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机构地区:[1]天津市滨海新区大港中医医院,天津300000 [2]天津中医药大学,天津300193 [3]天津药物研究院,天津300193
出 处:《中南药学》2016年第9期983-986,共4页Central South Pharmacy
摘 要:目的建立HPLC-DAD法同时测定肾衰宁胶囊中9种成分(太子参环肽B、盐酸小檗碱、橙皮苷、大黄素、大黄酚、丹参酮ⅡA、β-蜕皮甾酮、羟基红花黄色素A、甘草苷)的含量。方法采用Venusil ASB C18色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈(50∶50,A)-0.1%甲酸水溶液(B),梯度洗脱,洗脱程序如下:0~15 min(10%B),15~45 min(10%~50%B),45~60 min(50%~60%B),60~85 min(60%~80%B),85~100 min(10%B);流速为0.9 m L·min-1,柱温35℃。结果 85 min内9个成分分离度良好,在各自的检测范围内浓度与峰面积呈良好的线性关系,r均〉0.9980,加样回收率为98.4%~102.2%,RSD均〈1.5%。结论该法简便可行,结果可靠,可为本制剂多指标成分的质量控制提供参考。Objective To establish an HPLC-DAD to simultaneously determine 9 components (heterophyllin B, berberine, hesperidin, emodin, chrysophanol, tanshinone Ⅱ A, fl-ecdysone, hydroxysafflor yellow A, and liquiri- tin) in Shenshuaining capsules. Methods Samples were performed on an Venusil ASB Cls analytical column (250 mm × 4.6 mm, 5 μm) with a gradient elution of 0.1% formic acid (B) and methanol-acetonitrile (50:50) (A) at a flow rate of 0.9 mL · min - 1. The elution profile was: 0 - 15 min (10%B), 15- 45 rain (10% - 50%B), 45 - 60 min (50% - 60%B), 60 - 85 min (60% - 80%B), and 85 - 100 min (10%B). The column tempera- ture was 35 ℃. Results The 9 components were well separated with good linearity between the concentration of each component and peak area within 85 rain. The value of r was higher than 0.9980 for all analytes. The recov- eries were 98.4% - 102.2%, and the RSDs were less than 1.5%. Conclusion The method is simple and reliable and can provide reference for the quality control of multi-index components in Shenshuaining capsules.
关 键 词:高效液相色谱-二极管阵列法 肾衰宁胶囊 含量测定 太子参环肽B 盐酸小檗碱 橙皮苷 大黄素 大黄酚 丹参酮ⅡA β-蜕皮甾酮 羟基红花黄色素A 甘草苷
分 类 号:R917[医药卫生—药物分析学]
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