A kind of ibuprofen granule and preparation method thereof

Abstract

The invention relates to an ibuprofen granule and a preparation method thereof. The ibuprofen granule comprises ibuprofen, mannitol, sodium dodecyl sulfate and sucralose. The prepared ibuprofen granule is good in taste and favorable in dissolubility; meanwhile, after ibuprofen and special auxiliary materials are prepared into microcapsules, the dissolution rate of the ibuprofen granule is increased, and the added propylene glycol alginate and sodium dodecyl sulfate are coated, so that the ibuprofen granule is more completely dissolved; the stability of the ibuprofen granule is improved by the added pregel starch and colloidal silicon dioxide.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, in particular to ibuprofen granules and a preparation method thereof. Background technique [0002] Ibuprofen, whose chemical name is α-methyl-4-(2-methylpropyl)phenylacetic acid, is a phenylpropionic acid non-steroidal anti-inflammatory drug and is currently the most commonly used non-steroidal anti-inflammatory drug in clinical practice. One of the (NSAID class) drugs; it has anti-inflammatory, analgesic, and antipyretic effects, and is mainly used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, and dysmenorrhea; it is also used for Fever caused by the common cold or influenza; has been widely used clinically. [0003] The oral solid preparations of ibuprofen that have been on the market have dosage forms such as tablets, capsules, and sustained-release capsules. These oral solid preparations generally have technical problems such as poo...

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Problems solved by technology

[0003] The oral solid preparations of ibuprofen that have been on the market have dosage forms such as tablets, capsules, and sustained-release capsules. These oral solid preparations generally have technical problems such as poor absorption, low bioavailability, and relatively slow onset of action. It brings inconvenience to people and patients who cannot swallow solid preparations; while granules are convenient to take and take effect quickly, so the current research on granules is relatively extensive

The applicant obtained the drug registration approval document for the production of ibuprofen granules in August 2008, the main components of which are 200g ibuprofen, 700g dextrin, 50g cyclamate and 50g hydroxypropyl cellulose; the applicant has been in continuous production for 3 years And sales, it is concluded that the ibuprofen granules produced by it are convenient to take, especially suitable for children, and it has been recognized by the majority of patients; but after research, it is also found that there are some shortcomings in the original prescription, mainly: 1) The taste is not ideal, because The pungent taste of ibuprofen medicine itself, although add cyclamate after making granule, still be difficult to remove the pungent taste of granule, this is difficult to accept for patient, especially children's patient, and patient's compliance is bad; 2) solubility is not good , because ibuprofen is an insoluble drug, after being made into granules, most of the drugs cannot be dissolved and float on the water surface when it is added to water for ingestion. More importantly, due to the existence of a large amount of insoluble ibuprofen, the patient must drink it with water several times before taking all the medicine according to the dose; therefore, it is very easy to cause the patient to take the medicine inaccurately

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