Injection alprostadil fat emulsion and preparing method thereof
A technology of dil fat and alprostadil, which is applied in the field of alprostadil fat emulsion freeze-dried preparations, can solve problems such as widening particle size distribution, and achieve the effects of improving stability, reducing potential safety hazards, and increasing operability
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Embodiment 1
[0048] prescription:
[0049]
[0050] Process:
[0051] (1) Preparation of the water phase: add sucrose and glycerin into water to dissolve, heat to 65°C, and set aside;
[0052] (2) Preparation of the oil phase: heat the refined soybean oil to 65°C, add phosphatidylcholine (PC-98T, Shanghai Everett) and egg yolk phosphatidylglycerol (EPG, Shanghai Everett) to dissolve, and add the Dil, stir to dissolve;
[0053] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum
[0054] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 6.9, and high-pressure homogenize 3 times with a microfluidizer at a pressure of 1000-1200 bar;
[0055] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;
[0056] (6) Sterile filtration: the emulsion obtain...
Embodiment 2
[0059] prescription:
[0060]
[0061] Process:
[0062] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;
[0063] (2) Preparation of the oil phase: heat the olive oil to 65°C, add phosphatidylcholine (PC-98T, Shanghai Aiweite) and egg yolk phosphatidylglycerol (EPG, Shanghai Aiweite) to dissolve respectively, add Qianliedi Er, stir to dissolve;
[0064] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum
[0065] (4) High-pressure homogenization: Adjust the pH of the colostrum in step (3) to 7.1, and then use a microfluidizer for high-pressure homogenization 3 times at a pressure of 1000-1200 bar:
[0066] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;
[0067] (6) Sterile filtration: the emulsion obtaine...
Embodiment 3
[0084] prescription:
[0085]
[0086]
[0087] Process:
[0088] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;
[0089] (2) Preparation of the oil phase: heat refined soybean oil to 65°C, add phosphatidylcholine (PC-98T) and egg yolk phosphatidylglycerol (EPG, Shanghai Everett) to dissolve, add alprostadil, and stir to make its dissolution;
[0090] (3) Preparation of colostrum: Add the oil phase of step (2) to the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum.
[0091] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 7.2, and high-pressure homogenize 3 times with a microfluidizer at a pressure of 1000-1200 bar;
[0092] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;
[0093] (6) Sterile filtration: the emulsion obtained in step (...
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