Alprostadil medium-and-long-chain lipid emulsion for injection and preparation method thereof
An alprostadil and fat emulsion technology, applied in the field of biomedicine, can solve the problems of hypertriglyceridemia, increased liver load, poor solubility of long-chain triglycerides, etc. irritating effect
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Embodiment 1
[0022] This embodiment is the preparation experiment of alprostadil medium and long-chain fat emulsion, prepared according to the following implementation scheme:
[0023] In the sterile room, accurately weigh 0.4g of glycerol (glycerol), stir and dissolve in 50mL of water for injection as the water phase; weigh 2g of medium-chain triglycerides (purchased from Guangzhou Erlong Jingcheng Trading Co., Ltd. , containing 8 to 10 carbon atoms) heated to 40°C to completely dissolve, add 0.002g alprostadil, dissolve, add 0.4g egg yolk lecithin and 0.02g oleic acid, stir to dissolve, finally add 2g long-chain triglycerides (Soybean oil) was used as the oil phase after stirring; the obtained oil phase was added to the water phase using a peristaltic pump (control speed was 5mL / min), high-speed shearing, the speed was 5000 rpm, and the time was 20 minutes to obtain the initial Milk; add 0.1M sodium hydroxide solution to adjust the pH of the colostrum to 7.0; repeat the homogenization of...
Embodiment 2
[0025] This example is an experiment on the preparation of alprostadil medium and long-chain fat emulsion, and the influence of different phospholipids on the preparation process of the emulsion is investigated. Prepare according to the following scheme:
[0026] In a sterile room, accurately weigh 0.4g of glycerol (glycerol), stir and dissolve in 50mL of water for injection as the water phase; weigh 2g of medium-chain triglycerides, mix and heat to 50°C for complete dissolution, then add 0.002g Alprostadil, dissolve, add 0.4g soybean lecithin and 0.02g oleic acid, stir to dissolve, finally add 2g long-chain triglyceride (soybean oil), stir and use it as the oil phase; use a peristaltic pump to add the obtained oil phase to the water phase Medium (control speed is 10mL / min), high-speed shearing, rotating speed is 8000 rpm, time is 20 minutes, to obtain colostrum; add 0.1M sodium hydroxide solution to adjust the pH of colostrum to 7.5; The milk is repeatedly homogenized in the...
Embodiment 3
[0028] This example is an experiment on the preparation of alprostadil medium- and long-chain fat emulsions, investigating the influence of the addition order of medium-chain and long-chain triglycerides on the preparation process, and preparing according to the following implementation scheme:
[0029] In a sterile room, accurately weigh 0.4g of glycerol (glycerin), stir and dissolve in 50mL of water for injection as the water phase; weigh 2g of long-chain triglycerides, mix and heat to 40°C for complete dissolution, then add 0.002g Alprostadil, dissolve, add 0.4g egg yolk lecithin and 0.02g oleic acid, stir to dissolve, finally add 2g medium-chain triglyceride (soybean oil), stir and use it as the oil phase; use a peristaltic pump to add the obtained oil phase to the water In phase (control speed is 10mL / min), high speed shearing, rotating speed is 6000 rev / min, time is 30 minutes, obtains colostrum; Add 0.1M sodium hydroxide solution to adjust the pH of colostrum to be 8.5; T...
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