CN109745290A - A kind of form of Chinese drug-ultrafine Chinese herb pellet or piller and preparation method thereof - Google Patents
A kind of form of Chinese drug-ultrafine Chinese herb pellet or piller and preparation method thereof Download PDFInfo
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- CN109745290A CN109745290A CN201711068384.0A CN201711068384A CN109745290A CN 109745290 A CN109745290 A CN 109745290A CN 201711068384 A CN201711068384 A CN 201711068384A CN 109745290 A CN109745290 A CN 109745290A
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Abstract
The present invention proposes a kind of ultrafine Chinese herb dosage form, ultrafine Chinese herb dosage form is pellet or piller, the raw material of ultrafine Chinese herb dosage form is full ingredient ultrafine Chinese herb and ethanol excipients, ultrafine Chinese herb pellet or piller drugloading rate are up to 90% or more, the smashing fineness of full ingredient ultrafine Chinese herb is impalpable powder, i.e. 200 mesh do not abandon any effective component and position in medicinal material with thin, and in crushing process, the moisture content of ethanol excipients is experimentally determined according to specific drug, between 0%-90%.Also propose a kind of production method of ultrafine Chinese herb dosage form, ultrafine Chinese herb pellet or piller are manufactured using powder bed area method or extrusion spheronization method, powder bed area method uses general ball method or centrifugal process, and extrusion spheronization method extruder combines completion with spheronizator, and general ball method is the general ball method of coating pan or centrifugal granulation.Medicinal material used in ultrafine Chinese herb pellet or piller is that impalpable powder (200 mesh) saves medicinal material, raising with the efficiency that thin micro-powder of Chinese herbs can play Chinese medicine to greatest extent or keep drug effect.
Description
Technical field
The invention belongs to ultrafine Chinese herb pharmaceutical technology field, propose a kind of form of Chinese drug-ultrafine Chinese herb pellet or piller and
Its production method.
Background technique
Nearly 20 years, Chinese medicine crushing technology (referred in full composition and does not abandon any ingredient in medicinal material and position in crushing process)
Achieve rapid progress in terms of Crushing of Ultrafine fineness, Chinese medicine crushes industrialized production, full composition fineness can reach comprehensively " in
Magnificent people's republic's pharmacopeia " impalpable powder 200 mesh (75 microns) with thin；
Referring to by " pharmacopeia " regulation impalpable powder all to be sieved by No. eight, and contains the powder that 95% can be no less than by No. nine sieves
End, wherein the specification of No. eight sieves and No. nine sieves is as follows:
No. eight sieve 90 μm of ± 4.6 μm of 150 mesh nine sieves, 75 μm of ± 4.1 μm of 200 mesh
Commonly referred to as 75 microns of impalpable powders of maximum particle diameter < (200 mesh) manufactured Chinese medicine by thin Chinese medicine and based on it
Type is ultrafine Chinese herb.Ultrafine Chinese herb generally can achieve 95% or more to breaking-wall cell (film) rate of animals and plants Chinese medicine.Cell
Interior content has been all exposed to other than cell wall (film), and cell wall (film) dissolves in the cell wall of solvent to intracellular ingredient
(film) resistance has not existed, and therefore, should can significantly improve recovery rate when extracting traditional Chinese medicine ingredients with solvent.
Document: " folk prescription, compound Cellular Level Pulverizing and Ordinary pulverization quality versus " author: Du Xiaomin etc., be published on " at
Medicine " the 1st phase of volume 23 in January, 2001.Using Chinaroot Greenbier Rhizome soap in tlc scanning determination compound Tangtai Capsule coarse powder, cell grade micro mist
Aglycones content, as a result Chinaroot Greenbier Rhizome sapogenin content average out to 0.89% in the compound Tangtai Capsule containing fine powder, the compound containing coarse powder are sugared
Chinaroot Greenbier Rhizome sapogenin content average out to 0.71% in safe capsule, fine powder content is apparently higher than coarse powder content.
