Preparation method of lyophilization sulbactam sodium material medicine

Abstract

The invention belongs to the field of medicine and chemical industry. The invention relates to a preparation method of a lyophilization sulbactam sodium material medicine, which comprises the following steps of: (1) adding sodium bicarbonate into sulbactam acid suspension to obtain a lyophilization sulbactam sodium material liquid medicine; (2) filtering the liquid medicine by utilizing a filter; (3) uniformly pouring the sterile liquid medicine into a material disk of a freeze drier, setting the temperature of a baffle plate to be -40 DEG C to -10 DEG C for freezing for 1-6h, then setting the temperature of the baffle plate to be -10 DEG C to 10 DEG for keeping for 1-10h, then setting the temperature of the baffle plate to be 10 DEG C to 20 DEG C for drying 1-20h, then setting the temperature of the baffle plate to be 20-50 DEG C for drying for 1-30h, finally setting the temperature of the baffle plate to be 50-65 DEG C for drying 1-20h; and (4) grinding and uniformly mixing the lyophilization powder prepared from the step (3) to obtain the lyophilization sulbactam sodium material medicine. The products prepared by the preparation method of a lyophilization sulbactam sodium material medicine has the advantages of good clarity index and high content; and bad factors of solvent residues, clarity foreign matters, turbidity and the like prepared by utilizing a solvent method can be avoided.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and relates to a preparation method of freeze-dried sulbactam sodium bulk drug. Background technique [0002] Sulbactam sodium is a β-lactamase inhibitor. It has a synergistic antibacterial effect when used in combination with penicillins and cephalosporins. It can make Staphylococcus aureus, influenza bacillus, The minimum inhibitory concentration (MIC) of Escherichia coli, Bacteroides fragilis, etc. fell within the sensitive range. [0003] The sulbactam sodium crude drug currently used mainly adopts the crystallization solvent method to produce, and its production method is: add sulbactam acid to dissolve in the reaction solvent (ethyl acetate, acetone, ethanol or methyl alcohol etc.), add active carbon decolorization, filter, A solution of sulbactamic acid was prepared. Add the calculated amount of sodium isooctanoate until the reaction solution is completely white, and stop st...

AI Technical Summary

Problems solved by technology

[0004] In the above method, due to differences in the polarity of different solvents, crystal solubility, etc., there are differences in the crystal nucleus formation rate and the relative size of the grain growth rate in the chemical crystallization process of sulbactam sodium, and the crystal state of the product has a large difference. Therefore, the crystalline forms of the finished products prepared by different solvents are different, and the shapes are similar to discs, cylinders, cones or sectors, needles, etc. Among them, cylinders, cones or sectors have better fluidity, and the other two types of crystal forms The material has poor fluidity, and it is easy to produce differences in loading when subpackaged; and the production of the crystallization solvent method will leave solvent residues, foreign matter, turbidity, etc., and it cannot be better than the domestic mass-produced freeze-dried raw materials due to different preparation processes Compatibility and mixed powder, poor uniformity and fluidity, poor matching of mixed varieties, unstable quality