Paclitaxel liposome and preparation method therefor

[0027] Example 1

[0028] prescription:

[0029] Paclitaxel 0.4g

[0030] Soybean Phospholipid for Injection 20.0g

[0031] Cholesterol 2.4g

[0032] Excipient D 5.0g

[0033] Octadecylamine 0.1g

[0034] Vitamin E 0.2g

[0035] Buffered salt solution to 200mL

[0036] Preparation Process:

[0037]Dissolve the prescription amount of paclitaxel, soy phospholipid for injection, cholesterol, excipient D, vitamin E in an organic solvent and pour it into a pear-shaped bottle, then add a small amount of buffer salt solution containing stearylamine, ultrasonically make a uniform milk, rotary evaporator The organic solvent was removed under reduced pressure to form a gel, and the white uniform liposome solution was obtained by vortexing and distilling under reduced pressure at intervals, and then the volume was adjusted to 200 mL with a buffer solution. Then press the membrane (0.22μm) to remove the pyrogens, and then distribute them into vials for freeze-drying to obtain paclitaxel thermose

[0038] Example 2

[0039] prescription:

[0040] Paclitaxel 0.4g

[0041] Soybean Phospholipid for Injection 20.0g

[0042] Cholesterol 2.4g

[0043] Excipient D 5.0g

[0044] Octadecylamine 0.1g

[0045] Vitamin E 0.2g

[0046] Buffered salt solution to 200mL

[0047] Preparation Process:

[0048] Dissolve the prescription amount of paclitaxel, soy phospholipid for injection, cholesterol, excipient D, vitamin E in an organic solvent and pour it into a pear-shaped bottle, then add a small amount of buffer salt solution containing stearylamine, ultrasonically make a uniform milk, rotary evaporator The organic solvent was removed under reduced pressure to form a gel, and the white uniform liposome solution was obtained by vortexing and distilling under reduced pressure at intervals, and then the volume was adjusted to 200 mL with a buffer solution. Then the pyrogen is removed by pressing the membrane (0.22μm), and then dispensed into ampoules and frozen at room temperature. Repeated 3

[0049] Example 3

[0050] prescription:

[0051] Paclitaxel 0.4g

[0052] Soybean Phospholipid for Injection 20.0g

[0053] Cholesterol 2.4g

[0054] Excipient D 5.0g

[0055] Sucrose 5.0g

[0056] Mannitol 0.1g

[0057] Octadecylamine 0.1g

[0058] Vitamin E 0.2g

[0059] Buffered salt solution to 200mL

[0060] Preparation Process:

[0061] Dissolve the prescribed amount of paclitaxel, soybean phospholipids for injection, cholesterol, excipient D, and vitamin E in organic solvents and pour them into a pear-shaped bottle. Rotate and evaporate the organic solvent under the conditions of a water bath at 60°C and 30 revolutions per second. A dry film is formed on the wall. Dissolve the prescription amount of sucrose and mannitol in 200 mL of buffered salt solution, pour it into a pear-shaped bottle at 40 revolutions per second, and rotate at room temperature (25°C) to hydrate until the dryness on the bottle wall is removed. Until the membrane is completely eluted, the resulting crude s