乳腺增生丸质量标准研究  

Study on the quality of Ruxianzengsheng pills

作　　者：徐英宏[1] 张娴[2] 齐军[1] 杨君[1] 

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004 [2]成都市中西医结合医院西药剂科,成都610000

出　　处：《实用药物与临床》2014年第12期1582-1585,共4页Practical Pharmacy and Clinical Remedies

基　　金：中国医科大学附属盛京医院2011年度基金项目

摘　　要：目的 对乳腺增生丸的质量标准进行研究.方法 采用薄层色谱法同时鉴别乳腺增生丸中鸡血藤、当归、蒲公英3味药材.采用HPLC法三波长同时测定乳腺增生丸中绿原酸、咖啡酸、芍药内酯苷、芍药苷、阿魏酸和丹酚酸B的含量.色谱柱C18（4.6 mm ×250 mm,5μm）;以乙腈-水（含0.1％磷酸）为流动相梯度洗脱,流速1.0 mL/min;检测波长：绿原酸、咖啡酸、阿魏酸为320 nm,芍药苷、芍药内酯苷为230 nm,丹酚酸B为280 nm;柱温35℃;进样量20 μL.结果 薄层色谱斑点清晰,阴性对照无干扰.绿原酸、咖啡酸、芍药内酯苷、芍药苷、阿魏酸、丹酚酸B分别在10.0 ～70.0、20 ～140、55 ～385、42 ～294、10.0 ～ 75.0、250 ～1 750 μg/mL范围内呈良好的线性关系,平均回收率、RSD分别为100.5％、5.9％,100.2％、3.8％,101.2％、1.4％,99.9％、5.1％,100.6％、1.9％,99.8％、3.7％.结论 方法准确可靠、重现性好,能有效控制乳腺增生丸的药品质量,为完善和提高乳腺增生丸质量标准提供了依据.Objective To establish the qualitative control methods for Ruxianzengsheng pills.Methods Caulis spatholobi,radix angelicae sinensis,herba taraxaci of Ruxianzengsheng pills were identified by thin layer chromatography （TLC）at the same conditiona.C18 column （250 mm × 4.6 mm,5 μm）was used with the column temperature at 35 ℃ ; the detection wavelength：chlorogenic acid,caffeic acid,ferulic acid were at 320 nm,paeoniflorin and albi florin were at 230 nm,salvianolic acid B were at 280 nm,respectively; the injection volume was 20 μL at flow rate of 1.0 mL/min and a gradient solution of acetonitrile-H2O （acidified to 0.1％ with phosphoric acid）.Results TLC spots were clear,negative samples without interference.The calibration curves of chlorogenic acid,caffeic acid,albiflorin,paeoniflorin,ferulic acid,salvianolic acid B showed good linearity at the ranges of 10.0 ～70.0 μg/mL,20 ～ 140 μg/mL,55 ～385 μg/mL,42 ～ 294 μg/mL,10.0 ～ 75.0 μg/mL,250 ～ 1 750 μg/mL,and the average recoveries were 100.5％ （RSD =5.9％）,100.2％ （RSD =3.8％）,101.2％ （RSD =1.4％）,99.9％ （RSD =5.1％）,100.6％ （RSD =1.9％）,99.8 ％ （RSD =3.7％）,respectively.Conclusion The method is simple,accurate and reproducible.It is ef fective in controlling the quality of Ruxianzengsheng pills and providing the basis for improving the quality standards of Ruxianzengsheng pills.

关 键 词：乳腺增生丸 鸡血藤 当归 蒲公英 绿原酸 咖啡酸 芍药苷 芍药内酯苷 丹酚酸B TCL HPLC 

分 类 号：R286.0[医药卫生—中药学] O657.7[医药卫生—中医学]