind of any form of easy disintegrating freezes shaped preparation and preparation method thereof Download PDFInfo
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- CN106963737A CN106963737A CN201610022474.5A CN201610022474A CN106963737A CN 106963737 A CN106963737 A CN 106963737A CN 201610022474 A CN201610022474 A CN 201610022474A CN 106963737 A CN106963737 A CN 106963737A
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- 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
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
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- A23C9/18—Milk in dried and compressed or semi-solid form
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- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
- A23L2/385—Concentrates of non-alcoholic beverages
- A23L2/39—Dry compositions
- A23L2/395—Dry compositions in a particular shape or form
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- A61K31/265—Esters, e.g. nitroglycerine, selenocyanates of carbonic, thiocarbonic, or thiocarboxylic acids, e.g. thioacetic acid, xanthogenic acid, trithiocarbonic acid
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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Abstract
Shaped preparation and preparation method thereof is freezed the present invention relates to a kind of any form of easy disintegrating, it is more particularly to a kind of by the way that water or lyophilized formulations stoste to be sufficiently stirred for that Sorbet is made and further remaining supplementary material can be mixed into Sorbet in freezing, then contained into certain mould shape carry out lyophilized prepare, random molding shape, mainly contain active component, lyophilized shaping formulation products of binding agent and disintegrant and preparation method thereof.
Description
Technical field
Shaped preparation and preparation method thereof is freezed the present invention relates to a kind of any form of easy disintegrating, it is more particularly to a kind of by by water or lyophilized formulations
Stoste is sufficiently stirred for that Sorbet is made and further remaining supplementary material can be mixed into Sorbet in freezing, then is contained to enter into certain mould shape
Lyophilized prepare, the random molding shape of row, mainly contain active component, binding agent and the lyophilized shaping formulation products of disintegrant and its preparation
Method.
Background technology
Lyophilized excipient technology refers to addition skeleton supporting agent and binding agent in the active component of flowable liquid, semisolid or solid, or described
Itself contains binding agent and skeleton supporting agent in flowable liquid, semisolid or solid, is then filled into mould, dry by freezing
Drying process is able to the technology being molded, and the preparation prepared by freezing excipient technology is referred to as lyophilized excipient.
Because such preparation uses freeze drying process, thermally sensitive composition can be protected not to be destroyed, at the same by water sublimed produce a large amount of micropores and
Duct, can have disintegration quickly and dissolution velocity, therefore receive extensive use, can apply to oral disnitegration tablet, fast-release tablet, chewable tablets,
The multiple fields such as special cosmetics.
Lyophilized excipient currently on the market is big polymorphic single, and used mould is traditional mould, i.e., common fluted body
Mould, this traditional lyophilized excipient and preparation method thereof has the following disadvantages：
(1) preparation shape is single, and reason is that mold shape is all fixed, and can not only be stripped or be stripped from one direction, wherein not being stripped is
Finger is directly molded in the packaging material of definite shape, therefore the special shape such as rare spherical, elliposoidal, irregular ball-shape, due to tradition
Preparation method, it is difficult to be made special shape lyophilized excipient.
(2) tablet made from have the numerous tablets with sharp edge obtained after sharp edge, the demoulding together enter same packaging after sharp edge it
Between easily wear and tear, cause the inaccurate of drug dose.
(3) because one direction is filling, it is difficult to which, as sandwich construction, therefore, preparation structure is single.
(4) the lyophilized shaped preparation water-disintegration of the solid type of specific form is impacted, influences Product Experience.
Inventor dedicates itself to innovation, and has carried out a large amount of in-depth studies and experiment work, and it is excellent that the principle based on lyophilized excipient preparation manufacturing process carries out technique
Change there is provided a kind of method that can prepare easy disintegrating, arbitrary shape lyophilized shaped preparation and its according to product made from this method, especially
Be be related to it is a kind of by the way that lyophilized formulations stoste to be sufficiently stirred for that Sorbet is made and further supplementary material can be mixed into Sorbet in freezing, then by its
Contain into a fixed mold carry out lyophilized prepare, arbitrary shape, mainly contain active component, the lyophilized shaped preparation of binding agent and disintegrant
Preparation method and according to product made from this method.
The present invention solves the problem of lyophilized shaping dosage form is single, and mould can be designed as needed, lyophilized formulations are prepared into the various of needs
Shape, allows lyophilized formulations to show more various form, structure (double-layer tablets, multilayer tablet), while making the disintegrative of its preparation not because of preparation
The change of form and be affected, and large-scale production can be realized, by production cost control in a controlled range.
The content of the invention
A kind of any form of easy disintegrating provided by the present invention freezes shaped preparation and preparation method thereof, it is characterised in that in the lyophilized shaped preparation
Including water, binding agent, active material and disintegrant；Its preparation method comprises the following steps：
A. will as above four kinds of materials are after all mixing or part are mixed, wiring solution-forming, suspension or emulsion form liquid 1；Or water is individually deposited
Forming liquid 1；
B. liquid 1 is freezed, in refrigerating process or after freezing, liquid 1 is freezed by physical method and ice pellets is ground into or ice powder, is
For component 2；
C. prepare after liquid 1, if surplus materials, it is sufficiently mixed with component 2 in technical process A, form component 3；As fruit component 2 is
The ice pellets or ice powder of pure water formation, the then ice pellets formed binding agent, disintegrant and active material with the pure water or ice powder are sufficiently mixed,
Or the ice pellets that is formed with the pure water of the solution of binding agent, disintegrant and active material or ice powder are sufficiently mixed, component 3 is formed；
D. component 2 or component 3, are fitted into quantitative in the effigurate mould 11 of tool；Form quantitative component 4；
E. the component 4 after will be quantitative is freeze-dried, and forms lyophilized shaped article 12.
The particle diameter of ice pellets, ice powder in described step B, C, D, E is 0.1-5000 μm, preferably 0.1-200 μm.
