注射用银杏达莫的制备及稳定性

Study on the preparation and stability of ginkgo leaf extract and diphyridamole for injection

目的制备出稳定性良好的银杏达莫冻干针剂。方法通过药物的溶解情况筛选出增溶剂,结合制剂的色泽、外观和澄明度,选出支持剂。通过影响因素试验,加速试验和长期试验考察其稳定性。结果选用吐温–80为增溶剂,甘露醇为支持剂,注射用银杏达莫对光稳定性较差。结论本品制备方便,稳定性好。

Objective To prepare stable ginkgo leaf extract and diphyridamole for injection. Methods HPLC was used for the determination of the content of ginkgo flavonoides and diphyridamole, and the stability of drug exposure to heat and light was investigated; Results The photo-stability of ginkgo leaf extract and diphyridamole for injection was poor; Conclusions The technique of the preparation is feasible,the product has a good stability.