CAJ | 학술논문

　　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。
　　목적：제비염산청등감순질체응효병건립기질량공제방법。방법：이주입법제비순질체，통과정교설계우선최가처방화공예；채용연화법제비순질체응효；고효액상색보법측정염산청등감적함량；투석법측정순질체적포봉솔。결과：소득제제위담황색투명응효，도전성호；순질체형태원정，립경소이균균，평균포봉솔위62.8%。염산청등감검측농도선성범위위5～80μg/mL (r=0.9999)，평균회수솔위98.5%。결론：본제제제비공예간단가행，중현성호，질량은정가공。
Objective To prepare sinomenine hydrochloride ethosomes gel and to establish its quality con-trol metrod. Methods The sinomenine hydrochloride ethosomes were prepared by injection method and the opti-mal formation and preparation were selected by means of Orthogonal experiment. The ethosomes gel was pre-pared using mixing method.The content of sinomenine hydrochloride was determined by the HPLC and the en-trapment of the ethosomes was measured by dialytic method. Results The preparation obtained was canary gel and good in spreading. The shape of the sinomenine hydrochloride ethosomes was spherical with average encap-sulation efficiency of 62.8%.The linear range of sinomenine hydrochloride was 5~80μg·mL-1 (r=0.9999) .The average recovery of sinomenine hydrochloride was 98.5%. Conclusion The preparation method was simple and reasonable and its quality is stable and controllable.