The utility model content
The technical problem that the utility model institute desire solves is to provide a kind of preparation structure with good stable property, and can avoid in the preparation manufacture process, using chemical additive.
Therefore, an aspect of the utility model is to be to provide a kind of preparation, comprises the main body with a plurality of holes, and the thin layer that is positioned at body surfaces and one connection main body.Above-mentioned thin layer has a plurality of pores, and thin layer is more fine and close than main body.Thin layer has the ability of supporting and stablizing main body physical property structure, can be by adding, generate or after secondary operations, add naturally generation in the processing procedure.
According to the utility model one embodiment, a kind of preparation comprises the main body with a plurality of holes, and the thin layer that is positioned at body surfaces and one connection main body.Above-mentioned thin layer has a plurality of pores, and the size of pore is not more than the size of the hole of main body.
According to an embodiment of the utility model, the main body of said preparation comprises at least one microsome, and this MC particle diameter is the 100-400 micron.
According to an embodiment of the utility model, the main body of said preparation comprises at least one fine powder body, and the particle diameter of this fine powder body is the 20-160 micron.
According to an embodiment of the utility model, the diameter of described hole is the 1-200 micron.
According to an embodiment of the utility model, said main body and said thin layer constitute a lozenge, and the thickness of this lozenge is 0.1-5mm.
According to another embodiment of utility model, a kind of preparation comprises the main body with a plurality of holes, and the thin layer that is positioned at body surfaces and one connection main body.Above-mentioned thin layer has a plurality of pores, and the distribution density of pore is not more than the distribution density of hole.
According to the another embodiment of utility model, a kind of preparation comprises the main body with a plurality of holes, and the thin layer that is positioned at body surfaces and one connection main body.Above-mentioned thin layer has a plurality of pores, and the percent by volume that pore accounts for thin layer is not more than the percent by volume that hole accounts for main body.
According to an embodiment of the utility model, the percent by volume that described hole accounts for this main body is 3-10%.
According to an embodiment of the utility model, said main body and said thin layer constitute a lozenge, and the thickness of this lozenge is 0.1-5mm.
According to an embodiment of the utility model, said lozenge be shaped as circle, ellipse, square, rectangle or triangle.
The above-mentioned embodiment of the utility model has advantage:
(1) can not contain chemical additive and excipient in the preparation of the above-mentioned embodiment of the utility model, the user reached actual healthy effects psychologically to reduce.
(2) in the preparation of the above-mentioned embodiment of the utility model, thin layer than main body more densification and one connect main body, so thin layer has the protection main functions.In addition, but thin layer also isolating main bodies contact with extraneous air, moisture or light, reduce main body and extraneous chance or speed of reacting, and make preparation have good chemistry and biological stability.
(3) preparation of the above-mentioned embodiment of the utility model is a loose structure, therefore has good collapsibility.
Above-mentioned utility model content aims to provide the simplification summary of this disclosure, so that the reader possesses basic understanding to this disclosure.This utility model content is not the complete overview of this disclosure, and its purpose is not at the key/critical element of pointing out the utility model embodiment or defines the scope of the utility model.After consulting the hereinafter embodiment, has common knowledge the knowledgeable under the utility model in the technical field when the technological means that essence spirit and the utility model adopted that can understand the utility model easily and enforcement aspect.
The specific embodiment
Below will be with a plurality of embodiments of graphic exposure the utility model, for the purpose of offering some clarification on, the details on many practices will explanation in the lump in following narration.Yet, should be appreciated that the details on these practices is not used with restriction the utility model.That is to say that in the utility model part embodiment, the details on these practices is inessential.In addition, for the purpose of simplicity of illustration, habitual structure and the element of some conventions will illustrate it with the mode of simple signal in graphic.
The structure of preparation
Please with reference to Fig. 1, it illustrates the cross-sectional view according to a kind of preparation of the utility model one embodiment.Preparation 100 includes main body 110 and thin layer 120.Aforementioned body 110 includes a plurality of hole 112, microsome 114, fine powder body 116 and liquid 118.Have a plurality of pores 122 in the above-mentioned thin layer 120.And thin layer 120 is more fine and close than main body 110.
