CN101439048A - Chinese medicine glue rapid-release preparation for oral cavity and method for producing the same - Google Patents

Abstract

The invention relates to a mouth immediate-release preparation of a traditional Chinese medicine jelly, and a preparation method thereof. Basic raw materials of the preparation include a main material and a subsidiary material. The main material is mainly jelly, and the subsidiary material is mainly oil dispersant and can be added with water-soluble dispersant, flavoring and surface active agent when necessary; and the weight percentage of the main material is 0.1 percent to 80 percent, and the weight percentage of the subsidiary material is 20 percent to 99.9 percent. The detail operating steps are as below: (1) preparation of the materials; (2) preparation of a sizing agent: thinning and liquefying are included, final fineness of the thinning is less than 600 microns in the case of 70 percent of the preparation by weight, the liquefying is that solid grains are dispersed in the oil dispersant by means of mixing, and the weight percentage of the addition of the oil dispersant meets the condition that oil content in a finished product is not less than 15 percent; and (3) formation: the finished preparation is obtained by adopting a cooling forming method or a powder forming method. The mouth immediate-release preparation improves the dispersing speed of the traditional Chinese medicine jelly in the mouth in the precondition of good mouth taste, no water drinking is needed, and the taking of the mouth immediate-release preparation is convenient.

Description

A kind of Chinese medicine glue rapid-release preparation for oral cavity and manufacture method thereof

(1) technical field:

The invention provides a kind of Chinese medicine glue rapid-release preparation for oral cavity and manufacture method thereof, its primary raw material is the colloid Chinese crude drug, belongs to the technical field of medicine, food and health food preparation.

(2) background technology:

Colla Corii Asini has another name called basin and covers glue, Fu and cause glue, Colla Corii Asini (or claiming donkey glue), because of it originates in Donga, Shandong Province county, boils with the water of A Jing and to form, so a Colla Corii Asini.Because of it forms for the skin of animal boils, so the traditional Chinese medical science is called the in love product of flesh and blood.The making of Colla Corii Asini and medicinal, the history in existing more than 2,000 year proves all that through the ages Colla Corii Asini is the treasure of enriching blood so far.

This product beginning is stated from Shennong's Herbal, classifies as top grade." Mingyi Bielu " carries: " Colla Corii Asini is given birth to Dongping Prefecture (Dongping County, modern Shandong), boils Corii Bovis seu Bubali and does it, goes out the Donga County." TAO Hong-Jing again day: " also can do it under modern Dongdu.With skin the old and the young are also arranged, glue then has pure and impure." " Bencao Tujing " say: " modern Yun Zhou all can do it.Yi A county north of the city well water boils to very.Make it, well water is fried in shallow oil black donkey skin, the glue method of frying in shallow oil as usual.Its well official prohibits, and true glue scarcely ever.On the whole getting well water with donkey skin is good ear ... Jin the time Fan family use gelatinum oxhide, be mostly Corii Bovis seu Bubali, the Shennong's Herbal Colla Corii Asini is also used Corii Bovis seu Bubali, is that two skins are also general." the Compendium of Material Medica cloud: " and allly making all glue, between October to two, March, be last with Sha cattle, Babalus bubalis L., donkey skin person, and pig, horse, mule, hunchbacked skin person take second place, thing persons such as its old skin, footwear, shoe for time.All get rawhide, water logging four or five days, wash scrape extremely clean." according to above-mentioned record as can be known ancient times the Colla Corii Asini raw material with Corii Bovis seu Bubali, donkey skin and other multiple animal skins classes, be the best but fry in shallow oil into the person with well water with donkey skin.Modern times with animal glue single-row be a kind of medical material, i.e. gelatinum oxhide, nineteen ninety version, nineteen ninety-five version, the version Pharmacopoeia of the People's Republic of China in 2000 stipulate that all the glue that boils with donkey skin is the Colla Corii Asini certified products.After liberation also having with the Corii Sus domestica is the new Colla Corii Asini of raw material.

This colloid is neat rectangle bulk, is about 8.5 centimetres usually, and is wide about 3.7 centimetres, thick about 0.7 or 1.5 centimetre.Epidermis brownish black or corvinus, level and smooth, glossy.Illumination is looked slightly transparent.Matter is hard crisp frangible, and section brownish black or corvinus are level and smooth, glossy.A little less than the feeble QI, it is little sweet to distinguish the flavor of.

Colla Corii Asini both can be used as medicine, and can be used as food again, health product are taken, and as the Chinese medicine kind with the cognition of extensive consumer, can pulverize and be used as medicine, scald the glue pearl, but it should not decoct, and suitable molten is according to the very inconvenience of traditional instructions of taking.

Along with modern's rhythm of life is fast, the mode of taking of Chinese medicine compound preparation more and more is difficult to adapt to consumer demand.Though Colla Corii Asini has novel forms such as all kinds of unguentum, oral liquid, tablet, granule, powder, capsule and appears on the market, preparation carrying dosage, convenience and mouthfeel still are weak.

Pharmacopeia is indicated Colla Corii Asini taking dose 3～9g, and conventional tablet, the restriction of capsule drug loading can't reach, and Colla Corii Asini itself is exactly an extract, also can't extract method reduction dosage such as refining according to conventional Chinese crude drug.

Though unguentum, granule, powder drug loading can reach the dosage requirement, taking needs hot water to still have inconvenience towards converting, and oral liquid has been compared the convenience advantage with the former, because the solution high viscosity characteristic of colloid, the 10ml oral liquid also is difficult to carry the colloid of 3g.These several preparations are that raw material is difficult to hide its bad mouthfeel with Colla Corii Asini separately, generally all adopt compound recipe form balanced system agent dose, curative effect and correct taste.

China uses colloid treatment disease and is of long duration, and its history in more than 2000 years can be compared with pill.Shennong's Herbal is loaded with " white glues " and " Colla Corii Asini ", enjoys higher prestige in broad masses, still is being extensive use of so far.Colloid is many for for oral administration, and its function is for enriching blood, stop blooding, dispel the wind and gynecological's regulating menstruation etc., diseases such as, haematemesis thin with treatment asthenia, win, epistaxis, metrorrhagia, lassitude loin and legs.

The Chinese medicine colloid is very special in form of Chinese drug, both has been preparation, has also made decoction pieces, medical material, and part also is health product, food.Other form of Chinese drug are less relatively to relate to kind, comprise Colla Corii Asini, Colla cornus cervi, Colla Plastri Testudinis, gelatinum oxhide, Colla carapax Trionycis, Colla Os Tigris, Os pardi glue, dog bone glue, Air Bladder pseudosciaenae seu Acipenser, fish glue from skin, fish glue from scale, Chelonia mydas (Linnaeus), turtle and deer glue etc.Colla Corii Asini is a most widely used kind in the Chinese medicine colloid.

Chinese medicine colloid (also claiming glue class Chinese medicine) is meant with animal skins, bone, first, angle etc. and is raw material that water takes colloid, is condensed into to do gelationus oral preparations.Its main component is an animal hydrolyzed protein class material, and adds a certain amount of sugar, oils and fats, and wine adjuvants such as (yellow wine).Generally all dice or pane.

Colloid commonly used by its raw material sources difference, is broadly divided into following several:

Hide glue class: be that skin with animal is that raw material is made through tempering.Commonly used have donkey skin and a Corii Bovis seu Bubali, the ancient literature record, and the Colla Corii Asini before the Tang Dynasty is to do it with Corii Bovis seu Bubali, begins to select for use donkey skin afterwards.Practise the title Colla Corii Asini with the donkey skin for the raw material person now; With the Corii Sus domestica for the raw material person claims new Colla Corii Asini, with Corii Bovis seu Bubali be raw material then be called gelatinum oxhide.

Angle glue class: mainly refer to Colla cornus cervi, its raw material is the ossified angle of stag.Colla cornus cervi should be white in color translucent, but often mixes a certain amount of Colla Corii Asini when preparing Colla cornus cervi at present, thereby is pitchy.Endure the last angle slag of glue, also hyoscine is called Cornu Cervi Degelatinatum.

The osseocolla class: osseocolla system tempers with the skeleton of animal and forms, and Colla Os Tigris, Os pardi glue, dog bone glue etc. are arranged, and the latter two are all the succedaneum of Colla Os Tigris.

Nail gelatin class: temper with the carapace of Testudinis or its nearly edge animal or web and to form, as Colla Plastri Testudinis, Colla carapax Trionycis etc.

Other glue classes: allly containing proteinic animal drug, temper through decocting, generally all can be made into colloid, is through tempering the colloid that forms with beef as COLLA BOVIS.Turtle and deer glue is to be raw material with Carapax et Plastrum Testudinis and Cornu Cervi, tempers the mixing colloid that forms jointly; Also have and mix with Colla Plastri Testudinis and Colla cornus cervi.

