CN101757043A - Liquid traditional Chinese medicine decoction piece and preparation method thereof - Google Patents
Liquid traditional Chinese medicine decoction piece and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a liquid traditional Chinese medicine decoction piece and a preparation method thereof. The liquid traditional Chinese medicine decoction piece is prepared from raw materials of traditional Chinese medicine decoction pieces or crude drugs. The invention is characterized in that the liquid traditional Chinese medicine decoction pieces are spherical or nearspherical particles, and the raw materials are sieved by a screen of 40-200 meshes. The plant drug powder and the animal drug powder in the powder of the raw materials are fine powder in which plant cell organizations and animal plant cell organizations can be seen under the microscope. The liquid traditional Chinese medicine decoction piece does not contain any adhesives or adjuvant materials, and uses water as the forming agent; the particles of the novel decoction piece are manufactured by the modern granulating technology of shaping and shot blasting, and are equal in size, uniform in density and good at liquidity; and the liquid traditional Chinese medicine decoction piece meets the mechanization packing requirements, and realizes the normalization for packing and the quality standardization and the detection modernization of the traditional Chinese medicine decoction piece. The granulating process is a physical change rather than a chemical change, and conforms to the traditional Chinese medicine principle of multi-drug decoction. The invention pushes forward the production modernization and the industrial modernization of the traditional Chinese medicine, and plays an active role in expediting the technology innovation of the traditional Chinese medicine industry.
Description
Technical field
The present invention relates to a kind of prepared slices of Chinese crude drugs, the particularly a kind of novel mobile prepared slices of Chinese crude drugs and preparation for processing thereof.
Background technology
Three big pillars of Chinese medicine industry are Chinese crude drug (crude drug), the prepared slices of Chinese crude drugs, Chinese patent medicine.Wherein, the prepared slices of Chinese crude drugs are to concoct processing by Chinese crude drug, take after the decoction; It simultaneously also is the raw material that Chinese patent medicine is produced.Traditional prepared slices of Chinese crude drugs are simply to be processed on the basis of Chinese crude drug (crude drug), because raw materials of traditional Chinese medicinal materials (crude drug) is agricultural byproducts mostly, its out-of-shape, quality is uneven, causing the prepared slices of Chinese crude drugs is out-of-shape equally, quality is uneven, and is difficult to realize the standardization and the automatization of metering, packing.
This present situation has seriously hindered the modernization of the field of Chinese medicines.For a change this present situation of Chinese medicine worker both domestic and external has been carried out extensive work.For example, No. 01100033.3 Chinese invention patent discloses a kind of nanometer prepared slices of Chinese crude drugs and preparation method thereof: be that Chinese medicine powder is broken into superfines below 500 nanometers.The preparation process of this superfines, preparation cost are too high, and have smashed the cell wall of plant or animal Chinese medicine, have than big difference with the structure of Chinese medicine decoction pieces.The effect same that whether can reach the Chinese medicine decoction pieces needs checking.Simultaneously, the granularity of this superfines is too tiny, and is mobile unstable; If realize automatization's weighing, divide packing, might cause the obstruction of pipeline by equipment such as pipelines.
Main is: this superfines has been destroyed the cell tissue of the plant in the crude drug, animal, makes that the state of this superfines and Chinese medicine decoction pieces is inconsistent, does not possess equity on drug effect.
In addition, about preparation, automatization's fractional pack and the quality standard research project research contents thereof of the mobile prepared slices of Chinese crude drugs, so far as yet not with the authentication code product of listing, though there are some special dependencys reports to occur.These reports are reduced: 1. decoction pieces granule claims again to exempt to decoct granule, though solved flowability problem, but it is bigger to be considered to the basic principle gap of boiling altogether with Chinese medicine group medicine, dispute is fierce, the approval of medical circles in not obtaining as yet so far, and it is very big that difficulty is promoted in commercialization; 2. decoction pieces granule (decoction pieces fourth), abroad, Japan's hall of following the mandate of heaven is cut into slices raw medicinal herbs, be cut into silk, is cut into granule again, complex process, loss is big, promotes in China to face cost pressure; 3. granule decoction pieces, single-minded kind of nanometer prepared slices of Chinese crude drugs of No. 01100033.3 China's invention, technology difference, granular size difference, product form difference.
The fractional pack of the prepared slices of Chinese crude drugs, as the term suggests traditional decoction pieces is packaged in the small plastic bag, his release, though improved the prescription quality of the prepared slices of Chinese crude drugs at present, solved that Chinese medicine pharmacy's staff is few, the place is little, the problem of environment difference, but be actually and these problems are married again manufacturing enterprise gone, because of decoction pieces does not have flowability, production process is craft, make enterprise difficult negative its heavy the time, being absorbed in fractional pack does not have bar code, does not have labelled amount, do not have lot number, difference between batch apart from more greatly, especially among the inhomogenous difficult situation of product quality.
It is inhomogeneous how to break away from decoction pieces, quality gap is bigger between criticizing and criticizing, is fractional pack difficult to automatization's difficult situation? at first will improve the tonnage amount (to reduce the testing amount of unit batch) of single batch of the prepared slices of Chinese crude drugs, its core solves prepared slices of Chinese crude drugs inhomogeneity problem exactly; Inhomogeneity the very corn of a subject solves flowability problem exactly; The core of flowability problem prepares mobile prepared slices of Chinese crude drugs product exactly.The mobile prepared slices of Chinese crude drugs not only make small batch be merged into big batch; And make automated package, commercialization become possibility, therefore, the mobile prepared slices of Chinese crude drugs are only and solve decoction pieces inhomogeneities, decoction pieces automatization fractional pack key issue place, just can make on the tcm clinical practice combination drug hold more accurately, safety, effectiveness, the controllability of medication are fulfilled.