Document: " ultrafine powder technology is to the shadow of andrographolide and Dehydro and drographolide dissolution rate in Herba Andrographitis medicinal material
Ring " author: Qiu Rongli etc. is published on the 6th phase of volume 2 " Journal of Chinese Integrative Medicine " in November, 2004.Andrographolide and dehydration
Andrographolide is the principle active component of Herba Andrographitis medicinal material.Carry out ultramicro grinding and Ordinary pulverization respectively to Herba Andrographitis: with height
Effect liquid phase chromatogram method measures the dissolution of andrographolide and Dehydro and drographolide in Herba Andrographitis Ultramicro-powder and 120 mesh fine powder of medicinal material
Amount, as a result Ultramicro-powder average out to 14.6% and 12.9%, fine powder are 3.5% and 4.1%.It can be seen that Herba Andrographitis medicinal material is through pulverizing
The amount of dissolution of main indicator ingredient in medicinal material can be obviously increased afterwards.
Document: " the chemical contrast research of Yinqiao detoxification soup ultramicro decoction piece and traditional medicine materical crude slice " author: Cai Guangxian Yang Yong China etc.
It is published in the 6th phase of " Chinese experimental pharmacology of traditional Chinese medical formulae magazine " the 8th lane December in 2002.Same batch medicinal material is taken, prepares Yinqiao detoxification respectively
Soup ultramicro decoction piece (1-75 μm) soak and traditional medicine materical crude slice decoction liquor, and its extract, chlorogenic acid, Determination of forsythin etc. are carried out
Comparative test.The result shows that: the water-soluble extractives of Yinqiao detoxification soup ultramicro decoction piece are 1.71 times of traditional medicine materical crude slice, illustrate Lonicera and Forsythia
Detoxication Decoction prescription drug substantially increases water-soluble extractives by pulverizing；Chlorogenic acid, Determination of forsythin are respectively tradition
1.92 times, 1.43 times of medicine materical crude slice, illustrate Yinqiao detoxification soup recipe drug by pulverize can improve chlorogenic acid, forsythin it is molten
Output.
Same conclusion also appears in other a large amount of documents, it may be said that ultrafine Chinese herb has the utilization for improving Chinese medicine
Rate, significant saving Chinese medicaments material, the prospect for reducing Chinese medicine drug cost have become industry and widely know together.
How ultrafine Chinese herb is taken, and takes first as powder；Amount i.e. as required is put into mouth one or many with water
It takes after mixing it with water, this method, the phenomenon that oral mucosa is pasted since ultrafine Chinese herb is very fine and smooth, after entrance than more serious, causes oral cavity
Discomfort is swallowed unsmooth, brings certain medication difficult；It is such as used powder as decoction made from powder, i.e., amount as required is added boiling water and decocts
It boils and is taken after temperature, mouthfeel can significantly improve, and still, joined the process of " boiling water is decocted to temperature ", increase and take trouble.
There is no " the phenomenon that pasting oral mucosa after entrance " to be not necessary to " boiling water is added to decoct to temperature " again when traditional Chinese medicine pellet is taken,
Convenient to take, process is simple, can preferably solve the above problems.
Traditional Chinese medicine pellet is made of drug and auxiliary material, is less than 2.5mm for diameter, usually the spherical shape of 0.5mm-1.5mm
Or spherical preparation, belong to multiple agent type, it serves not only as independent dosage form and is used for clinic, can also need to be made according to different
At quick-release, sustained release or site specific delivery system, or it is further used as the semi-finished product original grain etc. of capsule, tablet, granule, closely
The attention of people is increasingly subject to over year using pellet preparations as the multi-unit drug delivery system of representative, becomes the one of preparation process development
Main trend is increasingly becoming one of current comparatively ideal modern medicines formulation application hot spot.
