Method for preparation of ceftriaxone sodium in vertical logistics system

Abstract

The invention relates to the pharmaceutical field, especially to production of bulk drugs by a solvent crystallization method, and also relates to an aseptic logistics method, and a method for preparation of ceftriaxone sodium in a vertical logistics system. The specific steps include: adding a ceftriaxone sodium crude product into an acetone solution, performing complete dissolution at 20-25DEG C, adding a seed crystal when the temperature drops to 15DEG C, and carrying out stirring until a large number of crystals precipitate; and conducting solid-liquid separation, and transferring the obtained solid from a separation device to a drying device. The separation device is positioned at the upper end, the drying device is located at the lower end, and the separation device and the drying device are in vertical connection through a connecting channel. With the method provided by the invention, the pollution problem caused by environmental exposure in a material transfer process is avoided, and the prepared bulk drug has a high aseptic level. In addition, the logistics system with gravity as the main driving force has the characteristics of high transport efficiency and low cost.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to the production of raw materials by solvent crystallization, and also to an aseptic logistics method. Background technique [0002] Ceftriaxone Sodium (Ceftriaxone Sodium) is a long-acting antibiotic among the third-generation cephalosporins. With the improvement of the status of ceftriaxone sodium in the domestic anti-infective drug market, higher requirements are put forward for its quality. The quality of the ceftriaxone sodium can be significantly improved by refining and separating the ceftriaxone sodium by adopting the dissolution and crystallization process. The raw materials of sterile ceftriaxone sodium usually go through processes such as dissolution, sterile filtration, crystallization, solid-liquid separation, drying, pulverization, and packaging. The traditional method adopts plane operation. Since the material obtained in the process of solid-liquid separation is powder, it...

AI Technical Summary

Problems solved by technology

The traditional method adopts plane operation. Since the material obtained in the process of solid-liquid separation is powder, it will inevitably be exposed to the air during the transfer process. Although 100-level laminar flow protection is used during the exposure process, due to the Manual operation is still required for remaining. In fact, exposed materials cannot be transferred in a dynamic A-level clean environment, and the level of sterility assurance is low.

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