Tacrolimus ophthalmic emulsion and its preparation method
A technology of tacrolimus and emulsion, applied in the field of tacrolimus ophthalmic emulsion and its preparation, can solve problems such as toxic and side effects of human body, and achieve good biocompatibility, good repeatability, good social and economic benefits. Effect
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[0020] The preparation method of the tacrolimus ophthalmic emulsion of the present invention: it is prepared by ultrasonic shearing emulsification or shearing high-pressure homogenization process, and its operation steps are: (1) Weigh the oil phase and antioxidant and stir evenly, and use it as a solution① ;
[0021] (2) Add emulsifier and auxiliary emulsifier into the solution ①, heat to 70°C, stir until the emulsifier and auxiliary emulsifier are completely dissolved, add tacrolimus, continue heating and stirring until tacrolimus is completely dissolved, as Solution ②;
[0022] (3) Add the osmotic pressure regulator and preservative into water, heat to 70°C, stir, and make a solution ③;
[0023] (4) Slowly drip the solution ② into the solution ③ under magnetic stirring, then stir for 5-10 minutes after the dripping, transfer to a high-shear dispersing emulsifier, 10000r·min -1 High-speed dispersion to form colostrum;
[0024] (5) The colostrum is then ultrasonically shea...
Embodiment 1
[0030] Preparation Process:
[0031] Weigh castor oil, MCT, and vitamin E and stir evenly to make solution ①. Add the prescribed amount of egg yolk lecithin (S100) into ①, heat to 70°C, stir until the egg yolk lecithin is completely dissolved, then add tacrolimus, continue heating and stirring until tacrolimus is completely dissolved, and make solution ②. Add glycerin and benzalkonium bromide into an appropriate amount of water and heat to 70°C to form a solution ③. Slowly drop the solution ② into the solution ③ under magnetic stirring, then stir for 5 minutes after the dripping, transfer to a high-shear dispersing emulsifier, 10000r·min -1 Disperses at high speed to form colostrum. The colostrum was homogenized by ultrasonic shearing for 10 minutes to obtain the final milk. Dilute with water for injection and dilute to the prescribed volume, with 0.1mol L -1 Sodium hydroxide is used to adjust the pH value to 7.0-8.0. Filter the prepared emulsion with a 220-mesh si...
Embodiment 2
[0034] Preparation Process:
[0035] Weigh olive oil and vitamin E and stir well to make solution ①. Add the prescribed amount of soybean lecithin into ①, heat to 70°C, stir until the soybean lecithin is completely dissolved, then add tacrolimus, continue heating and stirring until the tacrolimus is completely dissolved, and make solution ②. Add glycerin and phenylmercury acetate into an appropriate amount of water, heat to 70°C, and make a solution ③. Slowly drop the solution ② into the solution ③ under magnetic stirring, then stir for 5 minutes after the dripping, transfer to a high-shear dispersing emulsifier, 10000r·min -1Disperses at high speed to form colostrum. The colostrum is then homogenized by a high-pressure homogenizer to obtain the final milk. Dilute with water for injection to the prescribed volume, and adjust the pH value to 8.0-8.5 with phosphate buffer. Filter the prepared emulsion with a 220-mesh sieve cloth, fill it with nitrogen, sterilize it, a...
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