CN103860493A - Amoxicillin chewable tablet and preparation method thereof - Google Patents
Amoxicillin chewable tablet and preparation method thereof Download PDFInfo
- Publication number
- CN103860493A CN103860493A CN201410032897.6A CN201410032897A CN103860493A CN 103860493 A CN103860493 A CN 103860493A CN 201410032897 A CN201410032897 A CN 201410032897A CN 103860493 A CN103860493 A CN 103860493A
- Authority
- CN
- China
- Prior art keywords
- amoxicillin
- chewable tablet
- ethanol
- agent
- weight portion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of pharmaceutical preparation and particularly relates to an amoxicillin chewable tablet and a preparation method thereof. The chewable tablet consists of a main medicine amoxicillin, a filling agent, a flavoring agent, a flow aid, a deodorizing agent and a bonding agent. The chewable tablet can be used for a patient with difficult swallowing for common tablets, and the adaptability to medicines is good; the chewable tablet can be dissolved in saliva after being put into the mouth and being chewed, the medicines can be absorbed by the mucous membrane in the oral cavity or the esophagus, so that the bioavailability is high; not only is the taste sweet and the mouthfeel is good, but also the irritable smell is corrected, and the fragrance is strong; the taking is convenient, and the carrying is convenient; a direct tabletting method is adopted for preparation, the stability of the medicine is good, the production process is simple and the cost is low.
Description
Invention field
The present invention relates to a kind of pharmaceutical composition containing amoxicillin, more particularly, the present invention relates to a kind of amoxicillin chewable tablet.The invention still further relates to the preparation method of described amoxicillin chewable tablet.
Background of invention
Amoxicillin, its chemistry is 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, be penbritin class lactams semisynthetic antibiotics, mechanism of action is the synthetic of anti-bacteria cell wall, there is bactericidal action fast, effective to most of grams and positive bacteria and negative bacterium.To producing enzyme staphylococcus aureus, staphylococcus epidermidis, coagulase negative staphylococcus and the equal tool good action of enterococcus, intestinal liver Cordycepps antibacterial, hemophilus influenza, moraxelle catarrhalis, bacteroides fragilis etc. that some is produced to lactamase also have better antibacterial activity.
According to reports, amoxicillin oral absorption is good, and food has no significant effect its absorption.Oral amoxicillin 250mg on an empty stomach, amoxicillin reached blood peak concentration of drug (Cmax) in 1.5 hours, be about 5.6mg/L, and blood elimination half-life (tl/2b) is about 1 hour, and within 8 hours, urine discharge rate is 50%～78%, and oral bioavailability is 97%.
Amoxicillin is applicable to lower respiratory infection, otitis media, the sinusitis due to hemophilus influenza and moraxelle catarrhalis; Produce enzyme staphylococcus aureus and produce enzyme enterobacteriaceae lactobacteriaceae as respiratory tract, urinary tract and skin soft-tissue infection etc. due to escherichia coli, Klebsiella; Also can be used for the light grade and moderate infection due to enterococcus, it also can be used for the above-mentioned various infection due to responsive not zymogenic bacteria.
Amoxicillin is the severe infection one line infection medication of clinical common broad-spectrum high efficacy.
Due to the stability requirement of cephalo-type Orally administered composition preparation, principal agent is understable to moisture, temperature, especially facile hydrolysis under neutrality, alkali condition, prior art adopts sour-sweet property batching, think that acidity is conducive to combine the stable of agent principal agent amoxicillin, taste makes every effort to meet most patient needs, has used malic acid as flavoring agent.But the amoxicillin chewable tablet having gone on the market, occurred the sub-color burn of compositions and the problem that occurs mottle, and drug content is reduction trend in storage process.The technical problem to be solved in the present invention is to solve amoxicillin chewing composition quality instability problem, and a kind of stable amoxicillin chewing composition is provided, for patient provides a kind of determined curative effect, and the chewable tablet that can relievedly take.
The current clinical practice dosage form in amoxicillin mainly contains tablet, granule and capsule, needs patient's water to swallow, and for the patient of child, old people and the solid chemicals of can not swallowing, has certain inconvenience.Summary of the invention object of the present invention is just to provide a kind of stable in properties, evident in efficacy, is suitable for the amoxicillin chewable tablet of patient's use of child, old people and the solid chemicals of can not swallowing.Chewable tablet of the present invention has also used flavoring agent in order to eliminate the penetrating odor that in tablet, amoxicillin produces especially, makes this tablet before entrance, is difficult for being refused by the organum olfactorium of human body.
