Preparation method for pazufloxacin mesilate for injection

Abstract

The invention provides a preparation method for pazufloxacin mesilate for injection. The preparation method comprises the following steps of: preparing the pazufloxacin mesilate and mannitol according to a prescription, and regulating pH values to be 3.0-4.0; adding a proper amount of needle active carbon, heating the mixture to be 70-80 DEG C, and carrying out decoloring after stirring for 15-20 minutes; putting an encapsulated semi-finished product into a freezing vacuum drier, controlling the temperature to be below -30 DEG C and carrying out prefreezing for 1-1.5 hours; when the temperature of a cold trap of the drier is lower than -40 DEG C, vacuumizing until the pressure is 20 Pa, and carrying out constant-temperature drying for 0.5-1 hour; raising the temperature of a separation board of the drier to be -10 DEG C, carrying out the constant-temperature drying for 0.5-1 hour; and raising the temperature of the separation board to be 0 DEG C, carrying out the constant-temperature drying until the waterline of the product reaches the bottom, raising the temperature to be 10 DEG C in a temperature manner, after carrying out the constant-temperature drying until the temperature of the product approximates to 0 DEG C, raising the temperature of the separation board to be 35 DEG C, and judging that the product is qualified after carrying out the constant-temperature drying until reaching the end point. The preparation method has the advantages that the production cost is lowered and the product quality is improved and is more suitable for industrial production.

Description

technical field The invention belongs to the technical field of chemical pharmacy and relates to a preparation method of pazufloxacin mesylate for injection. Background technique Pazufloxacin mesylate is the fourth-generation quinolone antibacterial drug, widely used in respiratory tract infection, genitourinary system infection, surgical infection, etc. Clinical studies of pazufloxacin mesylate have shown that its curative effect is superior to that of levofloxacin, ofloxacin and ciprofloxacin currently on the domestic market. Compared with the quinolone antibacterial drugs commonly used in domestic clinical practice, the drug resistance and safety are improved, and the clinical application prospect is very broad. The chemical structure of Pazufloxacin Mesilate for Injection is as follows: . The sterile freeze-dried powder of pazufloxacin mesylate for injection is not easily oxidized and is good for long-term storage, and has been widely used in practice. At present...

AI Technical Summary

Problems solved by technology

At present, in the production process of pazufloxacin mesylate for injection, the sublimation time of the freeze-drying process is too long and the cost is wasted too much

Images