CN1201664A - Improvements in and relating to tablet manufacture - Google Patents

Improvements in and relating to tablet manufacture Download PDF

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Publication number
CN1201664A
CN1201664A CN98102950A CN98102950A CN1201664A CN 1201664 A CN1201664 A CN 1201664A CN 98102950 A CN98102950 A CN 98102950A CN 98102950 A CN98102950 A CN 98102950A CN 1201664 A CN1201664 A CN 1201664A
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dosage form
described method
natural origin
raw material
aforementioned
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安东尼·巴兰坦
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Abstract

A process for preparing dosage form such as pills from natural source substance of organisms is disclosed, which comprises freezing the substances hard, then disintegrating frozen hard substances, shaping into demanded shapes, drying and storing, transporting and using later.

Description

The improvement of relevant method for preparing tablet thereof
The present invention relates to prepare the method for pharmaceutical dosage form such as tablet from natural product.Preferred embodiment attempt to prepare a kind of tablet, this tablet has the feature of primitive component as much as possible.Such feature comprises mouthfeel, abnormal smells from the patient, color and luster and the feature that should consider as active component or required one-tenth branch.Keeping part or all of these features in varying degrees in the various dosage forms according to the present invention's preparation.
The present invention is directed to and dosage form such as the pill problem relevant with preparation tablets.All make with most of tablet in the past at present by dry efflorescence material.The general shape that under sizable pressure, it is pressed into required pill.Wherein can contain binding agent, contain inert filler but situation more generally is most tablets.
Filler generally is used in most tablets and other contain in the dosage form of synthetic ingredient, itself only accounts for the very little ratio of tablet weight.For conforming consideration, pharmaceutical industries preferably relies on the synthetic of known purity or extracts in preparation composition, the dosage that such composition adds in the tablet can be accurate.
Filler with known quantity dilutes these active component then, is easy to realize the concordance of dosage between the different tablets whereby.
If most active component are synthetic, when making medicine, only need several micrograms or several milligrams, so present method for preparing tablet thereof just has been not only suitable problem.
Asia especially but, bigger to the demand of the tablet that contains natural product and medicine, on the Western Hemisphere, this demand is also rising.General in the preparation of pill, with the natural product drying, be ground into powder, exsiccant method generally adopts heating.This desciccate can be pressed into ball with other filleies and ingredient alternatively then.
Because dry ingredient obtains easily, and can store to use, this preparation method is comparatively easily.These dry ingredients and the combination of other compositions only relate to the mixing of dried powder usually, are compactings or comprise these and become to be divided into required dosage form then.But unfortunately, tablet usually almost with its composition dissmilarity that is contained, almost dissimilar the same with Willow bark just as the aspirin sheet, the precursor substance of aspirin is found in Willow bark.Although what problem perhaps this do not illustrate concerning synthetic drug industry, the market of natural drug is still huge, and order develops.Use dry ingredient perhaps can not keep active component or the target composition that natural product contains.And a lot of market demands are that dosage form has a part of feature of ingredient, for example mouthfeel, color and luster, abnormal smells from the patient etc.Otherwise, because poor, perhaps even to compare the dosage form of drying (but not being efflorescence) also poor than natural product itself, these dosage forms can be suffered the public's refusal, dry in any case dosage form also can run into the problem same with tablet, more resembles the natural origin material object except it looks at least, rather than a tablet.
Distinct issues are active component that most drying meanss have destroyed medical value, have perhaps changed the various character (as mouthfeel or color and luster) of composition.Employed baking temperature not only makes the protein denaturation that contains in the natural product composition, also makes wherein heat sensitive enzyme is destroyed, and these all are quite common.
And then problem is some raw material because amount is bigger, is difficult to carry out drying or dry consuming time longer.A lot of Asian countries adopt tradition or manual method to be prepared, but these methods can not satisfy requirements of large-scale production.In order to solve the problem that medicine or unclassified stores affect adversely, general way is that natural product is placed the capsule that can wholely swallow.But, most capsules are still by gelatin or agar and make, and therefore requiring product must be relatively dry.
In order to prevent antibacterial and/or fungi growth in the encapsulated product, product is sterilized, but sterilization effect and cost be not inconsistent, also exceeded the capabilities scope of many non-medicines operations.
Even in present method for preparing tablet thereof, can use capsule, also need not to avoid relevant product in the problem of dry run mesometamorphism and the problem of the needed the whole bag of tricks of grinding product.
And capsule can not make the user go to taste or feel any feature of each composition, comprises fragrance and color and luster.Concerning a lot of people, such feature is very important.
