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Stable lornoxicam solution agent, preparation method and application thereof

A technology of lornoxicam and solution, which is applied in the field of meglumine and phosphate solution and salt, and can solve problems such as turbidity and unstable physical and chemical properties

Inactive Publication Date: 2008-10-08
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] But, lornoxicam has insoluble and unstable physical and chemical properties in solution (also known as "liquid preparation" or "solution preparation"), for example, lornoxicam is almost insoluble in water, at 0.1mol / L hydrogen Slightly soluble in sodium oxide solution, there are oxidation reactions and hydrolysis cleavage reactions in its solution, resulting in a large number of by-products
Although the stability of lornoxicam solution can be improved by freeze-drying technology, its freeze-dried product has very obvious turbidity after reconstitution

Method used

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  • Stable lornoxicam solution agent, preparation method and application thereof
  • Stable lornoxicam solution agent, preparation method and application thereof
  • Stable lornoxicam solution agent, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Preparation of lornoxicam injection

[0040] Lornoxicam 4g

[0041] Mannitol 50g

[0042] Meglumine 1g

[0043] Disodium hydrogen phosphate 0.6g

[0044] 2% sodium hydroxide solution appropriate amount

[0045]

[0046] Dilute to 1000ml with water for injection

[0047] Pack according to the specifications required for clinical treatment (2ml / branch, 5ml / branch or 10ml / branch).

Embodiment 2

[0048] Example 2 Preparation of lornoxicam injection

[0049] Lornoxicam 4g

[0050] Mannitol 50g

[0051] Meglumine 4g

[0052] Disodium hydrogen phosphate 2.4g

[0053] 2% sodium hydroxide solution appropriate amount

[0054]

[0055] Dilute to 1000ml with water for injection

[0056] Pack according to the specifications required for clinical treatment (2ml / branch, 5ml / branch or 10ml / branch).

Embodiment 3

[0057] Example 3 Preparation of lornoxicam freeze-dried preparation

[0058] Lornoxicam 4g

[0059] Mannitol 50g

[0060] Meglumine 1g

[0061] Trisodium hydrogen phosphate 0.6g

[0062] 2% sodium hydroxide solution appropriate amount

[0063]

[0064] Dilute to 1000ml with water for injection

[0065] Gained injection is subpackaged into 2ml / branches under aseptic conditions, and freeze-dried to obtain its freeze-dried preparation.

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PUM

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Abstract

The invention relates to stable lornoxicam solution and a preparation method and an application thereof; the solution contains the lornoxicam or the pharmaceutically-acceptable salt of the lornoxicam, meglumine, potassium phosphate salt and / or sodium phosphate salt, and has the advantages of good solubility, good stability and good security. The solution of the invention is suitable for parenteral administration such as intramuscular injection, intravenous injection or ophthalmic purpose; the solution which is suitable for the invention is selected from injection preparation, lyophilization formulation or spraying desiccant, preferably the lyophilization formulation.

Description

technical field [0001] The invention relates to a stable lornoxicam solution, its preparation method and application, in particular to a solution containing lornoxicam or its pharmaceutically acceptable salt, meglumine and phosphate. Background technique [0002] In recent years, extensive research has been conducted on non-steroidal anti-inflammatory drugs at home and abroad, and a series of new drugs with clinical treatment prospects have been developed. Among them, Oxycam non-steroidal anti-inflammatory drugs are playing an increasingly important role in clinical practice, especially after the withdrawal of COX-2 inhibitor Vioxx due to adverse reactions, it has inspired many domestic manufacturers to take Oxicam Enthusiasm for R&D and sales of non-steroidal anti-inflammatory drugs. [0003] Lornoxicam (also known as "fenoxicam") is a new type of non-steroidal analgesic anti-inflammatory drug of the Xicam class, and its chemical name is 6-chloro-4-hydroxy-2-methyl-3-( 2-...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/24A61K31/542A61P29/00A61K47/18
Inventor 封思阳王晨霞
Owner 南京易亨制药有限公司
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