CN108926546A - A kind of enteric solubility film coating pre-mix dose and preparation method thereof - Google Patents
A kind of enteric solubility film coating pre-mix dose and preparation method thereof Download PDFInfo
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- CN108926546A CN108926546A CN201810721068.7A CN201810721068A CN108926546A CN 108926546 A CN108926546 A CN 108926546A CN 201810721068 A CN201810721068 A CN 201810721068A CN 108926546 A CN108926546 A CN 108926546A
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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
- A61K9/28—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
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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
- A61K9/28—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
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Abstract
The present invention provides a kind of enteric solubility film coating pre-mix dose and preparation method thereof, which is characterized in that composed of the following components by mass percentage: polyacrylic resinⅡ 25-30%；Polyacrylic resinⅢ 25-30%；Plasticizer 10-15%；Titanium dioxide 5-9%；Colorant 5-8%；Talcum powder 15-20%；Pulullan polysaccharide 1-2%；Chitosan 3-4%.The present invention passes through the synergistic effect of polyacrylic resinⅡ and polyacrylic resinⅢ, so that coating pre-mixing agent obtained is until enteron aisle can just be decomposed, drug effect in coating is until enteron aisle can be just released, guarantee that drug directly works to enteron aisle, the drug effect for substantially increasing drug, has a good application prospect；The pulullan polysaccharide added in formula improves the antioxygenic property of coating；The chitosan of addition improves the fresh keeping property of coating, and using effect is preferable.
Description
Technical field
The present invention relates to pre-mixing agent technical field more particularly to a kind of enteric solubility film coating pre-mix dose and its preparation sides
Method.
Background technique
With the raising of pharmaceutical preparation level, the continuous application of medicinal new accessories, new technology, medicine coating also experienced sugar
It is coated the differentiation of film coating.Film coating is the packaging technique for starting development phase early 1950s, since it has
Stability is good, Coating times are short, weight gain less, the advantages that moisture resistance is good, gradually replace sugar-coat.
Film coating pre-mix dose is exactly that will there is the auxiliary material of various excellent performances to be used in conjunction with, and has the advantage of various raw materials
The combination of machine, the common formation for participating in film, forms perfect in shape and function, coating agent easy to use.In film coating pre-mix dose,
Multiple auxiliary materials are not simply to mix, the difference of composite type and proportion between each component, all can be to the mechanical property of coating agent
Matter includes that the generation of the indexs such as the tensile strength, Young's modulus and glass transition temperature of film significantly affects.It is used in pre-compounding process
Raw material is the variation that physical aspect has occurred, and without chemically reacting, each single auxiliary material all remains original
Property, and after mixing, coating pre-mixing agent then embodies excellent performance, better than any one auxiliary material in formula.
Enteric solubility film-coated technique, which is one, is applied to polymer the technology that solid drugs surface forms film, is one
The new technology of enteric coating is now matched in item substitution pharmaceutical factory, it uses high molecular material for film forming agent, is equipped with plasticizer, colorant etc.,
Suspension gun spraying is made into medical surfaces, and drying forms.Now match enteric coating technique tool compared to traditional pharmaceutical factory
It has many good qualities, such as: quality is stable, easy to use, Coating times are short, beautiful appearance, at low cost etc., external extensive
Packaging technique, at home this trend also development and application are now matched instead of traditional using film coating pre-mix dose.But it is existing
Some coating pre-mixing agents are difficult to resist gastric juice, and drug is caused to discharge in advance, and the drug for reaching enteron aisle is seldom, and drug effect substantially reduces,
Using effect is bad.
Summary of the invention
The present invention exactly against the above technical problems, provides a kind of enteric solubility film coating pre-mix dose and preparation method thereof.
The present invention to achieve the above object, using following technical scheme: a kind of enteric solubility film coating pre-mix dose, by quality
Percentage is composed of the following components:
The plasticizer is one of propylene glycol, polyethylene glycol, triethyl citrate, glycerol triacetate or any several
The mixture of kind.
The plasticizer is triethyl citrate.
