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Efinbuprofen sustained-release tablet and preparation method thereof

A technology of efluprofen and sustained-release tablets, applied in the field of efluprofen sustained-release tablets and preparation thereof, can solve the problems of low patient compliance, bitter taste of efluprofen, and inability to achieve taste masking and the like , to achieve the effect of reducing the number of doses, not easy to burst, and reducing irritation

Active Publication Date: 2022-05-06
南京一诺医药科技有限公司 +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the active component is S-flurbiprofen, wet granulation is used in the preparation process and then compressed; Ethanol is used in the drug, which requires the equipment to have explosion-proof devices, and the requirements for the equipment are relatively high. In addition, Effluprofen tastes bitter, which cannot achieve the effect of masking the taste, and the patient's compliance is not high.

Method used

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  • Efinbuprofen sustained-release tablet and preparation method thereof
  • Efinbuprofen sustained-release tablet and preparation method thereof
  • Efinbuprofen sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] A kind of Effluprofen slow-release tablet, its tablet formula (1000 preparation unit quantities) is as follows:

[0046]

[0047]

[0048] The preparation method is as follows:

[0049] 1. Preparation of drug-containing pill core:

[0050] 1.1 Pre-treatment: Weigh the raw materials of Effluprofen according to the formula; auxiliary materials: lactose and microcrystalline cellulose, pass through a 60-mesh sieve respectively, and set aside.

[0051] 1.2 Preparation of binder solution: take the formula amount of sodium carboxymethylcellulose and add it to 39.2g of purified water, stir to dissolve, and set aside. The mass content of sodium carboxymethylcellulose in the binder solution is 2.0%.

[0052] 1.3 Preparation of drug-containing pill core: Mix efloprofen, lactose, and microcrystalline cellulose evenly, slowly add binder solution to make soft material, and prepare pellets by extrusion spheronization, and place the prepared pellets in an oven at 60°C Medium-d...

Embodiment 2

[0066] A kind of Effluprofen slow-release tablet, its tablet formula (1000 preparation unit quantities) is as follows:

[0067]

[0068] The preparation method is as follows:

[0069] 1. Preparation of drug-containing pill core:

[0070] 1.1 Pre-treatment: Weigh the raw materials of Effluprofen according to the formula; auxiliary materials: lactose and microcrystalline cellulose, pass through a 60-mesh sieve respectively, and set aside.

[0071] 1.2 Preparation of binder solution: take the formula amount of sodium carboxymethyl cellulose and add 39.2g of purified water, stir to dissolve, and set aside. The mass content of sodium carboxymethylcellulose in the binder solution is 2.0%.

[0072] 1.3 Preparation of drug-containing pill core: Mix efloprofen, lactose, and microcrystalline cellulose evenly, slowly add binder solution to make soft material, and prepare pellets by extrusion spheronization, and place the prepared pellets in an oven at 60°C Medium-dried until the wate...

Embodiment 3

[0086] A kind of Effluprofen slow-release tablet, its tablet formula (1000 preparation unit quantities) is as follows:

[0087]

[0088]

[0089] The preparation method is as follows:

[0090] 1. Preparation of drug-containing pill core:

[0091] 1.1 Pre-treatment: Weigh the raw materials of Effluprofen according to the formula; auxiliary materials: lactose and microcrystalline cellulose, pass through a 60-mesh sieve respectively, and set aside.

[0092] 1.2 Preparation of binder solution: take the formula amount of sodium carboxymethyl cellulose and add 39.2g of purified water, stir to dissolve, and set aside. The mass content of sodium carboxymethylcellulose in the binder solution is 2.0%.

[0093] 1.3 Preparation of drug-containing pill core: Mix efloprofen, lactose, and microcrystalline cellulose evenly, slowly add binder solution to make soft material, and prepare pellets by extrusion spheronization, and place the prepared pellets in an oven at 60°C Medium-dried ...

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Abstract

The invention relates to an iflurprofen sustained-release tablet and a preparation method thereof, the tablet is composed of a sustained-release pellet and pharmaceutically acceptable auxiliary materials, the sustained-release pellet is prepared from a drug-containing pellet core, an isolation coating layer and a sustained-release enteric coating layer, the drug-containing pellet core is prepared from iflurprofen, lactose, microcrystalline cellulose and sodium carboxymethyl cellulose, and the sustained-release enteric coating layer is prepared from iflurprofen, lactose, microcrystalline cellulose and sodium carboxymethyl cellulose. The isolation coating layer is prepared from hydroxypropyl methylcellulose, the sustained-release enteric coating layer is prepared from an ethyl cellulose aqueous dispersion and Jacocos, and the proportions of all the components and the weight gain proportion of the coating are controlled, so that active ingredients in the prepared tablet can be slowly released for 24 hours and are not easy to suddenly release, the medicine can be continuously absorbed in a human body for 24 hours, the medicine taking frequency is reduced, and the curative effect of the tablet is improved. The compliance of a patient is improved, the irritation to gastrointestinal tracts can be reduced, and the bitter taste of the efiniprofen is covered. The iflurprofen sustained-release tablet provided by the invention solves the problems that an organic solvent is used in the preparation process in the prior art, and the medicine is easy to migrate to the surface layer under a long-term storage condition to generate burst release.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an efluprofen sustained-release tablet and a preparation method thereof. Background technique [0002] Effluprofen is the S configuration of flurbiprofen. Flurbiprofen is a non-steroidal anti-inflammatory drug, which plays an anti-inflammatory and analgesic effect by inhibiting the activity of prostaglandin synthase cyclooxygenase. It is suitable for rheumatoid arthritis, osteoarthritis and flexural spondylitis, etc. Compared with similar drugs, it has the advantages of small dose, high curative effect, quick onset, and small side effects. The current clinical application is its racemate. Studies have found that the active source of S-flurbiprofen is mainly its S(+)-enantiomer, while the R(-)-enantiomer lacks significant epoxidation. Enzyme inhibitory activity, gastrointestinal toxicity of this racemate is increased due to the presence of the R(-)-enantiome...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/22A61K47/38A61K47/26A61K31/192A61P29/00
CPCA61K9/2866A61K9/2018A61K9/2054A61K9/2095A61K31/192A61P29/00Y02A50/30
Inventor 张虹王剑王华娟
Owner 南京一诺医药科技有限公司
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