CN101564481A - Bone-setting anti-bruise powder preparation and preparation method thereof - Google Patents
Bone-setting anti-bruise powder preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal preparation, and in particular to a bone-setting anti-bruise powder preparation prepared by adopting ultra-micro pulverizing technology and a preparation method thereof. The invention provides a bone-setting anti-bruise powder ultra-micro pulverization preparation prepared by adopting a vibrating ultra-micro pulverizer, and also introduces assistant materials-adding ultra-micro pulverizing technology. The preparation and the method maintain the compound pulverizing homogenization, fully embody the characteristics of Chinese medicinal science, furthest maintain active ingredients 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 bone-setting anti-bruise powder preparation that superfine communication technique makes and preparation method thereof that adopts belongs to the field of Chinese medicines.
Background technology
JIEGU QILI PIAN is now recorded in the 3rd 156 pages in " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation, the weight proportion of its active ingredient raw materials medicine is: 2 parts of Olibanums (stir-fry), 2 parts of Myrrhas (stir-fry), 3 parts of Radix Angelicae Sinensis, 5 parts of Eupolyphaga Seu Steleophagas, 3 parts of Rhizoma Drynariae (scalding), 2 parts of Boraxs, 3 parts of Sanguis Draxonis, 2 parts of Pyritums (forging), 2 parts of Radix Et Rhizoma Rhei (wine stir-fry), be used for traumatic injury, reunion of fractured tendons and bones, the classics recipe of blood stasis pain, it is evident in efficacy, be subjected to the welcome of extensive patients deeply, but find in actual applications, still there is certain defective in it: the pill dose is big, take extremely inconvenience, be not easy to carry, 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 seven lis of class preparations of synthetism are 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 synthetism seven lis of micronizing preparations.
Another object of the present invention provides the preparation method of this bone-setting anti-bruise powder 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 bone-setting anti-bruise powder preparation that adopts superfine communication technique to make, prescription is made up of Olibanum (stir-fry), Myrrha (stir-fry), Radix Angelicae Sinensis, Eupolyphaga Seu Steleophaga, Rhizoma Drynariae (scalding), Borax, Sanguis Draxonis, Pyritum (forging), Radix Et Rhizoma Rhei (wine stir-fry), the prescription ratio that synthetism is seven lis meets each the flavour of a drug proportioning under the 3rd JIEGU QILI PIAN item of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation, that is:
5 parts of 3 parts of Eupolyphaga Seu Steleophagas of 2 parts of Radix Angelicae Sinensis of 2 parts of Myrrhas of Olibanum (stir-fry) (stir-fry)
2 parts of Rhizoma Drynariae (scalding) 3 parts of Boraxs, 3 parts of Pyritums of 2 parts of Sanguis Draxonis (forging)
2 parts of Radix Et Rhizoma Rhei (wine stir-fry)
For remedying the deficiency of existing bone-setting anti-bruise powder preparation, further improve the curative effect of bone-setting anti-bruise powder 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 seven lis of superfine powder of synthetism, existing crush efficiency height, the micropowder granularity is little, the advantage that energy consumption is little, can use novel superfine grinding method again---add the method for adjuvant micronizing, better bring into play the curative effect of preparation.
The invention provides the preparation method of seven lis of micronizing preparations of employing mode one preparation synthetism, be specially: get 2 parts of Olibanums (stir-fry), 2 parts of Myrrhas (stir-fry), 3 parts of Radix Angelicae Sinensis, 5 parts of Eupolyphaga Seu Steleophagas, 3 parts of Rhizoma Drynariae (scalding), 2 parts of Boraxs, 3 parts of Sanguis Draxonis, 2 parts of Pyritums (forging), 2 parts of Radix Et Rhizoma Rhei (wine stir-fry), 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.
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 synthetism seven lis of prescriptions that add 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 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.
Bioadhesive polymer chitosan, carbomer, polyvinylpyrrolidone 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 seven lis of micronizing preparations of employing mode two preparation synthetisms, be specially: get 2 parts of Olibanums (stir-fry), 2 parts of Myrrhas (stir-fry), 3 parts of Radix Angelicae Sinensis, 5 parts of Eupolyphaga Seu Steleophagas, 3 parts of Rhizoma Drynariae (scalding), 2 parts of Boraxs, 3 parts of Sanguis Draxonis, 2 parts of Pyritums (forging), 2 parts of Radix Et Rhizoma Rhei (wine stir-fry), be ground into coarse powder, add the recipe quantity 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;
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 seven lis of micronizing preparations of synthetism, and concrete advantage is as follows:
1, improves drug bioavailability: adopt bone-setting anti-bruise powder preparation that this patent invention preparation method makes and common JIEGU QILI PIAN agent 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: seven lis of micronizing preparations of synthetism of the present invention unique preparation process 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, seven lis of micronizing preparations of synthetism of the present invention and common bone-setting anti-bruise powder 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
Olibanum (stir-fry) 20g Myrrha (stir-fry) 20g Radix Angelicae Sinensis 30g Eupolyphaga Seu Steleophaga 50g
Rhizoma Drynariae (scalding) 30g Borax 20g Sanguis Draxonis 30g Pyritum (forging) 20g
Radix Et Rhizoma Rhei (wine stir-fry) 20g
More than nine flavors, carry out the flushing coarse pulverization, cross 10 mesh sieves, pulverized 10 minutes in the vibration type super micron mill then, make ultra-fine pharmaceutical composition, add 1.3 times refined honey, make seven lis of small honey pills of synthetism or big honeyed pills.
