通脉胶囊质量标准研究  

Quality Standard of Tongmai Capsules

作　　者：霍花[1] 卫向锋 顾洪双[1] 张红[3] 孙婷婷[3] 杨琳[1] 黄海波[1] 

机构地区：[1]沈阳军区总医院北方医院药剂科,辽宁沈阳110034 [2]西安中医脑病医院,陕西西安710032 [3]陕西省中医药研究院中药研究所,陕西西安710031

出　　处：《解放军药学学报》2015年第4期307-309,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题重点项目;No.14ZJZ09

摘　　要：目的建立通脉胶囊的质量控制方法。方法采用TLC法对通脉胶囊中的桑寄生、延胡索进行定性分析,采用HPLC法测定制剂中丹参酮ⅡA的含量。色谱柱：菲罗门Luna 5μC18（2）100A,流动相：甲醇-水（75∶25,V/V）,流速：1.0ml·min-1,检测波长：270 nm,柱温：35℃,进样量：20μl。结果桑寄生、延胡索的TLC图斑点清晰,分离较好,阴性对照无干扰。丹参酮ⅡA质量浓度在4.012～40.12μg·ml-1范围内与其峰面积积分值呈良好线性关系（r=0.9998）;平均加样回收率为99.74%,RSD为1.84%（n=6）。结论该方法操作简单,灵敏度高,专属性强,重复性好,可作为通脉胶囊的质量控制方法。Objective To establish a quality control method for Tongmai capsules. Methods Parasitic loran- thus and rhizoma corydalis were qualitatively identified by TLC. The content of tanshinone ⅡA was determined by HPLC on Phenomenex Luna 5 μC18 （2） 100A column with a mobile phase that consisted of methanol-water （75： 25, V/V ） at a flow rate of 1.0 ml ·min -1. The column temperature was set at 35 ℃ ,and the sample volume was 20 μl. Results TLC spots of Taxillus chinensis （ DC. ） Danser and Corydalis yanhusuo W. T. Wang were clear and well- separated without interference from negative control. The linear range of tanshinone ⅡA was 4. 012 - 40. 12 μg·ml-1（ r = 0.9998） with an average recovery of 99.74% （RSD = 1.84%, n = 6）. The RSD of precision, stabilityand reproducibility test was lower than 2%. Conclusion This method is simple, sensitive, specific and repro- ducible ,which can be used for quality control of Tongmai capsules.

关 键 词：通脉胶囊 TLC HPLC 丹参酮ⅡA 质量标准 

分 类 号：R927.2[医药卫生—药学]