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Parecoxib sodium freeze-dried powder, preparation method and powder product thereof

A technology of parecoxib sodium and freeze-dried powder, which is applied in the direction of freeze-dried transportation, medical preparations of non-active ingredients, anti-inflammatory agents, etc., can solve the problems of complex powder components and complicated preparation process, and achieve variety and use. The effect of small amount, simple preparation method and cost reduction

Active Publication Date: 2016-07-06
HUNAN KELUN PHARM RES CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In this preparation method, a buffering agent (such as disodium hydrogen phosphate) is necessary, and other adjuvants such as expansion agents need to be added as needed, which leads to complex components of the finally obtained powder, and the preparation process is also relatively complicated; At the same time, buffers have clinical safety risks

Method used

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  • Parecoxib sodium freeze-dried powder, preparation method and powder product thereof
  • Parecoxib sodium freeze-dried powder, preparation method and powder product thereof
  • Parecoxib sodium freeze-dried powder, preparation method and powder product thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0072] Add about 160ml of water for injection into the beaker and control the water temperature below 40°C, add 2.12g of parecoxib sodium, stir until completely dissolved, and add water for injection to a total of 200ml. Use sodium hydroxide solution to adjust the pH value of the solution to 8.5, stir evenly, and filter through a microporous membrane. After the filtrate is inspected for visible foreign matter, it is divided into 5ml borosilicate tube glass injection bottles, each bottle of 1ml solution, and Based on parecoxib, each bottle contains 10mg / 1ml of parecoxib. After the packaging is completed, the rubber stopper is half-pressed, and the product is sent to a freeze-drying box for freeze-drying. Control the temperature of the product from room temperature to -40°C within 2 hours and keep it warm for 3 hours. Then evacuate to a vacuum degree of about 25 Pa, and control the temperature to rise to 0°C for 12 hours, then control the temperature to rise to 40°C for 5 hours...

Embodiment 2

[0075] Add about 160ml of water for injection into the beaker and control the water temperature below 40°C, add 4.24g of parecoxib sodium, stir until completely dissolved, add water for injection to a total of 200ml, add sodium hydroxide solution to adjust the pH of the solution to 8.5. Stir evenly and filter through a microporous membrane. After passing the inspection of visible foreign matter, the filtrate is divided into 5ml borosilicate tube glass injection bottles. Each bottle has 1ml solution, and each bottle contains Parecoxib. Coxib 20mg / 1ml. After the packaging is completed, the rubber stopper is half-pressed, and the product is sent to a freeze-drying box for freeze-drying. Control the temperature of the product from room temperature to -40°C within 2 hours and keep it warm for 3 hours. Then evacuate to a vacuum degree of about 25 Pa, and control the temperature to rise to 0° C. over 12 hours, then control the temperature to rise to 40° C. over 5 hours, and keep the...

Embodiment 3

[0078] Add about 160ml of water for injection into the beaker and control the water temperature below 40°C, add 4.24g of parecoxib sodium, stir until it dissolves completely, add water for injection to a total of 200ml, add sodium hydroxide solution to adjust the pH value of the solution to 9.0, Stir evenly and filter through a microporous membrane. After passing the inspection of visible foreign matter, the filtrate is divided into 7ml borosilicate tube glass injection bottles. Each bottle contains 2ml solution, and each bottle contains Parecoxib Coxib 40mg / 2ml. After the packaging is completed, the rubber stopper is half-pressed, and the product is sent to a freeze-drying box for freeze-drying. Control the temperature of the product from room temperature to -45°C within 2 hours and keep it warm for 3 hours. Then evacuate to a vacuum degree of about 10 Pa, and control the temperature to rise to 0° C. in 12 hours, then control the temperature to rise to 40° C. in 5 hours, and...

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Abstract

The invention discloses a parecoxib sodium freeze-dried powder, a preparation method and a powder product thereof. The freeze-dried powder comprises 95-100 wt% of the parecoxib sodium and 0-5 wt% of a pH regulator; or 40-100 wt% of the parecoxib sodium and 0-60 wt% of L-malate. The freeze-dried powder has simple preparation method, is free of auxiliary materials or employs few auxiliary materials, is reduced in cost, and satisfies national medicine standards in storage stability, clinical application stability and safety.

Description

technical field [0001] The invention relates to an improved freeze-dried powder of parecoxib sodium, its preparation method and freeze-dried powder product. Background technique [0002] The mechanism of action of non-steroidal anti-inflammatory drugs (NSAIDs) is to inhibit the synthesis of prostaglandins by inhibiting the activity of cyclooxygenase (COX), thereby exerting anti-inflammatory, antipyretic and analgesic effects. Conventional NSAIDs such as ketorolac, diclofenac, naproxen and their salts inhibit both constitutively expressed COX-1 and inflammation-associated or inducible COX-2. COX-1 can catalyze the production of prostaglandins required for normal cell function, so the application of conventional NSAIDs will inhibit COX-1 and cause some toxic side effects. In contrast, if the drug can selectively inhibit COX-2 without substantially inhibiting COX-1, anti-inflammatory, antipyretic, analgesic and other useful therapeutic effects can be obtained, while reducing o...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/42A61K9/08A61K47/12A61K47/02A61P29/00
Inventor 朱朝清熊冠军何苗田添王利春胡思玉赵栋王晶翼程志鹏
Owner HUNAN KELUN PHARM RES CO LTD
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