Liquid 1 in the step A, can be water；Can also be water dissolving or scattered partly or completely binding agent；Can also be water-soluble
Solution or scattered partly or completely active material；Can also be water dissolving or scattered partly or completely disintegrant；Can also be part water
Dissolving or scattered binding agent and disintegrant, part aqueous solution or dispersed actives；It can also be water dissolving or disperse partly or completely
Active material, binding agent and disintegrant, can also be itself natural materials or extract containing moisture, including but not limited to milk, fruit juice and honeybee
Royal jelly etc..
Compression step can be added between the step D and E, quantitative component 4 is compressed into certain shape and density, component 5 is formed, afterwards
Component 5 is freeze-dried, freeze-drying prods 12 are formed.
Mould described in preparation method, can have any shape, and can be unidirectional demoulding type, can also be that multi-mould is combined；Its material should have
There is certain degree of hardness and heat conductivility is preferable.The hardness of material represents that its penetration hardness value is excellent in more than 0.1N, below 100000N with penetration hardness
Select 90000N, 80000N, 70000N, 60000N, 50000N, 40000N, 30000N or below 20000N.The thermal conductivity factor of material need to be in 0.01W/
(m.k) more than, wherein it is preferred that thermal conductivity factor is in 0.05W/ (m.k) -1000W/ (m.k) material, most preferably thermal conductivity factor is at 0.2W/ (m.k)
- 500W/ (m.k) material.The material can be metal, high polymer material, ceramics, glass etc. it is therein a kind of or by it is therein more than one
Collectively form.Meanwhile, the surface of mould can also be further surface-treated.The die surface processing, can be coating, plating, soda acid
Wash, polish, wire drawing, electrophoresis, PVD and other surface treatment methods, make lyophilized formulations stoste good break away from moulds after the freezing.
Obtained described lyophilized formulations are mainly made up of active component, binding agent and disintegrant, and the weight proportion of wherein binding agent and active component is
Binding agent：Active component=1:100 to 100:1.
The weight proportion of binding agent and active component can further preferably 1:90 to 90:1,1:80 to 80:1,1:70 to 70:1,1:60 to 60:1,
1:50 to 50:1,1:40 to 40:1,1:30 to 30:1, more preferably 1:20 to 20:1,1:10 to 10:1,1:9 to 9:1,1:8 to 8:1,1:7 to
7:1, most preferably 1：6 to 6:1,1:5 to 5:1.
Lyophilized formulations provided by the present invention also can further include other auxiliary materials, such as skeleton supporting agent, antioxidant, flavouring and essence, across
Mucous membrane or skin penetration enhancer, PH conditioning agents, lubricant etc., the content range of these other auxiliary materials can account for the lyophilized formulations prepared
Total content 0.1-5%, preferably 0.1-3%.
The active component used in preparation method, which 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 kinds of combinations in chemicals composition, traditional Chinese medicine ingredients, natural extract, bioactive ingredients, skin nursing beneficiating ingredient.
There is no particular limitation for the active component, can be selected from, but not limited to, the composition of following one or more of 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；
Treat migraine agent, such as Sumatriptan succinate；
Antalgesic, such as rotundin, buprenorphine, pentazocine, naloxone；
Anti-parkinson and treatment senile dementia medicine, such as levodopa, compound carbidopa, compound benserazide, amantadine hydrochloride, pyrrole shellfish
That, phenolicamine, donepezil, huperzine are first-class；
Psychotolytic, such as chlorpromazine, fenazil, pethidine, thioridazine, Chlorprothixene, Clozapine, Sulpiride, Tai Bili, five
Fluorine benefit, Risperidone etc.；
Antiepileptic and anticonvulsive drug, such as dilantin sodium, carbamazepine, Primidone, Gabapentin, Lamotrigine, sodium vedproate, chlorine nitre west
Dissolve.
Hypnotic sedative agent, such as diazepam, nitrazepam, Oxazepam, Lorazepam, phenobarbital；
Cholinesterase inhibitor, such as hyoscine；
Antiarrhymic, such as third pyridine, tocainide, mexiletine, aetmozine, dilantin sodium, Propafenone, amiodarone；
Antianginal and antiatherosclerotic, such as Propranolol, nifedipine, Gemfibrozil, Bezafibrate, Lovastatin, pungent cut down him
Spit of fland, Pravastatin etc.；
Antihypertensive, such as Enalapril, captopril, Hydrochioro, Amlodipine；
Adrenoceptor blocking agents, such as acebutolol, alprenolol；
Corticosteroid medicine, such as betamethasone, cortisone acetate；
Antidiabetic, such as Repaglinide；
Antithyroid drug, such as propylthiouracil (PTU), Carbimazole, methimazole；
Antithistamine, such as Cetirizine Hydrochloride, Loratadine；
Autacoid, such as dinoprostone, Alprostadil, Betahistine；
Digestive system surgical procedures, such as scopolamine butylbromide, Granisetron Hydrochloride；
Hematological system medicine, such as EPO, cobamamide；
Urinary system medicine, such as azosemide, frusemide；
Reproductive system medicine, such as estrogen, Nandrolone Phenylpropionate；
Antiparasitic agent, such as albendazole, cambendazole；
Antineoplastic, such as aminoglutethimide, amsacrine；
Antimicrobial, such as ampicillin, sulbenicillin sodium；
Tri-Biocin, such as Amoxicillin, cefalexin, Cefprozil, CEFUROXIME AXETIL, ROX, Erythromycin Ethylsuccinate, josamycin
Deng.
