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A kind of ibuprofen granule and preparation method thereof

A kind of particle and particle size range technology, which is applied in the field of ibuprofen granules and its preparation, can solve the problems of difficult to remove the pungent taste of granules, inaccurate dosage for patients, and poor patient compliance, so as to improve the pungent taste and eliminate the pungent taste. Taste, effect of improving solubility

Inactive Publication Date: 2017-01-04
哈尔滨华瑞生化药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

Method used

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  • A kind of ibuprofen granule and preparation method thereof
  • A kind of ibuprofen granule and preparation method thereof
  • A kind of ibuprofen granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044]

[0045] Preparation:

[0046] A. said component is passed through 100 mesh sieve respectively, for subsequent use;

[0047] b. Configuration of the mixed liquid: Weigh the prescribed amount of sucralose, sodium lauryl sulfate and milk-flavored powder essence and dissolve in 30% ethanol solution, and stir until completely dissolved;

[0048] c. Mix the sieved ibuprofen and mannitol evenly, add the mixed solution prepared in step b, make a soft material, granulate through a 20-mesh sieve, dry for 6 hours below 55°C, and screen out 20-40 mesh The granules in between, i.e. ibuprofen granules, are divided into 1000 packets.

Embodiment 2

[0050]

[0051] Preparation method: prepared according to the method of Example 1.

Embodiment 3

[0053]

[0054] Preparation:

[0055] 1) Preparation of ibuprofen microcapsules: add ibuprofen to cellulose acetate phthalate, add octyldodecanol while grinding, and grind evenly to obtain ibuprofen grinds; Add water at a volume ratio of 1:2 to obtain an aqueous solution; mix the ground ibuprofen and the aqueous solution evenly, and emulsify at high speed to obtain ibuprofen colostrum; place the ibuprofen colostrum in a high-pressure homogenizer Medium emulsification to obtain ibuprofen emulsion; the ibuprofen emulsion is ultrafinely pulverized and dried to obtain ibuprofen microcapsules with a particle size range of 5 μm and a yield of 95%;

[0056] 2) Configuration of the mixed solution: dissolve sodium lauryl sulfate in absolute ethanol, stir until completely dissolved, and obtain the mixed solution;

[0057] 3) adding the microcapsules prepared in step 1) to the mixed solution prepared in step 2), making a soft material, granulating through a 20-mesh sieve, spraying an...

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/192A61K9/16A61K47/26A61K47/20A61P29/00
Inventor 宋洋
Owner 哈尔滨华瑞生化药业有限责任公司
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