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Stable elaioplast composition

A liposome composition and liposome technology are applied in the direction of liposome delivery, drug combination, medical preparations of non-active ingredients, etc., which can solve the problems of not always being reliable, so as to improve tolerance and avoid Hypersensitivity, stable quality effect

Active Publication Date: 2007-07-25
SHANGHAI ALLIST PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Various factors in vivo affect pH, but as those skilled in the art recognize, controlling drug release based on in vivo pH is not always reliable

Method used

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  • Stable elaioplast composition
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The preparation of embodiment 1 paclitaxel liposome

[0056] prescription:

[0057] Paclitaxel 0.37g

[0058] Hydrogenated Soy Lecithin 4g

[0059] Cholesterol 1g

[0060] Sodium Cholesterol Sulfate 0.05g

[0061] Vitamin E 0.055g

[0062] Sucrose 15g

[0063] Water for injection 120ml

[0064] Weigh the prescribed amount of paclitaxel, hydrogenated soybean lecithin, cholesterol, sodium cholesteryl sulfate, vitamin E and add 100ml of absolute ethanol, after dissolving, dry the solvent with a rotary evaporator in the presence of nitrogen, prepare a film, and put it in a vacuum Place in a desiccator overnight to remove residual solvent. Add sucrose solution dissolved in water for injection, 55°C water bath, magnetically stir for 1 hour, ultrasonically disperse, homogenize with a high-pressure homogenizer, filter aseptically with a 0.22-micron PVDF membrane, divide into vials, and freeze-dry. Ventilate the vial with nitrogen, and seal it with a gland.

[0065] Acc...

Embodiment 2

[0067] The preparation of embodiment 2 paclitaxel liposomes

[0068] prescription:

[0069] Paclitaxel 0.09g

[0070] Hydrogenated Soy Lecithin 4g

[0071] Cholesterol 0.4g

[0072] Potassium Cholesterol Sulfate 0.006g

[0073] Vitamin E 0.012g

[0074] Lactose 10g

[0075] Water for injection 150ml

[0076] Respectively weigh paclitaxel, hydrogenated soybean lecithin, cholesterol, potassium cholesteryl sulfate, vitamin E and add 100ml of absolute ethanol to dissolve, prepare a film with a rotary evaporator, and place it in a vacuum desiccator overnight to remove the residual solvent. Add sucrose solution dissolved in water for injection, 58 ° C water bath, magnetic stirring for 1 hour, ultrasonic dispersion, sequentially use 0.8, 0.4, 0.2 micron polycarbonate film, extrude with extruder under high pressure, divide into vials, freeze dry , gland seal.

[0077] Measured in the same manner as in Example 1, the average particle diameter of the sample before freeze-drying ...

Embodiment 3

[0078] The preparation of embodiment 3 paclitaxel liposomes

[0079] prescription:

[0080] Paclitaxel 0.18g

[0081] Hydrogenated Soy Lecithin 4g

[0082] Cholesterol 0.9g

[0083] Sodium Cholesterol Sulfate 0.13g

[0084]Vitamin E 0.04g

[0085] Sucrose 25g

[0086] Water for injection 150ml

[0087] Weigh paclitaxel, hydrogenated soybean lecithin, cholesterol, sodium cholesteryl sulfate, vitamin E and add 100ml of absolute ethanol respectively, after dissolving, prepare a film with a rotary evaporator, place it in a vacuum desiccator overnight, and remove the residual solvent. Add sucrose solution dissolved in water for injection, 60°C water bath, magnetically stir for 1 hour, ultrasonically disperse, homogenize with a high-pressure homogenizer, extrude with a 0.2-micron polycarbonate membrane, filter aseptically with a 0.22-micron PVDF membrane, and dispense into Vials, freeze-dried, sealed with a gland.

[0088] Measured in the same manner as in Example 1, the ave...

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Abstract

A stable liposome composition used as the carrier of anticancer taxol is prepared from saturated hydrogenated phosphate, cholesterol, sodium (or potassium) cholesterol sulfate and cane sugar through thin-film evaporating-freeze-drying process.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable liposome composition, the application and preparation method of the liposome composition in encapsulating paclitaxel, and the use of the paclitaxel liposome. Background technique [0002] The anticancer drug paclitaxel is a natural product extracted from the bark of Taxus brevifolia Nutt. It is used to treat ovarian cancer, breast cancer and non-small cell lung cancer. However, because of its extremely low solubility in water, it is only soluble in organic solvents such as methanol, ethanol, and dimethyl sulfoxide, which brings great difficulties to the intravenous administration of paclitaxel. One of the known methods to solve its solubility is to adopt surfactant polyoxyethylene castor oil and ethanol as solvent to dissolve paclitaxel, as the paclitaxel injection (U.S. Bristol-Myers Squibb) approved by the U.S. Food and Drug Administration (FDA) i...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K47/28A61K31/337A61P35/00A61P15/00A61P15/14A61P11/00
CPCA61K9/1277A61K31/337A61K9/19A61P11/00A61P15/00A61P15/14A61P35/00
Inventor 潘弘刘善奎郭建辉
Owner SHANGHAI ALLIST PHARM CO LTD
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