目的:建立颈痹合剂的质量标准。方法:采用薄层色谱(TLC)法对制剂中羌活、木香、葛根进行鉴别;根据药典方法测定相对密度与p H;采用高效液相色谱法测定制剂中葛根素含量。色谱柱为XTerra®RP18,流动相为乙腈-0.05%磷酸(10∶90,V/V),流速为1.0 ml/min,检测波长为250 nm,柱温为25℃,进样量为10μl。结果:羌活、木香、葛根的TLC图斑点清晰,分离度好。制剂相对密度为1.08,p H为4.5。葛根素检测质量浓度线性范围为2.079~33.26μg/ml(r=0.999 8);精密度、重复性、稳定性试验的RSD<1.0%;加样回收率为99.50%~100.50%(RSD=0.42%,n=6)。结论:该方法操作简便、重复性好,可用于颈痹合剂的质量控制。 Objective: To establish the quality standard of Jiebi Mixture. Methods: Thin-layer chromatography (TLC) was used to identify Notopterygii, woody and kudzu roots. The relative density and p H were determined according to the pharmacopoeia method. The content of puerarin in the preparations was determined by high performance liquid chromatography. The column was XTerra® RP18. The mobile phase was acetonitrile-0.05% phosphoric acid (10:90, V / V), the flow rate was 1.0 ml / min, the detection wavelength was 250 nm, the column temperature was 25 ℃ and the injection volume was 10μl. Results: Notopterygium, woody, puerarin TLC spots clear, good resolution. The relative density of the preparation was 1.08 and the p H was 4.5. The linear range of the mass concentration of puerarin was 2.079 ~ 33.26μg / ml (r = 0.999 8). The RSD of precision, repeatability and stability test was less than 1.0%, and the recoveries were between 99.50% and 100.50% (RSD = 0.42 %, n = 6). Conclusion: The method is simple, reproducible, and can be used for the quality control of Jiabi Mixture.