Naproxen injection and preparation method thereof

Abstract

The invention discloses a naproxen injection and a preparation method thereof. The naproxen injection is prepared from a certain proportion of naproxen, a salt-forming agent, a complexing agent, a stabilizer, an adsorbent and water for injection. The preparation method comprises the following steps: 1) preparing a salt-forming agent solution from the salt-forming agent by using the water for injection; and 2) adding the naproxen into the remaining water for injection, adding the salt-forming agent solution, performing continuous stirring until the naproxen is completely dissolved, adding the complexing agent and the stabilizer, performing uniform stirring, wherein the pH value of the system at the time is 7.5-9.0, adding the adsorbent, performing uniform stirring, allowing the mixture to stand for 20-30 min, performing filtration, performing filling, introducing nitrogen, performing sealing, and finally performing sterilization for 25-35 min at 115-121 DEG C. The injection has high stability, and can be used for intramuscular administration, the administration is convenient and rapid, and the injection has a small preparation volume, and is convenient for transportation, and low intransportation cost.

Description

technical field [0001] The invention belongs to the technical field of clinical preparations, and in particular relates to a naproxen injection and a preparation method thereof. Background technique [0002] Naproxen, also known as methoxyisopropionic acid, is an aryl propionic acid non-steroidal drug, white or off-white powder crystal, chemical name (+)—α—methyl—6—methoxy— 2—Naphthylacetic acid, odorless or almost odorless, almost insoluble in water, soluble in methanol or chloroform. The drug has good anti-inflammatory, antipyretic, and analgesic effects, and has less adverse reactions. Naproxen can obviously inhibit the synthesis of prostaglandins, and can reduce or even stop the release of prostaglandins, so it has strong anti-inflammatory, antipyretic and analgesic effects. The anti-inflammatory effect of naproxen is 11 times that of phenylbutazone, the antipyretic effect is 22 times that of aspirin, and the analgesic effect is 7 times that of aspirin. Naproxen is cl...

AI Technical Summary

Problems solved by technology

Commercially available naproxen raw materials are mostly used to prepare oral preparations such as tablets and capsules, and naproxen sodium is also used to prepare solution-type preparations, such as eye drops, injections, etc., but naproxen sodium needs to use naproxen and alkali Salt formation, low-temperature crystallization with organic solvents, and refining. The impurities that may be introduced during this process are difficult to control, and also increase the manufacturing cost. There are no reports of using naproxen sodium to prepare injections for intramuscular administration.

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