参麦地黄丸质量标准提高研究  

Study on quality standard improving of Shenmai Dihuang Pills

作　　者：刘思飞[1] 徐翠玲[1] 崔钰琪 仇莹[1] 荚丽丽 魏岚[1] 孙立新[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳药科大学中药学院,辽宁沈阳110016

出　　处：《中草药》2017年第2期299-304,共6页Chinese Traditional and Herbal Drugs

基　　金：辽宁省教育厅创新团队项目(LT2012018);辽宁特聘教授项目(2014)

摘　　要：目的通过对参麦地黄丸(SDP)进行薄层鉴别、定量测定等研究,建立了合理可行的质量控制方法与标准。方法参照《中国药典》2015年版四部通则相关方法,建立鉴别SDP中牡丹皮、山茱萸(蒸)、泽泻、北沙参4味药材的TLC法;建立同时测定SDP中指标性成分补骨脂素、异补骨脂素和丹皮酚的HPLC法。采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);以0.1%甲酸水溶液-乙腈为流动相,梯度洗脱;体积流量1.0 m L/min;检测波长254 nm;柱温30℃。结果 TLC鉴别方法专属性强,能够有效鉴别4味药材;定量测定方法学研究结果表明,补骨脂素、异补骨脂素和丹皮酚质量浓度分别在6.531~58.780、6.115~55.040、20.40~183.60μg/m L与峰面积呈良好的线性关系,回归方程分别为Y=1.523×10~4 X-1.209×10~4,r=0.999 9;Y=1.809×10~4 X-1.523×10~4,r=0.999 9;Y=2.760×10~4 X-1.683×10~4,r=0.999 9;平均回收率分别为100.4%(RSD为1.1%)、101.5%(RSD为1.3%)、101.5%(RSD为0.79%)。5批SDP样品定量测定结果表明,该样品中补骨脂素为322.1~331.0μg/g,异补骨脂素为298.0~350.1μg/g,丹皮酚为929.5~982.7μg/g。结论建立的质量控制方法专属性强、重复性好、简便准确,为SDP的质量标准的提高提供依据。Objective To develop the quality standard for Shenmai Dihuang Pills（SDP）. Methods The TLC methods applied to identify Moutan Cortex, Corni Fructus, Alismatis Rhizoma, and Glehniae Radix in the formulation were carried out according to the methods recorded in general rules of Chinese Pharmacopeia（2015 edition, volume 4）. The contents of psoralen, iso psoralen, and paeonol were analyzed by high performance liquid chromatography on a Diamonsil C18 column（250 mm × 4.6 mm, 5 μm） with the mobile phase of acetonitrile（A）-0.1% formic acid（B） by gradient elution at a flow rate of 1.0 m L/min. The detection wavelength was set at 254 nm and the column temperature was controlled at 30 ℃. Results There were good specificities of TLC for Moutan Cortex, Corni Fructu, Alismatis Rhizoma, and Glehniae Radix. The methodology validation for the assay of psoralen, iso psoralen, and paeonol presented that they were in good linear correlation in the ranges of 6.531—58.78, 6.115—55.04 and 20.40—183.6 μg/m L, with the regression equations of Y = 1.523 × 10^4 X-1.209 × 10^4（r = 0.999 9）, Y = 1.809 × 10^4 X-1.523 × 10^4（r = 0.999 9）, and Y = 2.760 × 10^4 X-1.683 × 10^4（r = 0.999 9）, respectively. The average recoveries were 100.4%（RSD 1.1%）, 101.5%（1.3%）, and 101.5%（0.79%）. The content ranges of psoralen, isopsoralen, and paeonol from five different batches of SDP were 322.1—331.0, 298.0—350.1, and 929.5—982.7 μg/g, respectively. Conclusion The established quality of TLC and HPLC methods are specific, reliable, accurate, and suitable, which can be successfully applied to the quality control for the preparation.

关 键 词：参麦地黄丸 质量标准 薄层色谱 HPLC 牡丹皮 山茱萸 泽泻 北沙参 补骨脂素 异补骨脂素 丹皮酚 

分 类 号：R286.02[医药卫生—中药学]