三七叶总皂苷脂质体凝胶剂的研制与质量评价

目的：研究三七叶总皂苷脂质体凝胶剂的制备方法,并进行质量评价。方法：以薄膜分散法制备脂质体,通过正交试验设计优化三七叶总皂苷脂质体的处方。采用高速离心法测定其包封率,以包封率的高低做为脂质体优劣的评价指标,筛选出制备脂质体的最佳工艺。并进一步制备成凝胶,采用高效液相色谱法测定其中人参皂苷Rb3的含量,并初步观察其稳定性。结果：所制凝胶剂为半透明粘稠状胶体,考察符合《中国药典》2010年版的相关规定,稳定性良好,皮肤刺激性小。结论：本制剂制备工艺简单可行,检测方法可靠,质量稳定可控。

Preparation and Quality Evaluation of Total Leaves Saponins of Panax Notoginseng Liposomal Gels

ABSTRACT Objective: To study the preparation of total leaves saponins of panax notoginseng liposomal gels and evaluate the quality. Methods: The total leaves saponins of panax notoginseng liposomes were prepared by the film-dispersion method, and the formula was optimized by the orthogonal experimental design. A high-speed centrifugation method was applied to determine the encapsulation efficiency used as the evaluation index for the optimization of the preparation process. Then the gels were prepared and an HPLC method was used to determine the content of ginsenoside Rb₃. The stability was preliminarily studied as well. Results: The preparation was semi solid, and viscous gels with low skin irritation and good stability. The quality was accordance with the relevant provisions in Chinese Pharmacopoeia (2010 edition). Conclusion:The gels are with the properties of simple preparation process, reliable detection methods and stable and controllable quality.