CN104161734B - A kind of amoxicillin dispersible tablet, Preparation Method And The Use - Google Patents
A kind of amoxicillin dispersible tablet, Preparation Method And The Use Download PDFInfo
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- CN104161734B CN104161734B CN201410446830.7A CN201410446830A CN104161734B CN 104161734 B CN104161734 B CN 104161734B CN 201410446830 A CN201410446830 A CN 201410446830A CN 104161734 B CN104161734 B CN 104161734B
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
The present invention provides a kind of amoxicillin dispersible tablet, Preparation Method And The Use.The preparation of the present invention prepares amoxicillin dispersible tablet using direct powder compression, needs not move through soft material processed, granulation, drying and other steps, directly carries out dry powder sheeting；Its production process is few, and equipment is simple, cycle is short, impact of the humiture to product quality, stability is avoided to be improved, while the disintegration time of the amoxicillin dispersible tablet for according to said method preparing is short, dissolution homogeneity is good, so that drug effect is fast, absorb fast, by increasing capacitance it is possible to increase its bioavailability.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of amoxicillin dispersible tablet, Preparation Method And The Use.
Background technology
Amoxicillin (Amoxicillin), also known as be amoxicillin, it is the semi-synthetic wide spectrum of the third generation, acidproof green grass or young crops
Mycin, to Streptococcus such as streptococcus pneumoniae, Hemolytic streptococcuss, not produce penicillinase staphylococcuses, enterococcus faecalis etc. aerobic
The aerobic leather such as gram positive coccus, escherichia coli, proteus mirabilises, Salmonella, hemophilus influenza, Diplococcus gonorrhoeae
Blue negative bacterium do not produce beta lactamase bacterial strain and helicobacter pylori is respectively provided with good antibacterial activity.Amoxicillin is by suppressing
The synthesis of bacteria cell wall, is allowed to rapidly become spherical and rupture dissolving, so as to play bactericidal action.The amoxicillin side of taking
Just, good effect, untoward reaction are few, safe, be current Clinical practice at most, range of application most wide, the best antibiotic of curative effect
One of kind.
Amoxicillin, entitled (2S, 5R, 6R) -3,3- dimethyl -6- of its chemistry [(R)-(-) -2- amino -2- (4- hydroxyls
Phenyl) acetylamino] -7- oxo -4- thia -1- azabicyclos [3.2.0] heptane -2- formic acid trihydrates.Its chemical constitution
Formula is：
Molecular formula：C16H19N3O5S·3H2O
Molecular weight：419.46
Amoxicillin dispersible tablet is the novel troche prepared as crude drug with amoxicillin, and meeting water disintegrate can form rapidly
Uniform suspension, it is poor so as to solve the problems, such as amoxicillin dissolubility in water, be conducive to organizing quick absorption, have
Gastrointestinal tract rate is high, the low feature of side reaction.Amoxicillin dispersible tablet in the market adopts traditional processing technology mostly,
Wet granulation is carried out initially with suitable binding agent, granule re-compacted piece agent after drying.And amoxicillin raw material is to wet
Heat is very sensitive, and traditional wet granulation production technology produces impact to product quality, and content declines substantially, and relevant material is especially
It is that macromolecule impurity increases significantly, product stability is poor.And there are some researches show, amoxicillin self-polymerization forms different polymerizations
The mixture of degree, is to cause anaphylactoid main cause.Macromolecule impurity content in control Wymox, is to reduce
Penicillin antibiotics anaphylaxiss, the fundamental way for improving drug safety.
Direct powder compression refers to and the mixture of medicine and adjuvant is carried out the side of tabletting directly without pelletization
Method.Direct powder compression avoids pelletization, thus can time-saving energy-saving, simple process, operation it is few, suitable for damp and hot shakiness
The outstanding advantages such as fixed medicine, but there is also that powder flowbility is poor, tablet weight variation big, it is weak that pressed powder easily causes sliver etc.
Point, has that powder flowbility is poor, tablet weight variation big, and pressed powder easily causes the weakness such as sliver.Therefore to active component, adjuvant
Species and consumption are very fastidious.
The content of the invention
To contribute to understanding the present invention, some terms are defined below.Unless otherwise indicated, the term tool for occurring herein
The implication that the those of ordinary skill for having relevant art is generally understood that.Specifically：
Unless otherwise noted, " amoxicillin " specifically described herein or " amoxicillin active compound ", refers to that chemistry is entitled as follows
Compound：(2S, 5R, 6R) -3,3- dimethyl -6- [(R)-(-) -2- amino -2- (4- hydroxy phenyls) acetylamino] -7- oxygen
Generation -4- thia -1- azabicyclos [3.2.0] heptane -2- formic acid trihydrates.
