七宝美髯浓缩丸的质量标准研究  

Quality Standard of QiBao MeiRan Concentration Pills

作　　者：赵嘉将[1] 刘静 张静 卿玉玲[1] ZHAO Jia-jiang;LIU Jing;ZHANG Jing;QING Yu-ling(TaijiGroup Co.,Ltd.,Chongqing 401147,China;Southwest Pharmaceutical Co.,Ltd.,Chongqing 400038,China;Chongqing Medic&Health Produ I/E Co.,Ltd.,Chongqing 400020,China)

机构地区：[1]太极集团有限公司,重庆401147 [2]西南药业股份有限公司,重庆400038 [3]重庆市医药保健品进出口有限公司,重庆401120

出　　处：《海峡药学》2020年第3期83-87,共5页Strait Pharmaceutical Journal

摘　　要：目的建立七宝美髯浓缩丸的质量标准。方法采用薄层色谱(TLC)法对七宝美髯浓缩丸中的制何首乌、枸杞子、牛膝、补骨脂进行定性鉴别;采用高效液相色谱法测定制剂中二苯乙烯苷的含量:色谱柱为C 18色谱柱(4.6×250mm,5μm);流动相:乙腈-水(18∶82);检测波长:320nm;柱温为25℃;流速1mL·min^-1。结果制何首乌、枸杞子、牛膝、补骨脂的TLC斑点清晰、分离度好,且阴性对照无干扰。二苯乙烯苷的质量浓度在0.0382~0.873μg·mL^-1范围内呈良好的线性关系(r=0.9998);精密度、稳定性、重复性试验的RSD<2%;样品平均回收率为96.01%,RSD为0.41%(n=6)。结论所建标准可用于七宝美髯浓缩丸的质量控制。OBJECTIVE To establish the quality standard of QiBao MeiRan Concentration Pills.METHODS TLC was used to identify Fleece-flower Root,Medlar,Radix Achyranthis Bidentatae Salvia and Malaytea Scurfpea Fruit in QiBao MeiRan Concentration Pills qualitatively;the content of Stilbene glycosided was determined by HPLC.The separation was performed on C 18 chromatographic column(4.6×250mm,5μm);mobile phase:acetonitrile-water(18∶82);flow rate of 1mL·min^-1,detection wavelength was 320nm,the column temperature was 25℃.RESULTS TLC spots of them were clear and well-separated without interference from negative control.The linear range of Stilbene glycosided were 0.0382-0.873μg·mL^-1(r=0.9998);RSDs of preci-sion,stability and reproducibility tests were lower than 2%;average recovery was 96.01%(RSD=0.41%,n=6).CONCLUSION The standard can be used for quality control of Qibao Meiran Concentration Pills.

关 键 词：七宝美髯浓缩丸 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R927[医药卫生—药学]