CN112402395A - Venlafaxine sustained-release capsule composition and preparation process thereof - Google Patents
Venlafaxine sustained-release capsule composition and preparation process thereof Download PDFInfo
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- CN112402395A CN112402395A CN202011172962.7A CN202011172962A CN112402395A CN 112402395 A CN112402395 A CN 112402395A CN 202011172962 A CN202011172962 A CN 202011172962A CN 112402395 A CN112402395 A CN 112402395A
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- 229960004688 venlafaxine Drugs 0.000 title claims abstract description 20
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- 239000007963 capsule composition Substances 0.000 title claims abstract description 16
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Images
Classifications
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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
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/005—Coating of tablets or the like
-
- 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
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
The invention discloses a venlafaxine sustained-release capsule composition and a preparation process thereof, the composition comprises a hollow capsule and sustained-release pellets in a hollow capsule shell, wherein the sustained-release pellets comprise a drug-containing pellet core and a sustained-release coating, the drug-containing pellet core comprises venlafaxine hydrochloride, microcrystalline cellulose and hydroxypropyl methyl cellulose, and the sustained-release coating comprises ethyl cellulose and hydroxypropyl methyl cellulose; the invention also provides a preparation method of the capsule, which has the advantages of simple process, mild conditions, simple preparation, less auxiliary material types and dosage, low requirement on equipment and suitability for industrial production.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a venlafaxine sustained-release capsule composition and a preparation process thereof.
Background
Depression is one of the major mental diseases, with high morbidity, high recurrence rate, high disease burden and high self-life mortality. It is a group of mood disorders or affective disorders due to various causes and mainly manifested by depression, and is a group of clinical symptoms centered on depressed mood and self-situation. At present, the traditional Chinese medicine mainly treats depression by tonifying kidney, soothing liver-qi stagnation and regulating yin-yang balance, but basic research is lacked to clarify the action mechanism of the depression, and objective and standardized research is lacked on the differentiation of symptoms and signs determined by depression. Most western medicines adopt drug therapy, for example, antidepressants are the main drugs for treating various depression at present, and the effective rate of the traditional Chinese medicine for effectively relieving depression mood and accompanying anxiety, tension and physical symptoms is about 60-80%. According to the experience at home and abroad, the novel antidepressant is recommended in the acute stage. The novel antidepressant has a plurality of varieties, including selective 5-hydroxytryptamine reuptake inhibitors, such as fluoxetine, Paroxetine, fluvoxamine, sertraline and citalopram, selective 5-hydroxytryptamine and noradrenaline reuptake blockers, such as venlafaxine, duloxetine, noradrenergic and specific 5-hydroxytryptamine reuptake inhibitors, such as mirtazapine and hypericum perforatum plant extracts, and the like, but many antidepressant medicaments have the side effects of laziness, toxicity, hypomnesis, respiratory depression and the like.
Depression includes various symptoms and physical signs, wherein physical aspects are mainly manifested by sleep disorder, appetite change, fatigue, psychomotor slowing or arousing, and psychological aspects are mainly manifested by loss of self-esteem, feeling of self guilt, inattention, thoughts of suicide and self-injury, and the like. The main causes of the disease are as follows: environmental and genetic factors, low function of 5-HT system in brain, increased metabolic level of Norepinephrine (NE) in plasma or cerebrospinal fluid of depression disorder patients, relative insufficiency of Dopamine (DA) in brain, etc. Therefore, how to effectively relieve depression symptoms of patients, increase the compliance of patients and reduce the side effects of drug treatment is the pursuit of modern treatment of depression;
venlafaxine hydrochloride, chemically known under the name (R/S) -1- [2- (dimethylamine) -1- (4-methoxyphenyl) ethyl ] cyclohexanol hydrochloride, venlafaxine hydrochloride, the first dual inhibitor of 5-hydroxytryptamine and norepinephrine reuptake, is a new antidepressant different from tricyclic antidepressants and monoamine oxidase inhibitors.
Disclosure of Invention
The invention aims to provide a venlafaxine sustained-release capsule composition and a preparation process thereof.
