醒脑再造丸质量标准研究

Quality Standard of Xingnao Zaizao Pills

目的：建立醒脑再造丸（黄连、冰片、木香等）的质量标准。方法：采用TLC法鉴别处方中的黄连、冰片和木香；用HPLC—ELSD法测定黄芪中黄芪甲苷的含量，色谱柱PhenomenexGeminiC18（4．6mm×250mm，5μm），流动相：乙腈-水（36：64）；流速为1．0mL·min^-1；漂移管温度为105℃；载气流速：2．7L·min^-1。结果：TLC法鉴别色谱特征斑点明显，黄芪甲苷在0．486～2．43μg范围内呈线性关系，r=0．9997；平均回收率为101．7％（n=6），RSD=0．5％。结论：所建立的TLC和HPLC-ELSD方法操作简便，结果准确，重复性好，可用于醒脑再造丸的质量控制。

Objective： To establish a quality standard of Xingnao Zaizao Pills （ Rhizoma, eoptidis, Borneolum, synthetieum, Radix, auek- landae, etc. ）. Methods： Rhizoma coptidis, Borneolum syntheticum, and Radix aueklandae were identified by TLC. HPLC-ELSD Separa- tion was achieved on a Phenomenex Gemini CIS Column（4. 6 mm × 250 mm ,5 μm） and mobile phase composed of acetonitrile-water （36：64） ;Flow rate： 1. 0ml · min^-1 ;Drift tube temperature： 105℃ ;Gas flow rate：2.7 L · min^-1. Results： The developed TLC spots were quite clear. The calibration curve was linear in the range of 0. 486 - 2. 43 μg （ r = 0. 999 7 ） ; The average recovery rate was 101.7% （n = 6）, RSD was 0. 5%. Conclusion：The established TLC and HPLC-ELSD methods are simple, accurate and reproducible, thus can be useful in quality control of Xingnao Zaizao Pills.