Traditional Chinese medicine ingredients：
Effective component of chinese medicine monomer, such as：Breviscapinun, qinghaosu, huperzine, tetrahydropalmatine etc.；
Single medicinal material material extract and compound Chinese medicine extract, such as：Tanshinone extract, salvianolic acid extract, composite salvia dropping extract of bolus,
Cow-bezoar bolus compound extract, ginseng stem and leave general saponin, asiatic moonseed extract, general ginsenoside, American ginseng total saponins, Breviscapinun, swollen section
Wind medicinal extract, arasaponin, capillary extract, extractum rhei, andrographolide, hawthorne leaf P.E, asiaticoside, ginkgo biloba p.e
Deng.
Natural plant extracts：
As aloe extract, yam extract, Bilberry fruit P.E, Bitter Melon P.E, Echinacea Purpurea Herb P.E, Feverfew P.E, mangosteen extract,
Pine needle and Pine Bark, Brazilian blackberry extract, mulberries extract, elderberry extract, Cranberry extract, astaxanthin, tomato red
Element, green-tea extract, grape pip and grape skin extract, glabridin, Paeoniflorin, licoflavone, Cortex Moutan extract etc..
Bioactive ingredients：
EGF, bFGF, aFGF, KGF, IGF, NGF, TGF, HGH, EPO, G-CSF, GM-CSF, various antibody drugs,
Various vaccines, toxoid, antitoxin, various biology enzymes etc..
Skin nursing beneficiating ingredient：
Vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin C, vitamin D, dimension
Raw element 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 binding agent is edible or a kind of pharmaceutically useful water-soluble high-molecular material, can be polysaccharide, polypeptide, protein, be also likely to be people
Work polymerization macromolecule, or by the natural macromolecular material or its mixture of remodeling.Described binding agent includes but is not limited to, and gelatin class is (bright
Glue, isinglass, bird gelatin, gelatin hydrolysate etc.), cellulose ethers (methylcellulose, carboxymethyl cellulose, hydroxypropyl methyl cellulose, carboxylic
Ethylmethylcellulose etc.), modified starch (pulullan, hydroxymethyl starch etc.), hyalomitome acids, albumin, dextran, chitosan and
Its different molecular weight product, sodium alginate, PVP, PVA, polyethylene glycol, Arabic gum, guar gum, xanthans, konjac glucomannan, carragheen,
Carbomer, agar, carrageenan, pectin or combinations thereof etc..It is characterized in that described glue class binding agent be collagen, gelatin, gelatin hydrolysate,
Arabic gum, xanthans, carragheen, pectin, konjac glucomannan, carrageenan, locust bean gum, natural gum, locust bean gum；Described cellulose ethers glues
Knot agent is carboxymethyl cellulose, carboxyethyl cellulose, hydroxyethylmethylcellulose, hydroxypropyl methyl cellulose etc.；Described modified starch series are bonded
Agent is selected from pulullan, hydroxypropul starch, hydroxypropyl methyl starch, pregelatinized starch, amylose, CMS, HES, hydroxyl
Propyl group starch etc.；Described polyaminoacid is selected from polyglutamic acid, polyalanine, polylysine etc.；Affiliated glycan is selected from fucoidin, synanthrin etc..
Described disintegrant includes but is not limited to starch (wheaten starch, cornstarch, green starch, sweet potato starch, farina, cassava
Starch etc.), modified starch series (α, β, cyclooctaamylose, maltodextrin, amylose, crosslinked starch and its esters, esterification starch, ether
Change starch, graft starch, oxidative crosslinked starch, esterified and cross-linked starch and its esters, phosphate ester starch, acidified starch, cationic starch, carboxylic first
Base starch and its esters etc.), cellulose family (microcrystalline cellulose etc.), cellulose ethers (methylcellulose, carboxymethyl cellulose, carboxymethyl cellulose
Plain sodium, calcium carboxymethylcellulose, hydroxypropyl methyl cellulose, carboxyethylmethylcellulose, low substitution carboxy-propyl cellulose etc.), water-insoluble gathers
Compound (PVPP, grafting starch copolymer etc.), talcum powder, gelatin, silica, superfine silica gel powder etc..
Described lyophilized formulations wherein also contain other auxiliary materials, and other auxiliary materials are skeleton supporting agent, antioxidant, flavouring and essence, across glutinous
One or more in film or skin penetration enhancer, pH adjusting agent and lubricant.
The skeleton supporting agent is comprising sugared (such as maltose, trehalose etc.), sugar alcohol (such as mannitol, sorbierite), 2-12 carbon atoms is not limited to
The material such as amino acid (such as glycine, alanine, glutamic acid) and inorganic salts (such as sodium phosphate, alumina silicate).
