治糜灵栓质量标准研究

Study on Quality Standard for Zhimiling Suppository

目的建立和完善治糜灵栓质量标准。方法采用理化方法鉴别了方中冰片、儿茶、枯矾;采用高效液相色谱法测定了方中盐酸小檗碱的含量。结果盐酸小檗碱线性范围为0.0802～0.802μg,r=0.9999(n=5),平均加样回收率为100.4%,RSD为0.85%,n=6。结论本方法简便、快速、准确,可作为该制剂的质量控制标准。

Objective To establish the quality standard of Zhimiling Suppository （Cortex Phellodendri, Radix Sophorae Flavescenfis, Catechu, Borneolum Syntheficum, Alumen）. Methods Catechu, Bomeolum Syntheficum, Alumen in the preparation were identified by physics and chemstry method. Berberine Hydrochloride was determined by HPLC. Results The standard curve for Berberine Hydrochloride was linear in the range of 0.080 2-0.802μg, the average recovery was 100.4%, RSD was 0.85% （n=6）. Conclusion The methods are simple, accurate and reproducible.