One of purpose of the present invention is to address the above problem, and a kind of selection of practicality perhaps is provided to the public at least.
Further content and advantages of the present invention will become apparent because of the following explanation that only provides with by way of example.
According to one aspect of the present invention, a kind of method that always prepares pharmaceutical dosage form in the natural origin material of organism is provided, described method comprises the following steps:
I) be cooled to the natural origin material hard;
Ii) when this material is also enough hard, it is pulverized, so that it can be configured as the shape that needs;
Iii) the material of pulverizing is configured as required form;
The iv) material of dry forming then.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein this method is the material cooling that will be shaped in step I ii) and also comprise an additional step iv).
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein this method is in step I) and ii) between also comprise an additional step, be when material is hardened condition, remove hair, surface irregularities and/or the impurity that may be present in the natural origin material surface.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, this method is in step I) also comprise at least one cleaning or cleaning step before.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein this method is at step I i) and iii) between also comprise an additional step, be the material that screening is pulverized, to remove unwanted raw material or part.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein in final form, also comprise at least a additional natural origin material.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein additional natural origin material passes through step I at least) and ii) handle.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein additional natural origin material the step I of process) and processing ii) be to separate with main natural origin material to carry out.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein all natural origin materials mix before ii) in step I.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein additional natural origin material the step I of process) processing be to separate with main natural origin material to carry out, but through step I i) be to mix with main natural origin material and/or other additional natural origin materials to carry out when handling.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein at least a additional natural origin material is in step I) mix with main natural origin material before.
According to another aspect of the present invention, provide a kind of aforesaid basically method, wherein step I i) contain more than one continuous pulverizing step, pulverize raw material to be pulverized progressively.
According to another aspect of the present invention, provide a kind of aforesaid basically method, wherein the step I i of raw material pulverizing) obtain a kind of raw material of the pulverizing of denseness in the pasty state basically.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein the raw material of Fen Suiing can sieve by 2mm.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein preferred form is a tablet.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein preferred form is a thin slice.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein step I v) before with thin slice be divided into required form and the size less dosage form.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein superfluous or useless raw material reclaims in the cutting procedure, ii) handles through step I at least again.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein step I v) after with slice raw material be divided into required form and the size less dosage form.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein step I v) comprises drying under reduced pressure.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein v) the temperature of dosage form is increased between 30-50 ℃ in the process in step I, 30 ℃ and 50 ℃ be also contained in, and under this high temperature, kept at least 2 hours basically.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein take measures to remove dosage form steam on every side.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein the temperature of natural origin material remains below the required enzyme and the protein that wherein contain and will be degraded basically or destructive temperature.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, this method is applicable to any or several plant raw material, plant roots raw material, xylophyta raw material, leaves of plants raw material, herbaceous plant raw material, fruit, kernel and seed.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, and this method is applicable to young pilose antler (velvet), animal bone and cartilage raw material, animal organ, hair and skin raw material, Sargassum, shipworm (marine mulluscs) and the Crustacean in any or several animal product, animal bight.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein keep certain condition make at least a following be present in dosage form in the relevant factor of natural origin material be retained basically:
Color and luster, olfactory sensation characteristic, sense of taste characteristic.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, wherein natural product be basically give birth to or without the state that boiled.
According to another aspect of the present invention, provide a kind of and prepared the method for pharmaceutical dosage form from one or more natural origin material compositions, basically as mentioned above, wherein said method comprises or is made up of the following step:
I) letter sorting alternatively, sorting and/or cleaning ingredient;
Ii), it is touched up at least feel it is hard extremely-5 ℃ or following of natural origin composition quick-freezings;
Iii) refrigerative composition is crushed to the size that is enough to by 2mm grid aperture;