Animal glue class Chinese medicine has similarity on chemical composition, be mainly ossein, can get protein and several amino acids after the hydrolysis.Proper constituent is more stable, and albumen is about about 80%, and all the other are saccharide, fat and organic acid etc.Similarity in view of its each kind, color differentiating is only passed through in traditional discriminating, according to " Zhou Li examines worker's note " record, Qin period existing " Colla cornus cervi is bluish white, horse glue red white, NIUJIAO is fiery red; Mus glue is black, fish glue bait, rhinoceros glue Huang " etc. text description, show that Ancient Times in China has had variation in the application of animal glue class Chinese medicine.To for a long time traditional character identification, chemical reaction and the methods such as Fluirescence observation, gel disc electrophoresis and ultraviolet spectra of relying on of the discriminating of animal glue class Chinese medicine more.Along with the develop rapidly of related science, many modern discrimination methods of clamoring and analyzing occurred in recent years, made the Study on Identification of animal glue class Chinese medicine obtain new development based on instrument.Method for updating is to adopt directly Chinese medicine colloid enzymolysis is become mixed polypeptide, distinguishes that by the analytical characteristic polypeptide raw material sources difference is distinguished and judged quality.In fact, the drug effect difference of several colloids is exactly to be that it forms the difference of polypeptide after hydrolysis and the difference that forms in vivo, and difference is less with regard to colloid character (except the color), and all have the inconvenience of taking, characteristic that mouthfeel is not good.

Ancients just know with the collagen protein of prehydrolysis treatment disease before more than 2000 year, and the collagen protein that just to understand its essential mechanism up to now be separate sources becomes the curative effect that various micromolecule polypeptides produce in vivo behind acidolysis, enzymolysis.Under the production of ancient times, logistics, storage condition, can continue up to the present age, not only verify the curative effect that it is good, illustrate that also the colloid dosage form is at that time technological merit.The organic assembling of this collagen protein, sugar, Oleum Glycines, yellow wine forms densification, stable network structure, form low moisture activity and can adapt to external environment condition by the balance water holding, this is effective, the most reliable method of long preservation collagen protein in ancient times, Colla Corii Asini more than ten years even 20 years are deposited by a lot of families, still lose rottenly, take effect and also do not see difference.

In the improvement of current Chinese medicine, only Colla Corii Asini has more improved preparation, and other Chinese medicine colloids improve few, along with the raising of people's life quality, these kinds progressively atrophy until disappearance.The present invention is necessary this ancient dosage form is improved.

The present invention can be directly applied for other colloid kinds to the preparation technology and the prescription of Colla Corii Asini under the condition that does not need the adjusting process parameter.

(3) summary of the invention:

The objective of the invention is to: by a kind of oral cavity rapid release preparation and manufacture method thereof of utilizing hot melt mechanism is provided, to possess the adaptive preparation platform technology of wide spectrum, existing Chinese medicine colloid is transformed, form a kind of ideal oral cavity rapid release dispersion (as Fig. 1), water soluble dispersing agent and major ingredient composition are distributed in the oiliness dispersant jointly, can reach under the prerequisite of better mouthfeel, improve the rate of dispersion of colloid composition in mouth and the absorption of effective ingredient.

A kind of Chinese medicine glue rapid-release preparation for oral cavity of the present invention, the base stock of said preparation is divided into major ingredient and adjuvant, it is characterized in that: major ingredient is one or more the combination in Chinese medicine colloid or Chinese medicine colloid and other edible compositions, medicinal ingredient or the functional filler; Adjuvant is the oiliness dispersant or is one or more the combination in oiliness dispersant and water soluble dispersing agent, correctives and the emulsifying agent; The percentage by weight of major ingredient is 0.1%～80%, and the percentage by weight of adjuvant is 20%～99.9%.

Wherein, this water soluble dispersing agent, correctives and emulsifying agent account for the percentage by weight of adjuvant for being not more than 85%.

Wherein, described functional filler includes but not limited to high molecular polymer, saccharide, cellulose and derivant thereof, starch and derivant thereof, cyclodextrin and derivant thereof, polymer, inorganic salt, the pH regulator agent of natural origin, and they can single uses or are used in combination.The percentage by weight that this functional filler accounts for major ingredient is not more than 98%.

What need further specify is, owing to can comprise the oils and fats of certain content in the colloid of major ingredient, thus the addition of the oiliness dispersant in the adjuvant can reduce, in such cases, the percentage by weight of major ingredient of the present invention is 0.1%～88%, and the percentage by weight of adjuvant is 12%～99.9%;

Wherein, the more excellent proportioning of raw material of the present invention is that the percentage by weight of oiliness dispersant is 13～99.8%, and the percentage by weight of major ingredient is 0.1～86.9%, emulsifying agent 0.1～20%.

Wherein, the more excellent proportioning of raw material of the present invention is that the percentage by weight of oiliness dispersant is 15～99.7%, and the percentage by weight of major ingredient is 0.1～84.8%, and the percentage by weight of water soluble dispersing agent is 0.1～77.8%, emulsifying agent 0.1～20%.

Wherein, the proportioning of raw material optimum of the present invention is that the percentage by weight of oiliness dispersant is 15～99.6%, and the percentage by weight of major ingredient is 0.1～83%, and the percentage by weight of water soluble dispersing agent is 0.1～77%, correctives 0.01～82%, emulsifying agent 0.1～20%.

A kind of Chinese medicine glue rapid-release preparation for oral cavity of the present invention and manufacture method thereof, its technical scheme is as follows:

1, gets the raw materials ready: get the raw materials ready according to the major ingredient and the set of dispense ratio of adjuvant;

2, pulp preparation: with the solid particle refinement and be dispersed in the oiliness dispersant and become slurry, fineness of the particles be weight of formulation 70% below 600 microns, adopt the mode that stirs that solid particle is scattered in the oiliness dispersant; The percentage by weight of the addition of oiliness dispersant should satisfy that oil content is not less than 15% in the finished product, and can flow under 22～60 ℃ of conditions with slurry is as the criterion; According to the stage difference that the oiliness dispersant adds, solid particle refinement mode is that dry pulverization process, semidry method are pulverized or waterproof pulverization;

3, molding: adopt cooling molding method or powder compacting method to make finished product preparation.

Details are as follows in this method technological process:

1, gets the raw materials ready

The base stock of this preparation is made up of major ingredient and adjuvant two parts.

1. major ingredient

Major ingredient is Chinese medicine colloid or the medicine that contains the Chinese medicine colloid, health product and food (Chinese medicine colloid and other eat or the medicinal ingredient combination is used as major ingredient), wherein the Chinese medicine colloid includes but not limited to Colla Corii Asini (Colla Corii Asini or donkey glue), Colla cornus cervi, Colla Plastri Testudinis, gelatinum oxhide, Colla carapax Trionycis, Colla Os Tigris, Os pardi glue, dog bone glue, Air Bladder pseudosciaenae seu Acipenser, fish glue from skin, fish glue from scale, Chelonia mydas (Linnaeus), Solenognathus glue, Colla 0ssis Cervi, Colla Plastri Testudinis, antler gelatin, LVPIJIAO, donkey-hide gelatin with ginseng and pilose antler, good fortune word Colla Corii Asini, contain forever and close Colla Corii Asini, SANWUJIAO, fish bone glue, COLLA BOVIS, lake sturgeon glue, cobble glue, Os Caprae seu Ovis glue, Colla Os Bovis seu Bubali, Rangifer tarandus Linnaeus, new Colla Corii Asini, the animal glue or the collagen protein of turtle and deer glue and non-traditional Chinese medicine colloid category.Their single uses or be used in combination also can add other edible or medicinal ingredients and make up with colloid and use as major ingredient.

The form of major ingredient can be crude drug, bright medicine, decoction pieces, granule, powder, extract and refining thing thereof or purification thing, extract and refining thing thereof or purification thing, tunning, hydrolysis or zymolyte, effective site, monomer component, synthetic or semi-synthetic material etc. alone or in combination form add this preparation.

According to the actual needs of product or technology, can add functional filler in the major ingredient, to improve process conditions, raising stripping or to protect to become to grade, the percentage by weight that functional filler accounts for major ingredient is not more than 98%.

For example the volatility in the major ingredient, oiliness composition can be used as the oiliness dispersant and directly add, and also can add as solid constituent by (comprising enclose, absorption, solid dispersion etc.) after the functional filler solidification, prevent to lose in preparation with the protection composition.More after a little while, can add dosage stability and the convenience of functional filler at major ingredient single taking dose to improve preparation, to take.Also can in major ingredient, add functional filler by selectivity in order to adjust drug effect and protection composition.

