Study On The Technology Of Dexamethasone Sodium Phosphate Aseptic Powder

Aseptic powder, also known as powder injection, the powdery materials is mixed with drug and the adjuvant,handled with sterilizing and drying.Its characteristic is stable and convenient for transportation and preservation.Dexamethasone sodium phosphate is a kind of Corticosteroids, has a very important position in clinical practice,has the characteristics of high curative effect, small side effect, wide clinical use etc..Dexamethasone sodium phosphate injection of traditional production process is not stable, in a period of time it will be precipitation separation and degradation,and the production technology requirements change too sharply after the promulgation of Chinese Pharmacopoeia 2010 edition,the impurity of the products can not meet the requirements. In addition, packing conditions injection itself also brings hidden trouble for drug transport and storage.This paper focus on the dexamethasone sodium phosphate Aseptic powder’s Prescription screening,production technology scheme,prescription preparation engineering design and equipment selection,were investigated and the verificated on the quality stability of products of the new process, forming a set of dexamethasone sodium phosphate injection production.The research on the technology of information and literature, study the feasibility and the formulation of new dosage forms of powder for injection sterile powder preparation method of dexamethasone sodium phosphate, determine the initial preparation of dexamethasone sodium phosphate injection prescription, consider two aspects the quality stability and preparation production process based on process, determined the suitable solutions and ratio, established a quality related requirements and standards, design the process of the whole product, and the equipment design and selection of the production line are according to the scale of production and pharmaceutical production management requirements.This paper also designed the experimental group after the process scheme, and established in the production line,the quality and stability of product are verified experimentally. The results show that the experimental verification of this paper and dexamethasone sodium phosphate injection production process based on this determination is effective and feasible...