黄葵胶囊指纹图谱的建立及其在质量控制中的应用  

HPLC Fingerprint of Huangkui Capsules and Its Application in Quality Control

作　　者：刘霖[1] 唐仁茂[2] 刘汉清[1] 王进[1] 张平[2] 唐海涛[2] 

机构地区：[1]南京中医药大学,南京210046 [2]江苏苏中药业集团股份有限公司,江苏姜堰225500

出　　处：《中国药学杂志》2013年第8期593-597,共5页Chinese Pharmaceutical Journal

摘　　要：目的建立黄葵胶囊的HPLC指纹图谱,为本产品及其生产工艺过程质量控制提供有效方法与依据。方法采用高效液相色谱法。色谱条件:Thermo scientific Hypersil GOLD(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.2%磷酸水溶液为流动相进行梯度洗脱,流速0.8 mL.min-1,波长360 nm,柱温30℃。对原料、半成品、成品分别进行指纹图谱测定,并比较分析三者的相似度及相关性。结果 10批黄葵胶囊与其共有模式之间相似性良好,相似度均在0.95以上。黄葵胶囊原料、半成品、成品指纹图谱相关性较好。结论所建立的HPLC指纹图谱方法有较好的重现性,可有效地用于黄葵胶囊生产过程的质量控制和产品的质量评价。OBJECTIVE To establish the HPLC fingerprint of traditional Chinese medicine Huangkui Capsules, thus to provide an approach and a basis for the quality control in production. METHODS The analytical column was Thermo scientific Hypersil GOLD. The mobile phase was composed of acetonitrile （A） and 0. 2% phosphoric acid （B） with gradient elution. The flow rate was 0. 8 mL .main^ - 1 , and the detection wavelength was set at 360 nm with the column temperature maintained at 30 ℃. The fingerprints of the extracts from the raw materials, intermediate product, and Huangkui Capsules were compared. RESULTS The similarities of the chromatograms of 10 different lots of Huangkui Capsules were over 0. 95. The correlation was good between the raw materials, intermediate product and Huangkui capsules. CONCLUSION This validated method is suitable for the quality evaluation and quality control of Huangkui Capsules.

关 键 词：黄葵胶囊 指纹图谱 质量控制 

分 类 号：R284[医药卫生—中药学]