Unless otherwise noted, " carboxymethyl starch sodium " specifically described herein (CMS-Na), is also called carboxymethyl starch, refers to
A kind of anion starch ether, molecular formula：[C6H7O2(OH)2OCH2COONa]n, white or yellow powder, odorless, it is tasteless, nontoxic,
The hot easily moisture absorption.
Unless otherwise noted, " aspartame " specifically described herein, i.e. aspartame, molecular formula：C14H18N2O5, Mr=
294.30, it is a kind of artificial sweetener of non-carbohydrate class.Call as aspartame, APM, Canderel etc..
Unless otherwise noted, " direct powder compression " specifically described herein, refers to without pelletization directly medicine
The method that the mixture of thing and adjuvant carries out tabletting.Its technological process is as follows：
Medicine+adjuvant → crush → sieve → mix → (plus lubricant) mixing → tabletting.
For amoxicillin dissolubility is low, mobility and less stable, easily decompose the problem for producing high sensitization impurity, powder
There is the shortcomings of powder flowbility is poor, tablet weight variation big, and pressed powder easily causes sliver, the present inventor again in last direct compression process
By substantial amounts of experimental study, active component, the species of adjuvant and consumption are screened, have obtained mixed material good
Mobility well, compressibility and lubricity, can meet the requirement of direct compression, while shortening the production cycle, improve industry automatically
Change degree, greatly improves labor productivity, reduces production cost, reduces quality unstable factor in the medicine course of processing, it is ensured that
Product quality.
Therefore, it is an object of the present invention to provide a kind of stable amoxicillin dispersible tablet.Another mesh of the present invention
The preparation method for being to provide aforementioned amoxicillin dispersible tablet.It is a further object to provide aforementioned amoxicillin dispersion
The purposes of piece.
The purpose of the present invention is achieved through the following technical solutions：
On the one hand, the present invention provides a kind of stable amoxicillin dispersible tablet, the dispersible tablet by amoxicillin active compound and
Pharmaceutical carrier is made using direct powder compression, and described pharmaceutical carrier includes disintegrating agent, diluent and fluidizer, wherein Ah
Amdinocillin active compound is 1 with the weight ratio of pharmaceutical carrier:0.5-2, also, the diluent is Anhydrous Lactose or Microcrystalline Cellulose,
The disintegrating agent is carboxymethyl starch sodium.
Preferably, according to foregoing amoxicillin dispersible tablet, when the diluent is Microcrystalline Cellulose, which is at least also
Including a kind of filler with taste masking function.
It is further preferred that according to foregoing amoxicillin dispersible tablet, the filler with taste masking function is
Aspartame.
It is highly preferred that according to foregoing amoxicillin dispersible tablet, the fluidizer is magnesium stearate and/or micropowder silicon
Glue.
It is further preferred that according to foregoing amoxicillin dispersible tablet, diluent, disintegrating agent in the pharmaceutical carrier
Weight proportion relation with lubricant is：Anhydrous Lactose or Microcrystalline Cellulose are 10～20 parts, and carboxymethyl starch sodium is 2～5 parts,
Micropowder silica gel and/or magnesium stearate are 0.5～1 part.
It is highly preferred that according to foregoing amoxicillin dispersible tablet, in the dispersible tablet, amoxicillin active compound and described
The weight proportion relation of pharmaceutical carrier is：10～30 parts of 25 parts of amoxicillin, diluent Anhydrous Lactose or Microcrystalline Cellulose, disintegrate
2～8 parts of agent carboxymethyl Starch Sodium, fluidizer micropowder silica gel and/or magnesium stearate are 0.2～2 part.
On the other hand, the present invention provides the preparation method of aforesaid amoxicillin dispersible tablet, and methods described includes following step
Suddenly：
(1) amoxicillin active compound is crossed into standby after 80 mesh sieves；
(2) diluent and disintegrating agent are weighed respectively by the proportioning, be put into premixing in mixer, pulverize and sieve；
(3) above-mentioned two steps resulting material is placed in mixer, adds micropowder silica gel and magnesium stearate, fully mix；
With
(4) by step (3) resulting material direct compression, obtain final product the amoxicillin dispersible tablet.
Further aspect, the present invention provide aforementioned amoxicillin dispersible tablet and are preparing for reducing Penicillin antibiotics allergy
Purposes in the antibacterials of reaction.
