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Etomidate injection preparation and preparation method thereof

A technology for etomidate and injection preparations, applied in the field of pharmaceutical preparations, can solve problems such as affecting the stability of milk particles, and achieve the effects of avoiding the increase in the particle size of milk particles, reducing the content of impurities, and avoiding the increase in the particle size of milk particles.

Active Publication Date: 2020-07-17
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For those skilled in the art, the main way to control drug hydrolysis is to control the pH value, but adjusting the pH easily affects the stability of the emulsion, so it is necessary to provide a new method for etomidate injection preparations to improve etomidate injection. Formulation Stability

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A kind of etomidate injection preparation of embodiment 1

[0044] Its preparation raw materials include by weight:

[0045] Etomidate: 1 part;

[0046] Oil for injection: 40 parts;

[0047] Phospholipids: 4 parts;

[0048] Distearoylphosphatidylglycerol: 4 parts;

[0049] Trehalose: 0.5 parts;

[0050] Mannitol: 4 parts;

[0051] Sodium oleate: 0.4 parts;

[0052] Water for injection: 420 parts.

[0053] The phospholipid is a mixture of hydrogenated soybean lecithin and egg yolk lecithin; the mass ratio of the hydrogenated soybean lecithin and egg yolk lecithin is 1:3.

[0054] Its preparation method comprises the following steps:

[0055] (1) Heat the oil for injection in the prescribed amount to 55°C, add etomidate, phospholipids and distearoylphosphatidylglycerol in the prescribed amount, mix well, and cool to room temperature to obtain oil phase A;

[0056] (2) After heating the water for injection in the prescribed amount to 70°C, add the trehalose, manni...

Embodiment 2

[0061] A kind of etomidate injection preparation of embodiment 2

[0062] Its preparation raw materials include by weight:

[0063] Etomidate: 3 parts;

[0064] Oil for injection: 50 parts;

[0065] Phospholipids: 2 parts;

[0066] Distearoylphosphatidylglycerol: 1 part;

[0067] Trehalose: 1 part;

[0068] Mannitol: 1 part;

[0069] Sodium oleate: 0.05 parts;

[0070] Water for injection: 450 parts.

[0071] The phospholipid is a mixture of hydrogenated soybean lecithin and egg yolk lecithin; the mass ratio of the hydrogenated soybean lecithin and egg yolk lecithin is 1:5.

[0072] Its preparation method comprises the following steps:

[0073] (1) After heating the oil for injection in the prescribed amount to 60°C, add etomidate, phospholipids and distearoylphosphatidylglycerol in the prescribed amount, mix evenly, and cool to room temperature to obtain oil phase A;

[0074](2) After heating the water for injection in the prescribed amount to 65°C, add the trehalose...

Embodiment 3

[0079] A kind of etomidate injection preparation of embodiment 3

[0080] Its preparation raw materials include by weight:

[0081] Etomidate: 1.8 parts;

[0082] Oil for injection: 45 parts;

[0083] Phospholipids: 4 parts;

[0084] Distearoylphosphatidylglycerol: 2 parts;

[0085] Trehalose: 0.7 parts;

[0086] Mannitol: 2 parts;

[0087] Sodium oleate: 0.2 parts;

[0088] Water for injection: 435 parts.

[0089] The phospholipid is a mixture of hydrogenated soybean lecithin and egg yolk lecithin; the mass ratio of the hydrogenated soybean lecithin and egg yolk lecithin is 1:4.

[0090] Its preparation method comprises the following steps:

[0091] (1) After heating the oil for injection in the prescribed amount to 63°C, add etomidate, phospholipids and distearoylphosphatidylglycerol in the prescribed amount, mix well, and cool to room temperature to obtain oil phase A;

[0092] (2) After heating the water for injection in the prescribed amount to 68°C, add trehalos...

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Abstract

The invention belongs to the technical field of biomedicine, and particularly relates to an etomidate injection preparation and a preparation method thereof. The etomidate injection preparation is prepared from the raw materials in parts by weight: 1-3 parts of etomidate, 40-50 parts of oil for injection, 2-4 parts of phospholipid, 1-4 parts of distearoyl-phosphatidyl-glycerol, 0.5-1 part of trehalose, 1-4 parts of mannitol, 0.05-0.4 part of sodium oleate, and 420-450 parts of water for injection. According to the etomidate medication injection preparation, the mass ratio of hydrogenated soy lecithin to egg yolk lecithin in the phospholipid is adjusted, so the increase of grain diameter of emulsion grains in the process of sterilization can be avoided. Via the selection and application oftrehalose and mannitol, the problem of increased grain diameter of emulsion grains in the process of sterilization can be avoided, hydrolyzation of etomidate can be reduced, and the content of impurities is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an etomidate injection preparation and a preparation method thereof. Background technique [0002] Etomidate is an imidazole derivative, a hypnotic intravenous anesthetic, a white crystalline powder, soluble in water, propylene glycol, polyethylene glycol and fat emulsion. Etomidate is short-acting and quick-acting, has a slight effect on breathing and circulation, and is relatively safe to induce and wake up quickly. It can also slightly dilate coronary arteries and reduce intracranial pressure. [0003] There are mainly two dosage forms in clinical application: (1) water agent: an injection prepared by dissolving etomidate in 35% propylene glycol; (2) fat emulsion: such as B.Braun's "Yiduoli" imported from China . The injection prepared by dissolving etomidate in 20% medium and long-chain triglycerides, the osmotic concentration of the two preparations is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K47/44A61K47/24A61K47/36A61K47/10A61K47/12A61K31/4174A61P23/00
CPCA61K9/107A61K31/4174A61K47/10A61K47/12A61K47/24A61K47/36A61K47/44A61P23/00
Inventor 黄岭尹磊张晓花胡金涛
Owner WUHAN DOCAN PHARMA
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