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中药艾可清胶囊的质量标准研究(英文)

Study on Quality Standard for Aikeqing Capsules
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摘要 【目的】建立中药复方制剂艾可清胶囊的定性定量分析方法。【方法】采用硅胶薄层色谱对复方制剂中淫羊藿、虎杖、女贞子、黄芩、甘草等药材进行定性鉴别;采用反相高效液相色谱测定制剂中相应的指标成分淫羊藿苷、虎杖苷、黄芩苷、甘草酸的含量。【结果】采用硅胶薄层色谱能检出药材指标成分;高效液相色谱法测定,淫羊藿苷在0.18~1.41μg范围内与峰面积呈良好线性关系,平均回收率为99.02%;虎杖苷在0.40~4.00μg范围内与峰面积呈良好线性关系,平均回收率为100.72%;黄芩苷在0.44~1.54μg范围内与峰面积呈良好线性关系,平均回收率为101.53%;甘草酸在0.40~4.00μg范围内与峰面积呈良好线性关系,平均回收率为99.82%。【结论】所建立的质量分析方法操作简便,重复性好,结果准确,可作为该制剂的质量标准。 Objective To establish the quality standard of Aikeqing Capsules,a compound preparation of Chinese herbal medicine.Methods Silica gel thin-layer chromatography(TLC) was used to identify Herba Epimedii,Rhizoma Polygoni Cuspidati,Fructus Ligustri Lucidi,Radix Scutellariae,and Radix Glycyrrhizae.We assayed the content of marker compounds of icariin,polydatin,baicalin,and glycyrrhizic acid in the capsules with reverse phase high performance liquid chromatography(RP-HPLC).Results Marker compounds in medicinal material of Aikeqing Capsules were identified by the silica gel TLC.The results of HPLC showed that calibration curve was linear in the ranges of 0.18~1.41 μg for icariin,0.40~4.00 μg for polydatin,0.44~1.54 μg for baicalin,and 0.40~4.00 μg for glycyrrhizic acid,and the average recoveries were 99.02%,100.72%,101.53%,and 99.82%,respectively.Conclusion The established methods are reliable,reproducible and feasible for the quality control of Aikeqing Capsules
出处 《广州中医药大学学报》 CAS 2011年第3期277-283,共7页 Journal of Guangzhou University of Traditional Chinese Medicine
基金 Supported by China National Major Projects of Science & Technology(Grant No.2009ZX09103-414) International Science & Technology Cooperation Program of China(Grant No.2008DFA32320) Guangdong Provincial Projects of Science & Technology(Grant No.2007A050100008)
关键词 艾可清胶囊/分析 色谱法 薄层 色谱法 高效液相 质量控制 AIKEQING CAPSULES/analysis; CHROMATOGRAPHY,THIN LAYER; CHROMATOGRAPHY,HIGH PRESSURE LIQUID; QUALITY CONTROL
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