Traditional Chinese medicine pellet belongs to medicine pill." Pharmacopoeia of People's Republic of China 2000 editions " annex I A is in relation to micro-
Ball definition and regulation: " pill refers to that fine medicinal material powder or medicinal substances extract add spherical shape made of suitable adhesive or other auxiliary materials
Or spherical preparation, it is divided into the types such as honeyed bolus, water-honeyed pill, the water-bindered pill, starched pill, condensed pill, wax-wrapped pill and pellet." " pellet means diameter
" unless otherwise specified, the medicinal powder for pill agent should be fine powder or most fine powder to all kinds of pills less than 2.5mm "."
Piller refers to that diameter is not limited to be less than 2.5mm, also can be greater than 2.5mm diameter but also less big pill, such as directly
Diameter 3-4mm diameter.
It is provided by " pharmacopeia ":
The granularity of fine powder is: referring to all to be sieved by No. five, and containing the powder that can be no less than 95% by No. six sieves
No. five sieve 180 μm of ± 7.6 μm of 80 mesh six sieves, 150 μm of ± 6.6 μm of 100 mesh
The granularity of most fine powder is: referring to all to be sieved by No. six, and containing the powder that can be no less than 95% by No. seven sieves
No. six sieve 150 μm of ± 6.6 μm of 100 mesh seven sieves, 125 μm of ± 7.6 μm of 120 mesh
In practice, some documents sum up such conclusion: being used to prepare the medicinal powder of traditional all kinds of pills, crush
Fineness is most important to the quality of pill, should generally use fine powder, can pass through No. six sieves or the medicinal powder of No. five sieves.Such as use fine powder
The pill then moist rounding of pellet surface；If medicinal powder is thicker, then formed pellet surface is coarse, has piebald and fiber hair, very
To not easily molded.However pill fine powder cannot be meticulous, otherwise will affect leaching (see " pharmacy of Chinese materia medica " Shanghai science skill for pill
Art publishing house in December, 1997 first edition page 364).
It is exactly above the grain size characteristic of medicinal powder contained by traditional Chinese medicine pellet and the overview of the prior art, in such granularity
Under the conditions of, use water successfully to produce various pills as excipients, or even belong to the piller of pellet range.But fineness reaches
100 targeted fine powders or 120 purposes most fine powder Chinese medicine, due to its cell-wall breaking ratio and insufficient, and its internal component does not fill
Divide exposure, therefore seriously affects the sufficient degree that medicinal material utilizes.Traditional Chinese medicine pellet or piller is made using micro-powder of Chinese herbs as can searching out
Solution, then medicinal material can be made to be fully used.
Summary of the invention
In order to solve the above technical problems, the present invention proposes a kind of ultrafine Chinese herb pellet form of Chinese drug,
Ultrafine Chinese herb dosage form is pellet or piller, and the raw material of ultrafine Chinese herb dosage form is full ingredient ultrafine Chinese herb and ethyl alcohol figuration
Agent.
Preferably, ultrafine Chinese herb pellet or piller drugloading rate are up to 90% or more.
Preferably, the smashing fineness of Quan Chengfen ultrafine Chinese herb is impalpable powder, i.e. 200 mesh are with thin, and in crushing process not
Abandon any effective component in medicinal material and position.
Preferably, the moisture content of ethanol excipients is experimentally determined according to specific drug, between 0%-90%.
The object of the invention is also to provide a kind of production method of ultrafine Chinese herb dosage form, ultrafine Chinese herb pellet or piller are adopted
It is manufactured with powder bed area method or extrusion spheronization method.
Preferably, powder bed area method uses general ball method or centrifugal process, and extrusion spheronization method extruder has been combined with spheronizator
At.
Preferably, general ball method is the general ball method of coating pan or centrifugal granulation.
Using above technical scheme, medicinal material used in ultrafine Chinese herb pellet or piller is impalpable powder (200 mesh) with thin Chinese medicine
Micro mist can be not added or add adhesive less, adhesive be not added in most cases, only with the excipient machine-shaping such as alcohol.
Specific embodiment
Content in order to enable those skilled in the art to better understand the present invention, is below illustrated embodiment, institute
The embodiment shown does not play any restriction effect to the invention described in the claims content.In addition, composition represented by embodiment
Full content be not limited to necessary to the solution as the invention described in the claims.
