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Iguratimod sustained-release capsules and preparation method thereof

A technology of capsules and sustained-release pellets, applied in the field of pharmaceutical preparations, can solve the problems of large fluctuation of blood drug concentration, frequent administration, peak-to-valley phenomenon, etc.

Active Publication Date: 2021-04-27
JIANGSU SIMCERE PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is that the blood drug concentration of the existing iguratimod common dosage form fluctuates greatly, has a peak-valley phenomenon, requires frequent administration, and has poor safety, compliance and effectiveness.

Method used

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  • Iguratimod sustained-release capsules and preparation method thereof
  • Iguratimod sustained-release capsules and preparation method thereof
  • Iguratimod sustained-release capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1 A kind of iguratimod sustained-release capsule and preparation method thereof

[0036] iguratimod extended-release capsules, including extended-release pellets.

[0037] Composition of sustained-release pellets, unit (g):

[0038]

[0039] Preparation Process

[0040] Preparation of the active drug layer: Mix and grind the prescribed amount of iguratimod and microcrystalline cellulose through a 100 sieve for three times, add povidone k30 into water and stir to obtain a 5% binder solution. Add the microcrystalline cellulose core (24-30 mesh) into the coating granulator, the speed of the spray pump starts at 6rpm, wetting for 2-3 minutes, the speed of the main machine is 180rpm, the spray pressure is 0.15Mpa, and the blast volume is 6L / min, the powder supply speed is 5rpm, adjust the speed of the spray pump and the powder supply speed according to the motion state of the pellets and the powder supply state, collect the 16-20 mesh pellets, and dry them a...

Embodiment 2

[0043] Embodiment 2 A kind of iguratimod sustained-release capsule and preparation method thereof

[0044] iguratimod extended-release capsules, including extended-release pellets.

[0045] Composition of sustained-release pellets, unit (g):

[0046]

[0047] Preparation Process

[0048] Preparation of the active drug layer: the prescribed amount of iguratimod, microcrystalline cellulose, and lactose were mixed and ground through a 100 sieve for three times, and povidone k30 was added to water to obtain a 5% binder solution. Add 400g of sucrose ball cores (25-30 mesh) into the coating granulator, the speed of the spray pump is 5rpm at the beginning, wetting for 5min, the speed of the main machine is 200rpm, the spray pressure is 0.2Mpa, and the blast volume is 8L / min. The powder supply speed is 7rpm. Adjust the speed of the spray pump and the powder supply speed according to the movement state of the pellets, collect the pellets of 16-20 meshes, and dry them at 50°C for 4...

Embodiment 3

[0051] Embodiment 3 A kind of iguratimod sustained-release capsule and preparation method thereof

[0052] iguratimod extended-release capsules, including extended-release pellets.

[0053] Composition of sustained-release pellets, unit (g):

[0054]

[0055] Preparation Process

[0056] Preparation of the active drug layer: the prescribed amount of iguratimod, powdered microcrystalline cellulose and lactose were mixed and ground through a 100 sieve for three times, and povidone k30 was added to water to obtain a 6% binder solution. Add 420g of sucrose ball cores (25-30 mesh) into the coating granulator, the speed of the spray pump is 8rpm at the beginning, wetting for 5min, the speed of the main machine is 220rpm, the spray pressure is 0.2Mpa, and the blast volume is 10L / min. The powder supply speed is 8rpm, adjust the speed of the spray pump and the powder supply speed according to the movement state of the pellets, collect the 16-20 mesh pellets, and dry them at 50°C f...

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Abstract

The invention relates to an iguratimod sustained-release capsule and a preparation method thereof. The iguratimod sustained-release capsules of the present invention are made of iguratimod sustained-release pellets and then filled with capsules. The iguratimod-containing main drug layer and the isolation layer outside the pellet core are composed of a slow-release coating layer. The technology of the iguratimod sustained-release capsules of the present invention is simple and easy to implement, has good reproducibility, has obvious sustained-release properties, can maintain a relatively stable blood drug concentration and a longer action time, and greatly improves the safety of the drug , compliance, avoiding the disadvantages of frequent administration, shortening the treatment time and the number of consultations, and reducing the cost of treatment.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an iguratimod sustained-release capsule and a preparation method thereof. Background technique [0002] Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic erosive arthritis, which is generally believed to be closely related to genetic, environmental, infection and other factors. Erosive lesions of the joints will develop within 1 to 2 years. According to current research, the pathogenesis of RA is related to CD4 + T cells and B cells react with antigen presenting cells to produce autoantibodies, and their inflammatory mediators include tumor necrosis factor-α (TNFα), interleukin-1 (IL-1), interleukin-6 (IL-6) and protease etc. Currently, RA treatment is divided into two categories of drugs, non-steroidal anti-inflammatory analgesics (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs). The main effect of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/56A61K31/352A61P19/02A61P29/00
CPCA61K9/5042A61K9/5078A61K31/352
Inventor 林巧平施必伟李晓强任晋生李玲
Owner JIANGSU SIMCERE PHARMA
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