CN106176683B - A kind of tramadol hydrochloride slow release capsule and its preparation method and application - Google Patents
A kind of tramadol hydrochloride slow release capsule and its preparation method and application Download PDFInfo
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- CN106176683B CN106176683B CN201610779521.0A CN201610779521A CN106176683B CN 106176683 B CN106176683 B CN 106176683B CN 201610779521 A CN201610779521 A CN 201610779521A CN 106176683 B CN106176683 B CN 106176683B
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
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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
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
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Abstract
The invention discloses a kind of tramadol hydrochloride slow release capsule and its preparation method and application, which is packed into Capsules by tramadol hydrochloride slow release pellet and is made.The tramadol hydrochloride slow release pellet is made of band pill core, isolation coatings, sustained-release coating layer, protectiveness coatings from inside to outside；Band pill core is made of tramadol hydrochloride, adhesive and sucrose blank capsule core, specific weight percentage composition composition are as follows: tramadol hydrochloride 30%-80%, adhesive 10%-30%, sucrose blank capsule core 10%-60%.Sustained release preparation of the invention tramadol hydrochloride treatment concentration can hold time up to 12 hours in extension body, reduce the side effect of the excessive generation of blood concentration fluctuation, medicining times are reduced simultaneously, analgesic activity persistently and stablize, for need to treat moderate caused by different pathogeny to severe pain patient for significant effect and it is easy to use.
Description
Technical field
The present invention relates to technical field of medicine, and in particular to a kind of tramadol hydrochloride slow release capsule and its preparation side
Method.
Background technique
Tramadol hydrochloride (Tramadol Hydrochloride) be it is a kind of it is novel, safe, potent, without habituation sexual centre town
Pain medicine.It can treat moderate caused by different pathogeny to having an intense pain, as cancer pain, postoperative pain, myocardial infarction are drawn
Acute or chronic pain and skeletal pain caused by the treatment of traumatic pain such as pain, the fracture risen, strain property pain and other reasons.
It absorbs completely after tramadol hydrochloride is oral in gastrointestinal tract, works within 20-30 minutes after taking orally 100mg, 2 hours blood concentration reach to peak values, half
The phase of declining is about 5 hours, general daily 3-4 administration.This product side effect is mainly dizzy, drowsiness, Nausea and vomiting etc., in order to subtract
Few patient takes number while keeping effective analgesic feature, reduces the side effect that blood concentration fluctuates excessive generation, develops its sustained release
Preparation is a big important channel.
Summary of the invention
It is an object of the invention to overcome existing technological deficiency, a kind of tramadol hydrochloride slow release capsule and its preparation are provided
Method and purposes, the tramadol hydrochloride slow release capsule can in extension body tramadol hydrochloride treatment concentration hold time it is small up to 12
When, reduce the fluctuation of blood concentration.Effect is aobvious for it need to treat moderate caused by different pathogeny to the patient of severe pain
Write and it is easy to use.
The present invention is achieved through the following technical solutions the purpose:
The present invention is such a tramadol hydrochloride slow release capsule, which is packed into sky by tramadol hydrochloride slow release pellet
Heart-soothing capsule and be made, the tramadol hydrochloride slow release pellet be from inside to outside by band pill core, isolation coatings, sustained release coating
Layer, protectiveness coatings composition；Described includes the main ingredient coatings on sucrose blank capsule core and its surface, the main ingredient with pill core
Coatings are to be formed after being sprayed at sucrose blank pellet surface with main ingredient coating solution through dry, and the main ingredient coating solution is by hydrochloric acid
C16H25NO2 and adhesive are mixed after dissolving in a solvent；Each component weight percent in band pill core are as follows: tramadol hydrochloride
30%-80%, adhesive 10%-30%, sucrose blank capsule core 10%-60%；The isolation coatings, sustained-release coating layer,
The weight summation of protectiveness coatings is the 10%-100% of pellet core.
Wherein, described adhesive is by one of Macrogol 4000, ethyl cellulose, hydroxypropyl methylcellulose or several
Kind, the solvent is one of purified water or ethyl alcohol or the two combination.
