肺泰胶囊质量标准研究  

Quality Control of Feitai Capsules

作　　者：王玉鹏[1] 刘志宏[2] 宋洪涛[2] 

机构地区：[1]武警安徽省总队医院药剂科,安徽合肥230041 [2]南京军区福州总医院药学科,福建福州350025

出　　处：《解放军药学学报》2015年第4期313-316,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立肺泰胶囊的质量控制方法。方法采用TLC法对处方中黄芪、肿节风、土鳖虫、仙鹤草定性鉴别;采用HPLC法测定肺泰胶囊中异嗪皮啶的含量。色谱柱：依利特Hypersil ODS柱（4.6 mm×200 mm,5μm）;流动相：乙腈-0.1%磷酸,梯度洗脱;检测波长：342 nm;流速：1.0 ml·min-1;柱温：30℃。结果 TLC斑点清晰,阴性样品无干扰;异嗪皮啶含量在2.07～41.40μg·ml-1范围内具有良好的线性关系。回归方程为Y=61.9617 X-4.8349,r=0.9999（n=6）。平均加样回收率为98.77%,RSD为1.37%（n=9）。结论该方法简便、准确,专属性强,重复性好,阴性无干扰,可用于肺泰胶囊的质量控制。Objective To establish a qualitative method of identification for Feitai capsules. Methods As- tragalus, Sarcandra glabra, Agrimonia pilosa, Eupolyphaga were identified by TLC in Feitai capsules. The content of isofraxidin was determined by HPLC. The chromatographic column was Hypersil ODS （4.6 mm× 200 mm,5 μm）. The mobile phase was aeetonetrile-0.1% phosphoric acid with gradient elution . The column temperature was set at 30 ℃. The flow rate was 1.0 ml·min-1 and the UV detection wavelength was 342 nm. Results The quality identifi- cation by TLC was specific, efficient and separated with a clear spot in the thin layer plate. The calibration curve for isofraxidin was linear within the range of 2.07 -41.40 μg·m1-1. The regression equation was 98.77% with an RSD of 1.37% （ n = 9）. Conclusion This method is quick, simple, accurate, and can be used for quality control of Feitai capsules.

关 键 词：肺泰胶囊 质量标准 TLC HPLC 

分 类 号：R927.2[医药卫生—药学]