CN110302169A - A kind of sliding film coated tablet and preparation method thereof - Google Patents
A kind of sliding film coated tablet and preparation method thereof Download PDFInfo
- Publication number
- CN110302169A CN110302169A CN201910707716.8A CN201910707716A CN110302169A CN 110302169 A CN110302169 A CN 110302169A CN 201910707716 A CN201910707716 A CN 201910707716A CN 110302169 A CN110302169 A CN 110302169A
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- tablet
- synovial membrane
- film coated
- membrane clothing
- coated tablet
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Classifications
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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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2873—Proteins, e.g. gelatin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
Abstract
The invention discloses a kind of sliding film coated tablets and preparation method thereof, it is related to tablet packaging technique field, by being made in conventional tablet outer layer of the coated process of hydrophily synovial membrane clothing material, the hydrophily synovial membrane clothing material is selected from one of sodium alginate, gelatin, carbomer or a variety of.Cunning film coated tablet of the invention and commercially available identical tablet are through ifs vitro disintegration time limit, dissolution rate comparative study, cunning film coated tablet of the invention is consistent with the disintegration time limited of commercially available identical tablet and dissolution rate as the result is shown, and cunning film coated tablet of the invention is when swallowing without foreign body in esophagus sense, and foreign body in esophagus sense is obvious when solving the problems, such as to swallow existing for conventional tablet.
Description
Technical field:
The present invention relates to tablet packaging technique fields, and in particular to a kind of sliding film coated tablet and preparation method thereof.
Background technique:
Pharmaceutical tablet is the first big dosage form of clinical treatment drugs, it refers to drug medically very widely used
With suitable auxiliary material Formulation made of preparation technique.To make tablet reach certain functions, tablet can be wrapped
Clothing, at present tablet coating are divided into sugar coated tablet, Film coated tablets, Enteric coated tablets etc..Wherein sugar-coat, film-coating are to increase stability, cover
Lid adverse drug stink improves tablet appearance, and the purpose of enteric coating is to be disintegrated tablet in enteron aisle.Tablet has dosage accurate,
Stable in physicochemical property, storage period are longer, use, the advantages that transport and easy to carry, price are low, yield is high, convenient to take.But it
The shortcomings that also clearly, that is, when taking need water or liquid, esophagus has foreign body sensation, especially is not easy to gulp down for children and old man
Clothes.A small amount of water and esophagus no foreign body sensation are not needed or only needed when in this regard, developing a kind of take to be suitable for children and old man
The tablet swallowed is necessary.
Summary of the invention:
Technical problem to be solved by the present invention lies in provide a kind of sliding film coated tablet and preparation method thereof, made synovial membrane clothing
Tablet swallows no foreign body sensation under conditions of not changing tablet ifs vitro disintegration time limit and dissolution rate, gulps down suitable for children and old man
Clothes.
The following technical solution is employed for the technical problems to be solved by the invention to realize:
A kind of sliding film coated tablet, by being made in conventional tablet outer layer of the coated process of hydrophily synovial membrane clothing material.
The hydrophily synovial membrane clothing material is selected from one of sodium alginate, gelatin, carbomer or a variety of.
The preparation method of above-mentioned sliding film coated tablet the following steps are included:
(1) prepared by synovial membrane clothing Coating Solution: hydrophily synovial membrane clothing material being added to the water, is dissolved by heating to get synovial membrane clothing
Coating Solution;
(2) packet synovial membrane clothing layer: tablet is set in coating pan, starts coating pan, and synovial membrane clothing Coating Solution is added, makes piece heart table
Face wetting is degree, and stirring enables Coating Solution uniformly to attach to tablet surface, continues to stir and blows heat to coat tablets simultaneously
Wind repeats aforesaid operations after one layer of synovial membrane clothing layer to be formed, and 5-7 layers of synovial membrane clothing are wrapped on tablet;
(3) dry: tablet being uniformly put into pallet, then pallet is put into vacuum freeze drier, opens machine, quickly
- 45 DEG C are cooled to, starts to vacuumize after being kept for -45 DEG C of a period of times, vacuum degree is evacuated to 10Pa or less and maintains to product outlet,
Vacuum freeze drier heating function is opened while starting to vacuumize, is gradually heated to 0 DEG C, maintains one when temperature is to 0 DEG C
The section time, then it is gradually heated to 32-33 DEG C, it shuts down after 32-33 DEG C of maintenance a period of time, product goes out case packing.
