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Preparation method of mizolastine sustained release preparation

A technology of sustained-release preparations and mizolastine, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. High production cost and other issues, to achieve the effect of uniform size, good slow-release function and high production efficiency

Inactive Publication Date: 2018-12-18
刘丽
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in order to obtain ideal mizolastine sustained-release preparations, although the existing preparation methods about mizolastine sustained-release preparations can prolong the dosing interval relative to the quick-release preparations, there are still insufficient sustained-release drug effects. Ideal, multiple administrations are required, the process is complicated, and the production cost is high

Method used

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  • Preparation method of mizolastine sustained release preparation
  • Preparation method of mizolastine sustained release preparation
  • Preparation method of mizolastine sustained release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) Dissolve 100 g of mizolastine in 130 g of 95% ethanol to obtain a mizolastine ethanol solution, which is referred to as solution A;

[0024] 2) Add 130g 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 100g 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 D rises...

Embodiment 2

[0032] 1) Dissolve 100 g of mizolastine in 140 g of 95% ethanol to obtain a mizolastine ethanol solution, which is referred to as solution A;

[0033] 2) Add 140g of hydroxypropyl β-cyclodextrin and 25g of mannitol to solution A to obtain solution B;

[0034] 3) Dissolve 120g of polylactic acid and 30g of polyethylene glycol 200 in 120g 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 solution D rises...

Embodiment 3

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

[0042] 2) Add 150g of hydroxypropyl β-cyclodextrin and 30g of mannitol to solution A to obtain solution B;

[0043] 3) Dissolve 140g of polylactic acid and 40g of polyethylene glycol 200 in 140g 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 D rises...

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Abstract

The invention relates to a preparation method of a mizolastine sustained release preparation. The preparation method is characterized in that the mizolastine is dissolved in 95% ethanol to obtain a solution A, and hydroxypropyl beta-cyclodextrin and mannitol are added in the solution A to obtain a solution B; polylactic acid and polyethylene glycol 200 are dissolved in acetone to obtain a solutionC, the solution B and the solution C are mixed to obtain a solution D, the solution D is transferred to a magnetic stirrer, the temperature of the solution D is cotrolled to 15 DEG C to 18 DEG C, thesolution D is continuously stirred for 12 hours, the temperature of the solution D is lowered to 0 DEG C to 1 DEG C in 2 hours and the solution D is subjected to standing for 12 hours, and the temperature of the solution D is kept to 0 DEG C to 1 DEG C during a standing period; after standing for 12 hours, the solution D is heated, when the temperature of the solution D is increased to 15 DEG C to 18 DEG C, the solution D is continuously stirred, when the temperature of the solution D is controlled at 15 DEG C to 18 DEG C while stirring, after the material is continuously stirred for 12 hours, the mizolastine sustained release preparation is prepared by a low-temperature spray-drying method. The dosage of a capsule material is moderate, the drying temperature of the material is low, the obtained drug-loading preparation is uniform, the drug release is stable, and the mizolastine sustained release preparation has sustained release characteristics.

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 mizolastine sustained-release preparation. 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 sustained releas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/506A61K47/40A61K47/34A61P37/08A61P11/02A61P17/00
CPCA61K9/0053A61K31/506A61K47/34A61K47/40
Inventor 刘丽
Owner 刘丽
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