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Naproxen colon-specific drug-release micro pill and preparation method thereof

A colon positioning and naproxen technology, which is applied in sugar-coated pills, pharmaceutical formulations, antipyretics, etc., can solve the problems of poor reliability of time-dependent drug delivery systems, large individual differences in emptying time, etc., and achieve production process operation. Simple and feasible, easy to industrialize large-scale production, high production efficiency

Active Publication Date: 2014-04-09
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The same time-dependent drug delivery system also has its limitations. Although the emptying time of the small intestine is usually fixed at 3-4 hours, the individual differences in the emptying time of the stomach are very large, which has caused the poor reliability of the time-dependent drug delivery system. defect

Method used

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  • Naproxen colon-specific drug-release micro pill and preparation method thereof
  • Naproxen colon-specific drug-release micro pill and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027] Preparation of swelling layer coating solution: Weigh 1 g of hypromellose, add 70 mL of hot water (80° C.) to dissolve it, then add 5 g of croscarmellose sodium, disperse evenly, and add water to 100 mL.

[0028] Preparation of the coating solution for the controlled release layer: Take 50 mL of the ethyl cellulose aqueous dispersion coating solution (surelease), add 3 g of triethyl citrate, 1.5 g of magnesium stearate, homogenize with a homogenizer for 10 minutes, add water to 100mL.

[0029] Preparation of enteric layer coating solution: Take 6.25g of Eudragit L1000 and dissolve it in 80mL of 95% ethanol; take 1.25g of talcum powder and 0.63g of tributyl citrate, add appropriate amount of 95% ethanol, and homogenize with a homogenizer for 10 minutes. Then pour it into the solution of UTEK L100, add 95% ethanol to 100mL.

[0030] Fluidized bed preparation process parameters: coating temperature 35°C, blast frequency 27Hz, spray gun spray pressu...

Embodiment 2

[0033] prescription:

[0034] Preparation of swelling layer coating solution: Weigh 1g of hydroxypropyl cellulose, add 70mL of 95% ethanol to dissolve, then add 5g of croscarmellose sodium starch, after the dispersion is uniform, add 95% ethanol to 100mL.

[0035] Preparation of the coating solution for the controlled release layer: Take 50 mL of the ethylcellulose aqueous dispersion coating solution (aquacoat), add 3 g of dibutyl sebacate, 1.5 g of talcum powder, homogenize with a homogenizer for 10 minutes, add water to 100mL is ready.

[0036] Preparation of enteric layer coating solution: Take Eudragit L30D55 ​​8.67g; take 0.88g of glyceryl monostearate, 801.08g of Tween and 1.76g of triethyl citrate, add appropriate amount of water, and homogenize with a homogenizer for 10 Minutes, then pour into the solution of UTEK L30D55, add water to 100mL.

[0037] Fluidized bed preparation process parameters: coating temperature 50°C, blast frequency 18Hz, spray gun spray pressure...

Embodiment 3

[0040] prescription:

[0041] Preparation of swelling layer coating solution: Weigh 1g of hydroxypropyl cellulose, add 70mL hot water (80°C) to dissolve, then add 5g of crospovidone and 0.5g of sodium lauryl sulfate, after the dispersion is uniform, add water to 100mL.

[0042] Preparation of the coating solution for the controlled release layer: Weigh 25 mL of the ethylcellulose aqueous dispersion coating solution (surelease), add 3 g of polyethylene glycol, 1.5 g of magnesium stearate, homogenize with a homogenizer for 10 minutes, add water to 100mL.

[0043] Preparation of enteric layer coating liquid: Take 29.33g of Eudragit L30D555; take 0.88g of magnesium stearate, 1.08g of sodium lauryl sulfate and 1.76g of triethyl citrate, add appropriate amount of water, and homogenize with a homogenizer Leave it for 10 minutes, then pour it into the solution of UTEK L30D55, and add water to 100mL.

[0044] Fluidized bed preparation process parameters: coating temperature 45°C, bl...

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Abstract

The invention provides a naproxen colon-specific drug-release micro pill and a preparation method thereof, and belongs to the technical field of medicines. The micro pill comprises a pill core, a swelling layer, a controlled release layer and an enteric coated layer. The naproxen colon-specific drug-release micro pill prepared by a fluidized bed coating method can ensure that drugs do not release in the stomach and small intestine to achieve colon-specific rdug-release effects so as to reduce the irritation of naproxen on gastrointestinal mucosa, the process is simple and feasible, the production efficiency is high, the cost is low, and the industrialized production is easy to realize.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a naproxen colon-localized drug-releasing pellet and a preparation method thereof. Background technique [0002] Naproxen is a non-steroidal anti-inflammatory drug, which has anti-inflammatory, antipyretic and analgesic effects, and is a PG synthase inhibitor. It is effective for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, chronic degenerative diseases of the motor system (such as joints, muscles and tendons) and mild to moderate pain such as dysmenorrhea. Moderate pain can be relieved within 1 hour after taking the medicine, and the analgesic effect can last for more than 7 hours. For rheumatoid arthritis and osteoarthritis, it is similar to aspirin. However, naproxen is very irritating to the gastrointestinal tract, it can induce mucosal lesions or promote the occurrence of peptic ulcer, and cause damage to the integrity of gastric and duoden...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/30A61K9/36A61K9/52A61K31/192A61P29/00A61P19/02A61P19/06
Inventor 刘建平王畯霖阚淑玲
Owner CHINA PHARM UNIV
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