替硝唑葡萄糖注射液制备工艺研究

目的：探讨替硝唑葡萄糖注射液制备过程中相关因素对其质量的影响，以确定其最佳生产工艺。方法对pH值、药用炭加入量、配制时间、灭菌温度等因素进行考察，检查有关物质变化情况。结果根据实验考察数据，得出生产替硝唑葡萄糖注射液的最佳生产工艺条件为：控制配制pH值在4.0~4.5，药用炭使用量定为0.01%，放置时间不超过10 h。结论优化后的替硝唑葡萄糖注射液生产工艺可行，质量可控，适用于工业化大生产。

Study of preparation technology of tinidazole glucose injection

Objective To explore the influence of pH value, preparation time,added amount of activated carbon, the sterilization temperature and other factors in the production of tinidazole glucose injection on its quality ,so as to determine the op-timum production technology. Methods The pH value,added amount of activated carbon,preparation time,sterilization temper-ature and other factors were investigated to inspect the changes of quality. Results Based on the experimental data,the optimum production technology of tinidazole glucose injection：the pH value was 4.0-4.5,the usage amount of activated carbon was 0.01%and the storage time should not exceed 10 h. Conclusion The optimized production technology of tinidazole glucose injection is feasible with controllable quality,it is suitable for industrial production.