The antioxidant includes but is not limited in vitamin C and its derivative, anthocyanidin, resveratrol, the polyhydric phenols of plant origin
One or several kinds of mixtures；
The flavouring and essence include but is not limited to mint flavored, chocolate flavoured, fruity, vanilla flavored, caf, tea flavour, corn taste, lemon,
The mixture of essence such as milk flavor or more one or more fragrance；
Described any included but is not limited to across mucous membrane or skin penetration enhancer in lecithin, saponin(e, bay alkyd sodium, azone, tween, sapn
Plant or several mixtures；
The pH adjusting agent include but is not limited to any one of citric acid, tartaric acid, sodium acid carbonate, carbonate, sodium carbonate, phosphate or
Several mixtures；
Described lubricant is selected from calcium carboxymethylcellulose, sodium carboxymethylcellulose, glycerine, fatty acid glyceride, wheaten starch, sucrose-fatty
Ester, stearyl alcohol, stearic acid, cetanol, gelatin, cornstarch, tapioca, modified tapioca starch, farina, superfine silica gel powder, cunning
Stone flour, pearl powder, hydrogenated vegetable oil, polyoxyethylene polyoxypropylene glycol, the moon hang alcohol magnesium sulfate, polysorbate, polyethylene glycol, monostearate
Glyceride and any or several mixture of lauryl sodium sulfate etc..
The product prepared using the method for the present invention, according to mold shape or the difference of the cavity surrounded, its shape can have any shape.
It is preferred that, its be shaped as figure of tablet, capsule shape, soft capsule shape, spherical, elliposoidal or various personages, animal, plant, food,
Pattern identification or cartoon character.The product prepared using the method for the present invention, can be without sharp edge according to the shape of mould.
Lyophilized formulations are prepared using the method for the present invention, it is advantageous that：
(1) ice pellets, ice powder is made for raw material in preparation method, it is possible to the preparation method of other supplementary materials of further hybrid solid or liquid, will be formulated
The supplementary material scope increase adapted to, and also more existing lyophilized excipient formulation products are bigger for drugloading rate.
(2) word or pattern can be engraved on mould any part, correspondingly, word or pattern also occur on any part of obtained product,
It can be name of product or trade mark, and this is that existing lyophilized excipient product can not possess.
(3) product made from can be designed that arbitrary shape non-breakable within a package, reduces medicine loss and makes medicine taking dose accurate.
(4) method of the invention prepares form of the lyophilized formulations using the demoulding, and packaging material does not enter lyophilized process, improves production efficiency, reduces production
Cost, energy-conserving and environment-protective.
(5) lyophilized shaped preparation easy disintegrating prepared by method of the invention, will not because of dosage form specific effect to disintegrative.
Brief description of the drawings
Fig. 1-Fig. 7 is step of preparation process figure.
Embodiment
The present invention is further illustrated by the following examples, but the present invention is not restricted to this.
Embodiment 1
A, 1 liter of water, VC powder 100g, pulullan 40g be configured to solution, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into flakes ice powder, be for component 2；
C, by CMS 40g dry powder, talcum powder 30g dry powder is well mixed, is sufficiently mixed with component 2, forms component 3；
D, by component 3 be fitted into spherical die 11 it is quantitative form quantitative component 4, and be subject to external force and suppressed to close；
E, component 4 freezed, form freeze-dried type whitening solid elite.
Embodiment 2
A, by VE 100g, tween 30g, mannitol 50g, card ripple 30g, triethanolamine 50ml add 1 liter and are configured to emulsion, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into ice crystal, and travel further into Lowtemperaturepulverizer and crushed
It is for component 2 to 200 mesh sieves are crossed；
C, by sodium carboxymethylcellulose 40g dry powder, magnesium stearate 5g dry powder blends are uniform, are sufficiently mixed with component 2, form component 3；
D, component 3 is loaded into elliposoidal mould quantified, form quantitative component 4, and be subject to certain pressure, be pressed into component 4；
E, component after compacting 4 freezed, form freeze-dried type VE milk solids paste 12.
Embodiment 3
A, by nano-glass pearl powder 200g, xanthans 30g, add 1 liter of water and be configured to suspension, dispersed formation liquid 1；
B, liquid 1 freezed, and after the freezing, crushed its physics using Lowtemperaturepulverizer, formed ice pellets, be for component 2；
C, by low-substituted hydroxypropyl cellulose 40g dry powder, tapioca 10g dry powder blends are uniform, mixed with component 2, form component 3
D, component 3 is loaded into dome-type mould quantified, form quantitative component 4；
E, component 4 freezed, form the oral pearl powder health-care food of freeze-dried type.
Embodiment 4
A, by niacinamide 50g, gelatin 20g, PVPK20g, add 1 liter of water and be configured to solution, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into small ice crystal ice powder, be for component 2；
C, by pulullan 20g dry powder, trehalose 30g dry powder, crosslinked carboxymethyl fecula sodium 30g dry powder blends are uniform, are sufficiently mixed with component 2,
Form component 3；
D, by component 3 be fitted into spherical die 11 it is quantitative form quantitative component 4, and be subject to external force and suppressed to close；
E, component 4 freezed, form freeze-dried type whitening solid elite.
Embodiment 5
A, by GTCC 80g, polysorbas20 g, konjac glucomannan 10g, PVPP 10g adds 1 liter of water and is configured to emulsion, forms liquid 1；
B, liquid 1 freezed, sprayed in refrigerating process using liquid nitrogen, form it into small ice crystal ice powder, be for component 2；
C, by pulullan 30g dry powder, modified tapioca starch 10g is sufficiently mixed with component 2, is used as component 3；
D, component 3 is fitted into cubic type mould 11 quantitative, forms quantitative component 4；
E, component 4 freezed, formed and freeze instant type moisturizing emulsion.
