论文部分内容阅读
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。
Objective: To study the preparation method of Panax Notoginseng total saponin liposome gel and evaluate its quality. Methods: The liposomes were prepared by the method of membrane dispersion. The prescription of total saponin liposomes was optimized by orthogonal design. The entrapment efficiency of the liposomes was determined by high-speed centrifugation method. The best entrapment efficiency was obtained by using the entrapment efficiency as the evaluation index of liposomes. And further prepared into a gel, using high performance liquid chromatography determination of ginsenoside Rb3 content, and preliminary observation of its stability. Results: The prepared gels were translucent viscous colloids, which were in accordance with the relevant regulations of the 2010 edition of Chinese Pharmacopoeia. The stability was good and the skin irritation was small. Conclusion: The preparation process of the preparation is simple and feasible, the detection method is reliable, the quality is stable and controllable.