The present invention also provides a kind of methods for preparing above-mentioned enteric solubility film coating pre-mix dose, comprising the following steps:
(1) each raw material is weighed according to said ratio, it is spare；
(2) feedstock transportation after above-mentioned weighing to pulverizer is pulverized and mixed, smashed powder all crosses 100 mesh
Sieve, and mix after color it is uniform, then using color difference meter detection powder color the depth；
(3) powder obtained in step (2) is put into 0.5-5 times of water and is uniformly dispersed, the ratio of powder and water with
Poidometer, the suspension for the use of high pressure homogenizer or ball mill homogeneous being then 20-1000nm at partial size, the pressure of high pressure homogenizer
Power is not less than 0.7MPa；
(4) suspension obtained in step (3) is granulated using oscillating granulator, to obtained after granulation
Particle is dried until water content≤8%；
(5) inspection is sampled to particle obtained in step (4), is poured into coating pan after sampling is qualified, with water solubility
Coating solution carries out film coating according to weight gain 1.5-3%, obtains coated granule；And it is carried out again to underproof particle is sampled
It is granulated；
(6) coated granule obtained in step (5) is put into mixing machine, then by coated granule gross mass 0.1-
0.3% magnesium stearate is added in mixing machine, carries out total mix 20-60min, and it is 0.15- that tabletting, which obtains slice weight, after total mix
The plain piece of 0.4g；
(7) plain piece is poured into coating pan, carries out film coating according to plain piece weight gain 2-4% with water-soluble coating solution；
(8) it packs, storage.
Drum rotation speed in the step (4) in oscillating granulator is 50-65r/min, and particle obtained crosses 24-30 mesh
Sieve.
The beneficial effects of the present invention are: the present invention is made by the collaboration of polyacrylic resinⅡ and polyacrylic resinⅢ
With so that coating pre-mixing agent obtained is until enteron aisle can just be decomposed, the drug effect in coating can be just released up to enteron aisle, be guaranteed
Drug directly works to enteron aisle, substantially increases the drug effect of drug, has a good application prospect；The Pu Lu added in formula
Blue polysaccharide improves the antioxygenic property of coating；The chitosan of addition improves the fresh keeping property of coating, and using effect is preferable.
Specific embodiment
Below with reference to embodiment, the invention will be further described:
A kind of enteric solubility film coating pre-mix dose, composed of the following components by mass percentage:
The plasticizer is one of propylene glycol, polyethylene glycol, triethyl citrate, glycerol triacetate or any several
The mixture of kind.
The plasticizer is triethyl citrate.
The present invention also provides a kind of methods for preparing above-mentioned enteric solubility film coating pre-mix dose, comprising the following steps:
(1) each raw material is weighed according to said ratio, it is spare；
(2) feedstock transportation after above-mentioned weighing to pulverizer is pulverized and mixed, smashed powder all crosses 100 mesh
Sieve, and mix after color it is uniform, then using color difference meter detection powder color the depth；
(3) powder obtained in step (2) is put into 0.5-5 times of water and is uniformly dispersed, the ratio of powder and water with
Poidometer, the suspension for the use of high pressure homogenizer or ball mill homogeneous being then 20-1000nm at partial size, the pressure of high pressure homogenizer
Power is not less than 0.7MPa；
(4) suspension obtained in step (3) is granulated using oscillating granulator, to obtained after granulation
Particle is dried until water content≤8%；
(5) inspection is sampled to particle obtained in step (4), is poured into coating pan after sampling is qualified, with water solubility
Coating solution carries out film coating according to weight gain 1.5-3%, obtains coated granule；And it is carried out again to underproof particle is sampled
It is granulated；
(6) coated granule obtained in step (5) is put into mixing machine, then by coated granule gross mass 0.1-
0.3% magnesium stearate is added in mixing machine, carries out total mix 20-60min, and it is 0.15- that tabletting, which obtains slice weight, after total mix
The plain piece of 0.4g；
(7) plain piece is poured into coating pan, carries out film coating according to plain piece weight gain 2-4% with water-soluble coating solution；
(8) it packs, storage.
Drum rotation speed in the step (4) in oscillating granulator is 50-65r/min, and particle obtained crosses 24-30 mesh
Sieve.
A kind of enteric solubility film coating pre-mix dose of embodiment 1, composed of the following components by mass percentage:
The plasticizer is one of propylene glycol, polyethylene glycol, triethyl citrate, glycerol triacetate or any several
The mixture of kind.
