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Granatilide acetate multivescular liposome and preparation method thereof

A technology of glatiramer acetate and multivesicular liposomes, which is applied in the field of pharmaceutical preparations and can solve the problems of short action time and multiple administrations

Inactive Publication Date: 2019-12-31
HYBIO PHARMA WUHAN CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional morphine preparations require multiple doses due to their short duration of action

Method used

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  • Granatilide acetate multivescular liposome and preparation method thereof
  • Granatilide acetate multivescular liposome and preparation method thereof
  • Granatilide acetate multivescular liposome and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0043] The preparation of embodiment 1 glatiramer multivesicular liposome

[0044] Dissolve 50 mg of glatiramer acetate in 30 mL of water phase, 5 g of soybean lecithin, 5 g of cholesterol, 0.6 g of phosphatidylserine, and 0.6 g of triolein in 30 mL of chloroform-ether (1:1) (oil phase), The water phase was added into the oil phase, and the vortex mixer was shaken to emulsify for 8 minutes to prepare colostrum. Add the obtained colostrum into the same volume of external water phase, emulsify with a vortex mixer for 1-240s, usually 20-80s. The obtained double emulsion is blown dry with nitrogen gas to obtain the multivesicular liposome. The particle size of the obtained multivesicular liposome is related to the time of secondary emulsification, the longer the time, the smaller the particle size. Centrifuge, remove supernatant, and resuspend multivesicular liposomes with saline.

Embodiment 2

[0045] The preparation of embodiment 2 glatiramer multivesicular liposomes

[0046] Dissolve 200 mg of glatiramer acetate in 100 mL of water phase, 5 g of lecithin, 1.2 g of phosphatidylserine, and 1.1 g of glyceryl tricaprylate, dissolve in 120 mL of chloroform or a mixed solvent of chloroform and ether (oil phase), and dissolve the water phase Add it to the oil phase of the same volume, emulsify for 6-12min with a high-speed disperser at 8000-15000r / min, and prepare colostrum. Add the obtained colostrum into the same volume of external water phase, and emulsify with a high-speed disperser at 4500-5000r / min for 30-120s. The obtained double emulsion is blown dry with nitrogen gas to obtain the multivesicular liposome. Centrifuge, remove supernatant, and resuspend multivesicular liposomes with saline.

Embodiment 3

[0047] The preparation of embodiment 3 glatiramer multivesicular liposomes

[0048] Dissolve 50 mg of glatiramer acetate in 30 mL of water phase, 5 g of soybean lecithin, 5 g of cholesterol, 0.6 g of phosphatidylserine, and 0.1 g of triolein in 30 mL of chloroform-ether (1:1) (oil phase), The water phase was added into the oil phase, and the vortex mixer was shaken to emulsify for 8 minutes to prepare colostrum. Add the obtained colostrum into the same volume of external water phase, emulsify with a vortex mixer for 1-240s, usually 20-80s. The obtained double emulsion is blown dry with nitrogen gas to obtain the multivesicular liposome. The obtained double emulsion is blown dry with nitrogen gas to obtain the multivesicular liposome. Centrifuge, remove supernatant, and resuspend liposomes with saline.

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Abstract

The invention relates to a granatilide acetate multivescular liposome. The granatilide acetate multivescular liposome is a liposome membrane material composed of common phospholipid, triglyceride andcharged phospholipid, and active component granatilide acetate is encapsulated in the multivescular liposome. The liposome membrane material also comprises cholesterol. The mass ratio of the common phospholipid to the charged phospholipid to the triglyceride is (3-10):1:(0.8-1.2). The granatilide acetate liposome provided by the invention has a simple preparation method and a high drug loading rate, and a slow release effect can be achieved.

Description

technical field [0001] The invention relates to a composition of glatiramer, in particular to a slowly releasing multivesicular liposome of glatiramer and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Glatiramer acetate is a synthetic peptide preparation consisting of four amino acids: glutamic acid, alanine, tyrosine and lysine, and is used to treat multiple sclerosis. [0003] Glatiramer acetate (trade name: Copaxone) was developed and manufactured by the world-renowned Israeli pharmaceutical company TEVA. It was first approved for marketing in Israel in 1996, and was approved by the FDA for marketing in the United States in the same year. It is currently on the market in 43 major countries. In western countries with many multiple sclerosis patients, the efficacy and tolerability of glatiramer acetate have been fully affirmed. TEVA's 2013 annual report shows that the sales of glatiramer acetate reached U...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/16A61K9/127A61K47/14A61P25/00A61P37/02
CPCA61K9/127A61K38/16A61K47/14A61P25/00A61P37/02A61K47/16A61K47/24
Inventor 张伟明秦超陶安进袁建成
Owner HYBIO PHARMA WUHAN CO LTD
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