CN107296796A

CN107296796A - A kind of formula of lyophilized formulations and preparation method thereof

Info

Publication number: CN107296796A
Application number: CN201610232750.0A
Authority: CN
Inventors: 董玲
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-04-14
Filing date: 2016-04-14
Publication date: 2017-10-27

Abstract

The invention discloses a kind of formula of lyophilized formulations and preparation method thereof, more particularly to a kind of binding agent being made up of lysolecithin, Scleroglucan, xanthans, Propiram, sodium phytate, hydroxyethyl cellulose is combined, and the formula for lyophilized preparation that active component is constituted.Its preparation process is, formula supplementary material material is configured to solution, by lyophilized formulations stoste by process of congealing, form sludge ice mixture, by sludge ice mixture load freeze-drying and dehydrating formation after quantitative mould, arbitrary shape, mainly contain active component and the preparation method of the lyophilized formulations of binding agent and according to product made from this method.

Description

A kind of formula of lyophilized formulations and preparation method thereof

Technical field

The invention discloses a kind of formula of lyophilized formulations and preparation method thereof, it is more particularly to a kind of by lysolecithin, Scleroglucan, The formula for lyophilized preparation of xanthans, Propiram, sodium phytate, the binding agent combination of hydroxyethyl cellulose composition, and active component composition.Its Preparation process is that formula supplementary material material is configured into solution, by lyophilized formulations stoste by process of congealing, forms sludge ice mixture, will Sludge ice mixture load freeze-drying and dehydrating formation after quantitative mould, arbitrary shape, mainly contain active component and binding agent The preparation method of lyophilized formulations and according to product made from this method.

Background technology

Lyophilized figuration technology refer in the active component of flowable liquid, semisolid or solid addition skeleton supporting agent, binding agent etc. into Point, or itself, containing compositions such as binding agent, skeleton supporting agents, is then filled into the flowable liquid, semisolid or solid In mould, the preparation prepared by freezing figuration technology is referred to as lyophilized excipient.

Its technical process of lyophilized figuration technology, is that wet stock or solution are frozen into solid-state at relatively low temperature (- 10 DEG C~-50 DEG C), Then moisture therein is directly sublimed into gaseous state without liquid under vacuum (1.3~13 handkerchief), finally make material dewatering.

Because such preparation uses freeze drying process, thermally sensitive composition can be protected not to be destroyed, while being produced by water sublimed a large amount of Micropore and duct, can have disintegration and dissolution velocity quickly, therefore receive extensive use, can apply to oral disnitegration tablet, speed Release the multiple fields such as piece, chewable tablets, novel cosmetic, health products, solid beverage, medicine, medicine equipment.

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 taking off Mould refers to directly be molded in the packaging material of definite shape, therefore the special shape such as rare spherical, elliposoidal, irregular ball-shape, Due to traditional preparation method, it is difficult to the lyophilized excipient of special shape is made.

(2) adhesion between material and mould is big, causes mold wall to adhere to a large amount of materials, be difficult to be stripped, production cost is improved.

(3) there are tablet made from the numerous tablets with sharp edge obtained after sharp edge, the demoulding together to enter acute angle after same packaging Easily worn and torn between side, cause the inaccurate of drug dose.

(4) because one direction is filling, it is difficult to which, as sandwich construction, therefore, preparation structure is single.

Inventor is dedicated itself to innovation, and has carried out a large amount of in-depth studies and experiment work, and the principle based on lyophilized excipient preparation manufacturing process is carried out Process optimization is there is provided a kind of method of lyophilized formulations that can prepare arbitrary shape and its according to product made from this method, particularly It is related to a kind of binding agent being made up of lysolecithin, Scleroglucan, xanthans, Propiram, sodium phytate, hydroxyethyl cellulose to combine, And the formula for lyophilized preparation of active component composition.Its preparation process is formula supplementary material material to be configured into solution, by lyophilized formulations stoste By the process of congealing, sludge ice mixture is formed, sludge ice mixture is loaded into freeze-drying and dehydrating formation, arbitrary shape after quantitative mould Shape, mainly contain active component and the preparation method of the lyophilized formulations of binding agent and according to product made from this method.

