CN101564477A - Small activating collateral preparation and preparation method thereof - Google Patents
Small activating collateral preparation and preparation method thereof Download PDFInfo
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- CN101564477A CN101564477A CNA2008101051895A CN200810105189A CN101564477A CN 101564477 A CN101564477 A CN 101564477A CN A2008101051895 A CNA2008101051895 A CN A2008101051895A CN 200810105189 A CN200810105189 A CN 200810105189A CN 101564477 A CN101564477 A CN 101564477A
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Abstract
The invention discloses a Chinese medicinal preparation, and in particular to a small activating collateral preparation prepared by adopting ultra-micro pulverization technology and a preparation method thereof. The invention provides a small activating collateral ultra-micro pulverization preparation prepared by adopting a vibrating ultra-micro pulverizer, and also introduces assistant materials-adding ultra-micro pulverization technology. The preparation and the method maintain the compound pulverizing homogenization, fully embody the characteristics of Chinese medicinal science, furthest maintain the active ingredient at the same time, improve the utilization factor of medicinal materials, save the medicinal material resources and reduce the production cost.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly a kind of minor network quickening preparation that superfine communication technique makes and preparation method thereof that adopts belongs to the field of Chinese medicines.
Background technology
XIAOHUOLUO WAN is now recorded in " 356 pages of Chinese pharmacopoeia versions in 2005, the weight proportion of its active ingredient raw materials medicine is: 30 parts of Arisaema Cum Bile, 30 parts of Radix Aconiti Preparatas, 30 parts of Radix Aconiti Kusnezoffii Preparatas, 30 parts of Pheretimas, 11 parts of Olibanums (system), 11 parts of Myrrha (processed), be used for the numbness disease due to wind-cold damp pathogen impatency, the phlegm stagnation in collateral, disease is seen limbs joint pain, or cold type of pain, or twinge, or pain night very, joint joint stuffiness, numbness contracture, be expelling wind and cold, eliminating phlegm and removing dampness, the classics recipe of promoting blood circulation and stopping pain.It is evident in efficacy, is subjected to the welcome of extensive patients deeply, but finds that in actual applications still there is certain defective in it: the pill dose is big, takes extremely inconvenience, is not easy to carry, and the patient is difficult to be accepted; Prescription Chinese crude drug crushing fine powder granularity is excessive, fails to give full play to the effect of each composition in the medical material.
The thicker medicated powder bioavailability of granularity is lower, and crude drug can not be fully utilized, and because its huge market demand, thereby cause the Chinese material medicine resource serious waste.As seen, study a kind of reasonable, efficient and economically viable preparation technology minor network quickening class preparation is had very important significance, thereby further satisfy and ensure national medication demand.
Superfine communication technique is the machining process that makes the fine and super-refinement of material, provides one of important means of ultrafine powder.Micronizing is a new and high technology that grows up over nearly 20 years, refers to utilize machinery or hydromechanical approach that material is crushed to particle diameter less than the process below the 10 μ m.Ultramicro powder is the final products of micronizing, has some special physicochemical properties that general granule does not have, as fine solubility, dispersibility, adsorptivity etc.; For Chinese crude drug, the cell wall breaking rate improves greatly, and up to 90%, each effective constituents is release conditions, and dissolution and bioavailability are multiplied.Since the nineties in 20th century, superfine communication technique is applied to Chinese medicine gradually, has given the more modern high section of Chinese medicine content, and the broken technology of Chinese medicine ultra-fine powder is as the constantly development of a new technology.
Fully comprehend the marrow of the broken technology of Chinese medicine micropowder; choose representative classics side medicine, explore the process that a cover has operability, reasonably improvement and using ultramicro communication technique are in the herbal pharmaceutical industry; and, be one of problem that needs at present primary study with its scale, industrialization.
Summary of the invention
First purpose of the present invention is to provide a kind of minor network quickening micronizing preparation.
Another object of the present invention provides the preparation method of this minor network quickening preparation.