If iv) do not add in advance, add any supplementary element alternatively;
V) make the raw material of pulverizing be configured as thin slice or required dosage form;
Vi) the raw material that is shaped is refrigerated to-5 ℃ or following;
Vii) dosage form is dried to the water content that reaches required being decompressed under 1 holder or the lower condition.
According to another aspect of the present invention, a kind of aforesaid basically method is provided, this method comprises additional step:
Viii) be warming up to be essentially-5 ℃ and
Ix) further be warming up to alternatively and be at least 30 ℃.
According to another aspect of the present invention, provide according to the dosage form of aforesaid method preparation basically.
According to another aspect of the present invention, a kind of aforesaid basically dosage form is provided, and this dosage form contains one or several following ingredients: the young pilose antler of Cornu Cervi Pantotrichum, other animal in deer family, animal livers, Cauda cervi, Penis et testis cervi, fungus, Radix Ginseng, Radix Dauci Sativae, Bulbus Allii, kava, licorice, Folium Ginkgo, Herba Bacopae monnieri platymiscium, brazilian cocoa, Yohimbine bark and from the raw material of following plants: withania sopmiera, phytolacca american, Herba Melissae officinalis, and laurelia novae-zelandiae.
According to another aspect of the present invention, a kind of aforesaid basically dosage form is provided, this dosage form contains 80% composition of being made up of natural product at least.
The present invention can prepare pharmaceutical dosage form from natural product.This dosage form refers generally to tablet, but also may be other dosage forms.In numerous embodiments,, a lot of features have been kept in the dosage form, as taste, mouthfeel, color and luster and pharmaceutical properties or other activity by preparation condition being made wise selection.
Be used for the natural product that composition of the present invention generally contains normal form or native form, promptly without pretreated.But do not get rid of the composition that uses drying, grinds or handled according to a conventional method, its condition is to it has been recognized that owing to anticipating any Degradation that product is produced to reflect in end-product.Imagine these exsiccant compositions and will join in undried or the undressed composition, rather than only contain the natural product composition.
Typical situation is the moisture that most natural products contain remarkable ratio.One of subject matter that this is in the preparation tablets to be run into, so this area generally requires to use exsiccant composition.The way that prior art finds is strong drying and grinds composition, but generally also destroyed the multiple character and the feature of product, and these just the present invention to keep.The physical property that keeps raw material or natural product on the market is considered to the unappeasable needs of a kind of conventional tablet preparation method of a kind of required attribute more.
Most embodiment of the present invention is characterised in that the temperature of avoiding the use meeting that any required enzyme or protein substance in the product are had a negative impact.Required enzyme or protein generally help end-product to have required character (as mouthfeel, taste etc.).Therefore, most will be fully under 80 ℃ or lower temperature, carry out, more preferably under 50 ℃ or lower temperature, carry out according to method of the present invention.
Easy on illustrating, we will be with the example that is prepared as of tablet, and seems only to have used a kind of natural product composition.But can recognize in order that the natural product of arbitrary number, and other compositions all can be included as filler, synthesis material etc.
If contain other natural products, available different mode is handled it.For example, can be comprised in one or several existing natural product or and mix with it, again through the inventive method handle-as cooling, pulverize, be shaped then.
The another kind of selection is to cool off respectively and/or each composition of pulverising step remix.The decomposite afterwards alternative of other compositions also is feasible to some compositions beginning to mix.
It is optionally also to be preferred that natural product is cleaned, perhaps otherwise prepare according to the method that is applicable to food grade.This carries out soon in the beginning or the beginning of method usually.Generally avoid boiling or other any heating stepses, unless need do like this to generate required composition.Various types of cleaning known in the art, letter sorting and preparation process all can use.
Then that material composition is freezing, be freezing or hardened condition until it, generally use quick freezing or cooling method.Preferably, under special or the situation that material composition is softer usually higher in water content, temperature can be reduced to-15 to-20 ℃ or following, but this at least also will partly depend on the character of product.A kind of good suggestion is to be cooled in composition freezing point or the following 15K of solidification temperature (Kelvin), but also will depend on the hard degree of raw material under this temperature.
Can further clean or handle after the cooling with physical method.These treatment steps may be difficult to carry out under soft condition.
In case product is cooled to rigidity or freezing state, can be pulverized.Generally be ground into pasty consistency, or be at least required size or the denseness of formation product.As pulverizing suggestion fully, can pass through 2mm (or littler) mesh screen and get final product.
