苦黄消痣洗剂质量标准研究  

Quality Standard of Kuhuang Xiaozhi Lotion

作　　者：刘信秋 周萌萌 刘旭东 刘溪清 李思光 袁如柏 李小伟 LIU Xinqiu;ZHOU Mengmeng;LIU Xudong;LIU Xiqing;LI Siguang;YUAN Rubai;LI Xiaowei(Bozhou Hospital of Traditional Chinese Medicine,Anhui Bozhou 236800;Mengcheng County Hospital of Chinese Medicine,Anhui Bozhou 233500,China)

机构地区：[1]亳州市中医院,安徽亳州236800 [2]蒙城县中医院,安徽亳州233500

出　　处：《广州化工》2025年第3期68-70,78,共4页GuangZhou Chemical Industry

基　　金：“2020年安徽省中药特色人才培养项目”(皖卫中医药发[2020]1号);亳州市科技重大专项(项目编号:BZZD2021003)。

摘　　要：建立苦黄消痣洗剂的质量控制标准。采用薄层鉴别法对制剂中苦参、防风、甘草进行定性鉴别;采用高效液相色谱法对制剂中盐酸小檗碱进行含量测定,流动相为乙腈-0.6%磷酸(20∶80),流速1.0 mL/min,检测波长265 nm,柱温30℃,进样量5μL。在薄层鉴别中,苦参、防风、甘草的斑点清晰、分离度好、阴性对照无干扰,可纳入质量标准;在含量测定中,盐酸小檗碱质量浓度在5.1196~102.3928μg/mL范围内与峰面积呈良好的线性关系(R^(2)=1,n=5),精密度、稳定性、重复性试验结果的RSD值均小于0.50%,平均回收率99.22%,RSD=0.90%(n=6)。该方法操作简便、专属性强、稳定性及重复性良好,可作为苦黄消痣洗剂质量控制标准。Quality control standards for Kuhuang Xiaozhi Lotion was established.Thin-layer chromatography(TLC)was used to identify of Sophora flavescens,Saposhnikoviae radix and Radix grycyrrhizae in the preparation.The content of berberine hydrochloride in the preparation was determined by high-performance liquid chromatography.The mobile phase was acetonitrile-0.6%phosphoric acid solution(20∶80),the flow rate was 1.0 mL/min,and the detection wavelength was 265 nm.The column temperature was 30℃,and the injection volume was 5μL.Thin layer identification of Sophora flavescens,Saposhnikoviae radix and Radix grycyrrhizae had clear spots,good separation,and no interference from negative controls.The linear range of berberine hydrochloride was 5.1196~102.3928μg/mL(R^(2)=1,n=5).The RSD values of precision,stability and repeatability test results were all less than 0.50%.The average recovery rate was 99.22%,RSD=0.90%(n=6).This method is easy to operate,has strong specificity,good stability and repeatability,and can be used as a quality control standard for Kuhuang Xiaozhi Lotion.

关 键 词：苦黄消痣洗剂 TLC HPLC 质量控制 

分 类 号：TQ461[化学工程—制药化工]