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N-acetyl-cysteine salt xylitol injection, preparation method and application thereof

A technology of cysteine ​​salt xylose and acetylcysteine, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of accelerating N-acetylcysteine Acid auto-oxidation, high incidence of adverse reactions, increased oxidative impurities and other problems, to achieve the effect of improving systemic hemodynamics and tissue hypoxia, improving the activity of prothrombin, and increasing the level and properties

Active Publication Date: 2011-09-14
杭州市第六人民医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] But because S-H in the N-acetylcysteine ​​molecule is easy to split and autooxidizes, and it is more likely to produce autooxidation in aqueous solution, so the production and storage process of the N-acetylcysteine ​​injection currently on the market requires Tight control of N-acetylcysteine ​​autooxidation
However, when N-acetylcysteine ​​injection is used clinically, it must be diluted with glucose injection and then slowly intravenously infused. Since glucose is a reducing aldose, its oxidation potential is much higher than that of N-acetylcysteine, so in patients Oxidation-reduction reactions are prone to occur during treatment, which accelerates the auto-oxidation of N-acetylcysteine ​​and significantly increases oxidative impurities; N-acetylcysteine ​​injection has the highest activity and stability at pH 6.5-7.5. When N-acetylcysteine ​​injection is used, it is diluted with glucose injection and the pH of the administration drops below 5.0, its stability and activity in the body are significantly reduced, and the incidence of adverse reactions such as allergic dermatitis is also high. It brings many difficulties to clinical application
[0004] There is currently no better drug that can properly address this problem

Method used

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  • N-acetyl-cysteine salt xylitol injection, preparation method and application thereof
  • N-acetyl-cysteine salt xylitol injection, preparation method and application thereof
  • N-acetyl-cysteine salt xylitol injection, preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Weigh 12kg, 100 mesh xylitol fine powder, put into 100L water for injection, stir to dissolve; add 6kg of N-acetylcysteine ​​sodium and 30g of edetate disodium in turn, stir to dissolve; use water for injection to volume to 250L, then add 30ml of sodium hydroxide (pH regulator) with a concentration of 3mol / L to adjust the pH value of the solution to 7.0, stir well and filter, and make 250L of intravenous injection as usual, with a yield of 99.5%.

Embodiment 2

[0034] Take by weighing 16kg, 100 purpose xylitol fine powder, drop in 100L water for injection, stir and dissolve; Add 8kg N-acetylcysteine ​​potassium and 40g edetate dipotassium successively, stir and dissolve; Dilute to the volume with water for injection 250L, then add 40ml of magnesium hydroxide (pH regulator) with a concentration of 3mol / L to adjust the pH value of the solution to 7.4, stir well and filter, and make 250L of intravenous injection as usual, with a yield of 99.4%.

Embodiment 3

[0036]Weigh 7kg, 100 mesh xylitol fine powder, put it into 100L water for injection, stir and dissolve; add 3kg magnesium N-acetylcysteine ​​and 40g calcium disodium edetate in turn, stir and dissolve; dilute to volume with water for injection to 250L, then add 20ml of zinc hydroxide (pH regulator) with a concentration of 3mol / L to adjust the pH of the solution to 6.5, stir well and filter, and make 250L of intravenous injection according to routine, with a yield of 99.6%.

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Abstract

The invention belongs to the technical field of drugs, also relates to a method for preparing an injection and an application thereof in the drugs, aiming at providing an N-acetyl-cysteine salt xylitol injection which has obvious effects of biological oxidation resistance, inflammation resistance, antianaphylaxis, immune adjustment and detoxication, and features convenient use, good product quality, safe and reliable taking and the like. The method has the advantages of simple technological process and high product yield. The technical scheme of the invention is as follows: the N- acetyl-cysteine salt xylitol injection is characterized by comprising the following bulk pharmaceutical chemicals in weight percent: 1-4% of N- acetyl-cysteine salt, 3-8% of xylitol, 0.01-0.04% of complexing antioxidant, and the balance water for injection.

Description

technical field [0001] The invention belongs to the technical field of medicines, and specifically relates to an N-acetylcysteine ​​salt xylose which can be used for the medical treatment of diseases such as acute liver failure, acute renal failure, chronic severe hepatitis, chronic obstructive pneumonia, chronic nephritis and HIV infection. Alcohol injection, meanwhile, the present invention also relates to the method for preparing the injection and its application in medicine. Background technique [0002] N-acetylcysteine ​​is also known as Yikejing and Phlegm Yijing; properties: white crystalline powder with a garlic-like odor, sour taste and hygroscopicity; easily soluble in water or ethanol; it has a unique Antioxidant properties, can remove all kinds of free radicals in the body, and is also the precursor of intracellular reduced glutathione. Physiological effects of nitric oxide, improving microcirculation, correcting tissue hypoxia, and reducing the occurrence of m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/198A61K31/5375A61K47/10A61K47/18A61P1/16A61P11/00A61P13/12A61P31/18
Inventor 庄让笑娄国强梁伟峰王福根方红英邵益丹
Owner 杭州市第六人民医院
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