Preparation method of metformin hydrochloride sustained-release preparation

A technology of metformin hydrochloride and sustained-release preparations, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, and medical preparations containing active ingredients, etc., which can solve problems such as unfavorable oral administration, changes in drug release, and large amount of excipients. Good slow-release function, moderate dosage 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 metformin hydrochloride sustained-release preparation
  • Preparation method of metformin hydrochloride sustained-release preparation
  • Preparation method of metformin hydrochloride sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] 1) 100g metformin hydrochloride is dissolved in 120g95% ethanol to obtain metformin hydrochloride ethanol solution, which is denoted as solution A;

[0024] 2) Add 100g 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 sol...

Embodiment 2

[0032] 1) 100g metformin hydrochloride is dissolved in 130g95% ethanol to obtain metformin hydrochloride ethanol solution, which is designated as solution A;

[0033] 2) Add 120g of hydroxypropyl β-cyclodextrin and 25g of mannitol to solution A to obtain solution B;

[0034] 3) Dissolve 130g of polylactic acid and 30g of polyethylene glycol 200 in 130g 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 ...

Embodiment 3

[0041] 1) 100g metformin hydrochloride is dissolved in 150g95% ethanol to obtain metformin hydrochloride ethanol solution, which is designated 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 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 ...

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Abstract

The invention provides a preparation method of a metformin hydrochloride sustained-release preparation. The preparation method comprises the following steps: dissolving metformin 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 toobtain 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 whenstirring, and preparing the metformin hydrochloride sustained-release preparation with a low-temperature spray drying method after continuously stirring for 12 hours. According to the invention, thedosage 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 metformin 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 sustai...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K47/40A61K47/34A61K47/26A61K47/10A61K31/155A61P3/10A61P3/06
CPCA61K9/146A61K9/145A61K31/155
Inventor 刘丽
Owner 刘丽
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