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Paracetamol injection and preparation method thereof

A technology of acetaminophen and injection, applied in the field of medicine, can solve problems such as the stability of acetaminophen injection, and achieve effectiveness and safety, good stability, and low content of related substances Effect

Active Publication Date: 2015-05-06
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Acetaminophen is easily hydrolyzed in aqueous solution, making it unsuitable for making injections. However, injections have the advantages of fast onset of action and are suitable for patients who cannot be taken orally. The preparation method of liquid, in order to meet the clinical demand for injection, but the stability of paracetamol injection can not be solved well in prior art, therefore, need to research and develop a kind of new paracetamol injection Drug combination and preparation method to improve the stability of acetaminophen injection

Method used

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  • Paracetamol injection and preparation method thereof
  • Paracetamol injection and preparation method thereof
  • Paracetamol injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060]

[0061]

[0062] ① Add 9.7L of fresh water for injection into the concentrated preparation tank, fill with nitrogen, add 3.85Kg of mannitol, stir to dissolve, add 10g of medicinal activated carbon, stir evenly, heat to boil for 10 minutes, and filter to dilute the preparation tank.

[0063] ② Add 45L of water for injection to the concentrated preparation tank, fill with nitrogen, add 10.4g of disodium hydrogen phosphate and 25g of cysteine ​​hydrochloride, stir to dissolve, adjust the pH to 5.3, add 1.0kg of paracetamol, stir to make it fully Dissolve, add 10g of medicinal activated carbon, stir evenly, filter until dilute and fit into a tank.

[0064] ③ Mix the above-mentioned concentrated solution, fill with nitrogen for protection, add water for injection to 100L, stir evenly, test the content and pH value, and obtain a diluted solution.

[0065] ④ Filtrate, check the clarity, content and pH value of the liquid, fill with nitrogen, seal, and sterilize at 121°C...

Embodiment 2

[0067]

[0068] ① Add 9.0L of fresh water for injection into the concentrated preparation tank, fill with nitrogen, add 3.6Kg of mannitol, stir to dissolve, add 50g of medicinal activated carbon, stir evenly, heat to boil for 15 minutes, and filter to dilute the preparation tank.

[0069] ② Add 55L of water for injection to the concentrated preparation tank, fill with nitrogen, add 10.6g of disodium hydrogen phosphate and 22g of cysteine ​​hydrochloride, stir to dissolve, adjust the pH to 5.6, add 1.0kg of paracetamol, stir to make it fully Dissolve, add 50g of medicinal activated carbon, stir evenly, filter until dilute and fit into a tank.

[0070] ③ Mix the above-mentioned concentrated solution, fill with nitrogen for protection, add water for injection to 100L, stir evenly, test the content and pH value, and obtain a diluted solution.

[0071] ④ Filter, check the clarity, content and pH value of the liquid, fill with nitrogen, seal, and sterilize at 121°C for 15 minutes...

Embodiment 3

[0073]

[0074] ① Add 7.7L of fresh water for injection into the thick mixing tank, fill with nitrogen, add 3.8Kg of mannitol, stir to dissolve, add 100g of medicinal activated carbon, stir evenly, heat to boil for 20 minutes, and filter to dilute mixing tank.

[0075] ② Add 60L of water for injection to the concentrated preparation tank, fill with nitrogen, add 11g of disodium hydrogen phosphate and 28g of cysteine ​​hydrochloride, stir to dissolve, adjust the pH to 5.8, add 1.0kg of acetaminophen, stir to fully dissolve , add 100g of medicinal activated carbon, stir evenly, and filter until it is diluted with a tank.

[0076] ③ Mix the above-mentioned concentrated solution, fill with nitrogen for protection, add water for injection to 100L, stir evenly, test the content and pH value, and obtain a diluted solution.

[0077] ④ Filter, check the clarity, content and pH value of the liquid, fill with nitrogen, seal, and sterilize at 121°C for 12 minutes.

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Abstract

The invention discloses a paracetamol injection and a preparation method thereof. The preparation method is characterized by comprising the following steps: firstly, preparing concentrated mannitol solution and transferring the concentrated mannitol solution to a dilution preparation tank; dissolving disodium hydrogen phosphate and cysteine hydrochloride in a concentration preparation tank with freshly prepared water for injection, regulating the pH value to 5.3-5.9, adding paracetamol, adding activated carbon and stirring and adsorbing after the dissolving is completed, filtering, mixing the filtrate with the concentrated mannitol solution to be constant volume to obtain a diluted mannitol solution; and filling, sterilizing, performing lamp inspection and packaging. By adding disodium hydrogen phosphate and regulating the pH value of the disodium hydrogen phosphate and cysteine hydrochloride mixed solution to a proper range before addition of paracetamol, the condition that paracetamol is in a per-acidic or per-alkaline solution to be dissolved due to adjustment of pH when dilution is carried out is avoided, nitrogen is continuously introduced during the whole preparation process, so the generation of specific impurity paracetamol and other impurities can be effectively controlled; the prepared paracetamol injection is low in the contents of related substances, and both the quality and the stability of the paracetamol injection can be improved.

Description

technical field [0001] The invention relates to a medical injection, in particular to a preparation method of acetaminophen injection. It belongs to the field of medical technology. Background technique [0002] Acetaminophen, the chemical name is 4'-hydroxyacetanilide. Soluble in hot water or ethanol, soluble in acetone, slightly soluble in water, unstable to acid, alkali (most stable when pH is around 6) and oxygen in aqueous solution, odorless, slightly bitter taste, acetyl Aminophenol is an acetanilide antipyretic and analgesic drug, a cyclooxygenase inhibitor, which selectively inhibits the synthesis of prostaglandins in the hypothalamus thermoregulation center, causing peripheral blood vessels to dilate and sweat to achieve antipyretic effect; It acts as a peripheral analgesic by inhibiting the synthesis and release of prostaglandins and increasing the pain threshold. It is clinically used for cold and fever, joint pain, headache, neuralgia and muscle pain, etc. Bec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/167A61K47/04A61K47/18A61P29/00
Inventor 曲继广崔雪妹李建刚闫永娜焦翠欢韩锡缜刘晓娟吴雷杨亚贤孙伶
Owner SHIJIAZHUANG NO 4 PHARMA
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