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[摘要]
目的筛选丹参酮自乳化药物传递系统的处方,考察其稳定性。方法通过溶解度试验、乳化程度观察,乳化完全时间、乳滴粒径大小测定以及伪三相图绘制,确定丹参酮自乳化药物传递系统最佳处方,HPLC法测定处方中药物的量,光照、高温、低温条件下考察其稳定性。结果丹参酮自乳化药物传递系统最佳处方中的油相为油酸乙酯,乳化剂为TX10和聚山梨酯80,助乳化剂为异丙醇,四者比例为60:84:21:35。结论所得到的丹参酮自乳化药物传递系统处方在避光和常温下性质稳定。
[Key word]
[Abstract]
Objective To screen the formulation for tanshinone self-emulsifying drug delivery system (SEDDS) and evaluate its stability.Methods The optimal tanshinone SEDDS formulation was established through solubility experiment,emulsion examination,fully emulsified time,droplet size determination,and pseudo-ternary diagram drawing.The content and stability were evaluated by HPLC assay under the condition of illumination,high and low temperature.Results The oil phase,surfactant and co-surfactant in the optimal tanshinone SEDDS formulation were ethyl oleate,TX10,Tween 80,and isopropyl alcohol (60∶84∶21∶35).Conclusion The acquired formulation of tanshinone SEDDS is stable in the dark and room temperature.
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