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Meisuoshuli granule and preparation method thereof

A technology of sosulide and granules, applied in the field of methosulide granules and preparation thereof, can solve the problems of poor medication compliance of patients, inconvenience of patients taking tablets, difficulty in taking tablets, etc., and achieves good medication compliance and patient compliance. Good performance, good dissolution effect

Active Publication Date: 2016-03-30
WUHAN OPTICS VALLEY HUMANWELL BIO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Mesosulide can be prepared into tablets, but for children and elderly patients, or for patients who cannot swallow or have difficulty swallowing, it is difficult to take tablets, resulting in poor medication compliance of patients
Mesosulide has a slightly bitter taste. If it cannot solve the taste problem, it will also cause inconvenience to patients.
[0004] At present, research on mesosulide preparations still needs to be strengthened

Method used

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  • Meisuoshuli granule and preparation method thereof
  • Meisuoshuli granule and preparation method thereof
  • Meisuoshuli granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1: Prescription screening and preparation process optimization of mesosulide granules

[0054] In this example, taking 50 mg mesosulide granules as an example (i.e. specification: 50 mg), the prescription and preparation process of mesosulide granules are optimized, as follows:

[0055] Preliminarily considering the taste, suspension, and dissolution rate of the granules, the prescription of mesosulide granules is involved. The specific prescription is shown in Table 1, and then prepared according to the prescription shown in Table 1 and the following preparation method Mesosulide granules, and then observe and detect the properties, mouthfeel and dissolution rate of the prepared mesosulide granules according to conventional methods, wherein, the mouthfeel is tried orally by volunteers. The dissolution rate determination was carried out in a pH8.8 phosphate buffer solution according to the method stipulated in the Chinese Pharmacopoeia 2010 edition, and the phos...

Embodiment 2

[0089] prescription:

[0090] 25 parts by weight of mesosulide, 125 parts by weight of hydroxypropyl β-cyclodextrin, 200 parts by weight of mannitol, 17.5 parts by weight of microcrystalline cellulose, 7.5 parts by weight of aspartame, 50 parts by weight of povidone, 75 parts by weight % ethanol qs.

[0091] The preparation process is as follows:

[0092] 1) Mesosulide, hydroxypropyl β-cyclodextrin, mannitol, microcrystalline cellulose, aspartame, and povidone were all dried separately,

[0093] 2) Mix the prescribed amount of mesosulide and hydroxypropyl β-cyclodextrin, micronize once, then add mannitol to the above micronized particles and mix, and continue to micronize until the particle size is 10 microns (μm) particles,

[0094] 3) passing microcrystalline cellulose, aspartame and povidone through an 80-mesh sieve for subsequent use;

[0095] 4) Mix the raw and auxiliary materials in the above steps 2 and 3 evenly, add 75% ethanol solution to make soft material, pass ...

Embodiment 3

[0101] prescription:

[0102] Mesosulide 25 parts by weight, hydroxypropyl β-cyclodextrin 25 parts by weight, mannitol 125 parts by weight, microcrystalline cellulose 15 parts by weight, aspartame 10 parts by weight, povidone 25 parts by weight, 75 parts by weight % ethanol qs.

[0103] The preparation process is as follows:

[0104] 1) Mesosulide, hydroxypropyl β-cyclodextrin, mannitol, microcrystalline cellulose, aspartame, and povidone were all dried separately,

[0105] 2) Mix the prescribed amount of mesosulide and hydroxypropyl β-cyclodextrin, micronize once, then add mannitol to the above micronized particles and mix, continue to micronize until the particle size is 50 microns (μm) particles,

[0106] 3) passing microcrystalline cellulose, aspartame and povidone through an 80-mesh sieve for subsequent use;

[0107] 4) Mix the raw and auxiliary materials in the above steps 2 and 3 evenly, add 75% ethanol solution to make soft material, pass the soft material through ...

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Abstract

The invention provides a Meisuoshuli granule and a preparation method thereof. The Meisuoshuli granule comprises Meisuoshuli and pharmaceutically acceptable auxiliary materials. The Meisuoshuli granule can be effectively used to relieving fever, easing pains, preventing inflammations and eliminating swelling, has the advantages of stable quality, good dissolution rate, good mouthfeel and good medication compliance, solves the disadvantages of small dosage treatment of children, unfavorable separate administration of tablets and capsules, and is very convenient for young and old people and patients with swallowing dysfunction to administrate.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to mesosulide granules and a preparation method thereof. Background technique [0002] Mesosulide is the world's first Class 1.1 chemical drug jointly developed by the Academy of Military Medical Sciences and Humanwell Pharmaceutical Group. Mesosulide is a non-steroidal anti-inflammatory drug (NSAID for short), and its main mechanism of action is to inhibit cyclooxygenation. Enzyme (COX-2) activity, thereby inhibiting the final production of prostacyclin (PGⅡ), prostaglandin (PGE1, PGE2) and thromboxane A2 (TXA2) from arachidonic acid, that is, reducing the production of prostaglandin, thromboxane and other inflammatory mediators Synthetic, so it has good antipyretic, analgesic, anti-inflammatory, swelling and other effects. [0003] Mesosulide can be prepared into tablets, but for children and elderly patients, or for patients who cannot swallow or have difficulty swallowing, it ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/18A61K47/48A61K47/26A61K47/36A61K47/38A61K47/18A61K47/32A61K47/69
Inventor 许勇王学海李莉娥廖娟娟黄怡黄璐涂荣华杨仲文乐洋江曦朱垒余艳平刘荃王伟田华肖强吴迪杨菁张毅
Owner WUHAN OPTICS VALLEY HUMANWELL BIO PHARMA
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