Embodiment 2
Olibanum (stir-fry) 20g Myrrha (stir-fry) 20g Radix Angelicae Sinensis 30g Eupolyphaga Seu Steleophaga 50g
Rhizoma Drynariae (scalding) 30g Borax 20g Sanguis Draxonis 30g Pyritum (forging) 20g
Radix Et Rhizoma Rhei (wine stir-fry) 20g
More than nine flavors, carry out the flushing coarse pulverization, cross 10 mesh sieves, pulverized 80 minutes in the vibration type super micron mill then, make ultra-fine pharmaceutical composition, adds 0.6 times refined honey and suitable water, make seven lis of water-honeyed pills of synthetism.
Embodiment 3
Olibanum (stir-fry) 20g Myrrha (stir-fry) 20g Radix Angelicae Sinensis 30g Eupolyphaga Seu Steleophaga 50g
Rhizoma Drynariae (scalding) 30g Borax 20g Sanguis Draxonis 30g Pyritum (forging) 20g
Radix Et Rhizoma Rhei (wine stir-fry) 20g
More than nine the flavor, carry out the flushing coarse pulverization, cross 10 mesh sieves, add chitosan 5g, lecithin 5g, micropowder silica gel 10g and low-substituted hydroxypropyl cellulose 10g, pulverized 45 minutes in the vibration type super micron mill, make ultra-fine pharmaceutical composition, add 1.2 times refined honey, make seven lis of small honey pills of synthetism or big honeyed pills.
Embodiment 4
Olibanum (stir-fry) 20g Myrrha (stir-fry) 20g Radix Angelicae Sinensis 30g Eupolyphaga Seu Steleophaga 50g
Rhizoma Drynariae (scalding) 30g Borax 20g Sanguis Draxonis 30g Pyritum (forging) 20g
Radix Et Rhizoma Rhei (wine stir-fry) 20g
More than nine flavors, carry out the flushing coarse pulverization, cross 10 mesh sieves, add carbomer 5g, lecithin 5g, microcrystalline Cellulose 20g and carboxymethyl starch sodium 5g, pulverized 30 minutes, make ultra-fine pharmaceutical composition in the vibration type super micron mill, the refined honey that adds 1.0 times makes seven lis of small honey pills of synthetism or big honeyed pills.
Embodiment 5
Olibanum (stir-fry) 20g Myrrha (stir-fry) 20g Radix Angelicae Sinensis 30g Eupolyphaga Seu Steleophaga 50g
Rhizoma Drynariae (scalding) 30g Borax 20g Sanguis Draxonis 30g Pyritum (forging) 20g
Radix Et Rhizoma Rhei (wine stir-fry) 20g
More than nine the flavor, carry out the flushing coarse pulverization, cross 10 mesh sieves, and add polyvinylpyrrolidone 8g, poloxamer 5g, dextrin 25g and low-substituted hydroxypropyl cellulose 10g, pulverized 60 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 seven lis of capsules of synthetism.
Embodiment 6
Olibanum (stir-fry) 20g Myrrha (stir-fry) 20g Radix Angelicae Sinensis 30g Eupolyphaga Seu Steleophaga 50g
Rhizoma Drynariae (scalding) 30g Borax 20g Sanguis Draxonis 30g Pyritum (forging) 20g
Radix Et Rhizoma Rhei (wine stir-fry) 20g
More than nine the flavor, carry out the flushing coarse pulverization, cross 10 mesh sieves, and add chitosan 7g, poloxamer 5g, dextrin 15g, micropowder silica gel 10g and low-substituted hydroxypropyl cellulose 10g, pulverized 40 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 JIEGU QILI PIAN agent.
Claims (8)
1, a kind of bone-setting anti-bruise powder preparation that adopts superfine communication technique to make.
2, bone-setting anti-bruise powder 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, bone-setting anti-bruise powder 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, bone-setting anti-bruise powder preparation according to claim 3 is characterized in that the pharmaceutical adjunct among the method b comprises wetting agent, dispersant.
5, bone-setting anti-bruise powder preparation according to claim 4 is characterized in that pharmaceutical adjunct also comprises bioadhesive polymer, efficient disintegrating agent.
6, bone-setting anti-bruise powder 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, bone-setting anti-bruise powder 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 bone-setting anti-bruise powder preparation of claim 1 to 7 is characterized in that it can being following any method:
A, get 2 parts of Olibanum (parched)s, 2 parts of Myrrha (parched), 3 parts of Radix Angelicae Sinensis, 5 parts of Eupolyphaga Seu Steleophagas, 3 parts of Rhizoma drynariae preparatas, 2 parts of Boraxs, 3 parts of Sanguis Draxonis, 2 parts of Pyritum (calcined)s, 2 parts of Radix et Rhizoma Rhei (parched with wine) 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;
B, get 2 parts of Olibanum (parched)s, 2 parts of Myrrha (parched), 3 parts of Radix Angelicae Sinensis, 5 parts of Eupolyphaga Seu Steleophagas, 3 parts of Rhizoma drynariae preparatas, 2 parts of Boraxs, 3 parts of Sanguis Draxonis, 2 parts of Pyritum (calcined)s, 2 parts of Radix et Rhizoma Rhei (parched with wine) are ground into coarse powder, add 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.
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| CNA2008101051679A CN101564481A (en) | 2008-04-25 | 2008-04-25 | Bone-setting anti-bruise powder preparation and preparation method thereof |
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|---|---|---|---|
| CNA2008101051679A CN101564481A (en) | 2008-04-25 | 2008-04-25 | Bone-setting anti-bruise powder preparation and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973757A (en) * | 2012-12-27 | 2013-03-20 | 王绪友 | Compound traditional Chinese medicine for treating fracture and preparation method thereof |
-
2008
- 2008-04-25 CN CNA2008101051679A patent/CN101564481A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973757A (en) * | 2012-12-27 | 2013-03-20 | 王绪友 | Compound traditional Chinese medicine for treating fracture and preparation method thereof |
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Open date: 20091028 |