Said structure can use frozen vacuum dryer and mould and extra package material and arrange in pairs or groups lyophilization and mechanography are made preparation 100.After the vacuum freezedrying processing procedure finishes, also can carry out secondary operations to preparation 100 again, improve the integrality of preparation 100 outward appearances to help moulding.Above-mentioned secondary operations is meant can carry out 1-2 time slight compacting again.Therefore this preparation 100 can not add chemical additive and excipient in manufacture process, just can have good molding effect.
The kenel of main body 110 is a cellular.Main body 110 also can comprise microsome 114, fine powder body 116 and liquid 118 except a plurality of holes 112 are arranged.The composition of main body 110 can not contain chemical additive and excipient, promptly is entirely active component, and can reduces influencing on user's health.
Can contain air, microsome 114, fine powder body 116 or liquid 118 in the hole 112.Owing to have a plurality of holes 112 in the main body 110, therefore can help preparation 100 dissolvings and collapse diffusing.The diameter of above-mentioned hole 112 can be the 1-200 micron.The percent by volume that above-mentioned hole 112 accounts for main body 110 can be 3-10%.
Microsome 114 and fine powder body 116 can be embedded in the main body 110, perhaps are arranged in hole 112.Wherein the particle diameter of microsome 114 can be the 100-400 micron, and the particle diameter of fine powder body 116 can be the 20-160 micron.Microsome 114 and fine powder body 116 can not contain chemical additive and excipient, promptly are entirely active component.The difference of microsome 114 and fine powder body 116 is that microsome is by compound and multiple working procedure type of being processed into spherical or type cylinder, and the fine powder body can be obtained through the simple procedures pulverizing for the dry powder that forms of single-activity composition extraction.Fine powder body type of can be spherical, other fixedly body or non-regular outward appearance.
After vacuum freeze drying, still can have liquid 118, it can be arranged in hole 112.The composition of liquid 118 can be active component.
Thin layer 120 is positioned at main body 110 surfaces, has a plurality of pores 122, and one connects main body 110.Thin layer 120 can not contain chemical additive and excipient, promptly is entirely active component.Above-mentioned " one connection " when being meant this preparation 100 of microcosmic, and the structure that can find thin layer 120 and main body 110 is for being connected continuously, and do not have clear and definite interface.Said structure can use lyophilization collocation mould to make.Because thin layer 120 has pore 122 and hole 112 respectively with main body 110, so have good collapsibility.
The density that thin layer 120 and main body 110 difference structurally are thin layer 120 is obviously than main body 110 height.The difference of its density can be learnt with the percent by volume that pore 122 accounts for main body 110 and thin layer 120 respectively from hole 112 and size, distribution density and hole 112 on the pore 122.Therefore, the size of pore 122 is not more than the size of hole 112.Perhaps, the distribution density of pore 122 is not more than the distribution density of hole 112.Or the percent by volume that pore 122 accounts for thin layer 120 is not more than the percent by volume that hole 112 accounts for main body 110.Because thin layer 120 is comparatively fine and close and be connected with main body 110 one, so can protect main body 110.But and thin layer 120 also isolating main bodies 110 contact with extraneous air, moisture or light, reduce main body 110 and extraneous chance or speed of reacting, and make preparation 100 have good chemistry and biological stability.Therefore thin layer has the ability of supporting and stablizing main body physical property structure, can be by generating or after secondary operations, add generation in the processing procedure naturally.
With the lozenge that above-mentioned main body 110 and thin layer 120 are constituted, its thickness can be 0.1-5mm, and shape can be circle, ellipse, square, rectangle or triangle.
The composition of preparation
From the above, main body 110 can be entirely active component with the composition of the preparation 100 that thin layer 120 constitutes, and does not contain chemical additive and excipient, and can reduce the healthy effects to the user.Above-mentioned chemical additive and excipient are meant adhesive, collapse powder, diluent, glidant, lubricant, flavouring, emulsifying agent, anticorrisive agent, spices or pigment.