Preparation method: now to one kind provided in this embodiment for preparing double centner enteric solubility film coating pre-mix dose
The preparation method of enteric solubility film coating pre-mix dose is described below:
(1) 25kg polyacrylic resinⅡ, 30kg polyacrylic resin are weighed according to said ratio by staff first
III, 15kg plasticizer, 5kg titanium dioxide, 5kg colorant, 15kg talcum powder, 2kg pulullan polysaccharide and 3kg chitosan, it is spare；
(2) feedstock transportation after above-mentioned weighing to pulverizer is pulverized and mixed, smashed powder all crosses 100 mesh
Sieve, and mix after color it is uniform, then using color difference meter detection powder color the depth；
(3) powder obtained in step (2) is put into 0.5 times of water and is uniformly dispersed, the ratio of powder and water is with weight
Meter, the suspension for the use of high pressure homogenizer or ball mill homogeneous being then 20nm at partial size, the pressure of high pressure homogenizer is not small
In 0.7MPa；
(4) suspension obtained in step (3) is granulated using oscillating granulator, to obtained after granulation
Particle is dried until water content≤8%；
(5) inspection is sampled to particle obtained in step (4), is poured into coating pan after sampling is qualified, with water solubility
Coating solution carries out film coating according to weight gain 1.5%, obtains coated granule；And it is made again to underproof particle is sampled
Grain；
(6) coated granule obtained in step (5) is put into mixing machine, then by coated granule gross mass 0.1%
Magnesium stearate is added in mixing machine, carries out total mix 20min, and tabletting obtains the plain piece that slice weight is 0.15g after total mix；
(7) plain piece is poured into coating pan, carries out film coating according to plain piece weight gain 2% with water-soluble coating solution；
(8) it packs, storage.
Drum rotation speed in the step (4) in oscillating granulator is 50r/min, and particle obtained crosses the sieve of 24 mesh
Net.
A kind of enteric solubility film coating pre-mix dose of embodiment 2, composed of the following components by mass percentage:
The plasticizer is triethyl citrate.
Preparation method: now to one kind provided in this embodiment for preparing double centner enteric solubility film coating pre-mix dose
The preparation method of enteric solubility film coating pre-mix dose is described below:
(1) 30kg polyacrylic resinⅡ, 25kg polyacrylic resin are weighed according to said ratio by staff first
III, 10kg plasticizer, 6kg titanium dioxide, 8kg colorant, 16kg talcum powder, 1kg pulullan polysaccharide and 4kg chitosan, it is spare；
(2) feedstock transportation after above-mentioned weighing to pulverizer is pulverized and mixed, smashed powder all crosses 100 mesh
Sieve, and mix after color it is uniform, then using color difference meter detection powder color the depth；
(3) powder obtained in step (2) is put into 5 times of water and is uniformly dispersed, the ratio of powder and water is with weight
Meter, the suspension for the use of high pressure homogenizer or ball mill homogeneous being then 1000nm at partial size, the pressure of high pressure homogenizer is not small
In 0.7MPa；
(4) suspension obtained in step (3) is granulated using oscillating granulator, to obtained after granulation
Particle is dried until water content≤8%；
(5) inspection is sampled to particle obtained in step (4), is poured into coating pan after sampling is qualified, with water solubility
Coating solution carries out film coating according to weight gain 3%, obtains coated granule；And it is made again to underproof particle is sampled
Grain；
(6) coated granule obtained in step (5) is put into mixing machine, then by coated granule gross mass 0.3%
Magnesium stearate is added in mixing machine, carries out total mix 60min, and tabletting obtains the plain piece that slice weight is 0.4g after total mix；
(7) plain piece is poured into coating pan, carries out film coating according to plain piece weight gain 4% with water-soluble coating solution；
(8) it packs, storage.
Drum rotation speed in the step (4) in oscillating granulator is 65r/min, and particle obtained crosses the sieve of 30 mesh
Net.
The present invention is exemplarily described above, it is clear that present invention specific implementation is not subject to the restrictions described above,
As long as using the various improvement that the inventive concept and technical scheme of the present invention carry out, or not improved directly apply to other fields
It closes, it is within the scope of the present invention.
Claims (5)
1. a kind of enteric solubility film coating pre-mix dose, which is characterized in that composed of the following components by mass percentage:
2. enteric solubility film coating pre-mix dose according to claim 1, which is characterized in that the plasticizer be propylene glycol,
One of polyethylene glycol, triethyl citrate, glycerol triacetate or any several mixture.
