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Etomidate emulsion injection and preparation method thereof

A technology of etomidate and injection, which is applied in the field of etomidate emulsion injection and its preparation, can solve problems such as the influence of the stability of the emulsion system, and achieve the goals of easy availability of excipients, good safety, and improved effectiveness and stability Effect

Pending Publication Date: 2022-06-28
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, although this patent can reduce the content of etomidate, the stability of the emulsion system is greatly affected due to the weakly acidic pH conditions for preparing etomidate emulsion injection

Method used

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  • Etomidate emulsion injection and preparation method thereof
  • Etomidate emulsion injection and preparation method thereof
  • Etomidate emulsion injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] prescription:

[0034] etomidate 2g Soybean oil (for injection) 100g medium chain triglycerides 100g Refined egg yolk lecithin 12g Glycerin (for injection) 25g Oleic acid 0.3g Water for Injection Add to 1000mL

[0035] Preparation method of etomidate emulsion injection:

[0036] Under nitrogen protection, weigh 2 g of etomidate, 12 g of egg yolk lecithin (type E80), 100 g of soybean oil (for injection), 100 g of medium-chain triglycerides, and 0.3 g of oleic acid, heat and stir to make a uniform oil Mutually. Under nitrogen protection, 25 g of glycerol (for injection) was weighed and dissolved in 700 mL of water for injection to obtain an aqueous phase. Under nitrogen protection, the oil phase and the water phase were mixed with vigorous stirring, supplemented with water for injection to 1000mL, 300bar high pressure homogenization, filtered with 1μm filter membrane, packaged in a 10mL ampoule, filled with nitrogen, se...

Embodiment 2

[0038] prescription:

[0039]

[0040]

[0041] Preparation method of etomidate emulsion injection:

[0042] Under nitrogen protection, weigh 2 g of etomidate, 12 g of egg yolk lecithin (type E80), 100 g of soybean oil (for injection), 100 g of medium-chain triglycerides, and 0.9 g of oleic acid, heat and stir to make a uniform oil Mutually. Under nitrogen protection, 25 g of glycerol (for injection) was weighed and dissolved in 700 mL of water for injection to obtain an aqueous phase. Under nitrogen protection, the oil phase and the water phase were mixed with vigorous stirring, supplemented with water for injection to 1000mL, 500bar high pressure homogenization, filtered with a 1μm filter membrane, packaged in a 10mL ampoule, filled with nitrogen, sealed, and carried out at 121 °C Stable sterilization for 15min.

Embodiment 3

[0044] prescription:

[0045] etomidate 2g Soybean oil (for injection) 100g medium chain triglycerides 100g Refined egg yolk lecithin 12g Glycerin (for injection) 25g Phosphatidylglycerol 0.3g Water for Injection Add to 1000mL

[0046] Preparation method of etomidate emulsion injection:

[0047] Under nitrogen protection, weigh 2 g of etomidate, 12 g of egg yolk lecithin (type E80), 100 g of soybean oil (for injection), 100 g of medium-chain triglycerides, and 0.3 g of phosphatidylglycerol, and heat and stir to make a uniform oil phase. Under nitrogen protection, 25 g of glycerol (for injection) was weighed and dissolved in 700 mL of water for injection to obtain an aqueous phase. Under nitrogen protection, the oil phase was mixed with the water phase under strong stirring, and water for injection was added to 1000 mL, 800 bar high pressure homogenization, 1 μm filter membrane filtration, packaged in 10 mL ampoules, filled w...

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Abstract

The invention relates to an etomidate emulsion injection and a preparation method thereof, and belongs to the field of pharmaceutical preparations. The etomidate emulsion injection comprises etomidate, egg yolk lecithin, soybean oil, medium chain triglyceride, glycerol, a stabilizer and water for injection, wherein the stabilizing agent comprises oleic acid and / or phosphatidyl glycerol, and based on the total weight of the etomidate emulsion injection, the content of the stabilizing agent is 0.01 wt%-0.1 wt%. The preparation method of the etomidate emulsion injection comprises the following steps: dissolving etomidate, egg yolk lecithin and a stabilizer in soybean oil and medium chain triglyceride to obtain an oil phase; dissolving glycerol in the water for injection to obtain a water phase; and mixing the oil phase and the water phase, and carrying out high-pressure homogenization treatment and post-treatment to obtain the etomidate emulsion injection. The method provided by the invention is simple and convenient to operate, can solve the current technical problems of the product, and can produce the etomidate emulsion injection with better stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an etomidate emulsion injection and a preparation method thereof. Background technique [0002] Etomidate is a fast hypnotic intravenous general anesthetic, its hypnotic effect is 12 times stronger than that of thiopental sodium, and has a GABA-like effect. Unlike barbiturates, this product causes neocortex at the beginning of hypnotic effect. Sleep, reduces subcortical inhibition. Animal studies have shown that the effect of etomidate can be partly through the inhibition and activation of the brainstem reticular system. This product has little effect on the cardiovascular and respiratory systems, and can be used for general anesthesia induction in patients with shock or trauma. A large single intravenous injection can cause short-term apnea, does not increase the release of histamine, and can reduce intracranial pressure and cerebral blood flow. and intraocular press...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/4174A61K47/12A61K47/24A61P23/00
CPCA61K31/4174A61K9/0019A61K9/107A61K47/12A61K47/24A61P23/00
Inventor 黄岭尹磊胡金涛宋婷徐柳甘存军
Owner WUHAN DOCAN PHARMA
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