目的:制备盐酸青藤碱醇质体凝胶并建立其质量控制方法。方法:以注入法制备醇质体,通过正交设计优选最佳处方和工艺;采用研和法制备醇质体凝胶;高效液相色谱法测定盐酸青藤碱的含量;透析法测定醇质体的包封率。结果:所得制剂为淡黄色透明凝胶,涂展性好;醇质体形态圆整,粒径小而均匀,平均包封率为62.8%。盐酸青藤碱检测浓度线性范围为5～80μg/mL(r=0.9999),平均回收率为98.5%。结论:本制剂制备工艺简单可行,重现性好,质量稳定可控。 Objective: To prepare sinomenine hydrochloride gel and to establish its quality control method. Methods: Ethosomes were prepared by injection method, and the optimal prescription and process were optimized by orthogonal design. The ethosomes gel was prepared by the method of research and method. The content of sinomenine hydrochloride was determined by high performance liquid chromatography. Body encapsulation efficiency. Results: The obtained preparation was a light yellow transparent gel with good spreadability. The morphology of the ethosomes was round and the particle size was small and uniform. The average entrapment efficiency was 62.8%. The linear range of sinomenine hydrochloride was 5 ~ 80μg / mL (r = 0.9999), the average recovery was 98.5%. Conclusion: The preparation process is simple and feasible, reproducible, stable and controllable quality.