Paracetamol injection and preparation method thereof

Abstract

The invention belongs to the technical field of medical products, and relates to a paracetamol injection and a preparation method thereof. Every 100 mL of the paracetamol injection comprises the following components: 15 mL of propylene glycol, 25 mL of polyethylene glycol 300 or polyethylene glycol 400, 15 g of paracetamol, 0.1-3 g of an antioxidant and the balance of water for injection. The preparation method comprises the following steps: (1) sequentially adding the propylene glycol and the polyethylene glycol 300 or polyethylene glycol 400 into the water for injection; (2) adding the paracetamol to completely dissolve paracetamol; (3) slowly adding the antioxidant; (4) adjusting the pH value of the liquid medicine to 6.0-6.5; (5) adding water for injection to the total volume; and (6)carrying out sampling, measuring the content and the pH value, filtering, and after the content and the pH value are up to the standard, carrying out filling and sealing, and then carrying out sterilizing to obtain the paracetamol injection. The paracetamol injection prepared by the method is high in stability, and meanwhile, the medication safety is improved.

Description

technical field [0001] The invention belongs to the technical field of medical products, and relates to an acetaminophen injection and a preparation method thereof. Background technique [0002] Acetaminophen was first approved as a drug in the United States in 1951, and has now become a commonly used antipyretic and analgesic drug. One or several combinations of butalbital and other drugs can be used to make antitussive with good sedative effect. Analgesia with acetaminophen is peripheral rather than central. After more than 60 years of development, up to now, medicines with acetaminophen as the main ingredient include tablets, oral suspensions, capsules, suppositories, injections and other dosage forms. [0003] Among the injections with acetaminophen as the single main ingredient, China currently only has two small-volume injections of 1mL and 2mL approved for marketing. The administration method is intramuscular injection, and there is no injection of 100mL or 50mL. ;...

AI Technical Summary

Problems solved by technology

Domestic small needles usually use polyethylene glycol 300 or polyethylene glycol 400 as a stabilizer. Although polyethylene glycol is one of the few synthetic polymers approved by the FDA that can be used as a drug for internal injection, there are still clinical reports. According to case reports, the application of polyethylene glycol 300 or polyethylene glycol 400 in injections can increase the incidence of acute tubular necrosis; in addition, acetaminophen is slightly soluble in water, easily soluble in ethanol, and very slightly soluble in dichloromethane. methane, and it is easy to oxidize and decompose in aqueous solution, so the choice of excipients for acetaminophen injection is worthy of careful study

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