三七总皂苷纳米乳的研制及质量评价

Preparation and evaluation of Panax Notoginseng Saponins （PNS） na- noemulsion

研制三七总皂苷纳米乳并对其进行质量评价。方法先观察不同油相与表面活性剂的溶解情况，再利用伪三元相图法研究不同的油相、助表面活性剂、Km值形成纳米乳的能力和区域，绘制不同处方的相图，在此基础上制备三七总皂苷纳米乳；并对纳米乳的物理性质、稳定性进行研究。结果以CAPRYOL90／蛋黄卵磷脂／TRANSCUTOLP／水形成了均匀稳定并且粒径呈正态分布的纳米乳系统，粒径在100nm以内．高速离心稳定，高温和强光条件下仍能维持透明、澄清的状态，稳定性良好。结论三七总皂苷纳米乳制备简单，质量稳定。

OBJECTIVE To study the preparation of PNS nanoemulsion and its quality evaluation. METHODS PNS nanoemlsion was prepared by using the titration methods to obtain the pseudo-ternary diagram. The effect of various elements on the formation of the nanoemulsion was investigated. Physico-chemical property and stability of PNS nanoemulsion were evaluated. RESULTS PNS nanoemulsion prepared with egg yolk lecithin/TRANSCUTOL P/Capryol 90/water, was uniform and stable colloidal system. The droplet size of PNS nanoemulsion was within 100nm and showed Gaussian distribution, and kept constant all in distilled water. The preliminary stability test showed that the drug content and droplet size of PNS nanoemulsion were stable at high temperature and 45001x condition for 10d and at ambient tempera- ture for 1 month. CONCLUSION The PNS nanoemulsion is easy to product and its quality is stable.