Preferably, the purposes according to foregoing amoxicillin dispersible tablet, described antibacterials are to streptococcus, no
Produce penicillinase staphylococcuses, aerobic gram positive coccus, aerobic gram-negative bacteria does not produce beta lactamase bacterial strain and/or deep and remote
The antibacterials of Helicobacter pylori.
It is highly preferred that according to the purposes of foregoing amoxicillin dispersible tablet, the streptococcus include：Streptococcus pneumoniae
And Hemolytic streptococcuss；The penicillinase staphylococcuses of not producing include：Enterococcus faecalis；And/or the aerobic gram-negative bacteria
The beta lactamase bacterial strain that do not produce include：How are escherichia coli, proteus mirabilises, Salmonella, hemophilus influenza and gonorrhea
Plucked instrument bacterium.
A technical scheme of the invention, a kind of its pharmaceutical composition of amoxicillin dispersible tablet of offer, the dispersion
Piece is made up of amoxicillin crude drug and pharmaceutical carrier, and described pharmaceutical carrier includes disintegrating agent, diluent and fluidizer, and can
Selectively add sweeting agent and aromatic, wherein amoxicillin active compound and the weight ratio of pharmaceutical carrier are 1:0.5-2.
Preferably, the disintegrating agent is carboxymethyl starch sodium.
The diluent at least includes a kind of filler with taste masking function；It is highly preferred that described with taste masking function
Filler be Anhydrous Lactose or aspartame.
The fluidizer is magnesium stearate or micropowder silica gel.
The present invention still further provides the preparation method of above-mentioned amoxicillin dispersible tablet, comprise the following steps：
(1) amoxicillin raw material is crossed into standby after 80 mesh sieves；
(2) diluent and disintegrating agent are weighed respectively by the proportioning, be put into premixing in CH200 mixers, pulverize and sieve；
(3) above-mentioned two steps resulting material is put in V-Mixer, adds micropowder silica gel and magnesium stearate, fully mix；
(4) by (3) resulting material direct compression, obtain amoxicillin dispersible tablet.
The composition of prescription used in amoxicillin dispersible tablet of the present invention, amoxicillin is 25 parts, diluent anhydrous lactitol
Sugar or Microcrystalline Cellulose are 10～30 parts, and disintegrating agent carboxymethyl base Starch Sodium is 2～8 parts, lubricant or fluidizer be micropowder silica gel,
Magnesium stearate is 0.2～2 part.Preferably, the proportioning of three kinds of adjuvants is：Lactose or Microcrystalline Cellulose are 10～20 parts, carboxymethyl
Starch Sodium is 2～5 parts, and micropowder silica gel, magnesium stearate are 0.5～1 part.
Studied by lot of experiments, selection carboxymethyl starch sodium is its disintegrating agent, in prescription, also selected crystallite fine in addition
Dimension element or Lactose, and the micropowder silica gel of proper proportion is to improve the dissolution of amoxicillin, in addition, the addition of magnesium stearate, can
Sticking phenomenon is efficiently solved, unilateral smooth and beautiful appearance is made, the mouthfeel of addition sweeting agent that can also be appropriate and aromatic increase medicine.
The consumption of excipient is determined again according to the content and piece of principal agent in per piece, with reference to the equipment situation in oral formulations workshop, selects to close
Suitable supplementary product consumption, makes preparation technology accomplish science, reasonable, feasible, make imitated medicine reached safely, effectively, it is controllable
With it is stable.
The preparation method is that amoxicillin dispersible tablet is prepared using direct powder compression, need not move through system soft
Material, granulation, drying and other steps, directly carry out dry powder sheeting；Its production process is few, and equipment is simple, cycle is short, it is to avoid humiture pair
The impact of product quality, stability are improved, while the disintegration time of the amoxicillin dispersible tablet for according to said method preparing is short, it is molten
Go out homogeneity good, so that drug effect is fast, absorb fast, by increasing capacitance it is possible to increase its bioavailability.
The present invention with the addition of correctivess in prescription, covers the bitterness of amoxicillin dispersible tablet, improves patient and take Ah not
The mouthfeel of XiLin dispersible tablet.
Description of the drawings
Hereinafter, with reference to accompanying drawing describing embodiment of the present invention in detail, wherein：
Fig. 1 shows the In Vitro Dissolution testing inspection result of the amoxicillin dispersible tablet of embodiment 1.
Specific embodiment
With reference to specific embodiment, and with reference to the figures above and specific experiment data this to be described in further detail
It is bright.It should be appreciated that these embodiments are of the invention solely for the purpose of illustration, rather than the scope of invention is limited by any way.