Pulverizing can be carried out in many ways, but in preferred embodiment, pulverizes natural product progressively with the continuous pulverizing step.For example, general elder generation is with the section of high speed microtome or break into fritter, grinds or be chopped into more tiny form then.Because this method need spend certain hour, also because the kinetic energy in section and the process of lapping heats up product, need guarantee that initial cooling to natural product reaches the lower temperature of phase time (as-20 ℃ or lower), so that the product of pulverizing still is in the state of cooling basically in whole crushing process.Chamber of pulverizing or container may also will cool off, so that product keeps pulverizing required enough hardness.As the part in the cooling procedure, can carry out the intercooling step, composition is remained valid pulverize required enough hardness.
The result who pulverizes is (relevant with the water content of pulverized natural product) generally in the pasty state, because the existence of ice crystal, part may be the diploma.The size of pulverized particles is generally coarse powder or thinner, also depends on the character of composition and the degree of pulverizing.
If any other composition is not also included, then the pastel of pulverizing can be mixed with it, preparation is in flakes then.Other compositions also can be ground into pasty state by similar approach, perhaps with common cooling of all the components and grinding.Because the character of each composition is obviously different, preferably pulverize respectively sometimes, but this always unessential way, even because the most softish composition also is quite hard with inflexible pulverizing common under the preferred temperature of institute.
Product is shaped and adopts one of two kinds of main optimization approach usually.First kind of approach be, makes pastel be configured as the sheet of required form and profile, carries out drying then.Can use suitable scalable tablet machine, pastel partly is pressed in each pressing mold.Also can use mould, the bulk pastel is sprawled wherein, be shaped then.Similarly, can push (this need be cooled to harder denseness, perhaps adds suitable adhesive and sclerosing agent), longer extrudate be cut into required thickness pastel.Can rely on these distinct methods and other known flaking methods and from the raw material pulverized or mixture, prepare dosage form, thin slice and tablet.
Be dried to final dosage form with a kind of suitable drying means then.A kind of feasible drying means is a freeze-drying, and ideal condition is under reduced pressure.The drying process that also responsible employing heats up, but still should consider may produce required composition and destroy or decomposition.General any drying means all should carry out under 80 ℃ or following temperature, and ideal situation is below 50 ℃, but this depends on the composition that is specifically comprised.
Another kind of manufacturing process is that pastel is configured as thin slice or part, and it is thick or thinner to be generally 12mm.With these auxilliary part dryings of coming of launching, the drying process that is adopted is for example above-mentioned then.After obtaining exsiccant product, it is smashed or grind into powder, make it be configured as tablet or other dosage forms according to existing dry ingredient forming technology again.Although this method relates to additional step, but this method makes a large amount of compositions can keep storing with the agglomerate form before being configured as tablet and other products.If the heterogeneity mixture of tablet there are the needs of continuous variation in small-scale production, then this method is practical, and also can adapt to other needs.For example, be used further to prepare various products for a large amount of powder of preparation or raw material, this method has been represented a kind of effective method.And for the high natural product of moisture, this is that preferred approach-embodiment 3 sees below.
As further alternatives, can make thin slice, be divided into final dosage form again.This mode requires to cut apart before drying or bone dry, can comprise cooling, and cooling helps cutting apart of some dosage forms.Dividing method can relate to section, also can comprise extruding being shaped, and method is with similar with cake made of glutinous rice, sold in sliced pieces point machine.If excess raw material is arranged, can be recycled.Can sneak into the next group raw material, or reshape and be new thin slice.Can also be with excessive fritter drying, grinding, as the exsiccant raw material of bulk.
Multiple natural product all can be handled by the present invention.They should be biomaterial (plant or animal origin), rather than mineral.This biomaterial had both comprised the product of plant origin, RUGEN and woody raw material, leaf and draft raw material, fruit and kernel; The product that also comprises animal origin is as fine and soft (velvet), liver and other various materials.Multiple fungus also is used for tablet usually, also can handle by the present invention.Further provide some instantiations below, only should not regard restriction as for illustrating.
Example 1
This example is suitable for the product of animal origin, as Cornu Cervi Pantotrichum, Cauda cervi and Penis et testis cervi.
Earlier required composition is cleaned, chooses foreign body.Clean raw material quick-freezing is to below-5 ℃, perhaps the raw material inflexible temperature that becomes basically.Temperature about-20 ℃ is suitable for a lot of materials, but most material is in this enough rigidity just more than temperature.
Refrigerative product is cut into wide about 2mm or littler bar or sheet then.Of the present invention one preferred embodiment in, use 3 horsepowers, the 2800 high speed microtomes that change per minutes, and the embodiment of front has successfully used 7 horsepowers, the 1400 high speed microtomes that change per minutes.