Wherein, the isolation coatings are to be formed after being sprayed at band pill wicking surface by isolation coating solution through drying；
The isolation coating solution is mixed after being dissolved in a solvent by isolation coat material and antitackiness agent；It is solid in isolation coating solution
In shape raw material, weight percent shared by isolation coat material is 70%-95%, and weight percent shared by antitackiness agent is 5%-
30%.The isolation coat material is Macrogol 4000 or carboxymethyl cellulose, and the antitackiness agent is talcum powder, the solvent
It is one of purified water or ethyl alcohol or the two combination.
Wherein, the sustained-release coating layer is to be formed after being sprayed at isolation coating layer surface by sustained release coating liquid through drying；
The sustained release coating liquid is to be dissolved to be mixed in a solvent by acrylic polymer and osmotic pressure regulator；It is wrapped in sustained release
In clothing liquid solid raw material, weight percent shared by acrylic polymer is 20%-99%, weight shared by osmotic pressure regulator
Measuring percentage is 1%~80%.The acrylic polymer be Eudragit NE30D, Eudragit L30D,
One or more of Eudragit RS, the osmotic pressure regulator are hydroxypropyl methyl cellulose HPMC, polyvinylpyrrolidine
One or more of ketone PVP, PVAC polyvinylalcohol, the solvent are one of purified water or ethyl alcohol or the two combination.
Wherein, the protectiveness coatings are sprayed at after sustained release coating layer surface by protectiveness coating solution and are made through drying,
The protectiveness coating solution is dissolved in a solvent by retarding agent and glidant to be mixed；In protectiveness coating solution solid raw material
In, weight percent shared by retarding agent is 20%-90%, and weight percent shared by glidant is 10%~80%.The retardance
Agent be one or more of hydroxypropyl methyl cellulose HPMC, polyvinylpyrrolidone PVP, PVAC polyvinylalcohol, it is described to help stream
Agent is talcum powder, and the solvent is the combination of one or both of purified water or ethyl alcohol.
Further, the method for preparing this tramadol hydrochloride slow release capsule includes the following steps:
Step 1: preparing main ingredient coating solution, isolation coating solution, sustained release coating liquid, protectiveness coating solution respectively；
Step 2: after the preheating of sucrose blank capsule core, according to the structure of tramadol hydrochloride slow release pellet from interior in coating pan
To hydrojet coating, drying, sieving, total mix is successively carried out outside, finally it is packed into Capsules and obtains product.
Purposes the invention also provides this tramadol hydrochloride slow release capsule as analgesic drug product.
Technical solutions according to the invention are verified to have following advantage and good effect:
The present invention using acrylic polymer as sustained release main material, dosage be determine release it is main because
Element.The general composed structure of common sustained-release coating layer are as follows: coating agent, sustained release matrix, pore-foaming agent, gastrointestinal tract adhesive, and this
Acrylic polymer is used in invention, it cannot be dissolved in water and digestive juice, but can expand wherein, it and hydrophilic hydroxyl
Propyl methocel HPMC, polyvinylpyrrolidone PVP, PVAC polyvinylalcohol share the coated preparation for obtaining slow releasing function, it
It is all preferable with the compatibility of these three materials, different permeability can be obtained by adjusting ratio, principle is acrylic resin
When thin film coating material and gastro-intestinal Fluid contact, the pore-foaming agent of itself meets water section dissolution or falls off on film, is formed on coating membrane
Countless micropores and bending trail, make clothing film have permeability, and gastro-intestinal Fluid is penetrated into film by these micropores, and the drug of piece in-core is molten
Solution to a certain extent when, drug generates certain osmotic pressure, prevents moisture from continuing to penetrate into, due to concentration difference inside and outside film, drug is just
It is slowly discharged to outside film by these micropores, to achieve the effect that controlled release.Other complicated sustained-release coating layers are compared to simplify
Prescription and process flow, and different permeability is obtained by adjusting ratio and obtains different rate of release.
Tramadol hydrochloride slow release capsule is compared with conventional capsule in vivo, single oral dose 100mg tramadol hydrochloride slow release
After capsule and 100mg tramadol hydrochloride capsule, peak time is respectively 5.66 ± 1.05 hours, 1.73 ± 0.78 hours, reaches peak
Concentration is respectively 234.3 ± 27.6ng/ml, 394.77 ± 38.4ng/ml, hence it is evident that reduces blood concentration fluctuation amplitude and obvious
Peak time is postponed, display tramadol hydrochloride slow release capsule in vivo release is persistently, steadily, hence it is evident that is better than ordinary preparation.
