CN104161734A - Amoxicillin dispersible tablet as well as preparation method and use thereof - Google Patents
Amoxicillin dispersible tablet as well as preparation method and use thereof Download PDFInfo
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- CN104161734A CN104161734A CN201410446830.7A CN201410446830A CN104161734A CN 104161734 A CN104161734 A CN 104161734A CN 201410446830 A CN201410446830 A CN 201410446830A CN 104161734 A CN104161734 A CN 104161734A
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- amoxicillin
- dispersible tablet
- amoxicillin dispersible
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Abstract
The invention provides an amoxicillin dispersible tablet as well as a preparation method and use thereof. The amoxicillin dispersible tablet is prepared by use of a direct powder compression method, and steps such as soft material preparation, pelletizing and drying are avoided, and dry powder compression is directly carried out; the preparation method of the amoxicillin dispersible tablet is less in production steps, simple in equipment and short in period; the influence of temperature and humidity on the product quality is avoided and the stability is improved; meanwhile, the amoxicillin dispersible tablet prepared by use of the method is short in disintegration time and good in dissolution homogeneity, so that the medicine is enabled to take effect quickly and can be absorbed effectively and the bioavailability of the medicine can be improved.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of amoxicillin dispersible tablet, Preparation Method And The Use.
Background technology
Amoxicillin (Amoxicillin), have another name called for amoxicillin, for the semi-synthetic wide spectrum of the third generation, acidproof penicillin, 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 all has good antibacterial activity.Amoxicillin is synthetic by anti-bacteria cell wall, makes it to become rapidly the spherical and dissolving of breaking, thereby plays bactericidal action.Amoxicillin taking convenience, good effect, untoward reaction is few, safe, be current clinical use at most, one of the widest, the best antibiotic kind of curative effect of range of application.
Amoxicillin, its chemistry (2S by name, 5R, 6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxy phenyl) acetylamino]-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-formic acid trihydrate.Its chemical structural formula is:
Molecular formula: C
16h
19n
3o
5s3H
2o
Molecular weight: 419.46
Amoxicillin dispersible tablet is the novel troche of preparing as crude drug taking amoxicillin, meet water disintegrate form uniform suspension rapidly, thereby solve the poor problem of amoxicillin dissolubility in water, be conducive to organize quick absorption, there is the features such as intestines and stomach absorbance is high, side reaction is low.Amoxicillin dispersible tablet in the market adopts traditional processing technology mostly, first adopts suitable binding agent to carry out wet granulation, and granule is pressed into tablet after drying again.And amoxicillin raw material is to damp and hot very responsive, traditional wet granulation production technology exerts an influence to product quality, and content declines obviously, and related substance especially macromolecule impurity increases significantly, and product stability is poor.There are some researches show, amoxicillin self-polymerization forms the mixture of different polymerization degree, is to cause anaphylactoid main cause.Controlling the macromolecule impurity content in Wymox, is the fundamental way that reduces Penicillin antibiotics anaphylaxis, improves drug safety.
Direct powder compression refers to the method for directly mixture of medicine and adjuvant being carried out to tabletting without pelletization.Direct powder compression has been avoided pelletization, thereby can time-saving energy-saving, simple process, operation be few, be applicable to the outstanding advantages such as damp and hot unsettled medicine, but also exist, powder flowbility is poor, tablet weight variation is large, pressed powder easily causes the weakness such as sliver, have that powder flowbility is poor, tablet weight variation is large, pressed powder easily causes the weakness such as sliver.Therefore the kind to active component, adjuvant and consumption are all very fastidious.
Summary of the invention
For contributing to understand the present invention, some terms are defined below.Unless otherwise indicated, the term occurring herein has the implication that those of ordinary skill in the related art of the present invention understand conventionally.Particularly:
Unless otherwise noted, described " amoxicillin " or " the former medicine in amoxicillin " herein, refer to chemistry following compound by name: (2S, 5R, 6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxy phenyl) acetylamino]-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-formic acid trihydrate.