The technical problems to be solved by the invention are as follows:
the antidepressant in the prior art has complex components and high requirements on a production device, greatly improves the production cost, and also has the problems of complex structure of a coating device and easy agglomeration when coating tiny particles when coating the medicines.
The purpose of the invention can be realized by the following technical scheme:
a venlafaxine sustained release capsule composition and a preparation process thereof comprise a hollow capsule and a sustained release pellet in a hollow capsule shell, wherein the sustained release pellet comprises a drug-containing pellet core and a sustained release coating, the drug-containing pellet core comprises venlafaxine hydrochloride, microcrystalline cellulose and hydroxypropyl methyl cellulose, and the sustained release coating comprises ethyl cellulose and hydroxypropyl methyl cellulose.
The preparation method of the sustained-release capsule comprises the following steps:
s1, weighing the prescription: weighing the raw and auxiliary materials according to theoretical amount;
s2, adhesive preparation: preparing hydroxypropyl methylcellulose into an adhesive by using water;
s3, sieving the raw and auxiliary materials: the weighed microcrystalline cellulose and venlafaxine hydrochloride are packaged in a self-packaging bag to be shaken and mixed, and then the mixture is sieved by a 30-mesh sieve;
s4, premixing: adding venlafaxine and microcrystalline cellulose into a granulating pot, and starting stirring, shearing and mixing for 5 min;
s5, soft material preparation: stirring and shearing are started, and the adhesive is atomized and sprayed to prepare a soft material;
s6, extrusion: extruding the materials by using a 1.0mm sieve;
s7, rounding: rounding the extrudate into plain pills by a rounding machine;
s8, drying: drying the vegetarian pills by a fluidized bed to obtain medicine-containing pill cores;
s9, coating the drug-containing pellet core with a coating solution by a coating device to obtain a sustained-release pellet;
s10, filling the sustained-release pellets into a hollow capsule shell to obtain the venlafaxine hydrochloride sustained-release capsule.
As a further scheme of the invention, the sustained-release pellet comprises the following components in percentage by weight:
venlafaxine hydrochloride: 35 percent of
Microcrystalline cellulose: 58.7 percent
Hypromellose 2208(3 mpa.s): 0.5 percent
Coating and weight increasing: 5.0 to 5.5 percent;
the coating component comprises ethanol, ethyl cellulose and hydroxypropyl methyl cellulose.
As a further aspect of the present invention, the microcrystalline cellulose is microcrystalline cellulose PH 101; the ethyl cellulose is ethyl cellulose N50; the hypromellose is hypromellose E3, K6.
The coating device comprises a feeding mechanism and a coating mechanism, the feeding mechanism is fixedly arranged on the substrate mechanism, the feeding mechanism comprises a heat-preservation case, a first heat exchange tube and a second heat exchange tube are spirally arranged in the heat-preservation case, and the diameter of a spiral structure formed by the first heat exchange tube is smaller than that of a spiral structure formed by the second heat exchange tube;
the two ends of the first heat exchange tube are respectively connected with a first heat exchange tube air inlet end and a first heat exchange tube air outlet end, the two ends of the second heat exchange tube are respectively connected with one end of a second heat exchange tube feed end and one end of a second heat exchange tube discharge end, the other end of the second heat exchange tube feed pipe is connected with a discharge end of a filter, and the feed end of the filter is connected with a conveying pump;
the base plate mechanism comprises a bottom plate, a reinforcing support plate and a sliding sleeve, wherein the reinforcing support plate and the sliding sleeve are fixedly arranged on the bottom plate;
the base plate mechanism is also fixedly provided with an air blower, the air blower is connected with a feed end of the screen device, and a discharge end of the screen device is connected with the upper part of the box body through a pipeline;
a discharge pipe is arranged at the bottom of the box body, and one end of the discharge pipe is connected with a forming and separating device;
one end in the forming and separating device is provided with an air inlet hole, the other end of the forming and separating device is provided with an air outlet hole, the air inlet hole and the air outlet hole are funnel-shaped structures, the air outlet end of the air inlet hole is the end with the smaller diameter, the air outlet end of the air outlet hole is the end with the larger diameter, the joint of the air inlet hole and the air outlet hole is communicated with one end of the solid-phase feeding hole, the other end of the solid-phase feeding hole is communicated with the discharging pipe, and the air inlet end of the air inlet hole inputs nitrogen with the temperature.
