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Method for preparing magnesium valproate slow-release micro-capsule

A technology of magnesium valproate and sustained-release preparations, which is applied to non-active ingredients in medical preparations, pharmaceutical formulations, anhydride/acid/halide active ingredients, etc., and can solve changes in drug release, unfavorable oral administration, and large dosage of excipients, etc. problem, to achieve the effect of stable release, good slow-release function and high production efficiency

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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  • Method for preparing magnesium valproate slow-release micro-capsule
  • Method for preparing magnesium valproate slow-release micro-capsule
  • Method for preparing magnesium valproate slow-release micro-capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) Dissolve 200g of magnesium valproate in 300g of 95% ethanol to obtain a solution of magnesium valproate in ethanol, which is referred to as solution A;

[0024] 2) Add 200g hydroxypropyl β-cyclodextrin and 40g mannitol to solution A to obtain solution B;

[0025] 3) Dissolve 300g of polylactic acid and 40g of polyethylene glycol 200 in 240g 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 so...

Embodiment 2

[0032] 1) Dissolve 200g of magnesium valproate in 360g of 95% ethanol to obtain a solution of magnesium valproate in ethanol, which is referred to as solution A;

[0033] 2) Add 260g hydroxypropyl β-cyclodextrin and 50g mannitol to solution A to obtain solution B;

[0034] 3) Dissolve 330g of polylactic acid and 50g of polyethylene glycol 200 in 280g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which is referred to 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 200g of magnesium valproate in 400g of 95% ethanol to obtain a solution of magnesium valproate in ethanol, which is referred to as solution A;

[0042] 2) Add 300g hydroxypropyl β-cyclodextrin and 60g mannitol to solution A to obtain solution B;

[0043] 3) 360g of polylactic acid and 60g of polyethylene glycol 200 were dissolved in 320g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which was designated 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 ...

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Abstract

The invention provides a method for preparing magnesium valproate slow-release micro-capsules. The method comprises the following steps: dissolving magnesium valproate into 95% ethanol so as to obtaina solution A, and putting hydroxypropyl beta-cyclodextrin and mannitol into the solution A so as to obtain a solution B; dissolving polylactic acid and polyethylene glycol 200 into acetone so as to obtain a solution C, mixing the solution B with the solution C so as to obtain a solution D, transferring the solution D into a magnetic stirrer, continuously stirring the solution D for 12 hours, further lowering the temperature of the solution D to 0-1 DEG C within 2 hours, leaving 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 12 hours of standing still, heating the solution D, continuously stirring when the temperature of the solution D is increased to 15-18 DEG C, controlling the temperature of the solution D to 15-18 DEG C in stirring, continuously stirring for 12 hours, and implementing a low-temperature spraying drying method, thereby obtaining a magnesium valproate slow-release preparation. The method is appropriate in core material amount and low in material drying temperature, and the prepared medicine carrying preparation is uniform in size and stable in medicine release and has the characteristic of slow 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 magnesium valproate. 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 susta...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/40A61K47/34A61K47/10A61K47/26A61K31/19A61P25/08
CPCA61K9/1652A61K9/1623A61K9/1641A61K9/1647A61K31/19
Inventor 刘丽
Owner 刘丽