Polyenic phosphatidylcholine powder injection and its preparing method
A technology of polyene phosphatidylcholine and powder injection, applied in the direction of active ingredients of phosphorus compounds, etc., can solve the problems of drugs with low side effects, and achieve a stable and feasible preparation process
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Embodiment 1
[0029] Weigh 50g of deoxycholic acid, add 1 / 5 of the water for injection, add 2mol / L NaOH while stirring to dissolve, then accurately weigh 77.5g of polyene phosphatidylcholine, 3ml of 0.1% sodium sulfite solution, add it to the above solution, stir to disperse it evenly, then adjust the pH value to 8.0±0.1 with 2mol / L hydrochloric acid, add the prescribed amount of dextran 20, nicotinamide, sodium pantothenate, add water for injection to the full amount, add Activated carbon coarse filtration to obtain the crude filtrate, and then add the prescribed amount of vitamin B 2 and vitamin B 12 The intermediate product is obtained, and the content of the intermediate product is determined. After passing the test, filter it with a 0.2um filter membrane, pack it into ampoules, 3ml / bottle, routinely freeze-dry, and pack it after passing the sampling inspection.
Embodiment 2
[0031] Weigh 140g of deoxycholic acid, add it to 4 / 5 water for injection, add 5mol / L NaOH to dissolve it while stirring, then accurately weigh 250g of polyene phosphatidylcholine, 5ml of 0.1% sodium sulfite solution , added to the above solution, stirred to disperse it evenly, then adjusted the pH value to 8.6±0.1 with 5mol / L hydrochloric acid, added the prescribed amount of mannitol, nicotinamide, sodium pantothenate, and water for injection to the full amount, and added activated carbon Coarse filtration to obtain the crude filtrate, then add the prescribed amount of vitamin B 2 and vitamin B 12 The intermediate product is obtained, and the content of the intermediate product is determined. After passing the test, filter it with a 0.25um filter membrane, pack it into ampoules, 3ml / bottle, routinely freeze-dry, and pack it after passing the sampling inspection.
Embodiment 3
[0033] Take by weighing 420g of deoxycholic acid, add in 4 / 5 water for injection, add 5mol / L NaOH while stirring to make it dissolve, then accurately weigh 697.5g of polyene phosphatidylcholine, 6ml of 0.1% Add the sodium bisulfate solution to the above solution, stir to disperse it evenly, then adjust the pH value to 9.0±0.1 with 4mol / L hydrochloric acid, add the prescribed amount of dextran 60, nicotinamide, and sodium pantothenate, and add water for injection to The full amount, add activated carbon to get the coarse filtrate, and then add the prescribed amount of vitamin B 2 and vitamin B 12 The intermediate product is obtained, and the content of the intermediate product is determined. After passing the test, filter it with a 045um filter membrane, pack it into ampoules, 3ml / bottle, routinely freeze-dry, and pack it after passing the sampling inspection.
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