It is accurate that tramadol hydrochloride slow release capsule quality determination method is stablized, and especially embodies the dissolution rate of sustained releasing character
Experiment reaches the version requirement in 2015 of Chinese Pharmacopoeia current edition.
Specific embodiment
In order to deepen to understand that the present invention is described in further detail below with reference to embodiment to the present invention.In below
Appearance is such as related to numerical value or proportionate relationship, unless otherwise noted, refers both to weight amount or weight ratio.Each component in following embodiments
It is commercially available.The primary structure of pellet involved in following embodiment are as follows: band pill core, isolation coatings, sustained release coating
Layer, protection coatings.
Embodiment 1:
Preparation with pill core
1, main ingredient coating solution is prepared: ethyl cellulose 15g, the tramadol hydrochloride accurately weighed being added in 60% ethanol
35g, after mixing evenly, the suspensions obtained by 80 mesh net filtrations form the coating solution of solid content 55%, and when hydrojet persistently stirs
It mixes.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the Macrogol 4000 3g accurately weighed, talcum powder 0.2g in purified water, stirs uniformly
Suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, hydroxypropyl methyl cellulose HPMC 1g, the Eudragit L30D accurately weighed is added with stirring in purified water
30g, stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 60%, and when hydrojet persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring the PVAC polyvinylalcohol 0.6g accurately weighed, talcum powder 0.2g in purified water, stirs
Even suspension, and by 80 meshes, forms the coating solution of solid content 10%, and when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 2:
Preparation with pill core
1, main ingredient coating solution is prepared: hydroxypropyl methylcellulose 20g, the tramadol hydrochloride accurately weighed being added in purified water
45g, after mixing evenly, the suspensions obtained by 80 mesh net filtrations form the coating solution of solid content 50%, and when hydrojet persistently stirs
It mixes.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the Macrogol 4000 3g accurately weighed, talcum powder 0.2g in purified water, stirs uniformly
Suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, polyvinylpyrrolidone PVP 0.5g, the Eudragit accurately weighed is added with stirring in purified water
RS25g, stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 55%, and when hydrojet persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring the PVAC polyvinylalcohol 0.6g accurately weighed, talcum powder 0.2g in purified water, stirs
Even suspension, and by 80 meshes, forms the coating solution of solid content 10%, and when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 3:
Preparation with pill core
1, main ingredient coating solution is prepared: Macrogol 4000 10g, the tramadol hydrochloride accurately weighed being added in purified water
50g, after mixing evenly, the suspensions obtained by 80 mesh net filtrations form the coating solution of solid content 45%, and when hydrojet persistently stirs
It mixes.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the carboxymethyl cellulose 2g accurately weighed, talcum powder 0.1g in purified water, stirs uniformly
Suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, hydroxypropyl methyl cellulose HPMC 0.5g, the Eudragit accurately weighed is added with stirring in purified water
NE30D 10g, stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 50%, and when hydrojet persistently stirs
It mixes.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring hydroxypropyl methyl cellulose HPMC 1g accurately weighed, talcum powder 0.2g in purified water, stirs
It mixes to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 10%, when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 4:
Preparation with pill core
1, main ingredient coating solution is prepared: Macrogol 4000 5g, the ethyl cellulose accurately weighed being added in 60% ethanol
Plain 3g, tramadol hydrochloride 40g, after mixing evenly, the suspensions obtained by 80 mesh net filtrations form the coating of solid content 50%
Liquid, when hydrojet, persistently stir.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the carboxymethyl cellulose 2g accurately weighed, talcum powder 0.2g in 60% ethanol, stirs
Unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, polyvinylpyrrolidone PVP 0.75g, the Eudragit accurately weighed is added with stirring in 60% ethanol
L30D 15g, stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 50%, and when hydrojet persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, hydroxypropyl methyl cellulose HPMC 0.8g accurately weighed, talcum powder 0.3g are added with stirring in purified water,
It stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 10%, when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 5:
Preparation with pill core
1, main ingredient coating solution is prepared: Macrogol 4000 10g, the tramadol hydrochloride accurately weighed being added in purified water