The hot blast temperature is 50-70 DEG C.
The whole used time of the drying process is no more than 10h.
The beneficial effects of the present invention are:
(1) cunning film coated tablet of the invention and commercially available identical tablet are through ifs vitro disintegration time limit, dissolution rate comparative study, knot
Fruit shows the cunning film coated tablet of the invention synovial membrane consistent and of the invention with the disintegration time limited of commercially available identical tablet and dissolution rate
Garment piece agent is when swallowing without foreign body in esophagus sense, and foreign body in esophagus sense is obvious when solving the problems, such as to swallow existing for conventional tablet;
(2) preparation method of cunning film coated tablet of the invention is simple, and high production efficiency, capsule material dosage is moderate, is suitable for institute
There is the coating of tablet.
Specific embodiment:
In order to be easy to understand the technical means, the creative features, the aims and the efficiencies achieved by the present invention, tie below
Specific embodiment is closed, the present invention is further explained.
For the consistency of guarantee test result, the embodiment of the present invention has used the raw material of same producer's same batch,
And use the related sliding film coated tablet of consistent production technology preparation.
Embodiment 1
(1) prepared by synovial membrane clothing Coating Solution: first weighing 100g pharmagel, is added in 85 DEG C of 1kg of deionized water, no
Disconnected stirring, until dissolution finishes, then is added 20g sodium alginate in the above solution, up to synovial membrane clothing Coating Solution after heating for dissolving.
(2) packet synovial membrane clothing layer: by commercially available melbine ordinary tablet, 10000 are put into coating pan, are started coating pan, are added
100mL synovial membrane clothing Coating Solution makes coat tablets wetting for degree, helps to stir with the hand for wearing rubber gloves, enables Coating Solution
Coat tablets uniformly are attached to, continue to stir.It is while agitating 60 DEG C of hot wind to coat tablets blowing temp, when blowing hot-air
Between about 20min i.e. complete one layer of synovial membrane clothing enrobing processes, repeat aforesaid operations, altogether wrap 5 layers of synovial membrane clothing.
(3) dry: tablet is uniformly put into pallet, then pallet is put into vacuum freeze drier, opens machine,
Fast cooling starts to vacuumize, vacuum degree is evacuated to 10Pa or less and maintains to -45 DEG C after keeping subzero 45 DEG C of 60min in 60min
To product outlet, vacuum freeze drier heating function is opened while starting to vacuumize, 0 is gradually heated in 120min
DEG C, 60min is maintained when temperature is to 0 DEG C, then be gradually heated to 32 DEG C in 120min, shut down after maintaining 3h at a temperature of 32 DEG C,
Product goes out case packing, and the whole used time is no more than 10h.
Embodiment 2
(1) prepared by synovial membrane clothing Coating Solution: first weighing 100g pharmagel, is added in 85 DEG C of 1kg of deionized water, no
Disconnected stirring, until dissolution finishes, then is added 20g Acritamer 940 in the above solution, it is molten up to the coating of synovial membrane clothing after heating for dissolving
Liquid.
(2) packet synovial membrane clothing layer: by commercially available vitamin C ordinary tablet, 10000 are put into coating pan, are started coating pan, are added
100mL synovial membrane clothing Coating Solution makes coat tablets wetting for degree, helps to stir with the hand for wearing rubber gloves, enables Coating Solution
Coat tablets uniformly are attached to, continue to stir.It is while agitating 60 DEG C of hot wind to coat tablets blowing temp, when blowing hot-air
Between about 20min i.e. complete one layer of synovial membrane clothing enrobing processes, repeat aforesaid operations, altogether wrap 6 layers of synovial membrane clothing.
