希明妥颗粒剂的定性鉴别与含量测定

Identification and content determination of Ximingtuo granules

目的建立希明妥颗粒剂的定性鉴别及含量测定的方法。方法采用TLC法鉴别处方中的半枝莲、灵芝及紫草;以半枝莲中野黄芩苷为指标成分,采用HPLC法测定含量;采用Agilent Zorbax SB-C_(18)色谱柱(250 mm×4.6 mm,5μm),甲醇-水-乙酸(35∶61∶4)为流动相,流速1.0 m L·min^(-1),检测波长335 nm,柱温30℃。结果三味药材的斑点清晰,Rf值适中;采用50%甲醇为提取溶剂,超声处理30 min,可实现最佳的提取率;0.916~9.16μg野黄芩苷与峰面积的线性关系良好(r=0.9994),平均回收率为95.05%(RSD=1.83%)。结论所用方法简便可行,可用于希明妥颗粒剂的质量控制。

OBJECTIVE To establish methods for the qualitative identification and content determination of Ximingtuo granules （XG）. METHODS TLC methods were applied to identify Sculellaria barbara,Lucid ganoderma and Lithospermium erythrorhizon. The HPLC method was used to determine scutellarin of S. barbata. HPLC was performed on a Agilent Zorbax SB - Cls （250 mm x4.6mm, 5 μm） with methanol- water- acetic acid（35 ： 61 ： 4 ）as the mobile phase under the detection wavelength of 335 rim. The flow rate was 1.0 mL. min -1. The column temperature was 30 ℃. RESULTS Spots in the chromatogram were clear and the values of Rf were moderate. 50% methanol was chosen as the extraction solvent and 30 min of ultrasonic time gave the best extraction efficiency. The line- ar range of scutellarin was 0.916 - 9.16 μg（ r = 0. 9994 ） and the mean recovery was 95.05 % with the RSD of 1.83 % （ n = 9 ）. CON= CLUSION The methods established for the identification and determination of XG are feasible and can be used to control the quality.