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Acetylcysteine injection and preparation thereof

A technology of acetylcysteine ​​and injection, applied in the field of acetylcysteine ​​injection and preparation thereof, can solve problems such as allergic reactions, and achieve the effect of solving allergic reactions

Inactive Publication Date: 2010-12-22
上海国创医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Added to the acetylcysteine ​​solution, a stable acetylcysteine ​​injection can be obtained, thus successfully solving the problem that the above-mentioned acetylcysteine ​​injection is prone to allergic reactions

Method used

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  • Acetylcysteine injection and preparation thereof
  • Acetylcysteine injection and preparation thereof
  • Acetylcysteine injection and preparation thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0025] The present invention also provides a preparation method of the above-mentioned acetylcysteine ​​injection. The method comprises the steps of:

[0026] 1) Under nitrogen protection conditions, prepare an aqueous solution containing all components except acetylcysteine;

[0027] 2) Under the condition of nitrogen protection, prepare an aqueous solution of acetylcysteine, and adjust the pH to 6-8 with aqueous sodium hydroxide;

[0028] 3) Under nitrogen protection conditions, the solution prepared in step 1) is mixed with the solution prepared in step 2) to adjust the pH to 6-8, filtered, filled and sterilized.

[0029] Preferred sterilization conditions are conventional sterilization conditions for injections, for example, sterilization at 115° C. for 30 minutes.

[0030] The acetylcysteine ​​in the acetylcysteine ​​injection of the present invention has low allergenicity, and can still remain stable and not decompose after high-temperature (115°C, 30 minutes) steriliz...

Embodiment 1

[0058] Embodiment 1: the preparation of acetylcysteine ​​injection of the present invention

[0059] 1. Acetylcysteine ​​injection formula:

[0060] In order to test the stability of the acetylcysteine ​​injection of the present invention, seven exemplary acetylcysteine ​​injections were prepared in this example. The formulations of these exemplary injections are shown in Table 2 below.

[0061] The formula of table 2 exemplary acetylcysteine ​​injection

[0062]

[0063] Note: Sodium hydroxide was prepared into 20% and 5% solutions respectively

[0064] 2. Preparation of Acetylcysteine ​​Injection

[0065] 1) Measure and weigh all the ingredients in the above table except acetylcysteine ​​and sodium hydroxide solution according to the above formula, fully dissolve it in water for injection, boil, and absorb with activated carbon (the consumption of activated carbon is 0.4%, W / V), decarburization and filtration, cooling the filtrate to 50-60°C, and continuing to pass...

Embodiment 2

[0074] Embodiment 2: Stability test of acetylcysteine ​​injection of the present invention

[0075] The acetylcysteine ​​injection product prepared in Example 1 was placed in a container for six months at 40° C. to measure the stability of the product, and the results are shown in Table 2.

[0076] Table 2: Accelerated test results of acetylcysteine ​​injection

[0077]

[0078]

[0079] The results in the above table show that the content of related substances in the acetylcysteine ​​injection of the present invention is less than 3% after 6 months of accelerated stability test, and there is no obvious change in each index, and the product is stable.

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Abstract

The invention relates to an acetylcysteine injecta, which contains tromethamine with stable dosage, further relating to the preparation method of the injecta. The acetylcysteine injecta of the invention has low sensitization and keeps stability and indissolubility after being sterilized under high temperature (115 DEG, 30 minutes) and stored for a long period and the PH value also can keep stability after being stored for a long period.

Description

technical field [0001] The invention relates to an acetylcysteine ​​preparation, in particular to an acetylcysteine ​​injection and a preparation method thereof. Background technique [0002] Acetylcysteine ​​(Acetylcysteine, N-acetyl-3-mercaptoalanine) [0003] [0004] It is the precursor of reduced glutathione (GSH), which is an oxygen free radical scavenger in the body. The mechanism of its hepatoprotective effect is not very clear, and it may be related to maintaining or restoring glutathione levels. In addition, acetylcysteine ​​may also play a hepatoprotective role by improving hemodynamics and oxygen transport capacity and expanding microcirculation. [0005] Most of the beneficial effects of acetylcysteine ​​(NAC) stem from its ability to reduce the conversion of extracellular cystine to cysteine, as well as its ability to act as a source of sulfhydryl metabolism. Acetylcysteine ​​can stimulate glutathione (GSH) synthesis, enhance the activity of GSH-S-base tr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/198A61K47/18A61P1/16A61P11/10A61P11/14
Inventor 金三九蔡新楼金芳
Owner 上海国创医药股份有限公司
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