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Naproxen sodium soft capsule and preparation method thereof

A naproxen sodium and soft capsule technology, applied in the field of biomedicine, can solve problems such as increasing procurement, and achieve the effects of reducing equipment investment, safe treatment effect, and saving granulation and drying processes

Inactive Publication Date: 2014-10-08
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this patent involves two kinds of raw materials, which not only makes a single prescription into a compound prescription, but also increases the cost of procurement, inspection and management, and adds water to the content, which is prone to crystallization of naproxen during production and storage.

Method used

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  • Naproxen sodium soft capsule and preparation method thereof
  • Naproxen sodium soft capsule and preparation method thereof
  • Naproxen sodium soft capsule and preparation method thereof

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preparation example Construction

[0039] According to the method for preparing naproxen sodium soft capsules according to the embodiments of the present invention, the preparation of the contents is easy to operate, and is formed by mixing naproxen sodium, lactic acid, povidone K30, polyethylene glycol and propylene glycol in proportion, and No water is added in the process of preparing the contents, and naproxen sodium soft capsules with stable dosage form and safe therapeutic effect can also be prepared, thereby saving granulation and drying processes, thereby simplifying the preparation process and reducing equipment investment.

[0040] In another aspect of the present invention, the present invention provides a naproxen sodium soft capsule. According to an embodiment of the present invention, the naproxen sodium soft capsule is prepared by the above method. The water content in the content of the naproxen sodium soft capsule obtained according to the above-mentioned method is no more than 15% by volume, t...

Embodiment 1

[0043] 1) Content formula composition: Naproxen sodium 22g, lactic acid 6.5g, povidone K30 1.8g, polyethylene glycol 400 97.5g and propylene glycol 2.2g;

[0044] 2) Preparation method

[0045] a. Preparation of materials in soft capsules: Heat polyethylene glycol 400 to 60-80°C, then add povidone K30, lactic acid, and propylene glycol, stir and dissolve completely, add naproxen sodium, and turn at 2000-3000 rpm Stir at a high speed per minute until the naproxen sodium is completely dissolved, then degas and cool to room temperature to obtain the soft capsule contents;

[0046] b. Preparation of soft capsule shell material: mix glycerin, sorbitol, and water and heat to 70°C, then add gelatin, stir the solution, degas, keep warm at 60°C, and obtain soft capsule shell material;

[0047] c. Preparation of Naproxen Sodium Soft Capsules: The soft capsule contents and soft capsule shell materials obtained above are pressed into soft capsules on a soft capsule machine, dried, polish...

Embodiment 2

[0049] 1) Content formula composition: Naproxen sodium 22g, lactic acid 4.4g, povidone K30 2.6g, polyethylene glycol 400 64.2g and propylene glycol 1.8g;

[0050] 2) preparation method: with embodiment 1.

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Abstract

The invention discloses a naproxen sodium soft capsule and a preparation method thereof. The method comprises the following steps: (1) mixing polyethylene glycol, povidone K30, propylene glycol, lactic acid and naproxen sodium to obtain a content material of the soft capsule; (2) mixing glycerinum, sorbitol, water and gelatin to obtain a shell material of the soft capsule; (3) pelleting the content material and the shell material of the soft capsule on an encapsulating machine to obtain the naproxen sodium soft capsule. The method is simple in process and can be used for remarkably reducing equipment investment, and the content is stable in preparation and has a safe treatment effect.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, in particular, the invention relates to a naproxen sodium soft capsule and a preparation method thereof. Background technique [0002] Naproxen sodium (naproxen sodium), chemical name: S-(-) 2-(6-methoxy-2-naphthyl) sodium propionate, molecular formula: C 14 h 13 o 3 Na; molecular weight: 252.24; chemical structural formula is as follows: [0003] [0004] This product is white or off-white crystalline powder, odorless, slightly hygroscopic. Naproxen sodium is a kind of non-steroidal anti-inflammatory analgesic drug that is easier to be accepted by people. It belongs to phenylpropionic acid compounds. It exerts anti-inflammatory and analgesic effects by inhibiting the synthesis of prostaglandins. Within 4 hours, the peak plasma concentration is reached. Food has little effect on the absorption rate. Naproxen is highly bound to plasma proteins (99%), and the plasma concentration is bet...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/192A61P29/00
Inventor 沈福星吴文鹏蔡波涛秦巨波郭云梅周军伟张志刚丁超文学智黎晴霞
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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