Product after the section should still be in freezing state, and it is entered in two cutting knife mixing and grinding machines, and uniform pastel is cut, ground to form to frozen product.The degree of pulverizing generally should make it can be not more than the chipper dish of 2mm by the aperture.Permission is carried out rough lapping to some product, but pastel generally should be able to be not more than the chipper dish of 3mm by the aperture, is preferably 2mm or littler.One preferred embodiment in, 10 horsepowers of grinder just have been enough to cutting and have ground composition in conjunction with 1.5 horsepowers of mixers.
By the gained pastel is for example spread in the film-making mould, make it become figure of tablet.Quick-freezing is-20 ℃ extremely approximately then, the tablet that must be shaped.
Tablet can be placed pallet, preferably use the lyophilization step drying.In preferred drying steps, pressure be decreased to about 1 holder or below.Lower pressure is as 4 * 10 -1About holder or lower, can improve drying efficiency, but in practice, consider the high and low vacuum comparison of used medium cost one this comprise the situation of primordial plant, with the operating cost and the raw material properties of handling, can between the two, carry out compromise.
Moisture in the tablet generally can be reduced to and be lower than 10 weight %, preferably is less than 4 weight %.But moisture depends on the character of product component to a great extent.
One preferred embodiment in, tablet is placed on be separated from each other about 4cm or the following shelf or pallet.Shelf or pallet be arranged in-individual chamber in, and pressure is decreased to be generally 1 holder or below, preferred 0.1 holder or below.Concerning sambar's antlers and penis, temperature is risen to+30 ℃ about two hours, rise to then+50 ℃, and keep this temperature in all the other times (about 20 hours) in cycle.Perhaps refrigerative raw material (being suitable for Cornu Cervi Pantotrichum and other animal products) is placed 1 holder or following 30 minutes (pact).With temperature rise to basically from-5 ℃ to product freezing point/solidification temperature-contain in the scope of temperature range-following 15K (Kelvin), and finish the arid cycle-be generally 22 hours-all the other times.
Concrete drying condition can change according to necessary requirement, has such as pill shape and the parameter of size (as the ratio of quality with surface area) and initial moisture, and the method for package panel and quantity all depend on drying time and temperature required.
Another kind method is tablet to be poured out from mould be placed on chamber, generally makes its temperature reduce to-5 ℃ or following being generally-15 ℃.After the chamber sealing, when internal pressure further reduced, the steam freezing machine was started working.When reach ice begin the distillation or ebullient vacuum after, steam begins to diffuse out from product, to container and the colder inwall of freezing machine.Chamber internal temperature when generally-35 ℃ when the cycle begins are to end cycle-40 ℃ or following between.Heating makes internal temperature rise to 30 ℃ and reaches 2 hours then, rises to 50 ℃ (maybe can reach 80 ℃, decide on composition) again.Find that this drying process also is applicable to other a lot of embodiments of the present invention, but the present invention needn't only limit to these drying processes.
Example 2
The present invention is more suitable for being lower than in water content the raw material of medium, as the root of a lot of plants, woody and bark raw material, as Radix Ginseng, Radix Dauci Sativae, Rhizoma Zingiberis Recens, Bulbus Allii, kava, Radix Glycyrrhizae and Folium Ginkgo.
The composition of suitably preparing to give birth to be to remove foreign body and unwanted impurity, cleans and the pretreatment of any necessity.Generally with the product quick-freezing to-20 ℃ (usually in-5 ℃ or following scopes), cut into slices, break into pasty state then, method such as example 1.
According to the difference of moisture, can add suitable filler or natural instincts reagent on demand, the reagent that is added is moisture hardly, and if any, moisture is also very low.Do like this solid content in the raising pastel the content of moisture.A kind of like this filler can add before forming pastel, in the process or afterwards, and fully mixes with it.
Can make pastel be configured as tablet then, carry out drying (for example referring to example 1) again, perhaps, especially when moisture is higher, adopt the method for following example 3.
Example 3
This example is more suitable in the high composition of moisture, as fruit.Pastel moisture height (as surpassing 50%) can cause some problems in dry run thereafter.After removing moisture, the left solid content that gets off is not enough to form stablizes hard tablet.Therefore, this class product can cool off, grind to form pastel by the example 1 and the situation of example 2, but does not make pastel be configured as tablet, makes it be configured as thin slice or part earlier, presses and example 1 example 2 similar tablet drying means dryings again.
With moisture be reduced to low concentration (as be lower than 20%, preferably be lower than 10%, most preferably be lower than 5%), powder or pastel can be ground or be broken into to thin slice or part in this step, this will decide on moisture, and gained powder or pastel can be used to make tablet according to already known processes.Powder even can constitute pastel with the liquid of certain known proportion.Powder or pastel are for example made tablet by the method for example 1 again.According to the difference of moisture, can be further dry, method can be a lyophilization.
For example, thin slice or part material are dried to moisture about below 30%, in this step, it can be mixed again and/or further grind to form pastel (generally having the remaining pastel that makes of enough moisture forms) with pastel.Reduce the pastel of moisture and can make tablet by the method for example 1 again.
Example 4
A kind of is the method that composition prepares dosage form with one or several natural origin material, and described method comprises or is made up of the following step:
I) letter sorting alternatively, sorting and/or cleaning ingredient;
Ii), it is touched up at least feel it is hard extremely-5 ℃ or following of natural origin composition quick-freezings;
Iii) refrigerative composition is crushed to the size that is enough to by 2mm grid aperture;
If iv) do not add in advance, add any supplementary element alternatively;
V) the raw material of pulverizing is configured as thin slice or required dosage form;
Vi) the raw material that is shaped is refrigerated to-5 ℃ or following;
Vii) dosage form is dried to required moisture being decompressed under 1 holder or the lower condition.
Example 5
Below be the preparation method of natural piece of antler, this tablet contains or does not contain various other compositions.
1. wash products is removed useless material, and the quick-freezing Cornu Cervi Pantotrichum is to-5 ℃ or following.
2. remove hair by high speed rustless steel rotational line emery wheel.
3. change the per minute high-speed cutting with 2800 Cornu Cervi Pantotrichum is cut into the thin slice that thickness is no more than 2mm.
4. shred Cornu Cervi Pantotrichum and/or mix various other compositions, until even pulverizing, make required pastel by the chipper dish less than or be not wider than the aperture of 2mm.
5. put into or make it to enter required mould, be refrigerated to-5 ℃ or following.
6. frozen product is inserted on the chamber pallet, pallet is 40mm at interval, opens freezing machine; Make temperature reduce to-40 ℃ or following, and with pressure be decreased to 1 the holder or below, be preferably 1 * 10 -1, reach 30 minutes, again product is warming up to-5 ℃ or ideally about the following 15K of freezing point temperature (Kelvin); And all the other times that keep 22 hours periods, make moisture less than 10%, preferably less than 5%.
Example 6
This is a kind of drying means of natural product of medical purposes, and this natural product is lumps size or shape.
1. clean and discard garbage, quick-freezing is to-5 ℃ or following.
2. product is sliced into thickness and is no more than 2mm.
3. chopping maybe can place on mould or the pallet by being no more than 2mm dish hole to obtaining required pastel, is refrigerated to-5 ℃ or following again.
4. as above-mentioned each embodiment step 6 desciccate.
5. after the drying, shaping or stratiform product package storage or prepare accordingly.
Example 7
Below preparation has the dehydration lightweight nutritious food than long storage life, has wherein kept most of vitamin, mineral and the mouthfeel of initial product.This method can also be sneaked into any necessary medicine before preparation, and can not reduce the effect of medicine basically.
According to the nutritive value selection component, as meat and vegetable, flavoring agent or fruit;
Suitably prepare according to the their location, i.e. taste and the dietary habit that may exist;
Cleaning also discards garbage, product is refrigerated to-5 ℃ or following, to keep all nutritive values;
Require the chopping product according to preparation process, add any required medication simultaneously, be vitamin and mineral or antiviral substance, the pastel that has the character that is enough to handle until formation (in some cases, because the moisture height of some product, add a kind of filler), as be processed into powdered rice;
Molded or the shaping with product then is refrigerated to-5 ℃ or following again;
By example 4, step 6 method drying, make moisture less than 10%;
Product is vacuum-packed then, is stored in the temperature control room, can store for 6 years.
Example 8
This is the another kind of fine and soft method of cutting into slices that prepare, and this method has kept natural feature, time-consumingly also lacks than present method.
1. letter sorting and the required fine and soft product of sorting clean and discard garbage, and quick-freezing is to-5 ℃ or following.
2. young pilose antler is sliced into desired thickness is 5mm or bigger to be not less than the 2800rpm per second with high speed stainless steel cut machine when freezing.
3. young pilose antler is placed on the freezing pallet, go freezing again in the free-flow mode.
4. by the dry fine and soft product of example 4 steps 6.
Example 9
This is a kind of method for preparing natural antidepressant tablet or its powder agent.
1. typical component: Salvia japonica Thunb., Herba Rosmarini Officinalis, Laurelia novae-Zelandiae, kawa, Mel, Sucus Mali pumilae vinegar, Herba Melissae officinalis.
2. choose the required amount of product and preparation thereof, clean and discard garbage.Product must be that bright product are cut and/or with extremely-50 ℃ or following of liquid nitrogen flash freezers, then/or standby-25 ℃ or following storage.
3. by correct formulation method, each component chopping to required pastel denseness, is molded as required form.
4. according to example 4 step 6 dryings.
Example 10
This is a kind of method that belongs to the natural drug tablet that promotes the brain development type at present for preparing.
Typical component is: Radix Ginseng, brazilian cocoa, Herba Bacopae monnieri platymiscium and Folium Ginkgo.
By the preparation of example 9 methods.
Example 11
This is a kind of method for preparing the natural drug tablet that improves male's sexual.
Typical component is: African Yohimbine bark, Semen Ginkgo, Withania somrifera, Cornu Cervi Pantotrichum.
Prepare according to example 9 methods.
Example 12
This is a kind of method for preparing auxiliary type natural antiviral drug tablet, and this tablet can improve immunity and premunition.
Typical component is: phytolacca american, Salvia japonica Thunb., Herba Rosmarini Officinalis, Mel, Sucus Mali pumilae vinegar, Herba Melissae officinalis.
Prepare according to example 9 methods.
Only the mode by embodiment is described various aspects of the present invention, should think like this, under situation about not deviating from as the defined scope of claims, can make improvements and add.

