CN107115305A - Amoxicillin oral disnitegration tablet and preparation method thereof - Google Patents
Amoxicillin oral disnitegration tablet and preparation method thereof Download PDFInfo
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- CN107115305A CN107115305A CN201710247216.1A CN201710247216A CN107115305A CN 107115305 A CN107115305 A CN 107115305A CN 201710247216 A CN201710247216 A CN 201710247216A CN 107115305 A CN107115305 A CN 107115305A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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Abstract
The present invention discloses a kind of Amoxicillin oral disnitegration tablet and preparation method thereof, and the raw material of the oral disnitegration tablet includes：Granulation raw material：The parts by weight of Amoxicillin 10 15, the parts by weight of colloidal silica 13, the parts by weight of PVP K30 0.5 1；Granulation auxiliary material：The parts by weight of microcrystalline cellulose 48, the parts by weight of Aspartame 0.2 0.6, the parts by weight of Ac-Di-Sol 0.4 0.8；Additional auxiliary material：The parts by weight of Ac-Di-Sol 0.4 0.8, the parts by weight of magnesium stearate 0.1 0.2, the parts by weight of orange flavor 0.4 0.8.The disintegrated tablet of the present invention, by the use of specific consumption proportion and component between rational formula and each composition, the product of acquisition has character stable, and disintegration time meets expection, the effect met the requirements of the standard about material and Determination of amoxicillin.
Description
Technical field
The present invention relates to Amoxicillin preparation field, specially Amoxicillin oral disnitegration tablet and preparation method thereof.
Background technology
Amoxicillin is a kind of the most frequently used semi-synthetic penicillins wide spectrum beta-lactam antibiotic, is a kind of white powder
End, stablizes in acid condition, and intestines and stomach absorptivity is up to 90%.Amoxicillin bactericidal action is strong, the ability of penetration cell film
By force, it is one of current widely used oral semisynthetic penicillin, its preparation has capsule, tablet, granule, dispersible tablet etc..
But there is oral absorption to respond well to treatment not substantially for the Amoxicillin of these above-mentioned forms, the undesirable deficiency of effect.
The content of the invention
In view of the deficiencies of the prior art, the present invention provides a kind of oral absorption is responded well to treatment rapidly, effect is become apparent from, and it is fitted
For to the respiratory tract infection caused by this product sensitive bacterial, urethral infection, alimentary infection, Skin and soft tissue infection etc.
The Amoxicillin oral disnitegration tablet of therapy rehabilitation.
In order to solve the above-mentioned technical problem, the technical solution adopted by the present invention is：A kind of Amoxicillin oral disnitegration tablet, should
The raw material of oral disnitegration tablet includes：Granulation raw material：Amoxicillin 10-15 parts by weight, colloidal silica 1-3 parts by weight gather dimension
Ketone K30 0.5-1 parts by weight；Granulation auxiliary material：Microcrystalline cellulose 4-8 parts by weight, Aspartame 0.2-0.6 parts by weight are crosslinked carboxylic first
Base sodium cellulosate 0.4-0.8 parts by weight；Additional auxiliary material：Ac-Di-Sol 0.4-0.8 parts by weight, magnesium stearate 0.1-
0.2 parts by weight, orange flavor 0.4-0.8 parts by weight.
Preferably, described Amoxicillin oral disnitegration tablet, the raw material of the oral disnitegration tablet includes：Granulation raw material：Ah
Amdinocillin 12.5-14.5 parts by weight, colloidal silica 1.5-2.5 parts by weight, PVP K30 0.7-0.8 parts by weight；Granulation
Auxiliary material：Microcrystalline cellulose 5-6 parts by weight, Aspartame 0.4-0.5 parts by weight, Ac-Di-Sol 0.5-0.6 weight
Part；Additional auxiliary material：Ac-Di-Sol 0.5-0.6 parts by weight, magnesium stearate 0.1-0.2 parts by weight, orange flavor
0.4-0.8 parts by weight.
Colloidal silica in granulation raw material of the present invention may be replaced by glycine, and now glycine is in system
Consumption in grain raw material is 5-6 parts by weight.
Additional auxiliary material of the present invention can also include the anhydrous citric acid of 0.2-0.4 parts by weight.