The object of the invention mainly is to adopt following dual mode to realize:
Mode one: common micronizing
The inventor provides a kind of minor network quickening preparation that adopts superfine communication technique to make, and writes out a prescription by Arisaema Cum Bile Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Pheretima, Olibanum (system), Myrrha (processed), the prescription ratio of minor network quickening meet each the flavour of a drug proportioning under 365 pages of XIAOHUOLUO WAN items of Chinese Pharmacopoeia version in 2005, that is:
30 parts of 30 parts of Radix Aconiti Kusnezoffii Preparatas of 30 parts of Radix Aconiti Preparatas of Arisaema Cum Bile
11 parts of 11 parts of Myrrha (processed) of 30 parts of Olibanums of Pheretima (system)
For remedying the deficiency of existing minor network quickening preparation, further improve the curative effect of minor network quickening preparation, the present invention introduces superfine communication technique among the preparation technology.The broken technology of Chinese medicine ultra-fine powder claims broken technology of Chinese medicine cell grade micropowder or Chinese medicine cell wall breaking technology again, and it is meant the broken and cell grade ultrafine Chinese herb preparation to Chinese medicine cell grade micropowder mostly, is to break the comminution process that the Chinese crude drug cell is a purpose.The broken technology of Chinese medicine ultra-fine powder has plurality of advantages: a improves extraction ratio of effective constituents, thereby improves drug bioavailability, and taking dose reduces, and saves Chinese material medicine resource, meets " sustainable development " strategy; B improves compound recipe and pulverizes homogenization, embodies tcm characteristic; C retains biological activity composition improves curative effect of medication; D reduces the oral granule sense; E avoids outside contamination, parasite killing, adjection such as antibacterial.
The broken device category of Chinese medicine ultra-fine powder is various, normal at present use mainly contain three major types: vibration type super micron mill, air-flowing type super micron mill, mechanical type super micron mill.Though air-flowing type equipment does not have the association heat, it is low to pulverize temperature, but capacity usage ratio is low, and energy consumption is big, the production cost height, and be not suitable for the superfine communication technique that adds adjuvant; Mechanical equipment convenience simple to operation, it is big that charging is suitable for particle size range, but equipment easily heats up, the component of machine serious wear, and the direct contaminated material of wear particle, heavy metal exceeds standard greatly, and the granularity of gained micropowder is bigger than normal; And vibration type equipment adopts full alloy material to make abrasive media, and special principle has farthest been avoided the wearing and tearing of parts, crush efficiency height, gained powder granularity (D simultaneously
50) can reach below the 10 μ m, combine with cryogenic technique simultaneously, be equally applicable to low melting point and thermal sensitivity medical material, applied range is present optimal micronizing equipment.So the present invention adopts the vibration type super micron mill to prepare the minor network quickening superfine powder, existing crush efficiency height, the micropowder granularity is little, and the advantage that energy consumption is little can be used novel superfine grinding method again---and add the method for adjuvant micronizing, better bring into play the curative effect of preparation.
The invention provides the preparation method of employing mode one preparation minor network quickening micronizing preparation, be specially: get 30 parts of Arisaema Cum Bile, 30 parts of Radix Aconiti Preparatas, 30 parts of Radix Aconiti Kusnezoffii Preparatas, 30 parts of Pheretimas, 11 parts of Olibanums (system), 11 parts of Myrrha (processed) are ground into coarse powder, put in the vibration type pulverizing mill micronizing 10～80 minutes, make ultra-fine pharmaceutical composition, make pill, tablet or capsule according to pharmaceutics conventional formulation technology.
For guaranteeing this preparation curative effect, the ultra-fine pharmaceutical composition that preparation adopted must reach the granularity of regulation: D
50Less than 10 μ m, D
90Less than 50 μ m, thereby guarantee sporoderm-broken rate more than 90%, make each effective constituents in the crude drug cell come out preferably and be release conditions, farthest improve drug bioavailability.
Preparation of the present invention can be honey pill agent, water-honeyed pill, capsule or tablet.
Optimization formula of the present invention is formed in the back and is embodied in the specific embodiment.
Mode two: add the adjuvant micronizing
The inventor also provides minor network quickening to add the prescription of adjuvant micronizing preparation, and it is composed as follows:
0～10 part of 0～10 part of bioadhesive polymer of prescription 100 parts of wetting agent of medical material
0～10 part of 0～20 portion of efficient disintegrating agent of dispersant
Adjuvant used in the present invention is through screening and the final combination of determining, has uniqueness and irreplaceability, and wherein wetting agent is any or the compositions more than two kinds in lecithin, poloxamer, the Polyethylene Glycol; Bioadhesive polymer is the compositions of any or two kinds in chitosan, the carbomer; Dispersant is any or the compositions more than two kinds in micropowder silica gel, cyclodextrin, starch, the dextrin; Efficient disintegrating agent is that low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, super carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose are received, any or the compositions more than two kinds in the microcrystalline Cellulose.