For example when major ingredient contains active bacteria formulation or other easy oxidation, case of thermal instability composition, tend to use pretreating process such as coating, embedding, absorption, and adopt functional filler.When Main Ingredients and Appearance contains the extract of spray drying method for preparation, tend to add filleies such as lactose, dextrin, modified starch before the drying, to avoid the wall sticking phenomenon in the dry run as far as possible.Functional filler also can be selected not add.

Functional filler includes but not limited to high molecular polymer, saccharide, cellulose and derivant thereof, starch and derivant thereof, cyclodextrin and derivant thereof, polymer, inorganic salt, the pH regulator agent of natural origin, and they can single uses or are used in combination.

Wherein, the high molecular polymer of natural origin includes but not limited to: Lac, Resina persicae, arabic gum, xanthan gum, locust bean gum, more create glue, furcellaran glue, pectin, carrageenin, gelatin, POLY-karaya, Ficus elastica, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, sesbania gum, Furcellaran, tragacanth, tragcanth, carrageenan, tara gum, locust bean gum, guar gum, Eucheuma gelatinosum glue, ancient Ah's natural gum, English locust beam gum, karaya, antler glue, alginic acid and salt, XINGJIAO, agar, glucosan, chitin and derivant thereof, zein, casein etc.

Saccharide in the functional filler includes but not limited to:

Glucose, fructose, sucrose, brown sugar, remelt sugar, white sugar, crystal sugar, starch sugar, maltose, verbascose, lactose, dextrin, erythritol, xylitol, fructose alcohol, mannitol, Sorbitol, lactose, galactitol, maltose alcohol, hydroxyl isomaltulose, hydroxyl isomaltulose, Palatinitol, isomalt, oligomeric isomaltose alcohol, 1,2,3,4,5-pentanepentol, oligomeric isomaltose, soybean oligo saccharide, oligomeric galactose, Oligomeric manna sugar, oligofructose, Oligomeric maltose, oligomeric xylose, the sweet sugar in oligomeric Portugal, oligomeric lactulose, oligomeric lactose, oligomeric sugarcane fructose, the branch oligofructose, the Lac Bovis seu Bubali oligosaccharide, trehalose, chitin oligosaccharide, the inulin oligosaccharide, gentian oligose, the chitin oligosaccharide, Raffinose, panose, glucosyl group sucrose, coupling sugar, lactulose, the breast fructo-oligose, lactulose, stachyose, stachyose, the isomery lactose, the sucrose oligosaccharide, Tagatose, palatinose, isomaltulose, cellooligosaccharide, oligomeric lactosucrose, hydrogenated starch hydrolysate, arabinose, xylose, general Shandong indigo plant, how blue card is, more skin ulcer glue enzyme analyte etc.

Cellulose and derivant thereof include but not limited to:

Low-substituted hydroxypropyl cellulose, methylcellulose, sodium carboxymethyl cellulose, carboxymethyl cellulose, Cellulose Acetate Phthalate, microcrystalline Cellulose, ethyl cellulose, ethylmethylcellulose, cross-linking sodium carboxymethyl cellulose, cellulose acetate etc.

Starch and derivant thereof include but not limited to:

Modified starch, carboxymethyl starch, carboxymethyl starch sodium, hydroxymethyl starch, hydroxyl starch propionate, pregelatinized Starch, dextrin etc.

Cyclodextrin and derivant thereof include but not limited to:

Cyclodextrin, Methyl flamprop, hydroxypropyl cyclodextrin, hydroxyethyl cyclodextrin, polymer ring dextrin, ethyl cyclodextrin, branched cyclodextrin etc.

Polymer includes but not limited to:

Polyvinyl alcohol, polyvinyl butyral resin, styrene-vinylpyridine copolymer, acrylic resin, crosslinked polypropylene acid resin (carbomer), polyvinylpolypyrrolidone, polyvidone, polyvinyl acetate, methyl acrylate copolymer, polylactic acid, polyamino acid, poly-carboxylic acetic acid, Polyethylene Glycol, polyethers, ion exchange resin etc.

Inorganic material includes but not limited to:

Pulvis Talci, calcium carbonate, magnesium carbonate, calcium sulfate, calcium hydrogen phosphate, calcium phosphate, magnesium oxide, aluminium hydroxide, silicon dioxide, active carbon, active hargil, aluminium oxide, sodium chloride, titanium dioxide etc.

The pH regulator agent includes but not limited to:

Sodium bicarbonate, potassium bicarbonate, sodium dihydrogen phosphate, sodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, citric acid, tartaric acid, succinic acid, fumaric acid, adipic acid, malic acid, lactic acid etc.

2. adjuvant

The oiliness dispersant:

The fusing point of oiliness dispersant need satisfy finished product preparation and be solid forms at normal temperatures, oiliness dispersant fusing when being comparable to body temperature.The fusing point of preparation is between 23～46 ℃, and more excellent is between 26～39 ℃, and optimum is between 27～36 ℃.Certainly, the high more rapid release of fusing point is poor more, and the low more finished product of fusing point is easy to fusing more to be difficult to preserve.Under the low temperature service condition, fusing point can be low to moderate 18 ℃.The fusing point of preparation depends on the fusing point of oiliness dispersant basically.

The oiliness dispersant adopts oils and fats to be used alone or in combination, by adjusting greasy kind or the greasy proportional quantity of two or more different melting points, to satisfy the fusing point requirement of preparation.The oiliness dispersant adopts greasy fusing point generally to be in-20～70 ℃, is preferably fusing point and is in 10 ℃～60 ℃, and more excellent is that fusing point is in 22～40 ℃, and optimum is that fusing point is between 26～36 ℃.

This oiliness dispersant include but not limited to artificial fat, natural oil or through processing (include but not limited to make with extra care, refine, come unstuck, winterization, Crystallization Separation, hydrogenation, solidification, ester exchange, esterification, oils and fats reorganization, divide carry, oils and fats manufacturing process such as upgrading, oily hydrogen separation, hydrolysis, alcoholysis, acidolysis) oils and fats, they form alone or in combination.This oiliness dispersant can be divided into two classes, i.e. plant quasi-grease and animal quasi-grease.

Wherein, this plant quasi-grease is meant the oils and fats of plant origin, includes but not limited to vegetable oil, refining vegetable oil, hydrogenated vegetable oil or hydrogenation refinery vegetable oil.As cocoa butter (CB), cocoa butter substitute (CBS or CBR), cacaolike butter (CBE), and employing Petiolus Trachycarpi oil, palm-kernel oil, Oleum Cocois, Semen Maydis oil, Oleum Glycines, Oleum Brassicae campestris, Oleum Gossypii semen, Oleum Arachidis hypogaeae semen, Oleum Helianthi, Oleum sesami, Testa oryzae oil, olive oil, safflower oil, kopok oil, Radix Oenotherae erythrosepalae oil, galam butter, sal tree oil, Semen Tritici aestivi germ oil, litsea cubeba oil, Oleum Linderae, oleum sapii, peach kernel oil, walnut oil, Oleum Vitis viniferae, Oleum Hippophae, Semen Cucurbitae oil, Oleum pini koraiensis, Canola oil, apple seed oil, granada seed oil, Fructus Perillae oil, Fructus Dauci Sativae oil, blackcurrant oil, perilla oil, Camelina Sativa, siritch, Oleum Ricini, almond oil, babassu oil, tea tree oil, Oleum Camelliae, Camellia oil, the hazelnut wet goods is that raw material is through processing or unprocessed oils and fats their form uses alone or in combination.

Wherein, this animal quasi-grease is meant the oils and fats of animal origin, include but not limited to butter, cream substitute, and adopt Adeps Bovis seu Bubali, chicken oil, Adeps Caprae seu ovis, Adeps Sus domestica, fish oil, whale oil, axunge, Squalene, Cera Flava etc. for raw material through processing or unprocessed oils and fats, their form uses alone or in combination.

The oiliness dispersant also can adopt and be dissolved in greasy surfactant, include but not limited to lecithin, Polyethylene Glycol (PEG), polyethers (poloxamer), span (span), tween (tween), sucrose fatty acid ester, mono fatty acid glycidol, the bis-fatty acid glyceride, the tri-fatty glyceride, polyglyceryl fatty acid ester, polyglycereol Semen Ricini alcohol ester, xylitol acid anhydride mono fatty acid ester, sorbitan aliphatic ester, fatty acid and derivant thereof, octadecanol, hexadecanol, semi-synthetic fatty acid ester, methyl glycol fatty acid ester, the organic acid monoglyceryl ester, the monohydric alcohol fatty acid ester, their form uses alone or in combination partly or entirely replace plant quasi-grease or animal quasi-grease.

