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Ibuprofen liquid injection composition and preparation method thereof

A technology for injection and medicinal solution, applied in the directions of drug combination, medicinal formulation, drug delivery, etc., can solve the problems of unmentioned foreign bodies and insoluble particles, and achieve the effect of improving the inspection items of visible foreign bodies

Active Publication Date: 2012-10-03
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] U.S. Patent US6727286 discloses a kind of ibuprofen injection, and this injection is made up of ibuprofen and arginine, and this patent suggests that the molar ratio of ibuprofen and arginine is less than 1: 1, but this patent does not propose And this ibuprofen injection finished product inspection items can be seen foreign matter and insoluble particles, as well as compatibility with glucose injection and sodium chloride injection, etc.

Method used

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  • Ibuprofen liquid injection composition and preparation method thereof
  • Ibuprofen liquid injection composition and preparation method thereof
  • Ibuprofen liquid injection composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Each 1000 injection preparations contains the following ingredients:

[0034]

[0035] Add water for injection to 4000ml

[0036] Take by weighing ibuprofen 400g (1.94mol), arginine 338g (1.94mol) by recipe quantity, join in 3200ml water for injection, stir at room temperature and dissolve completely; Adjust pH value to 8.4 with 5% (W / V) ammonia solution Add activated carbon for needles at 0.05% (W / V), stir at 25°C for 20 min, filter coarsely, and filter the filtrate with a 0.22 μm microporous membrane; then adjust the pH value to 7.4 with 5% (W / V) hydrochloric acid solution, Finally, add water for injection to make the volume to 4000ml; intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121℃, 15min high-pressure steam sterilization, leak detection; light inspection of ampoules one by one; sampling Full inspection; packing.

Embodiment 2

[0038] Each 1000 injection preparations contains the following ingredients:

[0039]

[0040] Add water for injection to 4000ml

[0041] Take by weighing ibuprofen 400g according to prescription quantity, arginine 338g joins in 3200ml water for injection, stirs at room temperature and dissolves completely; Adjust pH value to 7.8 with 5% (W / V) ammonia solution; Press 0.05% (W / V) Add activated charcoal for needles, stir at 25°C for 20 minutes, coarsely filter, and then filter the filtrate with a 0.22 μm microporous membrane; then adjust the pH value to 7.0 with 5% (W / V) hydrochloric acid solution, and finally add water for injection to make the volume to 4000ml; Intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121°C, 15min high-pressure steam sterilization, leak detection; light inspection of ampoules one by one; full sampling inspection; packaging.

Embodiment 3

[0043] Each 1000 injection preparations contains the following ingredients:

[0044]

[0045] Add water for injection to 4000ml

[0046] Take by weighing ibuprofen 400g according to prescription quantity, arginine 338g joins in 3200ml water for injection, stirs and dissolves completely at room temperature; Adjust pH value to 9.0 with 5% (W / V) ammonia solution; Press 0.05% (W / V) Add activated carbon for needles, stir at 25°C for 20 minutes, coarsely filter, and then filter the filtrate with a 0.22 μm microporous membrane; then adjust the pH value to 8.0 with 5% (W / V) hydrochloric acid solution, and finally add water for injection to dilute to 4000ml; Intermediate inspection; nitrogen protection, filling and sealing in 5ml ampoules, 4ml / bottle; 121°C, 15min high-pressure steam sterilization, leak detection; light inspection of ampoules one by one; full sampling inspection; packaging.

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Abstract

The invention relates to an ibuprofen liquid injection which is characterized by comprising active ingredient ibuprofen and cosolvent arginine at molar ratio of 1:1-1:1.2, and adopting ammonia water and hydrochloric acid as pH regulator. Ammonia water is added into solution of ibuprofen and arginine to regulate pH value to 7.8-9.0, to obviously reduce insoluble particles, and solve compatibility problem between the liquid injection and sodium chloride and glucose liquid injection; then hydrochloric acid is adopted to regulate pH value back to 7.0-8.0, to enable solution pH value to be same asor approximate to human body blood pH value, and improve administration compliance and comfort of patient.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an ibuprofen injection composition and a preparation method thereof. Background technique [0002] Ibuprofen is a non-steroidal anti-inflammatory analgesic with the following structural formula, which has anti-inflammatory, analgesic and antipyretic effects. [0003] [0004] α-Methyl-4-(2-methylpropyl)phenylacetic acid [0005] Ibuprofen is a classic antipyretic and analgesic drug, which can inhibit the synthesis of prostaglandins and has analgesic and antipyretic effects. [0006] Ibuprofen is a classic antipyretic and analgesic drug, which can inhibit the synthesis of prostaglandins and has analgesic, antipyretic and anti-inflammatory effects. Due to its remarkable curative effect and few adverse reactions, it was widely used in the world after it went on the market, and the market continued to expand. In the late 1980s, many countries in Europe and the United Sta...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/18A61P29/00
Inventor 于艳春耿海明沈恒吴娟刘艺婷
Owner WUHAN WUYAO SCI & TECH
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