Clevidipine butyrate fat emulsion injection and preparation process thereof
The invention relates to a technology of clevidipine butyrate and a preparation process, which is applied in the field of pharmaceutical preparations, and can solve the problems of re-precipitation and enlargement of drugs, affecting the lipid metabolism of patients, etc., and achieve the effects of reducing toxic and side effects and ensuring safety.
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Embodiment 1
[0028] Under the protection of nitrogen, weigh 250g of soybean oil for injection and 250g of medium-chain triglycerides, mix well, heat to 80°C, add 30g of refined egg yolk lecithin, 2.5g of clevidipine butyrate, stir at high speed until completely dissolved, As the oil phase, keep it warm at 70°C; add 250g of xylitol for injection into 2500mL of water for injection, mix well, adjust the pH value to 8.5 with 1mol / L sodium hydroxide solution, and filter through a 0.22μm filter membrane as Water phase, heated and kept at 70°C; under high-speed shearing and stirring, slowly add the oil phase to the water phase, and continue high-speed shearing and stirring to make colostrum, add water for injection to 5L; Homogenize the milk under 600bar pressure until the droplet size is 50-500nm; adjust the pH value to 8.0, filter through 1μm, fill it into a 50mL glass infusion bottle, fill it with nitrogen, plug it, press the cap, and put it in a rotary water bath sterilizer Sterilize in mediu...
Embodiment 2
[0031] Under the protection of nitrogen, weigh 250g of soybean oil for injection and 250g of medium-chain triglycerides, mix well, heat to 75°C, add 30g of refined egg yolk lecithin, 5.0g of clevidipine butyrate, stir at high speed until completely dissolved, As the oil phase, keep it warm at 60°C; add 125g of glycerin for injection into 3000mL of water for injection, mix well, adjust the pH value to 10.0 with 1mol / L sodium hydroxide solution, and filter through a 0.22μm filter membrane as the water phase , heated and kept at 60°C; under high-speed shearing and stirring, slowly add the oil phase to the water phase, and continue high-speed shearing and stirring to make colostrum, add water for injection to 5L; Homogenize the milk until the droplet size is 50-500nm; adjust the pH value to 8.5, filter through 1μm, fill into a 100mL glass infusion bottle, fill with nitrogen, stopper, press the cap, and sterilize in a rotary water bath sterilizer Bacteria, after cooling promptly ob...
Embodiment 3
[0034]Under the protection of nitrogen, weigh 125g of soybean oil for injection and 125g of medium-chain triglycerides, mix well, heat to 65°C, add 15g of refined egg yolk lecithin, 2.5g of clevidipine butyrate, stir at high speed until completely dissolved, As the oil phase, keep it warm at 65°C; add 100g of glycerin for injection and 50g of xylitol into 3500mL of water for injection, mix well, adjust the pH value to 9.5 with 1mol / L sodium hydroxide solution, pass through a 0.22μm filter membrane Filtrate as the water phase, heat and keep it at 65°C; slowly add the oil phase to the water phase under high-speed shearing and stirring, and continue high-speed shearing and stirring to make colostrum, add water for injection to 5L; Under the pressure of 80MPa, homogenize the emulsion until the particle size of the emulsion is 50-500nm; adjust the pH value to 9.0, filter through 1μm, fill it into a 100mL glass infusion bottle, fill it with nitrogen, plug it, press the cap, and put i...
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