As a further scheme of the invention, a plurality of layers of filtering gauzes are arranged in the box-shaped shell of the filter, and the filtering gauzes are positioned between the feeding end and the discharging end of the filter.
As a further scheme of the invention, the outer side wall of the heat preservation case is fixedly provided with a U-shaped connecting piece through a bolt, and the substrate mechanism is fixedly connected with the U-shaped connecting piece through a bolt.
As a further scheme of the invention, the coating mechanism comprises a cross beam, two ends of the cross beam are respectively fixed with one end of a limiting sliding rod, the two limiting sliding rods are arranged in parallel and penetrate through a sliding sleeve on the base plate mechanism, the limiting sliding rods are connected with the sliding sleeve in a sliding manner, one end of a driving air cylinder is fixedly mounted on the reinforcing support plate, the other end of the driving air cylinder is fixedly connected with the cross beam, and the position of the cross beam in the vertical direction can be adjusted through the driving air cylinder.
As a further scheme of the invention, the other end of the limiting sliding rod is fixedly connected with a bottom supporting plate, and a coating box is arranged between the bottom supporting plate and the bottom plate;
the coating box comprises a box body, the box body is designed into two parts which can be vertically split, the upper part of the box body is fixedly arranged on the bottom surface of the bottom plate, the lower part of the box body is fixedly arranged on the bottom supporting plate, a through hole is formed in the top of the upper part of the box body, and the through hole is communicated with one end of a material conveying channel arranged in the bottom plate.
As a further scheme of the invention, the screen device comprises a shell and a plurality of layers of screens arranged in the shell.
As a further scheme of the invention, the working method of the coating device comprises the following steps:
pumping the coating liquid into a second heat exchange tube through a delivery pump, spraying the coating liquid out through an atomizing nozzle after passing through a discharge tube of the second heat exchange tube and a material conveying channel arranged in a bottom plate, and simultaneously conveying the medicine-containing pellet cores into a box body of a coating box through a blower;
the pill-containing cores entering the box body along with the air flow are dispersed in the box body, after a layer of coating liquid is sprayed on the surface, the pill-containing cores enter the forming and separating device from the discharge pipe, and then the coated pill-containing cores input from the solid phase feed hole are dispersed and cooled by high-pressure low-temperature nitrogen input from the air inlet hole.
The invention has the beneficial effects that:
the invention aims to provide a venlafaxine hydrochloride sustained-release capsule, which can realize the stable release of medicaments, has the effective sustained release time of 24 hours, and can be taken once a day, and also provides a preparation method of the capsule, wherein the method has the advantages of simple process, mild conditions, simple preparation, less types and dosage of auxiliary materials, low equipment requirement and suitability for industrial production; the method comprises the steps of dispersing a medicine-containing pill core entering a box body along with air flow in the box body, spraying a layer of coating liquid on the surface of the medicine-containing pill core, entering a forming and separating device from a discharge pipe, dispersing and cooling the medicine-containing pill core input from a solid phase feed hole through high-pressure low-temperature nitrogen input from an air inlet hole, impacting the material input from the solid phase feed hole due to the fact that a Venturi tube is adopted in the forming and separating device, separating the coated and adhered medicine particles, cooling and solidifying the coating on the surfaces of the particles through the low-temperature nitrogen, and avoiding the subsequent medicine particles from being adhered again to influence medicine processing.
Drawings
The invention is described in further detail below with reference to the figures and specific embodiments.
FIG. 1 is a schematic view of the structure of a coating apparatus according to the present invention;
FIG. 2 is a schematic structural view of a feeding mechanism and a substrate mechanism;
FIG. 3 is a schematic view of the feeding mechanism at another angle;
FIG. 4 is a schematic view of the internal structure of the feeding mechanism;
FIG. 5 is a schematic view of the coating mechanism;
fig. 6 is a partial structural view of a coating mechanism.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1:
the medicine-containing pill core consists of venlafaxine hydrochloride 34.8%, microcrystalline cellulose 58%, hydroxypropyl methyl cellulose 0.53%, and slow release coating (5.5%) comprising ethyl cellulose, hydroxypropyl methyl cellulose and ethanol.