Bioadhesive polymer chitosan, carbomer are macromolecular material, have the bio-adhesive performance, but prolong drug significantly improves bioavailability of medicament in the gastrointestinal holdup time.Self is electronegative under the meta-alkalescence condition for carbomer, and intestinal can provide the environment of meta-alkalescence, and carbomer can form hydrophilic high viscosity gel in intestinal, be adsorbed on the intestinal mucosa, strengthen medicine in the holdup time of intestinal, promote the medicine moistening, strengthen absorbing of effective ingredient; Chitosan is natural biodegradable pasting material and the slow-release material of using always, and tool promotes the effect of medicine mucosa absorption, it is the polycation polysaccharide of the only existence of nature, chitosan be N-acetyl-D-glucamine and D-glucamine by the linear long-chain high-polymer molecular that β (1-4) glycosidic bond is formed by connecting, contain in a large number can with other molecules form hydrogen bonds-OH and-NH
2Group ,-NH
2Protonated formation-NH
3 +Make the molecule positively charged, above-mentioned molecular characterization makes chitosan become good bio-adhesive material, under the condition of acidic pH of gastric juice, chitosan forms hydrophilic high viscosity gel, easily be adsorbed on the gastrointestinal tract mucosa, the holdup time of prolong drug promotes the medicine moistening, strengthens absorbing of effective ingredient; And chitosan can also open epithelial tight connection, further promotes drug absorption.
Wetting agent lecithin, poloxamer, Polyethylene Glycol have certain surface activity effect, abundant moistening micropowders surface, reduce the surface tension of micropowder greatly, prevent that micropowder is coalescent agglomerating, the raising of micropowders wettability has simultaneously strengthened itself and the coupling ability of gastrointestinal wall, fully contacts, discharge effective ingredient, improve bioavailability.
Dispersant micropowder silica gel, cyclodextrin, microcrystalline Cellulose, starch, dextrin, Polyethylene Glycol etc. provide surface area great carrier for the high degree of dispersion of micropowders, the part microgranule that can neutralize simultaneously institute is electrically charged, eliminate the microparticle surfaces air film, make the surface energy of micropowders reduce greatly, the coalescent agglomerating phenomenon of medicine no longer appears, the mobile enhancing can carry out the preparation of preparations such as tablet, capsule fully, the more important thing is to have strengthened stability of drug.
Efficient disintegrating agent low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, super carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose are received, the adding of microcrystalline Cellulose etc., be beneficial to preparations such as capsule, tablet, pill and discharge medicine rapidly, reach onset concentration in short period, onset rapidly.
The present invention also provides the preparation method of employing mode two preparation minor network quickening micronizing preparations, be specially: get 30 parts of Arisaema Cum Bile, 30 parts of Radix Aconiti Preparatas, 30 parts of Radix Aconiti Kusnezoffii Preparatas, 30 parts of Pheretimas, 11 parts of Olibanums (system), 11 parts of Myrrha (processed) are ground into coarse powder, add the recipe quantity pharmaceutical adjunct, put in the vibration type pulverizing mill micronizing 10～80 minutes, and made ultra-fine pharmaceutical composition, make pill, tablet or capsule according to pharmaceutics conventional formulation technology;
For guaranteeing this preparation curative effect, the ultra-fine pharmaceutical composition that preparation adopted must reach the granularity of regulation: D
50Less than 10 μ m, D
90Less than 50 μ m, thereby guarantee sporoderm-broken rate more than 90%, make each effective constituents in the crude drug cell come out preferably and be release conditions, farthest improve drug bioavailability.
Preparation of the present invention can be honey pill agent, water-honeyed pill, capsule or tablet.
Optimization formula of the present invention is formed in the back and is embodied in the specific embodiment.
Beneficial effect
Technical scheme of the present invention is considered from practical angle, adopts innovative technology to make minor network quickening micronizing preparation, and concrete advantage is as follows:
1, improves drug bioavailability: adopt minor network quickening preparation that this patent invention preparation method makes and common minor network quickening pill etc. to compare, significantly improved bioavailability of medicament.The Chinese medicine coarse powder is after micronizing, and the cell wall breaking rate reaches 90%, and intracellular each effective constituents comes out preferably and is release conditions, and effective ingredient dissolution and bioavailability improve greatly, can reach onset concentration within a short period of time, brings into play curative effect rapidly.