In addition, the production standardization of the prepared slices of Chinese crude drugs and quality standardization still do not have solution so far, its the underlying cause is the flowability problem of the prepared slices of Chinese crude drugs, solved this problem, could really realize automatic packaging, make it become qualified " medical commodity ", rather than " agricultural byproducts ", and then realize standardization and the quality standardization that the prepared slices of Chinese crude drugs are produced.
Pill is meant that medical material fine powder or medicinal substances extract add sphere or the spherical preparation of class that suitable binding agent or other adjuvants are made, are divided into types such as honeyed pill, water-honeyed pill, the watered pill, paste pill, concentrated pill, wax pill and micropill in the patent medicine of Chinese medicine.
Honeyed pill means that the medical material fine powder is the pill that adhesive is made with Mel.The title big honeyed pills of wherein every ball weight more than 0.5g (containing 0.5g), the title small honey pill of every ball weight below 0.5g.
Water-honeyed pill means that the medical material fine powder is the pill that adhesive is made with Mel and water.
Paste pill means that the medical material fine powder is the pill that adhesive is made with rice paste or batter etc.
Concentrated pill with suitable adjuvant or all the other medical material fine powders, is the pill that adhesive is made with water, Mel or Mel and water after meaning that medical material or part medicinal material extract concentrate.According to the difference of used adhesive, be divided into concentrated watered pill, concentrate honeyed pill and condensed water honeyed pill.
The watered pill means that the medical material fine powder binds the pill of making, the wherein rare medicine juice of water system with water (or according to method for making with yellow wine, vinegar, rare medicine juice, liquid glucose etc.).
And technology and equipment that various preparation patent medicine are arranged, for example, two kinds of preparation methoies of pill:
1. mould method for making, be with crude drug by the pill piece, prepare the ball bar with billet cutter, reuse rolls the ball machine ball bar is cut into a section pill, round immediately after rolling ball.
2. general method for making: be meant the alternately moistening and being spread in the suitable container or machinery of fine drug powder and water or other liquid adhesives (yellow wine, vinegar, medicine juice, extractum etc.), constantly roll, successively a kind of method of Zeng Daing.Main technique is by molding, and ball is made in molding, and drying prepares pill.
The general traditionally general ball by hand that adopts, its tool work has intensity big, and dust is big, shortcomings such as the different difficult control of the ball method of double differences.
General method for making need add binding agent on technology, and molding is spread in suitable container or the machinery by moistening alternately and with powder constantly rolls, and successively increases, though seldom water is cooked binding agent, promptly using also is rare medicine juice.
Tablet: be meant the solid preparation made from compacting or molded method that contains medicine.Mainly be by pulverizing, sieve, weighing mixes (solid-solid), solid-liquid with adjuvant), granulate, drying, tabletting finish.On preparation technology, must add adjuvant, because of the toughness and the elasticity of fiber and tracheal tissue's cell, easy loose sheet.
The column type granule: the applicant once carried out the research of this respect early stage; this method is meant medicinal powder with the 9KS120 granulation machine based on mechanical circular motion; motor is a power; drive belt pulley and be passed to main shaft and flat-die, greater than 80 ℃ friction temperature, material is by condensing between wiping dynamic pressure wheel and the template; under the extruding of pinch roller; from flat-die, extrude, advanced the segmentation of cutting cutter, roll out column type granule decoction pieces from feed opening at last.Though this method is not added binding agent, its shortcoming is the section out-of-flatnesses of cylindrical particles two ends, and outward appearance is indecency, chip is more.
Exempt to fry in shallow oil granule: granule is drug extract to be cooperated with suitable adjuvant and the granular formulations made.The extraction that main preparation flow is a Chinese medicine, adding adjuvant, granulation, drying.Need add adjuvant.
Summary of the invention
The purpose of this invention is to provide a kind of mobile prepared slices of Chinese crude drugs, and the preparation method of this mobile prepared slices of Chinese crude drugs.The mobile prepared slices of Chinese crude drugs of the present invention will solve the flowability problem of the prepared slices of Chinese crude drugs; Can want the content difference according to raw material, adopt Electronic Data Processing to feed intake, solve the inhomogeneity problem of the prepared slices of Chinese crude drugs; And make the automated package of the prepared slices of Chinese crude drugs, commercialization become possibility.
These mobile prepared slices of Chinese crude drugs are on the basis of the prepared slices of Chinese crude drugs, use pulverizer prepared slices of Chinese crude drugs powder was become 40～200 mesh sieve powder, and wherein the powder of plant amedica, animal drugs is in visible plant of microscopically or animal tissue cell.It is spherical to utilize ball blast excipient technology to be prepared into, drying, sterilization, packing.The reform of the mobile prepared slices of Chinese crude drugs meets the Chinese medicine traditional theory, meets the big production of modernization again.
The scheme of finishing the foregoing invention task is, a kind of mobile prepared slices of Chinese crude drugs, be to be raw material (comprising plant amedica, animal drugs, mineral drug etc.) with Chinese medicine decoction pieces powder or crude drug powder, described Chinese medicine decoction pieces raw material is 2005 editions, and " first one of Chinese pharmacopoeia recorded herbal species, described crude drug raw material is the kind that Shanghai science tech publishing house " Chinese medicine voluminous dictionary " records, it is characterized in that described raw material pulverizing, cross 40～200 mesh sieve powder, powder is in visible plant of microscopically or animal tissue cell; The granule that is shaped as spherical or near-spherical of the described mobile prepared slices of Chinese crude drugs, this diameter 0.1mm～10mm spherical or near-spherical; Roundness is at 1 °～40 °; Simultaneously, in the granule of this spherical or near-spherical, the granularity of crude drug medicated powder is 40～200 orders.