3. enteric solubility film coating pre-mix dose according to claim 2, which is characterized in that the plasticizer is citric acid three
Ethyl ester.
4. a kind of method for preparing enteric solubility film coating pre-mix dose described in claim 1, which is characterized in that including following step
It is rapid:
(1) each raw material is weighed according to said ratio, it is spare；
(2) feedstock transportation after above-mentioned weighing to pulverizer is pulverized and mixed, smashed powder all crosses the sieve of 100 mesh
Net, and color is uniform after mixing, then using the depth of color difference meter detection powder color；
(3) powder obtained in step (2) is put into 0.5-5 times of water and is uniformly dispersed, the ratio of powder and water is with weight
Meter, the suspension for the use of high pressure homogenizer or ball mill homogeneous being then 20-1000nm at partial size, the pressure of high pressure homogenizer is not
Less than 0.7MPa；
(4) suspension obtained in step (3) is granulated using oscillating granulator, to particle obtained after granulation
It is dried until water content≤8%；
(5) inspection is sampled to particle obtained in step (4), pours into coating pan after sampling is qualified, is coated with water solubility
Liquid carries out film coating according to weight gain 1.5-3%, obtains coated granule；And it is made again to underproof particle is sampled
Grain；
(6) coated granule obtained in step (5) is put into mixing machine, then by coated granule gross mass 0.1-0.3%'s
Magnesium stearate is added in mixing machine, carries out total mix 20-60min, and tabletting obtains the element that slice weight is 0.15-0.4g after total mix
Piece；
(7) plain piece is poured into coating pan, carries out film coating according to plain piece weight gain 2-4% with water-soluble coating solution；
(8) it packs, storage.
5. the method according to claim 4 for preparing enteric solubility film coating pre-mix dose, which is characterized in that the step
(4) drum rotation speed in oscillating granulator is 50-65r/min, and particle obtained crosses the sieve of 24-30 mesh.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810721068.7A CN108926546A (en) | 2018-07-04 | 2018-07-04 | A kind of enteric solubility film coating pre-mix dose and preparation method thereof |
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| CN201810721068.7A CN108926546A (en) | 2018-07-04 | 2018-07-04 | A kind of enteric solubility film coating pre-mix dose and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110018036A (en) * | 2019-04-26 | 2019-07-16 | 安阳天助药业有限责任公司 | A kind of method for quickly detecting of solid powder material color difference |
| CN118059053A (en) * | 2024-01-26 | 2024-05-24 | 海南海和制药有限公司 | Fluorouracil tablet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101279096A (en) * | 2008-05-29 | 2008-10-08 | 吕兴文 | Pullulan polysaccharide Vc coating combination |
| CN103920156A (en) * | 2014-04-04 | 2014-07-16 | 成都科特包衣技术有限公司 | Orally delivered intestinal site-specific drug release film coating premixed auxiliary material and preparation method thereof |
| CN104971354A (en) * | 2015-05-15 | 2015-10-14 | 广东一力罗定制药有限公司 | Film coating and preparation method thereof |
| CN107737341A (en) * | 2017-11-30 | 2018-02-27 | 江苏昕宇药业有限公司 | The film-coating premixing auxiliary material that a kind of resistant to gastric juice decomposes |
-
2018
- 2018-07-04 CN CN201810721068.7A patent/CN108926546A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101279096A (en) * | 2008-05-29 | 2008-10-08 | 吕兴文 | Pullulan polysaccharide Vc coating combination |
| CN103920156A (en) * | 2014-04-04 | 2014-07-16 | 成都科特包衣技术有限公司 | Orally delivered intestinal site-specific drug release film coating premixed auxiliary material and preparation method thereof |
| CN104971354A (en) * | 2015-05-15 | 2015-10-14 | 广东一力罗定制药有限公司 | Film coating and preparation method thereof |
| CN107737341A (en) * | 2017-11-30 | 2018-02-27 | 江苏昕宇药业有限公司 | The film-coating premixing auxiliary material that a kind of resistant to gastric juice decomposes |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110018036A (en) * | 2019-04-26 | 2019-07-16 | 安阳天助药业有限责任公司 | A kind of method for quickly detecting of solid powder material color difference |
| CN118059053A (en) * | 2024-01-26 | 2024-05-24 | 海南海和制药有限公司 | Fluorouracil tablet and preparation method thereof |
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Application publication date: 20181204 |
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