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注射用头孢噻肟新剂型的初步研究
引用本文:张强,沈萍,刘英. 注射用头孢噻肟新剂型的初步研究[J]. 中国抗生素杂志, 1988, 0(2)
作者姓名:张强  沈萍  刘英
作者单位:四川抗菌素工业研究所 成都(张强,沈萍),四川抗菌素工业研究所 成都(刘英)
摘    要:
为克服头孢噻肟在制备钠盐过程中的收率损失和高分子致敏杂质的增加,本文研制了注射用头孢噻肟的新剂型。其基本原理是在头孢噻肟游离酸的无菌粉中加入有效的助溶剂(或成盐剂),在临用时再成盐溶解。本文对处方和制备工艺进行了筛选,考察了助溶剂对头孢噻肟质量的影响和各种因素对本剂型稳定性的影响,并通过专用计算机程序和PC-1500微机处理数据,用经典法和单测点法预测了本剂型的有效期。

关 键 词:头孢噻肟  助溶剂  比色测定法

PRIMARY INVESTIGATION ON THE NEW DOSAGE FORM OF CEFOTAXIME
Zhang Qiang,Shin Ping Liu Ying. PRIMARY INVESTIGATION ON THE NEW DOSAGE FORM OF CEFOTAXIME[J]. Chinese Journal of Antibiotics, 1988, 0(2)
Authors:Zhang Qiang  Shin Ping Liu Ying
Abstract:
A loss of yield (about 15~17%) and an increase of allerig polymer (about 100%) occnr when Cefotaxime (CTX) was converted into its sodium salt (CTX-Na) due to the long stay in the mother liquor. The study was carried out inorder to overcome these two problems, and a new dosage form-the sterile powderfor injection of CTX along with an efficient solubilizer, has been finally developed after a series of experiments, the influence of the solubilizer on the quality of CTX, and the various factors on the stability of this sterile powder had been investigated. The shelf life of this dosage form has been estimated by classic and single measurement method, while the parameters was treated with the PC-1500 computer.
Keywords:Cefotaxime  Solubilizer  Colormetric analysi s
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