Claims (43)

1. one kind prepares the method for dosage form from the natural origin material of organism, and described method comprises the following steps:
I) be cooled to the natural origin material hard;
Ii) when this material is also enough hard, with its pulverizing, so that it can be configured as required form;
Iii) the material of pulverizing is configured as required form;
The iv) material of dry forming then.
2. the method for claim 1 in step I ii) and also comprise an additional step iv), is the material cooling that will be shaped wherein.
3. method as claimed in claim 1 or 2 is wherein in step I) and ii) between also comprise an additional step, be when material is hardened condition, remove hair, surface irregularities and/or the impurity that may be present in the natural origin material surface.
4. one kind as the described method of each aforementioned claim, wherein in step I) also comprise at least one cleaning or cleaning step before.
5. one kind as the described method of each aforementioned claim, wherein at step I i) and iii) between also comprise an additional step, be the material that screening is pulverized, to remove unwanted raw material or part.
6. one kind as the described method of each aforementioned claim, is wherein also comprising at least a additional natural origin material in final form.
7. method as claimed in claim 6, wherein additional natural origin material passes through step I at least) and ii) handle.
8. method as claimed in claim 7, wherein additional natural origin material the step I of process) and processing ii) be to carry out respectively with main natural origin material.
9. method as claimed in claim 7, wherein all natural origin materials mix before ii) in step I.
10. method as claimed in claim 7, wherein additional natural origin material the step I of process) processing be to carry out respectively with main natural origin material, and through step I i) be to mix with main natural origin material and/or other additional natural origin materials to carry out when handling.
11. a method as claimed in claim 7, wherein at least one additional natural origin material is in step I) mix with main natural origin material before.
12. one kind as the described method of each aforementioned claim, other compositions that wherein contained in dosage form and natural materials mix before ii) in step I.
13. one kind as the described method of each aforementioned claim, wherein step I i) contain more than one continuous pulverizing step, pulverize raw material to be pulverized progressively.
14. a method as claimed in claim 13, wherein step I i) contain a high speed slicing step, and former abrasive lapping or the chopping that will cut into slices after this.
15. one kind as claim 13 or 14 described methods, and a cooling step is wherein arranged between two pulverising steps.
16. one kind as the described method of each aforementioned claim, wherein at step I i) in raw material pulverizing is obtained a kind of raw material of the pulverizing of denseness in the pasty state basically.
17. one kind as the described method of each aforementioned claim, wherein the raw material of Fen Suiing can sieve by 2mm.
18. one kind as the described method of each aforementioned claim, wherein step I) comprise and be cooled to-15 ℃ or lower.
19. one kind as the described method of each claim, wherein step I in the claim 1 to 17) comprise in the 15K that is cooled to natural origin material freezing point or solidification temperature.
20. one kind as the described method of each aforementioned claim, wherein preferred dosage form is a tablet.
21. one kind as the described method of each aforementioned claim, wherein preferred dosage form is a thin slice.
22. a method as claimed in claim 21, wherein step I v) before with thin slice be divided into required form and the size less dosage form.
23. a method as claimed in claim 22 wherein is cooled to thin slice hard before cutting apart.
24. one kind as claim 22 or 23 described methods, wherein superfluous or useless raw material reclaims in the cutting procedure, ii) handles through step I at least again.
25. a method as claimed in claim 21, wherein step I v) after with slice raw material be divided into required form and the size less dosage form.
26. one kind as the described method of each aforementioned claim, wherein dosage form is the single dose dosage form.
27. one kind as the described method of each aforementioned claim, wherein step I v) comprises drying under reduced pressure.
28. one kind as the described method of each aforementioned claim, wherein v) the temperature of dosage form is increased between 30-50 ℃ in the process in step I, 30 ℃ and 50 ℃ be also included within, and under this high temperature, kept at least 2 hours basically.
29. a method as claimed in claim 28 wherein takes measures to remove dosage form steam on every side.
30. one kind as the described method of each aforementioned claim, wherein step I v) comprises the lyophilization of raw material.
31. a method as claimed in claim 30, wherein lyophilization is to carry out under-35 ℃ or following temperature.
32. one kind as the described method of each aforementioned claim, wherein the temperature of natural origin material remains on 80 ℃ or following in the entire method process.
33. a method as claimed in claim 32, temperature wherein are 50 ℃ or following.
34. one kind as the described method of each aforementioned claim, wherein the temperature of natural origin material remain below the required enzyme and the protein that wherein contain will be substantially by last degraded or destructive temperature.
35. one kind as the described method of each aforementioned claim, this method is applicable to any or several plant raw material, plant roots raw material, xylophyta raw material, leaves of plants raw material, herbaceous plant raw material, fruit, kernel and seed.
36. one kind as the described method of each claim in the claim 1 to 34, this method is applicable to young pilose antler (velvet), animal bone and cartilage raw material, animal organ, hair and the skin raw material in any or several animal product, animal bight.
37. one kind as the described method of each aforementioned claim, this method is used to prepare the dosage form that comprises at least a following ingredients:
Cornu Cervi Pantotrichum, animal livers, Cauda cervi, Penis et testis cervi, thalassophyte, shipworm (marine mulluscs), the living Crustacean in sea, fungus, Radix Ginseng, Radix Dauci Sativae, Bulbus Allii, kava, licorice, Folium Ginkgo, Herba Bacopae monnieri platymiscium, brazilian cocoa, Yohimbine bark and from the raw material of following plants: withaniasomipera, phytolacca american, Herba Melissae officinalis and laurelia novae zelandiae.
38. one kind as the described method of each aforementioned claim, wherein keep certain condition make at least a following be present in dosage form in the relevant factor of natural origin material be retained basically:
Color and luster, olfactory sensation characteristic, sense of taste characteristic.
39. one kind prepares the method for dosage form from one or several natural origin material composition, described method comprises or is made up of the following step:
I) letter sorting alternatively, sorting and/or cleaning ingredient;
Ii), it is touched up at least feel it is hard extremely-5 ℃ or following of natural origin composition quick-freezings;
Iii) refrigerative composition is crushed to the size that is enough to by 2mm grid aperture;
If iv) do not add in advance, add any supplementary element alternatively;
V) the raw material of pulverizing is configured as thin slice or required dosage form;
Vi) the raw material that is shaped is refrigerated to-5 ℃ or following;
Vii) dosage form is dried to required moisture being decompressed under 1 holder or the lower condition.
40. a method as claimed in claim 39, this method comprises additional step:
Viii) be warming up to be essentially-5 ℃ and
Ix) further be warming up at least 30 ℃ alternatively.
41. one kind as the described method of each aforementioned claim, this method is used to prepare the dosage form that comprises a kind of natural origin material.
42. dosage form according to the described method preparation of each claim in the claim 1 to 40.
43. a dosage form as claimed in claim 42, this dosage form comprises one or several following ingredients:
Cornu Cervi Pantotrichum, animal livers, Cauda cervi, Penis et testis cervi, fungus, Radix Ginseng, Radix Dauci Sativae, Bulbus Allii, kava, licorice and Folium Ginkgo.
CN98102950A 1997-06-05 1998-06-05 Improvements in and relating to tablet manufacture Pending CN1201664A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NZ328031/97 1997-06-05
NZ328031A NZ328031A (en) 1997-06-05 1997-06-05 Method of preparing a form (e.g.tablet) from a natually occurring substance includes chilling, comminuting, forming and drying the substance

