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Acetylcysteine granule and preparation technology thereof

A technology of acetylcysteine ​​and granules, applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, bulk delivery, etc., can solve DNA damage, instability to moisture, DNA single-strand breakage And other issues

Active Publication Date: 2013-03-13
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: 10000 bags in batch

[0042] prescription:

[0043]

[0044] Preparation method: (1) uncoat acetylcysteine ​​with acrylic resin; the particle size of the acetylcysteine ​​coating powder is controlled at 150um; (2) use water as a binder, granulate mannitol, Drying, the particle size of the mannitol dry granules is controlled at 75 μm to 300 μm, and the drying weight loss of the granules is controlled to be ≤0.5%; (3) Mix the acetylcysteine ​​coating powder, the mannitol dry granules, aspartame, and sweet orange essence evenly, Filling, finished product inspection, packaging.

Embodiment 2

[0045] Embodiment 2: 10000 bags in batch

[0046] prescription:

[0047]

[0048] Preparation method: (1) uncoat acetylcysteine ​​with acrylic resin; the particle size of the acetylcysteine ​​coating powder is controlled at 150um; (2) use water as a binder, granulate mannitol, Drying, the particle size of the mannitol dry granules is controlled at 75 μm to 300 μm, and the weight loss of the granules is controlled to be ≤0.5%; (3) Mix the acetylcysteine ​​coating powder, the mannitol dry granules, aspartame, and sweet orange essence evenly , Filling, finished product inspection, packaging.

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

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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 ​​granules, in particular to an acetylcysteine ​​granule and a preparation process thereof. Background technique [0002] The molecular formula of N-acetylcysteine ​​(NAC) is C 5 h 9 NO 3 S. It is an acetyl compound of L-cysteine, which contains an active sulfhydryl group. It is a commonly used expectorant in clinical practice, and is also often used to rescue the liver toxicity caused by acetaminophen. [0003] The structural formula is: [0004] [0005] In recent years, many literatures have reported that acetylcysteine, as a sulfhydryl donor, is also an antioxidant, which can interfere with the generation of free radicals, remove the generated free radicals, and regulate the metabolic activity of cells. System and AIDS (AIDS) clinical and experimental research are widely used. In foreign countries, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/198A61K47/32A61P11/10
Inventor 徐卓业
Owner NANJING ZENKOM PHARMA
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