Esomeprazole medicated pellet and preparing method thereof

A technology for esomeprazole and pellets, which is applied in the field of esomeprazole drug-containing pellet intermediates and the preparation field thereof, can solve the problem of large drug-loading capacity, waste of time, manpower and difficulty in mixing and granulating in a coating pan. Material resources, low production efficiency, etc., to achieve significant economic benefits, improve efficiency, and high production efficiency

Active Publication Date: 2012-12-19
ZHONGSHUAI PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with several commonly used methods, extrusion-spheronization has large drug loading, high hardness, good roundness, good continuity, high output and efficiency; coating pan mixing granulation has large drug loading, roundness Good wholeness and low hardness; fluidized bed and centrifugal coating granulation have good roundness, low hardness, low drug loading, and low production efficiency; extrusion-spheronization method is used in the preparation process of pellets has obvious advantages
[0007] However, the extrus

Method used

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  • Esomeprazole medicated pellet and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The esomeprazole drug-containing pellets of the present invention are mainly composed of 175g (mass percentage of 41.7%) of raw materials esomeprazole, 145g of mannitol (34.5% of mass percentage) and 100g of crospovidone (mass percentage is 23.8%); in addition, 150g of binder purified water (accounting for 35.7% of the total weight of the three main raw materials) is added.

[0031] Explanation: The purified water added in this example goes through the preparation method and is finally dried to obtain the product, and all the added purified water evaporates; therefore, the main raw materials in this example are composed of esomeprazole, mannitol and crospovidone.

[0032] The preparation method of esomeprazole drug-containing pellet of the present invention, its detailed steps are as follows:

[0033] a. First, the raw materials esomeprazole, crospovidone and mannitol are crushed through a 80-mesh sieve, sieved and placed in a stirring mixer to mix evenly. After mixing ...

Embodiment 2

[0035] Embodiment 2: basically the same as Embodiment 1, the difference is:

[0036]The esomeprazole drug-containing pellets of the present invention mainly consist of raw materials esomeprazole 145g (mass percentage is 34.5%), mannitol 173g (mass percentage is 41.2%) and crospovidone 102g (mass percentage is 24.3%); in addition, 165g of binder purified water (accounting for 39.3% of the total weight of the three main raw materials) is added.

[0037] Explanation: The purified water added in this example goes through the preparation method and is finally dried to obtain the product, and all the added purified water evaporates; therefore, the main raw materials in this example are composed of esomeprazole, mannitol and crospovidone.

[0038] The preparation method of the esomeprazole drug-containing pellets of the present invention is the same as in Example 1.

Embodiment 3

[0039] Embodiment 3: basically the same as Embodiment 1, the difference is:

[0040] The esomeprazole drug-containing pellets of the present invention mainly consist of raw materials esomeprazole 110g (mass percentage is 26.2%), mannitol 210g (mass percentage is 50%) and crospovidone 100g (mass percentage is 23.8%); in addition, 146g of binder purified water (accounting for 34.8% of the total weight of the three main raw materials) is added.

[0041] Explanation: The purified water added in this example goes through the preparation method and is finally dried to obtain the product, and all the added purified water evaporates; therefore, the main raw materials in this example are composed of esomeprazole, mannitol and crospovidone.

[0042] The preparation method of the esomeprazole drug-containing pellets of the present invention is the same as in Example 1.

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Abstract

The invention discloses an esomeprazole medicated pellet and a preparing method of the esomeprazole medicated pellet. The esomeprazole medicated pellet is mainly prepared from 25-50% of esomeprazole raw material and ramification of the esomeprazole raw material, 20-50% of mannitol and 5-30% of polyvinylpolypyrrolidone according to weight percentage; and in addition, pharmaceutic adjuvant acceptable pharmaceutically is also contained. The ingredients of the esomeprazole medicated pellet are proportioned, and the esomeprazole medicated pellet product can be prepared by virtue of an extruding-rolling preparing method. Compared with the prior art, the technical scheme provided by the invention has the advantages that the efficiency is greatly improved, and waste of a large amount of time, manpower and material resources are avoided; and the method is simple, and the midbody of the obtained product preparation has the advantages of stable medicine, high reproducibility and the like.

Description

technical field [0001] The invention relates to pharmaceutical preparation intermediates and preparation methods thereof in the field of pharmacy, in particular to a drug-containing micropill with esomeprazole as the main ingredient and a preparation method thereof, that is, a drug-containing micropill of esomeprazole Pill intermediate and preparation method thereof. Background technique [0002] Esomeprazole is the (S)-isomer of omeprazole, a newer proton pump inhibitor widely used in clinical practice, and its chemical name is 5-methoxy-2-((S )-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)-1H-benzimidazole, the structural formula is as follows: [0003] [0004] The mechanism of action of esomeprazole is the same as that of omeprazole, that is, it is protonated under acidic conditions, and esomeprazole is transformed into an inhibitor of H + / K + -ATPase active compound sulfenamide, rapidly reacts with H + / K + - The sulfhydryl group of cysteine ​​on the ATP...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4439A61K47/32A61K47/36A61K47/38A61P1/04
Inventor 任逢晓张胜华邬向东
Owner ZHONGSHUAI PHARMA SCI & TECH CO LTD
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