(3) dry: tablet is uniformly put into pallet, then pallet is put into vacuum freeze drier, opens machine,
Fast cooling starts to vacuumize to -45 DEG C after keeping -45 DEG C of 60min in 60min, and vacuum degree is evacuated to 10Pa or less and maintains extremely
Product outlet opens vacuum freeze drier heating function while starting to vacuumize, 0 is gradually heated in 120min
DEG C, 60min is maintained when temperature is to 0 DEG C, then be gradually heated to 32 DEG C in 120min, shut down after maintaining 3h at a temperature of 32 DEG C,
Product goes out case packing, and the whole used time is no more than 10h.
Embodiment 3
(1) prepared by synovial membrane clothing Coating Solution: first weighing 100g pharmagel, is added in 85 DEG C of 1kg of deionized water, no
Disconnected stirring, until dissolution finishes, then is separately added into 10g sodium alginate and 10g Acritamer 940 in the above solution, after heating for dissolving
Up to synovial membrane clothing Coating Solution.
(2) packet synovial membrane clothing layer: by commercially available azithromycin ordinary tablet, 10000 are put into coating pan, are started coating pan, are added
100mL synovial membrane clothing Coating Solution makes coat tablets wetting for degree, helps to stir with the hand for wearing rubber gloves, enables Coating Solution
Coat tablets uniformly are attached to, continue to stir.It is while agitating 60 DEG C of hot wind to coat tablets blowing temp, when blowing hot-air
Between about 20min i.e. complete one layer of synovial membrane clothing enrobing processes, repeat aforesaid operations, altogether wrap 7 layers of synovial membrane clothing.
(3) dry: tablet is uniformly put into pallet, then pallet is put into vacuum freeze drier, opens machine,
Fast cooling starts to vacuumize to -45 DEG C after keeping -45 DEG C of 60min in 60min, and vacuum degree is evacuated to 10Pa or less and maintains extremely
Product outlet opens vacuum freeze drier heating function while starting to vacuumize, 0 is gradually heated in 120min
DEG C, 60min is maintained when temperature is to 0 DEG C, then be gradually heated to 32 DEG C in 120min, shut down after maintaining 3h at a temperature of 32 DEG C,
Product goes out case packing, and the whole used time is no more than 10h.
We by the tablet of commercial product respectively with the synovial membrane garment piece of same kind embodiment by Chinese Pharmacopoeia method and
Regulation carries out disintegration time limited and dissolution rate contrast test, while counterpart takes foreign body sensation progress volunteer and takes comparison, as a result
Prove that synovial membrane garment piece, with commercially available indifference, and is taken on disintegration time limited and dissolution rate and feels to be better than commercially available tablet, synovial membrane
Without foreign body in esophagus sense when garment piece is taken, it is easier to take orally.
Detection method:
1, disintegration time limited
Method: lift disintegration tester, primary structure are the hanging basket that a metallic support that can be gone up and down and lower end stud with sieve, and
With baffle.It is 55mm ± 2mm that the metallic support of lifting, which moves up and down distance, and roundtrip frequency is 30~32 times per minute.
Hanging basket glass tube 6, pipe range 77.5mm ± 2.5mm;Internal diameter 21.5mm, wall thickness 2mm.2 pieces of transparent plastic sheet, diameter
90mm, thick 6mm, plate face have 6 holes, aperture 26mm;1 piece of stainless steel plate (is placed on one piece of plastic plate above), diameter 90mm, thick
1mm, plate face have 6 holes, aperture 22mm;Stainless steel wire sieve 1 is opened and (is placed under following one piece of plastic plate), diameter 90mm, sieve pore
Internal diameter 2.0mm;And stainless steel shaft 1 (being fixed in the above on one piece of plastic plate and stainless steel plate), long 80mm.By above-mentioned glass
In pipe 6 holes perpendicular to 2 pieces of plastic plates, and stainless steel plate, plastic plate and stainless steel wire sieve are fixed with 3 screws, i.e.,
?.
