Acetylcysteine granule and preparation method thereof

A technology of acetylcysteine ​​and granules, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. The bioavailability of acetylcysteine ​​cannot be known, and the physical and chemical properties are very different, so as to achieve the effect of high efficiency and no pollution in the preparation process, low drying temperature requirements, and improved bioavailability

Active Publication Date: 2021-01-12
HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The Chinese invention patent with the application number CN 102144978A discloses an acetylcysteine ​​granule and its preparation process. The granule is mainly composed of acetylcysteine, acrylic resin, mannitol, aspartame, and sweet orange essence , this technical scheme mainly improves the stability of acetylcysteine ​​granules through the preparation process. The disadvantages are: ①The preparation process is complicated, and the acrylic resin needs to be dissolved in organic reagents to coat acetylcysteine, which involves the use of organic reagents, and attention should be paid to the residue of organic reagents in the later stage. From the perspective of drug quality control, it is more complicated, so it is not conducive to the industrial development of acetylcysteine ​​granules; ②It is unknown whether the patented solution can improve the bioavailability of acetylcysteine
However, the drugs targeted by this patent are fluoroether compounds such as sevoflurane and desflurane, whose physical and chemical properties are quite different from those of acetylcysteine. Therefore, whether the stabilizer mentioned in this patent is applicable to acetylcysteine ​​granules development, there is uncertainty

Method used

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  • Acetylcysteine granule and preparation method thereof
  • Acetylcysteine granule and preparation method thereof
  • Acetylcysteine granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The prescription and technology of embodiment 1 acetylcysteine ​​granules

[0036] See the prescription below. Based on the total amount of 3g / bag, the dosage and weight ratio of each component (unit: mg) are:

[0037] Acetylcysteine 100(3.33％) sucrose 2766(92.2％) Menthol 24(0.8％) stevia 90(3.0％) Sweet Orange Flavor 20(0.67％)

[0038] The preparation method is as follows:

[0039] (1) acetylcysteine, sucrose, menthol, and stevioside are pulverized through an 80-mesh sieve for subsequent use;

[0040] (2) acetylcysteine, sucrose, menthol and stevioside are mixed evenly in prescription quantities;

[0041] (3) Add the above mixture into the fluidized bed, set the inlet air temperature at 45°C, add purified water to granulate and dry, the process conditions are: control the material temperature at 35±5°C during the granulation process, and control the material temperature at 45°C during the drying process ±5°C, dry to 0.5% to 1.5% dr...

Embodiment 2

[0044] The prescription and technology of embodiment 2 acetylcysteine ​​granules

[0045] See below for the prescription. Based on the total amount of 3g / bag, the dosage and weight ratio of each component (unit: mg) are:

[0046] Acetylcysteine 180(6.0％) sucrose 2700(90.0％) Menthol 45(1.5％) stevia 15(0.5％) Sweet Orange Flavor 60(2.0％)

[0047] The preparation method is as follows:

[0048] (1) acetylcysteine, sucrose, menthol, and stevioside are pulverized through an 80-mesh sieve for subsequent use;

[0049] (2) acetylcysteine, sucrose, menthol and stevioside are mixed evenly in prescription quantities;

[0050] (3) Add the above mixture into the fluidized bed, set the inlet air temperature at 40°C, add purified water to granulate and dry, the process conditions are: control the material temperature at 35±5°C during the granulation process, and control the material temperature at 45°C during the drying process. ±5°C, dry to 0.5% to 1....

Embodiment 3

[0053] The prescription and technology of embodiment 3 acetylcysteine ​​granules

[0054] See below for the prescription. Based on the total amount of 3g / bag, the dosage and weight ratio of each component (unit: mg) are:

[0055] Acetylcysteine 90(3.0％) sucrose 2850(95.0％) Menthol 27(0.9％) stevia 18(0.6％) Sweet Orange Flavor 15(0.5％)

[0056] The preparation method is as follows:

[0057] (1) acetylcysteine, sucrose, menthol, and stevioside are pulverized through an 80-mesh sieve for subsequent use;

[0058] (2) acetylcysteine, sucrose, menthol and stevioside are mixed evenly in prescription quantities;

[0059] (3) Add the above mixture into the fluidized bed, set the inlet air temperature at 50°C, add purified water to granulate and dry, the process conditions are: control the material temperature at 35±5°C during the granulation process, and control the material temperature at 45°C during the drying process ±5°C, dry to 0.5% to 1.5%...

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PUM

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Abstract

The invention relates to an acetylcysteine granule and a preparation method thereof. The acetylcysteine granule comprises a raw material acetylcysteine and auxiliary materials; and the auxiliary materials comprise a filler, menthol, a flavouring agent and essence, wherein the weight percentage of the menthol is 0.8%-1.5%. According to the acetylcysteine granule provided by the invention, the menthol is used; and furthermore, a fluidized bed one-step granulation process is adopted, so that the prepared acetylcysteine granule is better in stability and higher in bioavailability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to acetylcysteine ​​granules and a preparation method thereof. Background technique [0002] N-acetylcysteine ​​(N-Acetylcysteine, NAC) is formed by adding acetyl to L-cysteine, and is the precursor of reduced glutathione (GSH). Its appearance is white crystalline powder, with Smell similar to garlic, sour taste. It can directly scavenge free radicals in the body, enhance the body's ability to resist oxidative stress, and reduce the production of inflammatory cytokines, chemokines and adhesion molecules. In addition, acetylcysteine ​​can also regulate the body's immune status and cell apoptosis program. [0003] Acetylcysteine ​​is a mucolytic agent, the -SH group in its chemical structure can break the disulfide bond (-S-S-) in the mucin polypeptide chain in sputum, reduce the viscosity of sputum, and make it liquefied, easy to cough up. But at the same ti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/10A61K31/198A61P11/10
CPCA61K9/1617A61K31/198A61P11/10Y02A50/30
Inventor 戴娟邹永华陈晓萍黎瑶郦丹婷李青青沈锡明
Owner HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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