Improved method for preparing liposome by using ammonium sulfate gradient method
An ammonium sulfate gradient method and liposome technology are applied in the directions of liposome delivery, medical preparations of inactive ingredients, pharmaceutical formulations, etc., and can solve the problems of high cost, need for ultrafiltration equipment, and difficult implementation, etc. Time saving, avoidance of liposome leakage, high encapsulation efficiency
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Embodiment 1
[0035] Weigh 8g of soybean lecithin, 0.8g of cholesterol, and 80mg of vitamin E, add 200ml of ethanol and sonicate until dissolved. Slowly inject 200ml of 0.6mol / L ammonium sulfate solution preheated to 60°C while stirring. Rotary steam at 60°C to remove ethanol until there is no smell of ethanol, add water to the volume of the original ammonium sulfate solution, and hydrate at 37°C for 30 minutes. High-pressure homogenization treatment, passing through a 0.22 μm microporous membrane for sizing. 200ml of water for injection was dissolved with 1.3g of disodium hydrogen phosphate. Dissolve 533 mg of mitoxantrone hydrochloride in 133 ml of water for injection, incubate at 37°C for 20 minutes, and pass through a 0.22 μm microporous membrane to obtain the finished product. Liposome particle size 110.3nm (see particle size distribution figure 1 ), the encapsulation efficiency is 99.3%.
Embodiment 2
[0037] Weigh 10 g of egg yolk phospholipid, 1 g of cholesterol, and 100 mg of vitamin E, add 200 ml of ethanol and sonicate until dissolved. Slowly inject 200ml of 0.7mol / L ammonium sulfate solution preheated to 60°C while stirring. Rotary steam at 60°C to remove ethanol until there is no smell of ethanol, add water to the volume of the original ammonium sulfate solution, and hydrate at 37°C for 30 minutes. High-pressure homogenization treatment, passing through a 0.22 μm microporous membrane for sizing. Add 200ml of water for injection and stir evenly. Dissolve 533 mg of mitoxantrone hydrochloride in 133 ml of water for injection, incubate at 37°C for 20 minutes, and pass through a 0.22 μm microporous membrane to obtain the finished product. The particle size of the liposome is 112.5nm, and the encapsulation efficiency is 99.0%.
Embodiment 3
[0039] Weigh 9 g of soybean lecithin, 1.8 g of cholesterol, and 80 mg of vitamin E, add 200 ml of ethanol and sonicate until dissolved. Slowly inject 200ml of 0.7mol / L ammonium sulfate solution preheated to 60°C while stirring. Rotary steam at 60°C to remove ethanol until there is no smell of ethanol, add water to the volume of the original ammonium sulfate solution, and hydrate at 37°C for 30 minutes. High-pressure homogenization treatment, passing through a 0.22 μm microporous membrane for sizing. Add 200 ml of water for injection with 26.7 g of trehalose dissolved therein. Dissolve 533 mg of mitoxantrone hydrochloride in 133 ml of water for injection, incubate at 50°C for 20 minutes, pass through a 0.22 μm microporous membrane, and freeze-dry to obtain the finished product. The particle size of the liposome is 105.0nm, and the encapsulation efficiency is 99.1%.
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