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Acetylcysteine granule and preparation technology thereof

A technology of acetylcysteine ​​and its preparation process, which is applied in the field of acetylcysteine ​​particles and its preparation process, and can solve problems such as humidity instability, DNA single-strand breaks, and DNA damage

Active Publication Date: 2011-08-10
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(2) Peroxides can cause DNA damage, can produce base modifiers such as thymine glycol, hydroxymethyl uracil, and may also cause damage such as DNA single-strand breaks
[0036] At present, the dosage forms of acetylcysteine ​​in China include tablets, capsules, granules, injections, etc., but due to the presence of sulfhydryl groups, acetylcysteine ​​is very unstable to moisture and degrades rapidly

Method used

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  • Acetylcysteine granule and preparation technology thereof
  • Acetylcysteine granule and preparation technology thereof
  • Acetylcysteine granule and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1: Batch 10,000 bags

[0042] prescription:

[0043]

[0044] Preparation method: (1) Acrylic cysteine ​​is used for powder coating with acrylic resin; the particle size of the acetylcysteine ​​coating powder is controlled at 150um; (2) Water is used as a binder, and mannitol is granulated, Drying, the particle size of mannitol dry particles is controlled within 75μm~300μm, and the weight loss on drying of the particles is controlled ≤0.5%; (3) Mix acetylcysteine ​​coating powder, mannitol dry particles, aspartame, and orange flavor evenly, Filling, finished product inspection, packaging.

Embodiment 2

[0045] Example 2: Batch 10,000 bags

[0046] prescription:

[0047]

[0048] Preparation method: (1) Acrylic cysteine ​​is used for powder coating with acrylic resin; the particle size of the acetylcysteine ​​coating powder is controlled at 150um; (2) Water is used as a binder, and mannitol is granulated, Drying, the size of the mannitol dry particles is controlled within 75μm~300μm, and the weight loss on drying of the particles is controlled ≤0.5%; (3) Mix the acetylcysteine ​​coating powder, mannitol dry particles, aspartame, and orange flavor evenly , Filling, finished product inspection and packaging.

[0049] The stability of acetylcysteine ​​particles was investigated. Take the acetylcysteine ​​granules under Example 1 and Example 2, remove the outer packaging, and place them for 6 months at a temperature of 40℃±2℃ and a relative humidity of 75%±5%. Monthly, 2 months, 3 months, 6 months sampling and analysis to determine the loss on drying and related substances of the samp...

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Abstract

The invention discloses an acetylcysteine granule and a preparation method thereof, which belong to the new technical field of pharmaceutical preparation, and relates to a new composition of the acetylcysteine granule and the perpetration technology thereof. In the new composition and the preparation technology thereof, the granule mainly consists of acetylcysteine, acrylic resin, mannitol, aspartame and orange essence, and weight ratio of the main constituents is 10:1-50:2-200:0-1:0-1. After being coated with the acrylic resin, the acetylcysteine is mixed with the dry mannitol granule, the aspartame and the orange essence to prepare the acetylcysteine granule; and the prepared acetylcysteine granule has obviously improved stability in wet environment, and the taste of the acetylcysteine granule is greatly improved.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical manufacturing, and relates to a new combination and preparation process of acetylcysteine ​​particles, in particular to an acetylcysteine ​​particle and a preparation process thereof. Background technique [0002] The molecular formula of N-acelylcysteine ​​(NAC) is C 5 H 9 NO 3 S. It is an acetyl compound of L-cysteine, which contains active sulfhydryl groups, and is commonly used clinically as an expectorant. It is also commonly used to rescue the liver toxicity caused by acetaminophen. [0003] The structural formula is: [0004] [0005] In recent years, many literatures reported that acetylcysteine, as a sulfhydryl donor, is also an antioxidant. It can interfere with the generation of free radicals, remove the generated free radicals, and regulate the metabolic activity of cells. The system and AIDS have been widely used in clinical and experimental research. Foreign countries use it as a treatment fo...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/198A61K47/32A61P11/10
Inventor 徐卓业
Owner NANJING ZENKOM PHARMA
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