CN103768026A - Water-soluble micro-powder containing amoxicillin and preparation method thereof - Google Patents
Water-soluble micro-powder containing amoxicillin and preparation method thereof Download PDFInfo
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- CN103768026A CN103768026A CN201410053991.XA CN201410053991A CN103768026A CN 103768026 A CN103768026 A CN 103768026A CN 201410053991 A CN201410053991 A CN 201410053991A CN 103768026 A CN103768026 A CN 103768026A
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Abstract
The invention relates to the field of veterinary medicinal products, and in particular relates to water-soluble micro-powder containing amoxicillin. The micro-powder comprises amoxicillin, piperine, PVPK30 (polyvinylpyrrolidone K30), SDS (sodium dodecyl sulfonate) and mannitol. The preparation method adopts a micro-micronization technology and comprises the following steps: mixing the amoxicillin, the piperine, the PVP K30 and the SDS; crushing the mixture with an ultrafine grinder to obtain fine powder with grain diameter of 500-1,000 meshes (16-25mu m), adding the mannitol, and uniformly mixing. The water-soluble compound amoxicillin micro-powder can be prepared from the micro-powder and other medicines. The amoxicillin prepared by adopting the method is finer and uniform in granularity, increased in surface area, enlarged in porosity and strengthened in adsorbability and solubility, can be well dispersed and dissolved in gastric juice to increase the contact area with gastric mucosa, so that the amoxicillin can be absorbed by gastrointestinal tracts more easily, and the solubility of amoxicillin can be increased; the preparation process is simpler than an enveloping process, easy to operate and more suitable for large-scale production.
Description
Technical field
The present invention relates to veterinary drug goods field, particularly a kind of water-soluble micropowder that contains amoxicillin and preparation method thereof.
Background technology
Amoxicillin is the semi-synthetic acidproof penbritin class antibiotic of a new generation.The basic structure that amoxicillin antibacterial activity plays a major role is the β-Nei phthalein amine ring (meeting alkali unstable) in 6-amino-penicillanic acid, it in specific manner the penicillin-binding protein on antibacterial inner membrance be combined, and then suppress the activity of the mucopeptide synzyme of bacteria cell wall, small peptide just cannot be transformed into chain structure like this, the unique channel that antibacterial is built cell wall is cut off, antibacterial just cannot continue cellulation wall in the time of propagation, thereby cause cell wall defective, cell can not be shaped and be become spheroid, spheroid is difficult to bear intracellular hyperosmosis, cause thalline expansion cracking and death.Amoxicillin all has powerful antibacterial and sterilization to use to most of pathogenic G+ bacterium and G-bacterium (comprising coccus and bacillus), wherein to the Streptococcus such as streptococcus pneumoniae, Hemolytic streptococcus, do not produce the aerobic gram positive coccus such as penicillinase staphylococcus, enterococcus faecalis, the aerobic gram-negative bacterias such as escherichia coli, proteus mirabilis, Salmonella, hemophilus influenza, Diplococcus gonorrhoeae do not produce beta lactamase bacterial strain and helicobacter pylori has good antibacterial activity;
Amoxicillin is white or off-white color crystalline powder, mildly bitter flavor, and stable under acid condition, gastrointestinal absorption rate reaches 90%, and is not subject to most foods impact.Amoxicillin bactericidal action is strong, and the ability of permeates cell membranes is also strong, is one of current widely used oral penicillin, and its preparation has capsule, tablet, granule, dispersible tablet etc.This product is slightly soluble in water, and under room temperature, dissolubility is 0.4%, almost insoluble in ethanol.Poor dissolubility has determined that the dissolution of its capsule preparations is poor, solves its dissolution problem, becomes the difficult problem that Wymox faces at present.Nowadays most amoxicillin is all to adopt with clavulanate potassium to be used in conjunction with.Clavulanate potassium can improve the antibacterial activity of amoxicillin and the penetration capacity of cell membrane, but clavulanate potassium has and draws by force moistly, very easily decomposes poor stability, and higher to manufacturing technique requirent, length consuming time;
Air-flow micronizing is the one of superfine communication technique, amoxicillin can be processed into the even nano level micropowder of micron, increases its dissolubility.It is to utilize material under the effect of high velocity air, obtain huge energy, in pulverizing chamber, cause high velocity impact, acutely friction between material particles, high velocity air produces shear action to material simultaneously, thereby reach the object of comminuting matter, it can become Raw material processing superfine fine powder, and this technology is mainly used in Chinese medicine aspect at present, seldom this technology is applied to chemical drugs or Western medicine aspect, improves the defect that pharmaceutical preparation exists;
Piperine is active chemistry main in Fructus Piperis, belongs to Cortex cinnamomi japonici (Ramulus Cinnamomi) phthalein amine alkaloid.Be widespread in nature, especially in Piperaceae plant, exist in a large number.At present, found that piperine has antioxidation, immunomodulating, antitumor, promotion drug metabolism, strengthens the effects such as bioavailability.In numerous research, piperine more and more causes people's attention as the application of bioavailability reinforcing agent.The intestines and stomach that it can improve plurality of Chinese, Western medicine, vitamin, aminoacid, mineral etc. absorbs, increases blood drug level, improves bioavailability.