37g, after mixing evenly, the suspensions obtained by 80 mesh net filtrations form the coating solution of solid content 45%, and when hydrojet persistently stirs
It mixes.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the Macrogol 4000 2g accurately weighed, talcum powder 0.2g in purified water, stirs uniformly
Suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, it is added with stirring PVAC polyvinylalcohol 1.5g, the Eudragit RS 12g accurately weighed in purified water, stirs
Unit for uniform suspension forms the coating solution of solid content 50% and by 80 meshes, when hydrojet, persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring polyvinylpyrrolidone PVP 1g accurately weighed, talcum powder 0.5g in purified water, stirs
Unit for uniform suspension forms the coating solution of solid content 10% and by 80 meshes, when hydrojet, persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 6:
Preparation with pill core
1, main ingredient coating solution is prepared: the ethyl cellulose 10g accurately weighed, tramadol hydrochloride 40g are added in purified water,
After mixing evenly, the suspensions obtained by 80 mesh net filtrations, form the coating solution of solid content 55%, and when hydrojet persistently stirs.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the Macrogol 4000 1.5g accurately weighed, talcum powder 0.2g in purified water, stirs
Even suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, it is added with stirring PVAC polyvinylalcohol 1g, Eudragit NE30D13g accurately weighed in purified water, stirs
Unit for uniform suspension forms the coating solution of solid content 50% and by 80 meshes, when hydrojet, persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring polyvinylpyrrolidone PVP 0.8g accurately weighed, talcum powder 0.5g in purified water, stirs
It mixes to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 10%, when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 7:
Preparation with pill core
1, main ingredient coating solution is prepared: the Macrogol 4000 3g accurately weighed, ethyl cellulose being added in purified water
10g, tramadol hydrochloride 47g, after mixing evenly, the suspension obtained by 80 mesh net filtrations form the coating solution of solid content 55%,
It is persistently stirred when hydrojet.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the carboxymethyl cellulose 1.5g accurately weighed, talcum powder 0.15g in purified water, stirs
Even suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, polyvinylpyrrolidone PVP 0.5g, the Eudragit accurately weighed is added with stirring in 60% ethanol
L30D 17g, stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 50%, and when hydrojet persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring hydroxypropyl methyl cellulose HPMC 1g accurately weighed, talcum powder 0.3g in purified water, stirs
It mixes to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 10%, when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 8:
Preparation with pill core
1, main ingredient coating solution is prepared: hydroxypropyl methylcellulose 10g, the tramadol hydrochloride accurately weighed being added in purified water
45g, after mixing evenly, the suspensions obtained by 80 mesh net filtrations form the coating solution of solid content 50%, and when hydrojet persistently stirs
It mixes.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the carboxymethyl cellulose 1.5g accurately weighed, talcum powder 0.1g in purified water, stirs
Even suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, it is added with stirring PVAC polyvinylalcohol 1g, Eudragit RS17g accurately weighed in purified water, stirs
Unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 50%, and when hydrojet persistently stirs.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring hydroxypropyl methyl cellulose HPMC 1g accurately weighed, talcum powder 0.3g in purified water, stirs
It mixes to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 10%, when hydrojet persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
Embodiment 9:
Preparation with pill core
1, main ingredient coating solution is prepared: the ethyl cellulose 4g hydroxypropyl methylcellulose accurately weighed being added in 60% ethanol
6g, tramadol hydrochloride 40g, after mixing evenly, the suspension obtained by 80 mesh net filtrations form the coating solution of solid content 50%,
It is persistently stirred when hydrojet.
2,21g sucrose blank capsule core is poured into coating pan, preheat, when sucrose blank capsule core internal temperature reach 45 DEG C with
When upper, adjusting revolving speed in coating pan is 20rpm or so, opens peristaltic pump and spray gun starts to be coated, hydrojet flow control 70~
80g/min.After having wrapped main ingredient, air draft and air inlet air-valve are opened, coating pan revolving speed 5rpm, under dry heat temperature 50 C, dry 5
Hour, pellet cross 12 mesh and 20 mesh screens to get.
The preparation of isolation coat layer
1, it is added with stirring the Macrogol 4000 1.5g accurately weighed, talcum powder 0.2g in purified water, stirs
Even suspension, and by 80 meshes, forms the coating solution of solid content 40%, and when hydrojet persistently stirs.
