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Dexibuprofen lipid emulsion injection and preparation method thereof

A technology for preparation of injections and dexibuprofen, which is applied in the fields of emulsion delivery, pharmaceutical formulations, and medical preparations of non-active ingredients. It can solve problems such as injection pain, allergic reactions, and safety issues, and achieve pain relief and improve Safety, high drug loading effect

Pending Publication Date: 2019-10-18
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese invention patent CN104546706 A discloses a dexibuprofen injection emulsion and its preparation method. The oil phase auxiliary material only uses soybean oil, which often causes injection pain in clinical application; in addition, the process uses poloxamer as an emulsifier , in clinical application, adverse reactions such as hemolysis, vascular stimulation, and allergic reactions may occur, and there are certain safety issues

Method used

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  • Dexibuprofen lipid emulsion injection and preparation method thereof
  • Dexibuprofen lipid emulsion injection and preparation method thereof
  • Dexibuprofen lipid emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Take soybean oil, medium-chain triglycerides, glycerin, and water in appropriate amounts, add excess Dexibuprofen, and shake at room temperature for 24 hours to form a saturated solution. After centrifugation, take the supernatant oil layer and measure the solubility of Dexibuprofen.

Embodiment 2

[0048]Weigh 20.0g of soybean oil and medium-chain triglycerides, mix and stir; add 151.0g of solubilizer KolliphorHS, heat to 50 degrees, and stir until completely dissolved; add 10.0g of ibuprofen, stir until completely dissolved, as Oil phase: take 100mL of water for injection, add 5.0g of glycerin, 2.4g of refined egg yolk lecithin, heat to 50 degrees, grind, stir until the solution is uniform, and use it as the water phase; mix the oil phase and water phase, shear, and stir until The solution is homogeneous and a primary emulsion is formed. Use a high-pressure homogenizer for homogenization, the homogenization pressure is 500 Bar, and the number of homogenization is 6 times. After the 5th homogenization, add water to make the volume to 200 mL. After homogenization, the solution was sterilized with damp heat at 121°C for 15 minutes to obtain Dexibuprofen fat emulsion injection.

Embodiment 3

[0050] Weigh 20.0g of soybean oil and medium-chain triglycerides, mix and stir; add 151.0g of solubilizer KolliphorHS, heat to 50 degrees, and stir until completely dissolved; add 10.0g of ibuprofen, stir until completely dissolved, as Oil phase: take 100mL of water for injection, add 5.0g of glycerin, 2.4g of refined egg yolk lecithin, heat to 50 degrees, grind, stir until the solution is uniform, and use it as the water phase; mix the oil phase and water phase, shear, and stir until The solution is homogeneous and a primary emulsion is formed. Use a high-pressure homogenizer for homogenization, the homogenization pressure is 600 Bar, and the number of homogenization is 6 times. After the 5th homogenization, add water to make the volume to 200 mL. After homogenization, the solution was sterilized with damp heat at 121°C for 15 minutes to obtain Dexibuprofen fat emulsion injection.

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Abstract

The invention relates to a preparation method of a dexibuprofen lipid emulsion injection. The preparation method comprises the following steps that long-chain fatty acid, medium-chain fatty acid and KolliphorHS 15 are heated and stirred to form a homogeneous oil-phase solution; an emulsifier, an osmotic pressure regulating agent and water are evenly mixed to form a water-phase solution; the oil phase and the water phase are mixed, stirred at a certain temperature, sheared and emulsified, and after high-pressure homogenization, pH regulating, filtration, sterilization and the like, the dexibuprofen lipid emulsion injection is obtained. The novel solubilizer KolliphorHS 15 for injection is adopted, the problems about the compatible stability and the drug loading capacity of a dexibuprofen injection during clinical use are effectively solved, and the safety of a preparation is expected to be improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a Dexibuprofen fat emulsion injection and a preparation method thereof. Background technique [0002] Ibuprofen is an antipyretic and analgesic non-steroidal anti-inflammatory drug, which is often used for fever caused by colds, and is also used to relieve various mild and moderate pains. Dexibuprofen is the pure spatial counterpart of ibuprofen, and its activity is 160 times that of the levorotatory form and 1.6 times that of the racemic form. Dexibuprofen not only has good pharmacological activity, but also has small gastrointestinal adverse reactions and liver and kidney toxicity. At present, the dosage forms of Dexibuprofen clinically used in China mainly include tablets, suppositories, capsules and suspensions, which have poor solubility and slow drug effect, and no injections have been listed yet. In June 2009, the ibuprofen injection developed by Cumberland Com...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/192A61K47/14A61P29/00
CPCA61K9/0019A61K9/1075A61K31/192A61K47/14A61P29/00
Inventor 曹青日钱一忖
Owner SUZHOU UNIV
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