2, preparation technology's efficient height, energy consumption is little: it is big to be compared to air-flowing type super micron mill energy consumption, and capacity usage ratio is low, the deficiency that production cost is high, preparation technology of the present invention improves, and adopts the vibration type pulverizing mill that energy consumption is little, efficient is high to carry out micronizing, granule D
50Can reach below the 10 μ m, and also can add necessary adjuvants such as wetting agent among the preparation technology of the present invention, micropowder is reunited, adsorption phenomena is solved, and further strengthens drug effect, and this is that any micronizing mode is beyond one's reach.
3, promoted the application of superfine communication technique in pharmaceuticals industry to a certain extent: minor network quickening micronizing preparation unique preparation process of the present invention provides a practical way for similar technological innovation; along with updating of superfine communication technique; obtain the approval of numerous pharmaceutical researchers surely, the scale of the broken technology of Chinese medicine ultra-fine powder, industrialization are pointed the day and await for it.
4, minor network quickening micronizing preparation of the present invention and common minor network quickening preparation are comprehensively compared, the result is as follows:
Former technology of table 1 and innovative technology effect comparison sheet of the present invention
Annotate: above-mentionedly more all compare with same dosage form (pill).
As seen, the present invention has obtained outstanding technique effect, has reached goal of the invention.
The specific embodiment
Enumerate embodiment below, further specify the present invention, each embodiment only is used to illustrate the present invention, does not limit the present invention:
Embodiment 1
Arisaema Cum Bile 180g Radix Aconiti Preparata 180g Radix Aconiti Kusnezoffii Preparata 180g
Pheretima 180g Olibanum (system) 66g Myrrha (processed) 66g
Above Six-element carries out the flushing coarse pulverization, crosses 10 mesh sieves, pulverizes 55 minutes in the vibration type super micron mill then, makes ultra-fine pharmaceutical composition, adds 1.2 times refined honey, makes minor network quickening small honey pill or big honeyed pills.
Embodiment 2
Arisaema Cum Bile 180g Radix Aconiti Preparata 180g Radix Aconiti Kusnezoffii Preparata 180g
Pheretima 180g Olibanum (system) 66g Myrrha (processed) 66g
Above Six-element carries out the flushing coarse pulverization, crosses 10 mesh sieves, pulverizes 50 minutes in the vibration type super micron mill then, makes ultra-fine pharmaceutical composition, adds 0.6 times refined honey and suitable water, makes the minor network quickening water-honeyed pill.
Embodiment 3
Arisaema Cum Bile 180g Radix Aconiti Preparata 180g Radix Aconiti Kusnezoffii Preparata 180g
Pheretima 180g Olibanum (system) 66g Myrrha (processed) 66g
Above Six-element, carry out the flushing coarse pulverization, cross 10 mesh sieves, add chitosan 0.5g, lecithin 1.5g, micropowder silica gel 5g and crospolyvinylpyrrolidone 10g, pulverized 40 minutes in the vibration type super micron mill, make ultra-fine pharmaceutical composition, add 1.4 times refined honey, make minor network quickening small honey pill or big honeyed pills.
Embodiment 4
Arisaema Cum Bile 180g Radix Aconiti Preparata 180g Radix Aconiti Kusnezoffii Preparata 180g
Pheretima 180g Olibanum (system) 66g Myrrha (processed) 66g
Above Six-element, carry out the flushing coarse pulverization, cross 10 mesh sieves, add carbomer 70g, poloxamer 80g, microcrystalline Cellulose 8g and super carboxymethyl starch sodium 35g, pulverized 50 minutes in the vibration type super micron mill, make ultra-fine pharmaceutical composition, add 1.2 times refined honey, make minor network quickening small honey pill or big honeyed pills.
Embodiment 5
Arisaema Cum Bile 180g Radix Aconiti Preparata 180g Radix Aconiti Kusnezoffii Preparata 180g
Pheretima 180g Olibanum (system) 66g Myrrha (processed) 66g
Above Six-element, carry out the flushing coarse pulverization, cross 10 mesh sieves, and add carbomer 10g, poloxamer 12g, cyclodextrin 20g and microcrystalline Cellulose 15g, pulverized 40 minutes in the vibration type super micron mill, make ultra-fine pharmaceutical composition, add newborn proper amount of sugar, and it is an amount of to add debita spissitudo ethanol, make granule, add an amount of magnesium stearate, capsule charge makes the minor network quickening capsule.