Summary of the invention
The object of this invention is to provide a kind of water-soluble micropowder that contains amoxicillin, solve the poor problem of dissolution of amoxicillin, and then increase amoxicillin in the absorption in gastrointestinal tract, strengthen the therapeutic effect of amoxicillin.Amoxicillin is processed into the even nano level micropowder of micron by this invention, its granularity of amoxicillin that adopts the method to make is trickleer, even, surface area increases, porosity increases, adsorptivity and dissolubility strengthen, and can disperse preferably, be dissolved in gastric juice, increase the contact area with gastric mucosa, thereby more easily by gastrointestinal absorption, greatly improve the dissolution of amoxicillin; In addition, the present invention also provides a kind of preparation method of the water-soluble micropowder that contains amoxicillin, adopts the preparation technology of the method simpler than coated technique, and easily operation, is more suitable for large-scale production.
The object of the invention is to realize by the following technical solutions:
A water-soluble micropowder that contains amoxicillin, is made up of amoxicillin, piperine, PVP K30, SDS and mannitol.
Preferred version of the present invention is: a kind of water-soluble micropowder that contains amoxicillin, it is characterized in that, and in described micropowder, amoxicillin 10-20%, piperine 0.02-1%, PVP K302.5-2.75%, SDS 2.5-
2.75%, all the other are mannitol.
PVP K30 chemical name is PVP K30, and white is to off-white powder, and odorless or slightly special smell, have hygroscopicity.This product is dissolved in water, ethanol, isopropyl alcohol or chloroform, insoluble in acetone or ether, and solution viscosity and water below 10% are basic identical.This product has characteristic and the effects such as bonding, thickening, suspending, dispersion, complexation, film forming, is used as thickening agent, suspending agent, dispersant, chelating agent etc. in medicament.
SDS chemical name is sodium lauryl sulphate, for white or yellowish crystallization thin slice or powder, has slight special smell, similar fat, bitter in the mouth, soluble in water, be partially soluble in ethanol, be insoluble to chloroform, ether and petroleum ether, critical micelle concentration (20 ℃) is 8.2 × 10
-3mol/L, relative density is 1.07, and hydrophile-lipophile balance value (HLB) is 40, and interfacial tension is 11.8Mn/m.This product is anion surfactant, has the effects such as emulsifying, de-sludging, dispersion, moistening, foaming, all effective in acid, alkaline solution and hard water.
Mannitol and sorbitol are isomerss.This product is white crystalline powder, and odorless has tasty and refreshing refrigerant sweet taste.The stable chemical nature of mannitol, under drying regime, can with most of preparation compatibilities, under the high condition of relative humidity, do not there is hygroscopicity, and have resistance to bond, compressibility strong, make the features such as material property is good.Therefore, mannitol is commonly used for the filler (10%-90%) of tablet, due to its no hygroscopicity, valuable especially for the medicine tabletting to moisture-sensitive, its granule is easily dry.Mannitol has complexing, so can also make antioxidation synergist.
PVP K30, SDS all play solubilising and hydrotropy effect in the present invention, and mannitol is filler.
The micropowder that the present invention contains amoxicillin, adopts piperine as bioavailability reinforcing agent, the blood drug level can significantly improve amoxicillin gastrointestinal administration time, thereby can reduce medicining times, and extend the interval of taking medicine, subtract
Treat less the medication accumulated dose of disease, reduce treatment cost, improve curative effect, greatly improved bioavailability.The present invention is applicable to the infection due to sensitive organism: the upper respiratory tract infection such as otitis media, sinusitis, tonsillitis; Urogenital infects; Skin soft-tissue infection; Lower respiratory infection.
