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Preparation method and composition of fat emulsion for volatile anesthetic injection

A fat and anesthetic technology for injection, which is applied in the direction of drug combination, anesthetic, drug delivery, etc., can solve the problems of unavailable diseases, inaccurate drug dosage, increased cost, etc., and reduce the occurrence rate and intensity of adverse reactions, Effect of improving brain/blood partition coefficient and reducing stimulation of respiratory system

Pending Publication Date: 2022-03-01
YICHANG HUMANWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For fat emulsions of volatile anesthetics (including isoflurane), physical instability (emulsion breaking, delamination, oil floating, etc.) will directly lead to safety and effectiveness problems of drug use, uneven Drug emulsion particles will cause side effects such as redness and swelling at the injection site, coughing, failure to pass through the blood-brain barrier or even thrombus, and cannot be used for the treatment of diseases; and the large amount of volatilization of the main drug will lead to increased costs and inaccurate drug dosage
[0007] Up to now, there is no method for the smooth industrial production of fat emulsions of volatile anesthetics (including isoflurane), which also leads to the generation and use of no related products on the market

Method used

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  • Preparation method and composition of fat emulsion for volatile anesthetic injection
  • Preparation method and composition of fat emulsion for volatile anesthetic injection
  • Preparation method and composition of fat emulsion for volatile anesthetic injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Example 1 Preparation of Hisluoro Alkine Posemum A

[0068] formula:

[0069]

[0070]

[0071] (1) Put the egg yolk lecithin into soybean oil, cut to egg yolk phospholipids in 70 ° C completely dissolve, and the proof phase;

[0072] (2) Glycerol, oleate sodium is put into water, stirred and dissolve, and the water is obtained;

[0073] (3) Hybride the oil phase and the aqueous phase, cut to no obvious leaving oil at 70 ° C, resulting in ceremonial milk; in the case of primary pressure 600 bar and secondary pressure 60 bar, a blank milk is obtained;

[0074] (4) Put the isoflurane into white milk, stirred / cut to isoflurane is completely dissolved.

Embodiment 2

[0075] Example 2 Preparation of Tieluoro Alkine Pymmoform B

[0076] formula:

[0077]

[0078] (1) Put the egg yolk lecithin into soybean oil, cut to egg yolk phospholipids in 70 ° C completely dissolve, and the proof phase;

[0079] (2) Glycerol, oleate sodium is put into water, stirred and dissolve, and the water is obtained;

[0080] (3) Hybride the oil phase and the aqueous phase, cut to no obvious leaving oil at 70 ° C, resulting in ceremonial milk; in the case of primary pressure 600 bar and secondary pressure 60 bar, a blank milk is obtained;

[0081] (4) Put the isoflurane into blank milk, stir / shear to isoflurane completely dissolve;

[0082] (5) The hydraulic fluid is at least 2 times under the conditions of the primary pressure 100 bar and the secondary pressure 100 bar, and isotropytoxiamia;

[0083] (6) Erase the isoflurane fatty into the 10 ml ampoule, and sterilized for 15 minutes under high temperature conditions at 121 ° C.

Embodiment 3

[0084] Example 3 Preparation of THFOthipasto C

[0085] formula:

[0086]

[0087] (1) Put the egg yolk lecithin into soybean oil, cut to egg yolk phospholipids in 70 ° C completely dissolve, and the proof phase;

[0088] (2) Glycerol, oleate sodium is put into water, stirred and dissolve, and the water is obtained;

[0089] (3) Hybride the oil phase and the aqueous phase, cut to no obvious leaving oil at 70 ° C, resulting in ceremonial milk; in the case of primary pressure 600 bar and secondary pressure 60 bar, a blank milk is obtained;

[0090] (4) Put the isoflurane into blank milk, stir / shear to isoflurane completely dissolve;

[0091] (5) The hydraulic fluid is at least 2 times under the conditions of the primary pressure 100 bar and the secondary pressure 100 bar, and isotropytoxiamia;

[0092] (6) Erase the isoflurane fatty into the 10 ml ampoule, and sterilized for 15 minutes under high temperature conditions at 121 ° C.

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Abstract

The invention discloses a preparation method of a fat emulsion composition for volatile anesthetic injection, which comprises the following steps: distributing emulsifiers into a first emulsifier and a second emulsifier according to a weight ratio of 1: 10-10: 1, and forming blank emulsion by the first emulsifier and oil for injection, the blank emulsion and the second part of emulsifier participate in forming a pre-emulsion, and the pre-emulsion and the volatile anesthetic participate in forming the fat emulsion composition for volatile anesthetic injection. In addition, the invention also provides an improved fat emulsion composition for volatile anesthetic injection, and the fat emulsion composition can not generate a bottle flushing phenomenon during high-temperature sterilization, and can be stored at room temperature for a long time.

Description

Technical field [0001] The present invention relates to, but is not limited to, in the field of preparation of pharmaceutical preparation, therefore, in particular, a method for preparing a fatty milk for volatile anesthetic injection and a composition thereof. Background technique [0002] Volatile anesthetics, such as isoflurane (also known as isoflurane), is a low boiling anesthetic inhalation of the pulmonary, administered by a trained professionally passed the gasification device, and continuously maintains artificial breathing during clinical use. Machine, the effectiveness of the equipment and cyclic resuscitation equipment, and maintains the passage of the patient's airway. Many restriction factors lead to the clinical use of isoflurane extremely inconvenient, and there is a certain effect on health workers and patients in the operating room. In order to improve the operational convenience of volatile anesthetics such as isoflurane, people have begun to try new administra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K45/00A61K47/02A61K47/04A61K47/12A61K47/18A61K47/44A61P23/00
CPCA61K9/107A61K47/44A61K45/00A61K9/0019A61K47/02A61K47/12A61K47/183A61P23/00
Inventor 段罗俊郑文雅张翠英李莉娥袁靖吴有斌
Owner YICHANG HUMANWELL PHARMA
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