Unless otherwise noted, described " carboxymethyl starch sodium " (CMS-Na), is called again carboxymethyl starch herein, refers to a kind of anion starch ether, molecular formula: [C
6h
7o
2(OH)
2oCH
2cOONa]
n, white or yellow powder, odorless, tasteless, nontoxic, the easily moisture absorption of heat.
Unless otherwise noted, described " aspartame " herein, i.e. aspartame, molecular formula: C
14h
18n
2o
5, M
r=294.30, be a kind of artificial sweetener of non-carbohydrate class.Another name is aspartame, APM, Canderel etc.
Unless otherwise noted, described " direct powder compression ", refers to the method for directly mixture of medicine and adjuvant being carried out to tabletting without pelletization herein.Its technological process is as follows:
Medicine+adjuvant → pulverizing → sieving → mixing → (adding lubricant) mixing → tabletting.
Low for amoxicillin dissolubility, mobility and less stable, easily decompose the problem that produces high sensitization impurity, direct powder compression exists again powder flowbility poor, tablet weight variation is large, pressed powder easily causes the shortcomings such as sliver, the inventor is by a large amount of experimental studies, to active component, kind and the consumption of adjuvant screen, make the mixed material making there is good mobility, compressibility and lubricity, can meet the requirement of direct compression, shorten the production cycle simultaneously, improve industrial automatization, greatly raise labour productivity, reduce production costs, reduce quality unstable factor in the medicine course of processing, ensure product quality.
Therefore, an object of the present invention is to provide a kind of stable amoxicillin dispersible tablet.Another object of the present invention is to provide the preparation method of aforementioned amoxicillin dispersible tablet.Another object of the present invention is to provide the purposes of aforementioned amoxicillin dispersible tablet.
The object of the invention is to be achieved through the following technical solutions:
On the one hand, the invention provides a kind of stable amoxicillin dispersible tablet, described dispersible tablet adopts direct powder compression to make by the former medicine in amoxicillin and pharmaceutical carrier, described pharmaceutical carrier comprises disintegrating agent, diluent and fluidizer, wherein the weight ratio of the former medicine in amoxicillin and pharmaceutical carrier is 1:0.5-2, and described diluent is Lactis Anhydrous or microcrystalline Cellulose, described disintegrating agent is carboxymethyl starch sodium.
Preferably, according to foregoing amoxicillin dispersible tablet, when described diluent is microcrystalline Cellulose, it at least also comprises a kind of filler with taste masking function.
Further preferably, according to foregoing amoxicillin dispersible tablet, described in there is taste masking function filler be aspartame.
More preferably, according to foregoing amoxicillin dispersible tablet, described fluidizer is magnesium stearate and/or micropowder silica gel.
Further preferably, according to foregoing amoxicillin dispersible tablet, in described pharmaceutical carrier, the weight proportion relation of diluent, disintegrating agent and lubricant is: Lactis Anhydrous or microcrystalline Cellulose are 10～20 parts, carboxymethyl starch sodium is 2～5 parts, and micropowder silica gel and/or magnesium stearate are 0.5～1 part.
More preferably, according to foregoing amoxicillin dispersible tablet, in described dispersible tablet, the weight proportion relation of the former medicine in amoxicillin and described pharmaceutical carrier is: 25 parts of amoxicillin, 10～30 parts of diluent Lactis Anhydrous or microcrystalline Cellulose, 2～8 parts of disintegrating agent carboxymethyl base Starch Sodium, fluidizer micropowder silica gel and/or magnesium stearate are 0.2～2 part.
On the other hand, the invention provides the preparation method of aforesaid amoxicillin dispersible tablet, said method comprising the steps of:
(1) former amoxicillin medicine is crossed after 80 mesh sieves for subsequent use;
(2) take respectively diluent and disintegrating agent by described proportioning, put into mixer premixing, pulverize and sieve;
(3) above-mentioned two step gained materials are placed in to mixer, add micropowder silica gel and magnesium stearate, fully mix; With
(4) by step (3) gained material direct compression, obtain described amoxicillin dispersible tablet.
Also on the one hand, the invention provides aforementioned amoxicillin dispersible tablet in the purposes for the preparation of reducing in the anaphylactoid antibacterials of Penicillin antibiotics.
