Dexketoprofen trometamol injection and technology for preparing same

A technology of dexketoprofen trometamol and injection, which is applied in the field of medicine, can solve problems such as easy degradation, and achieve the effects of stable quality, good clarity, and simple process flow

Inactive Publication Date: 2018-03-30
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The invention provides a dexketoprofen tromethamine injection and a preparation process thereof. The injection and the process solve the problem that the active ingredients of common dexketoprofen tromethamine injections are easily degraded, making the quality of the injection stable , good clarity, easy operation, simple process, suitable for large-scale industrial production

Method used

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  • Dexketoprofen trometamol injection and technology for preparing same
  • Dexketoprofen trometamol injection and technology for preparing same
  • Dexketoprofen trometamol injection and technology for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015]

[0016] Dissolve the stabilizer phosphate in water for injection, then add dexketoprofen trometamol, stir at 60°C for 30 minutes, adjust the pH value to 6.8 with sodium hydroxide solution and citric acid solution, and filter through a 0.22 μm filter membrane , sterilized at 121° C. for 10 minutes to obtain dexketoprofen tromethamine injection.

Embodiment 2

[0018]

[0019]

[0020] Dissolve the stabilizer phosphate in water for injection, then add dexketoprofen trometamol, stir at 45°C for 40 minutes, adjust the pH value to 7.1 with sodium hydroxide solution and citric acid solution, and filter through a 0.22 μm filter membrane , sterilized at 121° C. for 8 minutes to obtain dexketoprofen tromethamine injection.

Embodiment 3

[0022]

[0023] Dissolve the stabilizer phosphate in water for injection, then add dexketoprofen tromethamine, stir at 55°C for 60 minutes, adjust the pH value to 7.2 with sodium hydroxide solution and citric acid solution, and filter through a 0.22 μm filter membrane , sterilized at 121° C. for 12 minutes to obtain dexketoprofen tromethamine injection.

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PUM

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Abstract

The invention provides dexketoprofen trometamol injection and a technology for preparing the same. The dexketoprofen trometamol injection and the technology have the advantages that phosphate is usedas a stabilizer, accordingly, the problem that effective components are easy to degrade in common dexketoprofen trometamol injection production procedures can be solved by the aid of the dexketoprofentrometamol injection and the technology, the dexketoprofen trometamol injection is stable in quality, good in clarity, easy and convenient to operate and suitable for industrial mass production, andtechnological processes are simple.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a dexketoprofen tromethamine injection and a preparation process thereof. Background technique [0002] Dexketoprofen trometamol is a derivative of dexketoprofen, a single optical isomer of 2-arylpropionic acid non-steroidal anti-inflammatory drugs (NASIDs) ketoprofen, which has a strong antipyretic effect , analgesic and anti-inflammatory effects, better water solubility than dexketoprofen, higher activity than free acid, high bioavailability, and better tolerance to patients, so it has broad clinical application prospects. Clinically applicable to mild to moderate pain of different causes, such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, joint pain of gouty arthritis, dysmenorrhea, toothache, postoperative pain, cancer pain, acute All kinds of acute and chronic pains such as sprain or soft tissue contusion pain, general pain caused by cold and...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/02A61P29/00
CPCA61K9/0019A61K9/08A61K31/192A61K47/02
Inventor 单飞祁艳徐卓业
Owner NANJING ZENKOM PHARMA
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