Embodiment 6
A, by resveratrol 120g, Propiram 20g, trehalose 50g, PVPP 10g adds 2 liters of water and is configured to suspension, forms liquid 1；
B, liquid 1 freezed, Lowtemperaturepulverizer is entered after freezing, powder to ice pellets crosses 200 mesh sieves, is for component 2；
C, carboxymethyl cellulose 15g, cornstarch 10g be sufficiently mixed with component 2, be used as component 3；
D, component 3 is fitted into quantitative in triangular prism pattern tool 11, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form the oral resveratrol health products of freeze-dried type.
Embodiment 7
A, by Brazilian blackberry extract 200g, add 1 liter of water and be configured to solution, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, Propiram 30g, trehalose 10g, microcrystalline cellulose 10g dry powder is sufficiently mixed, and is sufficiently mixed with component 2, be used as component 3；
D, component 3 is fitted into cylindrical type mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form the Brazilian blackberry, blueberry buccal tablet of freeze-dried type.
Embodiment 8
A, by skimmed milk power 300g, add 1 liter of water and be configured to emulsion, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, hydroxyethyl cellulose 20g, maltodextrin 200g, sodium carboxymethyl starch 40g be sufficiently mixed uniformly, and be sufficiently mixed with component 2, formed
Component 3；
D, component 3 is fitted into spherical die 11 quantitative, forms quantitative component 4；
E, component 4 freezed, form freeze-dried type milk piece.
Embodiment 9
A, by sildenafil citrate 100mg, add 1 liter of water and be configured to suspension, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, 200 mesh sieves can be crossed by being crushed to, form ice pellets, be for component 2；
C, by Propiram 10g, mannitol 30g, Lactis Anhydrous 15g, Ac-Di-Sol 15g dry powder blends are uniform, and abundant with component 2
Mixing, forms component 3；
D, component 3 is fitted into elliposoidal mould 11 quantitative, forms quantitative component 4；
E, component 4 freezed, form sildenafil citrate medicine oral disintegrating tablet.
Embodiment 10
A, by birch extract 100g, add 1 liter of water and be configured to solution, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, dried tremella extract dry powder 20g, Propiram 20g, tuckahoe extracts 5g, methylcellulose 10g, talcum powder 10g be sufficiently mixed with component 2,
Fully mixed, form component 3；
D, component 3 is fitted into leaf type mould 11 quantitative, forms quantitative component 4；
E, component 4 freezed, form freeze-dried type birch white fungus Poria cocos solid beverage.
Embodiment 11
A, by milk powder 100g, add 500ml water and prepare emulsion, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, by strawberry powder 20g, maltodextrin 50g, carboxymethyl cellulose 15g, magnesium stearate 1g, be sufficiently mixed with component 2, formed component 3；
D, component 3 is fitted into strawberry type mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type strawberry milk solid beverage.
Embodiment 12
A, by trehalose 30g, PVPK10g, Notogineng Extract 50g, PVPP 20g, add 1 liter of water and be configured to solution, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, ice pellets shape is ground into, is for component 2；
C, by ginseng extract dry powder, be sufficiently mixed with component 2, be used as component 3；
D, component 3 is fitted into tablet form mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form molten of freeze-dried type pseudo-ginseng liquor.
Embodiment 13
A, by Nexbase 2004 300ml, glycerine based oleic acid citrate 200ml, dried tremella extract 20g, fucoidin 10g, add 1 liter of water and prepare
Into emulsion, liquid 1 is formed；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, hyaluronic acid 10g will be hydrolyzed, green-tea extract 5g dry powder, Ac-Di-Sol 10g dry powder is sufficiently mixed with component 2, as
Component 3；
D, component 3 is fitted into spherical module 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type green tea moisturizing emulsion.
Embodiment 14
A, by Propiram 50g, VC100g, add in 1 liter of water, be configured to solution, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, ice pellets shape is ground into, is for component 2；
C, by VC powder 300g, modified tapioca starch 50g, low-substituted hydroxypropyl cellulose 30g dry powder is sufficiently mixed with component 2, is used as component 3；
D, component 3 is fitted into alphabetical shape mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type vitamin C buccal tablets.
Embodiment 15
A, by Propiram 80g, mannitol 30g, add 1 liter of water and be configured to solution, be used as liquid 1；Liquid 1 is freezed, liquid nitrogen is during which used
Sprinkling, forms it into snowflake ice powder, low-temperature grinding is carried out afterwards, obtain ice Granular compositions 2；
B, by racecadotril 75g, crosslinked carboxymethyl fecula sodium 15g dry powder is sufficiently mixed with component 2, is used as component 3；
C, component 3 is fitted into hemispherical 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
D, component 4 freezed, form freeze-dried type children therapy diarrhoea medicine.
Embodiment 16
A, by carbomer 20g, triethanolamine 30ml, EGF25000IU, be configured to solution, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, by Propiram 30g, polyglutamic acid 15g, Sodium Hyaluronate 5g, Ac-Di-Sol 15g, superfine silica gel powder 5g dry powder and component 2
It is sufficiently mixed uniform, formation component 3；
D, component 3 is fitted into alphabetical shape mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form the anti-ageing solid elite of freeze-dried type.