Preferably, according to the purposes of foregoing amoxicillin dispersible tablet, described antibacterials for to streptococcus, do not produce penicillinase staphylococcus, aerobic gram positive coccus, the antibacterials of not producing beta lactamase bacterial strain and/or helicobacter pylori of aerobic gram-negative bacteria.
More preferably, according to the purposes of foregoing amoxicillin dispersible tablet, described streptococcus comprises: streptococcus pneumoniae and Hemolytic streptococcus; The described penicillinase staphylococcus of not producing comprises: enterococcus faecalis; And/or the beta lactamase bacterial strain that do not produce of described aerobic gram-negative bacteria comprises: escherichia coli, proteus mirabilis, Salmonella, hemophilus influenza and Diplococcus gonorrhoeae.
According to a technical scheme of the present invention, it provides a kind of pharmaceutical composition of amoxicillin dispersible tablet, this dispersible tablet is made up of amoxicillin crude drug and pharmaceutical carrier, described pharmaceutical carrier comprises disintegrating agent, diluent and fluidizer, and can add selectively sweeting agent and aromatic, wherein the weight ratio of the former medicine in amoxicillin and pharmaceutical carrier is 1:0.5-2.
As preferably, described disintegrating agent is carboxymethyl starch sodium.
Described diluent at least comprises a kind of filler with taste masking function; The filler more preferably, with taste masking function is Lactis Anhydrous or aspartame.
Described fluidizer is magnesium stearate or micropowder silica gel.
The present invention also provides the preparation method of above-mentioned amoxicillin dispersible tablet in addition, comprises the following steps:
(1) amoxicillin raw material is crossed after 80 mesh sieves for subsequent use;
(2) take respectively diluent and disintegrating agent by described proportioning, put into the premixing of CH200 mixer, pulverize and sieve;
(3) above-mentioned two step gained materials are put in V-Mixer, added micropowder silica gel and magnesium stearate, fully mix;
(4) by (3) gained 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 Lactis Anhydrous or microcrystalline Cellulose are 10～30 parts, and disintegrating agent carboxymethyl base Starch Sodium is 2～8 parts, and lubricant or fluidizer are that micropowder silica gel, magnesium stearate are 0.2～2 part.Preferably, the proportioning of three kinds of adjuvants is: lactose or microcrystalline Cellulose are 10～20 parts, and carboxymethyl starch sodium is 2～5 parts, and micropowder silica gel, magnesium stearate are 0.5～1 part.
Study by lot of experiments, selecting carboxymethyl starch sodium is its disintegrating agent, in prescription, microcrystalline Cellulose or lactose are also selected in addition, and the micropowder silica gel of proper proportion is to improve the stripping of amoxicillin, in addition, adding of magnesium stearate, can solve sticking phenomenon effectively, make unilateral smooth and beautiful appearance, interpolation sweeting agent that also can be suitable and aromatic increase the mouthfeel of medicine.According to the consumption of the content of every middle principal agent and the heavily definite excipient of sheet, the equipment situation in combined mouth formulation workshop, select suitable supplementary product consumption, make preparation technology accomplish science, reasonable, feasible, make imitated medicine reach safe, effective, controlled and stable.
Preparation method of the present invention is to adopt direct powder compression to prepare amoxicillin dispersible tablet, without through soft material processed, granulation, drying and other steps, directly carries out dry powder sheeting; Its production process is few, and equipment is simple, and the cycle is short, avoid the impact of humiture on product quality, stability is improved, and according to said method the disintegration time of the amoxicillin dispersible tablet of preparation is short simultaneously, stripping homogeneity is good, thus make drug effect fast, absorb soon, can increase its bioavailability.
The present invention has added correctives in prescription, covers the bitterness of amoxicillin dispersible tablet, improves patient and take the mouthfeel of amoxicillin dispersible tablet.
Brief description of the drawings
Below, describe by reference to the accompanying drawings embodiment of the present invention in detail, wherein:
Fig. 1 shows the In Vitro Dissolution test testing result of the amoxicillin dispersible tablet of embodiment 1.
