Paracetamol and tramadol oral emulsion and preparation method thereof

Abstract

The invention discloses an oral emulsion of paracetamol tramadol, which is an oil-in-water emulsion formed by uniformly dispersing an oil solution of paracetamol in an aqueous solution of tramadol hydrochloride; the invention also discloses an oral emulsion of paracetamol A preparation method of tramadol oral emulsion, the method firstly adds the oil phase solution containing paracetamol to the mixed solution containing starch sodium octenyl succinate emulsifier, and then adds it to the aqueous phase solution containing tramadol hydrochloride Homogenize in. The present invention avoids the degradation and oxidation of paracetamol and covers its bitter taste by covering the paracetamol in the emulsion, and combines the masking effect of the taste masking agent and the corrective agent and the crosslinking effect of other components to cover the The bitter taste of tramadol hydrochloride improves the stability of oral milk of tramadol and improves the mouthfeel of oral milk of tramadol and enhances its bioavailability; the invention adopts an emulsification encapsulation method to prepare stable oil-in-water Tramadol-type paracetamol oral emulsion, the process is simple.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an acetaminophen tramadol oral emulsion and a preparation method thereof. Background technique [0002] In FDA (U.S. Food and Drug Administration) Medication Guidelines, the compound combination of non-steroidal anti-inflammatory analgesic drugs and opioid receptor agonist antagonist analgesic drugs is the current development direction of clinical analgesic drugs, trama hydrochloride Most of them are commonly used opioid receptor agonist analgesics, and paracetamol is a non-steroidal anti-inflammatory analgesic drug, which is often used to treat limb pain, headache and fever caused by colds. The characteristics of drug side effects are classic compound preparations combined analgesics. At present, the preparation forms that use the combination of paracetamol (aminophenol) and tramadol hydrochloride (tramadol) as the main drug include compound oral tablets, Chewable...

AI Technical Summary

Problems solved by technology

The publication number is CN110115708A patent using glycerin (or propylene glycol), polyethylene glycol, water as a mixed solvent system to co-dissolve acetaminophen and tramadol to make an oral liquid. Although this oral liquid solves the problem of some patients taking ordinary oral Difficulty in swallowing solid preparations, but water accounts for 39% to 49% or 39% to 59% of oral liquids. Since paracetamol is not a very stable compound, it will be hydrolyzed when placed in a water environment for a long time. Acetic acid, aminophenol, and some oxidized impurities lead to decreased drug efficacy and increased drug side effects

Therefore, how to solve the drug degradation and keep the drug stable is an important technical problem to be solved by the acetaminophen tramadol oral liquid; at the same time, for the bitter taste of the acetaminophen tramadol, polyethylene glycol coating is used in the oral liquid system. Taste masking in combination with flavoring agents, but the oral solution is a homogeneous solution formed by dissolving tramadol acetaminophen, so flavoring agents and polyethylene glycol can only partially mask their bitter taste

In addition, there is no reference to the use of antibacterial preservatives in this patent, so the acetaminophen tramadol oral solution preparation made with glycerin (or propylene glycol), polyethylene glycol, water as a mixed solvent system and flavoring agent is placed in the process of placing May breed bacteria and spoilage