Embodiment 17
A, by carbomer 30g, triethanolamine 50ml, ethoxy urea 100ml, PVPK30g, polypropylene glycerol ester 100ml, starch octenyl succinic
Sour sodium 50g, PVPP 50g are configured to emulsion, form liquid 1；
B, liquid 1 freezed, and in refrigerating process, sprayed using liquid nitrogen, formed it into snowflake ice powder, be for component 2；
C, by xanthans 15g, aloe extract 10g, superfine silica gel powder 10g dry powder is thoroughly mixed to form component 3 with component 2；
D, component 3 is fitted into elliposoidal mould 11 quantitative, forms quantitative component 4；
E, component 4 freezed, form freeze-dried type moisturizing emulsion elite.
Embodiment 18
A, by ultra-fine silicone elastomer 50g, gelatin 20g, ursin 50g, add and suspension be configured in 1 liter of water, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, ice pellets shape is ground into, is for component 2；
C, by licorice dry powder 10g, pulullan 20g, sodium carboxymethylcellulose 15g dry powder fully mixes with component 2 and forms component 3；
D, component 3 is fitted into tablet form mould 11 quantitative, forms quantitative component 4；
E, component 4 freezed, form freeze-dried type whitening BB powder.
Embodiment 19
A, by 100g maltodextrins, add and solution be configured in 1 liter of water, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, ice pellets shape is ground into, is for component 2；
C, by 30g acetylsalicylic acid powders, be sufficiently mixed with component 2, be used as component 3；
D, component 3 is fitted into tablet form mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type aspirin oral disintegrating tablet.
Embodiment 20
A, by 100g farinas, add and solution be configured in 1 liter of water, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, ice pellets shape is ground into, is for component 2；
C, by milk powder 500g, sodium carboxymethylcellulose 50g, magnesium stearate 10g dry powder is sufficiently mixed with component 2, is used as component 3；
D, component 3 is fitted into spherical module 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type milks solids beverage.
Embodiment 21
A, by hydroxypropyl cellulose 100g, add dispersed in 1 liter of water, form suspension, form liquid 1；
B, liquid 1 freezed, super-low temperature pulverizator is entered after freezing, ice pellets shape is ground into, is for component 2；
C, by general ginsenoside 30g, Notogineng Extract 10g, fully mixed with component 2 and be used as component 3；
D, component 3 is fitted into cylindrical type mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type Panax pseudoginseng oral disintegrating tablet medicine.
Embodiment 22
A, by 1 liter of water, as liquid 1, freezed, and in refrigerating process, sprayed using liquid nitrogen, form it into snowflake ice powder, be for component 2；
B, by xanthans 15g, rose extract dry powder 5g, radix paeoniae alba extraction 3g, mannitol 10g, Ac-Di-Sol 15g dry powder with
Component 2 fully mixes and forms component 3；
C, component 3 is fitted into Rose type mould 11 quantitative, forms quantitative component 4；
D, component 4 freezed, form freeze-dried type rose whitening facial treatment essence.
Embodiment 23
A, by 1 liter of water, as liquid 1, freezed, and in refrigerating process, sprayed using liquid nitrogen, form it into snowflake ice powder, carry out afterwards low
Temperature is crushed, and obtains ice Granular compositions 2；
B, by collagen protein powder 50g, vitamin C 10g, carragheen 10g, pectin 5g, glucose 30g, sodium carboxymethylcellulose 20g and component 2
It is thoroughly mixed to form component 3；
C, component 3 is fitted into fruit type mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
D, component 4 freezed, form freeze-dried type collagen solid beverage.
Embodiment 24
A, by 1 liter of water, as liquid 1, freezed, and in refrigerating process, sprayed using liquid nitrogen, form it into snowflake ice powder, carry out afterwards low
Temperature is crushed, and obtains ice Granular compositions 2；
B, by nano grade titanium white powder 50g, Sodium Hyaluronate 10g, Dextran 10 g, mannitol 20g, PVPP 15g dry powder fills with component 2
Divide mixing, form component 3；
C, component 3 is fitted into shell type mould 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
D, component 4 freezed, form freeze-dried type solid-state BB frosts.
Embodiment 25
A, by 1 liter of water, as liquid 1, freezed, and in refrigerating process, sprayed using liquid nitrogen, form it into snowflake ice powder, carry out afterwards low
Temperature is crushed, and obtains ice Granular compositions 2；
B, by whortle extract 300g dry powder, CMS 50g dry powder is sufficiently mixed with component 2, is used as component 3；
C, component 3 is fitted into spherical module 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
D, component 4 freezed, form freeze-dried type cowberry solid beverage.
Embodiment 26
A, 500g pollen is taken, extracted, retain the water-soluble substances of molecular weight 6000-16000 dalton；
B, by Sucralose 12g, pollen extract 100g, add that 1 liter of water is dispersed to be configured to suspension, be used as liquid 1；Liquid 1 is carried out
Freezing, is during which sprayed using liquid nitrogen, forms it into snowflake ice powder, low-temperature grinding is carried out afterwards, obtain ice Granular compositions 2；
C, by gelatin hydrolysate 80g, crosslinked carboxymethyl fecula sodium 40g dry powder is sufficiently mixed with component 2, is used as component 3；
D, component 3 is fitted into spherical die 11 quantitative, forms quantitative component 4, and be subject to external force and suppress to close；
E, component 4 freezed, form freeze-dried type pollen oral vaccine.