Amoxicillin oral disnitegration tablet of the present invention, can also include lubricant or glidant 1-2 parts by weight, glue
Mixture 6-8 parts by weight；Described lubricant or glidant can use magnesium stearate, and described adhesive can use poly- second
Alkene pyrrolidone.
Amoxicillin of the present invention can be Amoxicillin calomel mercurous chloride or Amoxicillin weight powder or Amoxicillin three
Hydrate (weight powder), preferably Amoxicillin calomel mercurous chloride.
The consumption of each component is interrelated in the above-mentioned Amoxicillin oral disnitegration tablet of the present invention, is used as composition Ah not
XiLin oral disnitegration tablet constitutes entirety, exists and sets up simultaneously according to above-mentioned specific proportion relation.
The present invention also provides a kind of preparation method of Amoxicillin oral disnitegration tablet, and preparation process includes：
(1) prepared by granules of main drug：Amoxicillin and silica are inserted after wet granulator is well mixed, 5% is added
PVP K30 95% ethanol solution (using concentration be 95% ethanol as solvent, prepare mass percent for 5% PVP K30
95% ethanol solution), 18 mesh are crossed, 40 DEG C are dry 3-4 hours, with 18 mesh sieve whole grains；
(2) prepared by granules of accessories：In addition to additional auxiliary material, by 75% ethanol solution of remaining auxiliary material with 5% PVP K30
(using concentration be 75% ethanol as solvent, prepare mass percent be 5% PVP K30 75% ethanol solution) dissolving, cross 18
Mesh sieve, 60 DEG C dry 3-4 hours, with 18 mesh sieve whole grains；
(3) it is total mixed：By the granules of main drug of step (1), the granules of accessories of step (2) and additional auxiliary material according to formula rate
Mixing；
(4) tabletting：Granule content according to Amoxicillin oral disnitegration tablet carries out tabletting, and Stress control 1.5-3KG is obtained
Target product.
The advantages of the present invention：
1. the disintegrated tablet of the present invention, by specific consumption proportion and component between rational formula and each composition
Use, the product of acquisition has character stable, and disintegration time meets expection, meets mark about material and Determination of amoxicillin
The effect of accurate requirement.
2. product prepared by the present invention be a kind of convenient oral, take effect rapid new formulation, in Clinical practice relatively on
State preparation to respond well to treatment rapidly in oral absorption, effect becomes apparent from, it is applied to the respiratory tract sense caused by this product sensitive bacterial
The therapy rehabilitation of dye, urethral infection, alimentary infection, Skin and soft tissue infection etc..
Brief description of the drawings
The process chart of 1 embodiment of accompanying drawing 1.
The process chart of 2 embodiment of accompanying drawing 2.
Embodiment
The present invention is described in further detail below by specific embodiment, but the present invention is not limited solely to following reality
Apply example.The person skilled in the art in the field according to present invention to some nonessential modifications and adaptations for making of the present invention still
Belong to protection scope of the present invention.
Experimental raw used unless otherwise instructed, can be obtained easily from commercial company in the present embodiment.
Embodiment 1：
Specific each amounts of components proportioning is as shown in table 1 below：
Table 1
Specific preparation process：
1st, granules of main drug：Amoxicillin (calomel mercurous chloride) and silica are inserted after wet granulator is well mixed, and add 5%
In right amount, softwood crosses 18 mesh to K30 95% ethanol (percent by volume), and 40 DEG C dry 3-4 hours, with 18 mesh sieve whole grains.
2nd, granules of accessories：Except additional, remaining auxiliary material (Ac-Di-Sol 1/2) 5%K30 (75% ethanol)
Appropriate solution.Softwood crosses 18 mesh sieves, and 60 DEG C dry 3-4 hours, with 18 mesh sieve whole grains.
3rd, it is total mixed：Granules of main drug, granules of accessories and additional auxiliary material.
4th, tabletting：Tabletting, Stress control 1.5-3KG or so are carried out according to granule content, disintegrated tablet is obtained；
Shown in detailed process flow refer to the attached drawing 1.
