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Ibuprofen injection and preparation method thereof

A technology of injection and water for injection, which is applied in the field of medicine, can solve problems such as stability being affected by the environment and affecting use, and achieve good stability and improve stability

Inactive Publication Date: 2017-10-10
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because ibuprofen injection is in use, because it is a liquid preparation, its stability will be affected by the environment, which will affect subsequent use

Method used

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  • Ibuprofen injection and preparation method thereof
  • Ibuprofen injection and preparation method thereof
  • Ibuprofen injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A preparation method of a preparation method of ibuprofen injection, comprising the following steps:

[0025] (1) Pretreatment: at a temperature above 80 °C, use 0.05% EDTA-Na solution, 200,000 ml to clean all dispensing equipment, pipelines, filters, etc. for 30 minutes, and then use water for injection for three times. 10,000 ml;

[0026] (2) at a temperature of 50°C-60°C, add water for injection with 80% of the total prepared amount into the dispensing tank, keep warm in a water bath at 55°C, and pass nitrogen for 30 minutes;

[0027] (3) take by weighing ibuprofen 400g, be 1:1 according to the mol ratio of ibuprofen and arginine, take by weighing the arginine of 338g, be 1 to the weight ratio with ibuprofen according to the described buffer: 25. Weigh 4 g of sodium dihydrogen phosphate and 12 g of disodium hydrogen phosphate, add the above medicines into the dispensing tank and stir to dissolve;

[0028] (4) Use hydrochloric acid with a molar concentration of 1 mo...

Embodiment 2

[0031] A preparation method of a preparation method of ibuprofen injection, comprising the following steps:

[0032] (1) Pretreatment: at a temperature above 80 °C, use 0.05% EDTA-Na solution, 200,000 ml to clean all dispensing equipment, pipelines, filters, etc. for 30 minutes, and then use water for injection for three times. 10,000 ml;

[0033] (2) at a temperature of 50°C-60°C, add water for injection with 80% of the total prepared amount into the dispensing tank, keep warm in a water bath at 55°C, and pass nitrogen for 30 minutes;

[0034] (3) take by weighing ibuprofen 400g, be 1:1 according to the mol ratio of ibuprofen and arginine, take by weighing the arginine of 338g, be 1 to the weight ratio with ibuprofen according to the described buffer: 100, weigh 1 g of sodium dihydrogen phosphate and 3 g of disodium hydrogen phosphate, add the above medicines into a dispensing tank, stir and dissolve;

[0035] (4) Adjust the pH value to 7.9 with hydrochloric acid with a mol...

Embodiment 3

[0038] (1) Pretreatment: at a temperature above 80 °C, use 0.05% EDTA-Na solution, 200,000 ml to clean all dispensing equipment, pipelines, filters, etc. for 30 minutes, and then use water for injection for three times. 10,000 ml;

[0039] (2) at a temperature of 50°C-60°C, add water for injection with 80% of the total prepared amount into the dispensing tank, keep warm in a water bath at 55°C, and pass nitrogen for 30 minutes;

[0040] (3) take by weighing ibuprofen 800g, be 1:1 according to the mol ratio of ibuprofen and arginine, take by weighing the arginine of 676g, be 1 to the weight ratio with ibuprofen according to the described buffer: 25. Weigh 8 g of sodium dihydrogen phosphate and 24 g of disodium hydrogen phosphate, add the above medicines into the dispensing tank and stir to dissolve;

[0041] (4) Adjust the pH value between 7.7 with hydrochloric acid with a molar concentration of 1 mol / L or an arginine solution with a molar concentration of 1 mol / L; add water f...

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Abstract

The invention relates ibuprofen injection. The ibuprofen injection is prepared from ibuprofen, arginine, hydrochloric acid, a buffer pair and injection water. The invention further provides a preparation method of the ibuprofen injection. The ibuprofen injection prepared with the method is good in stability, a preparationmethod is simple, and popularization is facilitated.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an ibuprofen injection and a preparation method thereof. Background technique [0002] Ibuprofen injection was developed by Cumberland Company in the United States. It is the first intravenous dosage form of ibuprofen and was launched in the United States in June 2009. Ibuprofen is a non-steroidal anti-inflammatory drug commonly used in clinical practice, which is mainly used for antipyretic and analgesic with definite curative effect. [0003] In a number of multi-center, randomized, double-blind, parallel, placebo-controlled trials, ibuprofen injection showed good antipyretic and analgesic effects. It can significantly reduce the body temperature of hospitalized patients with fever. Compared with other antipyretic analgesics such as acetaminophen and aspirin, it has a stronger and longer-lasting effect and is well tolerated. Ibuprofen has a good analgesic effect and can be u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/18A61K47/02A61K47/04A61P29/00
Inventor 侯念磊陈洪生孙晓波
Owner JINAN LIMIN PHARMA
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