The addition of oiliness dispersant need satisfy preparation under slurry form, and oil is continuous phase.

If also contain a certain amount of oiliness composition in the major ingredient, can play the effect that substitutes part oiliness dispersant to a certain extent, can adjust the addition of oiliness dispersant as required.Certainly, the oiliness composition in the major ingredient may influence the fusing point of finished product, can adjust the fusing point of oiliness dispersant as required.

Greasy freezing point and fusing point have situation inequality, and occur the combination fusing point difference that the not syncrystallization of oils and fats forms sometimes, can form the high-melting-point crystallization to improve stability by adjusting crystallization kind and ratio to adjust fusing point (being commonly called as homoiothermic).

Other adjuvant: water soluble dispersing agent, correctives, emulsifying agent etc.

Water soluble dispersing agent: can be in moisture in the oiliness dispersant fusing post-absorption oral cavity and dissolving, thus further improve the rapid release characteristic of this preparation.

The composition of water soluble dispersing agent is a saccharide, and its main feature is divided into monosaccharide, disaccharide, sugar alcohol, oligosaccharide and polysaccharide for possessing water solublity.This saccharide includes but not limited to glucose, fructose, sucrose, brown sugar, remelt sugar, white sugar, crystal sugar, starch sugar, maltose, verbascose, lactose, dextrin, erythritol, xylitol, fructose alcohol, mannitol, Sorbitol, lactose, galactitol, maltose alcohol, hydroxyl isomaltulose, hydroxyl isomaltulose, Palatinitol, isomalt, oligomeric isomaltose alcohol, 1,2,3,4,5-pentanepentol, oligomeric isomaltose, soybean oligo saccharide, oligomeric galactose, Oligomeric manna sugar, oligofructose, Oligomeric maltose, oligomeric xylose, the sweet sugar in oligomeric Portugal, oligomeric lactulose, oligomeric lactose, oligomeric sugarcane fructose, the branch oligofructose, the Lac Bovis seu Bubali oligosaccharide, trehalose, chitin oligosaccharide, the inulin oligosaccharide, gentian oligose, the chitin oligosaccharide, Raffinose, panose, glucosyl group sucrose, coupling sugar, lactulose, the breast fructo-oligose, lactulose, stachyose, stachyose, the isomery lactose, the sucrose oligosaccharide, Tagatose, palatinose, isomaltulose, cellooligosaccharide, oligomeric lactosucrose, hydrogenated starch hydrolysate, arabinose, xylose, general Shandong indigo plant, how blue card is, more skin ulcer glue enzyme analyte, it is single or be used in combination that these possess water miscible composition.These raw materials possess certain flavoring ability simultaneously.Water soluble dispersing agent also can adopt possesses water miscible Mel, Lac regis apis, aminoacid, amino acid salts, Sal, peptide, protein, and they can single uses or are used in combination.

Main component is a hydrolyzed protein in the Chinese medicine colloid, though possess certain water solublity, its solution viscosity is higher, and the inlet dissolving is easily glutinous greasy, if add favorable solubility and the low water soluble dispersing agent of solution viscosity, can effectively improve mouthfeel and improve rapid release.

Correctives: water soluble dispersing agent generally has the flavoring function, if the flavoring scarce capacity can add suitable flavoring material (correctives) as required.Correctives can be according to the taste characteristics and the single or combination interpolation of final products location selectivity of major ingredient.Correctives includes but not limited to non-sugar sweetener, aromatic, inclusion agents, adsorbent, deodorant tune, acidic flavoring agent, fumet, flavoring agent; Also include but not limited to cocoa powder (cocoa liquor), coffee, milk powder, butter, vanillin, ethyl maltol and edible essence, spice or spice that food service industry is commonly used.

If contain oils and fats or surfactant, can play the effect that substitutes part oiliness dispersant to a certain extent in the correctives, can adjust the addition and the fusing point of oiliness dispersant as required.

Emulsifying agent:, need to add emulsifying agent and reduce surface energy in order to help to form greasy continuous phase.Emulsifying agent generally adopts water-in-oil type, reaches the purpose that reduces material viscosity or reduce grease amount, also can adopt Water-In-Oil/oil-water emulsifiers composite.If the oiliness dispersant has contained surfactant in the prescription, then this can omit.

Emulsifying agent comprises but is not limited to lecithin, Polyethylene Glycol (PEG), polyethers (poloxamer), span (span), tween (tween), sucrose fatty acid ester, mono fatty acid glycidol, bis-fatty acid glyceride, tri-fatty glyceride, polyglyceryl fatty acid ester, polyglycereol Semen Ricini alcohol ester, xylitol acid anhydride mono fatty acid ester, sorbitan aliphatic ester, fatty acid and derivant thereof, octadecanol, hexadecanol, semi-synthetic fatty acid ester, methyl glycol fatty acid ester, organic acid monoglyceryl ester, monohydric alcohol fatty acid ester, and they can single uses or are used in combination.

3. the percentage by weight of major ingredient and adjuvant:

The percentage by weight of major ingredient is to account for 0.1%～80% of whole preparation ratio, and the percentage by weight of adjuvant is to account for 20%～99.9% of whole preparation ratio.Wherein the summation of the water soluble dispersing agent in the adjuvant, correctives and the emulsifying agent percentage by weight that accounts for adjuvant is not more than 85%.

What need further specify is, because the major ingredient among the present invention can comprise the oils and fats of certain content, thus the addition of the oiliness dispersant in the adjuvant can reduce, in such cases, the percentage by weight of major ingredient of the present invention is 0.1%～88%, and the percentage by weight of adjuvant is 12%～99.9%

2, pulp preparation

After getting the raw materials ready by above-mentioned any component, carry out pulp preparation.

Pulp preparation is at first with the solid particle refinement, also the solid particle after the refinement can be liquefied, the solid particle of refinement is dispersed in the oiliness dispersant and becomes slurry, the final fineness of this refinement be weight of formulation 70% below 600 microns, liquefaction process be adopt the mode that stirs make solid particle disperse with the oiliness dispersant in; The percentage by weight of the addition of oiliness dispersant should satisfy that oil content is not less than 15% in the finished product, and can free (or pressure) under 22～60 ℃ of conditions flowing with slurry is as the criterion; According to the stage difference that the oiliness dispersant adds, the refinement mode is that dry pulverization process, semidry method are pulverized or three kinds of waterproof pulverization; Wherein waterproof pulverization is refinement both also can carry out simultaneously with liquefaction, the method that dry pulverization process and semidry method pulverizing also can adopt first refinement to liquefy again.

The Ginding process that this refinement is adopted has roll-type polishing, correct grinding method, ball-milling method, vibro-grinding method, mixing method.

Liquefaction is the necessary process that solid material becomes slurry, purpose be make solid material become decentralized photo (discontinuous phase), the oiliness dispersant is liquid continuous phase, stirring is to realize dispersive necessary enforcement means.The temperature of oiliness dispersant must guarantee that the oiliness dispersant in the material is a liquid form, is not less than 22 ℃ (before the oils and fats of liquid forms crystallization, can occur being lower than melting temperature but still be the situation of liquid) in principle, is generally more than 26 ℃; The oiliness dispersant reaches percentage by weight that continuous phase must guarantee its addition should satisfy that oil content is not less than 15% in the finished product, is generally more than 20%, and the thick more then necessary addition of solid material is low more, and oil content lazy flow more is poor more, and vice versa.

According to arts demand, three kinds of methods can be used in combination, as adopting dry pulverization process earlier, before not reaching final fineness, add part oiliness dispersant again and make it to possess the waterproof pulverization condition, carry out waterproof pulverization again until final fineness.The process sequence that needs---semidry method---wet method according to dry method that is used in combination of these three kinds of breaking methods is implemented, with two or three method combination.

(1) dry pulverization process (as Fig. 3): the method that the refinement of this process using elder generation is liquefied again.Refinement under the low condition of material oil content, material pulverizing state are to possess mobile powdered.The interpolation of the oiliness dispersant whether size of the amount of reaching is decided by whether the total oil content amount of comminuting matter satisfies dry pulverization process state and technological requirement, and the original oil content of solid material contributes in this total oil content amount.

Refinement---specifically be that all solid materials (major ingredient and water soluble dispersing agent) that are insoluble to oil are mixed, add (or not adding) part oiliness dispersant, be crushed to final fineness, fineness reaches the back and is powdered, this is pulverized and is exothermal process, does not make temperature in principle and limits, but will avoid functional component rotten, its material oil content is that maximum is no more than 15% below 10%.

Liquefy again---add residue oiliness dispersant and stir and become discharging behind the slurry, oiliness dispersant sectional adds.