The preparation method comprises the following steps:
(1) mixing venlafaxine hydrochloride and microcrystalline cellulose;
(2) adding a mixed aqueous solution of hydroxypropyl methylcellulose to the mixture;
(3) extruding, rounding and drying to obtain a pill core containing the medicine;
(4) coating the drug-containing pellet core with coating liquid to obtain sustained-release pellets;
(5) filling the sustained-release pellets into hollow capsules to obtain the venlafaxine hydrochloride sustained-release capsules.
The sustained-release capsule has a size of 150 mg.
Example 2:
the medicine-containing pill core consists of venlafaxine hydrochloride 34.9%, microcrystalline cellulose 58.5%, hydroxypropyl methyl cellulose 0.52%, and slow releasing coating comprising ethyl cellulose, hydroxypropyl methyl cellulose and ethanol 5.3%.
The preparation method comprises the following steps:
(1) mixing venlafaxine hydrochloride and microcrystalline cellulose;
(2) adding a mixed aqueous solution of hydroxypropyl methylcellulose to the mixture;
(3) extruding, rounding and drying to obtain a pill core containing the medicine;
(4) coating the drug-containing pellet core with coating liquid to obtain sustained-release pellets;
(5) filling the sustained-release pellets into hollow capsules to obtain the venlafaxine hydrochloride sustained-release capsules.
The sustained-release capsule has a size of 150 mg.
As shown in fig. 1 to 6, the coating device includes a feeding mechanism 1 and a coating mechanism 2, the feeding mechanism 1 is fixedly mounted on a substrate mechanism 3, the feeding mechanism 1 includes a heat preservation cabinet 11, a first heat exchange tube 12 and a second heat exchange tube 13 are spirally disposed in the heat preservation cabinet 1, and a diameter of a spiral structure formed by the first heat exchange tube 12 is smaller than a diameter of a spiral structure formed by the second heat exchange tube 13;
high-temperature gas phase or high-temperature liquid phase flows in the first heat exchange tube 12, and coating liquid is input in the second heat exchange tube 13;
the two ends of the first heat exchange tube 12 are respectively connected with a first heat exchange tube air inlet end 121 and a first heat exchange tube air outlet end 122, the two ends of the second heat exchange tube 13 are respectively connected with one end of a second heat exchange tube feed end 132 and one end of a second heat exchange tube discharge end 131, the other end of the second heat exchange tube feed tube 132 is connected with a discharge end of the filter 14, and the feed end of the filter 14 is connected with the delivery pump 15;
the filter 14 is a box-shaped shell, a plurality of layers of filtering gauzes are arranged in the box-shaped shell, and the filtering gauzes are positioned between the feeding end and the discharging end of the filter 14 and are used for filtering the coating liquid pumped by the conveying pump 15;
the base plate mechanism 3 comprises a base plate 34, a reinforcing support plate 32 and a sliding sleeve 31 which are fixedly arranged on the base plate 34, a U-shaped connecting piece 33 is fixedly arranged on the outer side wall of the heat preservation case 11 through a bolt, the base plate mechanism 3 is fixedly connected with the U-shaped connecting piece 33 through a bolt, a material conveying channel is arranged in the base plate 34, one end of the material conveying channel is communicated with the other end of a second heat exchange tube discharging pipe 131, and the other end of the material conveying channel is arranged on the bottom surface of the base plate 34;
the coating mechanism 2 comprises a cross beam 21, two ends of the cross beam 21 are respectively fixed with one end of a limiting sliding rod 22, the two limiting sliding rods 22 are arranged in parallel, the two limiting sliding rods 22 penetrate through a sliding sleeve 31 on the base plate mechanism 3, the limiting sliding rods 22 are in sliding connection with the sliding sleeve 31, one end of a driving air cylinder is fixedly installed on the reinforcing support plate 32, the other end of the driving air cylinder is fixedly connected with the cross beam 21, and the position of the cross beam 21 in the vertical direction can be adjusted through the driving air cylinder;
the other end of the limiting sliding rod 22 is fixedly connected with a bottom supporting plate 25, and a coating box 26 is arranged between the bottom supporting plate 25 and a bottom plate 34;
the coating box 26 comprises a box body 261, the box body 261 is designed into two parts which can be vertically split, wherein the upper part of the box body 261 is fixedly arranged on the bottom surface of the bottom plate 34, the lower part of the box body 261 is fixedly arranged on the bottom supporting plate 25, the top of the upper part of the box body 261 is provided with a through hole, and the through hole is communicated with one end of a material conveying channel arranged in the bottom plate 34;