Three batches of samples are continuously produced according to the final formulation and technology of above-mentioned new determination, study on the stability (acceleration, length is carried out
Phase), as a result it see the table below：
The accelerated test of table 2 investigates result
The long term test of table 3 investigation result (25 DEG C ± 2 DEG C of temperature, humidity 60% ± 5%)
Conclusion：Experiment shows, according to the study on the stability of the three batches of production samples of formulation and technology enlarged experiment finally determined
As a result learn, this product all technical meets standard regulation, can produce qualified product, product quality meets standard gauge
It is fixed.
Experiment condition：
The Workplace of table 4
| Room number | Room function | Clean rank | Temperature/humidity requirement |
| QA-1-004 | Pulverize and sieve | D grades | 18 DEG C -26 DEG C/45%-65% |
| QA-1-006 | Weigh dispensing | D grades | 18 DEG C -26 DEG C/45%-65% |
| QA-1-008 | Granulation is total mixed | D grades | 18 DEG C -26 DEG C/45%-65% |
| QA-1-033 | Tabletting | D grades | 18 DEG C -26 DEG C/45%-65% |
The capital equipment list of table 5
The corresponding operating SOP documentation title and numbering of the key equipment of table 6
Embodiment 2：
The lab scale of table 7 amplifies 100,000 tablet recipes
Specifically preparation process is：
1st, glycine, anhydrous citric acid are crushed into 80 mesh respectively.By Ac-Di-Sol, microcrystalline cellulose, Ah
Si Patan crosses 80 mesh sieves respectively.Supplementary material after pulverizing and sieving is stored in the middle turning barrel for being equipped with clean polybag, capping.Enclose
Material label, is transported to weighing weighing area.Supplementary material after pulverizing and sieving should be used in 10 days.
2nd, granulation mixing
A. adhesive is prepared
Adhesives I：0.4kg PVP K30s are placed in stainless steel cask, 8L95% ethanol is added, slowly stirs, until complete
Portion dissolves, and 5% PVP K30 ethanol solution is made as adhesives I.
Adhesives II：0.35kg PVP K30s are placed in stainless steel cask, 7L70% ethanol is added, slowly stirs, until
All dissolving, is made the ethanol solution of 5% PVP K30 70% as adhesives II.
70% amount of alcohol=(95% amount of alcohol × 95%)/70%
Adhesive should be clarified, and be visible by naked eyes impurity, foreign matter.Adhesive should be stored in the stainless steel cask of cleaning, outside bucket
Wall should enclose material label.
B. wet granular processed
Particle I：Amoxicillin is put into high-speed mixing granulating machine, adhesives I is slowly added into, stirring at low speed 3-5 is opened
Minute, obtained softwood is crossed into 20 mesh nylon mesh pelleting I with oscillating granulator.
Particle II：By the amount of Ac-Di-Sol 1/2, microcrystalline cellulose, glycine, aspartame, anhydrous citron
In acid input high-speed mixing granulating machine, open stirring at low speed and be well mixed for 5-10 minutes, be slowly added into adhesives II, open low speed
Stirring 3-5 minutes, 16 mesh nylon mesh pelleting II is crossed with oscillating granulator by obtained softwood.
Wet granular special stainless steel container access, drying on duty.
C. whole grain is dried
Wet granular is dispersed evenly on drip pan, is advisable with 1.5-2.0cm thickness.After per car drip pan is all installed, push away immediately
Enter baking oven.
Particle I：Open blower fan and start drying, 40 DEG C of drying temperature, about 3-4 hours drying time.It is every to answer stirring within 1-2 hours
Once.
Particle II：Open blower fan and start drying, 60 DEG C of drying temperature, about 3-4 hours drying time.It is every to turn within 1-2 hours
Material is once.
Dried particle I and particle II are crossed into 20 mesh nylon screens with oscillating granulator respectively to carry out before whole grain, whole grain
After all should check whether screen cloth is broken.
D. it is total mixed
Particle I and particle II after whole grain is added in three-dimensional mixer, load weighted additional auxiliary material crosslinking is added
The amount of sodium carboxymethylcellulose 1/2, magnesium stearate, uniform mixing 20 minutes, mixer rotating speed：35hz.Qualified, QA is examined through QC rooms
Supervisor is agreed to after letting pass, and is transferred to subsequent processing.Particle after always mixed, should complete tabletting in 10 days.