Composition composition involved in the present invention, form and preparation method are not limited to form cited in embodiment, embodiment be only the present invention compared with
Good embodiment, it is impossible to which protection domain is limited with this.All simple or equivalent changes and modification with described in scope of the presently claimed invention,
Come under protection scope of the present invention.
Claims (16)
1. a kind of any form of easy disintegrating freezes shaped preparation and preparation method thereof, it is characterised in that wrapped in the lyophilized shaped preparation
Include water, binding agent, active material and disintegrant；Its preparation method comprises the following steps：
A. will as above four kinds of materials are after all mixing or part are mixed, wiring solution-forming, suspension or emulsion form liquid 1；
Or water individualism, form liquid 1；
B. liquid 1 is freezed, in refrigerating process or after freezing, liquid 1 is freezed by physical method and ice pellets is ground into
Or ice powder, it is for component 2；
C. prepare after liquid 1, if surplus materials, it is sufficiently mixed with component 2 in technical process A, form component 3；
Such as fruit component 2 is the ice pellets or ice powder of pure water formation, then by binding agent, disintegrant and active material and the pure water
The ice pellets or ice powder of formation are sufficiently mixed, or the solution of binding agent, disintegrant and active material is formed with the pure water
Ice pellets or ice powder be sufficiently mixed, formed component 3；
D. component 2 or component 3, are fitted into quantitative in the effigurate mould 11 of tool；Form quantitative component 4；
E. the component 4 after will be quantitative is freeze-dried, and forms lyophilized shaped article 12.
2. as claimed in claim 1, the liquid 1 of step A：Can be water；Can also be water dissolving or scattered part or complete
The binding agent in portion；Can also be water dissolving or scattered partly or completely active material；It can also be water dissolving or scattered
Partly or completely disintegrant；Can also be part aqueous solution or scattered binding agent and disintegrant, part aqueous solution or point
Dissipate active material；Water dissolving or scattered partly or completely active material, binding agent and disintegrant are can also be, can be with
It is itself natural materials or extract containing moisture, including but not limited to milk, fruit juice and royal jelly etc..
3. the preparation method as described in claim 1 and 2, it is characterised in that：Compression step is added between step D and E, will
Quantitative component 4 is compressed into certain shape and density, forms component 5, is afterwards freeze-dried component 5, forms lyophilized shaping
Product 12.
4. the preparation method according to claim 1-3, it is characterised in that：Active component, includes but is not limited to human body and moves
The beneficial chemicals composition of thing, traditional Chinese medicine ingredients, natural extract, bioactive ingredients, biological products, disinfectant,
Oral diet supplementation and to one or more kinds of combinations in skin nursing beneficiating ingredient；In some cases, activity into
Moisture can also be contained as binding agent or in itself by dividing, and is not used other adhesives or added water.
5. the preparation method according to claim 1-4 any one, it is characterised in that described binding agent be edible or
Pharmaceutically useful a kind of water-soluble high-molecular material or its mixture can be polysaccharide, polypeptide, protein or manually gather
Macromolecule is closed, or by modified natural macromolecular material or its mixture, can also be the day containing water soluble polymer
Right material.
6. the preparation method according to claim 1-5 any one, it is characterised in that described binding agent is including but not limited to bright
Glue class (gelatin, isinglass, bird gelatin, gelatin hydrolysate etc.), cellulose ethers (methylcellulose, carboxymethyl cellulose,
Hydroxypropyl methyl cellulose, carboxyethylmethylcellulose etc.), it is modified starch (pulullan, hydroxymethyl starch etc.), transparent
Matter acids, albumin, dextran, chitosan and its different molecular weight product, sodium alginate, PVP, PVA, poly- second two
Alcohol, Arabic gum, guar gum, xanthans, konjac glucomannan, carragheen, carbomer, agar, carrageenan, pectin, card
Ripple, polyaminoacid or combinations thereof etc., and the natural material containing water soluble polymer.
7. the preparation method according to claim 1-6 any one, it is characterised in that described disintegrant includes but is not limited to
Starch (wheaten starch, cornstarch, green starch, sweet potato starch, farina, tapioca etc.), it is modified to form sediment
Powder class (α, β, cyclooctaamylose, maltodextrin, amylose, crosslinked starch and its esters, esterification starch, etherificate
Starch, graft starch, oxidative crosslinked starch, esterified and cross-linked starch and its esters, phosphate ester starch, acidified starch, cation
Starch, CMS and its esters etc.), cellulose family (microcrystalline cellulose etc.), cellulose ethers (methylcellulose,
Carboxymethyl cellulose, sodium carboxymethylcellulose, calcium carboxymethylcellulose, hydroxypropyl methyl cellulose, carboxyethylmethylcellulose,
Low substitution carboxy-propyl cellulose etc.), insoluble polymer (PVPP, grafting starch copolymer etc.), talcum powder,
Gelatin, silica, superfine silica gel powder etc..
8. the preparation method according to claim 1-7, it is characterised in that described in step A-C, liquid 1, component 2,
Other auxiliary materials can also further be increased in component 3 and component 4, other auxiliary materials are skeleton supporting agent, antioxidant, flavouring
With essence, across the one or more in mucous membrane or skin penetration enhancer, pH adjusting agent, lubricant.