the base plate mechanism 3 is also fixedly provided with an air blower 23, the air blower 23 is connected with a feed end of a screen device 24, and a discharge end of the screen device 24 is connected with the upper part of the box body 261 through a pipeline;
the screen device 24 comprises a shell and a plurality of layers of screens arranged in the shell and is used for blocking the pill-containing cores which do not meet the size requirement and have larger grain diameters;
a discharge pipe 262 is arranged at the bottom of the box body 261, and one end of the discharge pipe 262 is connected with a forming and separating device 263;
an air inlet 2631 is arranged at one end in the forming and separating device 263, an air outlet 2632 is arranged at the other end of the forming and separating device 263, the air inlet 2631 and the air outlet 2632 are both funnel-shaped structures, the air outlet end of the air inlet 2631 is a smaller-diameter end, the air outlet end of the air outlet 2632 is a larger-diameter end, the connecting part of the air inlet 2631 and the air outlet 2632 is communicated with one end of the solid-phase feeding hole 2633, the other end of the solid-phase feeding hole 2633 is communicated with the discharge pipe 262, and nitrogen with the temperature of 4-8 ℃ is input at the air inlet end of the air inlet 2631;
the working method of the coating device comprises the following steps:
pumping the coating liquid into the second heat exchange tube 13 through the delivery pump 15, spraying the coating liquid through the atomizing nozzle after passing through the discharge tube 131 of the second heat exchange tube and a material conveying channel arranged in the bottom plate 34, and simultaneously conveying the medicine-containing pellet cores into the box body 261 of the coating box 26 through the blower 23;
the medicine-containing pellet cores entering the case body 261 with the air flow are dispersed in the case body 261, after a layer of coating liquid is sprayed on the surface, the medicine-containing pellet cores enter the forming and separating device 263 from the discharge pipe 262, and then the coated medicine-containing pellet cores input from the solid phase feed hole 2633 are dispersed and cooled by high-pressure low-temperature nitrogen input through the air inlet hole 2631, so that the coating is cooled and solidified in a short time without mutual adhesion.
The forming and separating device adopts a venturi tube design, so that high-pressure low-temperature nitrogen input from the air inlet can be injected into the air outlet at a high speed, and meanwhile, materials input from the solid phase feeding hole are impacted, so that coated and adhered medicine particles are separated, and the coating on the surface of the particles can be cooled and solidified through the low-temperature nitrogen, so that the subsequent medicine particles are prevented from being adhered again to influence the processing of medicines.
The foregoing is merely exemplary and illustrative of the present invention and various modifications, additions and substitutions may be made by those skilled in the art to the specific embodiments described without departing from the scope of the invention as defined in the following claims.
Claims (10)
1. A venlafaxine sustained-release capsule composition is characterized by comprising an empty capsule and sustained-release pellets in the empty capsule shell, wherein the sustained-release pellets comprise a drug-containing pellet core and a sustained-release coating, the drug-containing pellet core comprises venlafaxine hydrochloride, microcrystalline cellulose and hydroxypropyl methyl cellulose, and the sustained-release coating comprises ethyl cellulose and hydroxypropyl methyl cellulose;
the preparation method of the sustained-release capsule comprises the following steps:
s1, weighing the prescription: weighing the raw and auxiliary materials according to theoretical amount;
s2, adhesive preparation: preparing hydroxypropyl methylcellulose into an adhesive by using water;
s3, sieving the raw and auxiliary materials: the weighed microcrystalline cellulose and venlafaxine hydrochloride are packaged in a self-packaging bag to be shaken and mixed, and then the mixture is sieved by a 30-mesh sieve;
s4, premixing: adding venlafaxine and microcrystalline cellulose into a granulating pot, and starting stirring, shearing and mixing for 5 min;
s5, soft material preparation: stirring and shearing are started, and the adhesive is atomized and sprayed to prepare a soft material;
s6, extrusion: extruding the materials by using a 1.0mm sieve;
s7, rounding: rounding the extrudate into plain pills by a rounding machine;
s8, drying: drying the vegetarian pills by a fluidized bed to obtain medicine-containing pill cores;
s9, coating the drug-containing pellet core with a coating solution by a coating device to obtain a sustained-release pellet;
s10, filling the sustained-release pellets into a hollow capsule shell to obtain the venlafaxine hydrochloride sustained-release capsule.
