Anti-depression slow-release capsule

A slow-release capsule and antidepressant technology, which can be applied to drug combinations, nervous system diseases, organic active ingredients, etc., can solve the problems of large fluctuation of blood drug concentration, low technical content, hidden safety hazards, etc., and achieves reasonable structure and simple preparation process. , the effect of uniform particle size

Inactive Publication Date: 2013-04-03
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, venlafaxine hydrochloride has become the world's No. 1 antidepressant in sales, but the main market is monopolized by imported and joint-venture drugs. Imported products are coated with organic solvents, which cause large pollution and easily cause safety hazards
The share of domestic drugs is small, and they are immediate-release preparations or sustained-release capsules taken more than twice at the same time, which have defects such as low technical content, large fluctuations in blood drug concentration, and frequent medication

Method used

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  • Anti-depression slow-release capsule
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  • Anti-depression slow-release capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Prescription with pill core:

[0029]

[0030] Pill core preparation method:

[0031] 1. Mix venlafaxine hydrochloride and microcrystalline cellulose PH101 evenly

[0032] 2. Make soft materials with 5% hydroxypropyl cellulose (HPC-SL) aqueous solution

[0033] 3. Extrude in an extruder (screen diameter: 1mm, extrusion rate: 25rpm)

[0034] 4. The extruded material is rounded in a rounding machine (rounding speed: 1000rpm, extrusion time: 5min)

[0035] 5. Dry in an oven at 40°C for 2 hours

[0036] 6. Pass through a 12-mesh sieve to remove large pills, and pass through a 20-mesh sieve to remove small pills

[0037] Isolation Layer Prescription:

[0038]

[0039] Preparation method of the isolation layer solution: add hydroxypropyl cellulose (HPC-SL) into water to dissolve completely, and stir magnetically to obtain the product.

[0040] Isolation layer coating operation process: using fluidized bed bottom spray coating

[0041] Spray speed: 1~2ml / min

[004...

Embodiment 2

[0057] Prescription with pill core:

[0058]

[0059] Pill core preparation method:

[0060] 1. Mix venlafaxine hydrochloride and microcrystalline cellulose PH101 evenly

[0061] 2. Make soft materials with 5% hypromellose (HPMC E6) aqueous solution

[0062] 3. Extrude in an extruder (screen diameter: 1mm, extrusion rate: 25rpm)

[0063] 4. The extruded material is rounded in a rounding machine (rounding speed: 1000rpm, extrusion time: 5min)

[0064] 5. Dry in an oven at 40°C for 2 hours

[0065] 6. Pass through a 12-mesh sieve to remove large pills, and pass through a 20-mesh sieve to remove small pills

[0066] Isolation Layer Prescription:

[0067]

[0068] Preparation method of the isolation layer solution: add hypromellose and propylene glycol into water to dissolve completely, stir magnetically, and obtain.

[0069] Isolation layer coating operation process: using fluidized bed bottom spray coating

[0070] Spray speed: 1~2ml / min

[0071] Spray pressure: 0....

Embodiment 3

[0086] Prescription with pill core:

[0087]

[0088] Pill core preparation method:

[0089] 1. Mix venlafaxine hydrochloride and microcrystalline cellulose PH101 evenly

[0090] 2. Make soft material with 5% kollicoatIR aqueous solution

[0091] 3. Extrude in an extruder (screen diameter: 1mm, extrusion rate: 25rpm)

[0092] 4. The extruded material is rounded in a rounding machine (rounding speed: 1000rpm, extrusion time: 5min)

[0093] 5. Dry in an oven at 40°C for 2 hours

[0094] 6. Pass through a 12-mesh sieve to remove large pills, and pass through a 20-mesh sieve to remove small pills

[0095] Isolation Layer Prescription:

[0096]

[0097] Preparation method of isolation layer solution: add kollicoatIR to water to dissolve completely, stir magnetically, and obtain.

[0098] Isolation layer coating operation process: using fluidized bed bottom spray coating

[0099] Spray speed: 1~2ml / min

[0100] Spray pressure: 0.75bar

[0101] Air intake: 440L / min

...

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Abstract

The invention aims at providing an anti-depression slow-release capsule which is simple in preparation process, low in cost, small in pollution and high in safety. The slow-release capsule is formed by a drug-containing pill core, an isolating layer and a slow-release layer. The preparation method comprises the steps of adopting an extruding rounding method to prepare the drug-containing pill core, then coating a coating solution with the pill core together in a fluidized bed and drying to prepare the slow-release pellet. The prepared anti-depression slow-release pellet is further prepared into common capsules, and after being taken, the hold time of the effective blood concentration in the body is long and the adverse reaction is reduced. According to the invention, ethyl cellulose aqueous dispersion is adopted as the coating solution of the slow-release layer, plasticizer and antisticking agent are not needed to be added, the preparation method is simple and convenient, an organic solvent is not used in coating, the operation is simple and convenient, the cost is low, the safety is good, and no organic residue exists in the coating pellet, thereby effectively solving the problems of heavy pollution and low safety in coating of the organic solvent.

Description

technical field [0001] The invention provides a slow-release capsule prepared by using ethyl cellulose aqueous dispersion as a slow-release material. The slow-release capsule can achieve 24-hour sustained release and belongs to the field of slow-release pharmaceutical preparations. Background technique [0002] Venlafaxine hydrochloride is suitable for various types of depression, including depression accompanied by anxiety, and generalized anxiety disorder. Common adverse reactions are: gastrointestinal discomfort (nausea, dry mouth, anorexia, constipation and vomiting), central nervous system abnormalities (vertigo, drowsiness, strange dreams, insomnia and nervousness), visual abnormalities, yawning, sweating and sexual Dysfunction (impotence, abnormal ejaculation, decreased libido). Occasional adverse reactions are: weakness, flatulence, tremor, agitation, diarrhea, and rhinitis. Venlaxafine Hydrochloride (Venlaxafine Hydrochloride) is a representative drug of 5-HT and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/137A61K47/38A61K47/34A61K47/32A61P25/24
Inventor 林奋王贝高缘
Owner CHINA PHARM UNIV
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