Detailed description of the invention
Below in conjunction with specific embodiment, and with reference to above accompanying drawing and specific experiment data, the present invention is described in further detail.Should be appreciated that these embodiment just in order to demonstrate the invention, but not limit by any way scope of invention.
In following embodiment, various processes and the method do not described in detail are conventional methods as known in the art.Source, the trade name of agents useful for same and be necessary to list its constituent person, all indicates in the time occurring first, identical reagent used is if no special instructions, all identical with the content of indicating first thereafter.
embodiment 1
Prescription:
Preparation method:
(1) amoxicillin raw material pulverizing is crossed to 80 mesh sieves;
(2) by above-mentioned prescription Lactis Anhydrous and polyvinylpolypyrrolidone respectively, put into CH200 mixer and mix 30 minutes, cross 80 mesh sieves;
(3) above-mentioned two step gained materials are put in V-Mixer, added recipe quantity micropowder silica gel and magnesium stearate, mix 30 minutes, material is fully mixed;
(4) incite somebody to action the (3) mixed material direct compression of gained, make amoxicillin tablets dispersible tablet, specification is every 0.25g.
embodiment 2
Prescription:
Preparation method:
(1) amoxicillin raw material pulverizing is crossed to 80 mesh sieves;
(2) by above-mentioned prescription microcrystalline Cellulose, carboxymethyl starch sodium and aspartame respectively, put into CH200 mixer and mix 30 minutes, cross 80 mesh sieves;
(3) above-mentioned two step gained materials are put in V-Mixer, added recipe quantity micropowder silica gel and magnesium stearate, mix 30 minutes, material is fully mixed;
(4) incite somebody to action the (3) mixed material direct compression of gained, make amoxicillin tablets dispersible tablet, specification is every 0.25g.
embodiment 3
Prescription:
Preparation method:
(1) amoxicillin raw material pulverizing is crossed to 80 mesh sieves;
(2) by above-mentioned prescription microcrystalline Cellulose, polyvinylpolypyrrolidone and aspartame respectively, put into CH200 mixer and mix 30 minutes, cross 80 mesh sieves;
(3) above-mentioned two step gained materials are put in V-Mixer, added recipe quantity micropowder silica gel and magnesium stearate, mix 30 minutes, material is fully mixed;
(4) incite somebody to action the (3) mixed material direct compression of gained, make amoxicillin tablets dispersible tablet, specification is every 0.25g.
embodiment 4
The present embodiment carries out quality testing to the prepared amoxicillin dispersible tablet of embodiment 1～3, the results are shown in Table 1.
Table 1 embodiment 1～3 amoxicillin dispersible tablet quality testing result
As shown in Table 1, result shows, the dissolution of the amoxicillin dispersible tablet of embodiment 1-3 gained is better, and dispersed homogeneous degree is less, and medicine disintegrate is rapidly described, can make drug effect fast, absorb soon, can increase bioavailability.
embodiment 5
The standby amoxicillin dispersible tablet (Haikou Pharmaceutical Factory Co., Ltd., lot number 130601) of the amoxicillin dispersible tablet (dry powder direct tabletting) of the present embodiment to embodiment 1 and traditional wet granule compression tablet legal system compares.The results are shown in following table 2.
The impact of table 2 preparation process on amoxicillin dispersible tablet quality
Above result shows, through contrasting with wet granule compression tablet, adopts the amoxicillin dispersible tablet quality of dry powder direct tabletting gained to be significantly better than wet granule compression tablet; And the yield rate of two kinds of different preparation method gained samples also has marked difference, and dry powder direct tabletting and wet granule compression tablet make sample yield rate and be respectively 89.6% and 64.3%; So having significantly, the medicine waste of the prepared amoxicillin dispersible tablet of dry powder direct tabletting of the present invention reduces.
embodiment 6
The dissolution curve of the amoxicillin dispersible tablet of the present embodiment to embodiment 1 is measured, and result is as shown in following table 3 and accompanying drawing 1.
