Acetaminophen injection and preparation method thereof
A technology for acetaminophen and injection, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problem that the stability of acetaminophen injection cannot be solved well problems, to achieve the effect of good quality and stability, and high drug safety
Pending Publication Date: 2022-07-15
辽宁金品生物科技有限公司
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Problems solved by technology
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 take oral administration. The preparation method of liquid, in order to meet the clinical demand to injection, but prior art all can not well solve the stability of acetaminophen injection
Method used
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Embodiment 1
[0030] Embodiment 1: a kind of acetaminophen injection, by preparing 1000ml,
[0031]
[0032] Water for injection was added to 1000ml.
[0033] Its preparation steps are:
[0034] 1) After adding some water for injection at 40-50°C into the dilute preparation tank, at the same time continuously introduce nitrogen for protection, and the flow rate of nitrogen is controlled at 1m 3 / h; then add sodium bisulfite to the dilute preparation tank and stir for 20 minutes until fully dissolved, then add cysteine hydrochloride and stir for 20 minutes to dissolve;
[0035] 2) adding polyethylene glycol 400 to the liquid dispensing tank and stirring for 10 minutes, then adding paracetamol to the dilute dispensing tank and stirring for 20 minutes to dissolve;
[0036] 3) The pH buffer is added to the dilute preparation tank and stirred evenly;
[0037] 4) All the remaining water for injection at 50-60° C. is added to the dilute preparation tank, stirred for 10 minutes, and then un...
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The invention discloses an acetaminophen injection and a preparation method thereof.The acetaminophen injection is prepared from acetaminophen, sodium hydrogen sulfite, polyethylene glycol 400, a PH buffering agent, cysteine hydrochloride and activated carbon, the prepared acetaminophen injection is stable in clarity, pH value, related substances and other quality indexes, nitrogen is continuously introduced in the preparation process, and the injection is stable in quality and free of pollution. According to the present invention, the production of p-aminophenol and other impurities is effectively controlled, the acetaminophen content can be up to 102%, the requirement is met, the preparation process is feasible, and the product has characteristics of good production quality, good stability and high medication safety through the room temperature long-term stability investigation and the accelerated test investigation.
Description
technical field [0001] The invention relates to the technical field of medicinal products, in particular to a paracetamol injection and a preparation method thereof. Background technique [0002] Acetaminophen, the chemical name is 4'-hydroxyacetanilide. Easily soluble in hot water or ethanol, soluble in acetone, slightly soluble in water, unstable to acid, alkali (the most stable at pH 6) and oxygen in aqueous solution, odorless, slightly bitter taste, p-acetyl Aminophenol is an acetanilide antipyretic analgesic, a cyclooxygenase inhibitor, which can achieve antipyretic effect by selectively inhibiting the synthesis of prostaglandins in the hypothalamus thermoregulatory center, leading to peripheral vasodilation and sweating; By inhibiting the synthesis and release of prostaglandins, etc., and increasing the pain threshold, it has an analgesic effect and belongs to peripheral analgesics. It is clinically used for cold and fever, joint pain, headache, neuralgia and muscle ...
Claims
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IPC IPC(8): A61K9/08A61K31/167A61K47/02A61K47/10A61K47/18A61P29/00
CPCA61K31/167A61K9/08A61K9/0019A61K47/10A61K47/183A61K47/02A61P29/00
Inventor 王文宇彭诗华曹凯孙洪伟
Owner 辽宁金品生物科技有限公司