Prioritization scheme of the present invention has following further qualification:
Described spherical or approximate globular particulate diameter is 0.1mm～10mm; Diameter 0.5～8mm preferably; Optimum is: diameter 2mm～3mm;
Described spherical or approximate globular particulate roundness is at 1 °～40 °; Roundness is 1 °～30 ° preferably; Better roundness is 1 °～20 °; Optimum is: roundness is at 1 °～15 °; If can accomplish that roundness is at 1 °～12 ° then even more ideal;
Described spherical or approximate globular particulate water content is lower than 16%; Better numerical value is: water content is lower than 10%; Optimum is: water content is lower than 6%;
Simultaneously, the granularity of crude drug medicated powder is 40～200 orders in the granule of this spherical or near-spherical; Better numerical value is: 60～160 orders; Better numerical value is: 80～120 orders;
Simultaneously, the state of crude drug medicated powder is in the granule of this spherical or near-spherical: wherein the medicated powder of plant amedica, animal drugs is the fine powder that keeps cell tissue substantially.
Above-mentioned " keeping cell tissue substantially " is meant: the main part of crude drug medicated powder keeps cell tissue fully, is the agglomerate and bunch fast or cell long-chain of a plurality of cells; But do not get rid of the microparticle that individual cells is arranged; Or there are broken cell or damaged cell in the edge of granule (agglomerate) and a small amount of more fine powder is damaged cell wall or cell debris or cellular content.That is, crude drug medicated powder is the fine powder at the visible plant of microscopically, zooblast.
Described hardness spherical or approximate spherical particle is 3～180N; Better numerical value is: hardness is 5～60N; Optimum is that hardness is 5～30N;
Described friability spherical or approximate spherical particle is not more than 2%; Or be expressed as: friability 0.01～2%; Better numerical value is: friability is not more than 1%; Optimum is that friability is for being not more than 0.5%.It is considered herein that, if can accomplish that friability is not more than 0.3%; Even friability is not more than 0.2%, and is then better.
Grain density is 0.5～1.7; Depend on different Chinese medicine quality, better numerical value is: grain density is 0.6～1.6; Optimum is that grain density is 0.7～1.4;
Bulk density is 0.2～1.0; Depend on different Chinese medicine quality, better numerical value is: 0.3～0.9; Optimum is bulk density 0.4～0.8.
More optimize and more particularly, spherical or approximate globular granule of the present invention is meant, makes spherical or approximate globular granule according to " ball blast excipient technology " below the present invention:
Initiation material is be defined as 2005 " first Chinese medicine that records of Chinese pharmacopoeia and its decoction pieces; And vegetable drug, animal drug or mineral medicinal material, processing method is physical change, and is identical with the Chinese medicine decoction pieces, purposes is constant; Step is:
(1). pulverizing process:, do following processing according to the physical property and the character of raw material:
(1)-a. puts into powder beater with raw medicinal material and is broken into powder, crosses 40～200 mesh sieves;
(1)-b. for sugar content higher or or protein content is higher or the crude drug of the higher and difficult pulverizing of viscosity, adopt the freezing and pulverizing mode to be broken into powder, cross 40～200 mesh sieves;
(1)-c. " wire drawing cutting method " is difficult for the crude drug of pulverizing for other, and fiber leaf, rhizome, root, all grass herb big, that toughness is strong utilize the wire drawing cutting machine to cut into filament respectively; Utilize pulverizer to be ground into fine powder again, cross 40～200 mesh sieves;
(2). system soft material operation:
The medicated powder that step (1)-a, (1)-b, (1)-c. are obtained, pour hybrid granulator into, Bian Jiashui, the limit rotates in the same way, make the fiber in the granule be carded to equidirectional regularly arranged, rotation mixes, makes it to become the soft material that certain viscosity is arranged, and the weight ratio of its Chinese medicine powder and water is 1: 0.7～4; Recommending numerical value is 1: 3;
Described: " soft material that certain viscosity is arranged " is meant can bond agglomerating with thumb forefinger kneading medicated powder.
(3). the rotation granulation process:
(3)-and soft material that a. obtains step (2) places rotation granulator, the suitable moisturizing in limit, and the limit rotates in the same way, and it is equidirectional regularly arranged that fiber in the granule is carded to, and makes it to have certain viscosity, wet soft and formability;
When the mouldability as a result of step (3)-a better, the operation that then directly enters step (4); Bad when the molding as a result of step (3)-a, be loose particles, then enter step (3)-b operation, granule is carried out extrusion modling;
(3)-and b. extruder grain operation: for the bad loose particles of molding among step (3)-a, then adopt LSH-220 type wet granulator or screw Squeezinggranulator, granule is carried out extrusion modling;
(4). the ball blast operation:
(4)-a. puts into the shot-blasting machine rotation with step (3)-a or moistening soft granule that step (3)-b prepares and makes ball shape granule;
(4)-b. in the ball blast operation of described (4)-a. step, if any adhesion, can add a small amount of dried medicated powder;
(4)-c. in the ball blast operation of described (4)-a. step, divide for several times or spray water on granule continuously, divide then for several times or on granule, spray medicated powder continuously to make granule increase to required diameter;
(4)-b and two steps of (4)-c. in, the total weight ratio that adds powder amount and amount of water is 1: 0.7～4; Recommending numerical value is 1: 3;
(5). the operation of sieving: choose suitable aperture screen cloth, sieve is got the spherical of required diameter or near-spherical granule.
