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Injection acetylcysteine powdery medicinal composition and its making method

A technology of cysteine ​​powder injection and acetylcysteine, which is applied in the powder injection pharmaceutical composition containing acetylcysteine ​​sterile powder and its preparation field, achieving good stability, safety and wide application, and small reaction Effect

Inactive Publication Date: 2007-09-05
何晶
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Acetylcysteine ​​powder injection can be used as an injection route in clinical practice, but currently there are few acetylcysteine ​​powder injections on the market.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Acetylcysteine ​​Sterile Powder 1000g

[0026] Sodium bicarbonate sterile powder 450g

[0027] Made 1000 pieces

[0028] The preparation steps are as follows:

[0029] 1. Preparation of acetylcysteine ​​aseptic powder

[0030] Put water for injection and acetylcysteine ​​into the reaction tank at a weight ratio of 5:1, slowly raise the temperature to 60°C, stir until the solid dissolves, add medicinal charcoal with a weight of 0.5% of the solution, stir for 30 minutes, and filter while it is hot. Place the filtrate and crystallize for 60-80 hours, then filter the liquid medicine, rinse the crystals with water for injection that is 1 times the weight of acetylcysteine, drain the washing liquid, and dry the crystals in vacuum at 50-55°C for 8-12 Hour, obtain acetylcysteine ​​aseptic powder;

[0031] 2. Preparation of sodium bicarbonate sterile powder

[0032] Control the temperature at 8-12°C, stir and dissolve sodium b...

Embodiment 2

[0034] Embodiment 2: Acetylcysteine ​​sterile powder 1000g

[0035] Sodium carbonate sterile powder 350g

[0036] Made 1000 pieces

[0037] The preparation steps are as follows:

[0038] 1. Preparation of acetylcysteine ​​aseptic powder

[0039] (with the step 1 of embodiment one)

[0040] 2. Preparation of sodium carbonate sterile powder

[0041] Control the temperature at 8-12°C, stir and dissolve sodium bicarbonate in distilled water, control the temperature range, add medicinal charcoal with a weight of 0.1% of the solution, stir for 30 minutes, filter, and slowly dropwise add sodium bicarbonate to the solution 3 times of the weight of dehydrated ethanol obtained by filtering through a 0.22 μm microporous membrane, after the dropwise addition, continue to stir for 5 hours to crystallize, filter, and the crystals are successively washed with 40% ethanol solution that is 1 times the weight of sodium bicarbonate, Wash once with absolute ethanol ...

Embodiment 3

[0043] Embodiment 3: Acetylcysteine ​​sterile powder 1000g

[0044] Disodium bicarbonate sterile powder 950g

[0045] Made 1000 pieces

[0046] The preparation steps are as follows:

[0047] 1. Preparation of acetylcysteine ​​aseptic powder

[0048] (with the step 1 of embodiment one)

[0049] 2. Preparation of disodium hydrogen phosphate aseptic powder

[0050]Take disodium hydrogen phosphate and water for injection and put them into the reaction tank at a weight ratio of 1:2, stir and heat to 70°C to dissolve, add medicinal charcoal with a weight of 0.05% of the solution, stir for 20 minutes, keep it warm and adsorb for 20 minutes, decarbonize through filtration, and use After fine filtration with a 0.22 μm microporous membrane, cool to room temperature, add anhydrous ethanol obtained by filtering through a 0.22 μm microporous membrane, which is 3 times the weight of disodium hydrogen phosphate, stir and crystallize, filter, and add the crystals...

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PUM

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Abstract

An acetylcysteine composition in the form of powder injection with high solubility and stability is prepared from acetylcysteine and pH regulate chosen from sodium dicarbonate, sodium carbonate, sodium hydroxide and bisodium dicarbonate in weight ratio of 1: (0.25-1). Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a powder injection pharmaceutical composition and a preparation method thereof, in particular to a powder injection pharmaceutical composition containing acetylcysteine ​​aseptic powder and a preparation method thereof. Background technique [0002] Acetylcysteine ​​(NAC) is the precursor of intracellular glutathione, which can increase the biosynthesis of intracellular glutathione. Recent studies have proved that NAC can act as a carrier of nitric oxide molecules in vivo to exert nitric oxide Physiological effects, promote the dilation of contracted microcirculation blood vessels, effectively increase the oxygen delivery and release of blood to tissues, correct tissue hypoxia, and reduce the occurrence of multiple organ failure. It has been used abroad as a therapeutic drug for acute fulminant hepatic failure caused by drug poisoning, and it has been included in the 1993 and 1998 editions of the British Pharmacopoeia, and its ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/198A61K47/02A61P1/16
Inventor 何晶
Owner 何晶
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