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Method for controlling content of hydrogen sulfide in acetylcysteine solution

A technology of acetylcysteine ​​and solution, applied in the field of medicine, can solve problems such as blood calcium drop, calcium reduction, low calcium, etc., and achieve the effects of improving production process, reducing content and other impurity content, and alleviating bad smell

Active Publication Date: 2020-11-03
HAINAN STAR PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The instructions of the imported and marketed samples clearly stated that the prescription contained disodium edetate and sodium hydroxide as excipients. However, disodium edetate can combine with calcium ions to form a soluble complex to cause a decrease in calcium. Edetate used in intravenous preparations Disodium acid can cause blood calcium to drop, which can lead to hypocalcemia

Method used

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  • Method for controlling content of hydrogen sulfide in acetylcysteine solution
  • Method for controlling content of hydrogen sulfide in acetylcysteine solution
  • Method for controlling content of hydrogen sulfide in acetylcysteine solution

Examples

Experimental program
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Effect test

Embodiment

[0056] Example, preparation of acetylcysteine ​​solution for inhalation

[0057] (1) Acetylcysteine ​​solution for inhalation, the specification is: 3ml:0.3g, the prescription composition of the unit dose product is shown in the table below:

[0058]

[0059] (2) This product does not come with a special solvent.

[0060] (3) This product uses brown neutral borosilicate glass ampoule as the inner packing container, and the outer packing chooses plastic tray and carton.

[0061] refer to figure 1 The process flow chart and cleanliness requirements shown in the preparation of acetylcysteine ​​solution for inhalation

[0062] 1) Clean the liquid dispensing pipeline, the equipment used for liquid dispensing, the online steam sterilization of the liquid dispensing pipeline, and the damp heat sterilization of the equipment; the brown neutral borosilicate glass ampoule is cleaned with water for injection, and dried and sterilized in a high-temperature tunnel oven at 320°C for la...

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Abstract

The invention provides a method for controlling the content of hydrogen sulfide in an acetylcysteine solution. The acetylcysteine solution for inhalation is produced by adopting a sterile production process, compared with a sterilization production process of imported drug Fluimucil, the sterile production process has a better control effect on the hydrogen sulfide, and the content of the hydrogensulfide in the acetylcysteine solution for inhalation produced by adopting the process is not more than 100ppm. The acetylcysteine solution for inhalation provided by the invention is reasonable in prescription selection, safe and controllable in production process and stable in finished product quality.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for controlling the hydrogen sulfide content of acetylcysteine ​​solution. Background technique [0002] Acetylcysteine, English name: Acetylcysteine, chemical name: N-acetyl-L-cysteine, molecular formula: C5H9NO3S, molecular weight: 163.20, structural formula: [0003] [0004] This product is white crystal or crystalline powder, with odor similar to garlic, taste sour; soluble in water and ethanol, partially soluble in methanol; hygroscopic. [0005] Acetylcysteine ​​was first used in the 1960s as a classic drug for reducing phlegm. However, in the past ten years, with more and more clinical use and continuous deepening of research, it has been found that acetylcysteine It not only has mucus-dissolving effect, but also has strong anti-oxidation effect and the effect of promoting the generation of pulmonary surfactant. Many clinical evidences have shown that acetylcysteine ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K47/02A61K47/18A61K31/198A61P11/10A61P11/00A61P11/06
CPCA61K9/0073A61K47/02A61K47/183A61K31/198A61P11/10A61P11/00A61P11/06
Inventor 钟昌茂鲍瑞森符兴远符策裕
Owner HAINAN STAR PHARM CO LTD