保元抗癌口服液的质量标准研究

目的 提高并完善保元抗癌口服液的质量标准。方法 采用TLC对制剂中黄芪、西洋参、白花蛇舌草、半枝莲、白术进行定性鉴别；HPLC-ELSD测定制剂中黄芪甲苷含量，采用WondaSil C₁₈色谱柱（250 mm×4.6 mm，5 μm），流动相为乙腈-水（32：68），柱温35℃，进样体积20 μL，洗脱时间60 min；蒸发光散色检测器，漂移管温度70℃，氮气流速为1.5 L·min^-1。结果 黄芪、西洋参、白花蛇舌草、半枝莲、白术的TLC斑点清晰，分离良好，专属性强，阴性无干扰；黄芪甲苷检测浓度在139.01~1 112.12 μg·mL^-1与峰面积呈良好线性关系（r=0.998 5）；精密度、重复性、稳定性试验的RSD均符合要求，平均回收率为101.5%（RSD=3.4%，n=9）。结论 建立的质量标准方法准确、简便、专属性强，灵敏度高，可以更好地控制保元抗癌口服液的质量。

Study on the Quality Standard of Baoyuan Anticancer Oral Liquid

OBJECTIVE To improve the quality standard of Baoyuan anticancer oral liquid. METHODS TLC was used to identify Astragali Radix, Panacis Quinquefolii Radix, Hedyotidis Herba, Scutellariae Barbatae Herba and Atractylodis Macrocephalae Rhizoma and the content of Astragaloside IV was determined by HPLC-ELSD. The WondaSil C₁₈ chromatographic column(250 mm×4.6 mm, 5 μm) was adopted. The mobile phase was consisted of acetonitrile and water with a ratio of 32:48. The column temperature was 35℃ and injection volume was 20 μL. The elution time was 60 min. Evaporative light dispersion detector was adopted with drift tube temperature being 70℃ and nitrogen flow rate being 1.5 L·min^-1. RESULTS The TLC spots of Astragali Radix, Panacis Quinquefolii Radix, Hedyotidis Herba, Scutellariae Barbatae Herba and Atractylodis Macrocephalae Rhizoma were all clear with good separation, strong specificity and no interference with the negative sample. The detection concentration of Astragaloside IV has a good linear relationship in the range of 139.01-1 112.12 μg·mL^-1 with of peak area(r=0.998 5). The RSD of precision, repeatability and stability tests all met the requirements and the average recovery rate was 101.5%(RSD=3.4%, n=9). CONCLUSION The established quality standard method is accurate, simple, specific, and sensitive, and can better control the quality of Baoyuan anticancer oral liquid.