(6). drying process: it is dry that the spherical or near-spherical granule that will prepare is put into industrial acceptable drying equipment.
Not adding any binding agent and adjuvant in the mobile prepared slices of Chinese crude drugs of the present invention, is to be forming agent with water.
The above, the medical material of not getting rid of individual species, because the difficulty of molding, and need make little body core with adding a small amount of adjuvant in the raw material medicated powder earlier, be nuclear with this body core again, according to above technology, no longer add any binding agent and adjuvant, with water is forming agent, with more same raw material medicated powder, makes spherical or approximate globular granule.
Do not get rid of indivedual mineral medicinal materials yet, because the difficulty of molding, and need make spherical or the near-spherical granule with adding a small amount of adjuvant binding agent in the raw material medicated powder.
The scheme of finishing the 2nd invention task of the application is: the preparation method of the above-described mobile prepared slices of Chinese crude drugs is a raw material with traditional prepared slices of Chinese crude drugs, it is characterized in that step is as follows,
(1). pulverizing process: the prepared slices of Chinese crude drugs or crude drug are raw material, according to the physical property and the character of raw material, do following processing respectively:
(1)-a. puts into powder beater with raw medicinal material and is broken into powder, crosses 40～200 mesh sieves;
(1)-b. for sugar content higher or or protein content is higher or the crude drug of the higher and difficult pulverizing of viscosity, adopt the freezing and pulverizing mode to be broken into powder, cross 40～200 mesh sieves;
(1)-c. " wire drawing cutting method " is difficult for the crude drug of pulverizing for other, and fiber leaf, rhizome, root, all grass herb big, that toughness is strong utilize the wire drawing cutting machine to cut into filament respectively; Utilize pulverizer to be ground into fine powder again, cross 40～200 mesh sieves;
(2). system soft material operation:
The medicated powder that step (1)-a, (1)-b, (1)-c. are obtained, pour hybrid granulator into, Bian Jiashui, the limit rotates in the same way, make the fiber in the granule be carded to equidirectional regularly arranged, rotation mixes, makes it to become the soft material that certain viscosity is arranged, and the part by weight of its Chinese medicine powder and water is 1: 0.7～4;
Described: " soft material that certain viscosity is arranged " is meant can bond agglomerating with thumb forefinger kneading medicated powder;
(3). the rotation granulation process:
(3)-and soft material that a. obtains step (2) places rotation granulator, the suitable moisturizing in limit, and the limit rotates in the same way, and it is equidirectional regularly arranged that fiber in the granule is carded to, and makes it to have certain viscosity, wet soft and formability;
When the mouldability as a result of step (3)-a better, the operation that then directly enters step (4); Bad when the molding as a result of step (3)-a, be loose particles, then enter step (3)-b operation, granule is carried out extrusion modling;
(3)-and b. extruder grain operation: for the bad loose particles of molding among step (3)-a, then adopt LSH-220 type wet granulator or screw Squeezinggranulator, granule is carried out extrusion modling;
(4). the ball blast operation:
(4)-a. puts into the shot-blasting machine rotation with step (3)-a or moistening soft granule that step (3)-b prepares and makes ball shape granule;
(4)-b. in the ball blast operation of described (4)-a. step, if any adhesion, can add a small amount of dried medicated powder;
(4)-c. in the ball blast operation of described (4)-a. step, divide for several times or spray water on granule continuously, divide then for several times or on granule, spray medicated powder continuously to make granule increase to required diameter;
(4)-b and two steps of (4)-c. in, the total weight ratio that adds powder amount and amount of water is 1: 0.7～4;
(5). the operation of sieving: choose suitable aperture screen cloth, sieve is got the spherical of required diameter or near-spherical granule.
(6). drying process: it is dry that the spherical or near-spherical granule that will prepare is put into industrial acceptable drying equipment.
After the above step, can also be provided with following steps:
(7). sterilization process: press the medical industry common technology;
(8). packaging process: adopt tea filter paper, dry ball shape granule is packaged into fractional pack respectively according to taking dose.
The application recommends:
Among described step (1)-a or (the 1)-b., the powder of making was 60～100 mesh sieves;
The drying equipment of described (6) step is industrial acceptable equipment.
The baking temperature of described (6) step is by the receptible temperature of product.
Repeatedly say: in the pulverizing process (soft particulate front travel) of described step (1), can distinguish in the following ways: " the omnipotent method that grinds " is applicable to most of rhizomes, herb, mineral substance medical material.As Herba Menthae, the Rhizoma Atractylodis Macrocephalae etc.;
" wire drawing cutting method " is applicable to that fiber is big, water content is big, toughness reaches part leaf, flower, fruit, all grass herb by force.As Radix Morindae Officinalis, Herba Epimedii etc.;
Pull into filament, cutting method again;
Utilize " the broken mill method " of Universalpulverizer to be applicable to the fruit class, plant subclass, oiliness, frangible class medical material.As Fructus Schisandrae Chinensis, Periostracum Cicadae etc.;
" cut off broken mill method " and be applicable to stem wood class medical material.As Caulis Sargentodoxae, Caulis Clematidis Armandii etc.;
" freezing and pulverizing method " is applicable to mucous matter class, contains the high medical material of saccharide.As giving birth to Radix Rehmanniae Preparata, Rhizoma Polygonati etc.
In the ball blast operation of (3) step, can divide for several times, on granule, spray a spot of water.Described " on a small quantity " is also can stick identical medicated powder with the particle surface moistening that great majority are being shaped to be as the criterion.
According to cellular morphology, as cell categories such as fibrocyte, vessel cell, stone cell, cork cell, thin-walled what and characteristics, select different rotating speed and rotational time to be rotated combing, add the water rotation and make soft material, rotation is granulated, and in case of necessity, makes wet granular with the extruder grain operation, centrifugal throwing circle is drying to obtain.
