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Water-soluble medicine framework sustained release tablet and preparation method thereof

A sustained-release tablet and matrix technology, which is applied in the field of preparation of water-soluble drug matrix sustained-release tablets, can solve the problems of no interaction, narrow adjustment range, and few adjustment channels, and achieve low cost, reduced production cost, and simple process Effect

Active Publication Date: 2013-07-10
南京斯泰尔医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The above solution to the polyoxyethylene matrix sustained-release tablet is to adjust the release of the drug by adding substances of different types and viscosities, without interaction between the substances, the regulation is single, the regulation method is few, and the regulation range is narrow

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Prescription 1:

[0034] Metoprolol Tartrate 100g Polyoxyethylene 337g Magnesium Stearate 6g

[0035] Preparation Process:

[0036] 1) Weigh the prescribed amount of metoprolol tartrate and polyoxyethylene, grind them finely, pass through an 80-mesh sieve, and set aside. 2) Mix finely ground metoprolol tartrate and polyoxyethylene evenly. 3) Finally, add the magnesium stearate of the prescribed amount, mix and compress evenly.

[0037] Release Determination:

[0038] Release medium: 900ml; basket rotation speed: 100rpm / min; temperature: 37±0.5°C. According to Pharmacopoeia 2010 edition appendix release test method 1, take samples (10ml) at the scheduled time respectively, add 10ml of liquid at the same time, filter through a 0.45μm microporous membrane, take the subsequent filtrate, measure the absorption value A at 274nm, and calculate the concentration and accumulation according to the calibration curve Drug release percentage Q. For the first 2 hours, use pH 1....

Embodiment 2

[0067] prescription:

[0068] Alfuzosin Hydrochloride 5g Polyoxyethylene 30g Carbomer 60g

[0069] Sodium bicarbonate 20g Magnesium stearate 1g

[0070] Preparation Process:

[0071] 1) Weigh the prescribed amount of alfuzosin hydrochloride, polyoxyethylene, carbomer, and sodium bicarbonate, grind them finely, pass through an 80-mesh sieve, and set aside. 2) First mix finely ground alfuzosin hydrochloride and polyoxyethylene evenly, then add carbomer and sodium bicarbonate and mix evenly. 3) Finally, add the magnesium stearate of the prescribed amount, mix and compress evenly.

[0072] Release Determination:

[0073] Release medium: 900ml; basket rotation speed: 100rpm / min; temperature: 37±0.5°C. According to the Pharmacopoeia 2010 edition appendix release test method 1, samples (10ml) were taken at the scheduled time respectively, and 10ml of liquid was supplemented at the same time, filtered through a 0.45μm microporous membrane, and the subsequent filtrate was taken, a...

Embodiment 3

[0079] prescription:

[0080] Diltiazem hydrochloride 200g Polyoxyethylene 200g Polymethacrylic acid 150g

[0081] Sodium Carbonate 180g Magnesium Stearate 10g

[0082] Preparation Process:

[0083] 1) Weigh the diltiazem hydrochloride, polyoxyethylene, polymethacrylic acid, and sodium carbonate in the prescribed amount, grind them finely, pass through an 80-mesh sieve, and set aside. 2) Mix finely ground diltiazem hydrochloride and polyoxyethylene first, then add polymethacrylic acid and sodium carbonate and mix evenly. 3) Finally, add the magnesium stearate of the prescribed amount, mix and compress evenly.

[0084] Release Determination:

[0085] Release medium: 900ml; basket rotation speed: 100rpm / min; temperature: 37±0.5°C. According to the Pharmacopoeia 2010 edition appendix release test method 1, samples (10ml) were taken at the scheduled time respectively, and 10ml of liquid was supplemented at the same time, filtered through a 0.45μm microporous membrane, and the...

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PUM

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Abstract

The invention belongs to the field of medicine preparation, and provides a water-soluble medicine framework sustained release tablet. Through auxiliary material combination of a specific ratio, the framework sustained release tablet is prepared by adopting a direct compression method. On the basis of an ordinary polyoxyethylene framework tablet, an adjusting medicine release substance which can have mutual action with unshared electron pairs on ether oxygen bonds of polyoxyethylene and an inorganic salt auxiliary material which can affect the viscosity are added, a lubricant is further added, direct compression is carried out so as to prepare the novel framework sustained release tablet. The medicine can be uniformly released within 24 hours, the defects that the preparation process is complex, the sudden release at the early period and the release at the later period in medicine release are not complete, and the like, are overcome, and not only is the release effect ideal, but also the process is simple, the cost is low, and the industrialized production is facilitated.

Description

technical field [0001] The invention relates to the field of preparation of water-soluble drug matrix sustained-release tablets. Polyoxyethylene and drug release-adjusting substances are used as the main matrix materials to improve the sustained-release performance of the tablet and simplify the preparation process, which can achieve a 24-hour long-acting sustained-release effect. . Background technique [0002] Polyethylene oxide (PEO) is a water-soluble polymer produced by catalytic polymerization of ethylene oxide. It is a white crystalline powder with high expansibility, thermoplasticity and solubility in water. It can be used as a commonly used hydrophilic gel matrix material. PEO has excellent compatibility, fluidity, compressibility, and stability. medicine system. [0003] It is reported in the literature that polyoxyethylene alone is used as the skeleton material to make sustained-release tablets, which cannot reach near zero-order drug release. Adding different...

Claims

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Application Information

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IPC IPC(8): A61K47/34A61K9/22
Inventor 姚静周建平王福坚
Owner 南京斯泰尔医药科技有限公司
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