氟康唑氯化钠注射液生产工艺研究

Study on the preparation of Fluconazole Sodium Chloride Injection

目的 通过研究不同 pH值、加活性炭量、灭菌温度对氟康唑含量影响,得出最佳的生产工艺条件。方法 紫外吸收检测波长 2 6 1nm。结果 通过此工艺生产的氟康唑质量稳定。结论: 通过试验得出的生产工艺条件为:pH值 6 0～ 7 5加炭量以所配置量的 0 0 2 5 %,灭菌温度为 110℃。

Objective The optimum technical conditions have been studied by the test of different pH values, active carbon percentages and sterilizing temperature, which affect the content of Fluconazole. Methods UV spectrophotography was used and the detective wave-length was 261nm. Results The quality of Fluconazole is stable. Conclusion The optimum technical conditions were as the following: the range of pH value is 6.0～7.5, the active carbon percentage is 0.025%of the volume, the sterilizing temperature is 110℃.