Baffle is a flat and smooth transparent plastic block, relative density 1.18~1.20, diameter 20.7mm ± 0.15mm, thickness
9.5mm±0.15mm;Baffle shares 5 holes, aperture 2mm, central 1 hole, remaining 4 pitch-row center 6mm, each pitch of holes phase
Deng;There are 4 equidistant V-shaped grooves in baffle side, the wide 9.5mm in V-shaped groove upper end, deep 2.55mm, width and depth at bottom opening
It is 1.6mm.
Hanging basket is hung on metallic support by the stainless steel shaft of upper end, is immersed in 1000mL beaker, and adjust hanging basket
Sieve fills the water that temperature is 37 ± 1 DEG C in beaker, adjusting height of water level makes to hang away from beaker bottom 25mm when position makes its decline
Sieve is at the 15mm of underwater when basket rises.
Unless otherwise specified, tablet taking 6 in the glass tube for setting above-mentioned hanging basket respectively, add baffle, and starting disintegration tester carries out
It checks, each of medicinal material original powder piece should all be all disintegrated in 30min;Medicinal extract (half medicinal extract) piece, sugar coated tablet each should all be in 1h
All disintegrations.It cannot be disintegrated completely if any 1, should separately take 6 retrials, regulation should all be met.
If test sample sticks baffle, 6 should be separately taken, baffle is not added and checks according to the above method, regulation should be met.
2, dissolution rate
(1) turn basket point basket body and basket axis two parts, be that stainless steel metal material is made.Basket body A is by stainless steel cloth (silk
Diameter is 0.254mm, aperture 0.425mm) it is welded, cylindrical, internal diameter is 22.2mm ± 1.0mm, and upper and lower ends have gold
Belong to edge.The diameter of basket axis B is 9.4~10.1mm, and the tip of the axis connects a sheet metal, as the lid for turning basket;Venthole is covered
(aperture 2.0mm);Lid side is two layers, upper layer outer diameter with to turn basket outer diameter same, lower layer's diameter with to turn basket internal diameter same;Three bullets covered
Reed and center are in hexagonal angle.Amplitude of fluctuation must not exceed ± 1.0mm when turning basket rotation.
(2) process container is the round bottom beaker of 1000mL, and internal diameter is 98~106mm, high 160~175mm;Have one on beaker
Plexiglass cover has covered 2 holes, and centre bore is the position of basket axis, and another hole is for sampling or testing temperature.To protect process container
Constant temperature is held, housing water-bath is answered;The temperature of water-bath should be able to make the temperature of container internal solvent be maintained at 37 ± 0.5 DEG C.Turn basket bottom from
The distance of beaker bottom is 25mm ± 2mm.
(3) motor is connected with basket axis, and revolving speed can be adjusted arbitrarily at 50~200 turns per minute, and speed stabilizing error is no more than ±
4%.Package unit answers held stationary when operating, must not shake or vibrate.
(4) instrument is equipped with 6 sets of operating devices, can once measure 6 parts of test samples.Sample point position Ying Zhuan basket upper end is away from liquid
Among face, at walls of beaker 10mm.Unless otherwise specified measuring method, measures the solvent 900mL of degassed processing, injects each behaviour
Make in container, heating makes solvent temperature be maintained at 37 ± 0.5 DEG C, and adjustment revolving speed makes its stabilization.Test sample 6 (a) are taken, respectively
Investment 6 turns in basket, will turn basket and falls into container, immediately begins to timing, unless otherwise specified, until sampling when 45min in regulation
Point draw solution is appropriate, immediately through no more than 0.8 μm miillpore filter filtration, should complete in 30s from sampling to filtration.Take filter
Liquid is measured according to method defined under each drug item, calculates the amount of dissolution of every (a).
As a result judge the amount of dissolution of every (a) in 6 (a), calculated by mark content, prescribed limit should all be not less than
(Q);Unless otherwise specified, limit (Q) is indicate content 70%.As in 6 (a) only 1 it is (a) be lower than prescribed limit,
But it is not less than Q-10%, and when its average the amount of dissolution is not less than prescribed limit, can be still judged to meet regulation.As having 1 in 6 (a)
Piece is (a) to be lower than Q-10%, should separately take 6 (a) retrials;Just, in 12 (a) of retrial only have 2 it is (a) be lower than Q-10%,
And its average the amount of dissolution can also be judged to meet regulation when being not less than prescribed limit.The amount of taking of test sample for example 2 (a) or 2
When more than piece (a), the average the amount of dissolution of every (a) is calculated, must not be lower than prescribed limit (Q);No longer retrial.