Purpose and principle according to the present invention, micro-powder of Chinese herbs is broken to reach impalpable powder (200 mesh) with after thin, it is intracellular it is contained at
Dividing sufficiently to be exposed, wherein also including pelletization promotor starch and the various ingredients that can be used as adhesive.Due to each
Outside a ingredient is directly exposed to, the stickiness of powder is dramatically increased, and viscous powder makees excipient using water excessively, under pelletization ability is significant
Drop, and ethyl alcohol can reduce the viscosity of medicinal powder, therefore ultrafine Chinese herb pill selects ethyl alcohol for excipients.The moisture content of ethyl alcohol according to
Number of the medicinal powder containing natural glue and accordingly adjust, the content of natural glue is more, reduces the moisture content of ethyl alcohol, natural viscous
The few moisture content for then improving ethyl alcohol of the content of mixture.Specific aqueous rate score will determine according to experiment, and moisture content can be
It is adjusted between 0%-90%.
Since pill is only made of ultrafine Chinese herb and excipient, and excipient has remained little after drying, so it is carried
Dose reaches 90% or more, in the present embodiment close to 100%.
Powder bed area method still can be used in ultrafine Chinese herb pelletization technology and extrusion spheronization method is made.Powder bed area method generally uses
The general ball method of general ball method, generally coating pan and centrifugal granulation；Extrusion spheronization method extruder combines completion with spheronizator.
Specific pelletizing process is as follows:
Powder bed area method: carry out raw material preparation first: raw material configures medicine materical crude slice by prescription and is ground into impalpable powder (200 mesh),
Carry out excipient preparation simultaneously: the relationship for groping the ratio of viscosity and excipient ethyl alcohol and water configures figuration according to the determined proportion
Agent；Then it rises and touches on coating pan or centrifugal granulator, spray excipient and medicinal powder after molding repeatedly, form pellet；Pellet
Pellet is dried again after molding, grain is selected to obtain finished product, then finished product is packed as required.
Extrusion spheronization method:
Carry out raw material preparation first: raw material configures medicine materical crude slice by prescription and is ground into impalpable powder (200 mesh), while carrying out figuration
Agent prepares: the relationship for groping the ratio of viscosity and excipient ethyl alcohol and water configures excipient according to the determined proportion；Then softwood processed,
Medicinal powder and excipient are mixed and made into the plastic wet softwood of tool；Extruding medicinal strip is carried out again, i.e., by the wet of plasticity
Softwood is squeezed into high density medicinal strip through the fashion of extrusion such as screw propulsion or rolling rod；Medicinal strip is cut off again, i.e., is being cut medicinal strip
Particle is cut into off line tool；It is round as a ball to the particle after cutting again；I.e. by particle, round as a ball molding is made in spherical forming machine
Ultrafine Chinese herb pellet；Pellet is dried again after pellet molding, grain is selected to obtain finished product, then finished product is packed as required.
Specific implementation citing:
Prescription: aligning yang-tonifying soup
Aligning yang-tonifying soup
120 grams of Radix Astragali, 30 grams of radix paeoniae rubra, 15 grams of Rhizoma Chuanxiong, 30 grams of peach kernel, 15 grams of Radix Angelicae Sinensis, 10 grams of safflower, 10 grams of lilies of pheretima
30 grams of 10 grams of the root of three-nerved spicebush, 30 grams of Radix Salviae Miltiorrhizae, 15 grams of Radix Curcumae, 30 grams of Snakegourd Fruit, 30 grams of raw oyster, 15 grams of radix bupleuri, 15 grams of Radix Codonopsis 30 of radix scutellariae
Gram 15 grams of Schisandra chinensis, 3 grams of pericarpium zanthoxyli, 30 grams of perillaseed, 10 grams of Radix Glycyrrhizae, 10 grams 10 pairs of jujube
The above prescription is containing 21 single medicinal material side's weight, 491 grams of 10 pairs of 491*10=4910 grams of weights
Said medicine medicine materical crude slice is crushed to impalpable powder (200 mesh) with oscillatory type cracker for medicine with thin；10 grams of medicinal powder are taken to add
Enter appropriate 90% medical ethanol, kneading medicinal powder has plasticity, feel improper at dough, energy handedness (tack-free), adjusts ethyl alcohol
Moisture content, then try, find suitable moisture content.
