藤菔降压片质量控制研究  

Studies on Quality Control of Tengfu Antihypertensive Tablets

作　　者：徐有伟[1] 黄真[1] 周洪雷[1] 李运伦[2] 蒋海强[1] 齐冬梅[1] 刘震 

机构地区：[1]山东中医药大学药学院,山东济南250355 [2]山东中医药大学附属医院,山东济南250011 [3]济宁任城区中医院,山东济宁272100

出　　处：《中药新药与临床药理》2015年第5期690-694,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：山东省科技发展计划项目(2008GG2NS02011);国家科技重大专项-"重大新药创制"-"山东省重大新药创制中心建设"(2009ZX09301-013);山东省自然科学基金项目(ZR2010HM017);山东省教育厅科技计划项目(J105LL05);山东省科技计划项目(2013GSF11903)

摘　　要：目的 建立藤菔降压片的质量控制方法。方法 采用薄层色谱法（TLC）对藤菔降压片中芥子碱硫氰酸盐、钩藤碱进行定性鉴别;采用高效液相色谱法（HPLC）测定芥子碱硫氰酸盐和钩藤碱的含量。结果 TCL专属性强,简单可行。HPLC法测定芥子碱硫氰酸盐在41.2∽412μg·m L-1范围内线性关系良好（r=0.9998）,平均加样回收率为100.78%（RSD=3.98%,n=6）;钩藤碱在9.54∽159μg·m L-1范围内线性关系良好（r=0.9999）,平均加样回收率为101.50%（RSD=2.06%,n=6）。限定本品每片含芥子碱硫氰酸盐（C6H24NO5·SCN）含量限量在6.001∽7.335 mg之间。限定本品每片含钩藤碱（C22H28N2O4）含量限量在1.182∽1.444 mg之间。结论 建立的定性、定量方法简单,重复性好,结果准确可靠,可作为藤菔降压片的质量控制方法。Objective To establish a quality control method for Tengfu Antihypertensive Tablets. Methods Sinapine thiocyanate and rhynchophylline in Tengfu Antihypertensive Tablets were identified by thin layer chromatography （TLC）. The contents of sinapine thioeyanate and rhynchophylline were determined by reverse phase high performance liquid chromatography （RP-HPLC）. Results TLC identification method was simple and feasible with high specificity. Sinapine thiocyanate was linear in the range of 41.2-412μg·mL-1（r=0.9998）, the average recovery was 100.78 % and RSD was 3.98 %（n=6）. Rhynchophylline was linear in the range of 9.54 - 159μg·mL-1 （r=0.9999）, and the average recovery was 101.50 % and RSD was 2.06 %（n=6）. The content of sinapine thioeyanate was between 6.001 -7.335 mg per tablet, and that of rhynchophylline was between 1.182 - 1.444 mg per tablet. Conclusion The established qualitative and quantitative methods are simple, reproducible, accurate and reliable, and can be used as the quality control method for Tengfu Andhypertensive Tablets.

关 键 词：藤菔降压片 芥子碱硫氰酸盐 钩藤碱 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]