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Preparation method of diclofenac potassium sustained-release pellet capsule

A technology of diclofenac potassium pills and diclofenac potassium, which is applied in the field of preparation of sustained-release preparations of chemical drugs, can solve problems such as inconvenience, and achieve the effects of less pollution, easy industrial production, and reduced operating time and cost

Active Publication Date: 2009-12-30
ZHEJIANG JINHUA CONBA BIO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the oral dosage form of this drug in the domestic and foreign markets is mainly diclofenac potassium tablets, and the dosage is 100-150 mg per day, divided into 2-3 times, which is very inconvenient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: Preparation of Diclofenac Potassium Sustained-release Pellet Capsules

[0025] (1) Preparation of Diclofenac Potassium Pills: Get Diclofenac Potassium 100g, Microcrystalline Cellulose 200g and mix evenly, the mixture is made soft material with 2% hydroxypropyl methylcellulose (HPMC) E5 aqueous solution 160ml, then extrude The machine extruded at a frequency of 30Hz to obtain strips, and the resulting strips were placed in a spheronizer, spheronized at 30Hz for 3 minutes, then spheronized at 60Hz for 5 minutes, dried at 40°C for 12 hours, and passed through a 18-32 mesh sieve to obtain vegetarian pills;

[0026] (2) Pack isolation coat: the above-mentioned plain pills are wrapped with isolation coat, and the material of isolation coat is: ethyl cellulose (10cp) and polyvinylpyrrolidone (PVP K30) are mixed by weight gram ratio 5: 1, and with 95% ethanol aqueous solution Dissolve, or dissolve with absolute ethanol, prepare a solution with a concentration of 3...

Embodiment 2

[0031] (1) Preparation of Diclofenac Potassium Pills: Get Diclofenac Potassium 100g, Mannitol 150g, Lactose 50g, and mix well, the mixture is made soft material with 3% polyvinylpyrrolidone (PVP K30) aqueous solution 150ml, then in extruder with Extruded at a frequency of 50Hz to obtain strips, the obtained strips were placed in a spheronizer, spheronized at a frequency of 25Hz for 3 minutes, then spheronized at 60Hz for 10 minutes, dried at 40°C for 12 hours, and passed through a 24-40 mesh sieve to obtain diclofenac potassium pills;

[0032] (2) Isolation coat layer of vegetarian pills: wrap the above-mentioned vegetarian pills with isolation coats, use a coating pot to melt the coats with stearic acid, heat the vegetarian pills in the coating pot to 60°C, add stearic acid to make them uniform Melt on the surface of the plain pill, calculate the weight gain of the bag isolation coat as 3% of the weight of the plain pill with stearic acid, cool after the stearic acid is added,...

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Abstract

The invention relates to a preparation method of diclofenac potassium sustained-release pellet capsule. The preparation method sequentially comprises: preparing diclofenac potassium hormone pill by an extrusion-spheronization mothod, packing an isolation layer, packing a sustained-release layer and encapsulating the capsule, extruding the capsule into a stick on the condition that the set frequency of an extruder is 10-100Hz, and spheronizing the capsule for 3-30min on the condition that the frequency of a spheronization machine is 20-150Hz. In the invention, flying dust does not occur, the pollution is little and the production process meets the requirement of GMP; after the prepared diclofenac potassium sustained-release capsule is taken orally, the plasma concentration of the drug is gentle with small fluctuation and the capsule has good sustained-release effect.

Description

(1) Technical field: [0001] The invention relates to a preparation method of an oral chemical drug sustained-release preparation, in particular to a method for preparing diclofenac potassium sustained-release pellet capsules by extrusion and spheronization. (two) background technology: [0002] Diclofenac potassium is a third-generation potent anthranilic acid non-steroidal anti-inflammatory analgesic. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the transformation of arachidonic acid into prostaglandins. At the same time, it can also promote the combination of arachidonic acid and triglyceride (triacylglycerol), reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes. At present, the oral dosage form of this drug in the domestic and foreign markets is mainly diclofenac potassium tablets, and the usage and dosage are 100-150 mg per day, divided into 2-3 times, which is very inc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/58A61K9/56A61K9/50A61K31/196A61K47/38A61K47/36A61K47/32A61P29/00
Inventor 金庆平刘旭东李旭东陆纪宏应志洪唐星
Owner ZHEJIANG JINHUA CONBA BIO PHARM CO LTD
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