| CPC A61K 9/19 (2013.01) [A61K 9/0019 (2013.01); A61K 31/5365 (2013.01)] | 6 Claims |
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1. A lyophilization method of latamoxef sodium for injection comprising:
step S1, preparing a lyophilized adjuvant by mixing ginkgolide, β-Glucosidase and mannitol, adding 3-5 times volume thereof water and stirring to obtain a mixture solution, and placing the mixture solution at −14 degrees Celsius (C) to 10° C. to obtain the lyophilized adjuvant,
wherein a stirring rate thereof is 600-1200 revolutions per minute (rpm) and a stirring time thereof is 60-150 seconds(s);
step S2, mixing 20-40 parts of latamoxef sodium, 8-15 parts of lyophilized adjuvant, 6-18 parts of excipient and 30-55 parts of water by an oscillator, to obtain a suspension;
step S3, primary drying by placing the suspension on a shelf, heating the suspension to −6-3° C., performing heat preservation on the suspension at −6-3° C. until ice crystals in the suspension completely disappear to obtain a primary dried mixture, and performing heat preservation on the primary dried mixture for 3-5 hours at −6-3° C. to obtain a secondary dried mixture; and
step S4, secondary drying by heating the secondary dried mixture to 12-15° C., performing heat preservation on the secondary dried mixture at 12-15° C. for 0.3-1.5 hours to obtain a tertiary dried mixture, then heating the tertiary dried mixture to 33-37° C., and performing heat preservation on the tertiary dried mixture at 33-37° C. for 3-5 hours to obtain a powder of the latamoxef sodium for injection.
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