Publications (1)

Publication Number Publication Date
CN1201664A true CN1201664A (en) 1998-12-16

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ID=19926282

Family Applications (1)

Application Number Title Priority Date Filing Date
CN98102950A Pending CN1201664A (en) 1997-06-05 1998-06-05 Improvements in and relating to tablet manufacture

Country Status (2)

Country Link
CN (1) CN1201664A (en)
NZ (1) NZ328031A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012122678A1 (en) * 2011-03-16 2012-09-20 Dong Ling Uniform freeze-dried preparation containning all components of pilose antler and production method thereof
WO2014101291A1 (en) * 2012-12-27 2014-07-03 盐城市好运文具有限公司 Soft-shell crustacean active product rich in calcium invertase
CN110693885A (en) * 2018-07-09 2020-01-17 成都百裕制药股份有限公司 Pharmaceutical composition for preventing or treating sexual dysfunction and use thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012122678A1 (en) * 2011-03-16 2012-09-20 Dong Ling Uniform freeze-dried preparation containning all components of pilose antler and production method thereof
WO2014101291A1 (en) * 2012-12-27 2014-07-03 盐城市好运文具有限公司 Soft-shell crustacean active product rich in calcium invertase
CN110693885A (en) * 2018-07-09 2020-01-17 成都百裕制药股份有限公司 Pharmaceutical composition for preventing or treating sexual dysfunction and use thereof

Also Published As

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NZ328031A (en) 1999-11-29

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