脉络通胶囊质量标准  

Standard of Quality Control of Mailuotong Jiaonang

作　　者：谭琴[1] 沈婷[1] 金芳[2] 郭青[3] 姚仲青[1] 

机构地区：[1]扬子江药业集团有限公司,江苏泰州225321 [2]国家食品药品监督管理局药品审评中心,北京100038 [3]江苏省食品药品检验所,南京210008

出　　处：《中国实验方剂学杂志》2014年第19期93-96,共4页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的：提高脉络通胶囊的质量标准.方法：采用TLC法鉴别制剂中丹参、山楂、川芎、地龙,采用HPLC同时测定葛根素、芦丁、丹酚酸B含量.色谱条件为：Kromasil 100-5C18色谱柱（4.6 mm×250 mm,5μm）,柱温35℃,以甲醇（A）-1％冰醋酸溶液梯度洗脱（0～45 min,25％～45％A,45 ～ 55 min,45％ ～ 25％ A）,流速1.0 mL·min-1,检测波长254 nm.结果：TLC可鉴别丹参、山楂、川芎、地龙.葛根素的进样量在0.130 6 ～ 1.959 6μg呈现良好的线性,r=0.999 9;平均加样回收率97.77％,RSD 0.70％;芦丁的进样量在1.054 2～15.813 6μg呈现良好的线性,r=0.999 9;平均加样回收率98.66％,RSD0.89％;丹酚酸B的进样量在0.184 9～2.773 2μg呈现良好的线性,r=0.999 5;平均加样回收率99.55％,RSD 1.15％.结论：该法专属性强,重复性好,结果准确,可用于控制脉络通胶囊质量.Objective： To improve the standard of quality control of Mailuotong Jiaonang. Method： TLC identify Salviae miltiorrhizae radix et rhizoma, Crataegi fructus, Chuanxiong rhizome, Pheretima. The Kromasil 100-5C18 （4. 6 mm × 250 mm, 5 μm） was column adopted with the temperature at 35 ℃ , mobile phase A was methanol, mobile phase B was 1% glacial acetic acid solution （0-45 min, 25%-45% A; 45-55 min, 45%-25% A） the flow rate at 1.0 mL · min ^- 1, the detection wavelength was 254 nm. Result： The calibration curve of puerarin was linear in the range of 0. 130 6-1. 959 6 μg with the correlation of 0. 999 9 （n = 9）. The average recovery of puerarin was 97.77% , RSD 0. 70% （n =6）. The calibration curve of rutin was linear in the range of 1. 054 2-15. 813 6 p6g with the correlation of 0. 999 9 （n =9）. The average recovery of rutin was 98.66% , RSD 0. 89% （n =6）. The calibration curve of salvia acid B was linear in the range of 0. 184 9-2. 773 2 μg with the correlation of 0. 999 5 （ n = 9）. The average recovery of salvia acid B was 99.55%, RSD 1.15% （n = 6）. Conclusion： The method is specific, reliable and accurate, so it can be used for the quality control of Mailuotong Jiaonang.

关 键 词：脉络通胶囊 质量标准 葛根素 芦丁 丹酚酸B 薄层色谱 高效液相色谱 

分 类 号：R284.1[医药卫生—中药学]