2. The venlafaxine sustained-release capsule composition according to claim 1, wherein the sustained-release pellet comprises the following components in percentage by weight:
venlafaxine hydrochloride: 35 percent of
Microcrystalline cellulose: 58.7 percent
Hypromellose 2208(3 mpa.s): 0.5 percent
Coating and weight increasing: 5.0 to 5.5 percent;
the coating component comprises ethanol, ethyl cellulose and hydroxypropyl methyl cellulose.
3. The venlafaxine sustained release capsule composition according to claim 1 or 2, wherein the microcrystalline cellulose is microcrystalline cellulose PH 101; the ethyl cellulose is ethyl cellulose N50; the hypromellose is hypromellose E3, K6.
4. The process for preparing a venlafaxine sustained release capsule composition according to claim 1, comprising the steps of:
s1, weighing the prescription: weighing the raw and auxiliary materials according to theoretical amount;
s2, adhesive preparation: preparing hydroxypropyl methylcellulose into an adhesive by using water;
s3, sieving the raw and auxiliary materials: the weighed microcrystalline cellulose and venlafaxine hydrochloride are packaged in a self-packaging bag to be shaken and mixed, and then the mixture is sieved by a 30-mesh sieve;
s4, premixing: adding venlafaxine and microcrystalline cellulose into a granulating pot, and starting stirring, shearing and mixing for 5 min;
s5, soft material preparation: stirring and shearing are started, and the adhesive is atomized and sprayed to prepare a soft material;
s6, extrusion: extruding the materials by using a 1.0mm sieve;
s7, rounding: rounding the extrudate into plain pills by a rounding machine;
s8, drying: drying the vegetarian pills by a fluidized bed to obtain medicine-containing pill cores;
s9, coating the drug-containing pellet core with a coating solution by a coating device to obtain a sustained-release pellet;
s10, filling the sustained-release pellets into a hollow capsule shell to obtain the venlafaxine hydrochloride sustained-release capsule.
5. The venlafaxine sustained-release capsule composition according to claim 1, wherein the coating device comprises a feeding mechanism (1) and a coating mechanism (2), the feeding mechanism (1) is fixedly mounted on the substrate mechanism (3), the feeding mechanism (1) comprises a heat-preservation case (11), a first heat exchange tube (12) and a second heat exchange tube (13) are spirally arranged in the heat-preservation case (1), and the diameter of the spiral structure formed by the first heat exchange tube (12) is smaller than that of the spiral structure formed by the second heat exchange tube (13);
the two ends of the first heat exchange tube (12) are respectively connected with a first heat exchange tube air inlet end (121) and a first heat exchange tube air outlet end (122), the two ends of the second heat exchange tube (13) are respectively connected with one end of a second heat exchange tube feeding end (132) and one end of a second heat exchange tube discharging end (131), the other end of the second heat exchange tube feeding tube (132) is connected with a discharging end of a filter (14), and the feeding end of the filter (14) is connected with a conveying pump (15);
the base plate mechanism (3) comprises a bottom plate (34), a reinforcing support plate (32) and a sliding sleeve (31) which are fixedly arranged on the bottom plate (34), a material conveying channel is arranged in the bottom plate (34), one end of the material conveying channel is communicated with the other end of a second heat exchange tube discharge pipe (131), and the other end of the material conveying channel is arranged on the bottom surface of the bottom plate (34);
the base plate mechanism (3) is also fixedly provided with an air blower (23), the air blower (23) is connected with a feeding end of a screen device (24), and a discharging end of the screen device (24) is connected with the upper part of the box body (261) through a pipeline;
a discharge pipe (262) is arranged at the bottom of the box body (261), and one end of the discharge pipe (262) is connected with a forming and separating device (263);
one end in the forming and separating device (263) is provided with an air inlet hole (2631), the other end of the forming and separating device is provided with an air outlet hole (2632), the air inlet hole (2631) and the air outlet hole (2632) are funnel-shaped structures, the air outlet end of the air inlet hole (2631) is one end with a smaller diameter, the air outlet end of the air outlet hole (2632) is one end with a larger diameter, the joint of the air inlet hole (2631) and the air outlet hole (2632) is communicated with one end of the solid phase feeding hole (2633), the other end of the solid phase feeding hole (2633) is communicated with the discharging pipe (262), and nitrogen with the temperature of 4-8 ℃ is input into the air inlet end of the air inlet hole (.