Make excipient molding on centrifugal pelletizer with the ethyl alcohol of suitable moisture content, constantly repeatedly, is interrupted sprinkling tax
Shape agent and ultrafine Chinese herb, granularity stop operation after reaching 3-4mm, are then spontaneously dried or be dried in vacuo, then with screening
Method sifts out the piller of 3-4mm,.
Claims (7)
1. a kind of ultrafine Chinese herb dosage form, it is characterised in that: the ultrafine Chinese herb dosage form is pellet or piller, the ultrafine Chinese herb agent
The raw material of type is full ingredient ultrafine Chinese herb and ethanol excipients.
2. a kind of ultrafine Chinese herb dosage form according to claim 1, it is characterised in that: the ultrafine Chinese herb pellet or piller carry
Dose is up to 90% or more.
3. a kind of ultrafine Chinese herb dosage form according to claim 1 to 2, it is characterised in that: the powder of the full ingredient ultrafine Chinese herb
Chopping fine degree is impalpable powder, i.e. 200 mesh do not abandon any effective component and position in medicinal material with thin, and in crushing process.
4. a kind of ultrafine Chinese herb dosage form according to claim 1 to 3, it is characterised in that: the moisture content of the ethanol excipients
It is experimentally determined according to specific drug, between 0%-90%.
5. a kind of production method of ultrafine Chinese herb dosage form described in -4 according to claim 1, it is characterised in that: the ultrafine Chinese herb
Pellet or piller are manufactured using powder bed area method or extrusion spheronization method.
6. the production method of ultrafine Chinese herb dosage form according to claim 5, it is characterised in that: the powder bed area method uses
General ball method or centrifugal process, extrusion spheronization method extruder combine completion with spheronizator.
7. the production method of ultrafine Chinese herb dosage form according to claim 6, it is characterised in that: the general ball method is that coating pan is general
Ball method or centrifugal granulation.
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| CN101543515A (en) * | 2009-01-24 | 2009-09-30 | 湖南省中医药研究院 | Preparation method of super-micro aurantii immaturi and atractylodis pills |
| CN104224738A (en) * | 2014-09-11 | 2014-12-24 | 葛强 | Single traditional Chinese medicine pills and preparation method thereof |
| CN104622960A (en) * | 2015-01-23 | 2015-05-20 | 爱民药业集团股份有限公司 | Compound salviae miltiorrhizae condensed pill and preparation method thereof |
| CN105435144A (en) * | 2014-09-25 | 2016-03-30 | 天津尖峰弗兰德医药科技发展有限公司 | Raw ginger micro-pill and preparation method thereof |
-
2017
- 2017-11-03 CN CN201711068384.0A patent/CN109745290A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101513430A (en) * | 2009-01-24 | 2009-08-26 | 湖南省中医药研究院 | Method for preparing superfine liver-fire-purging and spleen-stomach-regulating pill |
| CN101543515A (en) * | 2009-01-24 | 2009-09-30 | 湖南省中医药研究院 | Preparation method of super-micro aurantii immaturi and atractylodis pills |
| CN104224738A (en) * | 2014-09-11 | 2014-12-24 | 葛强 | Single traditional Chinese medicine pills and preparation method thereof |
| CN105435144A (en) * | 2014-09-25 | 2016-03-30 | 天津尖峰弗兰德医药科技发展有限公司 | Raw ginger micro-pill and preparation method thereof |
| CN104622960A (en) * | 2015-01-23 | 2015-05-20 | 爱民药业集团股份有限公司 | Compound salviae miltiorrhizae condensed pill and preparation method thereof |
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Application publication date: 20190514 |