Medicinal composition and preparation thereof

A composition and drug technology, applied in the field of medicine, can solve problems such as kidney damage, frequent drug use to maintain therapeutic concentration, short biological half-life, etc., and achieve excellent quality results

Inactive Publication Date: 2014-06-11
北京美迪康信医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the ibuprofen products clinically used are mainly oral preparations. Although ibuprofen is relatively safer than other non-steroidal anti-inflammatory drugs, it still has the gastric side effects of general non-steroidal anti-inflammatory drugs Intestinal adverse reactions, and its biological half-life is short, frequent medication is required to maintain the therapeutic concentration, thus further increasing the gastrointestinal reactions of the drug, such as abdominal distension, indigestion, nausea, vomiting, diarrhea, peptic ulcer, etc., and even lead to Gastrointestinal bleeding also increases the damage to the kidneys, so people have been devoting themselves to research on new formulations and new technologies of the drug.

Method used

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  • Medicinal composition and preparation thereof
  • Medicinal composition and preparation thereof
  • Medicinal composition and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] 100g of ibuprofen, 83g of arginine, water for injection, and a pH regulator of arginine and ethanolamine in a weight ratio of 1:0.2.

[0076] Take the temperature as 50°C,

[0077] Add 60% of the dosage of water for injection into a closed liquid mixing tank, and pass nitrogen for 15 minutes; weigh arginine and add it to water for injection at 30°C and keep stirring for 30 minutes; weigh ibuprofen and add it to water for injection at 30°C and keep stirring 30 minutes; adjust the pH value to 7.4 with a pH regulator, and stir for 30 minutes; add activated carbon for needles with a weight-to-volume ratio of 0.1%, stir for 30 minutes at 50°C, filter and decarbonize, and add water for injection to 100%; after 0.22 Filter with a microporous membrane of μm; use neutral ampoules to fill and seal under nitrogen protection; sterilize at 121.0°C for 15 minutes to obtain 1,000 bottles of water injection (4ml per bottle).

Embodiment 2

[0079] 100g of ibuprofen, 83g of arginine, water for injection, and a pH regulator of arginine and ethanolamine in a weight ratio of 1:0.2.

[0080] Take the temperature as 60°C,

[0081] Add 60% of the dosage of water for injection into a closed liquid mixing tank, and pass nitrogen for 15 minutes; weigh arginine and add it to water for injection at 30°C and keep stirring for 30 minutes; weigh ibuprofen and add it to water for injection at 30°C and keep stirring 30 minutes; adjust the pH value to 7.8 with a pH regulator, and stir for 30 minutes; add activated carbon for needles with a weight-to-volume ratio of 0.1%, stir for 30 minutes at 60°C, filter and decarbonize, and add water for injection to 100%; after 0.22 Filter with a microporous membrane of μm; use neutral ampoules to fill and seal under nitrogen protection; sterilize at 121.0°C for 15 minutes to obtain 1,000 bottles of water injection (4ml per bottle).

Embodiment 3

[0083] 100g of ibuprofen, 83g of arginine, water for injection, and a pH regulator of arginine and ethanolamine in a weight ratio of 1:0.2.

[0084] Take the temperature as 55°C,

[0085] Add 60% of the dosage of water for injection into a closed liquid mixing tank, and pass nitrogen for 15 minutes; weigh arginine and add it to water for injection at 30°C and keep stirring for 30 minutes; weigh ibuprofen and add it to water for injection at 30°C and keep stirring 30 minutes; adjust the pH value to 7.4 with a pH regulator, and stir for 30 minutes; add activated carbon for needles with a weight-to-volume ratio of 0.1%, stir for 30 minutes at 55°C, filter and decarbonize, and add water for injection to 100%; after 0.22 Filter with a microporous membrane of μm; use neutral ampoules to fill and seal under nitrogen protection; sterilize at 121.0°C for 15 minutes to obtain 1,000 bottles of water injection (4ml per bottle).

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Abstract

The invention belongs to the technical field of medicines, and discloses a medicinal composition and a preparation thereof. The medicinal composition is prepared into a water injection which consists of ibuprofen, arginine, a pH regulating agent and water for injection, wherein the pH regulating agent comprises arginine. As proved by experimental study, the number of increased impurities in an ibuprofen injection which meets the requirement is small, and a new impurity M is not produced. The preparation prepared by using the medicinal composition is more excellent in quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing ibuprofen as an active ingredient and a preparation thereof. Background technique [0002] Ibuprofen injection is the first US FDA-approved injection for treating pain and fever at the same time. Clinical studies have confirmed that it is safe and effective for hospitalized patients with moderate to severe pain and fever after surgery, and can reduce the consumption and use of opioid analgesics frequency. [0003] Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the most used drugs in the world. About 30 million people in the world use them every day, and they are also one of the most sold drugs by pharmaceutical groups in the world. NSAIDs have been used in humans for more than 100 years. Due to their good anti-inflammatory, antipyretic and analgesic effects, NSAIDs are widely used to treat arthritis (especially RA, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/18A61P29/00
Inventor 刘实吴劲松赵海燕高红云崔琳
Owner 北京美迪康信医药科技有限公司
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