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 PDF

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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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CN
China
Prior art keywords
tablet
synovial membrane
film coated
membrane clothing
coated tablet
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
Application number
CN201910707716.8A
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Chinese (zh)
Inventor
张慧芬
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jiangsu chongheng Medical Technology Co.,Ltd.
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张慧芬
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 张慧芬 filed Critical 张慧芬
Priority to CN201910707716.8A priority Critical patent/CN110302169A/en
Publication of CN110302169A publication Critical patent/CN110302169A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2873Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet 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

A kind of sliding film coated tablet and preparation method thereof
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.
CN201910707716.8A 2019-08-01 2019-08-01 A kind of sliding film coated tablet and preparation method thereof Pending CN110302169A (en)

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CN104095825A (en) * 2014-08-11 2014-10-15 严白双 Metformin hydrochloride enteric-coated tablet and preparation method thereof
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