Supersaturated self-microemulsion as well as preparation method and application thereof
An emulsion preparation and a selected technology are applied in the field of supersaturated self-microemulsion preparations and their preparation, which can solve the problems of affecting clinical effect, low bioavailability, difficulty in indirubin and the like, and achieve simple preparation process, convenient administration and cost. low effect
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Embodiment 1
[0034] prescription composition
[0035] Indirubin: 15mg
[0036] Glyceryl monolinoleate (Maisine 35-1): 7.46g
[0037] Polyoxyethylene castor oil (Cremophor EL): 19.9g
[0038] Monoethyl ether oxalate (Transcutol P): 22.38g
[0039] Polyvinylpyrrolidone K17 (PVP K17): 0.245g
[0040] Make 100 indirubin supersaturated self-microemulsion soft capsules.
[0041] Preparation process: Weigh the oil phase glycerol monolinoleate of the prescription amount, the surfactant polyoxyethylene castor oil and the co-surfactant monoethyl ether oxalate and mix evenly, add the prescription amount of indirubin and the prescription amount of PVPK17 , Stir at 10°C to 25°C for 30 minutes to 3 hours, until the drug is completely dissolved, and then made into soft capsules.
Embodiment 2
[0043] prescription composition
[0044] Indirubin: 25mg
[0045] Glyceryl monolinoleate (Maisine 35-1): 10g
[0046] Polyoxyethylene castor oil (Cremophor EL): 18.48g
[0047] Monoethyl ether oxalate (Transcutol P): 20g
[0048] Hydroxypropylmethylcellulose (HPMC): 1.5g
[0049] Make 100 indirubin supersaturated self-microemulsion capsules.
[0050] Preparation process: Weigh the oil phase glycerol monolinoleate of the prescription amount, the surfactant polyoxyethylene castor oil and the co-surfactant monoethyl ether oxalate and mix evenly, add the prescription amount of indirubin and the prescription amount of HPMC , Stir at 10°C to 25°C for 30 minutes to 3 hours, until the drug is completely dissolved, and then made into capsules.
Embodiment 3
[0052] prescription composition
[0053] Indirubin: 5mg
[0054] Glyceryl monolinoleate (Maisine 35-1): 5g
[0055] Polyoxyethylene castor oil (Cremophor EL): 22.5g
[0056] Monoethyl ether oxalate (Transcutol P): 21.995g
[0057] Polyethylene glycol 4000 (PEG4000): 0.5g
[0058] Made indirubin supersaturated self-microemulsion oral liquid.
[0059] Preparation process: Weigh the oil phase glycerol monolinoleate in the prescription amount, the surfactant polyoxyethylene castor oil and the co-surfactant monoethyl ether oxalate and mix evenly, add the prescription amount of indirubin and the prescription amount of PEG4000 , Stir at 10°C to 25°C for 30 minutes to 3 hours, until the drug is completely dissolved, and then made into an oral liquid.
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