Ibuprofenlyophilized powder composition and preparation method

A technology of freeze-dried powder injection and freeze-dried powder injection, applied in the field of freeze-dried composition for injection, which can solve the problems affecting the stability of the appearance and properties of powder injection for injection, and achieve the effect of improving stability

Active Publication Date: 2015-05-20
JINAN ORIENT KAIYUAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patent CN 102488662 A discloses a preparation method of arginine ibuprofen powder for injection. The powder for injection consists of arginine and ibuprofen. However, the arginine ibuprofen powder for injection Sensitive to high temperature, affecting the appearance and long-term stability of injection powder

Method used

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  • Ibuprofenlyophilized powder composition and preparation method
  • Ibuprofenlyophilized powder composition and preparation method
  • Ibuprofenlyophilized powder composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

example 2

[0022] prescription:

[0023] Ibuprofen 400g

[0024] Sodium chloride 4~7g

[0025] L-Arginine 300~400g

[0026] 1) Mix the ingredients of arginine, sodium chloride and ibuprofen into water for injection, stir until fully dissolved, and the mass ratio of water for injection to ibuprofen is 10:1;

[0027] 2) ultrafiltration: the solution is subjected to ultrafiltration in a sterile environment, then aseptically subpackaged, and the packed solution is divided;

[0028] 3) Freeze-dry the filled semi-finished product, process parameters of freeze-drying curve: cool down to -40°C at full speed, keep warm for 2-5 hours; turn on the condenser, and turn on the vacuum pump when the temperature of the condenser drops to -80°C; When it drops below 10Pa, turn on the heating, raise the temperature to -15°C, and keep it warm for 6-10 hours; at 0°C, keep it warm for 1-5 hours, then raise the temperature to 25°C, and keep it warm for 8-20h; Seal the aluminum cover.

Embodiment 3

[0029] Implementation 3: The difference between this embodiment and Example 2 is that first arginine and sodium chloride will be dissolved in water for injection at 20-30° C. in step 1), and the others are the same as Example 2.

example 4

[0031] prescription:

[0032] Ibuprofen 400g

[0033] Sodium chloride 4~7g

[0034] L-Arginine 300~400g

[0035] 1) Mix the ingredients of arginine and sodium chloride into water for injection, slowly add ibuprofen under stirring and stir until completely dissolved, the mass ratio of water for injection and ibuprofen is 10:1;

[0036] 2) ultrafiltration: the solution is subjected to ultrafiltration in a sterile environment, then aseptically subpackaged, and the packed solution is divided;

[0037] 3) Freeze-dry the filled semi-finished product, freeze-drying curve process parameters: cool down to -40°C at full speed, keep warm for 2 to 5 hours; turn on the condenser, and turn on the vacuum pump when the temperature of the condenser drops to -80°C; When the temperature is below 10Pa, turn on the heating, raise the temperature to -15°C, and keep it warm for 6-10 hours; at 0°C, keep it warm for 1-5 hours, then raise the temperature to 25°C, and keep it warm for 8-20 hours; Al...

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Abstract

The invention provides anibuprofenlyophilized powder composition and a preparation method. The ibuprofenlyophilized powder composition comprises ibuprofen,a solubilizer arginine and sodium chloride of a stabilizer. The problems of instability of an existing ibuprofeninjection and related substance increase are solved; and the compliance of a patient is improved.

Description

technical field [0001] The invention relates to a freeze-dried composition for injection containing ibuprofen as a main medicinal component and a preparation method thereof. Background technique [0002] Ibuprofen is the product of long-term research in the 1950s and 1960s in the development of a "super aspirin" for rheumatoid arthritis. Ibuprofen is a phenylpropionic acid non-steroidal anti-inflammatory analgesic, which has strong antipyretic, analgesic, anti-inflammatory and anti-rheumatic effects, and has mild gastrointestinal side effects and good tolerance. It is an antipyretic and analgesic drug widely used at present. The preparations of ibuprofen have dosage forms such as injection, tablet, dry suspension, granule, drop, effervescent orally disintegrating tablet and ointment, gel at present. Ibuprofen injection is mainly used to relieve pain and reduce fever in hospitalized patients who cannot take it orally. Ibuprofen is insoluble in water, and for increasing the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/192A61K47/02A61K47/16A61P29/00
Inventor 鲍明梁
Owner JINAN ORIENT KAIYUAN PHARMA TECH
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