颈痹合剂的质量标准研究

Study on the Quality Standard for Jingbi Mixture

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＆#174;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 quality standard for Jingbi mixture. METHODS：TLC was adopted to identify the Notopterygii Rhizoma et Radix,Aucklandia lappa and Pueraria lobata and determine the relative density and p H according to pharmacopoeia method. HPLC was adopted to determine the content of puerarin. Column was XTerraRP18 with mobile phase of acetonitrile-0.05% phosphoric（10∶90,V/V）at flow rate of 1.0 ml/min,detection wavelength was 250 nm,column temperature was 25 ℃and volume injection was 10 μl. RESULTS：TLC of Notopterygii Rhizoma et Radix,A. lappa and P. lobata showed clear spots and good separation. The relative density was 1.08,and p H was 4.5. The linear range of puerarin was 2.079-33.26 μg/ml（r=0.999 8）;RSDs of precision,reproducibility and stability tests were lower than 1.0%;recovery was 99.50%-100.50%（RSD=0.42%,n=6）.CONCLUSION：The method is simple and good reproducibility,and can be used for the quality control of Jingbi mixture.