Lansoprazole for injection
A technology for lansoprazole and injection, applied in the field of pharmaceutical preparations
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[0030] Preparation:
[0031] The preparation method of mannitol is:
[0032] 1) Non-filtration: Roose a messenger film production was filtered with a nanofiltration membrane to collect the nanofiltration membrane.
[0033] 2) Decolorizing, concentrated: Putting step 1) The obtained nanofiltration membrane clutter is discharged into activated carbon, and the solution is concentrated under vacuum to concentrate.
[0034] 3) Crystallization: The concentrate obtained from which step 2) obtained was concentrated, stirred, centrifuged, washing crystals, and natural mannitol crude.
[0035] 4) Recrystallization: The natural mannitol obtained by step 3) was heated with a low alcohol solution, recrystallized, centrifuged, dried, and natural mannitol boutique.
Example Embodiment
[0036] Example 1:
[0037] 1) Welney liquid
[0038] Weigh 10 parts by weight of Lan Solarazole, 40 parts by weight of mannitol, 5 parts by weight of sodium hydroxide, spare; 90% injection water (temperature: 30 ° C or less) in the liquid solution tank ), First adding the above known amount of mannitol, sodium hydroxide, stirring to dissolve; then add Lamovazole raw material, slowly stirring the sodium hydroxide solution to make the liquid The pH is maintained at 11.7 or more, and the drug solution is completely dissolved into a compound, and then the water is completed to a full amount, stir mix; the control fluid pH is between 10.8 to 11.5 (3 mg / ml of dilution after dilution 3 mg / ml) After 0.45 μM sterilization, the epiton was sampled, and after passing the intermediate detection, after passing, the liquid liquid was moved to the filling machine 100-level lamination under 0.22 μm secondary terminal sterilization to the chemical liquid bucket, for supply Filling.
[0039] 2) ...
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