Sodium dichlorophenolate micro-pill pharmaceutical preparation and preparation method thereof

A technology of diclofenac sodium and pellets, applied in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., can solve the problems of unfavorable drug sustained release, absorption, and short duration of curative effect, so as to improve bioavailability and ensure The effect of using the effect

Active Publication Date: 2010-08-18
HANGZHOU SHARPLY PHARM R&D INSTIT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the sustained-release capsule dosage form reduces the irritation to the stomach, it is not conducive to the sustained release and absorption of the drug in the alkaline environment of the small intestine, resulting in a short duration of efficacy
Existing technologies cannot well solve the problem of adverse reactions to the gastrointestinal tract and ensure continuous effectiveness for 24 hours

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: In this example, 1000 g of diclofenac sodium enteric-coated sustained-release pellets were prepared using the following formula:

[0030] Diclofenac sodium 510g, blank ball core (starch) 400g, Ammonio Methacrylate Copolymer Type A 60g, shellac 10g, diethyl phthalate 2g, talcum powder 10g.

[0031] Preparation Process:

[0032] Load the main drug: put the starch pellet core in the coating pan, and adjust the temperature of the coating pan to 25±5°C. Prepare the ethanol solution of Ammonio Methacrylate Copolymer Type A with 95% ethanol, the concentration of Ammonio Methacrylate Copolymer Type A ethanol solution is 12%, regulate the rotating speed of coating pan to be 30 rev / mins, spray Ammonio Methacrylate Copolymer Type A ethanol solution with spray gun, spray The amount is 10-15g per second to moisten the core of the starch pellets, then sprinkle the main drug diclofenac sodium with a spoon, and at the same time ventilate to dry the particles, and pass throu...

Embodiment 2

[0038] Embodiment 2: This embodiment provides a kind of diclofenac sodium pellet-shaped tablet, which is prepared by compressing diclofenac sodium pellets.

[0039] The preparation of pellet is identical with embodiment 1, and adds 10% (w / w) disintegrating agent, the lubricant magnesium stearate of 0.5%; Disintegrating agent can select sodium carboxymethyl starch, cross-linked carboxymethyl cellulose Sulfate sodium, crospovidone, low-substituted hydroxypropyl cellulose, etc., preferably sodium carboxymethyl starch. It is obtained by tableting with an intelligent tablet press.

Embodiment 3

[0040] Example 3: In this example, 1000 g of diclofenac sodium enteric-coated sustained-release pellets were prepared using the following formula:

[0041] Diclofenac sodium 310g Sucrose blank core 600g Polyammonium methacrylate II 50g

[0042] Methacrylic Acid Copolymer Type A 10g Triethyl Citrate 2g Talc Powder 10g

[0043] The preparation process is the same as in Example 1. The obtained pellets were prepared into granules.

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PUM

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Abstract

The invention relates to the pharmaceutical preparation field and in particular to a sodium dichlorophenolate micro-pill pharmaceutical preparation and a preparation method thereof. The micro-pill pharmaceutical preparation is prepared by micro-pills, which is characterized in that the micro-pill is of enteric slow-release micro-pill, the micro-pill consists of a hollow pill core, an active layer and an outer layer lagging cover, the active layer comprises sodium dichlorophenolate, a binding-property slow-release material and a binding-property enteric material, and the outer layer comprises a slow-release material. With the particular process and formula, a release system thereof is made into a unique double slow-release system, i.e. a skeleton-type scattering system is combined with a multi-layer semi-penetration film lagging cover system, so the main medicine can be continuously and stably released in the complicated internal environment of the human body. In addition, by adopting unique auxiliary materials, the micro-pill is free from being dissolved in the stomach and almost has no harm on the gastric mucosa, the medicine is ensured to have continuous effect of 24 hours inside the intestinal tract, the bioavailability is improved, and the application effect of the medicine is ensured.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a diclofenac sodium pellet preparation and a preparation method thereof. Background technique [0002] Diclofenac sodium (diclofenac) is a non-steroidal anti-inflammatory and analgesic drug developed by Ciba-Geigy (Ciba-Geigy) in Switzerland in the late 1960s. This product reduces the synthesis of prostaglandins by inhibiting COX (cyclooxygenase) produced by tissue due to inflammatory response. Reduced local prostaglandin synthesis reduces pain sensation and acts as a peripheral analgesic. Since the patent expired in 1998, it has been listed in Germany, France, the United Kingdom, Japan, Italy, and the United States. At present, it has been sold and clinically used in more than 120 countries including China. Since 1974, the production and sales have grown rapidly year by year. Since 1998, the sales of diclofenac sodium have ranked first in antipyretic and analgesic dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/22A61K9/52A61K31/196A61K47/38A61P29/00
Inventor 范敏华徐海朱旭雷王菲方利明郭晓梅
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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