2, it will pour into coating pan, preheat with pill core, when band pill core internal temperature is up to 40 DEG C or more, adjustment coating
Revolving speed is 20rpm or so in pot, opens peristaltic pump and spray gun starts isolation coating, hydrojet flow control is in 70~80g/min.
After the completion of isolation coating, coating pan revolving speed is reduced to 5rpm, is ready for sustained release coating step.
The preparation of sustained-release coating layer
1, hydroxypropyl methyl cellulose HPMC 1g, the Eudragit accurately weighed is added with stirring in purified water
NE30D 18g, stirs to obtain unit for uniform suspension, and by 80 meshes, forms the coating solution of solid content 50%, and when hydrojet persistently stirs
It mixes.
2, when pellet internal temperature is up to 35 DEG C or less, coating pan revolution is adjusted to 20rpm or so, it is slow that spray can be started
Coating solution is released, hydrojet flow control is in 70~80g/min.After sustained release coating liquid has sprayed, pellet is made to continue the rotation in being coated,
It is ready for protectiveness coating steps.
The preparation of protectiveness coatings
1, it is added with stirring polyvinylpyrrolidone PVP 1g accurately weighed, talcum powder 0.5g in purified water, stirs
Unit for uniform suspension forms the coating solution of solid content 10% and by 80 meshes, when hydrojet, persistently stirs.
2, when in coating pan pellet temperature in 28~35 DEG C, relative humidity 10% or so can spray protectiveness coating solution,
After having wrapped clothing, air draft and air inlet air-valve are opened, heating temperature: 45 DEG C or so, 5 hours dry under the revolving speed 5rpm of coating pan.It is micro-
Ball cross 12 mesh and 20 meshes to get.
Load weighted tramadol hydrochloride slow release pellet is placed in coating pan, adjustment coating pan revolving speed is 10 revs/min, then
3 ‰ talcum powder of addition pellet amount, total mix 30 minutes.By the pellet after total mix be packed into Capsules to get.
The above described is only a preferred embodiment of the present invention, present invention is not to be limited in any way, although
The present invention has been disclosed as a preferred embodiment, however not to limit the present invention, any person skilled in the art,
It does not depart within the scope of technical solution of the present invention, when the method and technique content using the disclosure above makes a little change or repairs
The equivalent embodiment for equivalent variations, but all contents for being detached from technical solution of the present invention are adornd, according to the technical spirit according to invention
Any simple modification, equivalent change and modification to the above embodiments, in the range of still falling within technical solution of the present invention.
Claims (5)
1. a kind of tramadol hydrochloride slow release capsule, the capsule are packed into Capsules by tramadol hydrochloride slow release pellet and are made,
It is characterized by: the tramadol hydrochloride slow release pellet is by band pill core, isolation coatings, sustained release coating from inside to outside
Layer, protectiveness coatings composition；Described includes the main ingredient coatings on sucrose blank capsule core and its surface, the main ingredient with pill core
Coatings are to be formed after being sprayed at sucrose blank pellet surface with main ingredient coating solution through dry, and the main ingredient coating solution is by hydrochloric acid
C16H25NO2 and adhesive are mixed after dissolving in a solvent；Each component weight percent in band pill core are as follows: tramadol hydrochloride
30%-80%, adhesive 10%-30%, sucrose blank capsule core 10%-60%；The isolation coatings, sustained-release coating layer, protectiveness
The weight summation of coatings is the 10%-100% of pellet core；The isolation coatings are to be sprayed at band by isolation coating solution
It is formed after pill wicking surface through dry；The isolation coating solution mixes after being dissolved in a solvent by isolation coat material and antitackiness agent
Conjunction is made；In isolation coating solution solid raw material, weight percent shared by isolation coat material is 70%-95%, antitackiness agent
Shared weight percent is 5%-30%；The isolation coat material is Macrogol 4000 or carboxymethyl cellulose, described anti-glutinous
Agent is talcum powder, and the solvent is one of purified water or ethyl alcohol or the two combination；The sustained-release coating layer is by sustained release coating
Liquid is formed after being sprayed at isolation coating layer surface through dry；The sustained release coating liquid is by acrylic polymer and infiltration
Pressure regulator dissolves in a solvent to be mixed；In sustained release coating liquid solid raw material, weight shared by acrylic polymer
Amount percentage is 20%-99%, and weight percent shared by osmotic pressure regulator is 1%~80%；The acrylic polymer is
One or more of Eudragit NE30D, Eudragit L30D, Eudragit RS, the osmotic pressure regulator are hydroxypropyl
One or more of ylmethyl cellulose HPMC, polyvinylpyrrolidone PVP, PVAC polyvinylalcohol, the solvent is purified water
Or one of ethyl alcohol or the two combine.