The especially process of congealing of supplementary material.Feed liquid pours into the congealing in cylinder of freezing machine by charging aperture, is mixed by the curette therein that stirs, The refrigerant congealed simultaneously in barrel is freezed to slurry, is frozen in the feed liquid congealed on an inwall and is gathered by the super high molecular weight stirred on curette The ceaselessly scraping of ethene blade.Feed liquid is continuously freezed, scraping, be mixed into air stirring, eventually becomes expansion rate, tissue fine and smooth Sludge ice mixture, temperature is generally -6 DEG C~-9 DEG C.This technique requires higher to the solid content of feed liquid.

The invention further relates to a kind of zero attachment technique.Have recognized that the physical phenomenon of zero sticking temperature in WO90/06693 patents, and Applied in the manufacturing process of frozen food in the patents of WO 2007128658.Thus inspired inventor that zero attachment technique is applied into this work Skill.

The present invention solves the problem of lyophilized formulations form is single, and mould can be designed as needed, and lyophilized formulations are prepared into each of needs Shape is planted, allows lyophilized formulations to show more various form, structure (double-layer tablets, multilayer tablet) and control production cost at one In controlled range.

The content of the invention

The invention provides a kind of formula of lyophilized formulations, it is made up of the active component and binding agent of effective dose, binding agent is by haemolysis lecithin Fat, Scleroglucan, xanthans, Propiram, sodium phytate, hydroxyethyl cellulose composition, it is 0.1%-99.9%'s to account for tablet weight percentage Binding agent is combined, and the ratio between weight and the volume of lyophilized formulations are 0.1mg/cm³-5000mg/cm³。

The binding agent to account for tablet weight percentage 0.1%-99.9%, can further be optimized for 0.5%-50%, 1%-50%, 0.5%-30%, 1%-30%, 0.5%-20%, 1%-20%, 0.5%-10%, 1%-10%, most preferably 1%-20%.

The ratio between weight and volume of the lyophilized formulations are 0.1mg/cm³-5000mg/cm³, can further be optimized for 1mg/cm³-500 mg/cm³、10mg/cm³-50mg/cm³、100mg/cm³-50mg/cm³、1000mg/cm³-5mg/cm³, most preferably 100mg/cm³-50mg/cm³。

The formula of described lyophilized formulations, can also further add additional adhesive, account for tablet weight percentage for 0.1%-99.9%, enter One step can be optimized for 0.5%-50%, 1%-50%, 0.5%-30%, 1%-30%, 0.5%-20%, 1%-20%, 0.5%-10%, 1%-10%, Most preferably 1%-20%.

Described additional adhesive be selected from native starch, modified starch series, cellulose ethers, polyvinyl alcohol copolymer class, glue class, PVP, Carbomer, PVA, hyalomitome acids, albumin, chitosan, dextran, agar, polyaminoacid, glycan or combinations thereof.

The native starch class includes tapioca, farina, cornstarch, rice starch, wheaten starch, oat starch, open country One or more combinations in amylum marantae；The modified starch include modified corn starch, modified potato starch, modified tapioca starch, Hydrogenated starch, hydrogenated starch hydrolysate, Sodium Polyacrylate graft starch, polyacrylic acid grafted starch, hydroxypropul starch, hydroxypropul starch Phosphate, amylose, amylopectin, CMS, sodium carboxymethyl starch, cornstarch/acrylamide/sodium Acrylate copolymer In one or more combinations；It is carboxymethyl cellulose, carboxyethyl cellulose, hydroxyl that the cellulose ethers, which includes cellulose ethers binding agent, One or more combinations in ethylmethylcellulose, hydroxypropyl methyl cellulose；The polyvinyl alcohol copolymer class is handed over including polyvinyl alcohol One or more groups in linked polymer, polyvinyl alcohol/methyl acrylate graft copolymer, polyving alcohol/polylactic acid co-glycolic acid Close；The glue class include pectin, carragheen, xanthan gum, collagen, hydrolytic collagen, gelatin, gelatin hydrolysate, Arabic gum, konjac glucomannan, Carrageenan, locust bean gum, natural gum, locust bean gum etc.；Described polyaminoacid is selected from polyglutamic acid, polyalanine, polylysine etc.； Affiliated glycan is selected from fucoidin, synanthrin etc..

