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Study on the quality standard of Zhideke Granules |
HUANG Min1 HUANG Guodong2 WEI Yulong3 XIE Guangyuan3 LU Danping4 WU Bianmei4 |
1.Pharmacy Department, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Guangxi Zhuang Autonomous Region, Nanning 530023, China; 2.Department of Lung-Kidney of Zhuang Medicine, Guangxi International Zhuang Medical Hospital, Guangxi Zhuang Autonomous Region, Nanning 530001, China; 3.Center of Pharmaceutical Research and Development, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Guangxi Zhuang Autonomous Region, Nanning 530011, China;
4.Department of Quality Research, Guangxi Huike Pharmaceutical Research and Development Co., Ltd, Guangxi Zhuang Autonomous Region, Nanning 530007, China |
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Abstract Objective To establish a study method for the quality standard of Zhideke Granules. Methods Thin layer chromatography (TLC) was used for the qualitative identification of Cynanchum glaucescens and Belamcanda chinensis. High performance liquid chromatography (HPLC) was used to determine baicalin and irisflorentin by C18 chromatographic column, the mobile phase was methanol-0.2% phosphoric acid solution (49∶51), the flow rate was 1 mL/min, the detection wavelength was set at 266 nm. Results The TLC spots were clear and free from negative interference. In HPLC quantitative determination, baicalin and irisflorentin showed good linear relationships within the ranges of 947.1-7577.2 ng (r = 0.9998) and 18.032-180.32 ng (r = 0.9999), whose average recovery were 100.6% (RSD = 0.4%) and 93.1% (RSD = 0.6%), respectively. Conclusion The method is simple, feasible, sensitive and accurate, which can be used as the quality control method of Zhideke Granules.
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