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Slow-release dry dexibuprofen suspension and preparation method thereof

A technology of dry suspension and dexibuprofen, which is applied in anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., can solve the problem that the slow-release effect of the suspension needs to be further improved, and avoid blood drug concentration Peak-valley phenomenon, improving medication compliance, good taste-masking effect

Inactive Publication Date: 2019-03-29
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The Chinese patent application number 2016112152983 discloses a sustained-release dry suspension of ibuprofen and a preparation method thereof. In the suspension, ibuprofen is used as the main drug, and the sustained-release pellets of ibuprofen contain an isolation layer. When preparing the suspension, the suspending agent is prepared into granules, the sustained release effect of the suspension in the above invention needs to be further improved, and it cannot be dispersed into a homogeneous suspension in a short time before use

Method used

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  • Slow-release dry dexibuprofen suspension and preparation method thereof
  • Slow-release dry dexibuprofen suspension and preparation method thereof
  • Slow-release dry dexibuprofen suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1: Preparation of Dexibuprofen sustained-release pellets

[0048] Prepare Dexibuprofen sustained-release pellets according to the formula in table 1:

[0049] Table 1 Dexibuprofen sustained-release pellet formula

[0050]

[0051] The specific preparation process of the above-mentioned Dexibuprofen sustained-release pellets is as follows:

[0052] 1. Drug-loaded layer coating:

[0053] A. Add Poloxamer 188 to 95% ethanol solution, stir slowly to make it fully dissolved, then add Dexibuprofen, stir evenly to obtain a clear drug-loaded layer coating solution, set aside.

[0054] B, open the fluidized bed coating machine, put microcrystalline cellulose into the fluidized bed coating machine, use the above drug-loaded layer coating liquid to carry out the drug-loaded layer coating operation to it (coating parameters: material temperature is 28~31℃, inlet air temperature is 38~42℃, atomization pressure is 0.05~0.07MPa, liquid spraying speed is 1.0~1.5mL / min)...

Embodiment 2

[0058] Embodiment 2: Preparation of Dexibuprofen sustained-release pellets

[0059] Prepare Dexibuprofen sustained-release pellets according to the formula in table 2:

[0060] Table 2 Dexibuprofen sustained-release pellet formula

[0061]

[0062] The specific preparation process of the above-mentioned Dexibuprofen sustained-release pellets is as follows:

[0063] 1. Drug-loaded layer coating:

[0064] A. Add PVP-K30 to 95% ethanol solution, stir slowly to make it fully dissolved, then add Dexibuprofen, stir evenly to obtain a clear drug-loaded layer coating solution, set aside.

[0065] B, open the fluidized bed coating machine, put microcrystalline cellulose into the fluidized bed coating machine, use the above drug-loaded layer coating liquid to carry out the drug-loaded layer coating operation to it (coating parameters: material temperature is 28~31℃, inlet air temperature is 38~42℃, atomization pressure is 0.05~0.07MPa, liquid spraying speed is 1.0~1.5mL / min), afte...

Embodiment 3

[0071] Embodiment 3: Preparation of Dexibuprofen Sustained Release Dry Suspension

[0072] Prepare Dexibuprofen Sustained Release Dry Suspension according to the formula in Table 3:

[0073] Table 3 Dexibuprofen Sustained Release Dry Suspension Formulation

[0074]

[0075] The concrete preparation process of above-mentioned Dexibuprofen slow-release dry suspension is as follows:

[0076] 1. Preparation of diluted granules:

[0077] Poloxamer 188 was dissolved in water to obtain solution A. Mix sucrose, sodium citrate, anhydrous citric acid, sucralose, and sodium benzoate evenly, add solution A dropwise to it while mixing, and disperse evenly with a grinding rod. Pass the obtained sample through a 20-mesh sieve, crush it, and dry it at 60°C for 2 hours to obtain diluted granules.

[0078] 2. Preparation of dry suspension:

[0079] Sucrose, starch, xanthan gum, talcum powder, strawberry essence, silicon dioxide are mixed uniformly to obtain mixture B, and the diluted gr...

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Abstract

The invention relates to a slow-release dry dexibuprofen suspension. The slow-release dry dexibuprofen suspension comprises slow-release dexibuprofen pellets, dilute particles and auxiliary materials,wherein each slow-release dexibuprofen pellet comprises a blank pellet core, a medicine-carrying layer and a slow-release layer; each dilute particle comprises a surfactant, a first filler, a flavoring agent and a preservative; the auxiliary materials include a second filler, a suspending aid, a first anti-adhesive agent, a flow aid and an essence; based on the total weight of the slow-release dry dexibuprofen suspension, the slow-release dry dexibuprofen suspension comprises the following components in percent by weight: 10-15% of the slow-release dexibuprofen pellets, 0.2-0.5% of the surfactant, 65-85% of the first filler and the second filler together, 2-7% of the flavoring agent, 0.5-3% of the suspending aid, 0.5-3% of the preservative, 0.5-3% of the first anti-adhesive agent, 0.5-3%of the flow aid and 0.1-2% of the essence. The slow-release dry dexibuprofen suspension provided by the invention has a relatively good slow-release effect and relatively good preparation stability, so that the number of medications is reduced and the medication compliance of a patient is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dexibuprofen sustained-release dry suspension and a preparation method thereof. Background technique [0002] Ibuprofen is an anti-inflammatory, antipyretic and pain-relieving OTC product, and is one of the most commonly used NSAID drugs in clinical practice. Dexibuprofen (dexibuprofen) is the S(+)-isomer of the widely used non-steroidal anti-inflammatory drug ibuprofen (racemate), the study found that the pharmacological activity of ibuprofen Mainly from the dextro-form, 75% dose of dextroibuprofen has the same curative effect as the ibuprofen racemate, and its activity is 160 times that of the levo-form and 1.6 times that of the racemate. Dexibuprofen was developed and listed in 1994 by the Gebro-Broscheh GmbH company of Austria, and its trade name is Seractil. Compared with racemic ibuprofen, Dexibuprofen has better clinical efficacy, faster analgesic effect, hig...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K9/52A61K31/192A61K47/32A61K47/38A61K47/10A61K47/36A61K47/24A61K47/26A61P29/00
CPCA61K9/10A61K9/5026A61K9/5031A61K9/5042A61K9/5078A61K31/192A61K47/10A61K47/24A61K47/26A61K47/36A61K47/38A61P29/00
Inventor 曹青日夏亚男徐结红
Owner SUZHOU UNIV
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