The active component, which can be dissolved in water, can also be insoluble in the material of water, and the active component is selected from chemicals composition, Chinese medicine One or more kinds of combinations in composition, 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, for example levodopa, compound carbidopa, compound benserazide, amantadine hydrochloride, Piribedil, phenolicamine, donepezil, huperzine are first-class；

Psychotolytic, such as chlorpromazine, fenazil, pethidine, thioridazine, Chlorprothixene, Clozapine, Sulpiride, Thailand must Profit, penfluridol, Risperidone etc.；

Antiepileptic and anticonvulsive drug, such as dilantin sodium, carbamazepine, Primidone, Gabapentin, Lamotrigine, sodium vedproate, Clonazepam etc..

Hypnotic sedative agent, such as diazepam, nitrazepam, Oxazepam, Lorazepam, phenobarbital；

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, Simvastatin, 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, friendship Arenomycin etc..

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, compound danshen dripping pills 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, hawthorne leaf P.E, accumulated snow Careless total glycosides, ginkgo biloba p.e etc..

Natural plant extracts：

Such 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, lycopene, green-tea extract, grape pip and grape skin extract, glabridin, Paeoniflorin, licoflavone, the root bark of tree peony are carried Take thing etc..

Bioactive ingredients：

EGF, bFGF, aFGF, KGF, IGF, NGF, TGF, HGH, EPO, G-CSF, GM-CSF, various antibody Medicine, 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, 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..

A kind of formula of described lyophilized formulations, can also further contain other auxiliary materials, and other auxiliary materials include skeleton agent, anti-oxidant One or more in agent, flavouring and essence, skin penetration enhancer, PH conditioning agents, disintegrant.

A kind of formula of described lyophilized formulations, the skeleton agent is (such as sweet comprising sugar (such as maltose, trehalose), sugar alcohol is not limited to Reveal alcohol, sorbierite), the amino acid (such as glycine, alanine, glutamic acid) of 2-12 carbon atoms and inorganic salts (such as sodium phosphate, Alumina silicate etc.) etc. material；The antioxidant is selected from vitamin C, anthocyanidin, resveratrol, the polyhydric phenols of plant origin In one or several kinds of mixtures；The flavouring and essence are selected from mint flavored, chocolate flavoured, 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；The skin penetration enhancer be selected from lecithin, Any of tween, sapn or several mixtures；The PH conditioning agents are in citric acid, tartaric acid, sodium acid carbonate, sodium carbonate Any or several mixture；The disintegrant include but is not limited to starch (wheaten starch, cornstarch, green starch, Sweet potato starch, farina, tapioca etc.), modified starch series (α, β, cyclooctaamylose, maltodextrin, amylose, Crosslinked starch and its esters, esterification starch, etherification starch, graft starch, oxidative crosslinked starch, esterified and cross-linked starch and its esters, phosphorus Acid esters starch, acidified starch, cationic starch, CMS and its esters etc.), cellulose family (microcrystalline cellulose etc.), cellulose Ethers (methylcellulose, carboxymethyl cellulose, sodium carboxymethylcellulose, calcium carboxymethylcellulose, hydroxypropyl methyl cellulose, carboxylic second Ylmethyl cellulose, low substitution carboxy-propyl cellulose etc.), insoluble polymer (PVPP, grafting starch copolymer etc.) is sliding Stone flour, gelatin, silica, superfine silica gel powder etc..

Any one described formula, the lyophilized formulations being made up of freeze drying process, it is characterised in that preparation method uses ice powder pressure Piece method, comprises the following steps：

A. after the mixing of supplementary material whole will be formulated or partly mixed, wiring solution-forming, suspension or emulsion, formation liquid 1；

B. by liquid 1 by congealing, and stirred during congealing, form sludge ice mixture, be for component 2；

C. prepare after liquid 1, if surplus materials 11, it is sufficiently mixed with component 2 in technique A, form component 4；

It is liquid condition after being mixed such as surplus materials 11, then by surplus materials again by congealing, stirring, forms sludge ice mixing Thing component 3, then component 2 and 3 is thoroughly mixed to form component 4；

Such as surplus materials 11 is solid state, then after surplus materials is fully mixed, and adds component 2, continues to stir, and forms component 4；

D. component 2 or component 4, are quantified using having effigurate mould 13, form quantitative component 5；

E. component 5 is carried out quick-frozen；

F. the component 5 after will be quick-frozen carries out freeze-drying and dehydrating, forms freeze-drying prods 12.

Described preparation method, the liquid 1 of step A：Can be water dissolving or scattered partly or completely binding agent；Can also be water Dissolving or scattered partly or completely active material；Can also be part aqueous solution or scattered binding agent, part aqueous solution or point Dissipate active material；Water dissolving or scattered partly or completely active material and binding agent are can also be, can also be and contain moisture in itself Natural materials or extract, including but not limited to milk, fruit juice and royal jelly etc..

