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Preparation method of pseudoephedrine hydrochloride sustained-release preparation

A technology of pseudoephedrine hydrochloride and slow-release preparations, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, and medical preparations containing active ingredients, etc. It can solve problems such as unfavorable oral administration, large amount of excipients, and changes in drug release. Good slow-release function, high production efficiency and moderate dosage

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 pseudoephedrine hydrochloride sustained-release preparation
  • Preparation method of pseudoephedrine hydrochloride sustained-release preparation
  • Preparation method of pseudoephedrine hydrochloride sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) Dissolve 100 g of pseudoephedrine hydrochloride in 120 g of 95% ethanol to obtain an ethanol solution of pseudoephedrine hydrochloride, which is recorded as solution A;

[0024] 2) Add 120g of hydroxypropyl β-cyclodextrin and 20g of mannitol to solution A to obtain solution B;

[0025] 3) Dissolve 120g of polylactic acid and 20g of polyethylene glycol 200 in 120g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which is recorded 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℃~18℃, continuously stir solution D for 12 hours, and then reduce the temperature of solution D to 0℃~1℃ within 2 hours and let it stand for 12 Keep the temperature of solution D at 0℃~1℃ during standing;

[0028] 6) Heat the solution D obtained in step 5, and when the temperature of the solution D rises to 15°C-18°C, continue stirring for 12 hour...

Embodiment 2

[0032] 1) Dissolve 100 g of pseudoephedrine hydrochloride in 125 g of 95% ethanol to obtain an ethanol solution of pseudoephedrine hydrochloride, which is recorded as solution A;

[0033] 2) Add 125g of hydroxypropyl β-cyclodextrin and 25g of mannitol to solution A to obtain solution B;

[0034] 3) Dissolve 135g polylactic acid and 30g polyethylene glycol 200 in 135g acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which is recorded 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℃~18℃, continuously stir solution D for 12 hours, and then reduce the temperature of solution D to 0℃~1℃ within 2 hours and let it stand for 12 Keep the temperature of solution D at 0℃~1℃ during standing;

[0037] 6) Heat the solution D obtained in step 5, and when the temperature of the solution D rises to 15°C-18°C, continue stirring for 12 hours, and th...

Embodiment 3

[0041] 1) Dissolve 100g of pseudoephedrine hydrochloride in 130g of 95% ethanol to obtain an ethanol solution of pseudoephedrine hydrochloride, which is recorded as solution A;

[0042] 2) Add 130g of hydroxypropyl β-cyclodextrin and 30g of mannitol to solution A to obtain solution B;

[0043] 3) Dissolve 150 g of polylactic acid and 40 g of polyethylene glycol 200 in 150 g of acetone to obtain a solution of polylactic acid and polyethylene glycol 200, which is recorded 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℃~18℃, continuously stir solution D for 12 hours, and then reduce the temperature of solution D to 0℃~1℃ within 2 hours and let it stand for 12 Keep the temperature of solution D at 0℃~1℃ during standing;

[0046] 6) Heat the solution D obtained in step 5, and when the temperature of the solution D rises to 15°C-18°C, continue stirring for 12 hou...

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Abstract

The invention provides a preparation method of a pseudoephedrine hydrochloride sustained-release preparation. The preparation method comprises the following steps: dissolving pseudoephedrine hydrochloride 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 solution B with the solution C to obtain a solution D, transferring the solution D to a magnetic stirrer, continuously stirring the solution D for 12 hours, lowering the temperature of the solution D to 0-1 DEG C within 2 hours, allowing to stand still for 12 hours, and maintaining the temperature of the solution D at 0-1 DEG C during the standing period; heating the solution D after standing till for 12 hours, continuously stirring when the temperature of the solution D is raised to 15-18 DEG C, controlling the temperature of the solution D at 15-18 DEG C when stirring, and preparing the pseudoephedrine hydrochloride sustained-release preparation with a low-temperature spray drying method after continuously stirring for 12 hours. According to the invention, the dosage of a capsule wall material is moderate, the drying temperature of materials is low, and the prepared drug-loading preparation is uniform in size and stable in drug release, and has the characteristic of slow release.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation of a drug-carrying polymer preparation, in particular to a preparation method of a pseudoephedrine hydrochloride 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 poorly soluble drugs, increase drug stability, improve drug bioavailability, increase the efficacy of the drug or reduce the dosage, adjust or control the release rate of the drug, and reduce the toxic side effects of the drug. It can be used for oral drugs, injections, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), transdermal drug delivery systems, and lipophilic targeted drug carriers. [0003] Polylactic acid is highly safe to the human body, has good biocompatibility and biodegradability, and is widely used in sustained drug release. At...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/14A61K47/40A61K47/34A61K47/10A61K31/137A61P11/02A61P37/08A61P11/06
CPCA61K9/146A61K31/137
Inventor 刘丽
Owner 刘丽
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