Above-mentioned active component can be the active component that is applied to food or medicine.Distinguish according to activity, can be divided into the active material of active material or adjuvanticity.Above-mentioned active material can be organic acid, aliphatic acid, polypeptide or protein, probio, fungi, alkaloid, flavonoids or chemical compound.The active material of above-mentioned adjuvanticity can be polysaccharides or carbohydrate.
Above-mentioned organic acid can be citric acid, malic acid, lactic acid, fruit fermentate or other can be applicable to the organic acid that food adds.
The carbon number that above-mentioned aliphatic acid can be carbochain is less than 50 unrighted acid.For example, Omega3 aliphatic acid, Omega6 aliphatic acid, Omega9 aliphatic acid, lecithin or phosphoric acid silk amino acid.
Aforementioned polypeptides or protein can be polypeptide or the protein with physiological regulatory action.
Above-mentioned probio can be lactobacillus, Bifidobacterium, gemma Pseudomonas, hay bacillus, streptococcus, enterococcus spp or Blastocystis.
Above-mentioned fungi can be edible or medicinal hypha,hyphae, edible or medicinal fungus sporophore, Ascomycetes fungi or list Gammaproteobacteria fungi.For instance, fungal material can be Antrodia camphorata, Cordyceps sinensis, glossy ganoderma, Cordyceps militaris, rainbow conk or splits the folding bacterium.
Above-mentioned alkaloid can be the extract of the plant, animal or the fungi that can be applicable to food additives.For example pipering, trigonelline, theophylline and caffeine, resveratrol, thrombocytin, ergotin and derivative thereof, carnitine or choline.
Above-mentioned flavones inflammation can be the flavonoids from fruit, vegetables, tea, grape wine, seed or plant roots, or other can be applicable to the flavonoids of food additives.For instance, flavonoids can be rutin sophorin, hesperidin, Quercetin, green tea polyphenols, Red Wine Polyphenols or olive polyphenol.
The manufacturing approach of preparation
Preparation 100 can use frozen vacuum dryer, bed die, middle mould and extra package material and arrange in pairs or groups lyophilization and mechanography are made, and its step is summarized as follows.At first, above bed die, spread a release layer, middle mould is placed the release layer top.The semisolid that will mainly constitute with active ingredient and water then is filled in the mould, covers another release layer again in the top.Then, use vacuum freezedrying equipment, under suitable cryogenic conditions, the water in the fluid is freezed to form solid.Carry out in regular turn afterwards that low pressure is bled and the heating sublimation processing procedure, make the solid distillation stay the preparation that constitutes by active component for gas.At last, can carry out 1-2 time slight compacting again to preparation, improve the integrality of preparation outward appearance to help moulding.Therefore this preparation can not add chemical additive and excipient in manufacture process, just can have good molding effect.The material of above-mentioned extra package material for example can be macromolecule, paraffin paper of water-fast material etc. or water-soluble wafer, starch paper etc., its function be to increase in case of necessity preparation integrality, be beneficial to the convenience of processing procedure, packing and use.
Above-mentioned preparation can be applicable to physiology and pharmacological use.For instance, can be applicable to regulate physiological change or the indication that causes because of disorder.Like the immune system activity imbalance, comprise allergy, allergic rhinitis, Atopic dermatitis, asthma etc.; Metabolic syndrome comprises obesity, high fat of blood, fatty liver, diabetes etc.; The imbalance of intestines and stomach physiological status comprises constipation, flatulence, diarrhoea etc.; And the imbalance of the urinary tract physiological status, comprise urinary tract infection, vagina infection, external genital infection etc.
This preparation also has advantage on characteristic, as improving the yield of specific prescription, to be applied to the preparation volume production.In application facet, can be applicable to the active improvement of sensitiveness substance preparation.In addition, also can be developed into mouthful solvent-borne type and buccal absorption formulation, as arrange in pairs or groups little fat body or other nano raw material increase the buccal absorption degree and change pharmacokinetic properties, to improve bioavailability.
Though the utility model discloses as above with embodiment; Right its is not in order to limit the utility model; Anyly have the knack of this art; In spirit that does not break away from the utility model and scope, when can doing various changes and retouching, so the protection domain of the utility model is as the criterion when looking the scope that the accompanying Claim book defined.