This dry pulverization process also can add part oiliness dispersant and make it to possess the semidry method pulverization conditions when any fineness before being crushed to final fineness, carries out semidry method again and pulverizes until final fineness.

This dry pulverization process also can add part oiliness dispersant when any fineness before being crushed to final fineness makes it to possess the waterproof pulverization condition, carries out waterproof pulverization again until final fineness.

Dry pulverization process equipment includes but not limited to: vibrating mill, rotator type pulverizer, jet mill, ball mill, sand mill (ball mill), Raymond mill, planet mill, impact grinder, beater grinder, three-stage roll mill, vertical mill etc.

(2) semidry method is pulverized (as Fig. 4): the method that the refinement of this process using elder generation is liquefied again.Refinement under the moderate condition of material oil content, material pulverizing state is moistening leather hard.The interpolation of the oiliness dispersant whether size of the amount of reaching is decided by whether the total oil content amount of comminuting matter satisfies semidry method and pulverize state and technological requirement, and the original oil content of solid material contributes in this total oil content amount.

Refinement---specifically be that all solid materials (major ingredient and water soluble dispersing agent) that are insoluble to oil are mixed, add (or not adding) part oiliness dispersant, be crushed to final fineness, fineness reaches the back and is moistening leather hard, temperature of charge is generally more than 26 ℃ during pulverizing, the crushing process heat production, and continuous production needs cooling, its material oil content in principle 10%～23%, general 15%～20%.

Liquefy again---add residue oiliness dispersant and stir and become discharging behind the slurry, oiliness dispersant sectional adds.

This semidry method pulverizing also can add part oiliness dispersant when any fineness before being crushed to final fineness makes it to possess the waterproof pulverization condition, carries out waterproof pulverization again until final fineness.

The semidry method disintegrating apparatus includes but not limited to: three-stage roll mill, vibrating mill, rotator type pulverizer, beater grinder, ball mill, sand mill (ball mill), drum-type refiner (scraper-type refiner), colloid mill etc.

(3) waterproof pulverization (as Fig. 5): this technology is that refinement is carried out simultaneously with liquefaction.Refinement under the high condition of material oil content, material pulverizing state are liquid (or mastic) state.The interpolation of the oiliness dispersant whether size of the amount of reaching is decided by whether the total oil content amount of comminuting matter satisfies waterproof pulverization state and technological requirement, and the original oil content of solid material contributes in this total oil content amount.

Refinement and liquefaction---specifically be that all solid materials (major ingredient and water soluble dispersing agent) that are insoluble to oil are mixed, interpolation (or not adding) partly (or all) oiliness dispersants becomes slurry, be crushed to final fineness, fineness reaches the back and is slurry form, and oiliness dispersant sectional adds.Temperature of charge is more than 32 ℃ during pulverizing, the crushing process heat production, and the general shortage of heat that produces is to offset the cooling that circumstance of temperature difference was brought, and continuous production need heat equipment.Its material oil content is in principle more than 20%, and is general more than 23%.

Waterproof pulverization equipment includes but not limited to: drum-type refiner (scraper-type refiner), ball mill, sand mill (ball mill), basket grinder, three-stage roll mill, vibrating mill, rotator type pulverizer, colloid mill, planet mill, high shear dispersant, homogenizer etc.

In these three kinds of breaking methods, the interpolation of oiliness dispersant needs to grasp interpolation time and addition according to the viscosity characteristics of the material process efficiency of adaptive phase whether.Final finished product addition is as the criterion can flow under 22～60 ℃ of conditions.

The original oil content of solid material since the difference of raw material and variant, the original oil content of solid material has reached the requirement of finished product oil content under some extreme case, does not then need to add the oiliness dispersant again.

In the pulp preparation operation, if the oiliness dispersant at normal temperatures for solid-state can be by being heated as liquid state.

The percentage by weight of oiliness dispersant addition should satisfy the finished product oil content and be not less than 15%, and more excellent is to be not less than 20%, and optimum is to be not less than 26%.The finished product oil content is meant that the surfactant and other materials that is dissolved in oil that comprise oils and fats in finished product, be dissolved in oil account for the summation of finished weight percentage ratio.

The final fineness of preparation: weight of formulation 70% can below 600 microns (promptly greater than 600 microns be no more than 30%, thin person does not limit), weight of formulation that more excellent is 60% below 200 microns (promptly greater than 200 microns be no more than 40%, thin person does not limit), weight of formulation that more excellent is 80% below 74 microns (promptly greater than 74 microns be no more than 20%, thin person does not limit), optimum is 15～36 microns (specially referring to the micrometer detection method that food service industry is commonly used herein).Preparation was good with slurry form when fineness detected.If pulp particle slightly then has granular sensation in the mouth, granule is crossed detailed rules and regulations and may be eked out a living.The detection of fineness can be before molding also can or add solvent at the molding post-heating to be become under liquid or the slurry form and carries out.

In order to improve the effect of refinement operation, the feed size of major ingredient can be controlled at below the 60mm, be preferably major ingredient and be controlled at below 10 orders, be more preferably major ingredient and be controlled at that 100 orders are following to surpass 90%, best is, and major ingredient is controlled at that 200 orders are following to surpass 90%.

Add emulsifying agent lecithin generally commonly used, the period of any one before molding adds as required.

Three kinds of preparation methoies in liquefaction process for dispersive comparison:

Because this preparation is the hot melt rapid release system of solid dispersion, solid material should be well dispersed in the oil phase dispersant, must have good stirring to finish.Good stirring also can dissociate out with the oils and fats in the solid material, incorporates in the oil phase, to reduce the addition of oiliness dispersant.

In the waterproof pulverization technological process, the process of solid particle refinement also is the process of dispersed with stirring simultaneously, and oiliness dispersant addition height, process of lapping are liquid (pulpous state), and refinement is carried out simultaneously with dispersion, and solid particle has been finished refinement and dispersion during discharging.

Dry pulverization process and semidry method disintegrating process need progressively add the oiliness dispersant and stir making it become the liquefaction operation of liquid slurry after refinement is finished.The purpose that stirs prevents to form the bulky grain agglomerate except improving solid material dispersed homogeneous degree in oils and fats, can also suitably reduce moisture.Stirring herein also can be referred to as refine.Progressively open by the granule that stirs agglomerated in this process, make the oiliness dispersant progressively be coated on solid particle surfaces, after solids were soaked into, coat by the oiliness dispersant fully, forming the oiliness dispersant was continuous phase and liquefaction.In the process that agglomerated particle is opened and the oiliness dispersant soaks into, need very high power of agitator, when the oiliness dispersant became continuous phase, then power significantly reduced, and added until the oiliness dispersant to finish.Before power significantly reduces, agglomerated particle must be scatter, otherwise oils and fats only is difficult to agglomerated Dispersion of Particles again with stirring after forming continuous phase.

3, molding

(1) cooling molding method---utilize the thermal fluidity of material and cooling curing characteristic to implement.Comprise the die casting method of forming, pouring on flat molding, cold stamping die molding, cutting molding, extrusion modling, exempt from demoulding moulding by casting etc.

The die casting method of forming is that the material (22～60 ℃) that will finish refinement and liquefaction quantitatively pours in the mould that presets, and then packs after cooled and solidified, the demoulding, the taking-up.

The pouring on flat molding is meant quantitative discontinuous the watering on the plane of static or serial movement of the material (22～60 ℃) that will finish refinement and liquefaction, takes out packing after cooled and solidified.

The cold stamping die molding is meant before the still uncolled molding of material (22～60 ℃) that will finish refinement and liquefaction that by low temperature (being lower than 20 ℃) metal die location compacting fast cooling shaping, pack the demoulding, taking-up back.

The cutting molding is meant that the material (22～60 ℃) that will finish refinement and liquefaction extrudes continuously or be cast on the plane of static or serial movement, and quantitatively cutting before cooled and solidified is fully solidified the back and taken out packing.

Extrusion modling is meant that the material (22～60 ℃) that will finish refinement and liquefaction is before complete cooled and solidified, the circular roller that has symmetrical die that is inwardly rotated by two constant speed is with the material extrusion modling, unhairing is packed behind the limit, also can polish, be coated with sugar-coat or film-coat before the packing.

Exempt from demoulding moulding by casting and be meant that the material (22～60 ℃) that will finish refinement and liquefaction quantitatively pours in the mould that presets, then seal cooled and solidified again, also can in process of setting or after solidifying, seal.The method mould is together sold with product.

(2) powder compacting method: the material cooling curing is become powder or granule, then compression moulding.Powder or particulate preparation include but not limited to adopt spray granulation method, extrusion granulator method, stir granulation, cutting method etc.The method of compression moulding can adopt tablet machine or other mould pressing mode molding.

