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Acetylcysteine solution preparation for inhalation and preparation method of preparation

An acetylcysteine ​​and preparation technology, applied in the field of preparation, can solve the problems of long-term stability control difficulty, mucosal irritation, bone calcium loss, etc., and achieves a preparation method that is easy to operate, low in production cost, and reliable in quality. Effect

Inactive Publication Date: 2020-03-10
BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Existing acetylcysteine ​​solution for inhalation has following two defects: 1. contain stabilizer in the prescription composition, and wherein stabilizer mostly is edetate disodium, improves preparation after adding edetate disodium in the liquid preparation. The principle of stability is that disodium edetate undergoes a complex reaction with metal ions in the drug to form a stable water-soluble complex, thereby inhibiting the catalytic effect of metal ions on the oxidation of the drug itself, but the ingested edetate disodium Sodium will form a water-soluble chelate with calcium ions in the human body and be excreted from the body. Excessive intake may lead to hypocalcemia or loss of bone calcium. It can stimulate the mucous membrane, so the content of edetate disodium in the product should be reduced as much as possible under the premise of ensuring effective anti-oxidation, so it is the safest prescription composition not to add stabilizers in the preparation; 2. Acetyl cysteine Amino acid is easy to absorb moisture, and it is easy to change color when exposed to light. When it is developed into an inhalation preparation, its physical and chemical properties determine its stability, especially long-term stability control.

Method used

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  • Acetylcysteine solution preparation for inhalation and preparation method of preparation
  • Acetylcysteine solution preparation for inhalation and preparation method of preparation
  • Acetylcysteine solution preparation for inhalation and preparation method of preparation

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Effect test

Embodiment 1

[0036]

[0037] Process:

[0038] Product configuration: Take 70% water for injection (70L) to a suitable container, fill with nitrogen until the dissolved oxygen concentration is less than 1mg / L and continue until the solution preparation is over, add acetylcysteine ​​and stir to dissolve, adjust the pH of the solution with sodium hydroxide 6.5. Use water for injection to make the volume constant. After fine filtration, divide it into ampoules and fill with nitrogen for protection, melt and seal, and sterilize at 121°C for 12 minutes.

Embodiment 2

[0040]

[0041] Process:

[0042] Product configuration: Take 80% water for injection (80L) into a suitable container, fill with nitrogen until the dissolved oxygen concentration is less than 1mg / L and continue until the solution is prepared, add acetylcysteine ​​and stir to dissolve, adjust the pH of the solution with sodium hydroxide 7.0, make the volume constant with water for injection, after fine filtration, divide it into ampoules and fill with nitrogen for protection, melt and seal, and sterilize at 121℃ for 12min.

Embodiment 3

[0044]

[0045] Process:

[0046] Take 70% water for injection (70L) into a suitable container, fill with nitrogen until the dissolved oxygen concentration is less than 1mg / L and continue until the solution preparation is over, add acetylcysteine ​​and stir to dissolve, adjust the pH of the solution to 7.5 with sodium hydroxide to The volume of water for injection is constant, and after fine filtration, it is divided into ampoules and filled with nitrogen for protection, melt-sealed, and sterilized at 121°C for 12 minutes.

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Abstract

The invention provides an acetylcysteine solution preparation for aerosol inhalation and a preparation method of the preparation. The acetylcysteine solution preparation for the aerosol inhalation includes acetylcysteine, a salt of the acetylcysteine and / or a hydrate of the acetylcysteine, a pH regulator, and a solvent. The acetylcysteine solution preparation for the aerosol inhalation provided bythe invention has the characteristics of high efficiency, low toxicity, good stability and high safety.

Description

Technical field [0001] The invention belongs to the field of pharmacology, and specifically relates to an acetylcysteine ​​solution preparation for inhalation and a preparation method thereof. Background technique [0002] N-acetylcysteine ​​(NAC) is the precursor of reduced glutathione (GSH) in cells. It has been used as a mucolytic agent to treat various respiratory diseases for many years. In recent years, it has been discovered that NAC has a protective effect on liver cells and is used to treat liver cell damage caused by various reasons. Among them, NAC treatment of acetaminophen-induced acute liver failure has been approved by the US FDA. N-acetylcysteine ​​also has the effect of treating acute lung injury and pulmonary interstitial fibrosis. It can exert anti-oxidant effects through direct and indirect means, protect lung tissue from oxidative damage, thereby reducing clinical symptoms. Preliminary clinical trial results show that long-term high-dose NAC treatment can he...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/198A61P11/00
CPCA61K31/198A61K9/0078A61K9/08A61P11/00
Inventor 张保献胡杰丁冬
Owner BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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