The solid content of described preparation method, its solution 1 or surplus materials 11 be 0.1%-99.99%, preferably 0.5%-90%, 1%-90%, 5%-80%, 10%-80%, 20%-70%, 30%-60%, 35%-50%, most preferably 20%-50%.

Described preparation method, its frozen temperatures are 0 DEG C to -100 DEG C.Preferably -1 DEG C to -90 DEG C, -5 DEG C to -80 DEG C, -10 DEG C to -70 DEG C, -20 DEG C to -60 DEG C, -30 DEG C to -50 DEG C；More preferably -1 DEG C to -50 DEG C, -3 DEG C to -30 DEG C, -5 DEG C to -10 DEG C；Most preferably For -1 DEG C to -10 DEG C.

Described preparation method, compression step is added between step D and E, and quantitative component 5 is compressed into certain shape and density, Component 6 is formed, afterwards component 6 is freeze-dried, freeze-drying prods 12 are formed.

Described preparation method, the mould for being compressed into definite shape or sizing can have any shape, and can be unidirectional demoulding type, also may be used To be that multi-mould is combined；It is made up of penetration hardness in more than 0.1N, thermal conductivity factor in more than 0.01W/ (m.k) material, and it is selected Collectively formed from one kind in metal, high polymer material, ceramics, glass or by more than one of the material.

Described preparation method, it is characterised in that sludge ice mixture in the step B can further mixing air, make it have one Determine expansion rate, its expansion rate is 0%-100%, preferably 0-90%, 10-90%, 10-80%, 20-80%, 20-70%, 30-60%, most preferably 20-80%.

Described a kind of lyophilized formulations product, it is characterised in that the product does not have sharp edge.

Described a kind of lyophilized formulations product, it is characterised in that it is figure of tablet, capsule shape, soft capsule shape, spherical, ellipse Spherical or various personages, animal, plant, food, pattern identification or cartoon character.

A kind of described lyophilized formulations product, can apply to cosmetics, health products, food, human drugs, animal-use drug product, medical treatment Instrument field.

Embodiment

The present invention is further illustrated by the following examples, but the present invention is not restricted to this.

Embodiment 1：

By Va：Binding agent combination=5:The raw material of 2 ratios, be configured to 2% mixed solution；Mixing liquid is congealed by freezing machine, and Stirred during congealing, form sludge ice mixture；Sludge ice mixture is quantitatively fitted into heart-shaped mould quantitative, it is quick-frozen laggard Row freeze-drying, removes moisture removal, packs, and forms lyophilized formulations product.

Embodiment 2：

1g oligopeptides -5,3g notoginseng extracts, the combination of 2g binding agents are sufficiently mixed, 2.5% mixed solution is configured to；Mixing liquid is passed through Cross freezing machine to congeal, and stirred during congealing, form sludge ice mixture；1g Propirams and sludge ice mixture are fully mixed Close, be quantitatively fitted into spherical die；- 150 DEG C of freeze-dryings are carried out after quick-frozen, are packed, lyophilized formulations product is formed.

Embodiment 3：

Pure water is congealed by freezing machine, and stirred during congealing, sludge ice is formed；Combined with 1.5g binding agents, 3g Notogineng Extract, 2g radix paeoniae alba extractions, 4g white pond lilies flower extract, 0.5g modified tapioca starch, 0.5g xanthans are sufficiently mixed；Will Sludge ice mixture is fitted into water-drop-shaped mould quantitative；Mixture after will be quantitative packs after quick-frozen, freeze-drying, is formed and frozen Dry preparation product.