The spray granulation method is meant that the material (22～60 ℃) that will finish refinement and liquefaction is sprayed with the droplet form by shower nozzle, and the droplet cooling in overcooled gas will move makes the material cooled and solidified become powder or granule.

The extrusion granulator method is meant that the material (22～60 ℃) that will finish refinement and liquefaction with extruder is extruded into granule continuously.

Stir granulation and be meant the material (22～60 ℃) that will finish refinement and liquefaction under refrigerative condition, continuous stirring becomes granule or powder.

Cutting method be meant the material that will will finish refinement and liquefaction and solidify by cut, cut, file, mode such as pulverizing makes granule or powder.

Granule that these methods are made or powder also can directly use.

The content ordinary circumstance of finished product preparation preparation moisture should not be higher than 13% of finished product preparation percentage by weight, better is 7%, and the best is 3%.

The fusing point of finished product preparation of the present invention is between 23～46 ℃, and said preparation can containing, and also can chew clothes.Chew when clothes, not only improve the rapid release effect, and the process of chewing also is the process that mechanical energy is converted into heat energy, also can promote the fusing of oiliness dispersant by the heat production of chewing, to improve the rate of release of main component by the surface area that increases preparation.When the described preparation of this patent uses in consumer, also this preparation can be heated as paste or liquid is taken.

Utilize heating liquefaction---the reciprocal characteristics of cooling curing of this preparation, before finished product is finished, can repeat this process, be beneficial to production and processing.Generally between 6～26 ℃, the low more setting rate of temperature is fast more for refrigerative temperature.

Preparation of the present invention can all adopt the made preparation of this patent method composite in the composite use of secondary after the molding, also raw material and other batching of this preparation as other dosage forms can be used.This dosage form is solid-state or is heated as liquid state or paste when composite, and the mode of molding can be according to the mode molding of this patent, also can be according to other dosage form molding mode molding.

As: coating---the slurry form with this preparation applies the postcooling hardened forming to food, or based on this preparation, the external skin other materials; Mix---mix with other food with the slurry of this preparation or granule, powder type; Sandwich---with this preparation is shell, middle liquid, mastic or the solid of adding; Fill---slurry or solid form with this preparation are filled in other food.Above-mentioned several method can use alone or in combination.

The invention provides a kind of Chinese medicine glue rapid-release preparation for oral cavity and manufacture method thereof, its advantage and effect are: according to this method gained preparation, adaptability to raw material is wide, drug loading is big, can reach under the prerequisite of better mouthfeel, improve the dispersion rate of colloid composition in mouth, and need not drink water taking convenience.After some people had obeyed colloid, inappetence appearred, stomach is glutted.This is that taking for a long time can imapirment of the spleen and stomach, digestive functional disturbance occurs, and then influences appetite because colloid is relatively grown greasyly.The micropartical two-phase disperse system of uniqueness of the present invention, colloid is scattered in gastric juice fast with pre-emulsifying micropartical form, effectively avoid collagen protein excessively to assemble and durable attachment, solve colloid and take the taste discomfort, protein secondary hydrolysis in vivo is also helpful for improving.

(4) description of drawings:

Fig. 1 is the existence sketch map of various compositions in the Chinese medicine glue rapid-release preparation for oral cavity

Fig. 2 is an oral cavity rapid release preparation manufacture method FB(flow block) of the present invention

Fig. 3 is the dry pulverization process process chart

Fig. 4 is a semidry method disintegrating process flow chart

Fig. 5 is the waterproof pulverization process chart

Fig. 6 is the roll-type polishing process chart of specific embodiment 1

Fig. 7 is specific embodiment 2 correct grinding method process charts

Fig. 8 is specific embodiment 3 ball-milling method process charts

Fig. 9 is specific embodiment 4 vibro-grinding method process charts

Figure 10 is specific embodiment 5 mixing method process charts

(5) specific embodiment:

Oiliness dispersant of the present invention is an important component of the present invention, and its effect is that solid constituent is dispersed in the oiliness dispersant.Wherein the fusing point of oiliness dispersant and human body temperature are fallen closely, are slurry when promptly approaching human body temperature, and (room temperature) is solid when being lower than human body temperature.This hot melt oral cavity rapid release and traditional aqueous rapid release mechanism are completely different.

Solid preparation of the present invention enters the mouth, oral temperature makes oiliness dispersant melted by heat, along with the progressively fusing of oiliness dispersant, the solid constituent that comprises colloid is distributed in the mouth with slurry form with the oiliness dispersant of liquid state, to finish the preliminary dispose procedure of colloid composition.

All solid constituents are scattered among the oiliness dispersant equably in the component of the present invention, are slurry form surpassing under the temperature of room temperature, are solid state at normal temperatures, and solid constituent is wrapped in the oiliness dispersant that is solid forms.And the state of this heat is that slurry, cold state are that solid is reversible.The present invention utilizes this reversible character just, can keep the dispersion stabilization (prevent the solid constituent that is easy to generate under the slurry form from reuniting or sedimentation, oils and fats is separated out) of solid constituent and the stability (moisture absorption, oxidation etc.) of composition itself when normal temperature storage.

Below in conjunction with drawings and the specific embodiments technical scheme of the present invention is described further.

Embodiment 1: the manufacture method of ass hide gelatin preparation

(1) gets the raw materials ready: major ingredient 200kg (6 parts in Colla Corii Asini, 7 parts of Fructus Crataegis, 2 parts of Fructus Lyciis, 2 parts of Fructus Jujubaes), adjuvant (xylitol 100kg, hydrogenated vegetable oil 150kg, lecithin 10kg)

(2) pulp preparation: carry out refinement earlier---adopt semidry method, roll-type polishing (see figure 6).Be specially: major ingredient 200kg is crushed to 100～200 orders, adding 100kg xylitol and 90kg hydrogenated vegetable oil (36～60 ℃) mixes, enter two roller mills (or three-roll grinder) and be milled to 60～150 microns in advance, then enter five roller mills (or three-roll grinder) and grind, to 20～33 microns.Liquefy again---material is dropped into refiner (blender) carry out refine (stirring) 3～6 hours, progressively add residue hydrogenated vegetable oil and lecithin to even according to material viscosity therebetween.This technology also can be made raw material with xylitol powder process, behind each composition mixing, directly enters five roller mills (or three-roll grinder) without pre-grinding and grinds, and other technologies are identical.

(3) molding: refine (stirring) discharging that finishes, to insert hopper and extrude continuously, fixed length cutting cooled and solidified is taken out packing, the 10g/ piece.

Embodiment 2: the manufacture method of Colla cornus cervi preparation

(1) gets the raw materials ready: major ingredient 200kg (9 parts of Colla cornus cervis, 1 part of microcrystalline Cellulose), adjuvant (sugared 300kg, refining vegetable oil 300kg, lecithin 10kg)

(2) pulp preparation: refinement is carried out simultaneously with liquefaction---adopt wet method, correct grinding method (see figure 7).Be specially: major ingredient 200kg mixed powder is broken to 15～200 orders, adds (or mixing the back adding) scraper-type refiner with 300kg Icing Sugar and 270kg refining vegetable oil (38～60 ℃) successively and grind, to 26～30 microns.Reserving the 30kg refining vegetable oil adds in the lump in preceding 1 hour of end and lecithin.

(3) molding: finish grind the discharging that finishes, inject preforming plastic-aluminum mould and also seal cooling and shaping, 10g/ piece.

Embodiment 3: the manufacture method of Colla Plastri Testudinis preparation

(1) gets the raw materials ready: Colla Plastri Testudinis 200kg, adjuvant (hydroxyl isomaltulose 200kg, lactose 100kg, cocoa butter 300kg, lecithin 10kg)

(2) pulp preparation: refinement is carried out simultaneously with liquefaction---: adopt wet method, ball-milling method (see figure 8).Be specially: Colla Plastri Testudinis 200kg is crushed to 10～200 orders, and with hydroxyl isomaltulose 200kg, lactose 100kg and 300kg cocoa butter (39～60 ℃) add (or mixing the back adding) ball mill grinding successively, to 30～33 microns.Lecithin adds in process of lapping successively.

(3) molding: the ball milling discharging that finishes, pour into after the homoiothermic in the mould that presets, then cooled and solidified is taken out packing, the 10g/ piece.

