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 recog

Method used

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  • Stable elaioplast composition
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Examples

Experimental program
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Effect test

Example Embodiment

[0055] Example 1 Preparation of paclitaxel liposomes

[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] Cane sugar 15g

[0063] Water for injection 120ml

[0064] Weigh paclitaxel, hydrogenated soybean lecithin, cholesterol, sodium cholesteryl sulfate, and vitamin E in the prescribed amounts, add 100 ml of absolute ethanol, dissolve, and dry the solvent with a rotary evaporator in the presence of nitrogen to prepare a film and place a vacuum. Place in a desiccator overnight to remove residual solvent. Add sucrose solution dissolved in water for injection, 55°C water bath, magnetic stirring for 1 hour, ultrasonically dispersed, homogenized with a high pressure homogenizer, sterile filtered with a 0.22 micron PVDF membrane, divided into vials, and freeze-dried. Pour the vial with nitrogen and seal it with a cap.

[0065] According to t...

Example Embodiment

[0067] Example 2 Preparation of 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] 150ml water for injection

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

[0077] Measured by the same method as in Example 1, the average particle size of the sample before freeze-drying was 164.6 nm...

Example Embodiment

[0078] Example 3 Preparation of 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] Cane sugar 25g

[0086] 150ml water for injection

[0087] Weigh the recipe amounts of paclitaxel, hydrogenated soybean lecithin, cholesterol, sodium cholesterol sulfate, vitamin E, add 100 ml of absolute ethanol, dissolve, prepare a film with a rotary evaporator, and place it in a vacuum desiccator overnight to remove residual solvent. Add sucrose solution dissolved in water for injection, water bath at 60°C, magnetic stirring for 1 hour, ultrasonically disperse, homogenize with high pressure homogenizer, extrude with 0.2 micron polycarbonate membrane, sterile filter with 0.22 micron PVDF membrane, and divide into Vials, freeze-dried, and capped.

[0088] Measured by the same method as in Example 1, the average particle size of the...

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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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