The preparation method of the above-mentioned mobile prepared slices of Chinese crude drugs can be called " ball blast excipient technology ".Comprising:
1. wet method: refer to the crude drug in whole fine powder is not added any adjuvant, with water by suitable material ratio uniform mixing, be rotated combing, rotation is granulated, extruder grain is made wet (soft) granule, through throwing the centrifugal ball shape of making of system, drying is made the method for the prepared slices of Chinese crude drugs with certain flowability again.
2. dry method: refer to that it is body core that the Chinese medicine fine powder is got less grit (diameter is less than 1mm), centrifugal throwing system on shot-blasting machine adds water therebetween, adds powder and is rolled into the ball shape.
Principal character of the present invention is:
Not adding what binding agent and adjuvant, is forming agent with water.Outside dewatering, do not add external adjuvants such as any binding agent.
Machining feature is meant, with the prepared slices of Chinese crude drugs, drying is ground into powder, according to cellular morphology, as cell categories such as fibrocyte, vessel cell, stone cell, cork cell, thin-walled what and characteristics, the rotation combing adds the water rotation and makes soft material, and rotation is crushed to wet granular, centrifugal throwing circle, dry.Animality, mineral Chinese medicine machining feature are also together;
It is cell tissue that the particulate material of the present invention is formed, but not the Chinese medicine extract that extracts or the reactive compound material, promptly cell tissue level but not molecular level are formed;
Conventional particles (powder) decoction pieces: refer to the Chinese medicine decoction pieces is pulverized the decoction pieces that cuts into fine particle (powder).
The difference of mobile decoction pieces and conventional particles (powder) decoction pieces:
1, mobile decoction pieces: have certain shape, size is even, and characteristics such as good fluidity can satisfy modernization, mechanization production.Thoroughly solved the problem left over by history such as filthy of the prepared slices of Chinese crude drugs.
Granule (powder) decoction pieces: i.e. medical material thickness powder, it does not have certain shape, and is mobile poor, is easy to generate powder simultaneously and flies upward, and loss is big, endangers thereby human body produced, so be not suitable for modern production.
2, mobile decoction pieces is the Chinese medicine decoction pieces to be broken into the powder post-treatment make, and can scatter during decoction, and this has just improved the leaching rate of medical material, different medical materials are fully mixed, thereby improved the Chinese medicine curative effect, can not scatter when some kind decocts, and decocting rate and traditional decoction pieces equity.
3, mobile decoction pieces is because of having good flowability, and do not have dust, can realize automated production, and the granule decoction pieces is because of there being very big dust, thereby causes prepared slices of Chinese crude drugs fractional pack quality inhomogeneous.
Mobile decoction pieces and traditional compatibility decoction pieces granule (granule, difference down together): mobile decoction pieces is that the Chinese medicine decoction pieces processes with ball blast excipient technology, be physical change but not chemical change, identical with the Chinese medicine decoction pieces, decoct the back through compatibility and use, meet traditional Chinese medicine principle of multi-drug decoction.Tradition compatibility decoction pieces granule: be that the single medicinal material decoction pieces is made graininess after drying is extracted in industrialization, mix according to the doctor formula single medicinal material and take after mixing it with water that what this had just lost Chinese medicine boils principle altogether, thereby makes curative effect produce uncertainty.
On the basis of the various new medicine decoction pieces pluses and minuses that the mobile prepared slices of Chinese crude drugs of the present invention are occurred in summing up the Study on Modernization process of the prepared slices of Chinese crude drugs more over the years, need according to Chinese medical theory and clinical practice, and Chinese crude drug and the prepared slices of Chinese crude drugs are carried out the new medicine decoction pieces of a kind of originality of special processing.It can boil by group's medicine altogether, meets the requirement of decoction, and similar again Chinese patent medicine production technology can be accomplished scale production.
The mobile prepared slices of Chinese crude drugs from radical change for thousands of years the prepared slices of Chinese crude drugs changed the decoction pieces production technology and the rough form that fall behind with the method that root, stem, leaf, flower, fruit etc. directly are used as medicine and decoct, reach standardization of technology.By modern pharmaceutical technology-ball blast excipient The Application of Technology, make granular size homogeneous, density evenly, the novel decoction pieces of good fluidity, reach the mechanical packaging requirement, realize packing specificationization.By the quality monitoring of whole process of production, utilization Electronic Data Processing hybrid technology reduces the mass discrepancy between each batch decoction pieces, the tonnage amount that increases batch, thereby really realize prepared slice quality control, the requirement that prepared slice quality is stable realizes prepared slices of Chinese crude drugs quality standardization, detects modernization.Meet the requirement that medicine GMP produces, adapt to the mass mechanized production of modernization industry.Better standard the production of the prepared slices of Chinese crude drugs, to promoting the modernization and the Chinese medicine modernization of industry that Chinese medicine is produced, accelerate the innovation of Chinese medicine industrial technology and have positive effect.
Simultaneously, the mobile prepared slices of Chinese crude drugs substitute traditional prepared slices of Chinese crude drugs and had both met Chinese traditional medicine principle, meet the modern production requirement again, not only satisfy the requirement of the preventing and treating diseases that the people improves constantly, and be the requirement of social progress, also be the step that prepared slices of Chinese crude drugs industry must be stepped out.The research and development and the industrialization of the mobile prepared slices of Chinese crude drugs have significant meaning.
Following digital proof mobile decoction pieces of the present invention and the equity of traditional decoction pieces on drug effect:
Show traditional decoction pieces and the research of mobile decoction pieces equity
Not adding any binding agent and adjuvant in the mobile prepared slices of Chinese crude drugs of the present invention, is to be forming agent with water.
