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 circulation pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and continue to freeze when the product temperature reaches -30°C. When the temperature of the product reaches about -40°C, close the plate cooling valve, turn on the electric heating and the automatic setting of the cold mixing valve, keep the temperature of the product for 3 hours, then open the condenser valve, and turn on the vacuum when the temperature of the condenser valve reaches -45°C System, when the vacuum of the front box reaches below 20Pa, it starts to heat up and sublimate and dry, and the final drying temperature is 30°C, keep this temperature for 3 hours, until the vacuum of the front box is closed and the septum valve is not significantly damaged, press the plug, take out the box, and use aluminum The plastic combination cover is tied up, and after passing the quality inspection, it is packaged and ready to be obtained.

[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 pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and continue to freeze when the product temperature reaches -30°C. When the temperature of the product reaches about -40°C, close the plate cooling valve, turn on the electric heating and the automatic setting of the cold mixing valve, keep the temperature of the product for 2 hours, then open the condenser valve, and turn on the vacuum when the temperature of the condenser valve reaches -45°C System, when the vacuum of the front box reaches below 20Pa, it starts to heat up and sublimate and dry, and the final drying temperature is 30°C, keep this temperature for 4 hours, until the vacuum of the front box is closed and the septum valve is not significantly damaged, press the plug, take out the box, and use aluminum The plastic combination cover is tied up, and after passing the quality inspection, it is packaged and ready to be obtained.

[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 circulation pump, compressor and plate cooling valve, use heat transfer oil to lower the product temperature, and continue to freeze when the product temperature reaches -30°C. When the temperature of the product reaches about -40°C, close the plate cooling valve, turn on the electric heating and the automatic setting of the cold mixing valve, keep the temperature of the product for 4 hours, then open the condenser valve, and turn on the vacuum when the temperature of the condenser valve reaches -45°C System, when the vacuum of the front box reaches below 20Pa, it starts to heat up and sublimate and dry, and the final drying temperature is 30°C, keep this temperature for 4 hours, until the vacuum of the front box is closed and the septum valve is not significantly damaged, press the plug, take out the box, and use aluminum The plastic combination cover is tied up, and after passing the quality inspection, it is packaged and ready to be obtained.