银杏达莫氯化钠注射液制备工艺研究

Preparation process of ginkgo leaf extract and diphyridamole sodium chloride injection

目的确定银杏达莫氯化钠注射液制备工艺。方法对抗氧剂及用量进行选择,对中间体pH控制范围、活性碳对主药是否吸附、灭菌温度等进行了工艺研究。结果选择抗坏血酸作抗氧剂、中间体pH控制(4.0±0.2)、灭菌温度115℃30 min成品的外观色泽、含量及有关物质无明显影响。结论本制备工艺质量稳定可控,为大生产提供可行工艺。

Aim To determine The preparation process technology of ginkgo leaf extract and diphyridamole sodium chloride injection. Methods The study process was to choose an optimal anti-oxidant agent,intermediate pH, sterilization for the formulation, and to determine if activated carbon absorbs the active ingredient. Results This study demonstrated that ascorbic acid,intermediate pH 4.0 ± 0.2, sterilization at 115 ℃ for 30 min were the best choices for the formulation. Conclusion The preparation process was clear, colorless and stable.