替硝唑葡萄糖注射液配制工艺的探讨

Studiy on the Preparation Condtions of Tinidazole Glucose Injection

目的:考察替硝唑葡萄糖注射液(200ml葡萄糖11g和替硝唑0.4g)在配制环节上的最佳条件及中间体pH值控制范围.方法:在三种不同配制条件下配制替硝唑葡萄糖注射液,并将pH值分别调至4.0、4.2、4.4、4.6、4.8,经灭菌冷却后分别测定成品的有关物质.结果:煮沸时间长短及pH值大小对替硝唑葡萄糖注射液成品有关物质有较大影响.结论:采用加完替硝唑后不再煮沸的配制方法,中间体pH值控制在4.0—4.2之间.

Objective： In order to find out the best condition, this experiment studied the technologic and pH of middle production for Tinidazole glucose injection（specification：Tinidazole 0.4g and llg in 200ml）.Methods： Use three methods to cotect tinidazole glucose injection and control it＇s pH at 4.0,4.2,4.4,4,6,4,8.After it＇s being heated to be sterilized, check the product＇s impurity.Results： The time of it＇s boiling and the pH are the important effects. Conclusion： Use the method of stopping boiling after adding tinidazole and the pH of intermediate product should be controled at 4.0-4.2.