Tirofiban hydrochloride freeze-dried powder injecta and preparing method
A technology of tirofiban and needle injection, which is applied in the field of pharmaceutical preparations and its preparation, can solve the problems of solution-insoluble particles, inconvenient transportation, large volume, and heavy weight, and achieve easy storage and transportation, reduced transportation costs, and obvious economic benefits Effect
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Embodiment 1
[0023] prescription
[0024] Tirofiban Hydrochloride Monohydrate 5.62g
[0025] Lactose 200g
[0026]
[0027] Make 1000 pieces
[0028] Get the lactose of prescription quantity, add 1600ml water for injection, stir to dissolve, add 0.1% (g / ml) active carbon for needles, stir at 50 ℃ for 30 minutes, filter and decarbonize, add tirofiban hydrochloride of prescription quantity, stir Make it dissolve, add water for injection to 2000ml, adjust the pH value of the solution to 2.5 with hydrochloric acid or sodium hydroxide, filter aseptically with a 0.22 μm microporous membrane, measure the content of the semi-finished product, quantitatively fill it in a vial, half-tamp, and freeze Dry, aseptic full press stopper, press aluminum plastic cover, and pack it.
[0029] Inspection: 1. Visible foreign matter: According to the method of Appendix IX H of the 2005 edition of the Chinese Pharmacopoeia,...
Embodiment 2
[0032] prescription
[0033] Tirofiban Hydrochloride Monohydrate 5.62g
[0034] Lactose 75g
[0035]
[0036] Make 1000 pieces
[0037] Get the prescription amount of lactose, add 1200ml water for injection, stir to dissolve, add 0.01% (g / ml) active carbon for needles, stir for 60 minutes at 25°C, filter and decarbonize, add the prescription amount of tirofiban hydrochloride, stir Make it dissolve, add water for injection to 1500ml, adjust the pH value of the solution to 2 with hydrochloric acid, aseptic fine filter with a 0.22 μm microporous membrane, measure the content of the semi-finished product, quantitatively fill it in a vial, half stopper, freeze-dry, and aseptic Fully press the plug, press the aluminum-plastic cover, and pack it.
[0038] Inspection: 1. Visible foreign matter: According to the method of Appendix IX H of the 2005 edition of the Chinese Pharmacopoeia, it meets th...
Embodiment 3
[0041] prescription
[0042] Tirofiban Hydrochloride Monohydrate 5.62g
[0043] Lactose 800g
[0044]
[0045] Make 1000 pieces
[0046] Get the prescribed amount of lactose, add 3200ml of water for injection, stir to dissolve, add 0.5% (g / ml) active carbon for needles, stir for 10 minutes at 100°C, filter and decarbonize, add the prescribed amount of tirofiban hydrochloride, stir Make it dissolve, add water for injection to 4000ml, use sodium hydroxide to adjust the pH value of the solution to 3, 0.22 μm microporous filter membrane aseptic fine filtration, measure the content of semi-finished products, quantitatively fill in vials, half stopper, freeze-dry, Sterile fully pressed stopper, pressed aluminum-plastic cap, ready to pack.
[0047] Inspection: 1. Visible foreign matter: According to the method of Appendix IX H of the 2005 edition of the Chinese Pharmacopoeia, it meets the regulations.
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