Ball blast excipient technology preparation method of the present invention is different with the general ball of traditional-handwork, and the technical parameter of prescription, product is also different.
Show mobile decoction pieces and watered pill distinctive points
The specific embodiment
Embodiment 1, the mobile decoction pieces of Herba Leonuri.
Purpose: traditional decoction pieces is prepared into mobile decoction pieces, is convenient to the production of mechanical automation fractional pack.
Used instrument is: Universalpulverizer, mixer-granulator, rotatable granulator, Squeezinggranulator, shot-blasting machine, drying equipment, plurality of specifications sieve.
Crude drug: Herba Leonuri.
1, pulverizing process: medical material is put into powder beater smash, cross 80 mesh sieves.Powder diameter distributes and sees the following form.
Table powder diameter distribution situation
| Powder diameter (order number) | ??150 | ??120 | ??80 | ??65 | ??40 |
| Weight % (g/g) | ??8 | ??13 | ??60 | ??13 | ??6 |
| Microscopically | Cell debris etc. | Cell debris etc. | Fiber, tracheal tissue's cell, cell debris etc. | Fiber, tracheal tissue's cell | Fiber, tracheal tissue's cell |
Last table, though cross 80 mesh sieves, but 19% powder diameter is arranged greater than 80 orders, reason is that Plant fiber, tracheal tissue's cell mostly are slender type, radially less than axially, be easy to by 80 mesh sieves, fiber, tracheal tissue's cell pliability and elasticity are bigger in addition, do not add the adjuvant molding and be difficult to, adopt ball blast excipient technology of the present invention to address this problem.
2, system soft material operation: get an amount of dry powder, add low amounts of water, and mix homogeneously.
3, (3)-a rotation granulation process: pour mixed powder into rotary granulator and granulate.
(3)-and b extruder grain operation: above-mentioned (3)-a mouldability is better, can directly enter the ball blast operation; Above-mentioned (3)-a molding is bad, is loose particles, then further uses (3)-b extruder grain operation, and granule is carried out extrusion modling;
4, ball blast operation: the granule for preparing is put into the shot-blasting machine rotation make ball shape granule.
5, the operation of sieving: choose suitable aperture sieve, sieve is got required ball shape granule.
6, drying process: it is dry that the ball shape granule for preparing is put into drying equipment.
The result data record:
Each parameter of table ball blast excipient technology
The ball blast data: air blast 9HZ, rotation 8HZ, about 10min (14: 15～14: 24), during between the limit add the waterside and improve the HZ of air blast and rotation and reach air blast 12HZ at last, rotate 50HZ.After ball blast finishes, as above slowly reduce the frequency of air blast and rotation.
Embodiment 2, and is substantially the same manner as Example 1, but crude drug is a Radix Rehmanniae Preparata.The pulverizing process of step (1) wherein, adopt (1)-b: the freezing and pulverizing mode is broken into powder, crosses 80 mesh sieves.
Embodiment 3, and is substantially the same manner as Example 1, but crude drug is a Herba Epimedii.Wherein the pulverizing process of step (1) adopts (1)-c: use the wire drawing cutting machine, cut into filament, the pulverizing of reuse pulverizer, 100 mesh sieves excessively.
Embodiment 4, and is substantially the same manner as Example 1, but crude drug is a Pheretima.In the granule of this spherical or near-spherical, crude drug medicated powder is crossed 120 mesh sieves; The diameter of made spherical or near-spherical is 3mm; 1 °～30 ° of roundness; Water content is lower than 10%; Hardness is 15N; Friability is less than 1%; Grain density is 1.3; Bulk density is 0.8.
Embodiment 5, and is substantially the same manner as Example 1, but the granularity of crude drug Flos Lonicerae medicated powder is 180 orders in the granule of this spherical or near-spherical; The diameter of made spherical or near-spherical is 8mm; 1～20 ° of roundness; Water content is lower than 10%; Hardness is 30N; Friability is less than 0.5%; Grain density is 1.5; Bulk density is 0.8.
Embodiment 6, and is substantially the same manner as Example 1, but the granularity of crude drug Herba Menthae medicated powder is 60 orders in the granule of this spherical or near-spherical; The diameter of made spherical or near-spherical is 0.5mm; Roundness is at 1-30 °; Water content is lower than 8%; Hardness is 40N; Friability is less than 0.3%; Grain density is 1.7; Bulk density is 1.0.
Embodiment 7, and is substantially the same manner as Example 1, but the granularity of crude drug Herba Epimedii medicated powder is 160 orders in the granule of this spherical or near-spherical; The diameter of made spherical or near-spherical is to be 2mm; Water content is lower than 6%; Hardness is 180N; Roundness is 1 °～10 °; Friability is 0.2%; Grain density is 0.9; Bulk density is 0.4.
Embodiment 8, and is substantially the same manner as Example 1, but should be spherical or the granule of near-spherical in the granularity of the plain medicated powder of raw material web be 100 mesh sieves; This particle diameter spherical or near-spherical is 10mm; Roundness is 1 °～40 °; Friability is not more than 2%; Grain density is 1.0; Bulk density is 0.5; Water content is 16%; Hardness is 3N.
Embodiment 9, and is substantially the same manner as Example 1, but the granularity of crude drug Herba Cirsii medicated powder was 120 mesh sieves in the granule of this spherical or near-spherical; The diameter 0.2mm of made spherical or near-spherical; Roundness is 1 °～15 °; Friability is 0.01%; Water content is 10%; Hardness is 5N.
