Medicament composition and preparation method thereof
A composition and drug technology, applied in the field of medicine, can solve problems such as easy oxidation, patient pain, poor compliance of muscle agglomeration, difficulty in controlling the particle size of emulsion, etc.
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Embodiment 1
[0039] Example 1 Preparation of Cycloartenol Ferulate and 24-Methylene Cycloartenol Ferulate Complex
[0040] 1. Take 1 kg of commercially available oryzanol raw material (purity is 70%), reflux and dissolve with 5 times the mixed solution of ethyl acetate and absolute ethanol with a ratio of 20:1, filter, let stand, filter the precipitated crystals, and dry. The dried crystals (purity about 84%) were reconstituted with 8 times the amount of ethyl acetate, filtered, and allowed to stand, and the precipitated crystals were filtered and dried. The above recrystallization steps were repeated 3-5 times.
[0041] 2. Combine and recover the mother liquor filtered out after recrystallization in step 1 until the volume is 2 times that of the contained solute, then let it stand, filter and dry the precipitated crystals.
[0042] 3. The crystals (purity is about 85-87%) in step 2 are dissolved with 8 times the amount of ethyl acetate under reflux, filtered, left standing, and the preci...
Embodiment 2
[0049] Complex 10mg
[0050] Soy Lecithin 50mg
[0051] Hyodeoxycholic Acid 50mg
[0052] Mannitol 80mg
[0053] Water for injection to 10ml
[0054] Dissolve the complex, soybean lecithin, and hyodeoxycholic acid in 3ml of ethyl acetate, heat to 80°C and stir until fully dissolved. Distilled by evaporation under reduced pressure to obtain an organic phase. Add water for injection in which mannitol has been dissolved to the full amount into the above organic phase, and stir well at 60°C to obtain the composition injection of the present invention. Adjust the pH to 7.3 with sodium hydroxide solution, add 0.05% activated carbon for injection and stir for 30 minutes, after decarburization and filtration, perform fine filtration with a 0.22um microporous filter membrane, and pack into vials.
Embodiment 3
[0056] Complex 40mg
[0057] Soy Lecithin 200mg
[0058] Chenodeoxycholic Acid 300mg
[0059] Glycine 100mg
[0060] Water for injection to 10ml
[0061]Dissolve the complex, chenodeoxycholic acid, and soybean lecithin in 5ml of propylene glycol, heat to 80°C and stir until fully dissolved. Distilled by evaporation under reduced pressure to obtain an organic phase. Add water for injection in which glycine has been dissolved to the full amount into the above organic phase, and stir thoroughly at 70°C to obtain the composition injection of the present invention. Adjust the pH to 9.0 with sodium hydroxide solution, add 0.05% activated carbon for injection and stir for 30 minutes, after decarburization and filtration, perform fine filtration with a 0.22um microporous filter membrane, and pack into vials.
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