Summary of the invention
Another order of the present invention is to provide the preparation method of above-mentioned amoxicillin chewable tablet, and it adopts modern technology of preparing, can commercial scale, high efficiency production, and it is stable that product quality keeps.The concrete technical scheme that the present invention adopts is as follows:
On the one hand, the present invention relates to a kind of amoxicillin chewable tablet, wherein, described amoxicillin chewable tablet is composed of the following components: weight portion is the amoxicillin of 100～500 parts, weight portion is the filler of 100～1000 parts, and weight portion is the correctives of 5～200 parts, the fluidizer that weight portion is 2～80 parts, weight portion is the flavoring agent of 10～300 parts, and weight portion is the binding agent of 2～100 parts.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described amoxicillin chewable tablet is composed of the following components:
Amoxicillin 25～250g
Lactose 100～1000g
Cyclamate 5～90g
Sweet 5～the 20g of A Siba
Magnesium stearate 2～80g
Powdered flavor 10～300g
Ethanol 2～100g
Food coloring 2～80g
Be pressed into the sheet that 0.2～2.0g is heavy.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described filler is lactose, sucrose, dextrin, mannitol, xylitol, sorbitol, microcrystalline Cellulose, glucose, erithritol or starch, or above-mentioned any two kinds or any two or more mixture.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described correctives is, cyclamate, A Siba are sweet, glycyrrhizin, saccharin sodium, thaumati, vitamin C, or above-mentioned any two kinds or two or more mixture arbitrarily.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described fluidizer is following formula magnesium stearate, micropowder silica gel, Pulvis Talci, Polyethylene Glycol, stearic acid, or above-mentioned any two kinds or any two or more mixture.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described binding agent is ethanol, 1～10% Polyethylene Glycol ethanol, 1～10% polyethylene pyrroles protective embankment ketone ethanol, 1～10% ethyl cellulose ethanol, or above-mentioned any two kinds or two or more mixture arbitrarily.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described flavoring agent is the powdered flavor that human body can be accepted taste.
Some embodiments therein, amoxicillin of the present invention chewable tablet, wherein, described imatinib mesylate chewable tablet is made by following prescription:
Amoxicillin 125g
Lactose 600g
Cyclamate 90g
The sweet 20g of A Siba
Magnesium stearate 75g
Powdered flavor 40g
Ethanol 40g
Food coloring 10g
Make 1000.
On the other hand, the present invention relates to the preparation method of a kind of amoxicillin chewable tablet, wherein, described method is carried out according to following steps order: a. supplementary material is crossed respectively 100 mesh sieves; B. amoxicillin, filler, rectify and hide agent, mix homogeneously, add binding agent to make soft material, cross 20 mesh sieves and granulate, dry under 30～80 DEG C of vacuum conditions, then cross 20 mesh sieves and carry out granulate; C. add fluidizer and flavoring agent, mix; D. be pressed into the sheet that 0.2～2.0g is heavy.
Some embodiments therein, the method for preparing amoxicillin chewable tablet of the present invention wherein, adds to rectify in hiding agent also to add food coloring in step b.
Some embodiments therein, the method for preparing amoxicillin chewable tablet of the present invention, wherein, and sugar coating again after steps d tabletting, described food coloring adds in the time of coating.
Used in the present inventionly rectify that to hide agent be the mouthfeel sense of taste of improving tablet, being adjusted to as far as possible human body easily accepts, flavoring agent is especially in order to eliminate the penetrating odor that in tablet, amoxicillin produces, and makes this tablet before entrance, is difficult for being refused by the organum olfactorium of human body.Add the outward appearance that food coloring can chewable tablet more beautiful.Described filler, as diluent, can be selected lactose, sucrose, dextrin, mannitol, xylitol, sorbitol, microcrystalline Cellulose, glucose, erithritol, starch, or above-mentioned any two kinds or any two or more mixture.Wherein preferably lactose is filler.Described correctives is used for correcting the poor taste bringing due to amoxicillin or adjuvant, can select that cyclamate, A Siba are sweet, glycyrrhizin, saccharin sodium, thaumati, vitamin C, or above-mentioned any two kinds or two or more mixture arbitrarily.Be used for increasing the fluidizer of drug flow, can select magnesium stearate, micropowder silica gel, Pulvis Talci, Polyethylene Glycol, stearic acid, or above-mentioned any two kinds or any two or more mixture.Wherein preferably magnesium stearate is fluidizer.In order to correct the flavoring agent of medicine penetrating odor, can accept with human body the powdered flavor of taste, as various fruity powdered flavors.
