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Meisuoshuli orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and Susulide, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, pill delivery, etc., can solve problems such as no reports on orally disintegrating tablets of Mesosulide, and achieve improvement Effectiveness and emergency response, cost reduction, and the effect of overcoming high friability

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

[0004] At present, there are no related reports about mesosulide orally disintegrating tablets

Method used

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  • Meisuoshuli orally disintegrating tablet and preparation method thereof
  • Meisuoshuli orally disintegrating tablet and preparation method thereof
  • Meisuoshuli orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Prescription: 25 grams of mesosulide, 20 grams of mannitol, 30 grams of microcrystalline cellulose, 305 grams of povidone K, 2 grams of low-substituted hydroxypropyl cellulose, 5 grams of aspartame, 0.5 grams of silicon dioxide, micropowder Silica gel 0.1 g, made 1000 mesosulide orally disintegrating tablets in total.

[0054] Preparation method: This dosage form is produced by conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows:

[0055] Step 1. Micronize the prescription amount of mesosulide, the particle size after micronization is 1-30 microns, add micronized silica gel and mix evenly; grind aspartame and pass through an 80-mesh sieve, and mix mesosulide Lee, micronized silica gel and aspartame are mixed evenly;

[0056] Step 2, micronize the mannitol and microcrystalline cellulose of the prescription amount, the particle size after micronization is 120-200 microns; pass low-substitute...

Embodiment 2

[0059] Prescription: 25 grams of mesosulide, 20 grams of mannitol, 40 grams of microcrystalline cellulose, 10 grams of povidone K30, 2 grams of low-substituted hydroxypropyl cellulose, 5 grams of aspartame, 0.5 grams of silicon dioxide, micropowder Silica gel 0.1 g, made 1000 mesosulide orally disintegrating tablets in total.

[0060] Preparation method:

[0061] Methosulide orally disintegrating tablets were prepared by the same method as in Example 1, the difference being that the particle size of mesosulide after micronization was 60-100 microns, and that of mannitol and microcrystalline cellulose after micronization. The particle size is 10-60 microns.

Embodiment 3

[0063] Prescription: 50 grams of mesosulide, 40 grams of mannitol, 60 grams of microcrystalline cellulose, 15 grams of sodium carboxymethyl cellulose, 10 grams of crospovidone, 10 grams of orange flavor, 2 grams of magnesium stearate , 0.2 g of micronized silica gel, made into 1000 orally disintegrating tablets of mesosulide.

[0064] Preparation method:

[0065] Step 1. Micronize the prescribed amount of mesosulide, the micronized particle size is 30-60 microns, add micronized silica gel and mix evenly; grind the orange essence and pass through an 80-mesh sieve, then mix the mesosulide , micronized silica gel and orange essence are mixed evenly;

[0066] Step 2, micronize the mannitol and microcrystalline cellulose of the prescription amount, the particle size after micronization is 60-120 microns; cross-linked povidone through 80 mesh sieve, carboxymethylcellulose sodium through 40 mesh sieve , respectively weighed according to the prescription amount and added to the mixe...

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Abstract

The invention provides a Meisuoshuli orally disintegrating tablet and a preparation method thereof. The Meisuoshuli orally disintegrating tablet comprises Meisuoshuli and pharmaceutically acceptable auxiliary materials. The Meisuoshuli orally disintegrating tablet has the advantages of fast disintegration, good dissolution rate and stable quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to mesosulide orally disintegrating tablets and a preparation method thereof. Background technique [0002] Mesosulide is a Class 1.1 new chemical drug jointly developed by the Academy of Military Medical Sciences and Humanwell Pharmaceutical Group. [0003] Mesosulide is a non-steroidal anti-inflammatory drug (NSAID for short). Prostaglandins (PGE1, PGE2) and thromboxane A2 (TXA2), that is, reduce the synthesis of prostaglandins, thromboxanes and other inflammatory mediators, so it has good antipyretic, analgesic, anti-inflammatory, detumescence and other effects. Mesosulide raw materials are insoluble in water, so seeking to increase its solubility and improving the bioavailability in vivo through optimization of dosage forms has become a top priority for mesosulide preparations. [0004] At present, there are no related reports on mesosulide orally disintegrating tabl...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/18A61K47/38A61P29/00
Inventor 王学海李莉娥许勇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