左归浓缩丸质量标准的研究  

Quality Standard for Zuogui Concentrated Pills

作　　者：李玲[1] 杨骏[1,2] 王冰[1] 张彤[1] 徐本亮[1] 袁秀荣[1] 

机构地区：[1]上海中医药大学,上海201203 [2]上海市卢湾区香山中医医院,上海200020

出　　处：《中华中医药学刊》2016年第4期791-794,I0002,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：国家教育部新世纪优秀人才支持计划项目(NCET-10-0944);上海市教委知识服务平台项目

摘　　要：目的：建立左归浓缩丸（熟地黄、菟丝子、牛膝、枸杞子等）的质量标准。方法：采用TLC法对左归浓缩丸中枸杞子、牛膝、山茱萸、菟丝子进行定性鉴别,并用HPLC法测定左归浓缩丸中的毛蕊花糖苷、马钱苷、金丝桃苷。结果：TLC能定性检出枸杞子、牛膝、山茱萸、菟丝子,斑点清晰,分离度好,且阴性对照无干扰;毛蕊花糖苷、马钱苷和金丝桃苷分别在2.955-17.73μg（r=0.999 8）、4.697-150.3μg（r=1）、3.492-27.94μg（r=0.999 3）范围内与峰面积均呈现良好的线性关系,平均回收率分别为97.8%、100.8%和102.7%,RSD（n=9）分别为2.4%、2.6%和2.2%。结论：所建立的定性、定量检测方法操作简便,专属性强、重复性好、结果准确可靠,可作为左归浓缩丸的质量控制方法。Objective： To establish the quality standard for Zuogui Concentrated Pill（ Rehmanniae Radix Praeparata,Cuscutae Semen,Achyranthis Bidentatae,Lycii Fructus,etc.）.Methods： TLC method was used for qualitative identification of Lycii Fructus,Achyranthis Bidentatae,Corni Fructus,Cuscutae Semen.HPLC method was used to simultaneously determine the contents of acteoside,loganin and hyperoside in the pills.Results： The TLC method can qualitatively identify the Lycii Fructus,Achyranthis Bidentatae,Corni Fructus,Cuscutae Semen.The spots were clear with good separation and without interference in the negative reference.The acteoside,loganin and hyperoside showed a good linearity in the measurement range of 2.955 - 17.73 μg（ r = 0.999 8）,4.697 - 150.3 μg（ r = 1）,3.492 - 27.94 μg（ r = 0.999 3）.The average recoveries were 97.8%,100.8% and 102.7% with the RSD values（ n = 9） were 2.4%,2.6% and 2.2%,respectively.Conclusion： The established qualitative and quantitative detection method is simple,specific,reproducible,accurate and reliable and can be used for quality control of Zuogui Pill.

关 键 词：左归浓缩丸 毛蕊花糖苷 马钱苷 金丝桃苷 TLC HPLC 

分 类 号：R284.1[医药卫生—中药学]