苍柏祛痛胶囊的质量标准研究

Study on the Quality Standard for Cangbai Qutong Capsule

目的：建立苍柏祛痛胶囊的质量标准.方法：采用薄层色谱（TLC）法对制剂中苍术、细辛、赤芍和黄柏进行鉴别;采用反相高效液相色谱（RP-HPLC）法测定制剂中盐酸小檗碱的含量.色谱柱为Waters Symmetry-C18,流动相为乙腈-0.1%磷酸（梯度洗脱）,流速为1.0 ml/min,检测波长为265 nm,柱温为30℃,进样量为10μl.结果：苍术、细辛、赤芍和黄柏的TLC图斑点清晰,分离良好.盐酸小檗碱检测质量浓度线性范围为21.12～84.48 μg/ml（r=0.999 6）;精密度、稳定性、重复性的RSD〈3%;加样回收率为96.439%～100.950%,RSD为1.34%（n=9）.结论：该方法操作简便、重复性好,可用于苍柏祛痛胶囊的质量标准评价.

OBJECTIVE：To establish the quality standard for Cangbai qutong capsule. METHODS：TLC was conducted to iden-tify the Rhizoma atractylodis,Asarum sieboldii,Paeoniae Radix Rubra and Cortex phellodendri;RP-HPLC was conducted to deter-mine the content of berberine hydrochloride. The column was Waters Symmetry-C18 with mobile phase of acetonitrile-0.1% phos-phoric acid （gradient elution） at flow rate of 1.0 ml/min,the detection wavelength was 265 nm,column temperature was 30 ℃, and the injection volume was 10 μl. RESULTS：TLC showed R. atractylodis,A. sieboldii,Paeoniae Radix Rubra and C. phelloden-dri had clear spots and good separation. The linear range of berberine hydrochloride was 21.12-84.48 μg/ml（r=0.999 6）;RSDs of pre-cision,stability and reproducibility tests were lower than 3%;recovery was 96.439%-100.950%（RSD=1.34%,n=9）. CONCLU-SIONS：The method is simple and reproducible,and can be used for the quality standards of Cangbai qutong capsule.