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Dexamehasone palmitate freeze-dried emulsion and its preparation method

A technology of dexamethasone palmitate and freeze-dried emulsion, which is applied in the field of medicine and can solve the problems of high curative effect on formaldehyde edema, high anti-inflammatory effect of carrageenan granuloma, etc.

Inactive Publication Date: 2005-03-23
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The results show that Lipo-Dpal and DP have the same curative effect on the acute inflammation model of carrageenan edema, but the curative effect of the former on formaldehyde edema is 2 times greater, and the anti-inflammatory effect on carrageenan granuloma is 5.3 times greater

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prescription composition: 0.4g of dexamethasone palmitate, 5g of soybean lecithin, 0.01g of anhydrous sodium bisulfite, a total of 100ml.

[0023] Process:

[0024] 1) In the preparation equipment, dissolve 0.4 g of dexamethasone palmitate in an appropriate amount of ethanol;

[0025] 2) Mix 5 g of soybean lecithin for injection with an appropriate amount of water for injection, and add 0.01 g of anhydrous sodium bisulfite;

[0026] 3) Add 2) into 1) under the condition of stirring, and after stirring at 20□, pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Add 4% mannitol as a lyoprotectant to prepare 100ml of liquid medicine; pass through a 0.22um microporous membrane to sterilize, and pack aseptically under grade 100.

[0027] 4) remove moisture through freeze-drying to obtain dry dexamethasone palmitate freeze-dried emulsion;

[0028] 5) Add the prepared lyophilized emulsion into water for injection according to the r...

Embodiment 2

[0030] Prescription composition: 0.2g dexamethasone palmitate, 0.5g egg yolk lecithin, 0.2g tea oil for injection, 0.01g anhydrous sodium bisulfite, 0.01g ethylparaben, 5g glucose and 1g mannitol, total into 100ml.

[0031] Process:

[0032] 1) In the preparation equipment, 0.2 g of dexamethasone palmitate is dissolved in 0.2 g of tea oil for injection;

[0033] 2) Mix 0.5 g of egg yolk lecithin for injection with an appropriate amount of water for injection, and add 0.01 g of ethylparaben and 0.01 g of anhydrous sodium bisulfite;

[0034] 3) Add 1) into 2) under the condition of stirring, and after stirring at 40□, pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Glucose and mannitol were added as freeze-drying protective agents to prepare 100ml of liquid medicine; sterilized by passing through a 0.22um microporous membrane, and aseptically dispensed under 100 grades.

[0035] 4) remove moisture through freeze-drying to obtain ...

Embodiment 3

[0038] Prescription composition: 0.2g of dexamethasone palmitate, 1g of poloxamer (F68), 1g of olive oil for injection, 0.1g of anhydrous sodium sulfite, a total of 100ml.

[0039] Process:

[0040] 1) In the preparation equipment, 0.2 g of dexamethasone palmitate is dissolved in 1 g of olive oil for injection;

[0041] 2) Mix 1 g of poloxamer with an appropriate amount of water for injection;

[0042] 3) Add 2) into 1) under the condition of stirring, and after stirring at 60° C., pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Hydrochloric acid and sodium hydroxide adjust the pH to 4-5, add 40% sucrose as a freeze-drying protective agent, add water for injection to 100ml;

[0043] 4) Freeze-drying removes moisture to obtain dry dexamethasone palmitate dexamethasone palmitate freeze-dried emulsion;

[0044] 5) To prepare the freeze-dried emulsion, add water according to the required amount, hydrate and shake, and restore to th...

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Abstract

A freeze-dried emulsion of dexamethasone palmitate contains dexamethasone palmitate, oil phase, emulsifier, stabilizer, pH regulator and freeze-drying protector.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a dexamethasone palmitate freeze-dried emulsion and a preparation method thereof. Background technique: [0002] Rheumatoid arthritis (RA) and osteoarthritis are common chronic inflammatory joint diseases. At present, the drugs for treating such diseases are mainly steroids and non-steroids. Due to the definite curative effect of steroids, they are necessary for the treatment of severe patients, and their role is irreplaceable by non-steroids. At present, the dosage forms of steroid drugs on the market are mainly divided into two categories, one is solution type (including freeze-dried powder injection) injection, and the other is suspension injection. The former can be "intravenously injected", "intramuscularly injected" and "joint cavity injected", but the elimination speed is fast, and the effective concentration cannot be maintained in the blood and tissues for a long time...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/573A61P19/02
Inventor 邓意辉王绍宁吴琼
Owner SHENYANG PHARMA UNIVERSITY
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