Embodiment 6
Arisaema Cum Bile 180g Radix Aconiti Preparata 180g Radix Aconiti Kusnezoffii Preparata 180g
Pheretima 180g Olibanum (system) 66g Myrrha (processed) 66g
Above Six-element, carry out the flushing coarse pulverization, cross 10 mesh sieves, and add polyvinylpyrrolidone 10g, poloxamer 10g, dextrin 20g, micropowder silica gel 15g and carboxymethyl starch sodium 8g, pulverized 50 minutes in the vibration type super micron mill, make ultra-fine pharmaceutical composition, add starch and microcrystalline Cellulose is an amount of, and it is an amount of to add debita spissitudo ethanol, makes granule, compressed tablets makes the minor network quickening tablet.
Claims (8)
1, a kind of minor network quickening preparation that adopts superfine communication technique to make.
2, minor network quickening preparation according to claim 1 is characterized in that the grain graininess D of the ultra-fine pharmaceutical composition of preparation intermediate
50Less than 10 μ m and D
90Less than 50 μ m.
3, minor network quickening preparation according to claim 2 is characterized in that adopting following either party's method to make:
A, get the prescription medical material, be ground into coarse powder, put in the vibration type super micron mill micronizing 10～80 minutes, make ultra-fine pharmaceutical composition, make pill, tablet, capsule according to pharmaceutics conventional formulation technology;
B, get the prescription medical material, be ground into coarse powder, add pharmaceutical adjunct, put in the vibration type super micron mill micronizing 10～80 minutes, make ultra-fine pharmaceutical composition, make pill, tablet, capsule according to pharmaceutics conventional formulation technology.
4, minor network quickening preparation according to claim 3 is characterized in that the pharmaceutical adjunct among the method b comprises wetting agent, dispersant.
5, minor network quickening preparation according to claim 4 is characterized in that pharmaceutical adjunct also comprises bioadhesive polymer, efficient disintegrating agent.
6, minor network quickening preparation according to claim 5 is characterized in that wetting agent is any or the compositions more than two kinds in lecithin, poloxamer, the Polyethylene Glycol; Bioadhesive polymer is any or the compositions more than two kinds in chitosan, carbomer, the polyvinylpyrrolidone; Dispersant is any or the compositions more than two kinds in micropowder silica gel, cyclodextrin, starch, the dextrin; Efficient disintegrating agent is that low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, super carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose are received, any or the compositions more than two kinds in the microcrystalline Cellulose.
7, minor network quickening preparation according to claim 6, the weight proportion of it is characterized in that writing out a prescription medical material and wetting agent, bioadhesive polymer, dispersant and efficient disintegrating agent is: 100: 0～10: 0～10: 0～20: 0～10.
8, the method for preparing the arbitrary described minor network quickening preparation of claim 1 to 7 is characterized in that it can being following any method:
A, get 30 parts of Arisaema Cum Bile, 30 parts of Radix Aconiti Preparatas, 30 parts of Radix Aconiti Kusnezoffii Preparatas, 30 parts of Pheretimas, 11 parts of Olibanum (processed)s, 11 parts of Myrrha (processed)s, be ground into coarse powder, put in the vibration type pulverizing mill micronizing 10～80 minutes, and made ultra-fine pharmaceutical composition, make pill, tablet or capsule according to pharmaceutics conventional formulation technology;
B, get 30 parts of Arisaema Cum Bile, 30 parts of Radix Aconiti Preparatas, 30 parts of Radix Aconiti Kusnezoffii Preparatas, 30 parts of Pheretimas, 11 parts of Olibanum (processed)s, 11 parts of Myrrha (processed)s, be ground into coarse powder, add pharmaceutical adjunct, put in the vibration type pulverizing mill micronizing 10～80 minutes, make ultra-fine pharmaceutical composition, make pill, tablet or capsule according to pharmaceutics conventional formulation technology.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101051895A CN101564477A (en) | 2008-04-25 | 2008-04-25 | Small activating collateral preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101051895A CN101564477A (en) | 2008-04-25 | 2008-04-25 | Small activating collateral preparation and preparation method thereof |
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| CN101564477A true CN101564477A (en) | 2009-10-28 |
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ID=41280953
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| CNA2008101051895A Pending CN101564477A (en) | 2008-04-25 | 2008-04-25 | Small activating collateral preparation and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726835A (en) * | 2016-03-30 | 2016-07-06 | 韩志强 | Small collateral circulation activating tablets and preparation method thereof |
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2008
- 2008-04-25 CN CNA2008101051895A patent/CN101564477A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726835A (en) * | 2016-03-30 | 2016-07-06 | 韩志强 | Small collateral circulation activating tablets and preparation method thereof |
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Open date: 20091028 |