The dissolution curve determination result of the amoxicillin dispersible tablet sample of table 3 embodiment 1
| Time | 5min | 10min | 15min | 30min | 45min | 60min |
| Dissolution rate (%) | 71.5 | 83.4 | 90.7 | 99.9 | 99.8 | 99.9 |
As above shown in table 3 and accompanying drawing 1, result shows, the prepared amoxicillin dispersible tablet sample of the present invention was all greater than 80%, conformance with standard requirement in 30 minutes.
One of ordinary skill in the art are to be understood that, all embodiment disclosed in this invention are only for illustrating technical scheme of the present invention, its parameter can change to some extent according to the operating practice of this area, but do not affect inventive concept involved in the present invention, therefore can not be used for limiting claim involved in the present invention.
Claims (10)
1. a stable amoxicillin dispersible tablet, it is characterized in that, described dispersible tablet adopts direct powder compression to make by the former medicine in amoxicillin and pharmaceutical carrier, described pharmaceutical carrier comprises disintegrating agent, diluent and fluidizer, wherein the weight ratio of the former medicine in amoxicillin and pharmaceutical carrier is 1:0.5-2, and described diluent is Lactis Anhydrous or microcrystalline Cellulose, described disintegrating agent is carboxymethyl starch sodium.
2. amoxicillin dispersible tablet according to claim 1, is characterized in that, when described diluent is microcrystalline Cellulose, it at least also comprises a kind of filler with taste masking function.
3. amoxicillin dispersible tablet according to claim 2, is characterized in that, described in there is taste masking function filler be aspartame.
4. according to the amoxicillin dispersible tablet described in claim 1-3 any one, it is characterized in that, described fluidizer is magnesium stearate and/or micropowder silica gel.
5. amoxicillin dispersible tablet according to claim 4, it is characterized in that, in described pharmaceutical carrier, the weight proportion relation of diluent, disintegrating agent and lubricant is: Lactis Anhydrous or microcrystalline Cellulose are 10～20 parts, carboxymethyl starch sodium is 2～5 parts, and micropowder silica gel and/or magnesium stearate are 0.5～1 part.
6. amoxicillin dispersible tablet according to claim 5, it is characterized in that, in described dispersible tablet, the weight proportion relation of the former medicine in amoxicillin and described pharmaceutical carrier is: 25 parts of amoxicillin, 10～30 parts of diluent Lactis Anhydrous or microcrystalline Cellulose, 2～8 parts of disintegrating agent carboxymethyl base Starch Sodium, fluidizer micropowder silica gel and/or magnesium stearate are 0.2～2 part.
7. according to the preparation method of the amoxicillin dispersible tablet described in claim 1-6, it is characterized in that, said method comprising the steps of:
(1) former amoxicillin medicine is crossed after 80 mesh sieves for subsequent use;
(2) take respectively diluent and disintegrating agent by described proportioning, put into mixer premixing, pulverize and sieve;
(3) above-mentioned two step gained materials are placed in to mixer, add micropowder silica gel and magnesium stearate, fully mix; With
(4) by step (3) gained material direct compression, obtain described amoxicillin dispersible tablet.
According to the amoxicillin dispersible tablet described in claim 1-6 in the purposes for the preparation of reducing in Penicillin antibiotics anaphylactoid antibacterials.
9. purposes according to claim 8, it is characterized in that, described antibacterials for to streptococcus, do not produce penicillinase staphylococcus, aerobic gram positive coccus, the antibacterials of not producing beta lactamase bacterial strain and/or helicobacter pylori of aerobic gram-negative bacteria.
10. purposes according to claim 9, is characterized in that:
Described streptococcus comprises: streptococcus pneumoniae and Hemolytic streptococcus;
The described penicillinase staphylococcus of not producing comprises: enterococcus faecalis; And/or
The beta lactamase bacterial strain that do not produce of described aerobic gram-negative bacteria comprises: escherichia coli, proteus mirabilis, Salmonella, 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 |
| CN109432027A (en) * | 2019-01-16 | 2019-03-08 | 四川制药制剂有限公司 | A kind of preparation process of amoxicillin dispersible tablet |
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