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Vonoprazan fumarate tablets and preparation method thereof

A technology of vonoprazan fumarate and fumaric acid, which is applied in pill delivery, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of slow drug effect and inability to increase drug absorption speed, and achieve improved Safety and efficacy, effect of improving content uniformity

Inactive Publication Date: 2021-01-19
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Most of the existing voronoprazan fumarate tablets are prepared by wet granulation. The addition method and order of each material will affect the content uniformity of the tablet, and the coating solution used cannot increase the human body’s ability to react. The rate at which the drug is absorbed makes the drug take effect slowly

Method used

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  • Vonoprazan fumarate tablets and preparation method thereof
  • Vonoprazan fumarate tablets and preparation method thereof
  • Vonoprazan fumarate tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A vonoprazan fumarate tablet, comprising the following raw materials in parts by weight: 10 parts of vonoprazan fumarate, 25 parts of microcrystalline cellulose, 55 parts of mannitol, 1 part of hydroxypropyl cellulose, 1 part of fumarate 0.5 part of acid, 5 parts of croscarmellose sodium, 1 part of magnesium stearate;

[0044] Described vonoprazan fumarate tablet is made by the following steps:

[0045] Step S1: take by weighing the above-mentioned raw materials in parts by weight;

[0046] Step S2: dissolving 50% by weight of hydroxypropyl cellulose in purified water to obtain a granulation solution;

[0047] Step S3: adding the granulation solution prepared in step S2 to the auxiliary material composed of vonoprazan fumarate, mannitol, fumaric acid, microcrystalline cellulose and remaining hydroxypropyl cellulose to wet granulation;

[0048] Step S4: sieve and granulate after drying and add magnesium stearate and croscarmellose sodium to mix;

[0049] Step S5: the ...

Embodiment 2

[0059] A vonoprazan fumarate tablet, comprising the following raw materials in parts by weight: 13.36 parts of vonoprazan fumarate, 30 parts of microcrystalline cellulose, 57.99 parts of mannitol, 1.3 parts of hydroxypropyl cellulose, 0.75 parts of acid, 5.5 parts of croscarmellose sodium, 1.1 parts of magnesium stearate;

[0060] Described vonoprazan fumarate tablet is made by the following steps:

[0061] Step S1: take by weighing the above-mentioned raw materials in parts by weight;

[0062] Step S2: dissolving 50% by weight of hydroxypropyl cellulose in purified water to obtain a granulation solution;

[0063] Step S3: adding the granulation solution prepared in step S2 to the auxiliary material composed of vonoprazan fumarate, mannitol, fumaric acid, microcrystalline cellulose and remaining hydroxypropyl cellulose to wet granulation;

[0064] Step S4: sieve and granulate after drying and add magnesium stearate and croscarmellose sodium to mix;

[0065] Step S5: the obt...

Embodiment 3

[0075]A vonoprazan fumarate tablet, comprising the following raw materials in parts by weight: 15 parts of vonoprazan fumarate, 35 parts of microcrystalline cellulose, 60 parts of mannitol, 1.5 parts of hydroxypropyl cellulose, fumarate 1 part of acid, 6 parts of croscarmellose sodium, 1.5 parts of magnesium stearate;

[0076] Described vonoprazan fumarate tablet is made by following steps:

[0077] Step S1: weighing the above raw materials in parts by weight;

[0078] Step S2: dissolving 50% by weight of hydroxypropyl cellulose in purified water to obtain a granulation solution;

[0079] Step S3: adding the granulation solution prepared in step S2 to the excipients consisting of vonoprazan fumarate, mannitol, fumaric acid, microcrystalline cellulose and remaining hydroxypropyl cellulose for wet granulation;

[0080] Step S4: After drying, sieve the granules and add magnesium stearate and croscarmellose sodium for blending;

[0081] Step S5: pressing the obtained granules i...

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Abstract

The invention discloses vonoprazan fumarate tablets and a preparation method thereof. The tablets are prepared from the following raw materials in parts by weight: 10-15 parts of vonoprazan fumarate,25-35 parts of microcrystalline cellulose, 55-60 parts of mannitol, 1-1.5 parts of hydroxypropyl cellulose, 0.5-1 part of fumaric acid, 5-6 parts of croscarmellose sodium and 1-1.5 parts of magnesiumstearate. By use of the preparation process of dissolving 50% by weight of hydroxypropyl cellulose in purified water to obtain a granulation solution and adding other raw materials in the form of solid powder, the content uniformity of the tablets can be improved, the safety and the effectiveness of the drug can be further improved, a coating liquid is prepared during the preparation process, andthe coating liquid can increase the fluidity of cell membrane lipids, induce the enlargement of plasma membrane gaps to destroy the complete structure of membranes, accelerate the transfer of the medicine and ensure the effective absorption of the medicine.

Description

technical field [0001] The invention belongs to the technical field of drug synthesis, in particular to a vonoprazan fumarate tablet and a preparation method thereof. Background technique [0002] Vonoprazan fumarate is a new class of gastric acid secretion inhibitors belonging to potassium ion (K+) competitive acid blockers. (Proton pump) combined effect, early termination of gastric acid secretion, with strong and lasting inhibition of gastric acid secretion, clinically used for the treatment of duodenal ulcer, gastric ulcer and reflux esophagitis, gastric ulcer caused by low-dose aspirin Ulcer or recurrent duodenal ulcer; eradication of Helicobacter pylori, adjuvant treatment of the following diseases: gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, early gastric cancer, Helicobacter pylori infection gastritis. [0003] Most of the existing preparation methods of vonoprazan fumarate tablets are wet granulation. The addition met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K9/36A61K31/4439A61P1/04A61P7/02A61P31/04A61P35/00C08F220/18C08F220/06C08F220/14C08F220/46C08B37/08
CPCA61K31/4439A61K9/2054A61K9/2846A61K9/286A61P1/04A61P35/00A61P7/02A61P31/04C08F220/1804C08B37/003C08F220/06C08F220/14C08F220/46
Inventor 马莉李珠珠史权杰
Owner HAINAN WEI KANG PHARMA QIANSHAN