银杏叶提取物氯化钠注射液处方工艺研究

Research on Formulation Process of Ginkgo biloba Extract Sodium Chloride Injection

目的:对银杏叶提取物氯化钠注射液处方进行工艺研究。方法:分析比较银杏叶提取物与市售GBE注射液(金纳多、悦康)的HPLC指纹图谱,以银杏黄酮、萜内酯含量来监控GBE原料及其氯化钠注射液质量。结果:确定处方工艺为GBE用95%乙醇:聚乙二醇400:注射用水(1:1:100)溶解,pH调节至5.0左右,定容分装后于115℃灭菌30分钟。结论:该制剂处方工艺合理可行,初步稳定性良好。

Objective: To research on formulation process of Ginkgo biloba extract sodium chloride injection. Methods: HPLC fingerprints of Ginkgo biloba leaf extract and commercial GBE injection (Ginaton and Yuekang) were analyzed and compared, and the quality of GBE raw material and sodium chloride injection was monitored by the contents of Ginkgo biloba flavonoid and terpene lactone. Results: The formula was determined as follows: GBE was dissolved with 95% ethanol:polyethylene glycol 400:water for injection (1:1:100), pH was adjusted to 5.0, and sterilization was performed at 115˚C for 30 min after packaging at constant volume. Conclusion: The formulation process of this prepara-tion is reasonable and feasible, and its initial stability is good.