论文部分内容阅读
目的 :研究新的中药复方制剂心康平的质控指标。方法 :采用细胞膜色谱法对三七、丹参和当归进行有效成分的筛选 ,在此基础上对原料药中三七的 4种有效成分三七皂苷R1、人参皂苷Rg1、Re和Rb1进行薄层色谱鉴别 ,薄层展开条件为氯仿 -醋酸乙酯 -甲醇 -水 (15∶40∶2 2∶10 ) ;对丹参和当归中的丹参酮ⅡA 和藁本内酯用HPLC法同时进行了含量测定 ,色谱条件为KromasilODS柱 (15 0mm× 4 6mm ) ,甲醇 -水 (80∶2 0 )为流动相 ,流速 1mL·min-1,2 5 4nm下检测结果 :TLC鉴别方法专属性强。HPLC法测定丹参酮ⅡA 和藁本内酯的回收率分别为 98 9%和 10 0 9% ,RSD分别为 3 0 %和 2 5 %。结论 :本文方法可全面有效地控制心康平原料药及其制剂的质量
Objective : To study the quality control criteria of Xin Kang compound preparation. METHODS: Cell membrane chromatography was used to screen the active constituents of Panax notoginseng, Radix Salviae Miltiorrhizae and Angelica sinensis. Thin-layer chromatograms of Panax notoginseng saponins R1, Ginsenoside Rg1, Re, and Rb1 in the active ingredients of Panax Notoginseng were performed on this basis. Identification, thin layer unfolding conditions were chloroform-ethyl acetate-methanol-water (15:40:2 2:10); simultaneous determination of tanshinone IIA and ligustilide in Radix Salviae Miltiorrhizae and Angelica Sinensis was carried out by HPLC. The conditions were Kromasil ODS column (15 mm × 46 mm), methanol-water (80:20) as mobile phase, flow rate of 1 mL·min-1, and 254 nm. Results: TLC identification method was highly specific. The recoveries of tanshinone IIA and ligustilide by HPLC were 98 9% and 100%, respectively, with RSDs of 30% and 25%, respectively. Conclusion: This method can effectively and comprehensively control the quality of Xin Kangping API and its preparations.