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Naproxen slow-release tablet and preparation method thereof

A naproxen and sustained-release tablet technology, applied in the field of drug naproxen, can solve problems such as nonconformity, and achieve the effects of good compatibility, stable release behavior, and low side effects

Inactive Publication Date: 2017-06-23
DIAO GRP CHENGDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The paper also discloses that the average release percentages of the products prepared with this prescription in the phosphate buffer solution of pH 7.4 are: 19.49% in 1h, 48.64% in 3h, 73.25% in 5h, and 98.24% in 8h. The 1h 5%~15%, 6h 25%~45%, 12h 45%~70%, 24h 70% or more stipulated in the national drug standard WS1-(X-140)-2003Z of Naproxen Sustained-release Tablets do not meet the current National Drug Standard Requirements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Naproxen 250 g

[0032] Hypromellose 45g

[0033] Lactose 140g

[0034] Calcium bicarbonate 8g

[0035] Talc powder 2g

[0036] Magnesium stearate 1g

[0037] Povidone K30 solution 6-20g

[0038] Preparation method: Take 250g of naproxen, 45g of hypromellose, 8g of calcium bicarbonate, and 40g of lactose, mix evenly, add the prepared povidone K30 solution to make soft material, and pass the soft material through a 16-mesh sieve to make wet granules , dried at 90-105°C, after the dry granules are sized, add 2 g of talc powder and 1 g of magnesium stearate, mix evenly, press into tablets, and coat.

Embodiment 2

[0040] Naproxen 250 g

[0041] Hypromellose 90g

[0042] Lactose 90g

[0043] Calcium bicarbonate 15g

[0044] Talc powder 5g

[0045] Magnesium stearate 3g

[0046] Povidone K30 6-20g

[0047] Preparation method: Take 250g of naproxen, 90g of hypromellose, 15g of calcium bicarbonate, and 90g of lactose and mix evenly, add povidone K30 solution to make soft material, and pass the soft material through a 16-mesh sieve to make wet granules. Dry at -105°C, after the dry granules are sized, add 5 g of talc powder and 3 g of magnesium stearate, mix evenly, press into tablets, and coat.

Embodiment 3

[0049] Naproxen 250 g

[0050] Hypromellose 150g

[0051] Lactose 30g

[0052] Calcium bicarbonate 25g

[0053] Talc powder 8g

[0054] Magnesium Stearate 4g

[0055] Povidone K30 6-20g

[0056] Preparation method: Take 250g of naproxen, 150g of hypromellose, 25g of calcium bicarbonate, and 150g of lactose and mix evenly, add povidone K30 solution to make a soft material, and pass the soft material through a 16-mesh sieve to make wet granules. Dry at -105°C, after the dry granules are sized, add 8 g of talc powder and 4 g of magnesium stearate, mix evenly, press into tablets, and coat.

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Abstract

The invention discloses a naproxen slow-release tablet and a preparation method thereof. The naproxen slow-release tablet comprises an active component naproxen and medicinal auxiliary materials, wherein the medicinal auxiliary materials comprise hydroxypropyl methylcellulose, lactose, calcium bicarbonate, talcum powder and magnesium stearate. The method is simple and easy to implement; and the obtained product can durably release the effective component and keep the blood concentration stable, and has the advantages of narrow peak concentration / trough concentration change ranges, smaller medicine dosage, lower medicine taking frequency and lower side effects.

Description

technical field [0001] The invention relates to a drug naproxen, in particular to a naproxen sustained-release tablet and a preparation method thereof. Background technique [0002] Naproxen is a non-steroidal anti-inflammatory drug, which is suitable for all kinds of mild to moderate pain, such as pain after tooth extraction and other operations, primary dysmenorrhea and headache. Compared with ordinary tablets, Naproxen sustained-release tablets have a longer peak time and lower peak concentration, and one tablet of Naproxen sustained-release tablets (0.25g) per day is compared with ordinary tablets (0.25g) per day for 2 -3 times equivalent. However, ordinary tablets have a so-called "peak-valley" phenomenon due to large fluctuations in blood concentration, that is, when the blood concentration is high, side effects or even poisoning may occur; curative effect. [0003] Zheng Lingmei and Jin Zhaoying disclosed the preparation of Naproxen Sustained-release Tablets in the...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/192A61K47/26A61K47/38A61K47/02A61K47/12A61P29/00
CPCA61K9/2018A61K9/0002A61K9/2009A61K9/2013A61K9/2054A61K9/2806A61K31/192
Inventor 颜霞晏梅
Owner DIAO GRP CHENGDU PHARMA
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