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Diclofenac natrium slowly released capsule and its preparation method

A technology of diclofenac sodium and sustained-release capsules is applied in the directions of drug delivery, non-central analgesics, antipyretics, etc., and can solve the problems of safety, poor compliance and effectiveness, large fluctuation of blood drug concentration, frequent administration and the like, Achieve the effect of avoiding treatment blind spots, less fluctuation of blood concentration, and maintaining quality of life

Inactive Publication Date: 2003-05-07
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is that the blood concentration of the existing common dosage form of diclofenac sodium fluctuates greatly, has a peak-valley phenomenon, requires frequent administration, and has problems of poor safety, compliance and effectiveness.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach 1

[0027] 1. Preparation of blank pellet core:

[0028] Weigh 800g starch through a 100-mesh sieve, mix well, use 15% (W / V) polyvinylpyrrolidone in 50% ethanol as a wetting agent, make a blank pellet core in a coating granulator, and dry at 40°C 8 hours, that's it.

[0029] 2. Preparation of Vegetarian Pills:

[0030] Weigh 50 g of diclofenac sodium, 60 g of starch, and 2.0 g of sodium lauryl sulfate, respectively, and crush them through a 100-mesh sieve, and place the blank pellet core in a coating pan with a rotation speed of 50 rpm. Add the mixture of medicine, starch and sodium lauryl sulfate, spray wetting agent 60% ethanol, and operate alternately until all the powder is added. After adding the medicine, take it out, put it in a tray, and dry it overnight at 60-70°C.

[0031] 3. Coating:

[0032] Weigh 40 g of acrylic resin I and add it to 500 ml of 95% ethanol, and place it overnight. Add 30 g of diethyl phthalate and 0.5 g of titanium dioxide. Put the above-mentioned vegetari...

specific Embodiment approach 2

[0035] 1. Preparation of blank pellet core:

[0036] Weigh 400g starch and 300g dextrin through a 100-mesh sieve, mix them evenly, use 5% (W / V) polyvinylpyrrolidone in 30% ethanol as a wetting agent, and prepare a blank pellet core in a coating granulator , Dry for 5 hours at 40°C, and get it.

[0037] 2. Preparation of Vegetarian Pills:

[0038] Weigh 50 g of diclofenac sodium, 79 g of dextrin, and 1.0 g of sodium dodecyl sulfonate, respectively, and crush them through a 100-mesh sieve, and place the blank pellet core in a coating pan with a rotation speed of 100 rpm. Add the mixture of the medicine, dextrin and sodium lauryl sulfonate, spray the wetting agent with 90% ethanol, and operate alternately until the powder is completely added. After adding the medicine, take it out, put it in a tray, and dry it overnight at 40-55°C.

[0039] 3. Coating:

[0040] Weigh 50 g of acrylic resin II and add it to 700 ml of 95% ethanol, and place it overnight. Add 10 g of diethyl phthalate an...

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PUM

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Abstract

A slowly-releasing diclofenac sodium capsule is prepared from diclofenac sodium (4.5-6.0 wt.%), excipient (60-90 wt.%), coating (4-10 wt.%), wtting agent (0-10 wt.%), surfactant (0-1 wt.%), plasticizer (0-2 wt.%) and opacifying agent (0-2 wt.%). Its advantages are high curative effect, low by-effect and high durability (12 hrs).

Description

Technical field [0001] The invention relates to a diclofenac sodium sustained-release capsule and a preparation process thereof. Background technique [0002] Diclofenac Sodium (Diclofenac Sodium) is a powerful anti-inflammatory and analgesic with good safety and tolerance. It is an ideal first-line non-steroidal anti-inflammatory analgesic. Its ingredients have become the number one non-steroidal anti-inflammatory analgesic in the world for 16 consecutive years. The results of the use of rheumatism patients in more than 100 countries around the world show that diclofenac sodium has a strong anti-inflammatory and analgesic effect, a low incidence of side effects and a small dosage. However, because the release of diclofenac sodium in the common dosage form cannot be effectively controlled, the blood concentration fluctuates greatly, with peaks and valleys, and frequent administration is required, and the safety, compliance, and effectiveness are poor...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/196A61P29/00
Inventor 晁阳陈静裘福荣
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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