E. tabletting
Tablet press machine installs corresponding mould.Mould specification：Flat oblique impact mould, Φ 11mm.Calculated the theoretical tablet weight according to granule content,
Section pressure testing is resetted by theoretical piece.Theoretical piece is determined again：Theoretical loading amount=0.125g/ granule content QA supervisors check weight differential
After (± 7.0%), hardness (1.0-3.0kg), disintegration time limited (being less than 1 minute) are qualified, tabletting is proceeded by.It is every in tableting processes
Check the piece weight that is once averaged within 15 minutes, the plain piece pressed is equipped with the middle turning barrel of clean polybag, be capped, enclose material mark
Label, are transferred to intermediate station.
Keep sample investigation：Above-mentioned trial-manufacture of sample 1 batch, investigates the stability of Amoxicillin oral disnitegration tablet product quality, presses《In
State's pharmacopeia》Four general rules 9001 of version in 2015《Material medicine and preparation stability test direction principle》To screening prescription small sample
Product carry out influence factor experiment.Investigate and find, significant changes occur for slice, thin piece appearance character, and caramel color chips is changed into from colour prime white piece,
It is against regulation and content declines substantially.Influence factor experiment process of the test is as follows：
The sample message of table 8
2. experimental condition
Hot test：Each test sample is taken in 60 DEG C of Homothermal Proof Box, was sampled in the 5th day and the 10th day；
Exposure experiments to light：Test sample (without capsule) is taken in 5000Lux lighting box, it is (total to shine in sampling in the 5th day and the 10th day
Degree is not less than 1.2 × 106Lux·hr)；
Freezing-thawing test：3 circulations are carried out, circulation is to place test sample in -20 DEG C of refrigerators 2 days every time, then at 40 DEG C
Place 2 days, sampling detection；
Accelerated test：Sample is placed into 40 DEG C ± 2 DEG C of temperature, the investigation under the conditions of humidity 75% ± 5% 6 months, in 1,
2nd, 3,6 the end of month sampling detection；
Investigation project：Character, disintegration time, relevant material, Determination of amoxicillin, (the only inspection of circulation twice before freezing-thawing test
Survey character).
Result of the test is seen below：
The exposure experiments to light of table 9 investigates result
Result is investigated in the hot test of table 10
The freezing-thawing test of table 11 investigates result
The accelerated test of table 12 investigates result
Analytical conclusions：It can be seen from above-mentioned exposure experiments to light result, this product is insensitive to light；Hot test piece sub-color occurs
Slight flavescence, content is on a declining curve；Freezing and thawing test is without obvious change；Accelerated test investigates unstable result, former
Supplementary material structure composition is interfered in prescription, and there is certain chemical reaction causes piece protonatomic mass to morph.Therefore, need pair
Prescription carries out screening design again.Decomposed and learnt by above-mentioned prescription, main ingredient Amoxicillin character is attached most importance to powder particles, adds postorder
Whole grain process time, while weight powder has a certain impact to disintegration time, lower step is intended being adjusted to Amoxicillin calomel mercurous chloride addition.Through looking into
The main cause for readding data slice, thin piece electrochromic variable matter is probably certain simply or multi-flavor auxiliary material unstable chemcial property itself causes,
Found by comparative analysis, one of glycine system amino acid, predominantly protein structure composition, its chemical property are more unstable
Fixed, glycine has the sweet taste of uniqueness, can relax acid, alkali taste, cover bitter taste and strengthen sweet taste, such as allocates improper easy generation degraded and becomes
Matter.Its main function of addition anhydrous citric acid is to ensure that tart flavour and comfort of the slice, thin piece in oral cavity in this prescription, theoretically examines
Considering amino acid, easily catalysis is rotten in acid condition, therefore lower step investigates the compatibility stability of Amoxicillin and glycine, A Mo
Compatibility stability lab scale of the XiLin together with the compatibility stability of citric acid and three's blending simultaneously is studied.
Design following 3 and investigate experiment：
Table 13
Test brief summary：Show through above-mentioned three result of the tests, anhydrous citric acid, glycine and main ingredient Amoxicillin compatibility are not
It is stable, cause content to be gradually reduced, piece sub-color is changed into coke black.
