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Etomidate composition for injection and preparation method thereof

A technology of etomidate and composition, applied in the field of etomidate composition for injection and preparation thereof, can solve the problems of inability to carry out visible foreign bodies, strong irritation, poor stability and the like, achieve good freeze-thaw stability and ensure safety Use, effect of small particle size

Inactive Publication Date: 2015-11-25
SHANGHAI INST OF PHARMA IND CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Aiming at the shortcomings of existing etomidate composition injection sites that are highly irritating, or poor in stability, and cannot be inspected for visible foreign matter, the invention provides a new etomidate composition for injection, which is better than fat emulsion The particle size is greatly reduced and the stability is enhanced

Method used

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  • Etomidate composition for injection and preparation method thereof
  • Etomidate composition for injection and preparation method thereof
  • Etomidate composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Composition prescription:

[0044]

[0045] Preparation:

[0046] Under heating conditions, dissolve phospholipids in MCT and SolutolHS15, add etomidate and glycerin and stir evenly to obtain an oil phase; dissolve other excipients in water for injection; add the water phase to the oil phase under continuous stirring, and add water to 100ml , hydrochloric acid and sodium hydroxide to adjust the pH to 6-8, filtered, potted, sterilized, and obtained.

Embodiment 2

[0048] Composition prescription:

[0049]

[0050] Preparation:

[0051] Under heating conditions, mix MCT and SolutolHS15, add etomidate and glycerin and stir evenly to obtain an oil phase; dissolve other excipients in water for injection; add the water phase to the oil phase under continuous stirring, add water to 100ml, filter, Potting, sterilization, that is.

Embodiment 3

[0053] Composition prescription:

[0054]

[0055] Preparation:

[0056] Under heating conditions, dissolve phospholipids in MCT and SolutolHS15, add etomidate and glycerin and stir evenly to obtain an oil phase; dissolve other excipients in water for injection; add the water phase to the oil phase under continuous stirring, and add water to 100ml , filtered, potted, sterilized, and obtained.

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PUM

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Abstract

The invention discloses an etomidate composition for injection. The etomidate composition is characterized by comprising a) etomidate, b) solutol HS 15 and any phospholipid, c) oil for injection and d) a pharmacy acceptable auxiliary material. The invention further discloses a preparation method for the etomidate composition for injection. According to the invention, the particle diameter of the etomidate composition for injection is less than 100 nm, the appearance is transparent, the pH value is 5 to 8, and the composition can be preserved at room temperature, cannot cause hemolysis, can be supplied for injection dosing, and is used of anesthesia induction and maintenance.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an etomidate composition for injection and a preparation method thereof. Background technique [0002] Etomidate (see formula 1 for structure) is a non-barbiturate intravenous anesthesia inducer, and its action strength is 4 times that of barbital sodium and 12 times that of thiopental sodium, and the induction of general anesthesia is fast. The awakening and recovery are also fast, and the patient no longer suffers from drowsiness, dizziness and other adverse reactions after waking up, and has a certain anti-vomiting effect, so it has been widely used. Etomidate has water injection and fat emulsion injection with propylene glycol aqueous solution as the solvent. Due to the high injection osmotic pressure of water injection, side effects such as pain at the injection site, muscle tremor, postoperative phlebitis, and thrombophlebitis often occur. [0003] [0004] F...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4174A61K47/34A61P23/00
Inventor 金方蔡伟惠徐颖
Owner SHANGHAI INST OF PHARMA IND CO LTD
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