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目的制备离子敏感型三七总皂苷(PNS)鼻用原位凝胶。方法以去乙酰结冷胶为材料,采用旋转黏度计测定溶液-凝胶相转变特性筛选处方;采用HPLC法测定PNS中人参皂苷Rg1,并以不同动物模型对制剂进行安全性评价。结果离子敏感型原位凝胶的黏度随着去乙酰结冷胶质量分数的增加而上升,加入模拟鼻液后形成具有一定强度的凝胶。该制剂的pH值为6.0～6.5,人参皂苷Rg1在0.2～50μg/mL线性关系良好(r=0.999 5),平均回收率为101.72%,RSD为1.74%。本制剂能延长药物与鼻黏膜的接触时间。结论该制剂制备工艺简便,性质稳定,安全无明显刺激性,在PNS鼻腔给药方面表现出良好的发展潜力。
Objective To prepare the nasal in situ gel for ion-sensitive Panax notoginseng saponins (PNS). Methods The dextran gellan gum was used as the material and the solution-gel phase transition characteristics were determined by rotary viscometer. The prescription of ginsenoside Rg1 in PNS was determined by HPLC, and the safety of the formulation was evaluated by different animal models. Results The viscosity of ion-sensitive in situ gels increased with the increase of the mass fraction of deacetyl gellan gum, and the gels formed a certain strength after adding simulated nasal fluid. The pH value of the preparation was 6.0-6.5. The ginsenoside Rg1 showed good linearity (r = 0.999 5) at 0.2-50μg / mL. The average recovery was 101.72% and the RSD was 1.74%. The preparation can prolong the contact time between medicine and nasal mucosa. Conclusion The preparation of the preparation is simple, stable in nature and safe without obvious irritation. It shows good potential in nasal delivery of PNS.