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Lipid microsphere preparation and preparation method thereof

A technology of lipid microspheres and preparations, which is applied in the field of esterified lipid microsphere preparations, and can solve problems such as influence, side effects, and restrictions on popularization and application

Active Publication Date: 2014-04-09
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, during the intravenous injection or infusion of propofol, side effects of pain at the injection site occur frequently, which seriously affects the patient's body and spirit, thus limiting its clinical application.

Method used

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  • Lipid microsphere preparation and preparation method thereof
  • Lipid microsphere preparation and preparation method thereof
  • Lipid microsphere preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] 1. Prescription composition

[0057] Element

Dosage

effect

Propofol

10g

drug

flurbiprofen axetil

10g

drug

Refined egg yolk lecithin

12g

Emulsifier

Refined soybean oil

100g

Oil phase solvent

Glycerin

22.5g

osmotic regulator

Oleic acid

0.3g

stabilizer

sodium hydroxide

Appropriate amount

pH regulator

Water for Injection

Dilute to 1000ml

solvent

[0058] 2. Preparation process

[0059] (1) Preparation of the oil phase: Take the prescribed amount of refined egg yolk lecithin (Germany Lipoid Company), refined soybean oil (Tieling Beiya Pharmaceutical Oil Co., Ltd.), oleic acid (Germany Lipoid Company) into the container, place Heating in a water bath at 70°C, high-shearing for 30 minutes to dissolve until clear, and make an oil phase, add the prescribed amount of propofol (Wuhan Daan Pharmaceutical Co., Ltd.), flurbiprofen axetil ...

Embodiment 2

[0067] The preparation method of this example is the same as that of Example 1, except that flurbiprofen axetil is replaced by an equivalent amount of flurbiprofen propionyloxymethyl ester (Wuhan Daan Pharmaceutical Co., Ltd.).

[0068] Encapsulation Efficiency Test of Liposphere Preparation

[0069] Determination of the encapsulation efficiency of propofol and flurbiprofen esterified products of the liposome preparations prepared in the above-mentioned examples 1 and 2, and carried out with the commercially available contrast preparations of propofol or flurbiprofen axetil Comparison (control preparation 1: propofol injection (10ml: 100mg), produced by Xi'an Libang Pharmaceutical Technology Co., Ltd.; control preparation 2: flurbiprofen axetil injection (5ml: 50mg), produced by Beijing Tide Pharmaceutical Co., Ltd.) .

[0070] (1) Liposphere supernatant: Precisely pipette 2.0 mL of the prepared liposphere preparation or control preparation, place in a micro ultracentrifuge, ...

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Abstract

The invention provides a lipid microsphere preparation comprising propofol, flurbiprofen ester, oil phase solvent and emulgator. The invention also provides a method for preparing the lipid microsphere preparation. The method comprises the following steps: (1) mixing an oil phase mixture containing the propofol, the flurbiprofen ester, the oil phase solvent and the emulgator to generate uniform oil phase; (2) adding the oil phase to water phase to form colostrum; (3) homogenizing the colostrums. The lipid microsphere preparation is used as a dope and has improved abirritation simultaneously.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lipid microsphere preparation of a compound drug, more specifically, to a lipid microsphere preparation comprising an esterified product of propofol and flurbiprofen. Background technique [0002] Propofol is a new type of alkylbenzene intravenous anesthesia drug, which has the characteristics of fast onset, short duration, rapid and stable recovery, and safety. Propofol is mainly used clinically for induction of anesthesia, maintenance of anesthesia, and sedation of critically ill ICU patients. However, during the intravenous injection or infusion of propofol, side effects of pain at the injection site occur frequently, which seriously affects the patient's body and spirit, thus limiting its clinical application. [0003] Therefore, need a kind of new propofol preparation that alleviates injection pain, to improve the clinical application of propofol. Contents of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/05A61K47/14A61K9/19A61P23/00
Inventor 黄岭张文军尹磊胡金涛胡淑静
Owner WUHAN DOCAN PHARMA
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