The dosage of film-making of the present invention can be adjusted on demand, owing to being chewable tablet, can make common sheet heavy prescription amount, also can be made into the special-shaped tablets more great than ordinary tablet, as can be made into polygon, capsule shape, circle, annular.
The beneficial effect of amoxicillin of the present invention chewable tablet and preparation method thereof is mainly reflected in: (1) the inconvenient patient of conventional tablet that can be used for swallowing, and drug compliance is good; (2) can be dissolved in saliva after putting into mouth and chewing, medicine can absorb by oral cavity or intraesophageal mucosa, and bioavailability is high; (3) not only the sweet mouthfeel of taste is good, and has corrected penetrating odor, has fragrance; (4) do not need drinking water also can take, taking convenience and being easy to carry; (5) adopt direct compression process preparation, medicine stability is good, and production technology is simple, cost is low.Detailed description of the invention, by specific embodiment given below, can further be well understood to the present invention, but they is not limitation of the invention.
Detailed description of the invention
Following examples have further described and demonstrated embodiment within the scope of the present invention.Embodiment is only used to the object of illustrations and provides, and is not intended to be regarded as limitation of the present invention, and it may exist the multiple variant that does not deviate from spirit and scope of the invention.
Embodiment 1 amoxicillin chewable tablet preparation
1.1 prescription
Amoxicillin 25g
Lactose 200g
Cyclamate 75g
The sweet 20g of A Siba
Magnesium stearate 20g
Fresh milk essence 100g
Ethanol 20g
Grape pigment 40g
Make altogether 1000
The amoxicillin chewable tablet of the above-mentioned prescription of 1.2 preparation, carries out according to following steps:
1.2.1 supplementary material is crossed respectively 100 mesh sieves;
1.2.2 sweet to amoxicillin, lactose, cyclamate, A Siba, grape pigment mix homogeneously, add ethanol to make soft material, cross 20 mesh sieves and granulate, dry under 50 DEG C of vacuum conditions, then cross 20 orders. sieve carries out granulate.1.2.3 add magnesium stearate and fresh cream, mix.
1.2.4 tabletting.
Embodiment 2 amoxicillin chewable tablet preparations
2.1 prescription
Amoxicillin 50g
Dextrin 300g
Cyclamate 20g
Glycyrrhizin 30g
Micropowder silica gel 15g
Green apple essence 60g
5% ethyl cellulose ethanol 20g
Fructus Gardeniae blue pigment 5g
Make altogether 1000
The amoxicillin chewable tablet of the above-mentioned prescription of 2.2 preparation, carries out according to following steps:
2.2.1 supplementary material is crossed respectively 100 mesh sieves;
2.2.2 amoxicillin, dextrin, cyclamate, glycyrrhizin, Fructus Gardeniae blue pigment mix homogeneously, add 5% ethyl cellulose ethanol to make soft material, cross 20 mesh sieves and granulate, dry under 40 DEG C of vacuum conditions, then cross 20 mesh sieves and carry out granulate.
2.2.3 add micropowder silica gel and green apple essence, mix.
2.2.4 tabletting.
Embodiment 3 amoxicillin chewable tablet preparations
3.1 prescription
Amoxicillin 75g
Mannitol 500g
Erithritol 100g
Cyclamate 100g
Stearic acid 10g
Orange flavor 100g
5% polyethylene pyrroles protective embankment ketone ethanol 100g
Gardenia yellow pigment 15g
Make altogether 1000
The amoxicillin chewable tablet of the above-mentioned prescription of 3.2 preparation, carries out according to following steps:
3.2.l supplementary material is crossed respectively 100 mesh sieves:
3.2.2 amoxicillin, mannitol, erithritol, cyclamate mix homogeneously, add 5% polyvinylpyrrolidone ethanol to make soft material, cross 20 mesh sieves and granulate, dry under 55 DEG C of vacuum conditions, then cross 20 mesh sieves and carry out granulate.
3.2.3 add stearic acid and orange flavor, mix.
3.2.4 tabletting, carries out coating, and wrap and add gardenia yellow pigment farming season.
Embodiment 4 amoxicillin chewable tablet preparations
4.1 prescription
Amoxicillin 250g
Sucrose 200g
Dextrin 100g
Glucose 200g
Cyclamate 50g
Thaumati 50g
Polyethylene Glycol 50g
Chocolate essence 60g
8% polyvinylpyrrolidone ethanol 10g
Monascorubin 30g
Make altogether 1000
The amoxicillin chewable tablet of the above-mentioned prescription of 4.2 preparation, carries out according to following steps:
4.2.1 supplementary material is crossed respectively 100 mesh sieves;
4.2.2 amoxicillin, sucrose, dextrin, glucose, cyclamate, thaumati mix homogeneously, add 8% polyvidon ethanol to make soft material, cross 20 mesh sieves and granulate, under 60 DEG C of vacuum conditions, thousand is dry, then crosses 20 mesh sieves and carry out granulate.
