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Study on the improvement of quality standard of Xinwuyou Tablets |
LUO Lei1 SHAO Xiying2 |
1.Department of Traditional Chinese Medicine, Zhejiang Institute for Food and Drug Control, Zhejiang Province, Hangzhou 310052, China;
2.Department of Medical Oncology, Zhejiang Cancer Hospital, Zhejiang Province, Hangzhou 310022, China |
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Abstract Objective To eastablish and improve the quality standard of Xinwuyou Tablets. Methods Thin-layer chromatography was used to identify Asari Radix et Rhizoma, Artemisiae Scopariae Herba and Salviae Miltiorrhizae Radix et Rhizoma, and high performance liquid chromatography was applied for the determination of salvianolic acid B in Xinwuyou Tablets. Kromasil C18 column (4.6 mm×250 mm, 5 μm) was adopted with a mobile phase of acetonitrile-0.1% phosphoric acid (25∶75) at the flow rate of 1.0 mL/min. The detection wavelength wad set at 286 nm and the column tempetature was 30℃. Results The thin-layer chromatography identification was highly specific. The method of content determination was simple and accurate. The good linearity with peak areas was achieved in the range of 0.0735-3.6750 μg (r = 1.0000) for salvianolic acid B. The average recovery was 101.20% and the RSD was 1.05%. Conclusion The method is simple, accurate and reproducible, and can be used for the quality control of Xinwuyou Tablets.
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