椎痛安胶囊质量标准的研究  

Quality Standard for New Drug Zhuitong'an Capsules

作　　者：汪艳[1] 陈晓燕[1] 熊富良[1] 陶君彦[1] 张双硕[1] 毛培[1] 

机构地区：[1]武汉理工大学化学工程学院湖北中药制剂工程研究中心,武汉430070

出　　处：《医药导报》2009年第1期100-102,共3页Herald of Medicine

基　　金：湖北省科技攻关重点项目(基金编号:2006AA301B08)

摘　　要：目的建立椎痛安胶囊的质量标准。方法采用薄层色谱(TLC)法对处方中的乳香、狗脊、葛根进行定性鉴别;采用高效液相色谱(HPLC)法测定椎痛安胶囊中芍药苷的含量,以十八烷基硅烷键合硅胶为填充剂(4.6mm×150mm,5μm);以乙腈-0.1%磷酸水溶液(15:85)为流动相;柱温:25℃;流速为1.0mL.min-1;进样量:10μL。结果TLC色谱中斑点清晰,易于识别;HPLC法精密度、重现性良好。芍药苷在14.15～113.20μg.mL-1范围内有较好的线性关系(r=0.9997,n=5),平均回收率为98.21%(RSD=1.06%,n=9)。结论所建立的方法简便可靠,重复性好,可用于椎痛安胶囊的质量控制。Objective To establish the quality standard for zhuitong＇an capsules. Methods Boswellia carterii Birdw, Cibotium barometz （ L. ） J. Sm. and Pueraria lobata （ Willd. ） Ohwi were identified by TLC. The contents of peoniflorin in the capsules were determined by HPLC. Results The TLC spots were quite clear and easy to be identified. The HPLC method was very precise and reproducible, and the contents of peoniflorin showed a good linear relationship at the range of 14.15- 113.2μg·mL^-1（r=0.9997, n=5）. Theaverage reeoverywas98.38%（RSD=1.30%, n=9）. Conclusion The method is simple, feasible, and reproducible, which could be applied to the quality control of zhuitong＇an capsules.

关 键 词：椎痛安胶囊 芍药苷 色谱法 薄层 色谱法 高效液相 

分 类 号：R286[医药卫生—中药学] R927.2[医药卫生—中医学]