竹黄止呕胶囊质量标准探究.docVIP

竹黄止呕胶囊质量标准探究 　 作者：孙冠芸 宋丹 赵颖 喻强 丁小林 【摘要】 目的建立竹黄止呕胶囊的质量标准。方法采用薄层色谱（TLC）法鉴别处方中太子参；用高效液相色谱（HPLC）法测定黄连中盐酸小檗碱的含量。流动相为乙腈-0.033 mol·L-1磷酸二氢钾溶液（30∶70），流速1.0 ml·min-1，检测波长345 nm，柱温 30℃。用HPLC 法测定陈皮中橙皮苷含量。流动相: 甲醇-0.1%醋酸水溶液（35∶65），流速1.0 ml·min-1，检测波长283 nm，柱温35℃。结果薄层色谱斑点清晰，阴性无干扰。盐酸小檗碱在0.012 41～0.124 1 mg·ml-1浓度范围内峰面积与浓度呈良好的线性关系，平均回收率95.7%（RSD=1.27%）。橙皮苷在浓度0.038 25～0.382 5 mg·ml-1范围内峰面积与浓度呈良好的线性关系，平均回收率的值为96.8%（RSD=1.16 %）。结论该法专属性强，重复性好，可有效控制竹黄止呕胶囊的质量。 【关键词】 竹黄止呕胶囊 薄层色谱 高效液相色谱 质量标准 Abstract：ObjectiveTo establish the quality standard of Zhuhuang Zhiou capsules (Radix Pseudostellariae, Rhizoma Coptidis, Pericarpium Citri Reticulatae). MethodsRadix Pseudostellariae was identified by TLC. Berberine Hydrochloride was determinated by HPLC. The HPLC condition of berberine hydrochloride was as follows：the mobile phase consisted of acetonitrile∶0.033 mol·L-1potassium dihydrogen phosphate (30∶70)，the UV detection wavelength was at 345 nm，the flow rate was 1.0 ml·min-1 and the column temperature was 30℃．Hesperidin was determined by HPLC. The HPLC condition of hesperidin was as follows： The mobile phase consisted of menthol∶0.1% acetic acid in water (35∶65)，the UV detection wavelength was at 283 nm ，the flow rate was 1.0 ml·min-1 and the column temperature was 35℃．ResultsThe characteristic identification by TLC was distinct and highly specific．The quantitative evaluation of berberine hydrochloride was linear within the range of 0.012 41 ～0.124 1 mg·ml-1，and the average recovery was 95.7% (RSD=1.27%). The quantitative evaluation of hesperidin was linear within the range of 0.038 25～0.382 5 mg·ml-1，and the average recovery was 96.8% (RSD= 1.16%). ConclusionThe method is exclusive， reproducible and suitable for the quality control of Zhuhuang Zhiou Capsules． Key words：Zhuhuang Zhiou Capsules； TLC； HPLC； Quality standard 竹黄止呕方在临床上用于治疗癌症病人由放化疗所引起的呕吐。临床上应用效果极佳，缓解了病人的不适，增强了食欲，从而提高自身免疫力。该制剂由陈皮、黄连、竹茹、北沙参等9味组成。为了有效地控制本产品质量，本课题对太子参进行了定性鉴别，测定了陈皮中橙皮苷的含量及黄连中盐酸小檗碱的含量。 1 仪器与试药 1.1 仪器高效液相色谱仪（岛津LC10A）；硅