4.2.3 add Polyethylene Glycol and chocolate essence, mix.
4.2.4 tabletting, carries out coating, adds monascorubin when coating.
Embodiment 4 amoxicillin chewable tablet preparations
4.1 prescription
Amoxicillin 125g
Lactose 600g
Cyclamate 90g
The sweet 20g of A Siba
Magnesium stearate 75g
Powdered flavor 40g
Ethanol 40g
Food coloring 10g
Make 1000
The amoxicillin chewable tablet of the above-mentioned prescription of 4.2 preparation, carries out according to following steps:
4.2.1 supplementary material is crossed respectively 100 mesh sieves;
4.2.2 amoxicillin,
Lactose, cyclamate, aspartame mix homogeneously, add magnesium stearate ethanol to make soft material, crosses 20 mesh sieves and granulate, and under 60 DEG C of vacuum conditions, thousand is dry, then crosses 20 mesh sieves and carry out granulate.
4.2.3 add ethanol and powdered flavor, mix.
4.2.4 tabletting, carries out coating, adds monascorubin when coating.
The clinical bioequivalence Journal of Sex Research of test example 1
20 health volunteers are random intersects after the amoxicillin chewing composition 500mg (2X250mg/ compositions) of oral embodiment 5 amoxicillin chewable tablet 500mg (4X125mg/ grain) and reference examples, by amoxicillin concentration in HPLC method mensuration blood plasma.Taking the amoxicillin of Nat'l Pharmaceutical & Biological Products Control Institute as standard control, with the relative bioavailability F of area-method estimation embodiment 5 amoxicillin chewing compositions be 97.8% ± 9.%.After the amoxicillin chewable tablet 500mg of 20 oral embodiment 5 of health volunteer, the elimination half-life of amoxicillin is 0.52 ± 0.14, peak time and reach peak concentration and be respectively 0.8 ± 0.2 hour and 17.68 ± 3.28u g/ml.After the amoxicillin chewing composition 500mg of oral reference examples, the elimination half-life of amoxicillin is 0.50 ± 0.06h hour, peak time and reach that peak concentration is respectively 0.8 ± 0.2 hour and 18.34 ± 4.10ug/ml illustrates that the pharmacokinetic parameter of two kinds of Wymoxs is close.
Claims (10)
1. an amoxicillin chewable tablet, wherein, described amoxicillin chewable tablet is composed of the following components: weight portion is the amoxicillin of 100～500 parts, weight portion is the filler of 100～1000 parts, weight portion is the correctives of 5～200 parts, the fluidizer that weight portion is 2～80 parts, weight portion is the flavoring agent of 10～300 parts, weight portion is the binding agent of 2～100 parts.
2. amoxicillin as claimed in claim 1 chewable tablet, wherein, described amoxicillin chewable tablet is composed of the following components:
Amoxicillin 25～250g
Lactose 100～1000g
Cyclamate 5～90g
Sweet 5～the 20g of A Siba
Magnesium stearate 2～80g
Powdered flavor 10～300g
Ethanol 2～100g
Food coloring 2～80g
Be pressed into the sheet that 0.2～2.0g is heavy.
3. amoxicillin as claimed in claim 1 chewable tablet, wherein, described filler is lactose, sucrose, dextrin, mannitol, xylitol, sorbitol, microcrystalline Cellulose, glucose, erithritol or starch, or above-mentioned any two kinds or any two or more mixture.
4. amoxicillin as claimed in claim 1 chewable tablet, wherein, described correctives is, cyclamate, A Siba are sweet, glycyrrhizin, saccharin sodium, thaumati, vitamin C, or above-mentioned any two kinds or two or more mixture arbitrarily.
5. amoxicillin as claimed in claim 1 chewable tablet, wherein, described fluidizer is following formula magnesium stearate, micropowder silica gel, Pulvis Talci, Polyethylene Glycol, stearic acid, or above-mentioned any two kinds or any two or more mixture.
6. amoxicillin as claimed in claim 1 chewable tablet, wherein, described binding agent is ethanol, 1～10% Polyethylene Glycol ethanol, 1～10% polyethylene pyrroles protective embankment ketone ethanol, 1～10% ethyl cellulose ethanol, or above-mentioned any two kinds or two or more mixture arbitrarily.