9. the preparation method according to claim 1-8, it is characterised in that described skeleton supporting agent, which is included, is not limited to sugar (such as
Maltose, trehalose etc.), sugar alcohol (such as mannitol, sorbierite), amino acid (such as glycine, third of 2-12 carbon atoms
Propylhomoserin, glutamic acid etc.) and the material such as inorganic salts (such as sodium chloride, sodium phosphate, alumina silicate)；Described antioxidant choosing
One or several kinds from vitamin C and its derivative, anthocyanidin, resveratrol, the polyhydric phenols of plant origin
Mixture；Described flavouring and essence are selected from mint flavored, chocolate flavoured, fruity, vanilla flavored, caf, tea flavour, jade
The mixture of the one or more of fragrance of the essence such as rice taste, lemon, milk flavor or more；Described promotees across mucous membrane or Transdermal absorption
Enter agent and be selected from any of lecithin, saponin(e, bay alkyd sodium, azone, tween, sapn or several mixtures；It is described
PH adjusting agent be selected from any one of citric acid, tartaric acid, sodium acid carbonate, carbonate, sodium carbonate, phosphate or number
The mixture planted；Described lubricant be selected from calcium carboxymethylcellulose, sodium carboxymethylcellulose, glycerine, fatty acid glyceride,
Wheaten starch, sucrose fatty ester, stearyl alcohol, stearic acid, cetanol, gelatin, cornstarch, tapioca, innovation wood
Sweet potato starch, farina, superfine silica gel powder, talcum powder, pearl powder, hydrogenated vegetable oil, polyoxyethylene polyoxypropylene glycol,
The moon hangs any or several of alcohol magnesium sulfate, polysorbate, polyethylene glycol, glycerin monostearate and lauryl sodium sulfate
Mixture etc..
10. the preparation method according to claim 1-9 any one, it is characterised in that ice pellets or ice powder in the step B
Particle diameter be 0.1-5000 μm, preferably 0.1-200 μm.
11. the preparation method according to claim 1-10 any one, it is characterised in that described mould can be arbitrary shape
Shape can be unidirectional demoulding type, can also be that multi-mould is combined；It is existed by penetration hardness in more than 0.1N, thermal conductivity factor
More than 0.01W/ (m.k) material is made, its one kind in metal, high polymer material, ceramics, glass or by described
More than one of material are collectively formed.
12. the preparation method according to claim 1-11 any one, it is characterised in that the surface of the mould can also be entered
One step is surface-treated, can break away from moulds well after making it upon compression or being lyophilized.
13. the product that any one preparation method is prepared in claim 1-12.
14. product according to claim 13, it is characterised in that it is arbitrary shape.
15. product according to claim 14, it is characterised in that the product does not have sharp edge.
16. the product according to claim 13 or 15, it is characterised in that it is figure of tablet, capsule shape, soft capsule
Shape, spherical, elliposoidal or various personages, animal, plant, food, pattern identification or cartoon character.
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| CN201610022474.5A CN106963737A (en) | 2016-01-13 | 2016-01-13 | A kind of any form of easy disintegrating freezes shaped preparation and preparation method thereof |
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| CN201610022474.5A CN106963737A (en) | 2016-01-13 | 2016-01-13 | A kind of any form of easy disintegrating freezes shaped preparation and preparation method thereof |
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| WO2018028531A1 (en) * | 2016-08-11 | 2018-02-15 | 董玲 | Lyophilized preparation and preparation method therefor |
| CN108057134A (en) * | 2017-12-26 | 2018-05-22 | 湖北回盛生物科技有限公司 | A kind of milk cow midwifery lubricant and preparation method thereof |
| CN109430409A (en) * | 2018-12-24 | 2019-03-08 | 光明乳业股份有限公司 | A kind of milk tablet and preparation method thereof for adding marine algae extract |
| CN112569134A (en) * | 2020-12-29 | 2021-03-30 | 广州星际悦动股份有限公司 | Cleaning composition and preparation method thereof |
| CN112655769A (en) * | 2020-12-21 | 2021-04-16 | 山东天源人乳库科技发展有限公司 | Human milk flash-release tablet and preparation method thereof |
| CN112972404A (en) * | 2019-12-02 | 2021-06-18 | 北京兴源联合医药科技有限公司 | Sildenafil freeze-dried orally disintegrating tablet and preparation method thereof |
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| WO2018028531A1 (en) * | 2016-08-11 | 2018-02-15 | 董玲 | Lyophilized preparation and preparation method therefor |
| CN108057134A (en) * | 2017-12-26 | 2018-05-22 | 湖北回盛生物科技有限公司 | A kind of milk cow midwifery lubricant and preparation method thereof |
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| CN109430409A (en) * | 2018-12-24 | 2019-03-08 | 光明乳业股份有限公司 | A kind of milk tablet and preparation method thereof for adding marine algae extract |
| CN109430409B (en) * | 2018-12-24 | 2022-09-27 | 光明乳业股份有限公司 | Milk tablet added with seaweed extract and preparation method thereof |
| CN112972404A (en) * | 2019-12-02 | 2021-06-18 | 北京兴源联合医药科技有限公司 | Sildenafil freeze-dried orally disintegrating tablet and preparation method thereof |
| CN112655769A (en) * | 2020-12-21 | 2021-04-16 | 山东天源人乳库科技发展有限公司 | Human milk flash-release tablet and preparation method thereof |
| CN112569134A (en) * | 2020-12-29 | 2021-03-30 | 广州星际悦动股份有限公司 | Cleaning composition and preparation method thereof |
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