豨红通络口服液质量标准的研究

Study on Quality Standard of Xihong Tongluo Oral Liquids

目的:建立豨红通络口服液的质量标准。方法:采用TLC法鉴别处方中的豨莶草和川牛膝;采用HPLC法测定豨莶草中奇壬醇的含量,色谱柱为Luna C18(4.6 mm×250 mm,5μm);流动相为乙腈-水(24∶76);检测波长215 nm;柱温30℃;流量0.8 mL.min-1。结果:TLC法鉴别色谱特征斑点明显,含量测定方法奇壬醇进样量在0.214 8～2.148 0μg范围内呈良好的线性关系(r=0.999 9),平均回收率为100.1%,RSD=0.74%(n=6)。结论:所建立的TLC和HPLC方法操作简便,结果准确,重复性好,可作为该制剂的质量控制方法。

Objective： To establish a quality control method of Xihong Tongluo Oral Liquids. Methods： Siegesbeckiae Herba and Cyathulae Radix were identified by TLC. The content of Kirenol was determined by HPLC. HPLC separation was achieved on a Luna Cls Column （4. 6 mm × 250 mm, 5 μm） and mobile phase composed of acetonitrile-water （24： 76） ; UV-detection wavelength was set at 215 nm; column temperature was 30 ℃ ; flow rate was 0. 8 mL . min^-1. Results：The developed TLC spots were quite clear. The calibration curve was linear in the range of 0. 214 ±2. 148 0 μg（r =0. 999 9）. The average recovery rate was 100. 1% （n =6） with RSD was 0. 74%. Conclusion：The established TLC and HPLC methods are simple, accurate and reproducible, and can be used for quality control of Xihong Tongluo Oral Liquid.