Vertical logistics based method for sterile preparation of N-(2)-L-alanyl-L-glutamine

Abstract

The invention relates to the pharmaceutical field, especially to production of bulk drugs by a solvent crystallization method and to a sterile logistics method, particularly a vertical logistics based method for sterile preparation of N-(2)-L-alanyl-L-glutamine. According to the traditional solvent crystallization method, a N-(2)-L-alanyl-L-glutamine reaction solution is concentrated and is adjusted to a pH value of 5-6.5, desalination treatment is performed, then solid-liquid separation is conducted, and the separated solid is transferred by action of gravity. Environmental exposure caused pollution problems are avoided during material transfer. The prepared bulk drug has a high sterile 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] Alanyl dipeptide, name: N-(2)-L-alanyl-L-glutamine, is an amino acid parenteral nutrition agent, which plays an important role for patients in critical moments of life. According to data, timely supplementation of alanyl dipeptide can significantly shorten the life expectancy of patients. Hospitalization and recovery time have both medical and economic implications. The particularity of its medicinal value of glucodipeptide, just like normal saline and glucose, will become a necessity for rescuing patients. [0003] In the solvent crystallization method, the production of sterile triglutide dipeptide raw materials usually goes through processes such as dissolution, sterile filtration, crystallization, solid-liquid separation, drying, crushing, and packaging. ...

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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