竹黄止呕胶囊质量标准研究.docVIP

竹黄止呕胶囊质量标准研究 目录 TOC \o 1-9 \h \z \u 目录 1 正文 1 文1：竹黄止呕胶囊质量标准研究 1 1 仪器与试药 2 2 方法与结果 3 3 讨论 7 文2：血安片质量标准研究 7 1 实验资料 8 2 性状 9 3 薄层定性鉴别 9 4 检查 10 5 含量测定 12 6 讨论 19 参考文摘引言： 19 原创性声明（模板） 20 文章致谢（模板） 21 正文 竹黄止呕胶囊质量标准研究 文1：竹黄止呕胶囊质量标准研究 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 coisted of acetonitrile∶ mol·L-1potassium dihydrogen phosphate (30∶70)，the UV detection wavelength was at 345 nm，the flow rate was 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 coisted of menthol∶% acetic acid in water (35∶65)，the UV detection wavelength was at 283 nm ，the flow rate was 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 41 ～ 1 mg·ml-1，and the average recovery was % (D=%). The quantitative evaluation of hesperidin was linear within the range of 25～ 5 mg·ml-1，and the average recovery was % (D= %). 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 仪器高效液相色谱仪（岛津LC10A）；硅胶G（薄层色谱用，青岛海洋化工厂） 药品和试剂 竹黄止呕胶囊（自制，批号071101，071102，071103）；盐酸小檗碱对照品（ 中国 药品生物制品检定所，批号0713-9906）；橙皮苷对照品（中国药品生物制品检定所，批号0721-200208） 2 方法与结果 太子参的TLC鉴别［1］取本品内容物 g用30 ml甲醇超声提取45 min，过滤，滤液挥干, 残渣加甲醇1 ml使溶解，作为供试品。另取太子参对照药材和缺太子参的阴性对照品各 g，同样品处理方法作为对照药材溶液和阴性对照溶液。照薄层色谱方法，分别取上述溶液