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Propyl gallate liposome injection

A technology of propyl gallate and injection, which is applied in the field of medicine, can solve problems such as unqualified clarity, decreased main drug content, instability, etc., and achieve the effects of improving the product quality of preparations, good preparation stability, and good bioavailability

Inactive Publication Date: 2013-04-17
海南路易丹尼生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The freeze-dried powder injection of propyl gallate is difficult to dissolve when the room temperature is lower than 15°C, and it needs to be pre-dissolved in a special solvent containing propylene glycol, and propylene glycol is prone to hemolysis and irritation; and the freeze-dried powder injection of propyl gallate is generally There is oily precipitation and wall-hanging phenomenon, which not only reduces the content of the main drug, but also has the risk of vascular obstruction after infusion
Propyl gallate is unstable in aqueous solution and is easily degraded. At the same time, the drug is also easily oxidized. Therefore, the injection of propyl gallate is unstable during storage, and the related substances increase, and the clarity is unqualified

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The preparation of embodiment 1 propyl gallate liposome freeze-dried powder injection

[0053] The ingredients used and their weights are as follows:

[0054]

[0055] The following preparation process is adopted to prepare propyl gallate liposome freeze-dried powder injection:

[0056] (1) Dissolve 60g of dilauroylphosphatidylglycerol, 200g of cholesterol and 40g of Tween 80 in 1500ml of phosphate buffer solution with a pH of 6.2 to make blank liposomes;

[0057] (2) The blank liposomes prepared above were sterilized by circulating steam, and then sonicated twice, each time for 15 minutes;

[0058] (3) Under sterile conditions, add 60 g of propyl gallate to the molten liposome, and add 0.05 g of sodium bisulfite, 0.01 g of EDTA-2Na and 100 g of dextran under constant stirring;

[0059] (4) Filtrate through a 0.45um microporous membrane, subpackage, and freeze-dry to prepare 1,000 bottles of propyl gallate liposome freeze-dried powder for injection.

Embodiment 2

[0060] The preparation of embodiment 2 propyl gallate liposome injection

[0061] The ingredients used and their weights are as follows:

[0062]

[0063] Adopt following preparation process to prepare propyl gallate liposome injection:

[0064] (1) Dissolve 80g of dilauroylphosphatidylglycerol, 50g of cholesterol and 100g of Tween 80 in 1500ml of phosphate buffer solution with a pH of 6.2 to make blank liposomes;

[0065] (2) The blank liposomes prepared above were sterilized by circulating steam, and then sonicated twice, each time for 15 minutes;

[0066] (3) Under sterile conditions, add 60 g of propyl gallate to the molten liposome, and add 0.1 g of sodium bisulfite, 0.05 g of EDTA-2Na and 50 g of dextran under constant stirring;

[0067] (4) Filter through a 0.45um microporous membrane, freeze quickly, then return to room temperature, dilute to 2000ml with water for injection, fill and sterilize to obtain 1000 propyl gallate liposome injections.

Embodiment 3

[0068] The preparation of embodiment 3 propyl gallate liposome injection

[0069] The ingredients used and their weights are as follows:

[0070]

[0071]

[0072] Adopt following preparation process to prepare propyl gallate liposome injection:

[0073] (1) Dissolve 60g of dilauroylphosphatidylglycerol, 150g of cholesterol and 90g of Tween 80 in 3000ml of phosphate buffer solution with a pH of 6.2 to make blank liposomes;

[0074] (2) The blank liposomes prepared above were sterilized by circulating steam, and then sonicated twice, each time for 15 minutes;

[0075] (3) Under sterile conditions, add 120 g of propyl gallate to the molten liposome, and add 0.4 g of sodium bisulfite, 0.2 g of EDTA-2Na and 160 g of dextran under constant stirring;

[0076] (4) Filtrate through a 0.45um microporous membrane, quickly freeze, then return to room temperature, dilute to 5000ml with water for injection, fill, and sterilize to obtain 1000 propyl gallate liposome injections.

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Abstract

The invention discloses propyl gallate liposome injection and a preparation method thereof. The propyl gallate liposome injection with excellent quality is prepared by selecting propyl gallate, dilauroyl phosphatidyl glycerol, cholesterol, tween 80, sodium hydrogen sulfite, ethylene diamine tetraacetic acid (EDTA)-2Na and dextranum. Compared with the conventional preparation, the preparation provided by the invention has the advantages that the stability and the bioavailability of the preparation is greatly improved, the medicine release is stable, the quality of the preparation product is improved, the toxic or side effect is reduced and obvious curative effect is achieved.

Description

technical field [0001] The invention relates to a liposome injection and a preparation method thereof, in particular to a propyl gallate liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Propyl gallate is a derivative of gallic acid ester, the active ingredient in the traditional Chinese medicine Radix Paeoniae Rubra, and it is a drug with stronger biological effects obtained by modifying the structure of gallic acid ester. Its chemical name is 3,4,5-trihydroxybenzoic acid propyl ester, molecular formula: C 10 h 12 o 5 , molecular weight 212.20, structural formula: [0003] [0004] Propyl gallate is an antithrombotic drug, which has anti-platelet aggregation, inhibits thrombolysis, promotes thrombolysis, and expands blood vessels. It has been widely used in ischemic cerebrovascular disease, sequelae of cerebral coma, traumatic brain injury, concussion, and coronary heart disease. , Prevent...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K9/19A61K31/235A61K47/28A61K47/24A61P7/02A61P9/08A61P9/10A61P25/02A61P9/12A61P9/04A61P9/00
Inventor 王平
Owner 海南路易丹尼生物科技有限公司
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