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Pellet composition containing diclofenac sodium and preparation method thereof

A technology of diclofenac sodium and its composition, which is applied in the field of capsules containing diclofenac sodium micropills composition and its preparation, can solve the problems of high price, narrow selection, and increased economic burden on patients, and achieve high roundness and low Stable and uniform effect of stimulation and release performance

Inactive Publication Date: 2015-04-15
中盛特医食品(汕头)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, only the German "Diffen" is on the market in China, and its price is too high, which causes difficulties such as increased economic burden for patients and narrow selection.

Method used

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  • Pellet composition containing diclofenac sodium and preparation method thereof
  • Pellet composition containing diclofenac sodium and preparation method thereof
  • Pellet composition containing diclofenac sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033]

[0034] Preparation of pellet core: Mix the prescribed amount of diclofenac sodium, microcrystalline cellulose and micropowder silica gel through a 60-mesh sieve, pour the mixed powder into a high-shear granulator and mix for 3 minutes, then set the speed of the stirring paddle 5rpm, cutting knife rotation speed 15rpm, add 3% povidone to prepare soft material. Put the soft material into the extrusion spheronizer, set the extrusion temperature to 8°C, the extrusion speed to 40rpm, and the spheronization speed to 1500rpm to prepare pellet cores. The obtained pellet cores were dried in an oven at 60°C, and when the water content was lower than 3%, they were sieved with a 24-mesh to 40-mesh sieve to obtain medium-sized pellets.

[0035] Preparation of enteric-coated pellets: Formulate the prescribed amount of enteric-coated material into a coating solution, use 60% ethanol to prepare, set the fluidized bed inlet air temperature to 55°C, spray pressure to 1.8bar, materi...

Embodiment 2

[0039]

[0040] Preparation of pellet core: Mix the prescribed amount of diclofenac sodium, microcrystalline cellulose and micropowder silica gel through a 60-mesh sieve, pour the mixed powder into a high-shear granulator and mix for 3 minutes, then set the speed of the stirring paddle 5rpm, the cutter speed is 15rpm, and 5% povidone is added to prepare the soft material. Put the soft material into the extrusion spheronizer, set the extrusion temperature to 8°C, the extrusion speed to 40rpm, and the spheronization speed to 1000rpm to prepare pellet cores. The obtained pellet cores were dried in an oven at 60°C, and when the water content was lower than 3%, they were sieved with a 24-mesh to 40-mesh sieve to obtain medium-sized pellets.

[0041] Preparation of enteric-coated pellets: Formulate the prescribed amount of enteric-coated material into a coating solution, use 95% ethanol to prepare, set the fluidized bed inlet air temperature to 35°C, spray pressure to 1.8bar, ma...

Embodiment 3

[0045]

[0046] Preparation of pellet core: Mix the prescribed amount of diclofenac sodium, microcrystalline cellulose 101, croscarmellose sodium and micropowder silica gel through an 80-mesh sieve, pour the mixed powder into a high-shear granulator and mix After mixing for 5 minutes, set the rotation speed of the stirring blade to 5 rpm, the rotation speed of the cutting knife to 25 rpm, and add 5% povidone to prepare a soft material. Put the soft material into the extrusion spheronizer, set the extrusion temperature to 8°C, the extrusion speed to 40rpm, and the spheronization speed to 1000rpm to prepare pellet cores. The obtained pellet cores were dried in an oven at 60°C, and when the water content was lower than 3%, they were sieved with a 24-mesh to 40-mesh sieve to obtain medium-sized pellets.

[0047] Preparation of enteric-coated pellets: Formulate the prescribed amount of enteric-coated material into a coating solution, use 95% ethanol to prepare, set the fluidize...

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Abstract

The invention belongs to the field of pharmacy, and particularly relates to a pellet composition containing diclofenac sodium and a preparation method thereof. The composition consists of pellets with different release performances, specifically namely enteric pellets with the total weight of 20-35% and sustained-release pellets with the total weight of 80-65%, wherein the enteric pellets are prepared through enteric coating, the sustained-release pellets are prepared through sustained-release coating, and finally capsules are filled with the enteric pellets and the sustained-release pellets in proportion. The preparation can maintain long blood concentration, and thus the medicine taking frequency is reduced, the adaptability of patients is improved, and the toxic and side effects are reduced. Besides, the adopted preparation technology is easy for large-scale production, little in differences among product batches and high in stability.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a capsule containing diclofenac sodium pellet composition and a preparation method thereof. Background technique [0002] Diclofenac sodium is a non-steroidal anti-inflammatory analgesic first successfully developed by the Swiss Gida-Geigr company. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the transformation of arachidonic acid into prostaglandins. Diclofenac sodium is clinically available in various dosage forms such as tablets, capsules, and suppositories, which are used to relieve joint swelling and pain symptoms of various arthritis such as rheumatoid arthritis, gouty arthritis, and rheumatoid arthritis; soft tissue rheumatic pain, such as shoulder pain, tenosynovitis, myalgia, and traumatic pain after exercise; acute mild and moderate pain, such as post-operation, post-trauma, post-strain, dysmenorrhea, toothache and headache, etc. Fever ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/196A61K47/38A61K47/32A61P29/00A61J3/06
Inventor 孙小虎陈卫张永丰陈丹瑾
Owner 中盛特医食品(汕头)有限公司
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