2. tramadol hydrochloride slow release capsule according to claim 1, it is characterised in that: described adhesive is polyethylene glycol
4000, one or more of ethyl cellulose, hydroxypropyl methylcellulose, the solvent are one of purified water or ethyl alcohol or the two
Combination.
3. tramadol hydrochloride slow release capsule according to claim 1, it is characterised in that: the protectiveness coatings are by protecting
Property coating solution be sprayed at after sustained release coating layer surface and be made through drying, the protectiveness coating solution is by retarding agent and glidant molten
Dissolution is mixed in agent；In protectiveness coating solution solid raw material, weight percent shared by retarding agent is 20%-90%, is helped
Flowing weight percent shared by agent is 10%~80%.
4. tramadol hydrochloride slow release capsule according to claim 3, it is characterised in that: the retarding agent is hydroxypropyl methyl
One or more of cellulose HPMC, polyvinylpyrrolidone PVP, PVAC polyvinylalcohol, the glidant is talcum powder, institute
Stating solvent is the combination of one or both of purified water or ethyl alcohol.
5. a kind of method for preparing the tramadol hydrochloride slow release capsule as described in any one of claim 1,2,3,4, special
Sign is that this method comprises the following steps:
Step 1: preparing main ingredient coating solution, isolation coating solution, sustained release coating liquid, protectiveness coating solution respectively；
Step 2: after the preheating of sucrose blank capsule core, in coating pan from inside to outside according to the structure of tramadol hydrochloride slow release pellet
Hydrojet coating, drying, sieving, total mix are successively carried out, is finally packed into Capsules and obtains product.
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| CN106667968A (en) * | 2017-02-20 | 2017-05-17 | 佛山市弘泰药物研发有限公司 | Perampanel sustained-release capsule and preparation method thereof |
| CN106727438A (en) * | 2017-02-23 | 2017-05-31 | 佛山市弘泰药物研发有限公司 | A kind of Vortioxetine spansule and preparation method thereof |
| CN106667969A (en) * | 2017-02-23 | 2017-05-17 | 佛山市弘泰药物研发有限公司 | Brexpiprazole sustained-release capsule and preparation method thereof |
| CN106619575A (en) * | 2017-02-27 | 2017-05-10 | 佛山市弘泰药物研发有限公司 | Levetiracetam sustained-release capsule and preparing method thereof |
| CN107998104A (en) * | 2017-12-06 | 2018-05-08 | 佛山市弘泰药物研发有限公司 | A kind of pomalidomide spansule and preparation method thereof |
| CN108066323A (en) * | 2017-12-08 | 2018-05-25 | 佛山市弘泰药物研发有限公司 | A kind of Etoricoxib spansule and preparation method thereof |
| CN108066324A (en) * | 2017-12-19 | 2018-05-25 | 佛山市弘泰药物研发有限公司 | A kind of dronedarone hydrochloride spansule and preparation method thereof |
| CN107998105A (en) * | 2017-12-19 | 2018-05-08 | 佛山市弘泰药物研发有限公司 | A kind of Lurasidone HCl spansule and preparation method thereof |
| CN112294777B (en) * | 2020-11-04 | 2022-07-05 | 南京康川济医药科技有限公司 | Ivabradine hydrochloride sustained-release preparation and preparation method and application thereof |
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| US20070184115A1 (en) * | 2005-12-30 | 2007-08-09 | Biovail Laboratories International S.R.L. | Modified release formulations of tramadol and uses thereof |
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| CN1270029A (en) * | 1999-01-18 | 2000-10-18 | 格吕伦塔尔有限公司 | Thebaic analgesic with controllable releasement of active content |
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