Below in an example, the various processes and method not described in detail are conventional methods as known in the art.
The source of agents useful for same, trade name and it is necessary to list its constituent person, indicates when occurring first, thereafter phase used
With reagent if no special instructions, it is identical with the content indicated first.
Embodiment 1
Prescription：
Preparation method：
(1) amoxicillin raw material pulverizing is crossed into 80 mesh sieves；
(2) Anhydrous Lactose and polyvinylpolypyrrolidone are distinguished by above-mentioned prescription, mix 30 minutes, cross 80 in being put into CH200 mixers
Mesh sieve；
(3) above-mentioned two steps resulting material is put in V-Mixer, add recipe quantity micropowder silica gel and magnesium stearate, mixing
30 minutes, material is made fully to mix；
Will the (3) mixed material direct compression of gained, amoxicillin tablets dispersible tablet is obtained, specification is every 0.25g.
Embodiment 2
Prescription：
Preparation method：
(1) amoxicillin raw material pulverizing is crossed into 80 mesh sieves；
(2), by above-mentioned prescription difference Microcrystalline Cellulose, carboxymethyl starch sodium and aspartame, mix in being put into CH200 mixers
Close 30 minutes, cross 80 mesh sieves；
(3) above-mentioned two steps resulting material is put in V-Mixer, add recipe quantity micropowder silica gel and magnesium stearate, mixing
30 minutes, material is made fully to mix；
Will the (3) mixed material direct compression of gained, amoxicillin tablets dispersible tablet is obtained, specification is every 0.25g.
Embodiment 3
Prescription：
Preparation method：
(1) amoxicillin raw material pulverizing is crossed into 80 mesh sieves；
(2), by above-mentioned prescription difference Microcrystalline Cellulose, polyvinylpolypyrrolidone and aspartame, mix in being put into CH200 mixers
30 minutes, cross 80 mesh sieves；
(3) above-mentioned two steps resulting material is put in V-Mixer, add recipe quantity micropowder silica gel and magnesium stearate, mixing
30 minutes, material is made fully to mix；
Will the (3) mixed material direct compression of gained, amoxicillin tablets dispersible tablet is obtained, specification is every 0.25g.
Embodiment 4
The present embodiment carries out quality testing to the amoxicillin dispersible tablet obtained by embodiment 1～3, the results are shown in Table 1.
1 embodiment of table, 1～3 amoxicillin dispersible tablet quality measurements
As shown in Table 1, as a result show, preferably, dispersion is equal for the dissolution of the amoxicillin dispersible tablet obtained by embodiment 1-3
Evenness is less, illustrate medicine can rapid disintegrate, can make that drug effect is fast, absorb fast, bioavailability can be increased.
Embodiment 5
Amoxicillin dispersible tablet (dry powder direct tabletting) and traditional wet granule compression tablet method of the present embodiment to embodiment 1
(130601) Haikou Pharmaceutical Factory Co., Ltd., lot number are compared the amoxicillin dispersible tablet of preparation.As a result see table 2 below.
Impact of 2 preparation process of table to amoxicillin dispersible tablet quality
Result above shows that Jing is contrasted with wet granule compression tablet, is disperseed using the amoxicillin obtained by dry powder direct tabletting
Tablet quality is significantly better than wet granule compression tablet；And the yield rate of sample also has significance difference obtained by two kinds of different preparation methoies
Not, dry powder direct tabletting and wet granule compression tablet are obtained sample yield rate and are respectively 89.6% and 64.3%；So the present invention
The drug loss amount of the amoxicillin dispersible tablet prepared by dry powder direct tabletting has significantly to be reduced.
Embodiment 6
The present embodiment is measured to the Dissolution profiles of the amoxicillin dispersible tablet of embodiment 1, as a result such as table 3 below and
Shown in accompanying drawing 1.
The Dissolution profiles measurement result of the amoxicillin dispersible tablet sample of 3 embodiment 1 of table
| Time | 5min | 10min | 15min | 30min | 45min | 60min |
| Dissolution rate (%) | 71.5 | 83.4 | 90.7 | 99.9 | 99.8 | 99.9 |
As shown in upper table 3 and accompanying drawing 1, as a result show, prepared by the present invention, amoxicillin dispersible tablet sample is in 30 minutes
80% is all higher than, conformance with standard is required.
One of ordinary skill in the art should be appreciated that all embodiments disclosed in this invention are only to illustrate the present invention's
Technical scheme, its parameter can have been changed according to the operating practice of this area, but have no effect on invention involved in the present invention
Design, therefore cannot be used for limiting claim involved in the present invention.
