通脑溶栓胶囊的质量标准研究  

Study on Quality Standard of Tongnao Rongshuan Capsule

作　　者：窦建卫[1] 袁倩倩[1] 宋海林[1] 陈茹茹[2] 朱少英[1] 杨学礼 

机构地区：[1]西安交通大学医学部药学院,陕西西安710061 [2]陕西中医学院,陕西西安712046 [3]西安洲良明康生物医药科技有限公司,陕西西安710075

出　　处：《中药新药与临床药理》2014年第1期61-64,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家自然科学基金(30300444);科技部中小企业技术创新基金(12C26216106788)

摘　　要：目的建立通脑溶栓胶囊的质量控制方法。方法采用薄层色谱法对制剂中的粉葛、黄芪、鸡血藤和赤芍进行定性鉴别；采用高效液相色谱法对制剂中的粉葛所合成分葛根素进行含量测定。色谱柱：C18色谱柱（4．6mm×150mm．5μm）；流动相：甲醇-水（25：75）；检测波长：250nm。结果在薄层色谱中均能检出粉葛、黄芪、鸡血藤和赤芍；葛根素进样量在0．06784～0．40704Ixg范围内与峰面积呈良好的线性关系，r=0．9998，平均回收率为98．9％（n=6），RSD为1．1％。结论本研究所建立的方法简便，准确，重复性好，可用于通脑溶栓胶囊的质量控制。Objective To establish a quality standard for Tongnao Rongshuan Capsule. Methods Radix Puerariae, Radix Astragali, Caulis Spatholobi and Radix Paeoniae were identified by thin layer chromatography（TLC ）. Puerarin was determined by high performance liquid chromatography （HPLC）. The HPLC system consisted of chromatographic column C18 （4.6 mm×150 mm, 5μm） with methanol - water（25 ： 75） as the mobile phase, and the detective wave length was set at 250nm. Results Radix Puerariae, Radix Astragali, Caulis Spatholobi and Radix Paeoniae can be detectable by TLC. The linearity range of puerarin was 0.06784-0.40704 μg（r=0.9998）, the average recovery was 98.9 %, and RSD was 1.1% （n=6）. Conclusion The established method is simple, accurate and with good reproducibility, and can be used for the quality control of Tongnao Rongshuan Capsule.

关 键 词：通脑溶栓胶囊 质量标准 薄层鉴别 高效液相色谱法 葛根素 

分 类 号：R284.1[医药卫生—中药学]