Levofloxacin hydrochloride injection and preparation method thereof
A technology of levofloxacin hydrochloride and injection, applied in the field of medicine, can solve the problems of metal loss, difficulty in guaranteeing production lines, improper sterilization temperature and method, etc., and achieve the effects of increasing content, improving efficiency, and solving the loss of metal elements
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[0031] The invention provides a preparation method of levofloxacin hydrochloride injection, and the specific preparation steps include:
[0032] S1. Take the full amount of 45-55% water for injection, add glycerin by 0.1-2.0% (v / v) of the full amount of volume, then add lipoic acid and / or edetate calcium sodium 0.05-0.15 parts by weight, and sodium sulfite 0.1-0.3 Parts by weight, after dissolving, add diatomaceous earth and / or pretreated activated carbon for needles according to the weight to volume ratio of 0.1-0.2% (g / mL), heat and boil for 5-10min, cool to 35-40°C, and filter with a titanium rod filter, and then add pretreated activated carbon for needles to the filtrate according to the weight-to-volume ratio of 0.02-0.04% (g / mL), stir, and filter with a titanium rod filter to obtain liquid A;
[0033] S2. Take the full amount of 40-45% water for injection, add 10-15 parts by weight of levofloxacin hydrochloride, after dissolving, add the pretreated active carbon for need...
Embodiment 1
[0047] A preparation method of levofloxacin hydrochloride injection, the specific preparation steps are as follows:
[0048]S1. Take the full amount of 50% water for injection, add glycerol with a volume of 1.0% (v / v) of the total volume, then add 0.1 parts by weight of lipoic acid, and 0.2 parts by weight of sodium sulfite, stir to dissolve, and then add the water according to the weight to volume ratio (g / mL) ) 0.15% of diatomite and pretreated activated carbon for needles (the weight ratio of diatomite to activated carbon is 2:1), heated and boiled for 8min, cooled to 35°C, filtered with a titanium rod filter, and then filtered according to weight volume Ratio (g / mL) 0.03% Add pretreated activated carbon for needles to the filtrate, stir at a speed of 60r / min for 10min, and filter with a titanium rod filter to obtain liquid A.
[0049] S2. Take the full amount of 40% water for injection, add 12 parts by weight of levofloxacin hydrochloride, add the pretreated active carbon ...
Embodiment 2
[0053] A preparation method of levofloxacin hydrochloride injection, the specific preparation steps are as follows:
[0054] S1. Get the full amount of 45% water for injection, add the glycerol whose volume accounts for 0.1% (v / v) of the total volume, then add 0.15 parts by weight of calcium sodium edetate, and 0.3 parts by weight of sodium sulfite, stir and dissolve, and then according to the weight to volume ratio ( g / mL) 0.2%, add diatomaceous earth, heat and boil for 10min, cool to 35°C, filter with a titanium rod filter, and then add pretreated activated carbon for needles to the filtrate according to the weight-to-volume ratio (g / mL) 0.04% , stirred at a rotational speed of 50r / min for 10min, and filtered through a titanium rod filter to obtain liquid A.
[0055] S2. Take the full amount of 45% water for injection, add 15 parts by weight of levofloxacin hydrochloride, after dissolving, add the pretreated activated carbon for needles according to the weight volume ratio (...
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