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Preparation method of tramadol hydrochloride sustained-release preparation

A technology for tramadol hydrochloride and sustained-release preparations, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as changes in drug release, large amount of excipients, and unfavorable oral administration. , to achieve the effect of moderate amount of capsule material, high production efficiency and good sustained release function.

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) 100g tramadol hydrochloride was dissolved in 100g95% ethanol to obtain tramadol hydrochloride ethanol solution, which was designated 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 of the ...

Embodiment 2

[0032] 1) 100g tramadol hydrochloride was dissolved in 110g95% ethanol to obtain tramadol hydrochloride ethanol solution, which was recorded 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 140g of polylactic acid and 30g 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;

[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) 100g tramadol hydrochloride was dissolved in 120g95% ethanol to obtain tramadol hydrochloride ethanol solution, which was designated 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 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 of the so...

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Abstract

The invention provides a preparation method of a tramadol hydrochloride sustained-release preparation. The preparation method comprises the following steps: dissolving tramadol 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 thetemperature 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 thesolution 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 tramadol 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 tramadol 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 susta...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K9/50A61K47/40A61K47/26A61K47/10A61K47/34A61K31/137A61P31/04
CPCA61K9/5036A61K9/5015A61K9/5031A61K31/137
Inventor 刘丽
Owner 刘丽
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