Embodiment, 10, substantially the same manner as Example 1, but crude drug is a Concha Ostreae, makes spherical or the near-spherical granule with adding a small amount of adjuvant binding agent in the raw material medicated powder during ball blast.The diameter 10mm of made spherical or near-spherical.
Embodiment, 11, substantially the same manner as Example 1, but crude drug is a Gypsum Fibrosum, makes spherical or the near-spherical granule with adding a small amount of adjuvant binding agent in the raw material medicated powder during ball blast.
Claims (10)
1. mobile prepared slices of Chinese crude drugs are to be raw material with Chinese medicine decoction pieces powder or crude drug powder, it is characterized in that,
The granule that is shaped as spherical or near-spherical of the described mobile prepared slices of Chinese crude drugs;
Raw material powder particle size was 40～200 mesh sieves;
The state of described material powder is: wherein the powder of plant amedica, animal drugs is at the fine powder of the visible plant of microscopically, zooblast tissue.
2. the mobile prepared slices of Chinese crude drugs according to claim 1 is characterized in that, described spherical or approximate globular particulate diameter 0.1mm～10mm; Roundness is at 1 °～40 °; Water content is lower than 16%; The granularity of crude drug medicated powder is 60～160 orders in the granule of this spherical or near-spherical.
3. the mobile prepared slices of Chinese crude drugs according to claim 2 is characterized in that, described spherical or approximate globular particulate diameter is 0.5mm～8mm; Roundness is at 1 °～30 °; Water content is lower than 10%; The granularity of crude drug medicated powder is 80～120 orders in the granule of this spherical or near-spherical; Simultaneously, described hardness spherical or approximate spherical particle is 3～180N; Friability is not more than 2%; Grain density is 0.5～1.7; Bulk density is 0.2～1.0.
4. the mobile prepared slices of Chinese crude drugs according to claim 3 is characterized in that, described spherical or approximate globular particulate diameter is 2mm～3mm; Roundness is at 1 °～20 °; Described water content spherical or approximate spherical particle is lower than 6%; Simultaneously, described hardness spherical or approximate spherical particle is 5～60N; Friability is 0.01～2%; Grain density is 0.6～1.6; Bulk density is 0.2～0.9.
5. the mobile prepared slices of Chinese crude drugs according to claim 4 is characterized in that, described spherical or approximate spherical hardness is 5～30N; Roundness is 1 °～15 °; Friability is not more than 1%; Grain density is 0.9～1.4; Bulk density is 0.4～0.8.
6. the mobile prepared slices of Chinese crude drugs according to claim 5 is characterized in that, described spherical or approximate spherical roundness is 1 °～12 °; Friability is not more than 0.5%.
7. according to the described mobile prepared slices of Chinese crude drugs of claim 1～6, it is characterized in that described spherical or approximate globular granule is meant, the spherical or approximate globular granule of making according to following " excipient ball blast technology ":
(1). pulverizing process: the prepared slices of Chinese crude drugs or crude drug are raw material, according to the physical property and the character of raw material, do following processing respectively:
(1)-a. puts into powder beater with raw medicinal material and is broken into powder, crosses 40～200 mesh sieves;
(1)-b. for sugar content higher or or protein content is higher or the crude drug of the higher and difficult pulverizing of viscosity, adopt the freezing and pulverizing mode to be broken into powder, cross 40～200 mesh sieves;
(1)-c. " wire drawing cutting method " is difficult for the crude drug of pulverizing for other, and fiber leaf, rhizome, root, all grass herb big, that toughness is strong utilize the wire drawing cutting machine to cut into filament respectively; Utilize pulverizer to be ground into fine powder again, cross 40～200 mesh sieves;
(2). system soft material operation:
The medicated powder that step (1)-a, (1)-b, (1)-c. are obtained, pour hybrid granulator into, Bian Jiashui, the limit rotates in the same way, make the fiber in the granule be carded to equidirectional regularly arranged, rotation mixes, makes it to become the soft material that certain viscosity is arranged, and the part by weight of its Chinese medicine powder and water is 1: 0.7～4;
Described: " soft material that certain viscosity is arranged " is meant can bond agglomerating with thumb forefinger kneading medicated powder;
(3). the rotation granulation process:
(3)-and soft material that a. obtains step (2) places rotation granulator, the suitable moisturizing in limit, and the limit rotates in the same way, and it is equidirectional regularly arranged that fiber in the granule is carded to, and makes it to have certain viscosity, wet soft and formability;
When the mouldability as a result of step (3)-a better, the operation that then directly enters step (4); Bad when the molding as a result of step (3)-a, be loose particles, then enter step (3)-b operation, granule is carried out extrusion modling;
(3)-and b. extruder grain operation: for the bad loose particles of molding among step (3)-a, then adopt LSH-220 type wet granulator or screw Squeezinggranulator, granule is carried out extrusion modling;
(4). the ball blast operation:
(4)-a. puts into the shot-blasting machine rotation with step (3)-a or moistening soft granule that step (3)-b prepares and makes ball shape granule;
(4)-b. in the ball blast operation of described (4)-a. step, if any adhesion, can add a small amount of dried medicated powder;
(4)-c. in the ball blast operation of described (4)-a. step, divide for several times or spray water on granule continuously, divide then for several times or on granule, spray medicated powder continuously to make granule increase to required diameter;
(4)-b and two steps of (4)-c. in, the total weight ratio that adds powder amount and amount of water is 1: 0.7～4;
(5). the operation of sieving: choose suitable aperture screen cloth, sieve is got the spherical of required diameter or near-spherical granule.
(6). drying process: it is dry that the spherical or near-spherical granule that will prepare is put into industrial acceptable drying equipment.