Embodiment 4：

Pure water is congealed by freezing machine, and stirred during congealing, sludge ice is formed；By 3g Gotu Kola P.Es, 1g Cherry extract, 2h hyaluronic acids, 1.0g binding agents are combined, and are configured to 5% mixed solution；Sludge ice is sufficiently mixed with mixed solution, It is quantitative to load oval mould；Quick-frozen, freeze-drying is carried out, is formed after lyophilized formulations and carries out double alumiseal packagings.

Embodiment 5：

Pure water is congealed by freezing machine, and stirred during congealing, sludge ice is formed；By 3g white pond lilies flower extract, 1g aloe vera extracts, 2g Sodium Hyaluronates, 2g Propirams, the combination of 1g binding agents, 0.3g rice starch, 0.5g are modified Ma Ling Sweet potato starch, 0.2g polyvinyl alcohol crosslinked polymers, be configured to 4% mixed solution；Sludge ice is sufficiently mixed with mixed solution, loads capacity For 4ml mould；Volume of mixture is compressed to 2ml, is shaped as being freeze-dried after ellipse, progress after lyophilized formulations is formed double Alumiseal is packed.

The occupation mode of the present invention is not limited to form cited in embodiment, and embodiment is only presently preferred embodiments of the present invention, no Protection domain can be limited with this.All simple or equivalent changes and modification with described in scope of the presently claimed invention, come under this hair Bright protection domain.

Claims

1. a kind of formula of lyophilized formulations and preparation method thereof, it is characterised in that the lyophilized formulations are by one group by lysolecithin, Scleroglucan, Huang Virgin rubber, Propiram, sodium phytate, the binding agent combination of hydroxyethyl cellulose composition, and active component composition；Wherein, binding agent combination accounts for tablet weight Amount percentage is 0.1%-99.9%, and the weight and volume ratio of lyophilized formulations are 0.1mg/cm³-5000mg/cm³。

2. a kind of formula of lyophilized formulations as claimed in claim 1, it is characterised in that additional adhesive can also be further added in formula, piece is accounted for Agent percentage by weight is 0.1%-99.9%.

3. additional adhesive as claimed in claim 2, it is characterised in that the binding agent be selected from native starch, modified starch series, cellulose ethers, Polyvinyl alcohol copolymer class, glue class, PVP, carbomer, PVA, hyalomitome acids, albumin, chitosan, dextran, agar, poly- amino Acid, glycan or combinations thereof.

4. a kind of formula of lyophilized formulations as described in claim 1-3, it is characterised in that the native starch class include tapioca, farina, One or more combinations in cornstarch, rice starch, wheaten starch, oat starch, elegant jessamine starch；The modified starch include pulullan, Modified corn starch, modified potato starch, modified tapioca starch, hydrogenated starch, hydrogenated starch hydrolysate, it is Sodium Polyacrylate graft starch, poly- Acrylic acid grafted starch, hydroxypropul starch, hydroxypropyl starch phosphate, amylose, amylopectin, CMS, sodium carboxymethyl starch, One or more combinations in cornstarch/acrylamide/sodium Acrylate copolymer；It is carboxylic first that the cellulose ethers, which includes cellulose ethers binding agent, One or more combinations in base cellulose, carboxyethyl cellulose, hydroxyethylmethylcellulose, hydroxypropyl methyl cellulose；The polyvinyl alcohol is total to Polymers class is included in polyvinyl alcohol crosslinked polymer, polyvinyl alcohol/methyl acrylate graft copolymer, polyving alcohol/polylactic acid co-glycolic acid One or more combinations；The glue class include pectin, carragheen, xanthan gum, collagen, hydrolytic collagen, gelatin, gelatin hydrolysate, Arabic gum, Konjac glucomannan, carrageenan, locust bean gum, natural gum, locust bean gum etc.；Described polyaminoacid is selected from polyglutamic acid, polyalanine, polylysine etc.； Affiliated glycan is selected from fucoidin, synanthrin etc..

5. a kind of formula of lyophilized formulations as described in claim 1-4, it is characterised in that the active component be selected from chemicals composition, traditional Chinese medicine ingredients, One or more kinds of combinations in natural extract, bioactive ingredients, skin nursing beneficiating ingredient.

6. the formula of a kind of lyophilized formulations as described in claim 1-5, it is characterised in that wherein can also further contain other auxiliary materials, described other Auxiliary material includes the one or more in skeleton agent, antioxidant, flavouring and essence, skin penetration enhancer, PH conditioning agents, disintegrant.