Claims (8)
1. a kind of stable amoxicillin dispersible tablet, it is characterised in that the dispersible tablet is by amoxicillin active compound and pharmaceutical carrier
Made using direct powder compression, described pharmaceutical carrier includes disintegrating agent, diluent and fluidizer, wherein amoxicillin is former
Medicine is 1 with the weight ratio of pharmaceutical carrier:0.5-2；Also, the diluent is Anhydrous Lactose or Microcrystalline Cellulose, the disintegrate
Agent is carboxymethyl starch sodium, and the fluidizer is magnesium stearate and/or micropowder silica gel；Also, the Anhydrous Lactose is described micro-
Crystalline cellulose is 10～20 parts, and the carboxymethyl starch sodium is 2～5 parts, and the micropowder silica gel and/or the magnesium stearate are
0.5～1 part.
2. amoxicillin dispersible tablet according to claim 1, it is characterised in that when the diluent is Microcrystalline Cellulose,
Which at least also includes a kind of filler with taste masking function.
3. amoxicillin dispersible tablet according to claim 2, it is characterised in that the filler with taste masking function is
Aspartame.
4. the amoxicillin dispersible tablet according to any one of claim 1-3, it is characterised in that in the dispersible tablet, Ah
The weight proportion relation of Amdinocillin active compound and the pharmaceutical carrier is：25 parts of amoxicillin, diluent Anhydrous Lactose or crystallite are fine
10～20 parts of dimension element, 2～5 parts of disintegrating agent carboxymethyl base Starch Sodium, fluidizer micropowder silica gel and/or magnesium stearate are 0.5～1 part.
5. the preparation method according to the amoxicillin dispersible tablet described in claim 1 or 4, it is characterised in that methods described bag
Include following steps：
(1) amoxicillin active compound is crossed into standby after 80 mesh sieves；
(2) diluent and disintegrating agent are weighed respectively by the proportioning, be put into premixing in mixer, pulverize and sieve；
(3) above-mentioned two steps resulting material is placed in mixer, adds micropowder silica gel and magnesium stearate, fully mix；With
(4) by step (3) resulting material direct compression, obtain final product the amoxicillin dispersible tablet.
6. the amoxicillin dispersible tablet according to any one of claim 1-4 is being prepared for reducing Penicillin antibiotics
Purposes in anaphylactoid antibacterials.
7. purposes according to claim 6, it is characterised in that described antibacterials are to streptococcus, do not produce penicillin
Enzyme staphylococcuses, aerobic gram positive coccus, aerobic gram-negative bacteria do not produce beta lactamase bacterial strain and/or helicobacter pylori
Antibacterials.
8. purposes according to claim 7, it is characterised in that：
The streptococcus include：Streptococcus pneumoniae and Hemolytic streptococcuss；
The penicillinase staphylococcuses of not producing include：Enterococcus faecalis；And/or
The beta lactamase bacterial strain that do not produce of the aerobic gram-negative bacteria includes：Escherichia coli, proteus mirabilises, salmonella
Category, hemophilus influenza and Diplococcus gonorrhoeae.
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| CN104758264A (en) * | 2015-04-27 | 2015-07-08 | 四川制药制剂有限公司 | Process for preparing amoxicillin dispersible tablet |
| CN107019677A (en) * | 2017-04-26 | 2017-08-08 | 四川制药制剂有限公司 | The preparation method of amoxicillin dispersible tablet |
| CN109432027B (en) * | 2019-01-16 | 2020-11-24 | 四川制药制剂有限公司 | Preparation process of amoxicillin dispersible tablets |
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| CN101332196A (en) * | 2007-06-28 | 2008-12-31 | 上海华氏制药有限公司 | Amoxicillin/clavulanate potassium dispersible tablets and preparation method thereof |
| CN101524333B (en) * | 2008-03-04 | 2011-11-30 | 华北制药股份有限公司 | Amoxicillin dispersible tablet and production method thereof |
| CN103006589B (en) * | 2011-09-27 | 2015-11-25 | 闫亚梅 | Amoxicillin dispersible tablet and production method thereof |
| CN103145733B (en) * | 2013-03-20 | 2014-02-26 | 四川省惠达药业有限公司 | Amoxicillin compound and pharmaceutical composition of amoxicillin compound and potassium clavulanate |
| CN103768056B (en) * | 2014-01-21 | 2015-01-07 | 东药集团沈阳施德药业有限公司 | Amoxicillin and clavulanate potassium dispersible tablet |
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