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Epi-doxorubicine liposome and its preparing method

A technology of epirubicin lipid and epirubicin is applied in the field of epirubicin liposome and preparation thereof, and achieves the effects of high encapsulation efficiency and stable liposome quality

Inactive Publication Date: 2004-12-15
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Although epirubicin has lower side effects than doxorubicin, it is still highly toxic to humans

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of epirubicin liposomes:

[0029] Epirubicin 10mg

[0030] Lecithin 10mg

[0031] Cholesterol 15mg

[0032] Preparation method: Weigh the prescribed amount of epirubicin, phospholipids, and cholesterol and dissolve them in an appropriate amount of 10ml of ethanol solution to obtain a lipid solution. Slowly drop the lipid solution into 15ml of water while stirring to obtain the liposome-containing primary suspension. Place it in a water-bath sonicator and sonicate until the translucent colloidal solution is filtered through a 0.8 μm microporous membrane to obtain a liposome suspension. The encapsulation efficiency of the prepared epirubicin liposome was 49%.

Embodiment 2

[0034] Epirubicin 10mg

[0035] Lecithin 10mg

[0036] Sodium deoxycholate 10mg

[0037] Mannitol 30mg

[0038] Preparation method Weigh prescription amount of epirubicin, phospholipids, sodium deoxycholate and dissolve in 20ml ethanol solution to obtain lipid solution, transfer to 1000ml eggplant-shaped bottle, place in 60°C constant temperature water bath, The organic solvent was removed by a rotary thin film evaporator, and a uniform lipid film was formed on the bottle wall. Weigh the prescribed amount of mannitol, dissolve it with 15ml of hydration medium, add water, pour it into an eggplant-shaped bottle, shake gently, elute the lipidoid film and disperse it in the hydration medium to dissolve, and then the liposome suspension is obtained . It is poured into APV2000 milk homogenizer (Danish APV), under the pressure of primary valve 1760bar, secondary raft 270bar, continuous milk homogenizes 5 times to obtain the epirubicin liposome prepared by liposome suspension. Th...

Embodiment 3

[0040] Epirubicin 10mg

[0041] Lecithin 80mg

[0042] Cholesterol 20mg

[0043] Sodium deoxycholate 15mg

[0044] Glucose 130mg

[0045] Preparation method, take by weighing prescription amount of epirubicin, phospholipids, cholesterol, sodium deoxycholate, glucose and dissolve in 20ml of aqueous solution, transfer it to a high-speed stirrer and stir for a certain period of time to obtain liposome initial Suspension. The primary suspension was poured into an APV2000 homogenizer (APV, Denmark), and under the pressure of the primary valve 1760 bar and the secondary raft 270 bar, the liposome suspension was obtained by continuous homogenization 5 times. The encapsulation efficiency of the prepared epirubicin liposome was 73%. The powder is obtained by freezing or spray-drying.

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Abstract

The present invention relates to the field of pharmaceutical technology, and is especially epirubicin liposome and its preparation process. The epirubicin liposome of the present invention consists of epirubicin, phosphatide, cholesterol, sodium deoxycholate, etc.; has stable quality and less toxic side effect; and is suitable for clinical application.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to epirubicin liposome and a preparation method thereof. Background technique: [0002] Epirubicin [chemical name (Is: 9s)-9-hydroxyacetyl-4-methoxy-7,8,9,10-tetrahydro-6.7.9.10.11-tetrahydroxy-7-0-( 2,3,6-trideoxy-3-amino-Q-L-arabinose pyranyl)-5,12-naphthalenedione] is orange-red powder crystal, soluble in water, slightly soluble in ethanol, insoluble in Chloroform, acetone and other solvents, when the pH is 7 in the solution, they are orange-red; when the pH exceeds 9, they are blue-purple. Epirubicin is an anthracycline antitumor antibiotic synthesized by the Italian scholar Arcamone in 1975 through a semi-synthetic route. The difference from doxorubicin is that the hydroxyl group at the 4′ position of the amino sugar part changes from cis to trans. However, the subtle changes in the three-dimensional structure lead to significantly reduced toxicity to the heart and bone mar...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/7048A61P35/00
Inventor 朱家壁葛亮
Owner CHINA PHARM UNIV
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