Lower step need to make auxiliary material increase and decrease adjustment to prescription, adjust as follows：
Table 14
Remarks：New recipe removes anhydrous citric acid, glycine, and increase flavouring orange flavor is substituted as diplomatic auxiliary material
PH adjusting agent, flavouring anhydrous citric acid, sweetener glycine, due in piece mitigate, for ensure slice, thin piece have certain hardness,
Added help collapse, disperse, the silica of diluting effect.
Embodiment 3
The screening of table 15 prescription (presses design contained per tablet recipe)
Preparation technology be the same as Example 2.
Claims (10)
1. a kind of Amoxicillin oral disnitegration tablet, it is characterised in that：The raw material of the oral disnitegration tablet includes：Granulation raw material：A Mo
XiLin 10-15 parts by weight, colloidal silica 1-3 parts by weight, PVP K30 0.5-1 parts by weight；Granulation auxiliary material：Microcrystalline cellulose
Plain 4-8 parts by weight, Aspartame 0.2-0.6 parts by weight, Ac-Di-Sol 0.4-0.8 parts by weight；Additional auxiliary material：Hand over
Join sodium carboxymethylcellulose 0.4-0.8 parts by weight, magnesium stearate 0.1-0.2 parts by weight, orange flavor 0.4-0.8 parts by weight.
2. Amoxicillin oral disnitegration tablet according to claim 1, it is characterised in that：Described Amoxicillin Orally disintegrating
Piece, the raw material of the oral disnitegration tablet includes：Granulation raw material：Amoxicillin 12.5-14.5 parts by weight, colloidal silica 1.5-
2.5 parts by weight, PVP K30 0.7-0.8 parts by weight；Granulation auxiliary material：Microcrystalline cellulose 5-6 parts by weight, Aspartame 0.4-
0.5 parts by weight, Ac-Di-Sol 0.5-0.6 parts by weight；Additional auxiliary material：Ac-Di-Sol 0.5-0.6
Parts by weight, magnesium stearate 0.1-0.2 parts by weight, orange flavor 0.4-0.8 parts by weight.
3. Amoxicillin oral disnitegration tablet according to claim 2, it is characterised in that：Colloidal state in described granulation raw material
Silica may be replaced by glycine, and now consumption of the glycine in granulation raw material is 5-6 parts by weight.
4. Amoxicillin oral disnitegration tablet according to claim 2, it is characterised in that：Described additional auxiliary material can also be wrapped
Include the anhydrous citric acid of 0.2-0.4 parts by weight.
5. Amoxicillin oral disnitegration tablet according to claim 2, it is characterised in that：The disintegrated tablet also include lubricant or
Person's glidant 1-2 parts by weight, adhesive 6-8 parts by weight.
6. Amoxicillin oral disnitegration tablet according to claim 5, it is characterised in that：Described lubricant or glidant
For magnesium stearate.
7. Amoxicillin oral disnitegration tablet according to claim 5, it is characterised in that：Described adhesive is polyethylene pyrrole
Pyrrolidone.
8. Amoxicillin oral disnitegration tablet according to claim 2, it is characterised in that：Described Amoxicillin is A Moxi
Woods calomel mercurous chloride or Amoxicillin weight powder or Utimox weight powder.
9. Amoxicillin oral disnitegration tablet according to claim 2, it is characterised in that：Described Amoxicillin is A Moxi
Woods calomel mercurous chloride.
10. a kind of preparation method of Amoxicillin oral disnitegration tablet, it is characterised in that：Preparation process includes：
(1) prepared by granules of main drug：Amoxicillin and colloidal silica are inserted after wet granulator is well mixed, 5% is added
95% ethanol solution of PVP K30, crosses 18 mesh, 40 DEG C dry 3-4 hours, with 18 mesh sieve whole grains；
(2) prepared by granules of accessories：It is in addition to additional auxiliary material, remaining auxiliary material is molten with 75% ethanol solution of 5% PVP K30
Solution, crosses 18 mesh sieves, 60 DEG C dry 3-4 hours, with 18 mesh sieve whole grains；
(3) it is total mixed：The granules of main drug of step (1), the granules of accessories of step (2) and additional auxiliary material is mixed according to formula rate
Close；
(4) tabletting：Granule content according to Amoxicillin oral disnitegration tablet carries out tabletting, and Stress control 1.5-3KG obtains target
Product.
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Cited By (1)
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Application publication date: 20170901 |