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Preparation method of tamsulosin hydrochloride sustained-release preparation

A technology for tamsulosin hydrochloride and sustained-release preparations, which can be used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., and can solve problems such as changes in drug release, unfavorable oral administration, and large dosage of excipients. , 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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  • Preparation method of tamsulosin hydrochloride sustained-release preparation
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  • Preparation method of tamsulosin hydrochloride sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) Dissolve 100 g of tamsulosin hydrochloride in 120 g of 95% ethanol to obtain tamsulosin hydrochloride ethanol solution, which is referred to 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 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...

Embodiment 2

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

[0033] 2) Add 130g of hydroxypropyl β-cyclodextrin and 25g of mannitol to solution A to obtain solution B;

[0034] 3) 135g of polylactic acid and 30g of polyethylene glycol 200 were dissolved in 135g 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 tempe...

Embodiment 3

[0041] 1) Dissolve 100 g of tamsulosin hydrochloride in 140 g of 95% ethanol to obtain tamsulosin hydrochloride ethanol solution, which is referred to as solution A;

[0042] 2) Add 140g of hydroxypropyl β-cyclodextrin and 30g of mannitol to solution A to obtain solution B;

[0043] 3) Dissolve 150g of polylactic acid and 40g of polyethylene glycol 200 in 150g 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...

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Abstract

The invention provides a preparation method of a tamsulosin hydrochloride sustained-release preparation. The preparation method comprises the following steps: dissolving tamsulosin 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 acetoneto 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, loweringthe 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; heatingthe 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 tamsulosin 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-loaded polymer preparation, in particular to a preparation method of a tamsulosin 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 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 sus...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/50A61K31/4422A61K47/40A61K47/34A61K47/26A61K47/10A61K31/18A61P13/08
CPCA61K31/18A61K9/5015A61K9/5031A61K9/5036A61K9/5089
Inventor 刘丽
Owner 刘丽
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