The present invention to the preparation method of the above-mentioned water-soluble micropowder that contains amoxicillin is: above-mentioned micropowder is pulverized to such an extent that particle diameter is 500-1000 order fine powder with super micron mill.Concrete operation method is as follows: 1) by amoxicillin, piperine, PVP K30, SDS mix homogeneously; 2) mixture and dry air being injected to super micron mill jointly pulverizes to such an extent that particle diameter is 500-1000 object fine powder; 3) then in fine powder, add mannitol, mix homogeneously, obtains water-soluble micropowder.Gains can further be made various water solublity amoxicillin micropowders.
Above-mentioned preparation method, the grinding mode of employing is that high velocity air is pulverized, and equipment is CWJ-30 super micron mill, and pressure is 1.0-1.2MP, and temperature is≤50 ℃, grinding time is 30-40min.
According to water-soluble micropowder of above-mentioned amoxicillin, the present invention also provides a kind of water solublity amoxicillin micropowder, it is characterized in that, is mainly made up of amoxicillin, piperine, PVP K30, SDS.
The further technical scheme of the present invention is that a kind of water solublity amoxicillin micropowder, is made up of following raw material by weight percentage, amoxicillin 10%, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, quinolones 5%, mannitol 79.9%.By amoxicillin, piperine, PVP K30, SDS and quinolones mix homogeneously, mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powders.Then in fine powder, add mannitol, mix homogeneously.Described quinolones can be norfloxacin, ofloxacin, levofloxacin, pefloxacin, enoxacin, cinoxacin etc.This compound recipe, keeping, on the highly dissoluble of water-soluble micropowder and the basis of rate of release that contains amoxicillin, adding quinolones, plays the effect of Synergistic, and two kinds of anti-antibacterial activities of medicine are strengthened.
The further technical scheme of the present invention is that a kind of water solublity amoxicillin micropowder, is characterized in that, by heavy
Amount percentage ratio is made up of following raw material, amoxicillin 10%, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, bromhexine hydrochloride 5%, enrofloxacin sodium 7%, mannitol 72.9%.By amoxicillin, piperine, PVP K30, SDS and bromhexine hydrochloride, enrofloxacin sodium mix homogeneously, mixture and dry air are injected to super micron mill jointly to be pulverized to such an extent that particle diameter is 500-1000 object fine powder, then in fine powder, add mannitol, mix homogeneously.This compound recipe is keeping on the highly dissoluble of water-soluble micropowder and the basis of rate of release that contains amoxicillin, add bromhexine hydrochloride and enrofloxacin sodium, make it not only there is antibacterial functions, and there is function of relieving cough and calming asthma, accelerate the rehabilitation of respiratory tract infection.
The further technical scheme of the present invention is, a kind of water solublity amoxicillin micropowder, is characterized in that, made by following raw material by weight percentage, and amoxicillin 10%, piperine 0.1%, PVP K30 2.5%, SDS 2.5%,
Sulfamonomethoxine sodium 10%, doxycycline 5%, mannitol 69.9%.By amoxicillin, piperine, PVP K30, SDS and sulfamonomethoxine sodium, doxycycline mix homogeneously, mixture and dry air are injected to super micron mill jointly to be pulverized to such an extent that particle diameter is 500-1000 object fine powder, then in fine powder, add mannitol, mix homogeneously.This compound recipe, keeping, on the highly dissoluble of water-soluble micropowder and the basis of rate of release that contains amoxicillin, adding sulfamonomethoxine sodium and doxycycline, makes it not only have antibacterial functions, and can treat Eperythrozoon and the Toxoplasmosis of pig.
The further technical scheme of the present invention is that a kind of water solublity amoxicillin micropowder, is characterized in that, is made up by weight percentage of following raw material, amoxicillin 10%, PVP K30 2.5%, SDS 2.5%, gatifloxacin in human 5%, ambroxol hydrochloride 5%, mannitol 75%.By amoxicillin, piperine, PVP K30, SDS and gatifloxacin in human, ambroxol hydrochloride mix homogeneously, mixture and dry air are injected to super micron mill jointly to be pulverized to such an extent that particle diameter is 500-1000 object fine powder, then in fine powder, add mannitol, mix homogeneously.This compound recipe is keeping, on the highly dissoluble of water-soluble micropowder and the basis of rate of release that contains amoxicillin, adding gatifloxacin in human and ambroxol hydrochloride, has strengthened the antibacterial action of amoxicillin and the effect for the treatment of respiratory tract infection.
