Injection containing anti-infective, and its preparation method
An injection and anti-infection technology, which is applied in the field of pharmaceutical preparations and preparation, and achieves the effects of simple production process design, low production cost, and satisfying clinical application requirements.
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Embodiment 1
[0046] Add 10g of drug I to 1L of 0.9% sodium chloride solution at 15-20°C, add 28.8ml of 3% hydrochloric acid, and dissolve drug I completely under stirring, then add 1% sodium hydroxide solution dropwise to adjust the pH of the solution to 4.6 , then add 0.3g activated carbon for needles, stir for 10 minutes, filter for decarburization; filter with a 0.45μm filter membrane, then filter with a 0.22μm filter membrane, add 0.9% sodium chloride solution to a total of 10L, and the measured content is 99.3 %, check the clarity, fill it into a 100ml infusion bottle after passing the test, cork the aluminum cap, and sterilize at 121°C for 20min. The specification of the prepared injection: 100mg / 100ml.
[0047] Note: Drug I is 6-fluoro-1-methyl-4-oxo-7-(1-piperazinyl)-4H-[1,3]thiazine[3,2-a]quinoline-3- carboxylic acid.
Embodiment 2
[0049] Add 20g of drug I to 3L of 5% glucose solution at 10-15°C, add 34.5ml of 5% hydrochloric acid, and dissolve drug I completely under stirring, then add 1% sodium hydroxide dropwise to adjust the pH of the solution to 4.5, add 0.5g of activated carbon for needles, stirred for 10 minutes, decarburized by filtration; filtered through a 0.45μm filter membrane, then filtered through a 0.22μm filter membrane, added 5% glucose solution to a total of 10L, the measured content was 99.1%, checked for clarity, and filled Put it into a 100ml infusion bottle, cork the rolled aluminum cap, and sterilize at 121°C for 20 minutes. The prepared injection specification: 200mg / 100ml.
Embodiment 3
[0051] Add 10 g of drug I to 500 ml of water for injection at 15 to 20 ° C, add 28.8 ml of 3% hydrochloric acid, stir to completely dissolve drug I, then add 2% sodium hydroxide dropwise to adjust the pH of the solution to 4.3, add 0.5 g Activated carbon for needles, stirred for 10 minutes, decarburized by filtration; filtered with 0.45 μm filter membrane, then filtered with 0.22 μm filter membrane, added water for injection to a total of 1000ml, the measured content was 99.4%, checked for clarity, filled with nitrogen for potting Put it into a 10ml ampoule bottle and sterilize at 121°C for 20min. The prepared injection specification: 100mg / 10ml.
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