8. the preparation method of the described mobile prepared slices of Chinese crude drugs of claim 1 is raw material with the prepared slices of Chinese crude drugs, or is raw material with the crude drug, it is characterized in that, handles according to " excipient ball blast technology " that following each step constitutes:
(1). pulverizing process:, do following processing respectively according to the physical property and the character of raw material:
(1)-a. puts into powder beater with raw medicinal material and is broken into powder, crosses 40～200 mesh sieves;
(1)-b. for sugar content higher or or protein content is higher or the crude drug of the higher and difficult pulverizing of viscosity, adopt the freezing and pulverizing mode to be broken into powder, cross 40～200 mesh sieves;
(1)-c. " wire drawing cutting method " is difficult for the crude drug of pulverizing for other, and fiber leaf, rhizome, root, all grass herb big, that toughness is strong utilize the wire drawing cutting machine to cut into filament respectively; Utilize pulverizer to be ground into fine powder again, cross 40～200 mesh sieves;
(2). system soft material operation:
The medicated powder that step (1)-a, (1)-b, (1)-c. are obtained, pour hybrid granulator into, Bian Jiashui, the limit rotates in the same way, make the fiber in the granule be carded to equidirectional regularly arranged, rotation mixes, makes it to become the soft material that certain viscosity is arranged, and the weight ratio of its Chinese medicine powder and water is 1: 0.7～4;
Described: " soft material that certain viscosity is arranged " is meant can bond agglomerating with thumb forefinger kneading medicated powder;
(3). the rotation granulation process:
(3)-and soft material that a. obtains step (2) places rotation granulator, the suitable moisturizing in limit, and the limit rotates in the same way, and it is equidirectional regularly arranged that fiber in the granule is carded to, and makes it to have certain viscosity, wet soft and formability;
When the mouldability as a result of step (3)-a better, the operation that then directly enters step (4); Bad when the molding as a result of step (3)-a, be loose particles, then enter step (3)-b operation, granule is carried out extrusion modling;
(3)-and b. extruder grain operation: for the bad loose particles of molding among step (3)-a, then adopt LSH-220 type wet granulator or screw Squeezinggranulator, granule is carried out extrusion modling;
(4). the ball blast operation:
(4)-a. puts into the shot-blasting machine rotation with step (3)-a or moistening soft granule that step (3)-b prepares and makes ball shape granule;
(4)-b. in the ball blast operation of described (4)-a. step, if any adhesion, can add a small amount of dried medicated powder;
(4)-c. in the ball blast operation of described (4)-a. step, divide for several times or spray water on granule continuously, divide then for several times or on granule, spray medicated powder continuously to make granule increase to required diameter;
(4)-b and two steps of (4)-c. in, the total weight ratio that adds powder amount and amount of water is 1: 0.7～4;
(5). the operation of sieving: choose suitable aperture screen cloth, sieve is got the spherical of required diameter or near-spherical granule.
(6). drying process: it is dry that the spherical or near-spherical granule that will prepare is put into industrial acceptable drying equipment.
9. the preparation method of the mobile prepared slices of Chinese crude drugs according to claim 8 is characterized in that, the weight ratio ratio of medicated powder described in the step (2) and water is medicated powder: the weight ratio of water=1: 1～3;
In described step (2) or the step (3),, make spherical or the near-spherical granule with being added with binding agent in the raw material medicated powder for the mineral medicinal material of difficult forming;
(4)-b and two steps of (4)-c. in, the total weight ratio that adds powder amount and amount of water is 1: 3.
10. according to Claim 8 or the preparation method of the 9 described mobile prepared slices of Chinese crude drugs, it is characterized in that among described step (1)-a or (the 1)-b., the powder of making was 60～100 mesh sieves;
Simultaneously, after (6) step, also be provided with following steps:
(7). sterilization process: press the sterilization of medical industry technology;
(8). packaging process: adopt tea filter paper, dry ball shape granule is packaged into fractional pack respectively according to taking dose.
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| CN102113960A (en) * | 2011-04-15 | 2011-07-06 | 黄一清 | Method and device for preparing Chinese medicinal pill domestically |
| CN102406760A (en) * | 2011-10-10 | 2012-04-11 | 浙江中医药大学中药饮片厂 | Herba verbenae officinalis fluid decoction pieces and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102113960A (en) * | 2011-04-15 | 2011-07-06 | 黄一清 | Method and device for preparing Chinese medicinal pill domestically |
| CN102113960B (en) * | 2011-04-15 | 2013-03-13 | 黄一清 | Method for preparing Chinese medicinal pill domestically |
| CN102406760A (en) * | 2011-10-10 | 2012-04-11 | 浙江中医药大学中药饮片厂 | Herba verbenae officinalis fluid decoction pieces and preparation method thereof |
| CN102406760B (en) * | 2011-10-10 | 2013-05-01 | 浙江中医药大学中药饮片有限公司 | Herba verbenae officinalis fluid decoction pieces and preparation method thereof |
| CN103349679A (en) * | 2013-06-08 | 2013-10-16 | 浙江中医药大学中药饮片有限公司 | Mulberry leaf fluid decoction tablets and preparation method thereof |
| CN103385904A (en) * | 2013-06-13 | 2013-11-13 | 浙江中医药大学 | Chrysanthemum decocting pill and preparation process thereof |
| CN103385904B (en) * | 2013-06-13 | 2015-06-03 | 浙江中医药大学 | Chrysanthemum decocting pill and preparation process thereof |
| CN106771012A (en) * | 2016-05-21 | 2017-05-31 | 广州今典精方药业有限公司 | The quality standard and manufacturing process of the motherwort qualitative, quantitative prepared slices of Chinese crude drugs |
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