Gemcitabine hydrochloride lyophilized powder injection

[0019] Example 1:

[0020] prescription

[0021] Gemcitabine Hydrochloride 228g

[0022] Mannitol 228g

[0023] Sodium acetate 22.8g

[0024] Add water for injection to 6000ml

[0025]

[0026] A total of 1000 bottles were made

[0027] Weigh mannitol and sodium acetate, add 80% water for injection, dissolve and stir evenly, then add gemcitabine hydrochloride, dissolve and stir evenly, adjust pH to 2.7 with 0.1mol / L hydrochloric acid or 0.1mol / L sodium hydroxide solution, After passing the intermediate inspection, add water for injection to make up to full volume. The solution was sent to the sterile room by a peristaltic pump, filtered through a 0.22 μm microporous membrane until it was clear, filled in 25 ml vials with a volume of 6 ml per bottle, partially plugged with butyl rubber stoppers, and placed in a plate. Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circula

[0028] Example 2:

[0029] prescription

[0030] Gemcitabine Hydrochloride 228g

[0031] Mannitol 114g

[0032] Sodium acetate 11.4g

[0033] Add water for injection to 6000ml

[0034]

[0035] A total of 1000 bottles were made

[0036] Weigh mannitol and sodium acetate, add 80% water for injection, dissolve and stir evenly, then add gemcitabine hydrochloride, dissolve and stir evenly, adjust pH to 3.3 with 0.1mol / L hydrochloric acid or 0.1mol / L sodium hydroxide solution, After passing the intermediate inspection, add water for injection to make up to full volume. The solution was sent to the sterile room by a peristaltic pump, filtered through a 0.22 μm microporous membrane until it was clear, filled in 25 ml vials with a volume of 6 ml per bottle, partially plugged with butyl rubber stoppers, and placed in a plate. Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circulation pu

[0037] Example 3:

[0038] prescription

[0039] Gemcitabine Hydrochloride 228g

[0040] Mannitol 1140g

[0041] Sodium acetate 11.4g

[0042] Add water for injection to 6000ml

[0043]

[0044] A total of 1000 bottles were made

[0045]Weigh mannitol and sodium acetate, add 80% water for injection, dissolve and stir evenly, then add gemcitabine hydrochloride, dissolve and stir evenly, adjust pH to 3.0 with 0.1mol / L hydrochloric acid or 0.1mol / L sodium hydroxide solution, After passing the intermediate inspection, add water for injection to make up to full volume. The solution was sent to the sterile room by a peristaltic pump, filtered through a 0.22 μm microporous membrane until it was clear, filled in 25 ml vials with a volume of 6 ml per bottle, partially plugged with butyl rubber stoppers, and placed in a plate. Put the sample to be freeze-dried in the freeze-drying box, close the box door, turn on the machine, turn on the circulati