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Nimesulide enteric-coated formulation composition and method for preparing the same

A nimesulide enteric and composition technology, which is applied in the field of medicine, can solve the problems such as no reports of nimesulide enteric-coated preparation composition, and achieves the controllability and stability of the preparation process, and avoids nausea. Effect

Inactive Publication Date: 2009-08-12
山东淄博新达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] According to the search results of relevant patents and prior art literature, there is no relevant report on the composition of nimesulide enteric-coated preparations

Method used

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  • Nimesulide enteric-coated formulation composition and method for preparing the same
  • Nimesulide enteric-coated formulation composition and method for preparing the same
  • Nimesulide enteric-coated formulation composition and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Enteric-coated tablets

[0022] prescription:

[0023]

[0024] Preparation Process:

[0025] Pass nimesulide, sucrose powder, sodium carboxymethyl starch, starch, calcium hydrogen phosphate and magnesium stearate through an 80-mesh sieve for later use, weigh sucrose powder, sodium carboxymethyl starch, part of the starch, Calcium hydrogen phosphate is mixed in a mixer and then mixed with nimesulide in equal increments, adding an appropriate amount of 10% starch aqueous solution, granulating, granulating, drying at 50°C for 30 minutes, and adding stearic acid in the prescribed amount to the dry granules Mix the magnesium evenly, sieve through a 16-mesh sieve with a swinging granulator, measure the content of the granules, determine the weight range of the tablet, press the tablet, and then use 70% ethanol to prepare hydroxypropyl methylcellulose phthalate Ester-coated enteric coating solution, coated, and dried.

[0026] The nimesulide enteric-coated tablets prepa...

Embodiment 2

[0028] Enteric-coated capsules

[0029] prescription:

[0030]

[0031] Preparation Process:

[0032] Pass nimesulide and microcrystalline cellulose through 80-mesh sieve respectively, weigh nimesulide and microcrystalline cellulose according to the prescription amount, mix them in a mixer for 10-15 minutes, add 20% ethanol solution to make a soft material , Granulated in a granulator. The granules prepared above were dried at 45° C. for 30 min. Then pass through a swinging granulator, and use a 20-mesh sieve to sieve the granules. The content of the mixed granules is determined, and the filling capacity of the enteric-coated capsule shell is determined. After passing the inspection, pack.

[0033] The nimesulide enteric-coated capsules prepared by the above method meet the requirements of the relevant testing items specified in the "General Rules for Preparations" of the "Chinese Pharmacopoeia 2005 Edition, Part II".

Embodiment 3

[0035] Enteric-coated pellets and capsules

[0036] Prescription: Su Micropills

[0037]

[0038] Prescription: enteric coating solution

[0039] 4 parts talcum powder

[0040] Titanium dioxide 6 parts

[0041] Polyacrylic resin II 20 parts

[0042] Polyacrylic resin III 10 parts

[0043] Tween 80 1.5 parts

[0044] 3 parts propylene glycol

[0045] 50% ethanol solution appropriate amount

[0046] Preparation Process:

[0047] Pass nimesulide, lactose, microcrystalline cellulose, and magnesium stearate through a 120-mesh sieve respectively, weigh nimesulide, lactose, microcrystalline cellulose, and magnesium stearate according to the prescription amount of plain pellets, and put them in a mixer After mixing evenly in the medium, place it in a centrifugal granulator, spray an appropriate amount of 50% ethanol solution to prepare the plain pellets, prepare a coating liquid to coat the plain pellets according to the prescription of the enteric coating solution, and coa...

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Abstract

The invention discloses a Nimesulide enteric preparation combination and a preparation method thereof. The Nimesulide enteric preparation combination is mainly prepared from Nimesulide bulk drugs and suitable auxiliary materials. The improvement of the invention on the existing Nimesulide oral preparation is effective and obviously safe; compared with the common Nimesulide oral preparation, the Nimesulide enteric preparation combination has the advantages that the combination is less irritant to stomachs, thereby reducing the adverse reactions; and the Nimesulide enteric preparation combination is particularly suitable for patients with stomach-upset diseases, such as the active hemorrhage of digestive tract, active digestive ulcer and the like. The invention provides a Nimesulide preparation having the advantages of higher safety, equivalent curative effect and higher quality controllability and stability of the preparation process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a nimesulide enteric-coated preparation composition and a preparation method thereof. Background technique [0002] Nimesulide is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic, and antipyretic effects. It is currently under the control of non-prescription drugs. Its mechanism of action is not completely clear, and it may be mainly related to the inhibition of prostaglandin synthesis, the release of leukocyte mediators and the oxidation reaction of polymorphonuclear leukocytes. According to reports, nimesulide is absorbed through oral administration, and reaches the maximum blood concentration within 1 to 2 hours after taking the drug. Almost all of this product is excreted through urine, and there will be no accumulation even if it is taken several times. [0003] This product is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/18A61K9/00A61P29/00
Inventor 贺同庆贾法强安英张慧英张玲玲
Owner 山东淄博新达制药有限公司
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