7. amoxicillin as claimed in claim 1 chewable tablet, wherein, described flavoring agent is the powdered flavor that human body can be accepted taste.
8. the amoxicillin chewable tablet as described in claim 1-7 any one, wherein, described amoxicillin chewable tablet is made by following prescription:
Amoxicillin 125g
Lactose 600g
Cyclamate 90g
The sweet 20g of A Siba
Magnesium stearate 75g
Powdered flavor 40g
Ethanol 40g
Food coloring 10g
Make 1000.
9. a method of preparing the amoxicillin chewable tablet as described in claim 1-8 any one, wherein, described method is carried out according to following steps order: a. supplementary material is crossed respectively 100 mesh sieves; B. amoxicillin, filler, rectify and hide agent, mix homogeneously, add binding agent to make soft material, cross 20 mesh sieves and granulate, dry under 30～80 DEG C of vacuum conditions, then cross 20 mesh sieves and carry out granulate; C. add fluidizer and flavoring agent, mix; D. be pressed into the sheet that 0.2～2.0g is heavy.
10. prepare as claimed in claim 9 the method for amoxicillin chewable tablet, wherein, in step b, add to rectify in hiding agent also to add food coloring; Or after steps d tabletting sugar coating again, described food coloring adds in the time of coating.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410032897.6A CN103860493A (en) | 2014-01-23 | 2014-01-23 | Amoxicillin chewable tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410032897.6A CN103860493A (en) | 2014-01-23 | 2014-01-23 | Amoxicillin chewable tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103860493A true CN103860493A (en) | 2014-06-18 |
Family
ID=50899886
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410032897.6A Pending CN103860493A (en) | 2014-01-23 | 2014-01-23 | Amoxicillin chewable tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103860493A (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512386A (en) * | 2011-12-16 | 2012-06-27 | 南京农业大学 | Amoxicillin or amoxicillin and clavulanate potassium instant chewable tablets for pet and preparation method for same |
-
2014
- 2014-01-23 CN CN201410032897.6A patent/CN103860493A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512386A (en) * | 2011-12-16 | 2012-06-27 | 南京农业大学 | Amoxicillin or amoxicillin and clavulanate potassium instant chewable tablets for pet and preparation method for same |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101352449B (en) | Vitamin orally disintegrating tablet and preparation method thereof | |
| US20190269614A1 (en) | Chewable tablet containing vitamin c sodium and preparation method thereof | |
| WO2010092828A1 (en) | Disintegrating particle composition and rapidly disintegrating compression-molded material comprising same | |
| JP2001512451A (en) | Pharmaceutical formulations containing amoxicillin and clavulanate | |
| CN102038645A (en) | Desloratadine grain and preparation method thereof | |
| CZ170296A3 (en) | Organoleptic acceptable pharmaceutical preparation for peroral administration | |
| JP4689468B2 (en) | Tablet and production method thereof | |
| CN101756906B (en) | Pharmaceutical composition of cefcapene pivoxil hydrochloride granules and preparation method thereof | |
| JP2016174616A (en) | Disintegrable composition, and easily disintegrable compression molding | |
| JP2006076971A (en) | Orally disintegrating tablet | |
| CN101836994A (en) | Compound oral preparation of cefaclor and bromhexine and preparation method thereof | |
| CN104739816B (en) | Bad Portugal's zinc medical composition and its use including chiral photo-isomerisation compound | |
| CN102232929A (en) | Voriconazole dried suspension and preparation method thereof | |
| CN110325178A (en) | Improve the manufacturing method of the preparation of content uniformity | |
| JP3230002B2 (en) | Pharmaceutical formulations | |
| JP5201837B2 (en) | Orally disintegrating tablets | |
| JP6104038B2 (en) | Composite composition of crystalline cellulose | |
| CN103860493A (en) | Amoxicillin chewable tablet and preparation method thereof | |
| CN102525978A (en) | Children amoxicillin-potassium clavulanate composition | |
| CN101317843B (en) | Amoxicillin sulbactam pivoxil oral preparation and preparation method thereof | |
| CN101543298A (en) | Rutin chewing agent and method for preparing same | |
| CN107625733B (en) | A kind of clarithromycin anhydrous swallow granule and preparation method thereof | |
| CN103800298A (en) | Cefaclor chewable tablet and preparation method thereof | |
| CN104473879B (en) | A kind of Enrofloxacin pellet and preparation method thereof | |
| CN100536829C (en) | Erigeron breviscapita orally rapidly disintegrating tablet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20140618 |