Dexamethasone palmitate acid liposome injection

A technology of dexamethasone palmitate and liposome, which is applied in the field of medicine, can solve problems such as affecting the use effect, increasing manufacturing costs, and poor uniformity of automatic dispersion, and achieves the effects of improving curative effect, improving quality, and improving solubility

Inactive Publication Date: 2012-03-07
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation of the emulsion needs to add a large amount of organic co-surfactant, which increases the manufacturing cost; and the automatic dispersion uniformity is poor after dilution during use, which affects the use effect

Method used

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  • Dexamethasone palmitate acid liposome injection
  • Dexamethasone palmitate acid liposome injection
  • Dexamethasone palmitate acid liposome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The preparation of embodiment 1 dexamethasone palmitate liposome injection

[0059] The ingredients used and their weights are as follows:

[0060]

[0061] Adopt following preparation process to prepare dexamethasone palmitate liposome injection:

[0062] (1) 80g dicetyl phospholipid, 80g cholesterol, 100g Tween 80 are dissolved in 800ml buffered saline solution, make blank liposome;

[0063] (2) The blank liposomes prepared above were sterilized by circulating steam, and then ultrasonically treated twice, each time for 15 minutes;

[0064] (3) under aseptic conditions, add 4g dexamethasone palmitate in the liposome of 60 ℃ of molten state, add 30g glucose and 120g dextran under constantly stirring;

[0065] (4) Filter through a 0.45 μm microporous membrane, quickly freeze at -80° C., then return to room temperature, add sterile water to 1000 ml, fill, and prepare 1000 bottles of dexamethasone palmitate liposome injection.

Embodiment 2

[0066] The preparation of embodiment 2 dexamethasone palmitate liposome injection

[0067] The ingredients used and their weights are as follows:

[0068]

[0069] Adopt following preparation process to prepare dexamethasone palmitate liposome injection:

[0070] (1) 200g dicetyl phospholipid, 120g cholesterol, 100g Tween 80 are dissolved in 800ml buffered saline solution, make blank liposome;

[0071] (2) The blank liposomes prepared above were sterilized by circulating steam, and then ultrasonically treated twice, each time for 15 minutes;

[0072] (3) under aseptic conditions, add 4g dexamethasone palmitate in the liposome of 60 ℃ of molten states, add 60g glucose and 60g dextran under constantly stirring;

[0073] (4) Filter through a 0.45 μm microporous membrane, quickly freeze at -80° C., then return to room temperature, add sterile water to 1000 ml, fill, and prepare 1000 bottles of dexamethasone palmitate liposome injection.

Embodiment 3

[0074] The preparation of embodiment 3 dexamethasone palmitate liposome injection

[0075] The ingredients used and their weights are as follows:

[0076]

[0077] Adopt following preparation process to prepare dexamethasone palmitate liposome injection:

[0078] (1) 150g dicetyl phospholipid, 100g cholesterol, 50g Tween 80 are dissolved in 800ml buffered saline solution, make blank liposome;

[0079] (2) The blank liposomes prepared above are sterilized by circulating steam, and then ultrasonically treated twice, each time for 15 minutes;

[0080] (3) under aseptic conditions, add 4g dexamethasone palmitate in the liposome of 60 ℃ of melting states, add 40g glucose and 80g dextran under constantly stirring;

[0081] (4) Filter through a 0.45 μm microporous membrane, quickly freeze at -80° C., then return to room temperature, add sterile water to 1000 ml, fill, and prepare 1000 bottles of dexamethasone palmitate liposome injection.

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Abstract

The invention discloses a dexamethasone palmitate acid liposome injection and a preparation method thereof. The liposome injection is prepared from dexamethasone palmitate, dispermaceti phospholipids, cholesterol, tween80, glucose and dextran according to a certain weight ratio. The liposome injection provided by the invention has good preparation stability. During a freezing process, rupture of liposome due to fusion and ice crystals are prevented. After long-term storage, good entrapment rate is maintained in the liposome. With the injection and the method provided by the invention, dissolubility of dexamethasone palmitate is improved, quality of the preparation product is improved, toxic and side-effects are reduced, retention time of the medicine in systemic circulation is prolonged, bioavailability of the medicine is improved, and the curative effect is improved. The preparation method is simple, and the method is suitable for industrial productions.

Description

technical field [0001] The invention relates to a new preparation of dexamethasone palmitate, in particular to a dexamethasone palmitate liposome injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Dexamethasone palmitate, chemical name 9-fluoro-11β, 17,21-trihydroxy-16a-methylpregna-1,4-diene-3,20-dione-21-palmitic acid Esters, formula C 38 h 59 FO 6 , molecular weight 630.87, structural formula: [0003] [0004] Dexamethasone palmitate is a non-specific steroidal anti-inflammatory drug used in the treatment of chronic rheumatoid arthritis. The drug was launched in 1988. Clinical studies have shown that the drug is highly fat-soluble and is a "targeted" therapeutic agent. Different from steroidal drugs so far, it has a local therapeutic effect despite intravenous administration. [0005] At present, the formulations of dexamethasone palmitate on the market at home and abroad are mainly injections....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/19A61K31/573A61K47/34A61P19/02A61P29/00
Inventor 陶灵刚
Owner HAINAN YONGTIAN PHARMA INST
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