Loxoprofen sodium tablet and preparation process thereof

A technology for loxoprofen sodium and its preparation process, which is applied in the field of loxoprofen sodium tablets and its preparation, can solve problems affecting the properties of the main drug, and achieve the effects of good consistency, stable dissolution rate, and simple operation

Active Publication Date: 2020-09-25
福建东瑞制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, adding silicon dioxide during granulation may caus

Method used

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  • Loxoprofen sodium tablet and preparation process thereof
  • Loxoprofen sodium tablet and preparation process thereof
  • Loxoprofen sodium tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0036] Example 1-7

[0037] The formulations of Examples 1-7 are shown in Table 1.

[0038] Table 1.

[0039] Number of copies Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Loxoprofen sodium100120105115110110110 Microcrystalline cellulose250200230220225225225 Sophorolipid10201510121212 Konjac Glucomannan20101812161415 Crospovidone20151618171717 Magnesium stearate1324333

Example

[0046] Examples 1-7 and Comparative Examples 1-2 were prepared according to the following preparation methods:

[0047] (1) Take 102g loxoprofen sodium and the microcrystalline cellulose, sophorolipid, konjac glucomannan, and crospovidone converted according to the proportions in Table 1, and mix them uniformly according to the principle of equal increments to obtain a mixture 1. Put the mixture 1 into the feeding hopper of the hot melt extruder. The screw speed of the feeding is 45 rpm. At the same time, 95% ethanol (70g / 1000 tablets) is added to the filling port with a peristaltic pump. The rotation speed is 15 rpm, and the prepared wet granules are connected at the discharge port.

[0048] (2) After the wet granules prepared in step (1) are dried in a boiling dryer, magnesium stearate in the prescribed amount is added to obtain mixture 2.

[0049] (3) The mixture 2 obtained in step (2) is compressed with 9mm dimples to control the hardness of the plain tablets at 60-80N to obtain...

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Abstract

The invention discloses a loxoprofen sodium tablet and a preparation process thereof, and belongs to the technical field of pharmaceutical preparations. The loxoprofen sodium tablet is prepared from the following components: loxoprofen sodium, microcrystalline cellulose, sophorolipid, konjac glucomannan, crospovidone and magnesium stearate. The preparation process includes the steps that loxoprofen sodium, microcrystalline cellulose, sophorolipid, konjac glucomannan and crospovidone in the formula amount are evenly mixed to obtain a mixture 1, and a hot melt extruder is used to prepare the mixture 1 into wet granules; after the prepared wet granules are dried, magnesium stearate of the formula amount is added to obtain a mixture 2; the mixture 2 is tableted to obtain plain tablets; and theplain tablets are coated to obtain the loxoprofen sodium tablets. The dissolution rate of the loxoprofen sodium tablet is good in consistency with an original research drug, meanwhile, the property is stable, the dissolution rate remains stable after being placed for a certain period of time, and meanwhile, the hot melt extruder is used for granulation, so that the operation is simple.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a loxoprofen sodium tablet and a preparation process thereof. Background technique [0002] Loxoprofen sodium is a phenylpropionic acid non-pyroscopic anti-inflammatory drug, which is the sodium salt of ibuprofen oxidation product, and its structural formula is as follows: [0003] [0004] Loxoprofen sodium is a new type of prodrug with weak gastric mucosal stimulating effect, which belongs to the phenylpropionic acid class and is transformed into active metabolites after absorption in the body. Its mode of action is to inhibit the synthesis of unsaturated fatty acids. When administered orally, it is absorbed from the digestive tract in a prototype state that is weak to the gastrointestinal mucosa, and then quickly transforms into a trans-hydroxyl coordination active metabolism that strongly inhibits the biosynthesis of prostaglandins. It play...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/192A61K47/38A61K47/36A61K47/32A61K47/26A61P29/00
CPCA61K9/2018A61K9/2027A61K9/205A61K9/2054A61K9/2095A61K9/2806A61K31/192A61P29/00
Inventor 吴志红林明聪
Owner 福建东瑞制药有限公司
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