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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 problems such as research, and achieve the effects of stable quality, good stability, and less impurities

Inactive Publication Date: 2017-05-24
TIBET WEIXINKANG MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, so far, there is no published technical literature on the detailed study of the pH value of the composition of acetylcysteine ​​aqueous solution

Method used

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  • Acetylcysteine pharmaceutical composition and preparation method thereof
  • Acetylcysteine pharmaceutical composition and preparation method thereof
  • Acetylcysteine pharmaceutical composition and preparation method thereof

Examples

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Embodiment Construction

[0024] According to the prescriptions listed in Table 1 and Table 2, pre-fill the liquid preparation container and pipeline with nitrogen to remove oxygen, and keep it under the state of continuous nitrogen filling under the liquid surface, add acetylcysteine ​​and calcium sodium edetate to about Prepare 60% of the total amount of nitrogen-filled deoxidized water for injection, stir to dissolve it, add 20% sodium hydroxide solution prepared with deoxygenated water for injection to adjust the pH value, add deoxygenated water for injection to the full amount, and stir Mix evenly, filter the medicinal solution with a 0.2μm filter, dispense 10ml / bottle into 10ml ampoules pre-filled with nitrogen, and seal with nitrogen.

[0025] Table 1 Example prescription composition

[0026] prescription Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Example 8 Acetylcysteine ​​(kg) 1 2 2 2 2 2 2 2 Edetate Calcium Sodium (g) 5 4...

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Abstract

The invention aims to provide a more stable acetylcysteine pharmaceutical composition and a preparation method thereof. The acetylcysteine pharmaceutical composition comprises acetylcysteine and medically acceptable excipients, and the aqueous solution of the composition has a pH value of 7.0-7.5.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a more stable acetylcysteine ​​pharmaceutical composition and a preparation method thereof. Background technique [0002] Acetylcysteine ​​is a white crystalline powder with a garlic-like odor, sour taste, hygroscopicity, melting point 101-107°C, and easily soluble in water or ethanol. The molecular weight is 163.2, and the molecular formula is C 5 h 8 NO 3 S, CAS No. 616-81-1, and has the following chemical structure. [0003] [0004] In November 2004, Cumberland Pharmaceuticals launched acetylcysteine ​​injection "Acetadote" (NDA 021539) in the United States, which is a standard drug for preventing or alleviating potential liver damage caused by paracetamol overdose. Acetaminophen is a common component of many prescription painkillers and over-the-counter painkillers, as well as cold and fever medicines. Overdose (daily dose greater than 4000mg) can cause severe or e...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K47/02A61P1/16
Inventor 王冬生李琴胡军刘烽张勇
Owner TIBET WEIXINKANG MEDICINE CO LTD
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