Embodiment 4: the manufacture method of Colla Corii Asini compound preparation

(1) gets the raw materials ready: major ingredient 200kg (proportioning raw materials: 150 parts in Colla Corii Asini, 300 parts of Radix Rehmanniae Preparata, 300 parts of Radix Codonopsis, 150 parts of the Radixs Astragali, 150 parts of Fructus Lycii, 150 parts of the Rhizoma Atractylodis Macrocephalaes, all the other medicinal material extract are twice except that Colla Corii Asini, filter rear filtrate and merge adding Colla Corii Asini mixing, being evaporated to relative density is 1.05～1.10, add 100 parts of lactose, 30 parts in dextrin, behind the mix homogeneously, spraying drying powder-forming), adjuvant (sugared 200kg, hydrogenated vegetable oil 150kg, the 10kg sorbester p18)

(2) pulp preparation: carry out refinement earlier---adopt dry method, vibro-grinding method (see figure 9).Be specially: major ingredient 200kg and 200kg white sugar are crushed to 300 orders with vibromill, liquefy again---material is dropped into refiner (blender) stirred 2～6 hours, add 150kg hydrogenated vegetable oil (36～60 ℃) and sorbester p18 successively according to material viscosity therebetween.

(3) molding: refine (stirring) discharging that finishes, pour in the mould that presets, then cooled and solidified is taken out packing, the 10g/ piece.

Embodiment 5: the manufacture method of ass hide gelatin preparation

(1) gets the raw materials ready: Colla Corii Asini 200kg, adjuvant (cocoa powder 100kg, sugared 300kg, milk powder 100kg, refine Petiolus Trachycarpi oil 300kg, lecithin 10kg)

(2) pulp preparation: refinement is carried out simultaneously with liquefaction---adopt the mixing method (see figure 10).Be specially: with Colla Corii Asini 200kg (spray drying powder), the mixed slurry that adds ground in advance cocoa powder 100kg, milk powder 100kg, white sugar 300kg, lecithin 10kg and refine Petiolus Trachycarpi oil 300kg carries out refine (stirring) or ground 6～9 hours in refiner (blender) or scraper-type refiner.

(3) molding: refine (stirring) or grind the discharging that finishes, become the disk shape through extrusion modling, after the cooled and solidified, sugar coating and polishing are taken out packing, the 1g/ sheet.

For preventing the major ingredient loss or change that above-mentioned making overall process temperature is controlled at below 70 ℃, is preferably below 60 ℃, is more preferably below 48 ℃.

On the foregoing description basis, the slurry before the moulding by casting can be mixed with kernels such as Semen Juglandis, Semen Sesami or Semen Armeniacae Amarums, mixing temperature should make slurry keep flowing (general more than 31 ℃), and the kernel form can be granulate, granule or particle.Mix and to finish directly cooled and solidified or to insert preset die cooled and solidified then, take out and pack.This compound mode is one of the method for the flexible Application of this patent, also more meets traditional easing characteristic of Chinese medicine colloid.

Because what adopt is the dispersion of oil phase bag solid phase, guarantee that oil is continuous phase in the various technical schemes that the foregoing description provided, then must add enough oil masses.The oil phase ratio is big more, and slurry viscosity is low more before ot-yet-hardened, and vice versa.

In actual use, the oiliness DAR dispersing agent requirement of this preparation is accepted the heat in oral cavity and is converted into liquid, being wrapped in solid particle in the oiliness dispersant can enough dissociate out and contact with saliva in the oral cavity, and then mix to pulverize aqueous dispersion in the formed solid particle and be dissolved in saliva in the oral cavity rapidly, thereby the solid major ingredient is scattered in the oral cavity fast.In order to reach good rapid release effect, the one, aqueous dispersion and major ingredient must be uniformly distributed in the oiliness dispersant, and the high more rapid release of aqueous dispersion content is good more, and this taking dose with major ingredient is directly related; The 2nd, the oiliness dispersant should fast as far as possible fusing.The burn-off rate that improves the oiliness dispersant can solve by the method that reduces the oils and fats fusing point, but bigger for the temperature tolerance influence of finished product; More practical method is to reduce the addition of oiliness dispersant, melts the required heat from buccal absorption of oils and fats to reduce, thereby improves the rapid release effect.

In preparation, tend to contain certain moisture, especially oiliness becomes the solid discontinuous phase of branch parcel, is easier to combine with water with respect to the oiliness composition, thereby makes its imbibition and gel, increase discontinuous phase volume and surface area, slurry viscosity increases unusually before causing not solidifying.In order to keep suitable flowability, have to increase the content of oil, but this not best solution.

For further improving the present invention, be necessary to reduce the moisture in the slurry.

Adopt the more raw material of low-water-content at first as far as possible, also can before batching, adopt exsiccant mode to realize.But this pretreated method can not all be removed the moisture in the slurry, therefore need remove moisture in preparation process as far as possible.

In aforementioned implementation method, material exchanges transpiring moisture with air at a certain temperature in mixing and stirring (refine) operation.The process of mixing and stirring (refine) is an exothermal process, by adjusting the oiliness component ratio and the temperature of material, makes it be in effective viscosity, and the big more torsion to equipment of viscosity requires high more, and the material quantity of heat production also increases, and vice versa.For improving the effect of water evaporates, can add thermal material and ventilation.But if surpass the temperature of technological requirement, then need cool off in the preparation process.

Aforesaid lapping device also can be pulverized temperature adjustment, ventilation or the airtight evacuation of cavity by equipment, reaches the material refinement effect of transpiring moisture simultaneously.

The removal of moisture not only helps reduction and does not solidify the grease amount of slurry viscosity minimizing before, also can density improve, improve finished product hardness, help the good oil dispersion of formation to be owing to the solid discontinuous phase dewaters, prevent that also moisture improves the preservation of finished product to the migration of outside in the storage process.The more important thing is by avoiding the hydration of solid discontinuous phase, improve the oral cavity rapid release performance and improved mouthfeel.

In the production process of Chinese medicine colloid (or Colla Corii Asini), for from the thick paste state forming for possessing better weatherability and conservatory lump shape, generally all can add Shaoxing rice wine (yellow wine), crystal sugar and oils and fats (Oleum Glycines, Oleum Arachidis hypogaeae semen or other).Wherein Oleum Glycines is the most frequently used, except toughness, specific retention, the transparency that can improve block colloid, prevents from sugared recrystallization and cooperate crystal sugar to improve to dissolve characteristic, the more important thing is the adhesion that prevents discharging, dries in the air processes such as stand, stripping and slicing.The Oleum Glycines of this moment is scattered between the collagen protein, can not separate out.

Fat content in the general Chinese medicine colloid (or Colla Corii Asini) is all below 10%, more 6～8%, stirring (refine) by this preparation process can make Oleum Glycines separate out becomes free state, and with preparation in the oiliness dispersant that adds merge, can reduce the adding proportion that the oiliness dispersant becomes continuous phase with this.If spray drying powder is only added crystal sugar and Shaoxing rice wine in the general concentrated slurry before spraying.

Therefore be major ingredient when adopting pure Chinese medicine colloid (or Colla Corii Asini), when the oiliness dispersant is unique adjuvant,, can reduce the addition 8% of oiliness dispersant according to Chinese medicine colloid 9% fat content meter.Be major ingredient 88%, oiliness dispersant 12%.When major ingredient when to be Chinese medicine colloid (or Colla Corii Asini) with other medicines, food or functional additive proportioning use, can adjust oiliness additive content according to its proportional quantity size.

Below, enumerate the concrete material combination of some common glue rapid-release preparation for oral cavity again:

The base stock of said preparation is divided into major ingredient and adjuvant; The percentage by weight of major ingredient is 0.1%～88%, and the percentage by weight of adjuvant is 12%～99.9%.

The oiliness dispersant	Major ingredient	The component total amount
			The refine Petiolus Trachycarpi oil	Happiness word Colla Corii Asini
99.9	0.1	100
			Hydrogenated vegetable oil	Colla Corii Asini (piece)
12	88	100

More excellent proportioning is that the percentage by weight of oiliness dispersant is 13～99.8%, and the percentage by weight of major ingredient is 0.1～86.9%, emulsifying agent 0.1～20%.

The oiliness dispersant	Major ingredient	Emulsifying agent	The component total amount
				Hydrogenated vegetable oil	Good fortune word Colla Corii Asini	Sorbester p18

99.8	0.1	0.1	100
				Refining vegetable oil	New Colla Corii Asini (piece)	Sucrose fatty acid ester
13	86.9	0.1	100
				The refine Petiolus Trachycarpi oil	2 parts in Colla Corii Asini, 1 part of Ganoderma	Glyceryl monostearate: lecithin=1:3
13	67	20	100

More excellent proportioning is that the percentage by weight of oiliness dispersant is 15～99.7%, and the percentage by weight of major ingredient is 0.1～84.8%, and the percentage by weight of water soluble dispersing agent is 0.1～77.8%, emulsifying agent 0.1～20%.

