洽克库特颗粒的质量标准

目的: 建立洽克库特颗粒的质量标准. 方法: 采用薄层色谱法(TLC)定性鉴别洽克库特颗粒中的王不留行及关黄柏;采用高效液相色谱法测定制剂中王不留行黄酮苷、盐酸小檗碱、盐酸巴马汀及甘草酸的含量. 结果: 王不留行、关黄柏的TLC图谱斑点清晰、重复性好、专属性强、方法简便,阴性对照均无干扰.王不留行黄酮苷在7.204 0~108.059 3 mg·L^-1(r=0.999 5)与峰面积呈良好的线性关系,平均加样回收率为98.95%,RSD 2.2%;盐酸小檗碱在20.432 7~408.654 4 mg·L^-1 (r=0.999 6)与峰面积呈良好的线性关系,平均加样回收率为101.83%,RSD 1.6%;盐酸巴马汀在12.109 1~242.182 1 mg·L^-1(r=0.999 5)与峰面积呈良好的线性关系,平均加样回收率为98.24%,RSD 1.1%;甘草酸铵进样浓度在0.061 08~0.407 2 g·L^-1 (r=0.999 5)与峰面积呈良好的线性关系,平均加样回收率为100.10%,RSD 0.8%;4个指标测定的精密度、重复性、稳定性、中间精密度试验RSD均<2%. 结论: 所建标准可用于洽克库特颗粒的质量控制.

Quality Standards of Qiakekute Granules

Objective: The study aimed to establish the quality standards of Qiakekute granular. Method: Phellodendri Amurensis Cortex and Vaccariae Semen were identified by TLC. The contents of vaccarin, berberine hydro-chlorid, palmatine hydrochloride and ammonium glycyrrhizinate were determined by HPLC. Result: The TLC spots were clear and specific in good repeatability without inference from negative sample. The linear range of vaccarin was 7.204 0-108.059 3 mg·L^-1(r=0.999 5) with an average recovery of 98.95%(RSD 2.2%). The linear range of berberine hydrochloride was 20.432 7-408.654 4 mg·L^-1(r=0.999 6) with an average recovery of 101.83% (RSD 1.6%). The linear range of palmatine hydrochloride was 12.109 1-242.182 1 mg·L^-1(r=0.999 5) with an average recovery of 98.24% (RSD 1.1%). The linear range of ammonium glycyrrhizinate was 0.061 08-0.407 2 g·L^-1(r=0.999 5) with an average recovery of 100.10% (RSD 0.8%). The RSDs of precision, stability and reproducibility tests were all lower than 2%. Conclusion: The standard established in this study can be used for the quality control of Qiakekute granular.