6. A venlafaxine extended release capsule composition according to claim 5, wherein the filter (14) is a box-shaped housing with several layers of filtering gauze placed between the inlet and outlet ends of the filter (14).
7. The venlafaxine sustained-release capsule composition according to claim 5, wherein a U-shaped connecting piece (33) is fixedly installed on the outer side wall of the incubator box (11) through a bolt, and the substrate mechanism (3) is fixedly connected with the U-shaped connecting piece (33) through a bolt.
8. The venlafaxine sustained-release capsule composition according to claim 1, wherein the coating mechanism (2) comprises a cross beam (21), one end of a limit sliding rod (22) is fixed to each end of the cross beam (21), the two limit sliding rods (22) are arranged in parallel, the two limit sliding rods (22) pass through a sliding sleeve (31) on the base plate mechanism (3), the limit sliding rods (22) are slidably connected with the sliding sleeve (31), one end of a driving cylinder is fixedly mounted on the reinforcing support plate (32), the other end of the driving cylinder is fixedly connected with the cross beam (21), and the position of the cross beam (21) in the vertical direction can be adjusted through the driving cylinder.
9. The venlafaxine sustained release capsule composition according to claim 8, wherein the other end of the limiting sliding rod (22) is fixedly connected with a bottom supporting plate (25), and a coating box (26) is arranged between the bottom supporting plate (25) and the bottom plate (34);
the coating box (26) comprises a box body (261), the box body (261) is designed into two parts which can be vertically split, wherein the upper part of the box body (261) is fixedly installed on the bottom surface of the bottom plate (34), the lower part of the box body (261) is fixedly installed on the bottom supporting plate (25), a through hole is formed in the top of the upper part of the box body (261), and the through hole is communicated with one end of a material conveying channel arranged in the bottom plate (34).
10. The venlafaxine extended release capsule composition according to claim 9, wherein the coating means operates by:
the coating liquid is pumped into a second heat exchange pipe (13) through a delivery pump (15), is sprayed out through an atomizing nozzle after passing through a second heat exchange pipe discharge pipe (131) and a material conveying channel arranged in a bottom plate (34), and simultaneously, the medicine-containing pill cores are conveyed into a box body (261) of a coating box (26) through an air blower (23);
the medicine-containing pill cores entering the box body (261) along with the air flow are dispersed in the box body (261), a layer of coating liquid is sprayed on the surface of the medicine-containing pill cores, then the medicine-containing pill cores enter the forming and separating device (263) from the discharge pipe (262), and then the coated medicine-containing pill cores input from the solid phase feed hole (2633) are dispersed and cooled by high-pressure low-temperature nitrogen input from the air inlet hole (2631).
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011172962.7A CN112402395A (en) | 2020-10-28 | 2020-10-28 | Venlafaxine sustained-release capsule composition and preparation process thereof |
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| CN202011172962.7A CN112402395A (en) | 2020-10-28 | 2020-10-28 | Venlafaxine sustained-release capsule composition and preparation process thereof |
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Cited By (1)
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| CN114288273A (en) * | 2022-02-11 | 2022-04-08 | 桂林华信制药有限公司 | Venlafaxine hydrochloride sustained-release capsule and production process thereof |
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