复方黑参丸的质量标准研究  

Study on Quality Standard for Compound Heishen Pills

作　　者：张晋[1] 马宏达[1] 高军[1] 胡北[1] 史国兵[1] 

机构地区：[1]沈阳军区总医院药剂科,沈阳110840

出　　处：《中国药师》2014年第5期716-718,共3页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项重点课题(编号:13ZJZ02)

摘　　要：建立复方黑参丸的质量控制标准。方法：采用薄层色谱法对复方黑参丸中的玄参、山豆根、射干分别进行定性鉴别，采用高效液相色谱法同时测定哈巴俄苷及肉桂酸的含量。采用Welchrom C18色谱柱，流动相为甲醇-乙腈-1％冰醋酸溶液（8：21：71），柱温30℃，流速为1.0ml·min^-1，检测波长为278nm。结果：玄参、山豆根、射干的薄层色谱鉴别具有较好的专属性，阴性对照无干扰。哈巴俄苷与肉桂酸分别在1．32—65．80μg·ml“和0.38～19．20μg·ml^-1“浓度范围内与峰面积线性关系良好；精密度、稳定性、重复性试验的RSD均小于2％；平均加样回收率分别为98．06％、98.78％，RSD为2．16％、1.34％（n=6）。结论：所建立的定性和定量分析方法结果准确、可靠、重复性好，可用于复方黑参丸的质量控制。To establish the quality standard for compound Heishen pills. Methods： Scrophulariae Radix, Radix et Rhizoma and Belamcancae Rhizoma were identified by TLC. HPLC was used to determine the content of harpagoside and cinnamic acid in Scrophtdariae Radix on a Welchrom-C18 column using methanol -acetonitrile- 1% ethy.lic acid （8： 21：71 ） as the mobile phase. The flow rate was 1.0 ml·min^-l. The column temperature was at 30℃ and the detection wavelength was set at 278 nm. Results： The TLC method had good specificity without interference from negative control. The hnear range of harpagoside was 1.32-65.80 μg ·ml- i with the average recovery of 98.06% （RSD = 2.16% ）, and that of cinnamic acid was 0.38-19.20 μg·ml-1 with the average recovery of 98.78% （RSD = 1.34% ）. RSDs of precision, stability and reproductibility tests were all below 2%. Conclusion： The established method is accurate, feasible and reproducible. It can be used in the quality control of compound Heishen pills.

关 键 词：复方黑参丸 质量标准 哈巴俄苷 肉桂酸 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]