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Preparation method of diclofenac sodium sustained release preparation

A technology of diclofenac sodium and sustained-release preparations, applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., can solve problems such as changes in drug release, unfavorable oral administration, and large dosage of excipients, and achieve stable release and sustained-release functions. Good and productive effect

Inactive Publication Date: 2018-12-14
刘丽
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the dosage forms produced by this technology have the risk of sudden release and changes in drug release during storage, and the amount of excipients is large, which is not conducive to oral administration

Method used

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  • Preparation method of diclofenac sodium sustained release preparation
  • Preparation method of diclofenac sodium sustained release preparation
  • Preparation method of diclofenac sodium sustained release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) Dissolve 100g of diclofenac sodium in 100g of 95% ethanol to obtain diclofenac sodium ethanol solution, which is referred to as solution A;

[0024] 2) Add 150g of hydroxypropyl β-cyclodextrin and 20g of mannitol to solution A to obtain solution B;

[0025] 3) Dissolve 100g of polylactic acid and 20g of polyethylene glycol 200 in 180g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which is referred to as solution C;

[0026] 4) Mix solution B and solution C to obtain solution D;

[0027] 5) Transfer solution D to a magnetic stirrer, control the temperature of solution D at 15°C to 18°C, continuously stir solution D for 12 hours, then reduce the temperature of solution D to 0°C to 1°C within 2 hours and let it stand for 12 hours. Hours, keep the temperature of solution D at 0°C to 1°C during the standing period;

[0028] 6) Heat the solution D obtained in step 5, and stir continuously for 12 hours when the temperature of the solution...

Embodiment 2

[0032] 1) Dissolve 100g of diclofenac sodium in 130g of 95% ethanol to obtain diclofenac sodium ethanol solution, which is referred to as solution A;

[0033] 2) Add 180g of hydroxypropyl β-cyclodextrin and 25g of mannitol to solution A to obtain solution B;

[0034] 3) 110g of polylactic acid and 25g of polyethylene glycol 200 were dissolved in 190g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which was designated as solution C;

[0035] 4) Mix solution B and solution C to obtain solution D;

[0036] 5) Transfer solution D to a magnetic stirrer, control the temperature of solution D at 15°C to 18°C, continuously stir solution D for 12 hours, then reduce the temperature of solution D to 0°C to 1°C within 2 hours and let it stand for 12 hours. Hours, keep the temperature of solution D at 0°C to 1°C during the standing period;

[0037] 6) Heat the solution D obtained in step 5, and stir continuously for 12 hours when the temperature of the so...

Embodiment 3

[0041] 1) Dissolve 100g of diclofenac sodium in 150g of 95% ethanol to obtain diclofenac sodium ethanol solution, which is referred to as solution A;

[0042] 2) Add 200g of hydroxypropyl β-cyclodextrin and 30g of mannitol to solution A to obtain solution B;

[0043] 3) Dissolve 120g of polylactic acid and 30g of polyethylene glycol 200 in 200g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which is referred to as solution C;

[0044] 4) Mix solution B and solution C to obtain solution D;

[0045] 5) Transfer solution D to a magnetic stirrer, control the temperature of solution D at 15°C to 18°C, continuously stir solution D for 12 hours, then reduce the temperature of solution D to 0°C to 1°C within 2 hours and let it stand for 12 hours. Hours, keep the temperature of solution D at 0°C to 1°C during the standing period;

[0046] 6) Heat the solution D obtained in step 5, and stir continuously for 12 hours when the temperature of the solution...

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Abstract

The invention provides a preparation method of a diclofenac sodium sustained release preparation. The preparation method comprises the following steps: dissolving diclofenac sodium in 95% ethanol to obtain a solution A and adding hydroxypropyl-beta-cyclodextrin and mannitol into the solution A to obtain a solution B; dissolving polylactic acid and polyethylene glycol 200 in acetone to obtain a solution C, mixing the solutions B and C to obtain a solution D, transferring the solution D to a magnetic stirrer to be continuously stirred for 12 hours, then reducing the temperature of the solution Dwithin two hours to 0-1 DEG C and leaving the solution to stand still for 12 hours, and keeping the temperature of the solution D at 0-1 DEG C in the standing still period; after leaving the solutionto stand still for 12 hours, heating the solution D, continuously stirring the solution D when the temperature is raised to 15-18 DEG C, controlling the temperature of the solution D at 15-18 DEG C during stirring, and continuously stirring the solution for 12 hours and preparing the diclofenac sodium sustained release preparation according to a low-temperature spraying and drying method. The capsule wall material is proper in dosage, the drying temperature of the material is low, and the prepared drug-loading preparation has the characteristics of being uniform in size, stable to release drug and slow to release.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation of a drug-loaded polymer preparation, in particular to a preparation method of a sustained-release preparation of diclofenac sodium. Background technique: [0002] Hydroxypropyl β-cyclodextrin is an ideal injection solubilizer and pharmaceutical excipient in the pharmaceutical industry. It can improve the water solubility of insoluble drugs, increase the stability of drugs, improve the bioavailability of drugs, increase the curative effect of drugs or reduce the dosage, adjust or control the release speed of drugs, and reduce the toxic and side effects of drugs. It can be used as a carrier for oral drugs, injections, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), transdermal drug delivery systems, and lipophilic targeted drugs. [0003] Polylactic acid is highly safe to the human body, has good biocompatibility and biodegradability, and is widely used in drug sustain...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/40A61K47/34A61K47/10A61K47/26A61K31/196A61P29/00
CPCA61K9/1652A61K9/1623A61K9/1641A61K9/1647A61K31/196
Inventor 刘丽
Owner 刘丽
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