The oiliness dispersant	Major ingredient	Water soluble dispersing agent	Emulsifying agent	The component total amount
					Hydrogenated vegetable oil	Donkey-hide gelatin with ginseng and pilose antler	Sugar	Sorbester p38
22	0.1	77.8	0.1	100
					The refine Petiolus Trachycarpi oil	Gelatinum oxhide (piece)	Oligofructose	Lecithin
15	84.8	0.1	0.1	100
					Hydrogenated vegetable oil	Colla carapax Trionycis	Xylitol	Sodium stearate
99.7	0.1	0.1	0.1	100
					Refining vegetable oil	1 part of Colla cornus cervi, 2 parts of Radix Ginseng Rubra	Maltose alcohol	Lecithin
22	19	39	20	100
					Hydrogenated vegetable oil	SANWUJIAO	Erythritol	Polyglycereol Semen Ricini alcohol ester
56	0.1	43.8	0.1	100
					Refining vegetable oil	3 parts of Solenognathus glue, 1 part of cyclodextrin	Oligomeric xylose	Xylitol acid anhydride mono fatty acid ester
39	60.8	0.1	0.1	100
					The refine Oleum Cocois	30 parts of Air Bladder pseudosciaenae seu Acipenser, 1 part in protease	Lactose	Glyceryl monostearate
56	3	31	10	100

Optimum proportioning is that the percentage by weight of oiliness dispersant is 15～99.6%, and the percentage by weight of major ingredient is 0.1～83%, and the percentage by weight of water soluble dispersing agent is 0.1～77%, correctives 0.01～82%, emulsifying agent 0.1～20%.

The oiliness dispersant	Major ingredient	Water soluble dispersing agent	Emulsifying agent	Correctives	The component total amount
						The refine Oleum Cocois	Colla Plastri Testudinis	Sorbitol	Lecithin	Citric acid
22	0.1	77	0.89	0.01	100
						Refining vegetable oil	Antler gelatin (piece)	Glucose	Polyglycereol Semen Ricini alcohol ester	Vanillin
15	83	0.99	1	0.01	100

Hydrogenated vegetable oil	Turtle and deer glue	Oligomeric xylose	Lecithin	Defatted milk powder
						22	38.8	0.1	0.1	39	100
The refine Oleum Cocois	Colla cornus cervi	Oligomeric isomaltose alcohol	Glyceryl monostearate	Whole milk powder
						16	0.9	0.1	1	82	100
Oleum sapii	Dog bone glue	Lactulose	Lecithin	Cocoa powder
						36	23	8	20	13	100
Hydrogenated vegetable oil	SANWUJIAO	Oligomeric lactulose	Sorbester p38	Ethyl maltol
						99.6	0.19	0.1	0.1	0.01	100
Cocoa butter	Fish bone glue	Oligomeric sugarcane fructose	Sucrose fatty acid ester	Milk powder
						56	7.8	0.1	0.1	36	100

Claims (11)

1, a kind of Chinese medicine glue rapid-release preparation for oral cavity, the base stock of said preparation is major ingredient and adjuvant, it is characterized in that: major ingredient is one or more the combination in Chinese medicine colloid or Chinese medicine colloid and other edible compositions, medicinal ingredient or the functional filler; Adjuvant is the oiliness dispersant or is one or more the combination in oiliness dispersant and water soluble dispersing agent, correctives and the emulsifying agent; The percentage by weight of major ingredient is 0.1%～80%, and the percentage by weight of adjuvant is 20%～99.9%.

2, a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 1, it is characterized in that: the percentage by weight that the water soluble dispersing agent in the described adjuvant, correctives and emulsifying agent account for adjuvant is not more than 85%.

3, a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 1 is characterized in that: can add functional filler in this major ingredient; This functional filler accounts for the percentage by weight of major ingredient for being not more than 98%; This functional filler comprises: the high molecular polymer of natural origin, saccharide, cellulose and derivant thereof, starch and derivant thereof, cyclodextrin and derivant thereof, polymer, inorganic salt, pH regulator agent, their form uses alone or in combination.

4, a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 1, it is characterized in that: this oiliness dispersant comprises artificial fat, natural oil or the oils and fats through processing, their alone or in combination form use, the percentage by weight of the addition of this oiliness dispersant should satisfy that oil content is not less than 15% in the finished product; This oiliness dispersant adopts greasy fusing point to be in-20～70 ℃.

5, a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 1 is characterized in that: this oiliness dispersant also can adopt and be dissolved in greasy surfactant; This is dissolved in greasy surfactant is lecithin, Polyethylene Glycol, polyethers, span, tween, sucrose fatty acid ester, mono fatty acid glycidol, bis-fatty acid glyceride, tri-fatty glyceride, polyglyceryl fatty acid ester, xylitol acid anhydride mono fatty acid ester, sorbitan aliphatic ester, fatty acid and derivant thereof, octadecanol, hexadecanol, semi-synthetic fatty acid ester, methyl glycol fatty acid ester, organic acid monoglyceryl ester, monohydric alcohol fatty acid ester, their form uses alone or in combination.

6, a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 1, it is characterized in that: water soluble dispersing agent is a saccharide in the adjuvant; This saccharide comprises glucose, fructose, sucrose, brown sugar, remelt sugar, white sugar, crystal sugar, starch sugar, maltose, verbascose, lactose, dextrin, erythritol, xylitol, fructose alcohol, mannitol, Sorbitol, lactose, galactitol, maltose alcohol, hydroxyl isomaltulose, hydroxyl isomaltulose, Palatinitol, isomalt, oligomeric isomaltose alcohol, 1,2,3,4,5-pentanepentol, oligomeric isomaltose, soybean oligo saccharide, oligomeric galactose, Oligomeric manna sugar, oligofructose, Oligomeric maltose, oligomeric xylose, the sweet sugar in oligomeric Portugal, oligomeric lactulose, oligomeric lactose, oligomeric sugarcane fructose, the branch oligofructose, the Lac Bovis seu Bubali oligosaccharide, trehalose, chitin oligosaccharide, the inulin oligosaccharide, gentian oligose, the chitin oligosaccharide, Raffinose, panose, glucosyl group sucrose, coupling sugar, lactulose, the breast fructo-oligose, lactulose, stachyose, stachyose, the isomery lactose, the sucrose oligosaccharide, Tagatose, palatinose, isomaltulose, cellooligosaccharide, oligomeric lactosucrose, hydrogenated starch hydrolysate, arabinose, xylose, general Shandong indigo plant, how blue card is, more skin ulcer glue enzyme analyte, these possess the single use of water miscible composition or are used in combination, water soluble dispersing agent also can adopt and possess water miscible Mel in the adjuvant, Lac regis apis, aminoacid, amino acid salts, Sal, peptide, protein, they can single uses or are used in combination.

7, a kind of manufacture method of Chinese medicine glue rapid-release preparation for oral cavity is characterized in that: this method technological process is as follows:

(1) gets the raw materials ready according to the described component of above-mentioned any claim;

(2) pulp preparation: with the solid particle refinement and be dispersed in the oiliness dispersant and become slurry, fineness of the particles be weight of formulation 70% below 600 microns, adopt the mode that stirs that solid particle is scattered in the oiliness dispersant; The percentage by weight of the addition of oiliness dispersant should satisfy that oil content is not less than 15% in the finished product, and can flow under 22～60 ℃ of conditions with slurry is as the criterion; According to the stage difference that the oiliness dispersant adds, solid particle refinement mode is that dry pulverization process, semidry method are pulverized or waterproof pulverization;

(3) molding: adopt cooling molding method or powder compacting method to make finished product preparation.

8, the manufacture method of a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 7, it is characterized in that: the process of described solid particle refinement can adopt Ginding process, and Ginding process is roll-type polishing, correct grinding method, ball-milling method, vibro-grinding method or mixing method.

9, the manufacture method of a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 7 is characterized in that: described dry pulverization process is refinement under the low condition of material oil content, and material pulverizing state is to possess mobile powdered; Specifically be that the solid material that all is insoluble to oil---major ingredient and water soluble dispersing agent mix, add or do not add part oiliness dispersant, be crushed to final fineness.

10, the manufacture method of a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 7 is characterized in that: it is refinement under the moderate condition of material oil content that described semidry method is pulverized, and material pulverizing state is moistening leather hard; Specifically be that the solid material that all is insoluble to oil---major ingredient and water soluble dispersing agent mix, add or do not add part oiliness dispersant, be crushed to final fineness.

11, the manufacture method of a kind of Chinese medicine glue rapid-release preparation for oral cavity according to claim 7 is characterized in that: described waterproof pulverization is refinement under the high condition of material oil content, and material pulverizing state is liquid or mastic state; Specifically be that the solid material that all is insoluble to oil---major ingredient and water soluble dispersing agent mix, add or do not add part or all of oiliness dispersant, be crushed to final fineness.

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