7. the formula of a kind of lyophilized formulations as described in claim 1-6, it is characterised in that the skeleton agent, which is included, is not limited to sugared (such as maltose, sea Algae sugar etc.), sugar alcohol (such as mannitol, sorbierite), the amino acid (such as glycine, alanine, glutamic acid) and inorganic salts of 2-12 carbon atoms Materials such as (such as sodium phosphates, alumina silicate)；The antioxidant is selected from vitamin C, anthocyanidin, resveratrol, the polyatomic phenol of plant origin One or several kinds of mixtures in compound；The flavouring and essence are selected from mint flavored, chocolate flavoured, 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；The skin penetration enhancer be selected from lecithin, tween, Any of sapn or several mixtures；The PH conditioning agents are selected from any one of citric acid, tartaric acid, sodium acid carbonate, sodium carbonate Or several mixtures；The disintegrant includes but is not limited to starch (wheaten starch, cornstarch, green starch, sweet potato starch, potato Starch, tapioca etc.), modified starch series (α, β, cyclooctaamylose, maltodextrin, amylose, crosslinked starch and its esters, ester Change starch, etherification 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. any one formula, the lyophilized formulations being made up of freeze drying process, it is characterised in that preparation method includes as described in claim 1-7 Following steps：

It is liquid condition after being mixed such as surplus materials 11, then surplus materials is formed into sludge ice mixture group again by congealing, stirring Divide 3, then component 2 and 3 is thoroughly mixed to form component 4；

E. component 5 is carried out quick-frozen；

9. it is as claimed in claim 8, it is characterised in that the liquid 1 of step A：Can be water dissolving or scattered partly or completely binding agent； Can be water dissolving or scattered partly or completely active material；Can also be part aqueous solution or scattered binding agent, part aqueous solution or Dispersed actives；Water dissolving or scattered partly or completely active material and binding agent are can also be, day containing moisture itself is can also be Right material or extract, including but not limited to milk, fruit juice and royal jelly etc..

10. the solid content of the preparation method as described in claim 1-9, its solution 1 or surplus materials 11 is 0.1%-99.99%, it is preferably 0.5%-90%, 1%-90%, 5%-80%, 10%-80%, 20%-70%, 30%-60%, 35%-50%, most preferably 20%-50%.

11. the preparation method as described in claim 1-10, its frozen temperatures are 0 DEG C to -100 DEG C.Preferably -1 DEG C to -90 DEG C, -5 DEG C to -80 DEG C, -10 DEG C to -70 DEG C, -20 DEG C to -60 DEG C, -30 DEG C to -50 DEG C；More preferably -1 DEG C to -50 DEG C, -3 DEG C to -30 DEG C, -5 DEG C to -10 DEG C；Most preferably For -1 DEG C to -10 DEG C.

12. the preparation method as described in claim 1-11, it is characterised in that：Compression step is added between step D and E, by quantitative component 5 Certain shape and density is compressed into, component 6 is formed, is afterwards freeze-dried component 6, freeze-drying prods 12 are formed.

13. the lyophilized formulations product as described in claim 1-12, it is characterised in that described be compressed into definite shape or the mould of sizing can be to appoint Meaning shape, can be unidirectional demoulding type, can also be that multi-mould is combined；It is by penetration hardness in more than 0.1N, thermal conductivity factor at 0.01W/ (m.k) More than material be made, its one kind in metal, high polymer material, ceramics, glass or collectively formed by more than one of the material.

14. the preparation method according to claim 1-13 any one, it is characterised in that the sludge ice mixture in the step B can be mixed further Air is closed, certain expansion rate is made it have, its expansion rate is 0%-100%, preferably 0-90%, 10-90%, 10-80%, 20-80%, 20-70%, 30-60%, most preferably 20-80%.

15. the product according to claim 1-14, it is characterised in that the product does not have sharp edge.

16. the product according to claim 1-15, it is characterised in that it is figure of tablet, capsule shape, soft capsule shape, spherical, ellipsoid Shape or various personages, animal, plant, food, pattern identification or cartoon character.

17. a kind of lyophilized formulations product as described in claim 1-16, it is characterised in that can apply to cosmetics, health products, food, people's medication Product, animal-use drug product, medical instruments field.