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Oral sustained-release preparation of diclofenac sodium and preparation method of oral sustained-release preparation

A technology for diclofenac sodium and sustained-release preparations, which is applied to the oral sustained-release preparations of diclofenac sodium and the field of preparation thereof, can solve the problems of many preparation steps, complicated processes, long coating time, etc. Simple process, good slow release effect

Pending Publication Date: 2021-04-02
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Diclofenac sodium oral sustained-release preparations are mostly produced by wet granulation process, direct tablet compression process, or film-controlled release process for coating, but the preparation steps are many and the process is complicated, resulting in low production yield, and the obtained diclofenac Sodium oral sustained-release preparations have the problem of fast drug release in the early stage or incomplete release in the late stage, and the release is relatively unstable
[0006] In the prior art, CN 112022813 A discloses a preparation method of diclofenac sodium sustained-release pellets and pellets, which mixes diclofenac sodium, waxy materials, and fillers, and heats to obtain a slurry-like mixture, which is then treated with dry ice or liquid nitrogen cooling to make sustained-release pellets or pellets, the production process is complicated and energy consumption is high
Patent CN 110101686 A discloses a diclofenac sodium sustained-release capsule and its preparation process, but the coating time is long, the organic solvent is difficult to remove, and the yield is low, so it is difficult to realize large-scale production

Method used

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  • Oral sustained-release preparation of diclofenac sodium and preparation method of oral sustained-release preparation
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  • Oral sustained-release preparation of diclofenac sodium and preparation method of oral sustained-release preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] This embodiment provides an oral sustained-release preparation containing diclofenac sodium and a preparation method thereof, and the sustained-release preparation is obtained by the preparation steps of the prescriptions in Table 1 and Table 2:

[0028] Table 1

[0029]

[0030] Table 2

[0031]

[0032]

[0033] Preparation Process:

[0034] Dissolve diclofenac sodium and PVP K25 in the inner layer solvent ethanol to obtain the inner layer solution; dissolve PLGA75 / 25 in the outer layer solvent acetone to obtain the outer layer solution; use the coaxial electrostatic spray method to separate the inner layer solution and the outer layer solvent Placed in a syringe, slowly output by a constant-current pump, sprayed out through a coaxial nozzle under the action of a high-voltage electric field, and collected by aluminum foil to obtain the diclofenac sodium microcapsules. Take an appropriate amount of microcapsules, add lactose, magnesium stearate, and croscarm...

Embodiment 2

[0036] This embodiment provides a kind of oral sustained-release preparation containing diclofenac sodium and its preparation method, and described sustained-release preparation is obtained by the prescription and preparation steps of Table 3 and Table 4:

[0037] table 3

[0038]

[0039] Table 4

[0040]

[0041] Preparation Process:

[0042] Dissolve diclofenac sodium and PVP K25 in the inner layer solvent ethanol to obtain the inner layer solution; dissolve PLGA75 / 25 in the outer layer solvent acetone to obtain the outer layer solution; use the coaxial electrostatic spray method to separate the inner layer solution and the outer layer solvent Placed in a syringe, slowly output by a constant-current pump, sprayed out through a coaxial nozzle under the action of a high-voltage electric field, and collected by aluminum foil to obtain the diclofenac sodium microcapsules. Take an appropriate amount of microcapsules, add microcrystalline cellulose, magnesium stearate, an...

Embodiment 3

[0044] This embodiment provides an oral sustained-release preparation containing diclofenac sodium and a preparation method thereof, and the sustained-release preparation is obtained by the preparation steps of the prescriptions in Table 5 and Table 6:

[0045] table 5

[0046]

[0047] Table 6

[0048]

[0049] Preparation Process:

[0050] Dissolve diclofenac sodium and PVP K25 in the inner layer solvent ethanol to obtain the inner layer solution; dissolve PLGA75 / 25 in the outer layer solvent acetone to obtain the outer layer solution; use the coaxial electrostatic spray method to separate the inner layer solution and the outer layer solvent Placed in a syringe, slowly output by a constant-current pump, sprayed out through a coaxial nozzle under the action of a high-voltage electric field, and collected by aluminum foil to obtain the diclofenac sodium microcapsules. Take an appropriate amount of microcapsules, add lactose, microcrystalline cellulose, magnesium steara...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, particularly relates to an oral sustained-release preparation containing diclofenac sodium, and discloses a preparation method of the oral sustained-release preparation. The preparation method comprises the following steps: dissolving diclofenac sodium and an inner-layer carrier in an inner-layer solvent, dissolving an outer-layer carrier in an outer-layer solvent, preparing diclofenac sodium microcapsules with coaxial electrostatic spraying method, adding a filler, carrying out uniform mixing and granulating, and adding other pharmaceutical auxiliary materials for tabletting to obtain the oral sustained-release preparation. According to the oral sustained-release preparation containing diclofenac sodium and the preparation method of the oral sustained-release preparation, the electrostatic spraying technology is creatively applied to the diclofenac sodium sustained-release preparation, the sustained-release effect is good, the gastrointestinal tract side reaction can be effectively reduced, the compliance of patients is improved, and the diclofenac sodium sustained-release preparation is suitable for therequirements of clinical medication development.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an oral sustained-release preparation of diclofenac sodium and a preparation method thereof. Background technique [0002] Arthritis and rheumatoid arthritis are autoimmune diseases involving polyarticular synovial lesions, with a worldwide incidence of about 1%. Its pathogenesis is complex and influenced by genetic and environmental factors. The basic lesions of rheumatoid arthritis are synoviocyte hyperplasia, thickening of lining layer, infiltration of various inflammatory cells, formation of pannus and destruction of cartilage and bone tissue, eventually leading to joint deformity and loss of function. Arthritis and rheumatoid arthritis seriously affect people's physical and mental health. [0003] Diclofenac sodium is an analgesic, mainly used to treat arthritis or rheumatism. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/196A61K47/32A61K47/34A61P19/02A61P29/00
CPCA61K9/2027A61K9/204A61K31/196A61P19/02A61P29/00
Inventor 朱学东陈女贞封思阳周礼明
Owner 南京易亨制药有限公司
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