N-acetylcysteine pharmaceutical composition and preparation method thereof

A technology of acetylcysteine ​​and its composition, which is applied in the field of acetylcysteine ​​pharmaceutical composition and its preparation, can solve the problems of difficult production control, complicated preparation method, and easy destruction, so as to achieve the goal of not being easily destroyed, The preparation process is simple and the effect of easy mixing

Inactive Publication Date: 2012-10-24
苏州朗易生物医药研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation method is relatively complicated, and the acetylcysteine ​​raw materia

Method used

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  • N-acetylcysteine pharmaceutical composition and preparation method thereof
  • N-acetylcysteine pharmaceutical composition and preparation method thereof
  • N-acetylcysteine pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A pharmaceutical composition of acetylcysteine, including active ingredients and auxiliary materials;

[0030] The active ingredient is acetylcysteine;

[0031] The auxiliary materials are sucrose, sweet orange essence, aspartame, sunset yellow and glidant;

[0032] Described glidant is talcum powder.

[0033] A pharmaceutical composition of acetylcysteine, calculated by mass percentage, the content of various components in the described active ingredient and adjuvant is as follows:

[0034]

[0035] The above-mentioned preparation method of a pharmaceutical composition of acetylcysteine ​​specifically comprises the following steps:

[0036] (1), sucrose is pulverized and passed through a 40-mesh sieve, mixed with sweet orange essence, and poured into a wet granulation pot;

[0037] (2), aspartame and sunset yellow are dissolved in water to obtain an aqueous solution of aspartame and sunset yellow;

[0038] (3), start the wet granulator, add aspartame and sunset ...

Embodiment 2

[0045] A pharmaceutical composition of acetylcysteine, including active ingredients and auxiliary materials;

[0046] The active ingredient is acetylcysteine;

[0047] The auxiliary materials are sucrose, sweet orange essence, aspartame, sunset yellow and glidant;

[0048] The glidant is silicon dioxide.

[0049] A pharmaceutical composition of acetylcysteine, calculated by mass percentage, the content of various components in the described active ingredient and adjuvant is as follows:

[0050]

[0051] The above-mentioned preparation method of a pharmaceutical composition of acetylcysteine ​​specifically comprises the following steps:

[0052] (1), sucrose is pulverized and passed through a 60-mesh sieve, mixed with sweet orange essence, and poured into a wet granulation pot;

[0053] (2), aspartame and sunset yellow are dissolved in water to obtain an aqueous solution of aspartame and sunset yellow;

[0054] (3), start the wet granulator, add aspartame and sunset yell...

Embodiment 3

[0061] A pharmaceutical composition of acetylcysteine, comprising active ingredients and auxiliary materials;

[0062] The active ingredient is acetylcysteine;

[0063] The auxiliary materials are sucrose, sweet orange essence, aspartame, sunset yellow and glidant;

[0064] The glidant is silicon dioxide.

[0065] A pharmaceutical composition of acetylcysteine, calculated by mass percentage, the content of various components in the described active ingredient and adjuvant is as follows:

[0066]

[0067] The above-mentioned preparation method of a pharmaceutical composition of acetylcysteine ​​specifically comprises the following steps:

[0068] (1), after sucrose is pulverized, pass through an 80-mesh sieve and mix with sweet orange essence, and pour it into a wet granulation pot;

[0069] (2), aspartame and sunset yellow are dissolved in water to obtain an aqueous solution of aspartame and sunset yellow;

[0070] (3), start the wet granulator, add aspartame and sunset...

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Abstract

The invention discloses an N-acetylcysteine pharmaceutical composition and a preparation method thereof. The pharmaceutical composition comprises an active component and excipients, wherein the active component is N-acetylcysteine and the excipients are cane sugar, sweet orange essence, aspartame, sunset yellow and flow aid. The preparation method is as follows: first, granulating the excipients of cane sugar, sweet orange essence, aspartame and sunset yellow and drying the obtained granules and then carrying out size stabilization to the dried granules; and then mixing with the active component N-acetylcysteine and the flow aid to obtain the granular N-acetylcysteine pharmaceutical composition. The granular N-acetylcysteine pharmaceutical composition provided by the invention is simple in preparation, wherein the raw material N-acetylcysteine is more stable, difficult to be destroyed, and is easy to mix with other excipients.

Description

technical field [0001] The invention relates to a pharmaceutical composition of acetylcysteine ​​and a preparation method thereof. Background technique [0002] The molecular formula of N-acetylcysteine ​​(NAC) is C5H9N03S. It is an acetyl compound of L-cysteine, which contains an active -SH group. It is a commonly used expectorant in clinical practice, and is also often used to rescue the liver toxicity caused by acetaminophen. In recent years, many literatures have reported that NAC, 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. It has been widely used in clinical and experimental research. Abroad, it is used as a therapeutic drug for acute fulminant liver failure (Acute Liver Failure) caused by drug poisoning. Its structural formula is as follows: [0003] [0004] Acetylcysteine ​​granule is an expectorant, and the people who...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K47/04A61K9/16A61P11/10A61P1/16A61P39/06
Inventor 刘玉华任东春张晓光
Owner 苏州朗易生物医药研究有限公司
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