The further technical scheme of the present invention is that a kind of water solublity amoxicillin micropowder, is characterized in that, is made up by weight percentage amoxicillin 10%, PVP K30 2.5%, SDS 2.5%, berberine hydrochloride 10%, mannitol 75% of following raw material.By amoxicillin, piperine, PVP K30, SDS and berberine hydrochloride mix homogeneously, mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powder, then in fine powder, add mannitol, mix homogeneously.This compound recipe, keeping, on the highly dissoluble of water-soluble micropowder and the basis of rate of release that contains amoxicillin, having added berberine hydrochloride, has strengthened the therapeutic effect of amoxicillin to intestinal infection.
The invention has the beneficial effects as follows, the present invention adopts piperine as reinforcing agent, PVP K30, SDS are as surfactant, air-flow superfine communication technique is prepared the water-soluble micropowder that contains amoxicillin, make amoxicillin granularity reach micron level (500-1000 order, m), dissolubility is increased to more than 20% by original 0.4% 15-25 μ; And this preparation technology is simpler than coated technique, easily operation, is more suitable for large-scale production.
The specific embodiment
Below in conjunction with specific embodiment, the invention will be further described.
Embodiment 1:
As produce water-soluble micropowder that 100kg contains amoxicillin, 10kg amoxicillin, 0.02kg piperine, 2.5kg PVP K30,2.5kg SDS, mix homogeneously, injects super micron mill jointly by mixture and dry air, pulverize to such an extent that particle diameter is that 500-1000 object is thin, add the mannitol mix homogeneously of 84.98kg to make.
Suffer from the broiler of salmonellosis with the water-soluble micropowder treatment that contains amoxicillin in embodiment 1, test as follows:
1. experimental animal
Choose at random 90 of the broiler of suffering from salmonellosis, be divided at random 3 groups, 30 every group, body weight is at 1.5kg-2kg.
2, Experimental agents
Water-soluble micropowder that prepared by the embodiment of the present invention 1 contain amoxicillin;
Common amoxicillin powder: the amoxicillin that quality percentage composition is 10%, 90% starch mix homogeneously makes.
3, experimental technique
A group, for blank group, without medicine, is normally fed.
B group is treated with common amoxicillin powder, and the common amoxicillin powder spice of usage: 10g 10kg, one day twice, is used in conjunction 4.
Water-soluble micropowder that C group contains amoxicillin with the present invention, water-soluble micropowder spice 10kg that usage: 10g contains amoxicillin, one day twice, is used in conjunction 4.
After treatment starts, the sick fowl mental condition of every day entry and dead distribution, treat and add up therapeutic outcome after 4 days.
4, experimental result
Fail to respond to any medical treatment: refer to after 4 days, sick fowl symptom has the situation of increasing the weight of or death.
Treatment is effectively: refer to after 4 days, sick fowl symptom changes, and symptom is controlled or with respect to having obviously and alleviate before treatment.
Cure: refer to after 4 days, transference cure, the sick fowl mental status and feed intake are recovered normal condition.Its digital packets is contained in significant digits.
When end, have symptom: refer to treat after 4 days, sick fowl still has certain symptom, before its Symptoms is better than treatment or without change, sick fowl is not cured completely.Its numeral has been included in the numeral of invalid number of elements and effective number of elements.
Result of the test is as shown in table 1:
The each group of table 1 therapeutic effect statistics
5, conclusion:
From the result of the test statistical analysis of table 1, the present invention is containing extremely significantly (the P < 0.01) of water-soluble micropowder, 10% common amoxicillin powder group and matched group difference of 10% amoxicillin.The water-soluble amoxicillin of the present invention micropowder is better than the therapeutic effect of common amoxicillin powder.
Embodiment 2:
As produce water-soluble micropowder that 100kg contains amoxicillin, 12kg amoxicillin, 0.5kg piperine, 2.6kg PVP K30,2.6kg SDS, mix homogeneously, jointly injects super micron mill by mixture and dry air and pulverizes to such an extent that particle diameter is 500-1000 object fine powder, adds the mannitol mix homogeneously of 82.3kg to make.
Embodiment 3:
As produce 100kg water solublity amoxicillin micropowder, 10kg amoxicillin, 0.1kg piperine, 2.5kg PVP K30,2.5kg SDS, 5kg quinolones (ofloxacin), mix homogeneously; Mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powder, add the mannitol mix homogeneously of 79.9kg to make.