3, foreign body in esophagus sense
Foreign body in esophagus sensing examination when being taken by 100 20-50 years old volunteers, have water and it is anhydrous under the conditions of it is each
The commercially available tablet for taking orally same kind is a piece of a piece of with the synovial membrane garment piece in embodiment;Each volunteer individually records and takes
When feel, take and smooth be denoted as 0;Difficulty is taken, esophagus has foreign body sensation to be denoted as 1.The summation of all scores is calculated, as a result such as table 1
It is shown.
Test result:
Table 1
As shown in Table 1, the present invention can collapse the coating of tablet by the hydrophily synovial membrane clothing material not influencing tablet
Make the absolutely not foreign body in esophagus sense when taking of made sliding film coated tablet under conditions of solution time limit and dissolution rate.
The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention.The technology of the industry
Personnel are it should be appreciated that the present invention is not limited to the above embodiments, and the above embodiments and description only describe this
The principle of invention, without departing from the spirit and scope of the present invention, various changes and improvements may be made to the invention, these changes
Change and improvement all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and its
Equivalent thereof.
Claims (5)
1. a kind of sliding film coated tablet, it is characterised in that: by conventional tablet outer layer by the coated work of hydrophily synovial membrane clothing material
Sequence is made.
2. sliding film coated tablet according to claim 1, it is characterised in that: the hydrophily synovial membrane clothing material is selected from alginic acid
One of sodium, gelatin, carbomer are a variety of.
3. the preparation method of sliding film coated tablet of any of claims 1 or 2, which comprises the following steps:
(1) prepared by synovial membrane clothing Coating Solution: hydrophily synovial membrane clothing material being added to the water, is dissolved by heating to get the coating of synovial membrane clothing
Solution;
(2) packet synovial membrane clothing layer: tablet is set in coating pan, starts coating pan, and synovial membrane clothing Coating Solution is added, and moistens piece heart surface
Wet stirring enables Coating Solution uniformly to attach to tablet surface for degree, continues stirring and simultaneously to coat tablets blowing hot-air, to
Aforesaid operations are repeated after forming one layer of synovial membrane clothing layer, 5-7 layers of synovial membrane clothing are wrapped on tablet;
(3) dry: tablet being uniformly put into pallet, then pallet is put into vacuum freeze drier, opens machine, fast cooling
To -45 DEG C, starting to vacuumize after being kept for -45 DEG C of a period of times, vacuum degree is evacuated to 10 Pa or less and maintains to product outlet,
Vacuum freeze drier heating function is opened while starting to vacuumize, is gradually heated to 0 DEG C, maintains one section when temperature is to 0 DEG C
Time, then it is gradually heated to 32-33 DEG C, it shuts down after 32-33 DEG C of maintenance a period of time, product goes out case packing.
4. the preparation method of sliding film coated tablet according to claim 3, it is characterised in that: the hot blast temperature is 50-70
℃。
5. the preparation method of sliding film coated tablet according to claim 3, it is characterised in that: the whole of the drying process is used
When be no more than 10h.
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CN201910707716.8A CN110302169A (en) | 2019-08-01 | 2019-08-01 | A kind of sliding film coated tablet and preparation method thereof |
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Effective date of registration: 20210105 Address after: 226133 A15 / F, No.100 Dongtinghu Road, Linjiang Town, Haimen City, Nantong City, Jiangsu Province Applicant after: Jiangsu chongheng Medical Technology Co.,Ltd. Address before: 246260 No.79, Shangta group, wangmalou village, yatan Town, Wangjiang County, Anqing City, Anhui Province Applicant before: Zhang Huifen |
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Application publication date: 20191008 |