Embodiment 4:
As produce 100kg water solublity amoxicillin micropowder, 10kg amoxicillin, 0.1kg piperine, 2.5kg PVP K30,2.5kg SDS, 5kg bromhexine hydrochloride, 7kg enrofloxacin sodium, mix homogeneously; Mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powder, the mannitol mix homogeneously that adds 72.9kg is made.
Embodiment 5:
As produce 100kg water solublity amoxicillin micropowder, 10kg amoxicillin, 0.1kg piperine, 2.5kg PVP K30,2.5kg SDS, 10kg sulfamonomethoxine sodium, 5kg doxycycline, mix homogeneously; Mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powder, add the mannitol mix homogeneously of 69.9kg to make.
Embodiment 6:
As produce 100kg water solublity amoxicillin micropowder, 10kg amoxicillin, 0.1kg piperine, 2.5kg PVP K30,2.5kg SDS, 5kg gatifloxacin in human, 5kg ambroxol hydrochloride, mix homogeneously; Mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powder, add the mannitol mix homogeneously of 74.9kg to make.
Embodiment 7:
As produce 100kg water solublity amoxicillin micropowder, 10kg amoxicillin, 0.1kg piperine, 2.5kg PVP K30,2.5kg SDS, 10kg berberine hydrochloride, mix homogeneously; Mixture and dry air are injected to super micron mill jointly and pulverize to such an extent that particle diameter is 500-1000 object fine powder, add the mannitol mix homogeneously of 74.9kg to make.
Claims (10)
1. a water-soluble micropowder that contains amoxicillin, is characterized in that, is made up of amoxicillin, piperine, PVP K30, SDS, mannitol.
2. the water-soluble micropowder that contains amoxicillin according to claim 1, is characterized in that, in described micropowder, and amoxicillin 10-20%, piperine 0.02-1%, PVP K30 2.5-2.75%, SDS2.5-2.75%, all the other are mannitol.
3. the preparation method of the water-soluble micropowder that contains amoxicillin according to claim 1, is characterized in that, comprises the steps:
1) by amoxicillin, piperine, PVP K30, SDS mix homogeneously;
2) said mixture and dry air being injected to super micron mill jointly pulverizes to such an extent that particle diameter is 500-1000 object fine powder;
3) then in fine powder, add mannitol, mix homogeneously, obtains water-soluble micropowder.
4. preparation method according to claim 3, is characterized in that, described pulverizing is that high velocity air is pulverized, and pressure is 1.0-1.2MP, temperature≤50 ℃, and grinding time is 30-40min.
5. a water solublity amoxicillin micropowder, is characterized in that, is mainly made up of amoxicillin, piperine, PVP K30, SDS.
6. a kind of water solublity amoxicillin micropowder according to claim 5, is characterized in that, is made up by weight percentage amoxicillin 10%, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, quinolones 5%, mannitol 79.9% of following raw material.
7. a kind of water solublity amoxicillin micropowder according to claim 5, is characterized in that, is made up by weight percentage amoxicillin 10% of following raw material, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, bromhexine hydrochloride 5%, enrofloxacin sodium 7%, mannitol 72.9%.
8. a kind of water solublity amoxicillin micropowder according to claim 5, is characterized in that, is made up by weight percentage amoxicillin 10% of following raw material, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, sulfamonomethoxine sodium 10%, doxycycline 5%, mannitol 69.9%.
9. a kind of water solublity amoxicillin micropowder according to claim 5, is characterized in that, is made up by weight percentage amoxicillin 10% of following raw material, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, gatifloxacin in human 5%, ambroxol hydrochloride 5%, mannitol 74.9%.
10. a kind of water solublity amoxicillin micropowder according to claim 5, is characterized in that, is made up by weight percentage amoxicillin 10%, piperine 0.1%, PVP K30 2.5%, SDS 2.5%, berberine hydrochloride 10%, mannitol 74.9% of following raw material.
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| CN104398513A (en) * | 2014-09-12 | 2015-03-11 | 河南普瑞制药有限公司 | Medicinal composition for increasing dissolution rate of racanisodamine and preparation method thereof |
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| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN111686108A (en) * | 2020-07-09 | 2020-09-22 | 西南大学 | Application of epiberberine in preparation of anti-helicobacter pylori infection medicine |
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| CN103768026B (en) | 2015-06-17 |
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